chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling in right hand; injection site pain; A spontaneous report was received from a consumer concerning a 94-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain soreness at the injection site, tingling in his right hand.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received  first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) pain soreness at the injection site. tingling in his right hand.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain soreness at the injection site, tingling in his right hand was unknown.
Pt seen in office of 4-5 inch area of mild swelling and erythema. Not tender to touch, full range of motion and strength. Advised cold compresses and BENADRYL with follow up if no improvement in 3-5 days.
Patient received vaccination this morning. Patient informed me later on that day that she ended up having an anaphylactic reaction no more than 15 minutes after receiving the vaccination and went to the ER. Also informed me that she did not wait around for 15 minutes after the vaccine. She told me she administered an epipen at home and then went to the ER for further treatment. Patient has since been released and is doing well with medication prescribed from the ER. She called me after she left ER to let me know what had happened. The anaphylactic reaction did not happen at our pharmacy/store as patient already had left.
sweaty; Underneath the rib, in her diaphragm, having pain; Diarrhea was bright yellow; Underneath, the muscles are sore; Diarrhea; Joint pain and heaviness; Vomiting; Tired; Really chilly; Arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 (Lot number: FH8028) at the age of 60 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history includes block production of the aldosterone hormone, enlarged ventricle, Hyperaldosteronism, Conns Syndrome, diagnosed with a latex allergy, notes: Was diagnosed with a latex allergy, from an unknown date and unspecified if ongoing. Concomitant medication(s) includes metoprolol, spironolactone taken for blood aldosterone abnormal, entresto. Vaccination history includes Bnt162b2 (Dose:1, LOT: EN6207, Route: Injected into left arm), administration date: 15Mar2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): chills; Bnt162b2 (Dose: 2, LOT: ER8732, Route: Injected into left arm), administration date: 05Apr2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): chills, Legs felt heavy, Hepatitis (Back in 1991 or 1992, had vaccination for Hepatitis. Had a reaction in the thigh with itchiness, redness, and bumps.), for Immunization. On 28Oct2021 the patient had experienced Really chilly, Arm hurt, on 29Oct2021 Vomiting, Tired, on 30Oct2021 Joint pain and heaviness, on 31Oct2021 Diarrhea, On an unspecified date sweaty, underneath the rib, in her diaphragm, having pain, diarrhea was bright yellow, underneath, the muscles are sore. Patient underwent lab tests and procedures on an unspecified date for body height with results of getting shrunk. Provides 5 feet 2.5 inches and bloodwork investigations of unknown results. The outcome of Really chilly, Diarrhea was recovered on 31Oct2021, Vomiting was recovered on 29Oct2021, Arm hurt, Tired, was recovering, Joint pain and heaviness, sweaty, Underneath the rib, in her diaphragm, having pain, diarrhea was bright yellow, underneath, the muscles are sore was unknown   No follow-up attempts are possible. No further information is expected.  Follow-Up (08Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101495427 same patient/drug, different dose/event
Fever, pain while breathing. Onset of symptoms 9-26-06. Severe and continuing headache, profuse sweating, extreme chills, swelling of gland in right armpit area (very painful), severe body aches (including injection site).
Itching and redness began about 1? below the injection site on 2/13/21 (10 days after the shot was administered).  A bright red circular spot  ~ 1 5/8? high by 1 3/8? wide appeared on 2/13/21  with minor tenderness at the site when pushed.  Itching abated, but on 2/14/21, the  redness had increased to  ~2? high by 1 3/4? wide.
1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself having trouble breathing while dreaming. I sat up, elevated, and went back to sleep. SOB that afternoon. I slept and woke up the next day and felt fine, went to work.  1/14 I worked all day. 3:10 I couldn't breath. Was with my neurologist. Pulsox was 79. I went to the ER. Hooked me up to IV, chest xray. Dr. said anxiety was up. After 4.5 hours I was able to go home. symptoms subsided.
1st dose in Aug 2018 has not received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable. The patient had not yet received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. No demographics provided. The reporter did not consent to follow-up.
Few, scattered maculopapular lesions (<10) over trunk and limbs. 1-2 lesions are vesicles.
Approx 2 1/2 hrs p/vax pt had episode of projectile vomiting x 3; t101 R; taken to hosp & observed x 6 hrs;
Red, warm to touch about 10 pm 5/31/11 then increased 1 d 6/1/11.
Little pimples all around the injection site; developed itching at injection site; soreness at injection site while rubbing; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Little pimples all around the injection site), VACCINATION SITE PRURITUS (developed itching at injection site), VACCINATION SITE PAIN (soreness at injection site while rubbing) and VACCINATION SITE ERYTHEMA (redness at 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE REACTION (Little pimples all around the injection site), VACCINATION SITE PRURITUS (developed itching at injection site), VACCINATION SITE PAIN (soreness at injection site while rubbing) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, VACCINATION SITE REACTION (Little pimples all around the injection site), VACCINATION SITE PRURITUS (developed itching at injection site), VACCINATION SITE PAIN (soreness at injection site while rubbing) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
fatigue; I felt some chills; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 25-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03May2021 (at the age of 25-years-old) (Batch/Lot Number: Er8731) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included polycystic ovaries, depression, insulin resistance, asthma, allergies. The patient's concomitant medications were not reported.  It was reported that the patient felt some chills and fatigue for the first 24 hours after first vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
Began mild physical exercise 10 days after vaccine #2.  Extreme muscle soreness even though hydrating and following an appropriate diet.  Soreness continued for 4 days reaching a pain level of 9/10.  On the 4th day began urinating dark brown, foamy urine.
Rash & pruritis to back immediately following 1st dose of Pfizer COVID-19 vaccine.  While in the ED, rash continued to spread & itching of the throat developed.  Treated with oral Benadryl 25mg, Oral Pepcid 20mg, I.M. Decadron 2mg, I.M. Epinephrine 0.15mg.  Condition improved & she was discharged home with her mother.  Given prescriptions for Benadryl and Pepcid.
Patient presented at her primary providers office with a chief complaint of redness, soreness, swelling and a hard bump on her arm. Per nurse, at Medical Group it was recorded that the patient had swelling and a rash on the back of the right arm superior to the elbow, The pt was instructed to alternate applying heat with ice to the affected area, and to take ibuprofen as needed for pain. She was instructed to report to the emergency room if her symptoms worsened.
None but patient is pregnant. EDD is Nov. 9, 2019. Patient shouldn't have received this Men B vaccine.
inadvertent administration of only the diluent of Menveo to a patient; inadvertent administration of only the diluent of Menveo to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A, expiry date 31-MAY-2024) for prophylaxis.   On 21-JUL-2023, the patient received Menveo. On 21-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertent administration of only the diluent of Menveo to a patient) and inappropriate dose of vaccine administered (Verbatim: inadvertent administration of only the diluent of Menveo to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 28-Jul-2023 A nurse called to informed about the inadvertent administration of only the diluent of Menveo to a patient. The reporter told that it had not been determined who was the patient that received only the diluent. However, there were two potential patient who both received the 1st dose of Menveo back. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This is 1 of 2 linked patients cases, reported by the same reporter. The patient only received the diluent of Menveo vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023AMR104310:Different patient, same reporter, same product
suspected vaccination failure/had all the shots, they still pop up on me; they still pop up on me; Burning; Itching; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the burning sensation and pruritus were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The case was reported by the patient via interactive digital media. The patient stated that the so sorry for the loss. The patient had all the shots and they still pop up on him/her every few months. The patient started medication as soon as the burning and itching started and it stopped them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
RECOMMENDATION ASK FOR PREVNAR-2O , AT TIME OF VACCINATION IT WAS NOT AVAILABLE, PATIENT WAS GIVEN PREVNAR 13 AND ASKED HER TO COME BACK 12 MONTHS LATER TO GET PNEUMOVAX
Patient dies of covid-19 related illness weeks afetr receiving second covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient dies of covid-19 related illness weeks afetr receiving second covid vaccine) in a 36-year-old patient of an unknown 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, the patient experienced ILLNESS (Pateint dies of covid-19 related illness weeks afetr receiving second covid vaccine) (seriousness criterion death). The reported cause of death was covid related illness. It is unknown if an autopsy was performed.            No concomitant medications were provided. No treatment information was provided.  This case concerns a 36-year-old patient of an unknown gender with no reported medical history of who experienced the unexpected fatal event of covid 19 related illness. The event occurred after an unspecified time after administration of the second dose of mRNA-1273. The rechallenge was not applicable as this event occurred after the second dose with a reported fatal outcome. Causality assessment for the event was not reported. However, covid 19 is considered as not applicable due biologically implausible based on known etiology. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 36-year-old patient of an unknown gender with no reported medical history of who experienced the unexpected fatal event of covid 19 related illness. The event occurred after an unspecified time after administration of the second dose of mRNA-1273. The rechallenge was not applicable as this event occurred after the second dose with a reported fatal outcome. Causality assessment for the event was not reported. However, covid 19 is considered as not applicable due biologically implausible based on known etiology. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: covid related illness
Localized erythema, induration at site of vaccine (DTAP) injection. No fever or other systemic symptoms.
Patient was administered a dose / exposed to a freezing temperature; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old female patient who received HAB (Twinrix) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported.  The Pharmacist reported a patient was administered a dose of Twinrix after it had been exposed to a freezing temperature of negative 8 degrees Celsius, which led to incorrect storage of drug. The reporter consent to follow up.
Large area of erythema, warmth and swelling around site of IPV and DTAP vaccines right thigh noted 2 days after vaccine.
Complaints of low grade fever (99F), dizziness and fatigue, headache approximately 3.5 hours after receiving immunizations. Continues to complain of same symptoms on 11/24/04. Has been attending school; not ill enough to stay home or see doctor.
High fever, elevated heart rate, severe malaise, SOB, diffuse myalgia,  wheezing, headache, itching everywhere
Patient received his shot and then went to the checkout desk to check out. While standing at the checkout desk he passed out and hit his head on the wall.
Shots yesterday and low fev. Now rash spreading and swelling of both ankles and thighs. At 8:30 pm 9/16 swelling nearly gone after giving children's BENADRYL. Back an 9/17.
Burning, tingling down the right arm immediately.  After a few hours, involuntary twitching of same arm.
HAD HEP A VACCINE ON 01/07/2022 AT WELL CHILD EXAM, DURING EXAM WAS NOTED TO HAVE SLIGHT NASAL DRAINAGE, ON FOLLOWING DAY HE AWOKE WITH RASH ON ARMS AND LEGS, ALSO HAD MORE URINARY ACCIDENTS, THAT EVENING HIS ROLLED BACK AND HE BECAME UNRESPONSIVE FOR 2 MINUTES, WAS THEN NOTED TO BE TIRED. APPROX. 40 MINUTES LATER WHILE ENROUTE TO EMERGENCY ROOM HE AGAIN BECAME UNRESPONSIVE, BODY WENT STIFF, AND ALL FOUR EXTREMETIES WERE SHAKING. THIS LASTED APPROX 1-2 MINUTES. AGAIN TIRED AFTERWARDS.
Patient was administered TDAP at 28 weeks gestation on 9/7/23 and readministered on 10/17/23 @ 33 weeks gestion. No adverse reaction noted, patient has been seen in the office for 2 appointments since the injections. estimated due date 11/30/23.
Information has been received from a physician concerning a female (age not reported) who on 26-OCT-2006 was vaccinated with a first dose of Gardasil. In February 2007, approximately 3 to 4 months after receiving Gardasil, the patient experienced a spinning sensation along with tingly, paralyzed feeling. The physician stated that it was possibly basilar artery migraine, and the physician referred the patient to a neurologist. The physician did not plan to continue the series of injections. At the time of this report, the outcome was unknown. Additional information has been requested.
Passing out POT syndrome has occurred 10 times since initial vaccine; Passing out POT syndrome has occurred 10 times since initial vaccine; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 15:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included history of migraines from an unknown date and unknown if ongoing. Concomitant medication included vitamin d3 taken for an unspecified indication, start and stop date were not reported. Passing out POT syndrome has occurred 10 times since initial vaccine worsening post second vaccine on 13Apr2021 12:00. The patient experienced "passing out POT syndrome has occurred 10 times since initial vaccine" and was reported as worsening post second vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Therapeutic measures taken as a result of the event included a Heart monitor (as reported). Outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Injection site reaction after 3rd injection of GARDASIL HPV vaccination on left side arm. The subject's arm swelled from the shoulder to the elbow. The swelling was hot to touch. The injection left a dime sized bruise around the site. Swelling lasted greater than three days. The subject has difficulty moving limb. The entire left side of body is weak.
Numbness, tingling on left side of face and finger tips. Evaluated by EMS-Cleared
Approx 3 yrs post vax, pst seen w/ classic varicella, papulovesicular rash, umbilicated vesicles primarily on head and upper tunk.
A bad cough; The sides of my tongue went numb; My lips and cheeks started tingling; later my lips and cheeks started tingling.; I developed drainage in the back of my throat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 10:45 (at 34-year-old) (Batch/Lot number was not reported) as single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at workplace clinic. Medical history included fertility issues from an unknown date and unknown if ongoing. Concomitant medications reported as prenatal vitamin and folic acid supplement. Known allergies and allergies to medications, food, or other products was reported as no. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was waited for 15 minutes and then started drive to home. On 17Mar2021 at 11:15, the sides of tongue went numb, and then a few minutes later lips and cheeks started tingling. Also, developed drainage in the back of throat and a bad cough. The numbness in tongue only lasted a few minutes, but the other symptoms lasted several hours even after IV steroids and an epi shot. The events resulted in Emergency room/department or urgent care. The outcome of the event numbness in my tongue was recovered on 17Mar2021 whereas rest of the events was recovering.  Information about batch/ lot number has been requested.
Breakthrough case admission after 4 vaccines Pfizer 3/22/21 Lot# ER8727;  Pfizer 4/12/21 Lot# EW0150;  Pfizer 12/23/21 Lot# FE3594;  Pfizer 7/27/22 Lot# FP7150
the right axilla spot grew further and pain radiated toward the right breast; the right axilla spot grew further and pain radiated toward the right breast; shingles; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 39 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 14:00 (Batch/Lot Number: EW0169) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included herpes zoster from 2018 to an unknown date Previously had shingles in 2018. Concomitant medication(s) included fluoxetine hcl (FLUOXETINE HCL) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced rash. The patient experienced the right axilla spot grew further and pain radiated toward the right breast with skin discolouration on an unspecified date with outcome of not recovered and shingles with herpes zoster on an unspecified date with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.