chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shakes; Felt hot; Sore Throat; lost balance; Loss of energy; This non-serious case was reported by a consumer via call center representative and described the occurrence of tremor in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAY-2023, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 17-MAY-2023, less than a day after receiving Shingrix, the patient experienced tremor (Verbatim: Shakes), feeling hot (Verbatim: Felt hot), sore throat (Verbatim: Sore Throat), loss of balance (Verbatim: lost balance) and loss of energy (Verbatim: Loss of energy). On 18-MAY-2023, the outcome of the tremor, feeling hot, sore throat and loss of balance were resolved (duration 1 day). The outcome of the loss of energy was not resolved.   It was unknown if the reporter considered the tremor, feeling hot, sore throat, loss of balance and loss of energy to be related to Shingrix.     It was unknown if the company considered the tremor, feeling hot, sore throat, loss of balance and loss of energy to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter stated him and his wife both were on the call. They both had the first dose of Shingrix. The customer (husband) reported that he had all the symptoms on evening when he administered the first dose of Shingrix. The symptoms were resolved except the loss of energy. The patient was not feeling the same since then. The reporter did not consented to follow up.
Tongue had a white coating; Red spots in mouth; Tongue is swollen; This spontaneous case was reported by a consumer and describes the occurrence of   in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment of the event was not reported.
ACHINESS TO LEFT ARM. 7 HOURS AFTER RECEIVING VACCINE EXTREMELY PAINFUL WITH DECREASE ROM.
Pt under 50 and not eligible for 2nd booster but requested another shot of pfizer due to travelling to a Country and was inadvertently administered - primary series with J&J (4/6/21), initial booster with pfizer (12/4/21) and CDC has not made additional recommendations for this category
Severe and disabling vertigo and nausea, requiring being in one lying down position. Unable to ambulate safely. Same position for about 8 hours. Diminishing vertigo after that with lightheadedness continuing for several days.
Numbness on tip of tongue, extreme watering and burning in Left eye, progressed to sagging and and facial paralysis of full left side
SARS-CoV-2 test positive; SARS-CoV-2 test positive; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "SARS-CoV-2 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The patient received COVID 19 Treatment (Paxlovid).  Follow up information has been requested.
No symptoms or treatment needed.  Flu #2 for the season, had 2 last year.
irritability, crying for 2 days; treatment APAP, Ibuprofen; exam nl x/URI sx;
Pt started itching almost immediately. She was given 25mg diphenhydramine with instructions, to contact us and/or Dr if itching was not alleviated.
Fever, Flushing of face, Hoarseness, Acheing joints, Tired.
Pain, frozen shoulder, shoulder bursitis Pain on the outer front side of biceps,  pain when lifting arm above head, restricted arm movement
Developed shingles; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730; EP7533) via an unspecified route of administration in the left arm on 20Mar2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease. The patient was allergic to gluten. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021 at 14:30, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 01Apr2021, the patient underwent rapid PCR test (nasal swab) for COVID-19 and the result was negative. Therapeutic measures were taken as a result of shingles and included treatment with unspecified medication. The clinical outcome of the event developed shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Shoulder area swollen at site - gulf sized - fussy, fever - gave MOTRIN.
Pt called to report that 2 hours after receiving injection she began to have all over body itching and has developed hives. She is taking BENADRYL, hydroxyzine, prednisone. Residual itching/hives resolved.
Skipped a period.  Still have not had a period since the first shot on March 22.
administered frozen Fluarix; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra 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 reporter was a medical assistant. The age at vaccination was not reported. The reporter stated that, the patient was inadvertently administered frozen Fluarix vaccine (vaccine was exposed to minus 1.0 degree celsius), which led to incorrect storage of drug. The reporter did not have any information of patient available at hand and would call back later with patient information. The reporter consented to follow up. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266361:Same reporter US-GLAXOSMITHKLINE-US2021265861:
Information has been received from a nurse practitioner concerning an 18 year old female who on 07-AUG-2007 was vaccinated with a first dose of Gardasil. It was reported that the patient had a pap smear performed in November 2006 the results were positive for atypical squamous cells or undetermined significance but negative for human papillomavirus. On 27-AUG-2007 the patient had a follow-up pap smear. On 11-SEP-2007 the results were positive for the human papillomavirus. Unspecified medical attention was sought. Subsequently, the patient did not recovered. Additional information has been requested.
Vaccination site thrombosis / Blood clots after taking covid vaccines; Muscle atrophy / Lost muscle in legs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Vaccination site thrombosis / Blood clots after taking covid vaccines) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and Rheumatoid arthritis.    No Medical History information was reported.   In March 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced THROMBOSIS (Vaccination site thrombosis / Blood clots after taking covid vaccines) (seriousness criterion medically significant) and MUSCLE ATROPHY (Muscle atrophy / Lost muscle in legs). At the time of the report, THROMBOSIS (Vaccination site thrombosis / Blood clots after taking covid vaccines) and MUSCLE ATROPHY (Muscle atrophy / Lost muscle in legs) outcome was unknown.            No concomitant medications were reported. It was unknown if the patient was enrolled in a Covid-19 vaccine trial. No treatment medications were reported.  Company comment.  This spontaneous case concerns an adult male patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected, serious AESI of thrombosis. The patient received two doses of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The report stated that the patient experienced blood clots after taking COVID vaccines, and lost muscle in legs with Adalimumab. No further details were provided for medical review. Patient´s concomitant medication of Adalimumab (co  suspect product) and patient´s medical history of Rheumatoid arthritis could be confounders for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected, serious AESI of thrombosis. The patient received two doses of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The report stated that the patient experienced blood clots after taking COVID vaccines, and lost muscle in legs with Adalimumab. No further details were provided for medical review. Patient´s concomitant medication of Adalimumab (co  suspect product) and patient´s medical history of Rheumatoid arthritis could be confounders for thrombosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I have PCOS. Due to this I haven't had my period in over a year. Approximately an hour after receiving the first dose of Moderna, I was has severe cramps. Within 3 hours I had started my period. This is the only thing different in my life that could possibly have any effect.
tested positive for Covid; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2022, the patient received the 2nd dose of Shingrix. On 29th March 2022, 4 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: The patient received the 2nd dose of the Shingrix vaccine last Friday (25th March 2022) from day of reporting and on Tuesday (29th March 2022) tested positive for Covid and wanted to know if covid affects the efficacy of the Shingrix vaccine. Additional Supportive Information: This case has been linked to US2022AMR057946, reported by the same reporter. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR057946:same reporter - husband´s case
5cm area raised papular rash @ inj site rt anterolateral thigh w/firm 1cm groin node;
pt recv vax 24DEC96 & APR97 pt exp failure to seroconvert confirmed by serological testing;
Pt complained of a sore arm. She couldn't lift arm on 11/2/01. On 11/10/01, she had a sore throat with phlegm. She denied fever. On 11/11/01, she went to the doctor and was treated with amoxicillin. She feels better.
Pt came in on 10-25-19 with a visibly red, hot arm.  Area extended up & down her arm.  She was diagnosed with cellulitis per the provider who saw her.  She was given clindamycin to treat her cellulitis
administration of Pentacel that has expired on 07Oct2023 to a patient today with no reported adverse event; Initial information was received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was treated with diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [PENTACEL (VERO)] that has expired on 07oct2023 to a patient today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine and influenza vaccine for Immunisation.  On 10-Oct-2023, the patient received 0.5 ml, 1X (total) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, suspension for injection (lot UJ804AA, expiry-07-10-23 and strength: unknown) via intramuscular route in left leg  on  07oct2023 given to a patient today with no reported adverse event (expired product administered) (latency same day) for prophylactic immunization (immunization).  Action taken: not applicable.  At time of reporting, the outcome.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a consumer via an office concerning patient who was vaccinated with GARDASIL (route and site not reported).  The consumer reported that the office had a  "similar but not as serious case" of loss of pigmentation in the skin as his daughter had experienced.  The office said it was caused by GARDASIL.  The office also said it was not an allergic reaction.  Attempts are being made to verify the existence of an identifiable patient and reporter.  This is one of several reports received from the same source.  Additional information has been requested.
tingling in arm since injection.  Like "pins and needles".  Not painful and is sporadic.  Has not gone away.
Redness, swelling at injection site; some itching in body.  Recommended Benadryl and then pt to medical center if anything else.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.  The date of refrigeration was 7 May 2021.
Red raised bumps at injection site that have spread today down legs and feet, up to chest and face.
Case completed primary Covid series in May 2021, then suffered a nosocomial Covid infection in February 2022 while hospitalized for other issues.  Hospitalized  Covid-19: Tested positive after exposure in hospital for encephalopathy.  Treated with 5 days Remdesivir and 7 days of Decadron. "Possible that Covid caused some inflammatory changes of brain contributing to cognitive decline."
patient states she has had eye pain, formation of what she thinks is a cold sore on her nose, and cold hands since vaccination
I began having symptoms November 30th which included quickly becoming out of breath with a small amount of exercise and faster heart rate. Symptoms presented again that weekend (fast heart rate, out of breath, easily tired with minimal exercise). Beginning Decemeber 2nd I had glute and leg pain which I thought was Sciatic pain. I went to see my PCP office Dec 9th and ended up in the ER a few hours later due to left leg swelling to the point of barely being able to stand on it and pain. I was diagnosed with DVT from common femoral to common iliac and bilateral Pulmonary Embolism. I am an avid runner, cyclist, walker, and I eat healthier and stay better hydrated than average. Cause is unknown at this time, but suggestions were made about birth control that I had been on for 22 years or combination of factors. I have not yet had genetic testing, so may have genetic predisposition. I am reporting solely because of reading other reports where vaccines may contribute toward blood clots. I understand risk of getting clots is higher if I had Covid, but I never had Covid to my knowledge.  No injuries, surgeries, pregnancy, or other typical cause. This seems to be happening to a lot of younger otherwise healthy people.
Patient began feeling dizzy immediately after receiving 1st dose of Pfizer Covid-19 Vaccine. Patient ambulated steadily to EMS table. Vital signs checked and stable. Pt with history of type 1 DM, wears a continuous blood glucose monitor. BS within normal limits. Pt observed for extended period of time. Vitals rechecked 30 minutes later, remained stable. Patient eventually reported symptoms resolved and patient exited vaccination clinic in stable condition. No medications given.
24 hrs. after receiving DTAP,Comvax & IPV,pt complained of tender,red,raised area on lt thigh 31cm & rt thigh 29cm.
06jul90 pt vax hepta B. 1/2 hr aft pt ex taste perversion.  w/i next 2-8 hrs pt ex severe nausea which lasted 24 hrs.
I felt so weak - husband had to help me to get around/ I have weakness/ husband had to help me to get around/ My husband had to support me to go to bathroom; I felt so achy; My husband had to support me to go to bathroom; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I felt so weak - husband had to help me to get around/ I have weakness/ husband had to help me to get around/ My husband had to support me to go to bathroom), PAIN (I felt so achy) and MOBILITY DECREASED (My husband had to support me to go to bathroom) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced ASTHENIA (I felt so weak - husband had to help me to get around/ I have weakness/ husband had to help me to get around/ My husband had to support me to go to bathroom), PAIN (I felt so achy) and MOBILITY DECREASED (My husband had to support me to go to bathroom). At the time of the report, ASTHENIA (I felt so weak - husband had to help me to get around/ I have weakness/ husband had to help me to get around/ My husband had to support me to go to bathroom), PAIN (I felt so achy) and MOBILITY DECREASED (My husband had to support me to go to bathroom) outcome was unknown.            Action taken with response to the events are not applicable.   This case was linked to MOD-2021-090459 (Patient Link).
Patient presented to clinic for Moderna Covid19 vaccine administration on 11/6 ~0800.  Spikevax 0.5ml was given in right deltoid.  Lot #8058876.  Patient also had a breakfast drink contaminated with "little dry pack thing" mixed in without realizing this was the case until that evening.  After the end of the 15 minute waiting period, patient complained of bilateral pruritis on both arms.  On exam, provider states there was a rash on the arms.  Patient self medicated with 25mg diphenhydramine with resolution.  Rash reoccurred that evening but was managed with diphenhydramine without recurrence.   Unclear if patient had reaction to vaccine or to the contents in the breakfast drink.
Zostavax administered subcutaneously to Left arm on 4/12/12.  The patient states the area is tender to the touch and there is a reddened area of approximately the size of a half-dollar at the site of administration. The patient also states there is an obtuse-shaped lump under the injection site. The patient states she has not had a fever. The information about this reaction was reported to our pharmacy on 4/16/12.