chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NUMBNESS OF HANDS AND FINGERS; HANDS STIFFNESS; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 142 pounds, and height was 66 inches. The patient's past medical history included valve replacement, and concurrent conditions included diabetes, non alcohol user, non-smoker, and stent user, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced hands stiffness. On 03-APR-2021, the subject experienced numbness of hands and fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness of hands and fingers, and hands stiffness. This report was non-serious.
2 JUN 2021: Patient reported upset stomach and diarrhea; onset in June 2021. Patient was evaluated by provider while in theatre. Patient reported symptoms slightly improved; no longer watery per Patient. Patient stated that he continues to have multiple bowel movements per day; described stools to be loose.  1 OCT 2021: Patient reported that he can not keep an erection; "no morning erection" per Patient. Patient given permission to report this finding into VAERS.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Many grasses for which I take allergy shots" (unspecified if ongoing), notes: Known allergies: Many grasses for which I take allergy shots. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Very brief vasovagal response (syncope) lasting less than 5 seconds. Patient stated he has this response even when discussing  vaccines and advised us prior to vaccination that syncope was likely.    Following episode he was given a cool cloth and water.  He was able to move to our post vaccine waiting area in less than 15 minutes.  On a follow up phone call, patient stated his only side effect was a sore arm..
High pitched squeal. Patient fell from chair and hit head. Tremoring and went in to full seizures. Bit tongue, drooling. Excessive shaking. Pupils fully dilated and unable to respond until 15-20 min after seizure began. Paramedics took patient to ER. Put patient on oxygen and an IV then went into testing. Everything came back normal. Released one hour after arrived to ER triage.
High blood pressure; Rapid pulse; Body aches; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure), HEART RATE INCREASED (Rapid pulse), PAIN (Body aches) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19.    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 HYPERTENSION (High blood pressure), HEART RATE INCREASED (Rapid pulse), PAIN (Body aches) and HEADACHE (Headache). At the time of the report, HYPERTENSION (High blood pressure), HEART RATE INCREASED (Rapid pulse), PAIN (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Company Comment: 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.; Reporter'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.
pt had a brief unprovoked sz last wk;gen sz;pt was fussy or irritable and fell asleep;eyes were open and staring;arms & legs jerking;convuls cont for 90 sec, lethargic to ER;nl CBC & electrolytes; d/c home; 2 wk later recurrence sz
elevated white blood cell count; elevated neutros PCT/elevated Neutros ABS; lymph % low; This is a spontaneous report from a contactable consumer(patient).A 76-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection), (Batch/Lot Number: EL9269) via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 13:00 (age at vaccination 76-years-old) as dose 2, single for covid-19 immunization. Medical history included diabetes mellitus and hypersensitivity. There were unspecified concomitant medications that patient received within 2 weeks of vaccination. The other vaccines administered within 4 weeks was first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Batch/Lot Number: EL3249) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID. In Feb2021, the patient experienced elevated white blood cell count, Neutrophils increased and Lymphocyte count low. The patient underwent lab tests in Feb2021which included elevated White Blood Cell count, elevated neutros PCT, elevated Neutros ABS, lymph % was low and on 08Feb2021 sars-cov-2 test result: negative. Therapeutic measures were taken as a result of events included antibiotic. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected
Tired next am, fever 3/11/08.  Arm swollen, upper L deltoid - warm to touch, painful.
Patient showed signs of erythema, hives, and other allergy signs down length of upper arm. Very swollen. Patient required visit to MD and was informed of allergic reaction & infection. Called patient on 11/21/11 who informed me she is ok.
developed a rash on right side of body and lower back; a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed a rash on right side of body and lower back) and VACCINATION SITE RASH (a rash at the injection site) 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 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 RASH (developed a rash on right side of body and lower back) and VACCINATION SITE RASH (a rash at the injection site). On 10-Apr-2021, RASH (developed a rash on right side of body and lower back) and VACCINATION SITE RASH (a rash at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treated symptoms with Benadryl.
Pt recvd vax & devel a horrendous bowel & gut ache, weakness, fatigue, nausea, rhinorrhea, sweating, h/a, neck soreness & all over body ache, & tenderness in the lower back & thigh; pt had strange dreams, unable to think clearly
pt received Prevnar 20 vaccine on 11/23. pt came in to pharmacy 11/28/22 at around 6:30pm stating that his arm was swollen and it had been red and painful since last week. pt's arm showed a red area along the inner part of the arm to the bottom right of where vaccine was given. pt states that swelling, redness and pain has gone down since last week but is still concerned. pt was advised to contact his provider
Patient presented to the ED on 3/20/2021 and discharged. She presented to the ED again on 3/29/2021 and was hospitalized for 4 days.
gave acthib vaccine to a patient in december that was expired in october with no reported adverse event; Initial information received on 08-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old female patient to whom HIB (PRP/T) vaccine [ACT-HIB] given in december that was expired in october with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Dec-2022 , the patient was given 0.5 ml dose once (1X) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection, (lot UJ589AA:  Expiry date: Oct-2022; strength not reported) via unknown route in unknown administration site for Immunization that was expired in october with no reported adverse event (expired product administered) (latency: same day).  Action taken : not applicable.  Outcome : Unknown.   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 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.
Received ZOSTAVAX on Friday, July 31. When she removed bandage later that day she noted a hard lump about 2" by 1" at the injection site over next 2 days, a rash developed and spread down her arm to the elbow. She saw her family doctor who prescribed a Medrol dose pack. Two days later (8/5/09) saw another doctor who noted increased wheezing.(this is patient's account of symptoms) rash improving.
Receiving 2nd of 6 requested vaccines, had LOC 30-45 seconds.  Non-responsive to verbal/tactile stimuli, extremely pale, slumped in chair, minimal resp. effort.  911 called.  Regained consciousness by their arrival & was PO hydrating & VS monitored (BP 100/70, HR 110).  Given choice by EMT & chose to go to ED.
Violent uncontrollable full-body shaking for an hour with a high fever, shooting pain throughout the body for a day or so.
Injection site tender and warm within 3 hours after injection on 6/15/18. The following morning on 6/16/18, patient experienced malaise which progressed to body aches and chills in the afternoon. Patient woke up on 6/17/18 and body aches and chills had resolved, but patient had a red rash running from the injection site down the arm about 2.5 inches which is warm to the touch.
Case number PHEH2014US015858 is an initial spontaneous report received from the physician assistant on 06 Aug 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: X14024) intramuscularly on 05 Aug 2014. It was reported that the patient received only Men CYW-135 liquid component of vaccine without reconstituting it with Men A lyophilized component. No adverse event was reported following the maladministration.
Pain/ hurt all over; Product Complaint; This case was reported by a pharmacist via call center representative and described the occurrence of generalized aching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized aching (serious criteria hospitalization) and pharmaceutical product complaint. On an unknown date, the outcome of the generalized aching and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the generalized aching to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix from different batches (batch number was not provided). The patient had increased pain and due to which, the patient had to go to the hospital. The reporter indicated that she was seeing an increase in the number of patients reporting adverse events since GlaxoSmithKline had started to increase production of the Shingrix product. She was wondering if she should continue to administer the product. She believed that there might be something going wrong with the process GlaxoSmithKline was utilizing to manufacture the product more rapidly. The reporter hung up the phone and did not provide any additional details.  It was unknown if the reporter had product to return because she would not continue with the call. Additional information regarding events and seriousness criteria was requested. However, case is closed conservatively. This case has been linked to US2019098383 and US2019098282, reported by the same reporter.
1. Burning tongue, spread to mouth, throat, & chest  10:40 AM 10/21/2014. 2. Sensation of weight on chest, difficulty breathing  11:30 AM 10/21/2014. 3. Severe dizziness  10:40 AM 10/21/2014. 4. Severe headache 11:00 AM 10/21/2014. 5. Excessive thirst 11:00 AM 10/21/2014. 6. Nausea  10/22/2014. 7. Chills 10/22/2014. 8. Dry mouth & eyes  10/22/2014. 9. Muscle pain 11/01/2014. Resolved:  #s 2, 3, 4, 6, 7. Not resolved:  All others.
Proquad may have been improperly stored.  No adverse reaction noted.  Will reimmunize in 4 weeks.
This case was reported by a healthcare professional (Certified Medical Assistant) and described the occurrence of sick in stomach in a 15-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Historic vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined ;GlaxoSmithKline;unknown;unknown given on 30 June 2011 and 16 December 2011; diphtheria and tetanus toxoids and acellular pertussis vaccine; GlaxoSmithKline;unknown;unknown given on 16 September 2011. The subject had no reactions to his prior INFANRIX and PEDIARIX vaccinations. On 27 July 2012 the subject received a dose of INFANRIX (intramuscular, right thigh) as the 4th dose in series. On 27 or 28 July 2012, less than one week after vaccination with INFANRIX, the subject experienced sick in stomach, brain pain, injection site redness and puffiness injection site. The subject was sick to stomach complaining that "brain hurts" (brain pain) and redness in thigh closer to injection site, about a "quarter size with a little puffiness". At the time of reporting the events were unresolved. This case was associated with pharmaceutical product complaint. The Certified Medical Assistant (CMA) reported that the office received a new box of INFANRIX with lot AC14B157CA on Thursday, 26 July 2012. Four children received doses from the new box and all were given intramuscular shots. Three different individuals administered the shots. The CMA reported that three of the four subjects were having a "sizeable local reaction". According to the CMA, two subjects received the vaccine on Thursday, 26 July 2012 and two received the vaccine on Friday, 27 July 2012. The CMA explained that the subjects who received the vaccine on Thursday were having a "stronger reaction". This case is one of the subject's who received the vaccine on Friday. See cases A0989417A, A0989437A and A0989439A for details on the other subjects. Follow up received from the healthcare professional (Certified Medical Assistant) on 15 August 2012. The CMA reported that the physician was concerned that something was wrong with the reported lot (AC14B157CA) of INFANRIX since four patients experienced reactions after receiving the vaccination. The office requested replacement for the 3 boxes of vaccines with the reported lot. According to product complaint investigation results reported by GSK Biologicals quality assurance on 21 September 2012, the product complaint was assessed to be unsubstantiated.
Headache, pain at injection site, Extreme high body temp, uncontrolled shaking, fatigue.
This spontaneous report as received from license practical nurse refers to a patient of unknown age and gender. On 27-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported). On 27-AUG-2013 the patient was in the provider's office to receive the second dose in the GARDASIL series. Concomitant therapy was not reported. No adverse event reported. Additional information has been requested.
This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. It was reported that on 05-JAN-2018, the patient was vaccinated with a properly stored but expired dose of PROQUAD with lot number M031566 and expiration date on 24-DEC-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported.
Heavy period happened post primary series. (I was Covid positive at that time); This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 2, single (Lot number: EJ1685) at the age of 44 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for hyperlipidaemia, start date: 2001 (ongoing); CETIRIZINE oral taken for hypersensitivity, start date: 2011 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Time:4:PM, Anatomical Site of injection: L Arm, Route of administration: Intramuscular, Batch / Lot Number: EJ1685), administration date: 31Dec2020, when the patient was 44-year-old, for COVID-19 Immunization, reaction(s): "covid positive and didn't know it. Only symptoms (Sx) were fatigue and back pain", "Heavy period happened post Primary series". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Heavy period happened post primary series. (I was Covid positive at that time)".  Clinical course: Reporter consider Pfizer product had a causal effect to the adverse event. Dose 3, 30Dec2021, L Arm, Intramascular, Moderna 027H21B. Dose 4 15Nov2022 4 Pm, L Arm, Intramuscular, Pfizer GH9697. No Prior Vaccinations. Of note I am the Patient and I am the pharmacist and the vaccine coordinator of the hospital sights where I received the primary series and Moderna Booster. Heavy period happened post Primary series. (I was Covid Positive at that time). And After 2nd booster Nov2022. I did not have it after moderna booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201380361 Same patient, different dose/ AE;
get the shots but have had them twice/Suspected Vaccination Failure; had them twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: get the shots but have had them twice/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that you definitely did not want shingles. The reporter stated that he/she got the shingles shots now but had shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Onset <12 hrs generalized myalgias, arthralgias, upset stomach ("flu-like symptoms"). No history of similar reaction to prior usual doses.
This spontaneous report as received from a certified medical assistant to a 17 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
L arm redden and slightly swollen from under shoulder to 2"-3" above elbow.
Case number PHEH2015US026978, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 35 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 23 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Pt had a temperature of 104F for 48 hours and diarrhea which lasted until the next morning. Mom used Tylenol alternating with Motrin, tepid baths and increased fluids. She finally took him outside in the cold. She states she could not get his temperature to break.
Sharp pains in the chest area, which move around the body, sometimes in the stomach, sometimes around ribs, worse at night and evenings. Worse when sitting or laying down. Treating with Tylenol and Ibprofen according to doctor and nurses at hospital.