chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness of injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE RASH (Rash at injection site) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness of injection site) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient used Benadryl cream as a Treatment medication
Pt reported a pulling sensation on her left arm that felt deep and does not subside. Sensation mimics the sensation of someone grabbing your arm and pulling it. Pt reports no pain, no tingling, no numbness.
Only received the first dose on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose recevied in 2019).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient was late for the second dose of Shingrix. The consent to follow up was given. The patient only received the first dose. No lot number and expiration date provided. No vaccination date provided. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
22 minutes after vaccine had severe racing palpitations, a heart rate of over 150 and visual changes.  Lasted one hour.  Visual changes and some feelings of chest pressure lasted the rest of the day.
within days of vaccine   pt experienced  increased fatigue,  weakness and increased number of falls  ( 3 reported by family member)  , pt had dementia and family noticed worsening of memory after the vaccine ,  Pt experienced heart attack  July 25, 2021
Cold sweats overnight, body hot to the touch in the morning but no fever (98.7). Dehydrated, body sore, head ache. Numb finger tips.
Day 11 .. right arm .. red splotchy rash, hot to the touch  "Covid Arm" No prior symptoms other than sore arm.
Moderna 1/12/21, 2/5/21, 11/30/21. Positive on 5/29/22
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 5-year-old male patient who received FLUARIX Quadrivalent (batch number 29PD2, expiry date unknown). Previously administered products included Flu vaccine (experienced reaction after vaccination). Concurrent medical conditions included asthma. Concomitant products included Measles Mumps Rubella, Albuterol and FLOVENT. On 2nd November 2016, the patient received FLUARIX Quadrivalent .5 ml. On an unknown date, 1 day after receiving FLUARIX Quadrivalent, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovered/resolved. The reporter considered the erythema and swelling to be related to FLUARIX Quadrivalent. Additional information was reported as follows: The patient's mother reported that the patient was vaccinated with the suspect vaccine on the left arm. She states that the patient experienced a reaction after the vaccination and the events resolved within 24 to 36 hours later. She states that the events were not as severe as that of his brother. The patient's brother did not face any reaction after vaccination in 2015. The patient's mother describes that the, he had received MMR and possibly other vaccine 4 weeks within the flu vaccine. She states this year he received the FLUZONE and was having the same issues but not as severe. She noted the dermatologist had done skin testing but he still had a reaction. She also noted this year the vaccine was given as split doses, one in each bicep area. The patient was treated with BENADRYL. This case has been linked case US2017GSK195238, reported by the same reporter for the same patient.
Pain began at injection site (left arm) on Oct 22, 2004 (4 days after injection on Oct 18).  Pain worsened and spread to upper arm and left side of neck in next several days.  Patient saw physician on Oct. 25 who misdiagnosed the problem as a pinched nerve.  Pain became intolerable the evening of Oct 25, and patient went to emergency room where she was given valium and percoset.  On Oct 26, patient noticed a rash at the injection site and visited her physician who diagnosed shingles.
Rash appeared next day after vaccinaton on both arms and upper back.  Patient never had any allergies or rashes before.  It has been a month since immunization and rash is not any better.   I didn't take patient to doctor right away because thought vaccine reaction would go away. Patient also had excessive unusual sleepiness after vaccine.  He would collapse ansd sleep for 5 or 6 hoiurs after school and all day on weekends.  it lasted avbout 2 weeks.
Right after the vaccine I had arm soreness and that night i had the chills.  Now on day 8 after getting the vaccine i am having arm soreness again and it is red, warm and swollen.
COVID19 breakthrough case, patient hospitalized with pneumonia, cough, fatigue, SOB
a 6-inch circular red rash around the injection site that is blistering; a 6-inch circular red rash around the injection site that is blistering; about 7 hours after receiving the Shingrix vaccine she developed a high fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. In AUG-2023, 7 hrs after receiving Shingrix, the patient experienced fever (Verbatim: about 7 hours after receiving the Shingrix vaccine she developed a high fever). On 19-AUG-2023, the patient experienced injection site rash (Verbatim: a 6-inch circular red rash around the injection site that is blistering) and injection site blisters (Verbatim: a 6-inch circular red rash around the injection site that is blistering). The outcome of the injection site rash, injection site blisters and fever were not resolved.   It was unknown if the reporter considered the injection site rash, injection site blisters and fever to be related to Shingrix.     It was unknown if the company considered the injection site rash, injection site blisters and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-AUG-2023 The patient self-reported this case. The patient reported about 7 hours after receiving the Shingrix vaccine she developed a high fever.  The patient still had a fever (on the day of reporting), but it was about 100 degrees.  The patient also reported, a day after the Shingrix vaccine, a 6-inch circular red rash around the injection site that was blistering.  The reporter consented to follow up and gave permission to contact health care professional (HCP).
Patient was given a flu shot in her left deltoid muscle. Less than 5 minutes after administration, patient came back to show that the vaccination site had bled through her bandaid and left a raised, dark knot underneath the skin.
Night sweats; A report was received from a consumer concerning an anonymous female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced night sweats.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30-Dec-2020, approximately 3 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 02-Jan-2021, the patient experience night sweats. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
"armpit is swollen and painful of the arm I received vaccine in"; "armpit is swollen and painful of the arm I received vaccine in"; "underarm armpit lymph node sensitive to touch"; achy body; headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYALGIA (achy body), HEADACHE (headache), VACCINATION SITE PAIN ("armpit is swollen and painful of the arm I received vaccine in"), LYMPH NODE PAIN ("underarm armpit lymph node sensitive to touch") and LYMPHADENOPATHY ("armpit is swollen and painful of the arm I received vaccine in") in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and #031A21A) for COVID-19 vaccination.     Concomitant products included AMBEREN for Menopause, LACTOBACILLUS NOS (CULTURELLE) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (achy body) and HEADACHE (headache). On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN ("armpit is swollen and painful of the arm I received vaccine in") and LYMPH NODE PAIN ("underarm armpit lymph node sensitive to touch"). On an unknown date, the patient experienced LYMPHADENOPATHY ("armpit is swollen and painful of the arm I received vaccine in"). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. In April 2021, HEADACHE (headache) had resolved. At the time of the report, MYALGIA (achy body) had resolved and VACCINATION SITE PAIN ("armpit is swollen and painful of the arm I received vaccine in"), LYMPH NODE PAIN ("underarm armpit lymph node sensitive to touch") and LYMPHADENOPATHY ("armpit is swollen and painful of the arm I received vaccine in") outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vision blurring, cold sweat, racing heart rate, flushing and syncope 5 minutes post-injection. EKG showed ventricular arrhythmia which converted to normal sinus rhythm with regaining consciousness approximately 5 minutes later.
area on lt leg swelled red & hard purple in center;pt a little extra fussy a/APAP;MD office notified 7NOV97;
Chills, Muscle Spasms, Shortness of Breath, Fever, Sweating, Joint Pain, Muscle Aches, Severe Headache. Symptoms resolved within 24hrs except headache and fatigue. Headaches continue and new symptoms have emerged. Acute severe head pain, dizziness, mental confusion, difficulty speaking and visual affects of stars, dark spots and difficulty focusing.
inadvertently administered expired doses of IPOL with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who had inadvertently administered expired doses of ipol with no reported adverse event after receiving vaccine IPV (VERO) [ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (varicella vaccine) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for immunisation; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 24-Apr-2023, the patient received a dose 5, 0.5 ml once of suspect IPV (VERO) Suspension for injection, lot U1A601M, 27-FEB-2023 via intramuscular route in the right thigh for Immunization.  On 24-Apr-2023 the patient developed a non-serious inadvertently administered expired doses of ipol with no reported adverse event (expired product administered) (latency: same day).  Action taken was 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 guidelines. 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.
Patient contact me today to advise me that she received the second dose of the Moderna COVID-19 vaccine on Thursday, May 6, 2021 and noticed she was experiencing facial paralysis on Saturday, May 8, 2021. She also reports experiencing fatigue and chills after receiving the second dose of the Moderna COVID-19 vaccine.
soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 02AL20A) for COVID-19 vaccination.     No medical history was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm) outcome was unknown.            He is not immunocompromised but received a third full dose.  He had soreness in his shoulder and could not lift it for a day and a half.  Concomitant product include Clonipin with unknown indication .  He does not believe his sore arm was an adverse reaction and he is not interested in filling out the follow up form. He wantsto help Moderna by getting his antibody level checked, as a 3 dose recipient of the Moderna COVID-19 vaccine.   This case was linked to MOD-2021-359056, MOD-2021-359050, MOD-2021-359050 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received included date of birth and new reporter added
Severe, debilitating joint pain that presented exactly one week after the initial dose. Joints in my knees, hips, shoulders, and wrists were painful to the point that movement is limited. There is no pattern as to where or when the pain strikes. Usually the pain remains from 24 to 48 hours before it abates. Stiffness, pain, and swelling not helped with NSAIDS or heat. I did not have this severe joint pain before I had my initial Moderna vaccination.
Pt developed a febrile seizure.  Initially she was stiff and trembling with eyes open and rolled up.  Shaking lasted approx 1.5 minute and was followed by atonic episode with perioral cyanosis which lasted for approximately 1 minute.  Upon waking pt was at her behavioral baseline with no residual problems except a fever of 101.0.  The paramedics were called to the home, but no emergency room visit was required.
Swelling and redness surrounding the injection site (the whole upper arm area), some itching, and what seems to be a painful/swollen lump (lymph node) in my lower left armpit.
Information has been received from a registered nurse concerning a patient who on an unspecified date during a several week interval in June and July 2010, was vaccinated with a dose of PNEUMOVAX 23 (lot# 666639/0564Z). Subsequently, the patient developed a case of cellulitis center on the injection site. The patient was treated with antibiotics. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
BLURRED VISION AND ALMOST FAINTED THEN RASH BEGAN IN TORSO AND BREAST AREA.  NEXT DAY THE RIGHT EYE GOT REALLY SWOLLEN ALMOST SHUT
DX COVID-19, 71y.o. female who is admitted to IPR after prolonged hospitalization.  She initially presented with mild COVID (cough and SOB) and fatigue and diarrhea , however progressed significantly requiring MICU care.  She was treated with steroids, baricitinib, remdesivir as well as vanco and cefepime for presumed secondary pneumonia.  She had prolonged recovery and developed significant weakness.  She has been weaned to 2L NC and is feeling better. Discharged to Rehav. In addition she had pancytopenia and initial D-Dimer 1,305.
Started to had cough; Lot of body pain; Temperature 104°F; A lot of headache; Chills; Felt bad; Sore arm; Little headache; Arm tired or heavy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), COUGH (Started to had cough), MYALGIA (Lot of body pain) and HEADACHE (Little headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Little headache) and FATIGUE (Arm tired or heavy). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (Felt bad). On 21-Apr-2021, the patient experienced CHILLS (Chills). On 22-Apr-2021, the patient experienced COUGH (Started to had cough), MYALGIA (Lot of body pain), PYREXIA (Temperature 104°F) and HEADACHE (A lot of headache). The patient was treated with PARACETAMOL (TYLENOL) for Migraine and Headache, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), COUGH (Started to had cough), MYALGIA (Lot of body pain), HEADACHE (Little headache), FATIGUE (Arm tired or heavy), CHILLS (Chills), PYREXIA (Temperature 104°F) and HEADACHE (A lot of headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 104 (High) temperature 104°F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also include Tylenol for migraine.  Patient used wet towels for fever.   This case was linked to US-MODERNATX, INC.-MOD-2021-090600 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090600:Case for husband
This spontaneous report as received from a n unspecified nurse in a doctor's practice via company representative refers to a female patient of an unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# not reported). On an unknown date, within 24 hours following administration of the first dose in the GARDASIL vaccination series the patient experienced nausea and extreme dizziness. The outcome of the events was reported as recovered on an unspecified date. The relatedness for the events with the therapy was not provided. The patient sought medical attention, unspecified how. This is one of several reports received from the same source. Additional information has been requested.
Guillain barre syndrome; bones and joints hurt.; bones and joints hurt.; Now can't sleep due to pain and throbbing and tingling of bones, joints, and muscles;; tingling of bones, joints, and muscles;; Now can't sleep due to pain and throbbing and tingling of bones, joints, and muscles;; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Aug2021 at 09:15 (Batch/Lot Number: FC3810) as single dose for COVID-19 immunisation. Patient age at vaccination was 37-year-old. Medical history included COVID prior vaccination. Concomitant medications included cyanocobalamin (B12 [CYANOCOBALAMIN]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), both taken for an unspecified indication, start and stop date were not reported.  Other concomitant medication included Super B12 Complex. During the first couple of weeks, patient experienced bones and joints hurt. Patient can't sleep due to pain and throbbing and tingling of bones, joints, and muscles. Patient finally went to get blood work yesterday (30Aug2021) and won't know results for a few days. Patient called Primary Care doctor and was going to ER later to be evaluated and rule out that Guillain barre syndrome and anything else. Adverse events start date was 09Aug2021 at 18:00. No treatment was received for the events. Outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
I experienced injection site pain, my arm became swollen, diarrhea, loss of appetite, body aches, fatigue, fever, sweats, and those symptoms lasted for 2 days.
7/28/04 Client c/o arm hurting all day was given Motrin after leaving clinic. Next AM softball size, green colored bruised area to upper arm. Today 8/2/04. Bruising lessened, decreased soreness, leather like feeling to touch.
This spontaneous report has been received from a register nurse, and refers to a 14 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unspecified date, the patient received a dose of PROQUAD through the oral route for prophylaxis (strength, dose number, lot number and expiration date were not reported). There were no adverse effects or product quality complaint involved.