chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a patient of unknown demographics. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in approximately August 2015 (reported as 2 years ago), the patient got a prescription for both shingles vaccine (manufacturer unknown) and pneumonia vaccine (manufacturer unknown). On an unknown date in approximately August 2015, the patient was vaccinated with shingles vaccine (manufacturer unknown) injection (dose, route of administration, lot # and expiration date were not reported). On 03-AUG-2017, the patient went back to get the pneumonia vaccine (manufacturer unknown) injection (dose, route of administration, lot # and expiration date were not reported) and was told that they had gotten the pneumonia vaccine (manufacturer unknown) 2 years before. It could not be reliably determined whether the patient had received a dose of shingles vaccine (manufacturer unknown) or pneumonia vaccine (manufacturer unknown). No adverse effects were reported.
Patient complained redness the size of a quarter, soreness and swelling with concerns of an infections 3 days after the Vaccination when she called the Pharmacy. She was instructed to take TYLENOL and use Ice packs and if it continues to get worse by day 7 to call her medical doctor. In the mean time she was ask to come in the next day for the Pharmacist to evaluate the site of injections. The Pharmacist reported redness the size of a nickel. On day 7 Pharmacist tried to call patient to follow up with her condition related to the vaccination. Patient did not answer and a message was left to return the call. On 10-25-17 day 13 and second call was made, patient answered and stated her arm is getting better. There was no longer any redness, but she did have a sore hard lump in her muscle were the vaccination was given. Since her condition seemed to be getting better I told her it did not look like she needed to see her Doctor at this time and if she had any other concerns to call the Pharmacy.
Achy; Expired product administered; 101 degree temp; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Achy), EXPIRED PRODUCT ADMINISTERED (Expired product administered) and PYREXIA (101 degree temp) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (Achy) and PYREXIA (101 degree temp). 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On 12-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved. At the time of the report, PAIN (Achy) and PYREXIA (101 degree temp) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 101 (High) 101 degree temp.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that three doses were left out at ambient room temperature past there beyond use date. There is a possibility that this individual as well as two others may have received one of these doses. There have been no physical adverse effects reported due to the possible excursion  Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-076450, MOD-2021-076469, MOD-2021-076488, MOD-2021-076520, MOD-2021-076552, MOD-2021-076610, MOD-2021-076389 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Reporter and patient details updated. Event and first dose and second dose details updated.
This spontaneous report as received from a doctor of pharmacy refers to a 74 years old female patient. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SQ on 27-JUN-2011. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that "within the last week or two", in approximately September 2012, the patient experienced shingles. The patient received an unspecified antiviral medication. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after receiving injection.  Less than 10 minutes after receiving injection, pt's son reported to staff that pt was overheated and not feeling well. After receiving ice water, pt became non-responsive to questions and developed tongue swelling, blocked airway and audible wheezing. 0.3mg IM epinephrine injected into L thigh. Pt was laid down in empty exam room. Blood pressure 130/80, pulse 96, temp 96.9. Pt able to sit up, answer questions and breathe comfortably without distress within few minutes of receiving epinephrine. Examined by EMS and declined transportation to ER. Called by physician 4 hours later; pt reported doing well.
I was very tired and had a lot of pain in my left arm. I took Tylenol and had plenty of rest.
Client received Pfizer COVID-19  for 5 years to 11 years old that had expired on 9/30/2022.   No adverse symptoms noticed.
An MA reported that a 39 year old female received an injection of Flu Shield '00-'01 on 11/17/00 and subsequently, developed pain down her right side that extends to her toes. She is also having trouble walking.
COVID moderna vaccine side effects; Allergy ; morphine sulfate   1st dose 1/5/2021: numbness of left arm and right fingers ; left shoulder muscle inflammation for about 4 days and on the 7 th day then lymph node inflammation for about 4 days ; took nsaid for those days ;   2nd dose 2/2/21 ; left arm numbness; and pain ; numbness on the right fingers; Bodily heat, nausea   ; sweat. Temp 98.8 then 99.0 Bp; 124/79; then 115/73   Very tired !  Went home from work . Felt nauseated.  After taking shower felt weak and light headed ; almost fell. Went to sleep early . Throughout the night felt chills and bodily aches and headache; got up at 5:30 am ate a piece of bread with milk ; noticed left eye sight was blurry and both eyes had pus around them; and swollen ; took Tylenol 1000mg the chills and aches lessened after 3 hours .
Complaint of dizziness.  Skin noted warm and clammy to touch.  Onsite emergency response team notified at 3:40 pm.  Alert, oriented and responsive to all stimuli.  Emergency team arrived at 3:43 pm.  Vital signs:  pulse 61, O2Sat 97% on room air and blood sugar 113.  3:50 pm  Vital signs: 94/58, pulse 62 and O2Sat 98% on room air.  3:56 pm transferred to ambulance via stretcher for transport to  for medical evaluation.  Client accompanied by her mother,  .  When transfer from observation, client was alert, oriented and communicating with emergency team.  Transferred at 3:56 pm.
Prolonged pruritic rash x 1 month, treated with Prednisone im, po and Antihistamines
Today is beginning of week 4. Multiple issues main ones were/are Burning/itching at site, Red warm to the touch, knot under injection site, Swollen lymph nodes under arm (still). 2nd day I was wheezing, freezing but no fever, exhausted, palpations. It got worse the 1st week then went away. 2nd week seemed to be all good. middle of the 3r week red again, pain lymph nodes enlaged etc
I have been having high blood pressure issues after the vaccine. Been monitoring blood pressure and trying to control it without medication. Would like to know if anyone else is having the same issue  as me.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2a) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included GEMFIBROZIL, TERAZOSIN and SIMVASTATIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021, outcome of event updated. On 01-Jul-2021: No New Information was received.
Fever with no other symptoms. Fever spiked from 100.4 to 105.6 followed by a 10 to 15 second febrile seizure.
Sudden onset of severe headache, dizziness, joint pain, exhaustion at 9:00pm
patient in his usual state of health. Tested negative for Covid on 12/22/2020. Covid -19 vaccine-Pfizer-BioNTech administered on 12/28/2020. Patient tested  for Covid-19 by swab on 1/8/2021. Result positive. Provider and staff at nursing home communicating regarding patient's condition and care via tele-health - telephone due to restrictions during Covid - 19.
local react rt deltoid; indurated, erythema, warmth 2 cm x 1 cm
Ten minutes after vaccine administration patient started complaining of n/v, palpitations, lightheaded and was observed with cold clammy skin and tachycardia. Upon observation 911 was called.
Febrile seizures, occured in clinic with physician present a little over one month after vaccination. Now every time pt gets even a slight elevation of temperature, she has seizures. A recent pediatrician visit suggested reporting just to be safe as this initial event occurred in 2016, and is still a concern.
Fever, chills, muscle aches, sore joints, swollen glands, headache, fatigue all started the day after the vaccines were given. Patient had to leave work early, and was then unable to get out of bed. Ibuprofen given every 6 hours until symptoms improved, along with adequate hydration and rest.
Pt complained of these reactions after receiving SHINGRIX and visited his MD. Muscle pain, weakness, can't lift arm. Shaking arm stated about 4/13/19, TYLENOL is improving, MD provided Prednisone 4/18/19. Still recovering as of 4/24/19.
administered liquid portion only; administered liquid portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA747A, expiry date 31st October 2023) for prophylaxis.   On 31st August 2022, the patient received Menveo. On 31st August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 2-Sep-2022 Reporter's Comment: Nurse reported that patient administered liquid portion only of Menveo, then administered a properly reconstituted repeat dose the same day on 31st August 2022. Adverse event contains all details provide by health care professional. Health care professional only had one lot number/expiration date available and is unsure which dose it goes to. health care professional gives permission for safety team follow up. The reporter consented to follow up. Additional Supportive Information: The patient received then administered a properly reconstituted repeat dose the same day, inappropriate preparation of medication and inappropriate dose of vaccine administered.
103-104°F fever; nausea; severe pain at the injection site; had hives on the neck, which came and go for about a week.; flu like symptoms; This spontaneous case was reported by an occupational therapist and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), URTICARIA (had hives on the neck, which came and go for about a week.), PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043I20A and 025L20A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA) and HYDROXYZINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced URTICARIA (had hives on the neck, which came and go for about a week.). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site). In February 2021, URTICARIA (had hives on the neck, which came and go for about a week.) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and PYREXIA (103-104°F fever), NAUSEA (nausea) and VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103-104°F fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on birth control. Treatment medication was not reported. No medical history was provided by the reporter.  After the second dose, patient experienced flu like symptoms for 3 days. 8 days later she had hives on the neck, which came and go for about a week.   This case was linked to MOD-2022-466775, MOD-2022-466753 (Patient Link).
ADMINISTRATION ERROR: 17-YEAR-OLD FEMALE PATIENT RECEIVES SECOND DOSE OF MODERNA.
Facility acquired inaccurate data from patient/patient family stating he had received 1st dose of Pfizer vaccine from pharmacy in April, when in fact patient had received Moderna.  He was administered Moderna as a booster dose by the pharmacy, based off the information that had been provided.
No adverse reaction reported.   To whom it may concern: In November 2022 our Vaccine program did our every-other-year audits in both of our offices. It was discovered at that time, that some Covid Vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received.) The Program directed us to fill out VAERS forms and send them to you. They also counselled us that it was our providers and parents joint decision as to whether to re-vaccinate pts or not.  We only use Pfizer vaccines for Covid - and the listed lot #'s given outside the expiration date are listed below.  Location #1 FM0698 (orange top) FM0698 (purple top) FL8095 (orange top) FL8094 (orange top) FM7553 (purple)  Location #2 FM0698 (purple) FP4554 (purple) FL8094 (orange) FL8095 (orange) FT1551 (orange)  Please see the attached VAERS forms, and feel free to contact the office for further questions or concerns.
Lt arm with circumference 9", rt circ 8.5 both mid near deltoid measured no red streaks but mild induration, no increased tp of lt sight.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 24Nov2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates and unknown if ongoing. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER873) via an unspecified route of administration in the left arm on 04Apr2021 at 13:45 (at the age of 52-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 29Apr2021 at 14:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 25Nov2021 at 06:00, the patient experienced swollen and pain in the left armpit, close to the left breast. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and pain in the left armpit, close to the left breast was not resolved at the time of the report.
pt recv vax 11JAN98 & exp localized rxn on 13JAN98;area was reported to be the size of a fist @ the site of vax;instructed on care & if sx worsened med attention needed;w/in 2 days reduced in size & redness subsided;dx infect under skin
Vaccine administered at 11:00. Pt returned to office at 3 PM with gums bleeding. Examined by MD. Dx: bleeding spontaneous, etiology undetermined.
fever, headache, body aches, extremely sore injection sight for 2 days following injection. Jan 9th both legs have become broken out in TONS of bruises and have only increasingly become worse everyday.
Rash, Pain and Swelling. Patient went to Dr and was diagnosed with Cellulitis.
No adverse event; Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.
11FEB92 pt recvd Engerix-B vax & approx 6 hrs post inject c/o hives; hives subsided in a few hrs w/o tx;
3"x3.5" redness on right thigh at injuection Site on right anterior thigh.  No painful. Instructed per physician t apply coolpacks to area.
Within hours of injection I felt significant muscle and joint soreness throughout my body. Fatigue as well. These side effects were not as prevalent after the first vaccination a couple of months ago. I am a fit and active 59 1/2 year old man.
Pt received PENTACEL, PREV 13 and VZV on 8/2. Noted to have localized redness & swelling starting 8/3. Temp 101.9 8/3 pm. Ibuprofen given at home. Rec. to continue and watch for any worsening.
8 cm fairly well - demarcated erythematous, warm area and left shoulder - cellulitis
PATIENT REPORTED TO PHARMACY ON 1/18/2018 THAT HE HAS HAD BACK PAIN STARTING TWO DAYS AFTER IMMUNIZATION WAS ADMINISTERED. BEEN TAKING IBUPROFEN BUT IT'S BEEN TWO WEEKS NOW AND STILL NOW RELIEF. INFORMED HIM TO ALSO REPORT TO DR. GAVE PATIENT ANOTHER COPY OF VIS TO REPORT TO CDC. TO CHECK IN WITH ME IN A FEW DAYS.
Development of nephrotic syndrome; This is a spontaneous report from a contactable Physician.  A 26-year-old female patient the second dose of bnt162b2 (BNT162B2), via an unspecified route of administration in Aug2021 (Batch/Lot number was not reported) (at the age of 26-year-old ) as single dose for covid-19 immunisation.  The patient was not pregnant. The patient medical history was none.  No known allergies. Concomitant medications were not reported. On 30Aug2021 the patient developed nephrotic syndrome roughly 2 weeks after the 2nd dose. Renal biopsy showed minimal change disease. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Starting glucocorticoid therapy as treatment. The patient received treatment for the event.  The outcome of he event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Itchiness; some pain/ Tenderness; swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (some pain/ Tenderness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (some pain/ Tenderness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (some pain/ Tenderness) and VACCINATION SITE ERYTHEMA (redness) had resolved and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Events pain, pruritis and erythema outcome updated to recovered/resolved.Patient denied further contact.
pt recvd flu vax & 24 hrs later exp vomiting, diarrhea, fever to 103, blisters in mouth, axillary swelling & a local reaction consisting of swelling, heat, & redness of upper arm;