chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; prickling/tingling; cough; feeling hot/ flush; hypersensitivity reaction; nerve pain; shingles; severe diarrhea; upset stomach; swelling in armpit; fever; She experienced itchiness on her breast area; Blisters; She experienced itchiness on her left arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She experienced itchiness on her breast area), BLISTER (Blisters), URTICARIA (hives), PARAESTHESIA (prickling/tingling) and COUGH (cough) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Morphine, rash from head to toe), Allergy to antibiotic (amoxicillin rash, 5 to 10 days after.), Drug allergy (Opioids: Percocet, cause upset stomach, rash), Penicillin allergy (upset stomach after 5 days), Sulfonamide allergy (rash), Drug allergy (Vantin - severe diarrhea) and Drug allergy (Chlorycetin - rash and upset stomach). Concomitant products included RAMIPRIL, MULTIVITAMIN & MINERAL, UBIDECARENONE (COQ10 [UBIDECARENONE]), TURMERIC [CURCUMA LONGA RHIZOME] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (She experienced itchiness on her breast area), BLISTER (Blisters), VACCINATION SITE PRURITUS (She experienced itchiness on her left arm) and RASH (Rash). On 28-Mar-2021, the patient experienced URTICARIA (hives), PARAESTHESIA (prickling/tingling), COUGH (cough), HOT FLUSH (feeling hot/ flush), HYPERSENSITIVITY (hypersensitivity reaction), NEURALGIA (nerve pain), HERPES ZOSTER (shingles), DIARRHOEA (severe diarrhea), ABDOMINAL DISCOMFORT (upset stomach), LYMPHADENOPATHY (swelling in armpit) and PYREXIA (fever). The patient was treated with CLOTRIMAZOLE (TERRASIL ANTI FUNGAL TREATMENT) at a dose of 1 dosage form. At the time of the report, PRURITUS (She experienced itchiness on her breast area), PARAESTHESIA (prickling/tingling), NEURALGIA (nerve pain) and VACCINATION SITE PRURITUS (She experienced itchiness on her left arm) had not resolved and BLISTER (Blisters), URTICARIA (hives), COUGH (cough), HOT FLUSH (feeling hot/ flush), HYPERSENSITIVITY (hypersensitivity reaction), HERPES ZOSTER (shingles), DIARRHOEA (severe diarrhea), ABDOMINAL DISCOMFORT (upset stomach), RASH (Rash), LYMPHADENOPATHY (swelling in armpit) and PYREXIA (fever) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: ADR: safety info. anaphylaxis form
Employee returned to Employee Health office after 5 mins. of mumps (MMR) administration complaining of throat feeling "tight", sharp pain on (L) side of neck and nausea. Vitals were obtained, BENADRYL was administered and physician made aware.
warm; red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.
profuse vomiting, no nausea/had a huge episode of vomiting; felt really tired/felt tired; sleeping; This is a spontaneous report from a contactable nurse. A 76-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3302, expiration date: 31May2021), via an unspecified route of administration on 21Jan2021 at 11:00 at single dose on left arm for gain immunity against Covid-19. Medical history included stroke from 2017.  There were no concomitant medications. Caller was reporting on her husband. He received the first dose of the Covid-19 vaccine yesterday (21Jan2021). He felt tired today (22Jan2021). 24 hours after he received the vaccine, he had a huge episode of vomiting. He was not nauseated and didn't even feel sick. He ate this morning as usual. All of a sudden he vomited. He still did not feel nauseated. He was tired on 22Jan2021 and was sleeping in Jan2021. Reporter had not measured his temperature but said he did not have a fever. He hadn't vomited in years. Outcome of the events was unknown. This case was reported as non-serious.
Pt has been having a tingling sensation on her arms, heels and toes since she received the HPV4 vaccine. This was her 2nd dose of the vaccine. This has been happening intermittently and will last for 10-15 minutes each time.
Moderna COVID-19 Vaccine EUA: After receiving the 2nd dose at 7:07 AM, , vaccine recipient experienced headache, lightheadedness, dizziness, and vomiting at 7:10 AM..Vaccine recipient was taken to the emergency department .  The patient received ondansetron, metoclopramide, and fluids.  They felt much better upon reevaluation. They were discharged at 10:36 AM to home.
Patient reports a 4-6 inch x 1.5 inch pale red rash on her right upper arm. Rash appeared approximately 1 week post vaccine. Rash disappeared after 48 hours. Patient reports minor swelling and hot to the touch. Patient denies pain.
had paralyze sensation from her knees to toes/ unable to move her lower legs; This is a spontaneous report received from a contactable consumer (patient). A 22-years-old non-pregnant female patient received first dose of BNT162B2 (Lot number was not reported), via an unspecified route of administration on 13Mar2021 at 09:00 AM at age of 22-year-old at single dose for covid-19 immunisation. The patient had no relevant medical history. No covid-19 prior vaccination. No covid-19 tested post vaccination. No allergies to medications, food, or other products. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing Vitamins. On 20Mar2021, patient was unable to move her lower legs, had paralyze sensation from her knees to toes. Seriousness criteria was reported as hospitalisation. The event resulted to doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was hospitalized for 4 days. Patient received treatment included Morphine and Steroids. The outcome of event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient noticed vision impairment in right eye in September of 2021, was diagnosed with NAION.  Symptoms are stable and have not progressed or improved.
pt recvd vax for prophylaxis;at the same time pt recvd TB test;24 hrs later,exp recurrent fever, cold sweats,herpes-like sore lips,imbalance; resolved on 10feb94
Patient's guardian entered wrong birthday on the immunization constant form which allowed the computer to process 12 and up Pfizer vaccine  for 7 years old patient. The error was caught when the patient came to  get  the second dose. insurance rejection promoted wrong  date of birth. patient did not have any severe adverse event. No further dose was administrated
Booster for Pfizer.  Patient reports vaccine leaked out. Nurse reported small amount leaked out at end of vaccine but it was minimal.   Patient felt it was more around 0.25 ml.  Patient without any response after dose.  Suspect leakage due to available syringes based on my discussion with nurse.  Based on CDC guidelines regarding vaccine administration, will repeat booster dose.
Per parent reaction to shot on back of right arm-red streak, swollen, whole arm sore.  Improved since Saturday 11/10/07.
broken blood vessels around eye; bells palsy on the side of their face and broken blood vessels around the eye; loss of two teeth; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (broken blood vessels around eye) and BELL'S PALSY (bells palsy on the side of their face and broken blood vessels around the eye) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (broken blood vessels around eye) (seriousness criterion medically significant), BELL'S PALSY (bells palsy on the side of their face and broken blood vessels around the eye) (seriousness criterion medically significant) and TOOTH LOSS (loss of two teeth). At the time of the report, EYE HAEMORRHAGE (broken blood vessels around eye), BELL'S PALSY (bells palsy on the side of their face and broken blood vessels around the eye) and TOOTH LOSS (loss of two teeth) had resolved.            Concomitant medication details was not reported. Treatment details was not reported.  Company Comment: This spontaneous case concerns an unknown-years-old-patient, with  no medical history reported who experienced the  expected seriousness criterion medically significant AESI of  Bell´s palsy; the unexpected events of eye haemorrhage  (seriousness criterion medically significant), and tooth loss unknown days after a  dose of  mRNA- 1273 bivalent vaccine. Concomitant medication details nor Treatment details were reported The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2023-727542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727542:Same reporter
arm was red around the injection site about 2 inches; muscle weakness in the arm/ arm felt weak; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 13th August 2020, the patient received Shingrix. On 13th August 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and muscle weakness upper limb. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the muscle weakness upper limb was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and muscle weakness upper limb to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had muscle weakness in the arm. The arm was red around the injection site about 2 inches and then it felt weak. The patient can use arm and was able to do everything with her arm. The reporter consented to follow up.
Second vaccine scheduled 12 Weeks after first vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second vaccine scheduled 12 Weeks after first vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Second vaccine scheduled 12 Weeks after first vaccine). At the time of the report, OFF LABEL USE (Second vaccine scheduled 12 Weeks after first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were provided.
sinus infection; not feeling well; chronic respiratory issues; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Aug2021, the patient experienced sinus infection. On an unspecified date in 2021, the patient experienced not feeling well and chronic respiratory issues. The clinical details of the events as follows: Caller also is not feeling well and thought she may have a sinus infection. The caller reported having chronic respiratory issues. The caller was scheduled to receive her 2nd dose of the COVID vaccine on 09Aug2021, however she was not feeling well. She said she has a bad sinus infection and was seen by her PCP 07Aug2021. Caller was not tested for COVID, however her husband has recently had COVID. The caller would like to possibly delay the 2nd dose due to her not feeling well and wants to know if she can do this. Caller does suffer from respiratory issues. Caller would like to know when she cleared to get the vaccine by her provider or is feeling better. The patient outcome of the events was unknown at the time of this report.  The lot number for BNT162B2 was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
heart attack; This case has been considered as invalid as Unspecified Product. Upon follow-up information on [20Jun2023], this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol increased, start date: 2013, stop date: 02Oct2021; HYDROCHLOROTHIAZIDE taken for blood pressure measurement, start date: 2013, stop date: 02Oct2021. Vaccination history included: Covid-19 vaccine (Dose 1, single Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant) with onset 02Oct2021, outcome "fatal", described as "heart attack". Therapeutic measures were not taken as a result of myocardial infarction. The patient date of death was 02Oct2021. Reported cause of death: "heart attack". It was not reported if an autopsy was performed.   Clinical information: our product killed the reporter dad. The reporter does not know what it was worth, but the reporter father was a great man and killed him. The reporter knows you really do not give a shit, but the reporter thought you needed to know. Any compensation would be helpful for the reporters family and the reporter. After 2nd shot on 22Mar2021 died of heart attack on 02Oct2021. Admission to hospital due to the event was no. Any treatment received was no. The surgery planned prior to taking the product was no. The reporter feels each patient receiving the Pfizer shot should have had their health history looked at. There was no warning label.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: heart attack
Red very itchy filled with liquid spots they stay permanently after the heal arms, legs, buttock.
Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL was administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 28-FEB-2013 (lot # H011350, Expiration Date: 21-FEB-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
Pt recv vax on unspecified date; 20 min later pt exp maculopapular rash on forehead &face w/swelling &erythema on Lt leg.
This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 60 year-old male patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 31/40 which was not suggestive of malingering (<6). The patient was diagnosed with mild mircosmia (22nd percentile). The PEA (phenyl ethyl alcohol) test scores were -4.12 left, -3.12 right and -2.70 bilateral. The Whole-Mouth test identification test score was 88% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Fever - 99.9; Chills, muscle aches; chest tightness; headache, soreness at injection site.
Patient reported having inflammation, heat in area,  redness and itching at the right arm on vaccination site coming back again after it has resolved  approximately one week after his first dose . Patient was recommended to use cold compresses at the area and to take Benadryl for itching. He was recommended to see his primary care physician to evaluate area of skin for further treatment if needed.
Fever/chills, headache, exhausting fatigue, sever body aches that no OTC could help, muscle spasms and pain that started at 1 am the night of booster and lasted for 8 hours that I was aware of. Unable to sleep or function for 2 days- had to call in from work
Pt states that she developed a rash on her chest along with chest and back pain around 1012pm on 4Jan2021
He had a red swollen arm after pneumonia shot and was in hospital + 1 wk.
Patient described "swelling of throat", tachycardia, flushed. Nurse and paramedic collected vitals, nurse administered diphenhydramine HCL liquid 70mg PO at 10:10am. Patient was improving within minutes, and decision to transport via standby ambulance to local hospital ER less than a mile from clinic.  Coordinator spoke with ER - patient received dexamethasone and was discharged, already improved by arrival to ER per nurse. Spoke to patient at 4:30pm - reports return to normal, will not be seeking boost dose.
Flu-like symptoms, inability to utilize left arm (pain 6/10) muscle twitching/involuntary movement in neck and left arm and left side of face, left-sided chest pain (4/10), left axial pain (4/10), neck pain left side (5/10), upper back pain left side (5/10), enlarged lymph nodes on left side of neck and axilla, moderate pelvic cramps (4/10), bilateral leg pain (aching, 3/10)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Jul2022 as dose 4 (booster), single (Lot number: FP7138), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 20Mar2021 as dose 2, single (Lot number: ER8730), in right arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
This is a spontaneous report from a contactable physician and from Pfizer for a contactable Pfizer sales representative and a contactable nurse on behalf of physician. This contactable physician reported different events with the same suspect product for four patients. This is the third of four reports. A 91-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot J67644, expiry date Mar2016), intramuscular at 0.5 ml single dose on 08Jan2015 13:15. The patient medical history and concomitant medications were not reported. On 08Jan2015, the patient experienced large local reaction, cellulitis was also suspected, redness and itchy at site. The outcome of the was recovered. The Pfizer sales representative mentioned that the doctor believed that the reaction was experienced by the patient because of the vaccine, PREVNAR 13. Follow up (23Jan2015): New information from Pfizer for a contactable Pfizer sales representative includes causality assessment. Follow-up (18Feb2015): New information received from a contactable nurse includes: patient's details, date of administration vaccine, anatomical location, details of the events, onset and outcome. Follow-up attempts completed. No further information expected.
This case was reported by a healthcare professional and described the occurrence of arm burning in an adult male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  There were no concurrent medications.  In July 2008 the subject received unspecified dose of ENGERIX B in the left arm.  At an unspecified time after vaccination with ENGERIX B, the subject experienced burning and stinging in the left arm.  At the time of reporting the outcome of the events was unspecified.