chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse event reported; Proquad administered to an adult patient; PROQUAD and VARIVAX were administered on the same day to an adult patient instead of MMR II and VARIVAX; PROQUAD and VARIVAX were administered on the same day to an adult patient instead of MMR II and VARIVAX; PROQUAD and VARIVAX were administered on the same day to an adult patient instead of MMR II and VARIVAX; This spontaneous report was received from a nurse, referring to a female adult patient of unknown age. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 08-OCT-2020, the patient was vaccinated Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) 0.5 milliliter once, lot # S038146, expiration date reported as 25-MAY-2021 , for prophylaxis (strength and route were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter once, lot# S019463, expiration date reported as 24-JUN-2021, for prophylaxis (strength and route were not reported) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-MR II) prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX).
This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (fast heart rate), DYSPNOEA (difficulty breathing) and SWELLING (swelling of her face and throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.  No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced HEART RATE INCREASED (fast heart rate), DYSPNOEA (difficulty breathing) and SWELLING (swelling of her face and throat). At the time of the report, HEART RATE INCREASED (fast heart rate), DYSPNOEA (difficulty breathing) and SWELLING (swelling of her face and throat) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Sensitivity in her teeth; Discoloration near her gums; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (Sensitivity in her teeth), GINGIVAL DISCOLOURATION (Discoloration near her gums) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced HYPERAESTHESIA TEETH (Sensitivity in her teeth), GINGIVAL DISCOLOURATION (Discoloration near her gums) and PYREXIA (Fever). At the time of the report, HYPERAESTHESIA TEETH (Sensitivity in her teeth), GINGIVAL DISCOLOURATION (Discoloration near her gums) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever is consistent with the known safety profile of mRNA-1273.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She felt significantly more pain than the previous 3 doses) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 613A21A, 024M20A and 057M21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (She felt significantly more pain than the previous 3 doses). At the time of the report, VACCINATION SITE PAIN (She felt significantly more pain than the previous 3 doses) outcome was unknown. No concomitant medication were provided. No treatment details were provided. This case was linked to MOD-2022-555537, MOD-2022-555535, MOD-2022-555523 (Patient Link).
Injection irritations (redness, pain, swelling on injection site) started few hours after vaccine (on 5/6). Recommended pt to go ER and ER PA gave two doses of TYLENOLl 500mg and ice pack (5/6/16 PM). Patient came back to pharmacy on Sunday (5/8/16;2 days after vaccine and ER visit) and complained for inflammation moved to around arm pit and chest area. Recommended patient to take ibuprofen 600mg Q8H and zyrtec 10mg QAM. Patient came back to pharmacy on Monday (5/9) and told pt is completely recovered from sickness. Patient had 3 days minor sickness after PNEUMOVAX 23 (PPSV23).
Swollen right eye. Completely closed.  12 to 18 hours after vaccinated.  Swelling started to come down by 12:40pm.  Stayed until next day.
Swollen Armpit; Sore Arm; Bump under armpit was getting bigger and hurting her; A spontaneous report was received from a consumer concerning his wife a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen armpit/ swelling, sore arm/ pain in extremity and bump under her armpit was getting bigger and hurting her/ lymphadenopathy.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch: 0322L20A) via unknown route for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient developed swollen armpit, sore arm and bump under her armpit was getting bigger and hurting her. Treatment for the event included tylenol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events, swollen armpit, sore arm and bump under her armpit was getting bigger and hurting her were resolving.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "received the Pfizer vaccine and has been experiencing pain. She applied a Lidocaine Roll-on at the injection site."; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "it started to burn."; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "She says she noticed a breakout at the injection site as well.". Therapeutic measures were taken as a result of vaccination site pain, vaccination site warmth, vaccination site rash. Additional information: Patient applied a Lidocaine Roll-on at the injection site. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extra runny nose causing sore throat; Extra runny nose causing sore throat; Muscle aches all over; Slightly upset stomach; Chills; tiredness; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 at 08:45 as single dose for Covid-19 immunization. The patients medical history included ongoing Diabetes type 2, prostate cancer from 2004 to an unknown date and treated with radiation (since, undetected) and allergies to sulfa from an unknown date and unknown if ongoing. The patient did not have Covid prior vaccination and did not take any other vaccine in four weeks. The patient's concomitant medications were not reported. On 03Feb2021 at 15:00, the patient had extra runny nose causing sore throat, muscle aches all over, slightly upset stomach, chills, and tiredness. The patient was not covid tested post vaccination. No treatment received for the reported adverse events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
headache; mild fever; nausea; chills; body aches; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 26 years old male patient who experienced headache (headache), mild fever (pyrexia), nausea (nausea), chills (chills) and body aches (pain), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. There were no concomitant treatments.   On 08-Oct-2019, the patient received dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Injection lot number not reported via unknown route in unknown administration site.  On 09-Oct-2019, patient developed a non-serious mild headache (headache), fever (pyrexia), nausea (nausea), chills (chills) and body aches (pain) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 09-Oct-2019, patient outcome for events body aches, chills, nausea, mild fever and headache reported as recovered.   No lab data was reported.  Final diagnosis was body aches, chills, nausea, mild fever and headache.   It was not reported if the patient received a corrective treatment.  Information on the batch number was requested.
Fever, chills, body ache especially chest, rib, arms. Fatigue, glassy eyes, headache. Was unable to work for 1 day. Flu-like symptoms lasted about 36 hours. Extreme episode of vertigo/room spinning/nausea that lasted 3 hours.
FELT LIKE ABSOLUTE SHIT THE DAY AFTER VACCINATION, LIKE DEADASS. BUT DEADASS IT FELT LIKE GETTING THE FLU SHOT; BODY ACHES; HEADACHE; NAUSEA; MILD FEVERS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced felt like absolute the day after vaccination, like. but it felt like getting the flu shot, body aches, headache, nausea, and mild fevers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, mild fevers, nausea, and headache, and the outcome of felt like absolute  the day after vaccination, like deadass. but  it felt like getting the flu shot was not reported. This report was non-serious.
Administration after temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Menveo, Havrix, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Menveo, Havrix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Nov-2022 Reporter's comment: The physician called on the day of reporting, to reported that in July  Menveo, Infanrix and Havrix had a temperature excursion and were administered after that. The reporter was asked twice to give information on the vaccines or patients but declined. No consent for the follow-up but no declined either, the reporter was asked but the answer was about how they had no information about the event. Additional supportive information: The patients received Menveo, Infanrix and Havrix after temperature excursion, which led to incorrect storage of drug.
The vaccine batch was diluted with saline from a single-dose vial that had been previously punctured. Typical protocol is single use. Saline was properly sterilized and correct dose was given to the patient but the vial to dilute was punctured twice.
Pain in stomach , constantly vomiting started 8:30am 06/14 went to er at hosp. 10:30 pm blood work, ultra sound, mri completed . Transfer to another medical center. 900 am 06/16 was admitted inpatient and currently still in hospital They have done blood work and put her on a liquid diet . Is scheduled for a MRCP at 6 pm 06/18
Tuesday morning 10-11-2016 (24-36 hours after vaccine) pt had red, itching, burning skin; left neck and shoulder symptoms dissipate to touch; Wed AM (10/12) burning and redness worse; pt took antihistamine and Wed. pm symptoms were better.
1. WITHIN MINUTES OF THE VACCINE ADMINISTRATION IN MY LEFT ARM, I HAD LEFT SIDE NECK TENSION AND LEFT SIDE UPPER BACK TENSION 2. AT 9:15PM (DAY OF VACCINE ADMINISTRATION), I DEVELOPED A METALLIC TASTE PAIRED WITH A NUMB FEELING IN MY MOUTH (TONGUE, HARD PALATE).  3. THE METALLIC TASTED LASTED ~30 HOURS POST VACCINE ADMINISTRATION 4. THE MUSCLE TENSION IN MY NEXT AND UPPER BACK SUBSIDED ~2 DAYS POST VACCINE ADMINISTRATION
5/22 Patient claimed she was in a lot of pain. It started at the injection site and has traveled down her arm, behind her shoulder and near her arm pit. She also said her arm is becoming more red. I instructed her to take BENADRYL every 4-6 hrs and to seek care if it does not improve in a few days. Patient is also taking ADVIL which is helping the pain. Symptoms occurred several hours after shot was given. Pain has improved but not the redness. 5/25 - Pt says doing much better. Redness almost all gone.
pt recv vax 28SEP95 & on 15NOV97 pt devel chickenpox everywhere & exp itching;
Elevated temp 103.5. Swelling (L) leg 15 mm per mom crying a lot. Didn't want to move leg.
Patient developed urticaria (hives) 15 minutes after receiving H1N1 intranasal vaccine at unknown clinic and then came to the ED.
Pt. was vaccinated by another pharmacist at our remote clinic at an elementary school at 11:35am 3/11/21. Within less than 3 minutes the patient informed a student  that he did not feel well. He reported: itching, feeling hot, shortness of breath, dizziness, loss of vision, and thirst. The student alerted me and I assessed the pt. He was responsive, but felt "tired". He was sitting on the floor. I told the student to call 911. I continued talking with the pt. as I was preparing the epinephrine and placing a blood pressure cuff on his arm. He became less responsive and asked me for the epinephrine. I injected him with an EpiPen 0.3mg in his outer left thigh through his pants (at 11:43am). Within approximately 30s-1min the pt. became more responsive. I then took his pulse and BP shortly before EMS arrived (11:52am) . They performed the second blood pressure reading and the pt. was transferred to their care at that point.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients. Information about the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX lot # reported as L042266 with expiration date 27-OCT-2017; lot # reported as L04265 with expiration date 25-OCT-2017 and lot # L040419 with expiration date 14-OCT-2017, (route of administration was not provided). The vaccines were exposed to a temperature of -12F by a time frame of 3 hours. No adverse effects were noted. Additional information has been requested.
Expired Bexsero was given to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old patient who received Men B NVS (Bexsero) (expiry date 28-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received Bexsero. On 06-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero was given to patient). The outcome of the expired vaccine used was not reported.   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: 06-MAR-2023 The expired Bexsero was given to the patient at the time of reporting. The reporter wanted to know what would be the next step. The expired Bexsero was given to the patient, which led to expired vaccine used.
Pain at injection site but also pain in upper arm - inside (just below the shoulder) and radiating down the forearm. Also top of shoulder. Pain became progressively worse for the next 3 days (very severe) even at rest - just sitting. Very limited range of motion. Still painful - but not the extreme pain - by Friday. June 18th I went back to the Dr. who ordered physiotherapy - which I started and have been doing exercises. Still painful but not as severe. Still limited range of motion. Interferes with lifestyle.
Silver dollar - sized red swollen tender area and arm aches. Treatment cool compresses for 20 min QID and MOTRIN or ALEVE for the discomfort.
Admit to hospital for NSTEMI on 9/24/2022  Normal echo and Normal left heart cath.  No PCI indicated
Patient got 3 doses of Moderna vaccine by mistake. 1st dose on 01/06, 2nd dose on 01/26 and 3rd dose on 02/22
no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 23-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
After the vaccine I had a sore muscle at the vaccination site, but that went away after a day. 5 days after receiving my first Moderna vaccine, I noticed a swollen lymph node under my armpit on the same arm that I received the vaccine on (left armpit), but went to sleep not thinking anything of it. I woke up at 9am the next day to intense body aches and skin sensitivity and the lymph node even larger. The body aches have remained all day, but have subsided from rest. I went to my local urgent care center to get a Covid-19 rapid test and it came back negative.
given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that it was possible that the patient was given Hiberix that may have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have specific patient information or dates administered at the time of report. The reporter stated the specific lot was administered over a range of a couple of months. The reporter consented to follow up. This case has been linked to other 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
Patient called pharmacy 10/22/18 complaining of a lump/knot at site of injection. Our records indicate patient received vaccines in left arm but patient stated it was right arm that issue was in and that was arm that received vaccines. She was not sure exactly when this "knot" showed up but there was no heat or fever to the area and it was not painful or red.
Pt recv vax on 8/8/97; on 8/9/97 pt exp rash over entire body.
Feel so bad; Nausea; flu-like symptoms; This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 753EJ, expiry date 26th August 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell, nausea and influenza-like symptoms. On an unknown date, the outcome of the feeling unwell, nausea and influenza-like symptoms were unknown.   It was unknown if the reporter considered the feeling unwell, nausea and influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comments: The patient reported that the patient received initial Shingrix dose. The patient feel so bad and experienced nausea, flu-like symptoms so, refused to receive second dose.
swelling; rash on both arms: Allegra,Prednisone:   Rash cleared 02/20/2021
Moderna COVID-19 Vaccine EUA  Red, bumpy, itchy rash on arm and torso