chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional (HCP) reported that the patient experienced arm soreness. This report came from inside sales. The Inside Sales representative did not have any patient or vaccine information. The representative only had limited information about the adverse event. This is one of the 7 cases reported by the same reporter.
pt started having chest pains and SOB.  On 5/12/2021 pt went toShe had chest x-ray, EKG, lab work.  Everything came back normal. She was prescribed some medicine.  She was discharged and told to FU w PCP.  Pt has not followed up w/ PCP and no longer has these symptoms.
Pt had angio-edema within 15 min of receiving Covid-19 vaccine.  Reports having tingling in her mouth.  Denied shortness of breath/wheezing.  Alert and Oriented X4.  Pt's tongue was swollen/bumpy.  EPI auto-ject was given, EMS called to take pt to ER.
Bad heart palpitations/I'm skipping a beat about every 15 seconds or as bad as every 5 seconds; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9264 and expiration date were not reported), dose 1 via an unspecified route of administration, administered in right arm on an unspecified date in Apr2021 (at the age of 64 years) as dose 1, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included Light Emphysema and hyper inflated lung both from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications were not reported. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced bad heart palpitations on 05May2021 (one week after first shot). Reportedly, one week after first shot patient started having bad heart palpitations. Patient was skipping a beat about every 15 seconds or as bad as every 5 seconds. Since they seemed to improve slightly after 2 weeks or 3 weeks after first shot, patient went forward with second shot. They were not as bad for about a month and a half and then got worse again and have remained that way since. It was now more than three months after. Patient was skipping a beat about every 15 seconds or as bad as every 5 seconds. And his heart was beating very hard. Not necessarily fast, but very hard at times. Patient just went to cardiologist. He believed they are probably from the vaccine. He has patient on diltiazem 120 mg, calcium channel blockers. Patient had taken for 4 days, but no change. Event resulted in Doctor or other healthcare professional office/clinic visit. The 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. Reportedly, patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0185 and expiration date were not reported), dose 1 via an unspecified route of administration, administered in left arm on 28May2021 as DOSE 2, SINGLE for covid-19 immunisation in Pharmacy or Drug Store. The patient took treatment for vaccination with Diltiazem 120 mg (calcium channel blocker) for the event. The outcome of the event was not recovered.
DEATH; INTERNAL BLEEDING; HEMATOMA; LOW BLOOD OXYGEN; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID -19 INFECTION; This spontaneous report received from a consumer concerned a 69 year old white non- hispanic or latino male. Initial information was processed along with the additional information received on 30-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and was on CPAP (Continuous positive airway pressure ) machine, non-alcohol user, and non-smoker. The patient had no known allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 in total administered to left arm on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-JUL-2021, the patient developed shortness of breath and fever (Suspected covid -19 infection) and was taken to emergency room. There patient tested positive for covid-19 infection (suspected clinical vaccination failure). The patient was transferred to other hospital and was on CPAP machine along with Bi-PAP. The patient had low blood oxygen. The patient was put on oxgyen. On unspecified date the patient become negative for covid-19 infection. The patient had internal bleeding and was on blood thinner. The patient had hematoma and could not breath. On 19-AUG-2021 the patient was again transferred to another hospital and was intubated which made him worse. On 27-AUG-2021 the patient passed away. The number of days hospitalized was 32. It was unknown whether the cause of death was due to covid-19 infection or due to vaccine. It was unknown whether an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 27-AUG-2021, recovered from suspected covid -19 infection, had not recovered from hematoma, internal bleeding, and low blood oxygen, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with a product quality complaint 90000191347.; Sender's Comments: V0: 20210857346-covid-19 vaccine ad26.cov2.s-Death, internal bleeding, suspected covid -19 infection, hematoma and low blood oxygen. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210857346-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 06-OCT-2012 21:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During the 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This solicited report was received from a physician concerning unspecified number of patients of "all" ethnicities of unknown age and gender enrolled in a market research program. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with GARDASIL or with GARDISIL 9 (dose, strength, frequency, route of administration and lot number were not provided). On unknown dates, "almost all patients (95%)" experienced pain and burning at the injection site. On unknown dates, the patients recovered with sequelae from the pain and burning at the injection site. At the time of reporting, therapy with GARDASIL 9 and GARDASIL was continued. The reporting physician considered the event to be related to GARDASIL 9 and GARDASIL. It was reported that the AE diminished after stopping suspected therapy and that the AE re-appeared after restarting suspected therapy (conflicting information). Additional information is not expected since physician did not give consent to be contacted.
Pt states he received flu shot on 12/1/04. On 12/2/04 at 1:10PM c/o severe pain in L knee. Treated with ice pack and rest. At 2:30PM c/o severe pain in both knees. Denied pain at injection site in right arm. Mother was called and child was picked up from school. On 12/3/04 child states in AM and PM that he had no pain and that he received Tylenol at home.
Red circle on arm 2 inch diameter pain area feels hard and sensitive to touch. Feels like there is a ball under my skin. This started one day after I got the second dose of the Pfizer vaccine.
Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of thisevent, a causal relationship cannot be excluded.
Case number PHEH2012US020843 is an initial spontaneous report received from a consumer on 16 Oct 2012. This case refers to a 69-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on an unspecified date sometime in late Oct 2011 or early Nov 2011. Within few days after vaccination she developed loss of range of motion and muscle spasm in her arm. She stated that she saw a physician and was diagnosed with frozen shoulder and muscle spasms approximately two weeks after vaccination. She also stated that one of the pharmacists in place where she was vaccinated told her the vaccine had preservative in it. The outcome was reported as unknown. No other information was available at the time of this report.
pt recv vax & devel nausea,dry heaves,& intermittent h/a;no other info was available as of reporting date
Throat pain/swelling /exsoriation  /erythema /drooling/ lose of voice/ fever /chills /diarrhea vomiting /elevated LFT/ and WBC/ negative for  covid /strep and mono. No throat abscess.  I was seen in urgent care treated with augmentin 875mg 36 hours later much worse nor drooling not able to talk drink or eat. Seen in ED. Given fluids steroids and pain meds.... felt much better.  .... got home the next day started vomiting and diarrhea throat pain continues can only swallow  liquids
I had a significant headache that evening. Vaccination site was red raised and warm to the touch. I also had fever chills during all of this. It was more than 5 inches in diameter I had significant underarm pain that radiated, and it lasted for 5-7 days which was shocking. I had fatigue and overall pain that was so much more than dose 1 & 2. I just wasn't well at all. Sunday after going through all this I go to urgent care, and I was diagnosed UTI and a sinus infection. Blood in my urine (significant amount) and they both hit me sudden. I told them at the urgent care, and they couldn't tell me anything. What's been long standing is inflammation in my joints no breathing issues, but all my joints were in so much pain. So much inflammation I must now see a rheumatologist and I have never had these issues before. Less than a month 6 weeks max I had to go back my PCP and I was bleeding again. They did a culture and the finding wasn't bacterial. My doctor then put me on something else did work and I was in fact healed.
Allergic rhinitis, extremely sever.; This is a spontaneous report from a contactable other hcp (patient).  A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Ew0175) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included known allergies: pollen and no other medical history. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 04Aug2021 at 15:00 (Batch/Lot Number: Ew0175) as DOSE 1, SINGLE for covid-19 immunisation. There is no other vaccine in four weeks. There were no concomitant medications.  The patient experienced allergic rhinitis, extremely sever (medically significant) on 01Sep2021. The outcome of event was not recovered without treatment received.   The patient had no covid prior vaccination and had no covid test post vaccination.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Rhinitis allergic and BNT162B2.  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.
edema on chin and lower eyelids; edema on chin and lower eyelids; This is a spontaneous report from a non-contactable other healthcare professional (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was previously injected with 1ml Voluma in temples, 3 ml Voluma cheeks, 1 ml Volift midface, 1 ml Volbella tear trough and 3 ml Volux in chin. 2 months later patient also received 0.5 ml non-Allergan dermal filler in lips and a small correction of 0.1 ml in the left tear trough. Following month, patient received a COVID-19 vaccine. Next morning, patient woke up in the morning with oedema on chin and lower eyelids. Outcome of the events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Flu symptpms 30-48 hrs after adminsitration, lasting 2 days.
Left deltoid erythema and swollen in a 12 cm x 15 cm area. The ski is warm to the touch and hard, there is a blistery rash in the center of the area.
PER MOM: 5/9/08 - SON C/O R.A. "SORE". 5/10/08 - ARM WAS RED & SLIGHT SWELLING 5/11/08 - INCREASED SWELLING, ALMOST DOUBLE THE SIZE FROM 5/10, ABOUT 5". TAKEN TO ER AT 11:00 PM - MD DX CELLULITIS  TR. BACTRIM TO TAKE QID. X14D.NO CULTURE OR LABS DONE. AN ULTRASOUND DONE: NO ABSCESS SEEN UNDER THE SKIN. TOLD TO APPLY HEAT PAD TO SITE. FOLLOW UP WITH PCP THIS WEEK. HE MISSED SCHOOL 5/12/08 DUE TO REACTION. THINKS MAY BE STAPH OR STREP INFECTION CELLULITIS.
broke out w/chickenpox rash;total of approx 20 vesicles;afeb;all areas scabbed over w/in 48hr of onset;
PATIENT RECEIVED 1 COVID SHOT IN EARLY JANUARY FROM A DIFFERNT LOCATION. PHARMACIST UNAWARE OF THIS  GAVE  PATIENT  OUR FIRST SHOT ON 6/16/21 AND 7/17/21  SO PATIENT RECEIVED TOTAL 3 DOSES.  PASTIENT SIAD SHE WAS TOLD BY DOCTOR TO RESTART THE SERIES.  NO ADVERSE REACTIONS NOTED
Initial unsolicited report received from pharmacist on 27-Sep-2018. This case is linked to case 2018SA272287. This case involves a [59 years old] (unknown gender) patient who was vaccinated with a dose of TUBERSOL (Batch number: C5482AB, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients was positive to PPD previously. The patients past concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered (accidentally gave them IM Tubersol instead of flu vaccination). It was unknown whether patient experienced any adverse event following vaccination. 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.
Information has been received from a physician concerning a mother reported her daughter who was vaccinated with a first 0.5ml dose of GARDASIL, and "within a week of getting vaccinated, the patient became depressed and showed a sign of obsessive compulsive disorder." The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow up information was received from the physician concerning the 14 year old female student with 2 siblings, flat feet and back pain who on 17-AUG-2007 was vaccinated in the left deltoid with her first dose of GARDASIL (lot #: 658490/0802U). Concomitant therapy included a dose of HAVRIX and MENACTRA. The patient had learning difficulty and palpitations later diagnosed with supraventricular tachycardia at the time of vaccination. Subsequently the patient experienced anxiety, increased crying, depression and unusual aggressive behavior. The patient suspended from school and was evaluated by psychiatrist. The outcome was unknown. Additional information has been requested.
pt exp shakes & began to turn blue;pt hosp;the shakes worsened;pt was really sick;the shakiness & turning were considered other medical events;  Annual follow-up received on 11/27/00 states the pt has recovered.
Patient received Moderna vaccine for her primary series. After her 2nd dose of Moderna vaccine, patient experienced chest tightness and EMS was called. Patient informed RN of this previous adverse event to vaccination prior to being vaccinated today. Patient received her 3rd (booster) dose of Pfizer vaccine today. About 5 minutes into her observation period, patient began experiencing chest pain and her heart was racing. Patient was evaluated by on-site RN/provider staff who deemed it necessary to take patient to the ED for further evaluation, assessment, and monitoring. Patient left the vaccine clinic site on stretcher to go to on-site ED.
FACE SWELLING; CHEEK AREA VERY HOT AND RED; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, seasonal allergies, and drug allergy (sulfa quinolones (antibiotics)). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 21-MAR-2021 for covid-19 prophylaxis. Concomitant medications included diphenhydramine hydrochloride, and montelukast sodium.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1).  The patient additionally received Pfizer BioNTech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: FL3197 expiry: UNKNOWN) dose was not reported, administered at left arm on 30-DEC-2021 at 15:15 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On an unspecified date in 2023, the patient experienced suspected covid-19 infection (dose number in series 2). The patient took non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered from 19-AUG-2023 to 22-AUG-2023 for treatment of covid-19. On 21-AUG-2023, the patient experienced trouble breathing (subsumed under suspected covid-19 infection), face swelling, and cheek area was very hot and red (dose number in series 2). Treatment medications (dates unspecified) included: steroids. Patient had recovered from trouble breathing on 29-AUG-2023. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient recovered from face swelling, and cheek area very hot and red on 29-AUG-2023, and the outcome of revaccination with different covid-19 vaccine and suspected covid-19 infection was not reported. This report was non-serious.
Severe urine issues; Severe urgency/Has to go  every couple hours; This spontaneous case was reported by a consumer and describes the occurrence of URINE ABNORMALITY (Severe urine issues) and MICTURITION URGENCY (Severe urgency/Has to go  every couple hours) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINE ABNORMALITY (Severe urine issues) and MICTURITION URGENCY (Severe urgency/Has to go  every couple hours). At the time of the report, URINE ABNORMALITY (Severe urine issues) and MICTURITION URGENCY (Severe urgency/Has to go  every couple hours) outcome was unknown.    Concomitant and treatment medication was not provided.  Patient reported did not have this event with the first dose of vaccine.
I had it, but I did have the vaccine before it came/suspected vaccination failure; I had it/ Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient stated he/she had shingles, but the patient did have the vaccine before shingles came. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Cough, hoarseness, throat felt full, fever, eye mattering, mild wheezing.  Went to urgent care and then sent to ED where she received an SVN treatment.  Symptoms resolved by day after vaccination.