chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness/again it appear in other parts of her; burning sensation on the lips and tip of the tongue/strangest thing was in her mouth; voice is hoarse, it's not normal; burning sensation on the lips and tip of the tongue; itchy; rashes on her body skin; high fever; rashes on her legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness/again it appear in other parts of her), ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue) and PRURITUS (itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0MBF21A, 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, VITAMIN 15 for Sleep disturbance.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness/again it appear in other parts of her), ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue), PRURITUS (itchy), RASH (rashes on her body skin), PYREXIA (high fever) and RASH (rashes on her legs). The patient was treated with ACETAMINOPHEN for Fever, at a dose of 500 and LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness/again it appear in other parts of her) had not resolved, ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue), PRURITUS (itchy) and PYREXIA (high fever) outcome was unknown and RASH (rashes on her body skin) and RASH (rashes on her legs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took claritin and it got better but the redness was still there for the next day and again it appear in other parts of her body; first day was itchy but then it wasn't, the strangest thing was in her mouth, she had a burning sensation on the lips and tip of the tongue.
felt achy; found it hard to sleep; If she moved her arm, the soreness came out; had a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy), INSOMNIA (found it hard to sleep), PAIN IN EXTREMITY (If she moved her arm, the soreness came out) and VACCINATION SITE PAIN (had a little soreness at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (felt achy), INSOMNIA (found it hard to sleep), PAIN IN EXTREMITY (If she moved her arm, the soreness came out) and VACCINATION SITE PAIN (had a little soreness at the injection site). At the time of the report, PAIN (felt achy), INSOMNIA (found it hard to sleep), PAIN IN EXTREMITY (If she moved her arm, the soreness came out) and VACCINATION SITE PAIN (had a little soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided.   This case was linked to MOD-2021-406408, MOD-2021-406409 (Patient Link).
Next morning after vaccine I started feeling dizzy, nauseas and pain in my ear. It became progressively worse thru the Sunday to the point that I could not walk. I contacted my physician and was prescribed Hydroxyzine and Naproxen (for ear pain) .I am progressively getting better.
MMR and Hep B vaccines rec'd on 6/26/02. On 6/28/02 client noticed hearing loss in right ear. "Everything sounds muffled and I can hardly hear out of my right ear. There's a high pitch sound also". Client phoned clinic today (7/1/02) to report symptoms and still experiencing hearing loss.
Severe pain in left arm from shoulder to finger tips. I am tough when it comes to pain but I was almost in tears. It had swelled up into a hard bump, but was not red. I was also very drowsy. This is day two and I am still drowsy and in pain
recieved shot and complained of feeling an allergic reaction coming on. took 2 benadryl 25mg that he had, then request a epipen shot, he had one but was outdated. 1 epipen shot was given and pt laid down until paramedics arrived. Did not notice any swelling, difficulty in breathing hives etc.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the shot) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the shot). At the time of the report, VACCINATION COMPLICATION (Reaction to the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. No allergies, lab data and current condition was reported by patient. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUN-2021 and it contains no new information.; Sender'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.
Information has been received from a nurse practitioner concerning a female patient, who was vaccinated with the third dose of GARDASIL, 0.5ml.  No lot number was provided.  The nurse practitioner reported that the patient experienced a "lump" at the injection site, after receiving her third dose of GARDASIL vaccine.  The patient's outcome was unknown.  The patient sought unspecified medical attention.  Follow-up information was received from a nurse practitioner via telephone call indicating that the patient was 20 year old female patient, who on 09-OCT-2008 was vaccinated with the first dose of GARDASIL (Lot # 661044/0548X) in the right deltoid; on 10-DEC-2008 was vaccinated with the second dose of GARDASIL (Lot # 661764-0650X) in the left deltoid and on 18-MAR-2009, was vaccinated with the third dose of GARDASIL Lot # 661952/1129X) in the right deltoid.  The patient did not receive concomitant vaccines Concomitant included YAZ.  It was also reported that 1 week after receiving the third dose of GARDASIL vaccine, the patient experienced a marble sized knot or lump at the injection site.  The patient did not have a fever or pain.  The patient was not hospitalized.  Additional information has been requested.
Received Pfizer vaccines on 1/5/21, 1/26/21 Tested positive for COVID by PCR on 4/22/21 Onset date of symptoms 4/21/21 w/ mild SOB, cough, chills, myalgias, sore throat, H/A, rhinorrhea/congestion Possible household exposure to COVID
Large lump (size of orange) in armpit of left arm, aches and pains in body, no energy.  I have had aches and pains in areas of my body where I have had previous injuries.  The swelling in my armpit has gone down but I still have pain in my left breast.
I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in relived by Motrin and Tylenol , intense pain at injection site my underarms hurt very badly / nausea/ intense fatigue  all  about 20 hours after injection hit me hard like a wall - this went on for 24 hrs then I felt better but felt very weak for 2 more day s- to day is 6 days after injection first day I feel normal again
Brief but very painful chest pain. Felt on left side about half way up my ribs. Thought I was having a heart attack for about a minute. No signs of arrhythmia or faintness. Feel fine now.
"Covid Arm" Pain, swelling, redness, itching,  hot to the touch - all in the site of the injection
This case was reported by a healthcare professional (nurse) and described the occurrence of throat tightness in a 54 year-old male subject who was vaccinated with TWINRIX. Concurrent medical conditions included allergy to fish, egg allergy and latex allergy. Concurrent vaccination included tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine., absorbed; GlaxoSmithKline; unknown, unknown give on 9 AUGUST 2013. Concurrent medications included NEXIUM, ZYRTEC, SINGULAIR, DILTIAZEM, Asprin, Doxycycline, SPIRIVA, ALLEGRA, PULMICORT, VENTOLIN, HALOBETAZOL, and MUCINEX. On 09-AUGUST-2013 at 10:30 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). ON 09-AUGUST-2013 at 13:15, 2 hours and 45 minutes after vaccination with TWINRIX, the subject experienced throat tightness, throat swelling, increase in pulse, increased blood pressure and possible le allergic reaction. The nurse reported that she "believes the reaction may be latex related, as the BOOSTRIX he received concomitantly was from a vial and the TWINRIX was from a syringe". The subject has a latex allergy (possible allergic reaction). The subject was evaluated at the emergency room. At the time of reporting the events were resolved. The healthcare professional considered the events were related to vaccination with TWINRIX.
got a shot supposedly for shingles, three years later I still have them / suspected vaccination failure; still have them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got a shot supposedly for shingles. Three years later patient still had them and all the time, they never did go away. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Narrative:  Pt who had received two doses of the Moderna Vaccine in 2021, reported to the ED on 11/15/2022 with sore throat, unsteady gait, cough, and weakness. Pt was admitted and further testing revealed positive covid-19 infection. Per provider notes no indication for remdesivir at this time supportive care only.
A nurse with a history of varicella and herpes zoster was accidentally splashed in her eye with a drop of varicella virus vaccine live when she was drawing the vaccine for administration. Immediately after the incident she experienced eye irritation that lasted for approximately one hour.
Appendicitis. At 11am Sunday nausea and vomiting starting with sharp pain in lower abdomen  that would come and go. At about 530pm  cramping like pain began throughout the whole abdomen and by 830 was mostly on the lower right abdomen continuing to get worse. Arrived at the ER just before 930pm. Hospital was very busy so it took a long time for tests. Pain meds: dilauded, saline fluids, and zofran were given between 10-1030pm. Blood work and urine tests performed. CT scan performed. Around 1230am I was informed that inflamed appendix was confirmed, morphine was given around this time. Around 130am I met the surgeon, he ordered antibiotics and more dilauded. I was put in a room around 4am and given diapause?s every 2 hours until surgery (saline fluids continued and were constant through whole treatment). Another round of IV antibiotics were given around 11am. Surgery prep began around 1230pm, surgery performed around 130pm and I was back in my room around 2pm. I was discharged at 530pm with a prescription for Percocet. The surgery performed was a laparoscopic appendectomy. Appendix was confirmed to be inflamed and at risk of rupture (but had not yet ruptured) and the surgery was necessary.
ACT-HIB vaccine which had expired on 11-Jul-2022 was administered to a patient with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient and it was reported that HIB (PRP/T) VACCINE [ACT-HIB] vaccine which had expired on 11-Jul-2022 was administered to a patient with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX).   On 29-Jul-2022, the patient received a  dose of 0.5 ml of suspect HIB (PRP/T) VACCINE, (frequency: once), with an unknown formulation and strength ( lot: UJ521AAA ; expiry date: 11-Jul-2022) (diluent lot: U6999AB ; expiry date: 11-Jul-2022)  via intramuscular route in the left vastus lateralis for immunization.  It was reported that an Act-hib vaccine which had expired on 11-Jul-2022 was administered to a patient with no reported adverse event (Expired product administered) (onset date: 29-Jul-2022; latency: same day)   Action taken : Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
accidently administered an expired dose of ENGERIX B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HBV (Engerix B) (batch number f73dg, expiry date 03-JUL-2023) for prophylaxis.   On 14-JUL-2023, the patient received Engerix B. On 14-JUL-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: accidently administered an expired dose of ENGERIX B). The outcome of the expired vaccine used 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 18 Jul 2023. The pharmacist stated that a patient was accidently administered an expired dose of ENGERIX B which was expired on 03-JUL-2023. The reporter consented to follow up. The patient accidently administered an expired dose of ENGERIX B which led to expired vaccine used.
This spontaneous report was received from a pharmacist via a company representative refers to a male patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry, dose, route not reported). No concomitant medications were reported. On an unknown date, the patient developed a big red swollen spot after receiving a dose of ZOSTAVAX. No laboratory tests were performed. Patient sought medical attention (called the pharmacist). The outcome of big red swollen spot was unknown. The relationship of the events with ZOSTAVAX was unknown. Additional information has been requested.
patient washed her pieces before realizing that she had missed her last dose of tyvaso; a bit of a headache; Initial information received on 15-Nov-2022 regarding an unsolicited valid non-serious courtesy case received from a Consumer/Non-HCP.  This case involves a 85 years old female patient (50.3 kg) who had a bit of a headache and patient washed her pieces before realizing that she had missed her last dose of tyvaso after receiving influenza vaccine and while treated with treprostinil sodium [tyvaso].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included AMLODIPINE BESILATE.  Patient began therapy with IH Tyvaso (Treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 13-May-2019 for primary pulmonary arterial hypertension. The current dose was reported as 54 µg (9 breaths), four times a day (QID) via inhalation (IH) route.   On 07-Nov-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Influenza immunization.  On 07 Nov 2022 (yesterday), 3 years 5 months and 26 days after initiating Tyvaso, the patient got her flu shot and had a bit of a headache (headache) from that (latency: same day).   On 08 Nov 2022, 3 years 5 months and 27 days after initiating Tyvaso, the patient washed her pieces before realizing that she had missed her last dose of Tyvaso (product dose omission issue)(latency: 1 day) at 20: 30 PM.   The nurse advised her she could open a new ampule and do the last treatment of 9 breaths yet tonight or wait and do the next treatment in the morning.  She decided she would get up about 1 hour early and do the treatment a bit early.  Action taken with treprostinil sodium was unknown and was not applicable with respect to influenza vaccine.   It was not reported if the patient received a corrective treatment for the events (a bit of a headache).  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received SHINGRIX (batch number CH2X7, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on 3rd May 2018 and experienced fatigue, myalgia, and fever, refer linked case US2018GSK167608). On 10th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced pain, fatigue, myalgia and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain, fatigue, myalgia and fever were unknown. The reporter considered the pain, fatigue, myalgia and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient experienced pain, fatigue, myalgia, and fever. The reporter considered the symptoms were related.
new onset, bruising, heat, swelling and pain after flu vaccine 2 weeks ago. She denies any injury or trauma to the area shoulder pain. Symptoms:  shoulder pain, shoulder stiffness, localized bruising, localized swelling, localized redness, localized warmth, localized weakness and decreased range of motion at the shoulder. The patient is currently experiencing symptoms. Associated symptoms:  arm pain and nausea, but no fever, no chills, no rash and no neck pain. Current treatment includes ice, activity modification, acetaminophen and ibuprofen. By report, there is good adherence with treatment, good tolerance of treatment and poor symptom control.   Given Toradol and solumedrol.
Patient was seated on an exam table during vaccinations. She was advised to stay seated after vaccinations. Approximately 2 minutes after vaccinations, patient fell forward off of the table and onto the floor hitting her face. The Medical Assistant and the patient's mom were in the room at this time. The fall resulted in a bloody lip and a broken front tooth. Patient was evaluated by physicians and observed for 30 minutes. We contacted the patient's dentist and mom drove her straight over after she was discharged.
Had TD after having laceration sutured on 4/8/01 in ER. Had anorexia, fatigue, felt feverish the next day. Two days later, had a fever of 104.3F. Continued to have fevers especially in the evenings, headache, myalgia, anorexia and 15 lb weight loss for 2 1/2 weeks. No specific symptom of viral syndrome. Recovering
Patient came back to pharmacy around 5:00pm and reported her whole arm swelling from the wrist to her neck. She also had pain and numbness going up her arm.
patient fainted after immediately after vaccine administration.  however, recovered shortly.  no hospitalization required.
Within 5 min of receiving JE vaccination, client had a seizure lasting  1-2 min.  Alert & oriented after, though very pale and unsteady.  BP 122/80 No sob, N; V, DIAPHORESIS.  Had not eaten since 10am so given cheese & H20 Neuro check - WNL observed for 1 1/2 hrs and released to home F/up call to parent on 6/5 10 AM - No further seizure activity
Patient received Pfizer vaccines on 03/29/2021 and 04/19/2021. She was pregnant at the time with due date of 12/08/2021. The only noted pregnancy complication was fetal bradycardia at 30weeks gestation. She gave birth on 12/01/2021 via repeat C-section. Birth weight was 5lb 8oz. The baby had upper respiratory symptoms beginning on 12/15/2021 at 2 weeks of age. The baby then developed cardiogenic shock and had a cardiac arrest necessitating placement . There is concern for viral myocarditis as baby tested positive for rhinovirus/enterovirus on the nasal swab PCR.
an hour after receiving second dose: began sneezing and had runny nose, started "panting" and feeling short of breath (described as when you have gone up a flight of stairs and have trouble catching your breath) felt the onset of a headache. She then went home, where she did a nebulizer treatment and reported that it was helpful and was in and out of a deep sleep. Following day she reports "the worst headache," body aches and a low grade fever.