chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis (dosing details unspecified) (also reported as "it could not be confirmed as GARDASIL 9 or GARDASIL). On an unknown date, the patient experienced sore arm after the administration of vaccine.  The outcome of the event was reported as recovering/resolving (reported as "fine now"). The patient did not seek medical attention. Product quality complaint (PQC) was not reported. Causality assessment was not provided. No further information was provided. Additional information has been requested.
inj were given 830AM; pt was alert & talking; left the room to get lab tech to draw blood; w/in 30-45 seconds pt fainted; MD was outside of room & reached him immed; neck soreness; BP 120/70; C-spine, x-rays neg;
Information has been received from the agency (#2008023-2478662) from a nurse concerning an 11 year old female, who had reached menarche 8 months prior (approximately Nov-2006), who on 31-JUL-2007 was vaccinated with the first dose of GARDASIL, IM, (Lot # and dose not specified). On 04-OCT-2007 the second dose of GARDASIL, IM, (Lot # and dose not specified) was administered. On 07-FEB-2008 the third dose of GARDASIL (Lot #, dose and route not specified) was administered. The patient's mother reports that the GARDASIL vaccinations caused her daughter to stop menstruating. It was unknown if the daughters periods were regular. The outcome of the event was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. Information has been received from the agency (#2008023-2478662) froma a nurse concerning a 13 year old female (weight 117 1/2,  height 62"), who had reached menarche 8 months prior (approximately Nov-2006), who on 31-JUL-2007 was vaccinated with the first dose of GARDASIL vaccine (Lot # 658094/0924U), 0.5 mL, IM in the right arm. On 04-Oct-2007, the patient received the second dose of GARDASIL vaccine (Lot #658563/1063U), 0.5 mL, IM in the left arm. On 07-FEB-2008, the patient received the third dose of GARDASIL vaccine (Lot #658488/1264U), 0.5 mL, IM in the left arm. Concomitant medication was not reported. On 17-MAR-2008, the patient's mother visited the physician's office and discussed her concerns regarding GARDASIL vaccine going to cause long term problems according to "research" she had conducted on the internet. On 27-MAR-2008, the patient's mother reported that her daughter has not had her period since January 2008 and this being caused by GARDASIL vaccine. On 21-APR-2008, the patient's mother called again to report the patient still had not had her period. It was unknown if the daughter's periods were regular. The patient was advised to be evaluated by an Ob-Gyn which she had and appointment for on 27-MAY-2008. At the time of the report amenorrhea persisted. Additional information is not expected.
It was pretty unique event and started as a fever that lasted about 3 days. What was more strange is that I had body aches that I never experienced before. I couldn't sign my name or pick up a glass of water, I was incredibly weak and never experienced that before. This lasted for about a week. Then I gradually got better. Those were the only symptoms. The soreness was so severe I was concerned about neurological issues, the doctor informed me to wait a couple of days. I called the doctor on the 19th and waited and then started feeling better around the 22nd. I met with the doctor virtually. A month before I had COVID-19 on August 16th. I had a fever for 2 days and a little body aches but wasn't severe other than that. Also had lethargy.
Systemic: Fainting/Unresponsive-Mild, Additional Details: Patient experienced lightheadedness and required EMS due to passing out.
Headache, Myalgia, Fever, NauseaVomiting, xhills Narrative:  Other Relevant History:
Information has been received from a registered nurse concerning an 11-year-old male with no pertinent medical history or allergies who on 20-FEB-2007 was vaccinated in his left thigh with his first dose of VARIVAX (Oka/Merck) (Lot # 612219/1352D). It was unknown if there were any illnesses at the time of vaccination. On 20-FEB-1997 concomitant vaccination in the right thigh included a first dose of MMR II (Lot # 619799/0997D). On 23-JUL-2007 the patient developed 1 lesion on his abdomen. The patient was treated with ZOVIRAX 800 mg twice a day for 5 days. No diagnostic labs were performed. The patient recovered from the adverse event on 29-AUG-2007. The event was considered to be an other important medical event by the reporter. It was noted that the patient's brother (WAES#0709USA03363) experienced an adverse event. This is one of several reports received from the same source. Further information is not expected.
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 19-DEC-2016, the patient was vaccinated with a dose of improperly stored VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Patient's right arm became swollen and reddened day after shot.  Felt hot to touch, swollen shoulder to elbow as reported per Mom.  Talked with grandmother 2 days after shot - swelling going down - redness till very evident and hot to touch.  Child apparently afebrile.  Cool compress used.
flu like symptoms with fever  24-48 hours, red, swollen, and sore at injection site lasting 72 hours,  tender lymph nodes in groin lasting 48 hours,  lasting  nauseous  24 hours
Improper storage of product in use; No Adverse Event; This spontaneous report was received from a physician refers to a 6-month-old patient of unknow gender.  The patient's medical history and concurrent condition was not provided. The patient's concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (PREVENAR 13).  On 21-JUN-2023, the patient was vaccinated with the third dose of improper storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1968386, expiration date: 23-MAY-2024, oral (exact dose was not provided) for prophylaxis.   The administered dose underwent a temperature excursion during unreported amount of time on unreported temperature. It was reported the alarm was believed to be due to sensory issues and the temperatures were monitored with back up logger, which was by the time of the report was replaced with a new one and temperature was then in range. There was a previous temperature excursion (product storage error). No additional adverse event reported (no adverse event).  This is one of two reports of the same patient.
Redness, swelling, itching at injection site, measured at 40 mm X 50 mm. Advised to apply ice,  calamine cream to site, and oral BENADRYL for itching. Report to PCP if it worsens.
Woke during night, both hands (palms only) extremely itchy, red, puffy. They were very sensitive to pressure and painful if warm water touched them.  Symptoms lasted 24-36 hrs. 2 doses of Benadryl 25mg PO taken.
This spontaneous report as received from a consumer via Clinic refers to a currently 24 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # L049314, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Developed a diffuse non-raised blanching rash throughout body including face approximately 24 hours after receiving  the boost Pfizer vaccine. I had a similar reaction with my first and second shots. Although the diffuse redness was significantly worse with the booster when compared to the first 2 vaccines.
Patient reports she got her Covid-19 vaccine 2 days ago, first dose and has felt fatigued since then.  Patient states she vomited in the lobby and then passed out, now feels better, able to drink a glass of water.  No other symptoms, no CP, no SOB.
?Can?t get a full breath?  Nauseated, Dizzy, balance was off. ?Thought I was having a heart attack. Couldn?t walk without a cane because of pain and weakness.?
3. Need for COVID-19 vaccine 4. Encounter for immunization -- medication air regarding COVID vaccination.  Instead of 0.3ml dose, Patient was given 0.5ml dose.  Discussed with and his mother, recommended monitoring carefully for increased immune response.  Call with any questions or concerns. -- COVID Vaccine
This spontaneous report was received from a healthcare worker and refers to a 3 month old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 24-APR-2016, the patient was vaccinated with PNEUMOVAX23 (lot # reported as 1045710, expiry date 25-APR-2017, dose, route and anatomical site of injection were not reported. No adverse events were reported. NO product quality complaint (PQC) was involved. Lot number 1045710 is an invalid lot number for PNEUMOVAX23. Additional information has been requested.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history and drug allergy were not reported. On 11-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K010215 with expiration date of 05-MAY-2017, dose and strength unknown, intramuscular). No adverse event was reported. Additional information has been requested.
BODY ACHES / BODY SORE; ARM HEAVY; FEELING OF GETTING A COLD; FEELING COLD AND WARM ALTERNATING; SORE ARM; SHIVERS; LIGHT HEADACHE; This spontaneous report received from a consumer concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included cough. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination to the Right Deltoid. No concomitant medications were reported. On an unspecified date, the subject experienced body aches / body sore, arm heavy, feeling of getting a cold, feeling cold and warm alternating, sore arm, shivers, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold and warm alternating, and had not recovered from body aches / body sore, shivers, arm heavy, feeling of getting a cold, light headache, and sore arm. This report was non-serious.
Flet like she was going paralyzed; could barely even walk; legs were feeling a little bit numb/numbness in her face/numbness in her lips; tingling down her spine/awkward tingling in the spinal column area; tingling in the upper area of her spine and then in her legs and face; This spontaneous case was reported by a consumer and describes the occurrence of PARESIS (Flet like she was going paralyzed), PARAESTHESIA (tingling in the upper area of her spine and then in her legs and face), GAIT INABILITY (could barely even walk), HYPOAESTHESIA (legs were feeling a little bit numb/numbness in her face/numbness in her lips) and PARAESTHESIA (tingling down her spine/awkward tingling in the spinal column area) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C2117) for COVID-19 vaccination.     Concurrent medical conditions included Neurological disorder NOS (under control) and Brain lesion (under control).    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced PARAESTHESIA (tingling in the upper area of her spine and then in her legs and face). On 10-Jul-2021, the patient experienced PARESIS (Flet like she was going paralyzed), GAIT INABILITY (could barely even walk), HYPOAESTHESIA (legs were feeling a little bit numb/numbness in her face/numbness in her lips) and PARAESTHESIA (tingling down her spine/awkward tingling in the spinal column area). In July 2021, PARESIS (Flet like she was going paralyzed), PARAESTHESIA (tingling in the upper area of her spine and then in her legs and face), GAIT INABILITY (could barely even walk), HYPOAESTHESIA (legs were feeling a little bit numb/numbness in her face/numbness in her lips) and PARAESTHESIA (tingling down her spine/awkward tingling in the spinal column area) had resolved.        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. Patient reported that she is scheduled for an MRI on 17Aug2021 to check neurological issues and brain lesions. Patient reported that she is scheduled for the second dose on 06Aug2021.  Company comment: 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. Patients concurrent medical conditions of Neurological disorder and Brain Lesions may be a confounding factor to the events.; 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. Patients concurrent medical conditions of Neurological disorder and Brain Lesions may be a confounding factor to the events.
About an hour after getting my first Pfizer shot, I noticed intense numbness and tingling in the (left) arm that got the shot. From the area in the shoulder down to my fingertips.  After two hours symptoms are less but still remain.
I received the first dose of the Pfizer vaccine on 3/16 and did not feel any adverse effects until one week later. On 3/23 I started feeling a few twinges on my left side where my bra strap is normally, and then on 3/25 I noticed a rash in that same area. I thought it might be a reaction from the vaccine since it was on the same side as the injection site. But within a few days it was noticeably worse and painful. I went to urgent care on 3/27 and was diagnosed with shingles. I am now on antiviral medication and prednisone.
I got the Vaccine over a week ago and now I'm experiencing pain in my shoulder that radiates down my arm theny wrist is tingling and my hand is numb
Sore armpit region, right shoulder where vaccine was administered. Cannot raise right arm past horizontal.
Whole body pain; sweaty, feverish feeling but never registered a fever when checked. Extreme fatigue and brain fog, headache
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 62 years old patient (gender was unknown) who received vaccine FLUZONE QUADRIVALENT instead of TUBERSOL and reported that administered intradermally 0.1 ml of FLUZONE QUAD instead of the TUBERSOL and experienced itching at the injection site. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 13-Mar-2019, the patient received a dose of suspect 0.01 ml INFLUENZA QUADRIVAL A-B VACCINE (lot number: UI998AD and expiry date: 30-Jun-2019) via intradermal route in the left forearm. On an unknown date, following the vaccination the patient experienced injection site itching. It was also a case of actual medication error due to wrong vaccine administered, vaccine underdose and incorrect route of product administration. 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 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. List of documents held by sender: none.
Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 Reporter was a GSK representative who was reporting on behalf of an HCP (office manager) who stated that an unknown number of patients were administered a dose of Menveo with just the liquid conjugate component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
1 - 2 minutes after child recieved the H1N1 vaccine she began rubbing her throat and arms she stated she felt like ants were biting her all over, note on permission slip child has had hives with PCN,  observed child closely after 30 minutes no further s/s such as difficulty breathing or hives/welts etc.  She stated the feeling of ants biting her all over had subsided.  Mother called and child released to care of grandparent home.  No hives, itching or s/s on release from school.
Next day, after immunizations, body aches, cough & SOB, fever, & swollen arm came on.
No adverse reaction occurred during this event. Vaccine was given outside of usage date. Vaccine does not expire until 01/31/2024
fevers higher than usual; Muscle pain; Fatigue; Body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), PYREXIA (fevers higher than usual), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Body aches), MYALGIA (Muscle pain) and FATIGUE (Fatigue). On an unknown date, the patient experienced PYREXIA (fevers higher than usual). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Feb-2021, PAIN (Body aches), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had resolved. At the time of the report, PYREXIA (fevers higher than usual) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked.
Red, swollen, itchy, warm to touch. Lasted 10 days. Took Benadryl for 1 day.
Approximately 3 min after receiving the shot, I began to feel light headed.  Light headedness increased over the next few minutes and I began to feel faint.  My activity device indicated my heart rate took a sharp drop.  At this point, I thought it best to lie down. I spent the next 5-7 minutes on the floor until I was able to sit up without feeling faint. I waited an additional 15 minutes before leaving.  I felt somewhat shaky, but felt better by the minute.
couldn't move her arm; tried to move and it´s hurt; really bad hurt inside the injection site, in lthe eft arm; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little soreness), MOBILITY DECREASED (couldn't move her arm), PAIN IN EXTREMITY (tried to move and it´s hurt) and VACCINATION SITE PAIN (really bad hurt inside the injection site, in lthe eft arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal), Thyroid disorder, Cholesterol and Blood pressure abnormal. Concomitant products included POTASSIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (little soreness). On 01-Feb-2021, the patient experienced MOBILITY DECREASED (couldn't move her arm), PAIN IN EXTREMITY (tried to move and it´s hurt) and VACCINATION SITE PAIN (really bad hurt inside the injection site, in lthe eft arm). At the time of the report, PAIN (little soreness), MOBILITY DECREASED (couldn't move her arm), PAIN IN EXTREMITY (tried to move and it´s hurt) and VACCINATION SITE PAIN (really bad hurt inside the injection site, in lthe eft arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken were thyroids pills, cholesterol pills, blood pressure meds, medications for for acid reflux. Treatment medications taken was Ibuprofen.