chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigued no headache; Slight headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 05Jan2021 15:00 (Lot number: EL1284) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme Disease", start date: May2020, stop date: Jun2020, notes: 28 day course of doxycycline-resolved; "Superior Oblique Myokymia" (unspecified if ongoing), notes: Controlled with chiropractic care/stretching, with vertical double vision when first diagnosed; "HSV" (unspecified if ongoing); "HSV" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D 3; OMEGA 3 FISH OILS; ZOFRAN [ONDANSETRON HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin", notes: Vomiting. Vaccination history included: Flu vaccine (Allergy/didn't do well after flu vaccine in the 70s (according to the patient's mother).), reaction(s): "allergies: Flu Vaccine"; Mmr booster (MMR booster as an adult caused a low grade fever, jaw pain, swelling, difficulty chewing), reaction(s): "Difficulty chewing", "Jawpain", "Low grade fever", "Swelling jaw"; Tdap vaccine (First Tdap as an adult caused a cough for 6 weeks), reaction(s): "cough"; Tdap vaccine (Second Tdap 10 years later did not cause any issues), reaction(s): "No adverse effect"; Td vaccine (Prior to the first Tdap.).  The following information was reported: HEADACHE (non-serious) with onset 05Jan2021, outcome "recovered", described as "Slight headache"; FATIGUE (non-serious) with onset 07Jan2021, outcome "unknown", described as "Fatigued no headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information:Prior vaccination and family medical history relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
CONTRACTED COVID; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-DEC-2021, the patient experienced contracted covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contracted covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000211192.
No adverse effect; A patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On 12-SEP-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot #S002494, expiration date: 23-JUL-2020 (exact dose, frequency, route and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion between 6 to 14 degrees Fahrenheit (F) (10.2 F, multiple) for 50 minutes. There was no previous temperature excursion reported. Digital data logger was involved to capture the temperature excursion. No adverse effect was reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005525: US-009507513-1909USA005365: US-009507513-1909USA005424: US-009507513-1909USA005375: US-009507513-1909USA005139: US-009507513-1909USA005134: US-009507513-1909USA005129: US-009507513-1909USA005124: US-009507513-1909USA005119: US-009507513-1909USA005078: US-009507513-1909USA005220: US-009507513-1909USA005223:
Chills, fever (102) lasting  36 hours, weakness, rapid breathing, muscle pains, nausea, headache (three days), malaise, injection site pain, arm pain. Excepting the injection site pain and arm pain, all very similar to when I was getting COVID (Dec. 2020), with which I had 17 days of fever and illness with severe cough, positive COVID test (Dec. 2020).
Nasal Congestion, Swollen lymph nodes, fatigue, burning sensation in back, torso and extremities
Unauthrozied (Moderna) vaccine given to 13 year old patient. Moderna not currently authorized for emergency use in this age group.
diagnosed as Chickenpox; Severe vesicular rash started on face, neck, and arms, now everwhere.; pruritus; This non-serious case was reported by a consumer and described the occurrence of chickenpox in a 62-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had severe documented chickenpox at age 24.). Concomitant products included celecoxib (Celebrex), cetirizine and atenolol.   On 07-AUG-2023, the patient received Shingles vaccine. In AUG-2023, an unknown time after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: pruritus). On 16-AUG-2023, the patient experienced chickenpox (Verbatim: diagnosed as Chickenpox) and vesicular rash (Verbatim: Severe vesicular rash started on face, neck, and arms, now everwhere.).  The outcome of the chickenpox and vesicular rash were not resolved and the outcome of the pruritus was not reported.   It was unknown if the reporter considered the chickenpox, vesicular rash and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the chickenpox, vesicular rash and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 20-AUG-2023 The Patient states that she had Severe vesicular rash started on face, neck, and arms, now everwhere,  The serious was reported as Intervention.  The patient had severe documented chickenpox at age 24.  The patient asked could not see how you could develop chickenpox from a dead virus.  The physician stated that the patient was contagious. No pain, but severe pruritus.  The reporter consent to follow up.
Significant arm pain at and near injection site, lifting arm above head was VERY painful, avoided if at all possible - 3/12 until 3/16. Fatigue 3/14 until 3/20. Mild diarrhea 3/15 mid-day until evening. General muscle and joint pain 3/15 - 3/16ish. Sore throat and cough - 3/15 to present (3/22/2016).
t103, went down to 102, but up to 104 last noc;no other problems noted @ this time;
Started with a extreme body aches followed by fever and chills.  The adverse reaction however was the intense stomach pain.  Lasted about three days.  Started at the top of my stomach in the center and worked it's way down over the course of approximately three days, every day the pain lessening.
Patient began losing patches of hair (alopecia) in areas of her scalp that previously had hair.
Pt had tongue swelling when patient woke up the next morning, fatigued, developed whelps, arm soreness, no shortness of breath. Whelps have lasted at least 2 weeks. Instructed to report it by GSK.
Arm became sore at 8pm on the day of the 2nd shot, and was progressively worse throughout the evening and night. Around 11:30, severe shivering began and lasted around 3 hours, which stopped after covering myself with a blanket (they started again every time I was uncovered). Also, every 30 to 45 minutes, I had to urinate (seemed to be about half a cup of liquid each time). Next morning (21 hours after the second dose) shivering and constant urination have decreased but arm is still sore.
Per patient's mother, patient could not breathe-needed an inhaler, 103 fever, puking, whole body aches, massive headache, and slept for 5 hours straight.
COVID infection after COVID vaccine 08/20 COVID vaccine dose #1 09/29 c/o cough, Fever, Runny nose Rhinorrhea), CONGESTION, COVID test positive 09/03 c/o Chills- Cough- Fatigue- Fever- Headache- Nausea 10/02 c/o Cough- Fever - Nausea 10/04 c/o Cough- Fever- Loss of taste or smell- Muscle pain (Myalgias) 10/05 c/o cough- Headache- Muscle pain (Myalgias) - fatigue 10/06 c/o Cough- Fatigue- Fever- Headache- Muscle pain (Myalgias)- Shortness of Breath (Dyspnea) Went to ER for Sudden Numbness or Weakness of Face or Extremity- no dx available 10/07 c/o cough (annoying but lessening)- Fatigue 10/08 c/o cough, some fatigue 10/09 c/o frequent cough- Fatigue 10/11 seen at ED for worsening cough, shortness of breath, left arm numbness and tingling; EKG WNL, CXR showed pneumonia, MRI showed compressed nerve in neck that has been causing arm pain, rx'd antibiotics, cough syrup and prednisone 10/12 c/o mild, dry cough; clinically resolved infection
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008CZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided . No treatment medication was provided .   This case was linked to MOD-2021-313106 (Patient Link).
Right upper thigh 4cm x approximate 3.5cm circumscribed lesion. Somewhat light purplish discoloration. Some vesicular areas are hyper pigmented. Area is slightly raised. Triamcinolone given for acute treatment.
Patient called and told pharmacy that she started to taste something weird in her mouth when she got home after receiving vaccine. Communicated to her that we would follow up the next day but to call us if she starts experiencing any worsening symptoms such as rash, inflammation, trouble breathing. Called patient on 9/23/2020 and left a voicemail. Called patient on 9/24/2020 and spoke to patient who told us that the weird taste had resolved the day before and she feels fine.
she felt really cold (chills); she felt really cold (chills); she stated joint pain; not feeling well today; This is a spontaneous report from a contactable consumer (patient reported herself) via Pfizer Sales Representative. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER COVID 19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 28Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical Vaccine included BNT162B2 for Covid-19 immunization. It was reported that, "Pfizer Sales Representative had a scheduled call to discuss Pfizer Injectables updates today. The Pharmacy Buyer reported receiving her second dose of the Pfizer COVID 19 vaccine yesterday 28Jan2021. She reported not feeling well today (29Jan2021). She stated she felt really cold (chills) and believed she stated joint pain. She was going home sick for the day after our call today. Had no additional details. She received the vaccine via employer". Event took place after use of product. Outcome of the events was unknown.  Information about Lot/Batch number is requested.
Arm soreness, chills, fatigue, headache lasted 24 hours. Had same reaction to the first dose, almost identical.
The main symptoms I am having joint swelling in both of my hands. It's the middle and bottom joints.
Patient had flu shot on 10/23/2011. After the shot that evening patient's left arm became weak, she states 50% of arm strength gone. Feeling numbness ever since flu shot administered.
MMR to L arm on 8/2/10. 1-2 days numb fingers (palm side) and pain down (L) side, to ER 8/16/10 given pain meds. 8/23 not resolved yet- can't lay on (L) side- numb fingers & side and deltoid area pain. No noticeable swelling in deltoid area today pain when cross arm to (R) shoulder.
Injection site pain migrating to underarm area; Injection site pain; fatigue; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Dec2021 19:15 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN; FISH OIL; EMERGEN-C. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: P22089500682, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 02Oct2020, when the patient was 46 years old, for COVID-19 Immunization; Comirnaty (Dose Number: 1, Batch/Lot No: P22089500682, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 11Sep2020, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 19:15, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 07Dec2021, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 07Dec2021 07:00, outcome "recovering", described as "Injection site pain"; AXILLARY PAIN (non-serious) with onset 08Dec2021, outcome "recovering", described as "Injection site pain migrating to underarm area". Therapeutic measures were not taken as a result of fatigue, vaccination site pain, axillary pain.  Additional information: Patient not had other vaccine in four weeks. He did not have covid prior to vaccination, and was not tested for covid since vaccination. Patient had no known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
shingles; headache; muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 10th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th October 2020, 2 hrs after receiving Shingrix, the patient experienced muscle soreness. On 12th October 2020, the patient experienced shingles and headache. On an unknown date, the outcome of the shingles, muscle soreness and headache were recovered/resolved.   It was unknown if the reporter considered the shingles, muscle soreness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient experienced muscle soreness all over the major muscle groups. The patient two days after receiving Shingrix experienced shingles and headache. The patient consented to follow up.
On 5/23/21 wife noticed patient had left facial droop, slurred speech, stumbling, off balance. Seen by doctor on 5/24/21 also on 5/25/21 diagnosed with Thalamic stroke. 5/26/21 seen by cardiology. 6/29/21 seen by specialist. Seen  on 7/23/21 by another doctor who requested event be reported and documented in VAERS as recommended per supervisor. Still having right hand numbness and tingling.
muscle pain / following dose 2; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient enquired that how long does muscle pain usually last following to 2nd dose of Shingrix. No other information was available.
sick/ knocked down; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 4th December 2019, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter wanted to find out what was in Shingrix that was making people sick for days?  The reporter wanted to know if it had preservatives in it. The reporter asked pharmacist and pharmacist said that every once in a while people will be knocked down for a few days" after getting injection with Shingrix. This case was linked with the case US2019221810, reported by same reporter.
Information has been received concerning a 12 month old patient who on 05/11/2004 was vaccinated with a dose of varicella virus vaccine live.  On 09/23/2004 the patient developed a breakthrough case of chickenpox.  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter also indicated that another patient developed an adverse event.  No additional information is expected.
Pt given GARDASIL injection, within 5 min pt passed out and fell forward off table onto floor. Examined by dr.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA006643:
Fever CHILLS, BODY ACHES, FATIGUE FOR 2 DAYS. Narrative:  Other Relevant History:
Extreme dizziness and loss of balance for entire day 3 hours after vaccine along with nausea, same symptoms returned the following day around 2pm-11pm. Ongoing off and on
Local reaction to immunization (red, induration on right thigh) rx: cold/ice compress, Motrin 100mg q 6 hrs x 3 days.
Pt left clinic returned approx 1/2 hr later c.o jaws feeling tight; sl tightness of throat; pt has had chest pain & red rash x 1-2month; pt was anxious prior to Td; pt seen in ER given DPH, Decadron;
5 minutes after, stood up, felt dizzy. Tongue began to feel tingly sitting in 15 minute waiting area. Walked back to workplace, slightly tightness in the throat, tongue more tingly , and experienced more dizziness and vertigo. Needed to hold onto wall to walk. Feeling slight weakness in legs. Went to ED with continued dizziness and tightness in throat. Admitted to ED at 1035. VS 150/119, HR 64. Pt states she has white coat syndrome. EKG performed at 10:51. Fluid bolus given at 11:51. VS @11:52 150//91, HR 65. Pt given 975 mg Tylenol PO. After being discharged from ED at 1309, patient took first dose of Benadryl at home around 13:30. At home tongue felt thick/swollen. Second dose of Benadryl taken around 1930 or 2000.  During the night woke up again and felt difficulty breathing and took Benadryl again, around 0300. Has been taking 2 tablets Benadryl ever 6 hours. Patient following up in clinic next day at 1330.
This case was reported by a other health professional via a sales rep and described the occurrence of injection site swelling in a adolescent patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection sited swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown. It was unknown if the reporter considered the injection site swelling and injection site redness to be related to BEXSERO. Additional details were provided as follows: The exact age at vaccination was not reported. The reporter from vaccine service center reported that, a healthcare professional from office stated that three of four adolescent patients experienced bumps and redness at the injection site lasting more than one week after administrations. The reporter had no patient or product information.
I have inflamed lymph nodes under my right armpit. The inflamed lymph nodes pressure seems to be causing a sensation/ sensitivity in my small finger and finger next to it.  And have discoloration on my arm.
Patient immediately experienced soreness on the site of inoculation. Patient had headache for 3 days accompanied by extreme fatigue/tiredness and was lethargic. Patient also was sweating a lot at night.
Received Pfizer vaccines on 1/27, 2/17, 10/15/21 Tested positive for COVID by PCR on 1/5/22 Hospitalized 1/5-1/10 for multiple subsegmental pulmonary embolism, COVID 19 infection
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 12-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083: