chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported back to the vaccination clinic 8 days after receiving first dose Moderna.  She reported that initially after receiving the dose on 1/13/21, the injection site was itchy and sore.  That resolved completed by day 3 and was not accompanied by any other symptoms.  On 1/20/21, her injection site became itchy again and was accompanied by pain and swelling.  On inspection, the site was erythematous, warm, indurated approximately 4 cm in diameter.  Of note, the patient has a keloid scar above this current injection site that she reports was from a "reaction" to a vaccine when she was 5 y.o.  She received that vaccine when she was young and does not remember the name.   Patient was advised to f/u with PCP and educated about symptoms to monitor for and advised to reach out to urgent care if worsening or new symptoms.
HCP is calling because she reported an excursion about a month ago; Expired Vaccine Used; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling because she reported an excursion about a month ago) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling because she reported an excursion about a month ago) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP is calling because she reported an excursion about a month ago) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  Maximum Temperature reached 64°F. Excursion duration: Approximately 7 hours.  Those vials were returned to the freezer/refrigerator or maintained at room temperature. Temperature excursion date was as 10-Mar-2022.
I am unsure of the brand or lot number of TDaP vaccine I  had the vaccine on Wed, on Thurs when I woke up my arm was sore, swollen and red.  This are continued to grow.    Tx with Prednisone tapere dose - effective.    As of 1/10/2021 there is only a small, non-tender lump at injection site.
This spontaneous report was received from a other nurse regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # M043563 and expiry date: 09-JUN-2018 (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature range of 6 Fahrenheit to 47 Fahrenheit to 77 Fahrenheit for 41 minutes. There was no previous excursion. The call was because of a digital data logger. No adverse effect reported. No additional information was provided. No product quality complaint involved. This is one of the two reports from the same reporter. Sender's Comments: US-009507513-1708USA006988.
right arm was red; right arm felt hot; right arm felt swollen; soreness in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her right arm), PERIPHERAL SWELLING (right arm felt swollen), ERYTHEMA (right arm was red) and FEELING HOT (right arm felt hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in her right arm). On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (right arm felt swollen). On 10-Mar-2021, the patient experienced ERYTHEMA (right arm was red) and FEELING HOT (right arm felt hot). On 26-Feb-2021, PAIN IN EXTREMITY (soreness in her right arm) had resolved. At the time of the report, PERIPHERAL SWELLING (right arm felt swollen), ERYTHEMA (right arm was red) and FEELING HOT (right arm felt hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 4:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 4:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator, it was the day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.
23Sept95 Pt recv 1 dose of vax. 21Jan98 Pt devel vesicles on chest,back,legs,head & arms described as "moderate breakthrough"
Pain and swelling of left axillary lymph node on side of injection (left deltoid). Unable to move left arm or lay on left side without extreme pain.
I experienced a severe rash on my whole body, then both arms from my elbow are covered with a red rash, and my face. I  went to see my PCP and was referred to a Dermatologist who administered a steroid shot and some topical cream to apply to the affected areas which made my arms react badly to the cream and also my face. She prescribed doxycycline and I will be taking it along with continuing to apply the new topical creams (one for my arms and one for my face) to see if that will relieve my symptoms.
Information has been received from a Licensed Practical Nurse referring to a 21 year old female patient. On unknown dates the patient was vaccinated with all three doses of an unspecified Hepatitis B vaccine injection (manufacturer unknown) as a child. Then the patient had titers drawn on an unspecified date for Hepatitis B immunity. The titer results were negative for Hepatitis B. The patient did not seek medical attention. No treatment was given to the patient. At the time of this report, the event outcome was unknown. The causality between the event and the vaccination was not reported. Additional information has been requested.
PT NOTICED SMALL BUMPS ON NOSE AND RIGHT SIDE CHEEK DAY AFTER VACCINE GIVEN ON 8/3/17. NO FEVER, SWELLING, SOB, OR CHEST PAIN NOTED.
Patient was supposed to get 0.5 ml dose and was given 1.0 ml dose. No adverse events noted at this time.
PNEUMOVAX 23 admin. 8am 10/3/16 within 5 hrs pain worsening, swelling upper arm to below elbow, arm warm and reddened. Difficulty moving arm. Was improving with BENADRYL and ice by 9pm  Symptoms less today - some swelling, warmth and redness.
Post vax, the pt developed high fever, listless, quiet. Child started vomiting, eyes rolled back. Mom took child to ER and gave Motrin and a dose of Tylenol. Observed in ER for 2 hours. Instructed to give Motrin and Tylenol.
There has been consistent pain in my right arm and neck. I can?t raise right hand high enough when I?m wearing clothes or anything that requires me raising my arms.
Patients mother reports shortly after returning home (approximately 10 minutes after vaccination) patient complained of his arm tingling. Mother reports 20 minutes later, Patient began having a seizure.
This spontaneous report as received from a nurse refers to a 9 week old female patient. The patient has no pertinent medical history and drug reactions/allergies. On 09-JUL-2014 the patient was vaccinated with a dose of RECOMBIVAX HB (lot# J014232, expiration date 29-AUG-2015, dose/frequency reported as directed, intramuscular in the leg as directed). Other suspect therapies included PENTACEL in the same leg. The nurse explained that the office had a patient develop swelling and redness in her leg at the injection site on 09-JUL-2014 after receiving RECOMBIVAX HB. The patient had sought medical attention by office visit. No treatment was given for the events. No lab diagnostics studies were performed. Outcome of the events was reported as recovered. Additional information has been requested.
Patient came in for a Moderna Covid-19 Bivalent booster and received a Fluad flu shot. No adverse events reported by patient.
Pt seen in Medical Center on 8 Aug 2017 for the 7 day post vaccine follow-up. Upon assessment, pt noted to have some topical contact dermatitis due to irritants from bandage, hypoallergenic bandages provided. Pt also noted some localized (left axillary) lymphadenopathy. Pt denied fever, SOB, chest pain. Pt released from public health clinic with instructions to return to clinic if symptoms continue or worsen. On 11 Aug. pt admitted to medical ward via ER due to fever (although afebrile in ER and ward), headache and pain with tenderness to left axillary. Pt diagnosed with lymphadenitis. 12 Aug, pt discharged with follow up appt to ID.
pt recv vax 11AUG97 & 14SEP97 pt exp 8" varicella zoster vesicles on lt anterior lower leg that were painful & itchy;also had discomfort;16SEP97 pt was seen by MD who dx w/zoster like rash;
Red area 3 1/2" diameter with 1/4" area of redness in center. Sore and warm to touch.
Information has been received from a physician concerning a 10 year old female who on 10/21/99 was vaccinated IM with the first dose of Hep B vaccine in the left arm. On 10/21/99, the pt experienced a wheal that was larger than a 50 cent piece on her arm at the injection site. The area was also raised. It resolved after application of ice and then returned. On 10/25/99, the pt recovered. No further information is available.
pt recv vax;exp cold/flu sx,d & joint pain & weakness;this progressed to shoulder pain & right neck pain;also exp HA;
PATIENT BEGAN COMPLAINING OF PAIN, WARMTH AND REDNESS IN HER ARM AT INJECTION SITE A FEW HOURS AFTER ADMINISTRATION. BY THE NEXT MORNING THE PAIN HAD INCREASED AND THE REDNESS HAD EXPANDED. THE PAIN INCREASED AND REDNESS PROGRESSED THROUGHOUT THE DAY. BY THE SECOND MORNING AFTER ADMINISTRATION, THE PATIENT WAS VERY UNCOMFORTABLE AND SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM. SHE WAS DIAGNOSED WITH LOCALIZED CELLULITIS.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date excursion occurred), the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of PROQUAD (Merck): lot# L002419 with expiration date 23-JUL-2016 or lot# reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient fainted a few minutes after receiving the vaccine. He was sitting in a chair and did not fall. He felt dizzy and flushed afterward. He was seated for about 10 minutes until he felt better. He had a sip of water after feeling better and left the store. Upon, follow-up, he was sleeping at home but mother reported him to be feeling much better.
Cried a lot after vaccination. Seemed fussy all day, given Tylenol in afternoon but still fussy. Apnea monitor went off three times between 1-5 AM, one time mom checked and baby wasn't breathing for 20 seconds (usually starts breathing with audible alarm but this time didn't), mom rubbed her, breathing restarted.  This did not happen with vaccines given at before at 2 months or after at 4 months (same vaccines or different).
on and off severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (on and off severe diarrhea) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (on and off severe diarrhea). At the time of the report, DIARRHOEA (on and off severe diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Arm soreness starting around 6:30 pm and progressing until so painful could hardly move arm from 2:30 am on April 1 to 4:30 pm April 1. Nausea and unable to sleep 2:30 am to 6:30 am. Took Aleve and nausea medication. Alleviated a little but symptoms still persisted.
My first dose, my arm was just sore and I was tired.; My first dose, my arm was just sore and I was tired.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 15:45 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pregnancy" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing); "known allergies:Rosemary" (unspecified if ongoing). Date of last menstrual period: 24Jan2021. The patient was 27 weeks pregnant at the time of exposure to bnt162b2. The patient was 30 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 01Nov2021. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "My first dose, my arm was just sore and I was tired.". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: If other vaccine in four weeks: No. Other medications in two weeks: Prenatal vitamins. Adverse event: My first dose, my arm was just sore and I was tired. My second dose, I woke up around 3:30 in the morning shaking so bad I started having Braxton Hicks contractions. My nail beds were blue and I couldn't stop the chills. I ached all over and was running a fever. Then I started vomiting. The chills and shaking stopped after about three hours (with the help of a hot shower, lots of blankets, and a heating pad). The Braxton Hicks contractions stopped after the shaking stopped. I was achy and feverish for over 24 hours though every time the Tylenol wore off. If covid prior vaccination: No. If covid tested post vaccination: No.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient) via the Pfizer-sponsored program. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (administered in Arm Left) at the age of 57years at single dose for Covid-19 immunization: 1st dose on 10Jan2021 (13:00) (lot number: EK4245) and 2nd dose on 07Feb2021 (16:45) (lot number: EL9269). Medical history included allergies to medications (Allopurinol), allergy to food, allergy to Sulfa, allergy to Iodine, allergy to Latex, and allergy to Tramadol, NSAIDS. Concomitant medications included atorvastatin, emtricitabine, tenofovir alafenamide fumarate (DESCOVY), febuxostat (ULORIC), pantoprazole, and budesonide (also reported as budesonite-pending clarification); all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to know if there is any study on people who got the 2 doses of the vaccines and tested positive. The patient clarified that he got both doses of the COVID vaccines and tested positive for COVID a while after. On 05Mar2021, the patient tested positive for Covid-19 via PCR test. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient came into the pharmacy with caregiver to receive 2nd dose of Pfizer COVID-19 vaccine in order to complete primary series. Patient was given updated Pfizer COVID-19 Bivalent dose (booster).
I had a ring shaped rash that was itchy and hot to the touch, starting the day of the vaccine, after an hour. The rash stayed for almost two weeks.
Extreme pain at injection site. Limited ability to move arm, excruciating pain I trusting sleep patterns. Unable to put weight on arm
Chest tightness and coughing (15 minutes post injection) relieved by albuterol inhaler, 2 puffs. Some dizziness noted. No local injection site reaction noted. Recipient has history of asthma. Paramedics called. No additional intervention or treatment was required. Pulse and BP normal.
Vaccine given on 04/10/2000, Varicella reported 04/12/2000.
No adverse event; A patient was administered a second dose of the vaccine after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered a second dose of the vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered a second dose of the vaccine after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered a second dose of the vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A patient was administered a second dose of the vaccine after the published expiration date).    No concomitant medications were reported. No treatment medications were reported.
8 days after injection, I started to have itching at the site...within a few minutes of that, I started to have discomfort at the site and surrounding area...within half an hour, my upper back started to ache between shoulder blades and the site swelled up and became red and warm and more painful.  About an hour from the itching, I began to experience a headache.  The symptoms all lasted about 12 hours except the swelling which lasted about 36 hours.  I did take Tylenol, Advil, and Benadryl the evening of the reaction.
Patient Described initial 24 hours after 3rd booster dose having chills and dizziness which woke her up from sleep that night.  She was able to go back to sleep however the dizziness persisted the next day.  She then continued to have intermittent dizziness for the following 10 days.  This seems consistent with her reaction to the 2nd Pfizer dose of significant dizziness for about 12 hours which resolved spontaneously.  At the time of my exam and appointment on 11/26/2021 her symptoms had completely resolved and her exam was normal.
Had flu shot at 1145, continued work. Around 1345  to develop hives and diarrhea. Hives primarily head/neck/upper back but also in groin, back of legs and arm pits. Was sent to walk in care by supervisors. Was seen at walk in care and given Benadryl/famotidine and DC. Rash and other symptoms dissipated by 6 PM.
Severe Diarrhea, Fatigue and swelling and pain in neck, shoulders and back of head for atleast 10 days could barely move in seriously pain called doctor because pain was so unbearable!
came back to obs at 1304, c/o bue rash and pruritus. no visible redness/rash noted. 1307 bp 127/88, rr 18 sao2 97% on ra. denies pain or distress, continued to monitor, no redness, swelling, or rash noted by staff. 1315 bp 119/83, rr 18, sao2 96% on ra.  continued to show no adverse s/s of reaction, sent home stable with husband.