chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 vaccine administered. Counseled patient/family about possible side effects for COVID-19 vaccine, that two doses are needed at timeframe appropriate for specific manufacturer and what to do in case of emergency. Written Emergency Use Authorization (EUA) fact sheet was provided. Patient advised to continue masking and social distancing. Patient monitored for reaction as recommended per ACIP guidelines after vaccine administration.  Approximately 15 minutes after vaccine administration patient started to complain of bilateral upper extremity muscle aches. After another 20 minutes she noted that she was starting to have a sensation of her throat itching and closing. EMS was called.  No acute distress noted. Patient speaking clearly and in full sentences. Airway patent and no swelling to neck, face or lips noted. Lungs clear bilaterally and moving air well. Skin warm and dry. Mild redness noted to upper chest.   Patient evaluated by EMS and discharged. Patient monitored for an additional 10 minutes without incident. Patient still complained of upper body aches but stated that she felt ok to leave. She verbalized understanding to call 911 or go to ER if symptoms change or worsen.    Attempted to call patient 12/31 @ 1741 for follow up. No answer, left message with guidance to continue to monitor symptoms and go to ER for any urgent concerns.
This spontaneous report was received from a nurse practitioner and refers to a 7 month 22 days old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 20-MAY-2016, the patient was inadvertently vaccinated with dose of GARDASIL lot # L035105, expiry date 14-MAY-2017 (dose, administration route and anatomical site of injections were not reported). Concomitant therapies were not provided. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 30-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiration date, dose unspecified) subcutaneously. Other suspect and concomitant therapies were not reported. After vaccination, the patient came in contact with poison ivy. On 01-OCT-2015, the patient developed a "rash all over her body". The patient went to see a physician, but no treatment was given for event. At the time of this report, the patient had not recovered from the events. Causality was not provided. Additional information has been requested.
First injection, patient pulled away and patient didn't receive any amount of vaccine.  It was all on her skin.  Injected her a second time with correct amount.  Patient is ok.  This is the bivalent dose.
I developed what seems to be hives around the injection site of the vaccine on my left arm.  My skin felt hot to the touch where the hives had formed. It started just around the injection site, then spread to my left shoulder and lower on my left arm. I also had some mild pain in my armpit, which may have been my lymph nodes. This occurred about 8 days after the injection, and lasted about 2-3 days. I put a heating pad on my arm, and that seemed to help the symptoms to dissipate.
A spontaneous report was received from a consumer concerning a consumer of unknown age and gender who received Moderna's COVID-19 vaccine and experienced extreme chills, headache, muscle pain, joint pain and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Dec 2020, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient had extreme chills throughout the night, headaches, muscle and joint pain and fatigue. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events were unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient had arm swelling and redness.  She decided to go to urgent care and provider treated with an antibiotic.
2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, arm rashes shoulder to wrist.  Body aches and bad weakness  for about a week.  Rashes on arm  and swollen arm lasted 9 days.
10min p/vax pt devel swelling, erythema, warmth, & hives on both legs;tx w/DPH & recovered 20min p/DPH;
Site on upper right arm appeared red, swollen and hard with a measurement of 60mm induration. Patient denied any itching or difficulty breathing.
Cellulitis at site of vaccine, measuring 10cm x 9cm. Erythema and warmth present.
Patient presents with complaint of numbness, tingling sensation, and nerve-related pain in his left arm that has been occurring for 21 days. Vaccines administered on 10/10/2022 and has had these symptoms ever since. Pain does not go away with non-pharmacological treatments.
Within 90 minutes of receiving vaccinations - developed pruritus bilateral arms. Within 2 hours - rash spread to chest, trunk and bilateral lower extremities papules, pruritus. BENADRYL 25 mg given with relief @ 1200N took another BENADRYL 25mg at 130P symptoms resolved.
Pt recvd vax & devel pain & an abscess @ site of inject; Incision & drainage of the abscess was required on 3FEB92 & pt recvd ATB therapy;
Reported numbness in lips and L Malar area; no angioedema Narrative:  Employee was taken to facility in wheelchair, evaluated and stable. Diagnosis vasovagal due to needle anxiety vs mild allergic reaction to MODERNA vaccine. Given 50mg Benadryl and Solumedrol 125mg IM. Monitored for 30 minutes, completely asymptomatic. Release home in care of wife.
A nurse practitioner reported that a 65 year old female inadvertently received an intradermal injection of Pnu-Imune 23 vaccine on 03/28/01. That same day, she experienced an injection site reaction characterized by a 2 cm area of warmth, redness, two streaks going up her arms and axillary nodes swelling. No further information was available at the date of the report. Additional information received fromn the reporter on 07/02/01 provided additional information and responsible physician and stated that the patient recovered.
Patient fainted after receveing flu shot. He fell on the ground from a standing up position. 911 was called and ambulance took vitals of patient. He was unconscious for 20 seconds. Patient went home 20 minutes later with his wife.
Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am; No adverse event; Vaccine dose given outside the 12hr post puncture time.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose given outside the 12hr post puncture time.), PRODUCT STORAGE ERROR (Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am) and NO ADVERSE EVENT (No adverse event) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies or had any medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. It was unknown if patient was ever tested positive for COVID-19 or had diagnosis.     On 02-Sep-2022 at 9:42 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Sep-2022 at 9:42 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose given outside the 12hr post puncture time.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine dose given outside the 12hr post puncture time.), PRODUCT STORAGE ERROR (Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine dose given outside the 12hr post puncture time.) and PRODUCT STORAGE ERROR (Vial was first punctured on 01-Sep-2022 at 8:30 am and administered at 02-Sep-2022 at 09:42 am).    Concomitant drugs were not reported. It was reported that the patient received full dose. The 1 dose vial was stored in refrigerator post puncture and  was unknown when the vial was initially stored in refrigerator.  The vial was exposed to room temperature for less than an hour and did not undergo any temperature excursion. It was unknown if patient ever seek medical care or if experienced a similar event in the past. Unknown if the symptoms were improved or worsened. Treatment medications were not provided.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a lack of response.
headache; achiness; chills; a mild fever; received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised; some flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (some flu-like symptoms), HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (some flu-like symptoms) and OFF LABEL USE (received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised). On an unknown date, the patient experienced HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 31-Aug-2021, OFF LABEL USE (received her booster or the 3rd dose of Moderna COVID 19 vaccine, She said she's not immunocompromised) had resolved. On 01-Sep-2021, INFLUENZA LIKE ILLNESS (some flu-like symptoms) had resolved. At the time of the report, HEADACHE (headache), MYALGIA (achiness), CHILLS (chills) and PYREXIA (a mild fever) outcome was unknown.            Patient mentioned that her doctor's office did not say anything to her when they gave her the 3rd dose. She had some flu-like symptoms right after the 3rd dose. They lasted 24 hours and went away. She had the typical headache, achiness, chills, and a mild fever. She could not tell for sure if she had a fever since she did not have a thermometer. She slept and took acetaminophen.   For 3rd dose lot number provided as 062E214 or 062E219.  No concomitant medication was reported.
Vaccine vial put back in refrigerator & dose administered from that vial at approx 30 hours after opening. No adverse reaction reported by pt.
Pfizer 1/30/21, 2/20/21, 9/14/21. Positive on 4/28/22
Hand pain; Throbbing in hand; Hand is like red; Burning sensation; A spontaneous report was received from a 54-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throbbing, burning sensation, hand pain, and hand is like red.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) on her right hand for prophylaxis of COVID-19. She stated that her hand was like red and it was throbbing, had burning sensation and pain, red sharp pain. The patient took ibuprofen, which helped.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, throbbing, burning sensation, and hand pain, was resolving.; Reporter's Comments: This case concerns a 54-year-old, female patient, who experienced a non-serious unexpected event of pain in extremity and pain, and a non-serious expected events of injection site erythema, and injection site pain. The events occurred 1 day after first dose of mRNA-1273, lot # unknown. Treatment included Advil. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
bilateral wrist stiffness Narrative: Patient's husband reported patient had immediate, bilateral wrist weakness after both COVID-19 vaccinations. the Husband did not mention anything regarding if this problem went away on its own, how long it persisted, if the sought medical help, etc.
Patient reported significant swelling and redness at the injection site in the left arm. Patient was instructed to treat with OTC NSAIDS to reduce symptoms.
Patient received Meningococcal Conj. vaccine.  Did not wait more than couple minutes to exit office.  Fainted outside of office and parent states hit head.  Severe headache post fainting. Examined by physician in office right after.
21 y/o AD Female reports inadvertent receipt of yellow fever (live virus) and pre-exposure rabies #3 (inactivated virus) vaccines during pregnancy. The SM received the vaccines on 11MAY10 and signed a form saying she was not pregnant at the time, but a urine HCG was not obtained. On 13MAY10 the SM had a + Serum hCG test/ OB Hx: Gravida 1, para 0, aborta 0, stillbirths 0. Was notified and recommended that the SM be seen by OB and notify the Provider of her inadvertent receipt of live virus vaccines during early gestation. Her LMP was 11APR10. The SM also received pre-exposure rabies #1 on 19APR10, pre-exposure rabies #2 on 04-MAY10 and TYPHOID ViCPs on 04MAY10. SM reported experiencing intermittent "random" pelvic cramping initially on 13MAY10 and she thought it might be her menstrual period, as she did not know at the time that she was pregnant. She reported a hx of tobacco use of 1-2 cigarettes daily, decreased from 1ppd x 4 years and ETOH of 3 drinks over weekends prior to + Serum hCG. The SM's OB Nurse Intake Hx was obtained at OB on 17MAY10, at which time the SM's did not report any adverse events following immunization during pregnancy. On 25MAY10 the SM was seen at ED @ 13:40 for "threatened abortion." She reported noticing blood on the toilet tissue when she wiped early that day. She was d/c'd to home and returned to ED @ 0200 on 26MAY10 with increased vaginal bleeding and pelvic cramping. The SM was evaluated at 0801 at OB Clinic on 27MAY10 (EGA 6+4/7weeks) at which time she reported increased cramping, vaginal bleeding and passage of tissue x 8 hours, accompanied by lower back pain, but denied fever, V, diarrhea or dysuria. She also reported some nausea and constipation. A transvaginal US showed a thin endometrial stripe of 4mm, no solitary fetus, a gestational sac was not seen and a yolk sac was not seen. No intraabdominal pregnancy was appreciated and the cul de sac had no fluid present. There were no fetal heart sounds by Doppler. She was Dx as having a SPONTANEOUS ABORTION with indications to follow hCG levels to "0" and to f/u as needed. The SM was given 7 days of convalescent leave and prescribed PERCOCET 5/325 1 tab po q 4 h prn pain not controlled with MOTRIN. Tissue was sent to pathology for exam and Quantitative hCG was ordered.
This spontaneous report was received from a consumer and refers to a male patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, dosage number, route of administration, lot # and expiration date were not reported). No concomitant therapies were reported Weeks after getting vaccinated, on an unknown date, the patient complained of an inability to gain an erection. The outcome of the inability to gain an erection was unknown. The reporter did not explicitly provide causal relationship between the event and vaccination with the suspect vaccine. This is one of the several reports received from the same reporter. Additional information has been requested.
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 60-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 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-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 medications were reported.  No treatment medications were reported.  Date of refrigeration was provided as 07-May-2021   This case was linked to MOD-2021-364942 (Patient Link).
3-3-09 Child's mom reported fever, redness and hardness on left thigh today which began 3-2-09 p.m.  The doctor's office told her to check the temp and go to ER if at 104F or more.  3-4-09 Fever and redness gone.  3-9-09 Knot remains.
felt a very slight tingling on her lips; This is a spontaneous report from a non-contactable consumer (patient) via the Pfizer-sponsored program. A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the 1st dose of the bnt162b2 a few days prior to the date of this report in Jan2021. However, after 5 minutes, she felt a very slight tingling on her lips that lasted for about 10 minutes. HCP wants to know if she should still receive the 2nd dose. Outcome of the event was recovered on an unspecified date in Jan2021. The reporter assessed the event as non-serious.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt presented with erythema, swelling and pain to right arm 2 weeks after GARDASIL vaccine. Pt treated with cephalexin for cellulitis, which symptoms improved at follow up visit.
Case number PHEH2016US023436, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 37 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 15 Jan 2016. On 15 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. The nurse stated that, no adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
High fever (+5 deg F) from 4 hours to 17 hours after shot. Diminished to +2 deg F fever from 17 to24 hours after shot. Fever accompanied by sharp headache and fatigue.
Day after receiving Td booster woke up feeling dizzy. That evening she began experiencing severe muscle pain at site of injection which progressed down arm and eventually throughout body. Pt had shaking, chills, sxs resolved by mid day the following day, arm remained sore x3weeks.
Within a few hours, patient started to feel extreme fatigue. The next day, she had diffuse myalgias, right arm swelling. This was followed by several days of weakness, numbness, and tingling. Now with persistent fatigue and myalgias (3 weeks into vaccine).
2 hrs post inject started to shake violently, seeing "spots" a/eyes, turned "gray"; rxn not witnessed; non-bite exposure;
An hour after shot, he vomited 4 times within 20 minute period. Then he started jerking and his jaw locked in an open position and he drooled continuously.
pt was napping @ home 6-7PM woke mom picked pt up to nurse & pt started gasping for air & turned ash color then cyanotic face & upper extremities;father tried to clear airway & then started rescue breathing;parents called 911;taken to ER
pt recv vax & exp low back pain, flu sx, arm soreness & weakness;pt hosp;flu sx resolved p/3 days;
Unable to create wheel on first try, administered a second time on left forearm and wheel was successfully created.
Pt experienced a local reaction sometime after receiving a Tripedia vaccination. (No specifics provided)
Burning sensation, pain joints, allergies sleep disorder, vision problem / blister on side of mouth. blood pressure: high / high cholesterol, sinus depression, indigestion, gastritis, hemmaroids.
No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623209 (Patient Link).
7-28-13 fever, weakness, diarrhea. Stool sample - negative results, given IMODIUM. 8-14-13 rehospitalized overnight - diarrhea continues.
Headache, Diarrhea, NauseaVomiting, Chills, Vomiting, welts at injection site Narrative:
Patient  felt dizzy and vision became blurry. She also felt nauseous. Pt was assisted via wheelchair to observation area where vital signs were obtained  and pt was monitored for 39 minutes / until stable.    Vital signs stable ( O2 sat = 98%, RR =16, BP 108/45  sitting. Pt left with parents in stable condition after 30 minutes.