chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red; Sore; Flu-like symptoms; Body aches; Fever; Stomach ache; Weakness; All joints hurt; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, influenza like illness, general body pain, fever, stomach pain, weakness and joint pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in right deltoid. The patient presented with flu-like symptoms, including body aches, fever, stomach ache, weakness, and all joints hurting, that started 12 hours after receiving the Shingrix vaccine.   The patient also had pain at the injection site immediately upon vaccination and the injection site became red and sore.   All symptoms with the first vaccination lasted for three days and then resolved. For tolerance to 2nd dose, refer case US2018GSK213504.
no adverse event; Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator; Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator), PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (no adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. o13B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator). On 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator), PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator) and PRODUCT TEMPERATURE EXCURSION ISSUE (Receive Bivalent Booster from a vial that experienced excursion for 1 minute in the refrigerator).    Concomitant products were not reported.  It was reported that on 14-Oct-2022, the temperature went for vial up to 8.2C for 1 minute. There has not been a previous excursion. The vial was moved from Freezer to the refrigerator on 13-Oct-2022. The patient received 1 Booster Dose on Monday 17-Oct-2022 and the vial was discarded within 12 hours after first puncture. Storage condition at the time of excursion was reported as refrigerated. Vial size was 2.5ml. The maximum temperature reached was 8.2c. Visual inspection of the vial was normal.    No treatment medicine was reported.
5 days after my shot, I began to bleed. I continued to bleed vaginally for 5 days.  have been post menopausal for about 2 years.
Not received 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose). The outcome of the incomplete course of vaccination 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 Information: GSK receipt date: 05-Jul-2023 The pharmacist reported a patient received 1st dose and coming in for the 2nd dose restart series. Till the date of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Rash/hives resolved by BENADRYL. No further adverse affects as of 12/01/10.
DRUG ADMINISTRATION ERROR; This spontaneous report received from a health care professional concerned 3 patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug administration error was not reported. This report was non-serious. This case, from the same reporter is linked to 20211014697.
maculopapular rash on scalp, back, chest, upper legs and upper arms.
I gave the adult dose (1ml) of Hepatitis B to a child age 13 instead of the children's dose (0.5ml) by accident.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 08-MAR-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Covid after 2 doses of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid after 2 doses of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid after 2 doses of Moderna). At the time of the report, COVID-19 (Covid after 2 doses of Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter and the patient wanted to know how long should the patient wait before receiving the booster dose after experiencing COVID.  No treatment medications were reported.   Reporter did not allow further contact
mom reported 30MAR98 stating child has big red blotches all over body;feet are swollen & won't walk;T102;blotches resemble hives according to mom & are about 1" or larger in size;advised to contact MD;MD felt rxn r/t vax but caused by ATB;
------ SYNOPSIS --------   Recurrent (4 episodes in 7 weeks), initially self-resolving; though the 4th episode has been persistent after 14 days (duration: 3-14 days), unilateral (RIGHT) CHEEK & UPPER-LIP diffused swelling. 4th episode has area under & lateral to the RIGHT EYE involved as well.   - NO PERSONAL history of allergies; no exposure to any new foods or chemicals; no travel. Zyrtec, Benadryl, Flonase, Saline Spray did not *seem* to improve symptoms.  - NO PERSONAL history of sinusitis. - NO change in medication (current medication are Finasteride 1mg & Minoxidil 5% for Alopecia; multi-vitamin supplements). - NO trauma.   RECENT VACCINATIONS: COVID-19 - April 7th 2021, May 5th 2021, Nov 30th 2021 Tdap - Sept 16th 2021 Flu - Oct 28th 2021 HPV - Sept 16th 2021, Oct 28th 2021, final dose is scheduled for Mar 15th 2022.   AUTO-IMMUNE: - FAMILY HISTORY of auto-immune: [Vitiligo (Mom & both maternal grandparents), Grave's disease (maternal uncle), Diabetes (mom), Alzheimer's (maternal grandmother) etc]. - PERSONAL HISTORY of auto-immune: Alopecia Areata (auto-immune disorder) since 2017.   CANCER: - FAMILY HISTORY of cancer: Materal aunt died of Lymphoma.   - NO OTHER SYMPTOMS ... - NO pain/tenderness & erythema. - NO fever.  - NO headache. - NO nasal congestion, runny nose or any other upper respiratory symptoms.  - NO troubled breathing, swallowing or eating. - NO pain in gums or teeth while chewing or otherwise; Dentist did not find anything remarkable during his evaluation and read of panaromic dental x-rays.  - NO tingling/numbness/paralysis. - NO palpable hard mass. - NO fatigue. - NO unintentional weight loss.
FEVER, HEADACHE, DIZZINESS, FRIDAY 10:29 AM; SAT AM 10:15 STILL SICK. SUNDAY 10:30 FEVER DOWN, THROAT DNA-STOMACH UPSET. EATING AND DRINKING.
Patient lost consciousness almost immediately after receiving immunization.  Symptoms: Loss of Consciousness, Low B/P, Paleness, Sweating, Cold/Clammy skin, Nausea, Dizziness, Loss of vision.  She regained consciousness very quickly; but low B/P and Loss of vision persisted.  911 was called.  Response time was approximately 15 minutes after injection.  B/P was monitored and was slowly rising; but never reached a satisfactory level.  Initial B/P reading was 40/20, and rose to approximately 90/50.  Vision was restored in approximately 10 minutes.  Pt refused transport by EMS and was taken home by her mother.
Patient called 10/21/22 complaining of pain at the injection site that started at time of injection and was continuing that day. She stated that it was painful and she saw vaccine leakage at time of injection. Also stated that the injection site, to her, was too high.  As of 10/31/22, she was no longer experiencing active pain, but was concerned about residual nerve damage.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm is very painful/hurts to lift it) and PYREXIA (Running temp 100.1) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm is very painful/hurts to lift it) and PYREXIA (Running temp 100.1). At the time of the report, PAIN IN EXTREMITY (my arm is very painful/hurts to lift it) and PYREXIA (Running temp 100.1) outcome was unknown. Not Provided          Treatment : PII(32):ASqMhfjN9H5a1F2TMEGn2iJiPn6UAmEu No concomitant medication was reported .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 26-may-2021 Non significant information was reported .
After getting the booster shot I can not breathe right; I feel terrible now; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (After getting the booster shot I can not breathe right) and FEELING ABNORMAL (I feel terrible now) in a 99-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNEA (After getting the booster shot, I cannot breathe right) and FEELING ABNORMAL (I feel terrible now). At the time of the report, DYSPNEA (After getting the booster shot, I cannot breathe right) and FEELING ABNORMAL (I feel terrible now) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.
This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) who was vaccinated with PNEUMOVAX23 which was exposed to 12C for 78.5 hours. No adverse effect reported. This is one of several reports from the same source. Additional information is not expected.
About 5 days after the vaccine my arm pit on side of vaccine and both breasts swelled substantially.  Also hurt.  I just used heat and rest as I had had a similar reaction after an MMR about 16 months prior and the news was saying this was a common reaction for Covid-19 mRNA vaccines.   It lasts about 3 weeks so not as long as my MMR experience (which I had seen a doctor for the prior year)  I did report it in my V check reports.    Second.  I reported in my 6 month V check that I have been getting treated for "Low Sodium" in my bloodwork since spring of 2021.  That is for excessive muscle cramping, twitching, spasms in my lower legs, feet and both hands.   My doctor thinks it is part of my autonomic dysfunction issues.  Treatment is ongoing, increased sodium intake substantial, to include a daily 1000 mg sodium tablet.
By 4 pm date of shot the arm was extremely sore, unable to fully lift(even tho I tried to avoid w ROM of arm after shot).  The next day my head hurt, by 1pm I was feeling chilled, by 5pm fever of 100.   I took 3 doses of Tylenol from Thu 3/4 morning.   By 3/5 fever gone, arm still sore but full ROM, just normal post fever malaise.
Pt experienced redness and swelling to both ankles. Several large bumps on both forearms and chest. fever of 106, nauseated, loss of appetite, extreme lethargy, lasted approximately 14 days.
Fever 100.9; Headache; Had sore arm; Chills; This spontaneous case was reported by an other and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 100.9), HEADACHE (Headache) and VACCINATION SITE PAIN (Had sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) on 26-Mar-2020. Concurrent medical conditions included Drug allergy (Allergy to Levaquin.), Drug allergy (Allergy to Cipro.) and Drug allergy (Allergy to Avelox.). Concomitant products included VITAMIN C [ASCORBIC ACID] from 2000 to an unknown date for Sinus infection, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 2018 to an unknown date for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills) and VACCINATION SITE PAIN (Had sore arm). On 27-Feb-2021, the patient experienced PYREXIA (Fever 100.9) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 27-Feb-2021, CHILLS (Chills) had resolved. On 28-Feb-2021, PYREXIA (Fever 100.9) and HEADACHE (Headache) had resolved. On 03-Mar-2021, VACCINATION SITE PAIN (Had sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 100.9 (abnormal) 100.9- oral.         Treatment medication provided by the patient included lots of fluids.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-024820.
Sore throat; Muscle pain around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Muscle pain around the site of injection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Muscle pain around the site of injection). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and VACCINATION SITE PAIN (Muscle pain around the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  No treatment information was provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with first dose of 0.5 ml GARDASIL (lot # not reported) IM on 31-MAR-2011. It was reported that the patient administered the second dose of GARDASIL (lot # not reported) on 26-MAY-2011, and was in the office to receive the third dose of GARDASIL (lot # not reported) on 07-AUG-2012. No adverse effects reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information is not expected.
Patient was administered a booster dose past the BUD. Expiration was 1/20/22 at 1700. Vaccine was administered on 1/21/22 at 0830
Varicella - Information has been received from a registered nurse concerning a 4 year old Caucasin female patient who on 14 Jun 1995 was vaccinated with varicella virus vaccine live.  On 07 Mar 2000 the patient presented with chickenpox that consisted of approximately 30 lesions.  The patient was treated with oral diphenhydramine HCL (Benadryl) and calamine lotion.  Subsequently, the patient recovered.  Additional information has been requested.
Pt states he has numerous rashes all over his body, post vax #4 and rashes are still present. He states he used cortizone to see if it would help, however, he had no relief. Decided to see provider, since the rash was not going away. Provider prescribed Retin-A, triamcinolone and Zyrtec. Pt will be referred to dermatologist (depending on how cremes work). Pt will use creams for 5 days and than make an appointment to see provider again.  Follow up  on 06/05/2000: "Patient did not recover from adverse event.  Symptoms and conditions remain the same."
shortness of breath with exertion, syncopal episode.  Patient found to have significant pulmonary clot burden and CT evidence of heart strain.  O2 sats = 95% on room air.  No family or personal history of thromboembolic events.  Patient BMI = 47.6 kg/m2 and is sedentary.  Vascular is consulted who treats with EKOS.  Patient also has occlusive thrombus of the right distal femoral vein.  Xarelto started at day of d/c.
11/1/2023: Patient right arm where vaccine site was given was swollen red and had a blister.  11/1/2023: Patient went to ER and received ibuprofen, Benadryl, Kenalog 1% cream, and clindamycin.  11/9/2023: Patient blister healed and no issues at this time.
About 10 minutes after leaving H. D. pt. began to itch.  Later that evening she felt sick to her stomach.   The following day (Tuesday) the sick stomach continued and on Wed. she developed redness around the inj. site and fever in the arm.  Thur. still had redness in arm but not hot.Pt. took Tylenol, rested and applied Benadryl cream to arm.
headache; arm pain; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A female patient of unspecified age received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and arm pain on an unspecified date. The outcome of the events was unknown.  Information on Lot/ Batch number has been requested.
A non-serious spontaneous report of headache has been received from a non-health professional concerning a nine-year-old male subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST in 2010. The patient developed a headache in the beginning of Nov-2010 after receiving FLUMIST. The outcome was unknown.
Vaccine administered was discovered to have experienced a low temperature excursion that made the vaccine invalid.  Patient has not reported adverse events due to this administration.
Sweats, soreness around injection site, headache, fever, muscle aches, chills, limited right arm use (temporary).
at 9:12am pt c/o nausea dizziness with feeling of about to faint. patient placed in gurney in supine position with HOB elevated. Vitals monitored vitals BP 121/72 P-69 RR-18 o2- SAT 98% RA t- 98.2 pt. recovered well from symptoms. vitals BP- 135/86 RR-18 P-75 o2-98%  #21 pt stable and sent home  #23  nausea with other vaccine pt cannot remember specific name