chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 31st October 2018, the patient received FLUARIX QUADRIVALENT .5 ml. On 8th November 2018, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced Bell's palsy (serious criteria GSK medically significant), enlargement of lymph nodes (serious criteria hospitalization), swallowing difficult (serious criteria hospitalization), facial swelling, temporomandibular joint arthralgia, fever, neck swelling, gum swelling, gingival inflammation, numbness gingival, tingling gum, numbness facial and tingling of extremity. The patient was treated with antibiotics nos. On an unknown date, the outcome of the Bell's palsy, enlargement of lymph nodes, swallowing difficult, fever, numbness facial and tingling of extremity were recovered/resolved and the outcome of the facial swelling, neck swelling, gum swelling and gingival inflammation were recovering/resolving and the outcome of the temporomandibular joint arthralgia, numbness gingival and tingling gum were not recovered/not resolved. It was unknown if the reporter considered the Bell's palsy, enlargement of lymph nodes, swallowing difficult, facial swelling, temporomandibular joint arthralgia, fever, neck swelling, gum swelling, gingival inflammation, numbness gingival, tingling gum, numbness facial and tingling of extremity to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was administered FLUARIX QUADRIVALENT in the right deltoid. The patient experienced swelling on the right side of her face, neck and her gums. The patient had her teeth checked and there was nothing found except for the gum inflammation with numbness and tingling. The numbness was also present to her chin and lower lip area. The patient described it as feeling like a mild case of Bell's palsy. The patient had pain at the temporomandibular joint that progressed to a fever. Her lymph nodes on the right side were also swollen. Tingling presented in her right leg down to her ankle. Due to the swollen lymph node, she was had trouble swallowing and sought treatment at the emergency room. The patient was treated with antibiotics and the lymph node swelling resolved a week later. The patient went to the emergency room at 3 pm Thursday and was admitted to a room at 9:00 pm. The patient was discharged at 2:30 in the afternoon on Friday. The patient still had numbness and tingling in her mouth. The reporter did not consent to follow-up.
From telephone contact from reporting physician's office stated that a patient (3 of 3) received a Trihibit vaccination and an IPOL vaccination on 6/22/01. Reportedly the patient devleoped a local reaction of swelling and redness at the injection site (site not specified).
On day three after my Covid vaccine, after experiencing mostly mild side effects for the first two days, I experienced a severe episode of tachycardia while walking uphill. This is a walk I do three times a week and have never felt this way before. I couldn't catch my breath, and my heart rate remained abnormally elevated for another fifteen minutes. I walked down the hill and spoke to my doctor, who said it was likely a vaccine side effect and I should rest for the day. I continued to experience episodes of tachycardia, with heart rate in the 130s, throughout the rest of the day. I was short of breath just walking to the bathroom. My doctor had me come in and performed an EKG, which was normal. I continued having these symptoms the rest of the day, until eventually my heart rate stabilized  after 9pm. The next day I felt very tired, but no longer experienced the tachycardia. I had a follow up at my clinic and another normal EKG. Then yesterday evening, which was day 5 after the vaccine (technically day 6 maybe), I was walking my dog on a flat surface, taking my time, and I became short of breath, with pressure and tightness in my chest. I was unable to get a deep breath for another 30 minutes. Today, day 6/7 after my vaccine, I am fatigued, and continue to feel pressure and tightness in my chest throughout the day. I have asthma, and this feels different, though I have been using my inhaler to try to open up the tightness I'm experiencing. I also continue to have stomach pain and diarrhea since day one after receiving the vaccine. I also had that with the first vaccine three weeks ago--stomach pain and diarrhea.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 02-JUL-2015, the patient was vaccinated with an improperly stored dose of VAQTA 10 Pk 25U/0.5 ml SD Llok w Cap Ped, which had the lot # L001445, with expiration date 15-FEB-2016 (dose, dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On an unspecified date the vaccine experienced a temperature excursions of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Initial report received on 25 September 2012 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in an 2 year old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System database. The subject's vaccine history included 3 doses of PENTACEL: lot number C3614AA on 12 July 2010, lot number C3657AA on 17 September 2010, lot number C3716AB on 17 November 2010 (site and route of administration not reported). On 04 June 2012, the subject developed a cough, approximately 19 months after the last dose. On 11 June 2012, she developed a paroxysmal cough with a whoop. She also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 25 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 26 June 2012. The subject was not hospitalized. At the time of final contact on 29 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
18 hours after 3rd dose of Pfizer vaccine, developed visual field loss lasting 30 minutes, followed by headache and hypertension. This was a recurrence of symptoms experienced postpartum as part of reversible cerebral vasoconstriction syndrome (RCVS). Was evaluated by neurology the next day and abnormal transcranial doppler testing results were obtained. Symptoms have almost completely resolved as of this report filed 9 days after dose.
Information has been received from a registered nurse (RN) and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak occurred in the elementary school. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the index case was an unimmunized individual. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Jansen Covid 19 vaccine eua  Fever 100  chills body ache sweats
headache; Pulsing pain; This is a spontaneous report from a contactable consumer (patient).  A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 09:45 (Batch/Lot number was not reported), age at vaccination of 50-years-old, as single dose, for covid-19 immunisation. Medical history was none; the patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medications were not reported. The patient experienced headache traveling down the center of cranium on 23Apr2021 10:00 AM and pulsing pain on 23Apr2021 10:00 AM. No treatments for the events were given. The patient recovered from the events on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Pt became with dizziness; denies near syncope, BP well controlled, no fever, SOB, HA, palpitations, chills. Pt called clinic at 4:55pm 10/2/19 spoke to RN who ordered the vaccine and assessed pt this morning. Pt also received the flu shot with no hx of reactions to flu shot. Pt given ER precautions.  On 10/3/19 pt states eye pain in both eye and redness. No discharge, no headache, just dizziness, blurry vision and eye pain bilaterally. Pt given ER precautions for worsening pain and appt made for eye exam tomorrow in clinic 10/4/19
Received shot at 11:08 am Friday morning. Struggled to fall and stay asleep ~12-5:30 am Saturday morning. 4:10 am: messaged a friend saying the muscle spasms/cramping was similar to a full body mild period cramps and it was probably why women were getting their periods early. ~1:30 noticed I had gotten my period about 2 weeks early. Did not notice typical body signs that period was about to start.  My period has been inconsistent in the year of 2021. Some have been two weeks from each other, some have been 6 weeks. I typically notice  increased acne and breast firmness prior to start of period. It could be a coincidence.
Fever 100+ Chills Hot flashes Nausea with vomiting Severe headache Body aches Muscle weakness
Sweet syndrome with concurrent diarrhea/frequent stools. GI s/s lasted approximately 2-3 weeks. Sweet syndrome was treated with steroid taper.
Itching, swelling and good redness of left deltoid covering about 30 cm diameter area. Much improved (actually resolved) in 24 hours with 2 doses of Benadryl and within 18 hours of Keflex.
Chills lasted for about 16 hours Fever in the middle of the night Muscle pain in injection arm (current) Pain in arm pit of injection arm (current) Headache lasted about 24 hours
My arm hurt after shot. Next day it still hurt. On Friday I had two red circle's on my arm. One where shot was given the other 1/2 inch below it. It was very red & had heat in it, and hurt to touch, move and swollen. 1/12 - (L) arm pain from shoulder to elbow felt "heavy" - (L) hand tingling 1/14 - redness continue to be present
My son began complaining of his chest hurting meaning difficulty breathing (from chest up into neck area) and also rapid heart beat (intermittent).  He had the first shot 11/16/2015 and complained saying his chest hurt for the first two days, but didn't explain what he meant.  Second shot symptoms were worse and have lasted a week. We are going to his primary care today for course of treatment. I'm checking life threatening illness only because the vaccine info sheet shows these conditions as being serious allergic reactions.
This is the second time I?ve had this reaction to a Moderno vaccine. About a week after getting the vaccine, I experience severe itchiness across all my skin. I break out in hives and my tattoos raise up. When I scratch, my skin welts up and stays red for a long time this has been going on for over a week and the first time it lasted about two months.
This spontaneous report was received from a physician via a company representative, referring to two patients of unknown genders who were currently in their twenties. The patient's medical history or concurrent conditions were not reported. On an unknown date, years ago, in their pediatrician office, the patients were vaccinated with GARDASIL (dose, route, anatomical site of vaccination, lot numbers and expiration dates were not provided). Information regarding concomitant medication was not provided. On an unknown date, the patients experienced "chronic fatigue, tiredness and chronic pain. It was also reported that the mother of the two children sought medical attention with a family practice physician and there was not product quality complaint involved. At the time of reporting, the outcome of chronic fatigue and chronic pain was unknown. The causality assessment between the events and GARDASIL was not provided. Additional information has been requested.
slight headache; her arm is bothering her; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (slight headache) and LIMB DISCOMFORT (her arm is bothering her) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 21-Sep-2023, the patient experienced HEADACHE (slight headache) and LIMB DISCOMFORT (her arm is bothering her). At the time of the report, HEADACHE (slight headache) and LIMB DISCOMFORT (her arm is bothering her) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The Dosage text of the suspect was reported as unknown. The patient took the 5th dose on 21-Dec-2022. No treatment medication was reported.   Reporter did not allow further contact
It was reported that a 24 year old female received a Fluzone SV '99-'00 vaccination on 10/5/99, at 13:00. The vaccination "was given SQ instead of IM." Reportedly at 18:00 that evening, the pt experienced a "strong reaction"; 3" to 4" local red, raised area to arm, fever, nausea, diarrhea and headache. The pt reportedly is still experiencing these symptoms. Information received on 11/22/99, states that the pt has had a slight red blush at the area of injection. Otherwise, there are no further symptoms. The fever and headache lasted over a week as of 11/17/99.
extremely painful headaches; migraine; Cerebral Venous Sinus Thrombosis (CVST); This is a spontaneous report received from contactable consumer via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the patient.  A 43 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Apr2021, on 14:00 (Lot number: ER8727) at the age of 42 years as dose 2, single for covid-19 immunization. Relevant medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included: ADDERALL and VYVANSE. Vaccination history included the first dose of BNT162B2; Lot number EN6199, into the left arm on 18Mar2021, at  02:00 pm), when the patient was 42 years old, for COVID-19 Immunization. On 17Apr2021, at  17:00, the patient experienced extremely painful headaches, which was serious as it was life-threatening, and involved hospitalization from 25Jun2021; on 17Apr2021, at 17:00, the patient experienced migraine, which was serious as it was life-threatening, and caused and prolonged hospitalization from 25Jun2021. On 17Apr2021, at 17:00, the patient experienced Cerebral Venous Sinus Thrombosis (CVST), which was serious as it was life-threatening and involved hospitalization.  The patient underwent laboratory tests and procedures, which included diagnosed as having Cerebral Venous Sinus Thrombosis (CVST), on Friday, 02Jul. Therapeutic measures were taken as a result of headache, migraine, cerebral venous sinus thrombosis. Details were as follows: On, 17Apr2021, nine days after receiving the second vaccination, patient started to get extremely painful headaches that went on for weeks. Eventually, they got so bad that he went to the emergency room on 25Jun2021. Believing it was a migraine, the hospital sent the patient home. The headache didn't get better. Eventually, he was diagnosed as having Cerebral Venous Sinus Thrombosis (CVST) on Friday, 02Jul.  The adverse events (AE)( resulted In doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, involved hospitalization,  and was life threatening illness (immediate risk of death from the event).   The AE treatment, included Eliquis, Lovenox, Acetazolamide. There was no positive covid vaccination, post vaccination. There were no known allergies. The clinical outcome of extremely painful headaches, migraine and Cerebral Venous Sinus Thrombosis (CVST) was not recovered.
TREMORS; This spontaneous report received from a patient via a company representative from social media concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tremors was not reported. This report was non-serious.
It feels like there are spiders or bugs crawling on my arms and legs. In the arms, it is the area around the wrist and in the legs, it is around the ankles.
This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 61-year-old male patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix (received 1st dose 3 years before reporting). On an unknown date, the patient received the 2nd dose of shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had not gotten his second dose till the time of reporting due to limited availability, which led to Product Supply issue. The reporter did not consent to follow-up.
This spontaneous report was received from a pharmacist referring to a multiple unspecified patients of unknown ages and genders. There was no information about the patients' concurrent conditions or medical history provided. Concomitant therapies included properly stored sterile diluent. On an unknown dates, the patients were vaccinated with an improperly stored doses of ZOSTAVAX 19400 PFU, for prophylaxis (doses, routes of administration, lot numbers and expiration dates were not reported). The administered dose of the vaccine experienced a temperature excursion 15 degrees Fahrenheit to 46 degrees Fahrenheit for 3 hours, as recorded by a data logger. There was no adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012332.
Chills, achy fever of 103.8. Arm re swollen at injection sight.
Information has been received from an Immunization Officer concerning an unknown number of patients who, on unspecified dates might have received a dose of RECOMBIVAX HB (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports from the same source. The other linked reports are: 1211USA006714, 1211USA006715, 1211USA006716 and 1211USA006717. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
This is a spontaneous report from a contactable Consumer, The patient.   A 37-year-old female patient received BNT162B2 (Pfizer BIONTECH- COVID-19 m-RNA vaccine): (Lot number En5318) via an unspecified route of administration in the right arm on 28Feb2021 at 08:30 (Age at the time of vaccination was 37 -years) at an unknown dose for covid -19 immunisation.  Medical history included Multiple sclerosis, high blood pressure, Penicillin, shrimp and cat dander.  The patient concomitant medications were not reported. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for covid-19 test. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Feb2021 at 12:00, the patient experienced High blood pressure and Nausea. The adverse events resulted in Emergency room/department or urgent care. The most recent COVID-19 vaccine was administered to the patient in a health facility. Therapeutic measures were not taken for the events. The events High blood pressure and Nausea were resolving at the time of this report. No further information is expected.
Sore Arm; Shot burned as the fluid was going into my arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Shot burned as the fluid was going into my arm) and PAIN IN EXTREMITY (Sore Arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Shot burned as the fluid was going into my arm) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Shot burned as the fluid was going into my arm) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
As of today, patient reported that she still has a bruise and fluttering heart beat. She reported a metallic taste on the day the vaccine was given.
Felt lethargic, head noise, temperature for couple of days above 100.3, red spots developed on the arm apx 6.5" x 3.5" long, enlargement of lymph nodes under armpits, the red spots continued to be more than a week and started to itch, feel the pressure in the heart - as if its being squeezed/pressured and not released, pinching/aches like needles, lymph nodes under armpits still ache over 2 weeks now,  my eye sights after the 2nd shot has worsened.
ROTATEQ was administered via NG tube; patient was 3 years old; uncertain if product was administered to patient; No additional AE/PQC reported; This spontaneous report was received from a pharmacist referring to a 3-year-old patient of unknown gender with nasogastric tube (NG tube) insertion. The patient's medical history, concomitant drugs and drug allergies/reactions were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #, expiration date, dose and strength were not reported) via NG tube for prophylaxis (incorrect route of product administration; product administered to patient of inappropriate age).       The reporter inquired if rotavirus vaccine, live, oral, pentavalent (ROTATEQ) could be administered via NG tube and what was the oldest possible age that a patient could receive it. The reporter was also uncertain if this vaccine was administered to patient (circumstance or information capable of leading to medication error). No additional adverse event was reported.