chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue within an hour of receiving the shot.  Within 4 hours of receiving shot felt tenderness on left side high up in rib cage that ran along my left side torso into mid abdomen.   Hurt more when talking/sitting. If I would lay flat on back it wouldn't hurt. After 5 hours of this I took Tylenol and pain subsided.  Feel asleep early. Next morning, slight discomfort lower abdomen but went away.  That evening my asthma bothered me - I took Albuterol  inhaler (two pumps) felt better. Next night, same. Abdomen still uncomfortable if I sit too long, I have to stretch out my chest and stomach and it relieves the pressure. It comes and goes. That brings us to present day. 4/23
Patient was given an expired vaccine/ no AE; Initial information was received on 10-Aug-2021 regarding an unsolicited valid non-serious case received from an Other health professional.  This case involves a 16-month-old female patient reported that patient was given an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for prophylactic vaccination.  On 10-Aug-2021, the patient received a 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ357AA, expiry date 26-Jul-2021] via intramuscular route in the right thigh for prophylactic vaccination.  It was reported that, "Caller wanted to know if consumer needed to be re-vaccinated".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
A 56 year old FEMALE who has been waiting at monitoring area after Covid 19  vaccination, provided called to evaluate patient c/o: Chief Complaint: Patient was being checked at 1039 for final 15 min wait time  after Covid-19 vaccine. Patient states she is feeling light headed and  nauseated Doctor was informed.  Took patients vitals.      11:06 patient was put on 6 liter of O2 with face mask      11:08 patient was out on to 4 liters      11:10 patient states "I'm feeling better, flutter in my stomach"      11:17 Doctor instructed RN to give Solumedrol (IM) injection to  patient      11:22 Patient states "I'm having a heartburn feeling, tightness in my chest.       I put patient in a sitting position.      11:31 Patient states "I'm feeling better"      11:35 Employee came and gave patient solumedrol injection (IM) RT  Deltoid @11:36      11:41 Patient states "I'm feeling better, heartburn is going away slowly, I  can breath now"      11:49 Patient states "I'm feeling better"      11:50 Doctor states "I will be putting in an order for epi pen for patient  and she can pick that up from pharmacy when she leaves"
Severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headaches). At the time of the report, HEADACHE (Severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient has no prior history on headaches and migraines. upon the conversation caller confirmed patient has not  visited Primary HCP due to insurance issues, and is going to visit nearest urgent clinic.
RASH AT THE SITE OF INJECTION, STOMACH, BACK SINCE THE DAY AFTER THE INJECTION WAS ADMINISTED ON 11/3/24.  PATIENT HAS TAKEN ANTIHISTAMINE CLARATIN AND BENADRYL AND ALSO USING TOPICAL SARNA FOR ITCHING ON SCALP.
painful focal labial ulcerations 2 days after the Covid booster was provided; Revaccination with different COVID-19 vaccine; interchange of vaccine products; This spontaneous case was reported by a physician and describes the occurrence of ULCER (painful focal labial ulcerations 2 days after the Covid booster was provided), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Comirnaty (Dose 2) and Comirnaty (Dose 1). Past adverse reactions to the above products included No adverse event with Comirnaty and Comirnaty.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ULCER (painful focal labial ulcerations 2 days after the Covid booster was provided), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, ULCER (painful focal labial ulcerations 2 days after the Covid booster was provided), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
1.5 hour of intense screaming and crying, this baby doesnt cry. Same reaction with 2 and 4 month shots. He appears to have recovered and is now sleeping.
5:34pm- Patent reports lips and tongue tingling. 5:41pm- Forehead tingling also. Patient denies any shortness of breath, denies chest pain. 5:46pm-Patient reports left side of neck tingling. 5:49pm- Patient reports whole face tinging and headache.  B/P 122/86, pulse ox 98% on room air, RR 22, HR 97.    5:51pm- patient reports tingling to left hand. 5:58- 50 mg of Benadryl (Dye-free) given orally. 6:02pm- Patient reports inside of nose tingling. NO wheezing noted to auscultation. 6:13pm- pulse ox 98% room air, HR 89, RR 18. 6:14pm- Patient states all tingling still present and more pronounced. 6:16pm- Patient reports back of throat dry and scratchy. 6:24pm- Patient continues to have tingling to lips, tongue, forehead, left side of neck, left hand, and nose. Patient reports tingling is ?not as pronounced?. NO respiratory symptoms. Patient states scratchy throat ?feels better? but symptoms of scratchy throat still present. Discussed need for further assessment and care at hospital or urgent care. Patient wants Mom to drive her to ER. Mom verbalizes understanding to call 911 en route to hospital if patient symptoms increase in any way. 6:42pm- Patient left for Hospital ER with Mom driving. Report called in to Hospital and given charge nurse in ER, by Emergency Nurse that cared for patient onsite.  Benadryl was not given initially due to patient report of red dye allergy. Health Department nurse went to local drugstore and purchased dye- free Benadryl.  Onsite Emergency Nurse present with patient throughout entire event.
Blood pressure 209/100 plus; atherosclerosis renal arteries; speech changed; severe headaches; Joint pain; A Spontaneous report was received from a  Health care professional  concerning a  85 Years old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 8-jan-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On date or an unknown date, The patient experienced the events  atherosclerosis renal arteries, high blood pressure, severe head ache, joint pain. with hospitilization and disability  Treatment provided Tylenol, Advil, Norvasc, lisinopril, codeine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were unknown; Reporter's Comments: This case concerns an 85-year-old female who had serious expected events of headache and serious unexpected speech disorder, increased blood pressure, renal artery arteriosclerosis and NS expected arthralgia.  Event onset was the same day as the first dose of mRNA-1273. Treated with Tylenol, Advil, Norvasc, lisinopril, codeine. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
His girlfriend developed a high temperature after first shot of vaccine; This is a spontaneous report from a Pfizer sponsored program . A non-contactable consumer (patient's boyfriend) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced a high temperature after first shot of vaccine. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chronic inflammatory demyelinating polyneuropathy; This is a literature report for the following literature source(s): Neurology, 2022; Vol:98(18 SUPPL), pgs:3371.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), 2 weeks after the suspect product(s) administration, outcome "recovering", described as "Chronic inflammatory demyelinating polyneuropathy". The patient underwent the following laboratory tests and procedures: CSF test: albuminocytologic dissociation; Magnetic resonance imaging: no abnormalities; Magnetic resonance imaging head: no abnormalities; Nerve conduction studies: were consistent with demyelination; Neurological examination: 4/5 strength in upper and lower extremities, notes: generalized hyporeflexia, decreased vibration, and proprioception. Therapeutic measures were taken as a result of chronic inflammatory demyelinating polyradiculoneuropathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the reported event is assessed as unrelated to suspect drug and more likely related to intercurrent/ underlying medical condition.
Headache behind eyes, low grade fever ~ 101 degrees muscle aches began 12/26/09 x 3 days. Treating with TYLENOL everyday.
Patient reported signs of erythema, and swelling in right arm upon waking the morning following injection. She had been monitoring throughout the day and reports the swelling and redness has reduced throughout the day and arm is still tender. She reports not having had any rash, itching, or swelling in or around her throat, face, and trunk area. She had not had any difficulity in breathing.
experienced shingles after the first dose.; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient's demographic details were not provided. The age at vaccination was not provided. The age group of the patient was not reported but selected as an adult as per vaccine indication. The pharmacist reported that, in 2018, the patient received dose of Shingrix and experienced shingles. By the time this report was performed, the patient did not receive 2nd dose of Shingrix vaccine because of shingles after 1st dose. The reporter did not consent to follow up.
This spontaneous report was received from a registered nurse referring to a 14 month old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the patient was vaccinated with M-M-R II (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis, on 19-JUN-2017 and subsequently he was vaccinated with VARIVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis, on 29-AUG-2017 and PROQUAD (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis, on 05-SEP-2017. No adverse symptoms were reported. No further information was provided. There was no product quality complaint (PQC) involved.
Breakthrough case admission after 3 vaccines Pfizer 3/28/21 Lot# EN6207;  Pfizer 4824/21 Lot3 Ew0158;  Moderna 11/21/21 Lot# 034F21A
Patient was scheduled to receive Moderna dose #3, however she received Pfizer Covid vaccine in error.  When notifying  patient regarding the error (about 3 hours  after given) she denied any adverse effects at that time and was advised to report any adverse effects should they occur. She agreed with plan.
Lethargy, headache, body aches and fever onset within 2 hours, getting progressively worse. over the next 10 hours.  Within 12 hours, temperature had risen to 103.9.  Ibuprofen  brought the fever back to the 102 range, but headache, body aches and fever have persisted  for over 24 hours now.
Pt started with facial swelling 24 hours after her MMR vaccine. At 48 hours the swelling was severe enough to warrant an ER visit and treatment.
ATE A PIECE OF CAKE THEN, AFTER 30 MINUTES TOOK A DOSE OF VIVOTIF; This spontaneous case (PVX2019-1182) was received from a healthcare professional on 13-May-2019. It describes a female consumer who "ate a piece of cake then, after 30 minutes took a dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer ate a piece of cake and then, after 30 minutes she took the first dose of Vivotif. Also, she ate dinner about 1 hour later.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "ate a piece of cake then, after 30 minutes took a dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate a piece of cake then, after 30 minutes took a dose of Vivotif" was considered as not applicable.
Patient was due for four vaccinations in Clinic at 9:00 AM on Tuesday 03/20/2019. Patient was due for Hep A, Hep B, DTap and Hib. Pt had erroneous administration of KINRIX and PEDIARIX. There is no signs or symptoms from patient after receiving the wrong vaccinations. Right after the vaccinations, the patient presented normal; walking and holding mother's hand leaving the clinic. Provider, patient, patient's mother and all staff involved was made aware of the event and aware that there is no increased risk or danger to the child after receiving extra dose of DTaP and 2 extra doses of IPV.
Lump formed right away. Skin rash is red, irritated, and scabbed over from shoulder to elbow on left arm.
Five minutes after received Pfizer Covid-19 vaccine at 5:51 p.m., patient was sweaty and unable to verbalize thoughts.  Blood pressure was 95/  58, heart rate was 51.  One dose of  Epipen 0.3 mg was adminstered at 5:56 pm, EMS was called,  patient was placed on the floor with feet elevated, blood pressure was checked at 6:00 p.m and was at 116 /79 and heart rate was 66.  At this time patient became responsive and EMS arrived to  check patient out.  Patient declined to go with EMS.  We monitored patient at the store for 30 minutes at which time she left with husband who was instructed to dial 911 if symptoms returned.
72 hours of recurrent chills and fever accompanied by persistent headache and debilitating fatigue.
Shortness of breath for about 6 hours on 05/04/2021; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 23 years old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other vaccine in four weeks. Concomitant medication included norethindrone acetate (5mg Tablet) taken for an unspecified indication, start and stop date were not reported. On 04May2021 20:00, the patient experienced shortness of breath for about 6 hours. There was no treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event not recovered.  Information on Lot/Batch number has been requested.
Information has been received from a nurse (R.N.) concerning a patient who on an unspecified date was vaccinated a dose of GARDASIL (lot # unspecified). The patient from another office fainted and had seizures after administration of GARDASIL. The outcome was unknown. Upon internal review, seizures were considered to be other important medical events. This is one of several reports received from the same source. Additional information has been requested.
brain fog and chills since the vaccine.  started with nausea, fever and chills.  nausea lasted for 10 days.
Taking that shot was the worst decision of my life. I had never slept so horribly before. I went to bed with chills and woke up continuously throughout the night with a fever. I had a huge headache and my arm was so sore I couldn?t even sleep. My body feels so tired and In pain. I am scared to get my second dose.
Random Heart palpitations. Eventually 2 separate issues of atrial fibrillation. One on April 4th and one on the 11th. No previous history of palpitations.
EKG showed "sinus arrhythmia"; Heart "was skipping beats"; Heart was pounding; It was uncomfortable; Could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable), INSOMNIA (Could not sleep) and SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia") in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable) and INSOMNIA (Could not sleep). On 05-Mar-2021, the patient experienced SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia"). At the time of the report, EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable) and INSOMNIA (Could not sleep) outcome was unknown and SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
Sepsis like syndrome tmax 102.9, he 110 to 120; Sepsis like syndrome tmax 102.9, he 110 to 120; myalgia; severe fatigue; nausea; shaking chills; The patient received booster dose of BNT162B2 on 04Nov2021 at 16:30; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: Fh8028, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 04Nov2021 16:30 (at the age of 53 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included HTN (hypertension) from an unknown date. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: El9274), via an unspecified route of administration, administered in left arm on 02Feb2021 at 12:00 (at the age of 53 years old) as dose 1, single and second dose of BNT162B2 (lot number: En6200), via an unspecified route of administrationm administered in left arm on 25Feb2021 at 12:00 (at the age of 53 years old) , both for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received booster dose of BNT162B2 on 04Nov2021 at 16:30. On 05Nov2021 at 10:00, the patient experienced sepsis like syndrome "tmax 102.9, he 110 to 120" (as reported), myalgia, severe fatigue, nausea and shaking chills. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Pt had a nose bleed within 5 minutes of H1N1 injection. No other symptoms noted. Nosebleed stopped within 15 minutes.
intense vertigo almost 48 hours after getting the shot. major vertigo symptoms dissipated after about 6 hours, but minor symptoms for 24 hours
This spontaneous report was received from a pharmacist referring to a 68 year old female patient of unknown age The patient's concurrent conditions, medical history and concomitant medications were not provided. On 13-DEC-2010, the patient was vaccinated with the first dose of ZOSTAVAX subcutaneous (Lot number, expiration date and dose were not provided). On 02-NOV-2012, the patient received a second dose of ZOSTAVAX (Lot number reported as HD11332 expiration date 08-SEP-2013) dose and route were not provided. On an unspecified date in July 2014, the patient experienced shingles. The reporter stated that they reviewed the patient's record on an unspecified date and learned of the second dose of ZOSTAVAX. At the time of the report, the outcome of herpes zoster was reported as recovered/resolved (also reported as "the patient was alive and well"). The reporter did not assess the causal relationship between the adverse event and the vaccination with ZOSTAVAX. Additional information has been requested.