chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles; The next day, his left hand was shaking; shooting pain every time he took a step; burning sensation over part of his chest/his ribs were burning/his left leg was burning; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cervical disc disease.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning). On 01-Aug-2021, the patient experienced PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step). At the time of the report, PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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. Lab data included CT scan of the brain, ultrasound of his leg, and bloodwork  were normal.  It was reported that his complete neurological exam on 20-Oct-2021 was normal. The physician reported that the patient went to the emergency room on 02-Aug-2021 but was not hospitalized. Neurological exam was normal including light touch, pin prick, vibratory sense, simultaneous  stimulation and temperature .   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Significant follow up received contain  Patient demographic details added, Medical history added, events outcome updated, event verbatim added, lab data added.
Swelling behind and above my eyes.  Headache.  I took 200mg. of Benadryl.
A non serious, spontaneous report of gave expired FLUMIST to a three-year-old female patient was received from a medical assistant. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 moths of age for FLUMIST. This is in follow-up to report(s) previously submitted on 12/16/08. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 06-Jan-2009 and incorporated the narrative: no adverse event occurred. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Swelling redness and tenderness at vaccine site (cellulitis)- parent went to ER and then to clinic 11/12/14 for evaluation, cellulitis persisted for 20 days.
Within few hours from the vaccination I started to feel numbness in my left cheek, left side of neck,  left lower arm, left side of waist, left lower leg. The feeling in the cheek was as when you get anesthesia at the dentist. By the end of the day the numbness was almost gone except at the cheek where was also a feeling of tenderness and tingle sensation. The feeling on the cheek has lasted as of today 4/5/2021.
Child developed wheals (raised,irregular nodules) near eyes, right cheek, posterior neck, arms, and abdomen, approx. 15-20 mins. after vaccines given. Instructed mo. to take child to ED if unable to be seen stat by PMD.
Shotty lymphadenopathy. Fever 104-105x 2 days blanching papules chest, extremities and head (no vascular). MMR given 2 weeks prior DTaP/HIB. Treatment for symptoms: only fluids.
A mother reported that her 18 month old daughter received Prevnar, IPV (Aventis Pasteur SA) and DTAP vaccines on 7/20/00. On 7/23/00, she developed wheezing and shortness of breath. She was taken to the ER and monitored for 3 hours; no drugs were administered. She recovered within 24 hours.
01/10/22: FEVER, BODY ACHES, FATIGUE, HA, RN, EAR PAIN, COUGH, SOB, DIARRHEA, LOSS OF APPETITE
Patient was administered dose of the monovalent COVID-19 vaccine after they were no longer authorized. Patient's parents were notified and reported patient did not have any symptoms.
Tingling sensation down left arm to wrist, pain extending from left shoulder to cervical spine.
Whole body ache. I had severe testicular pain and after several days the whole body ache goes away but the testicular pain doesn't go away and persist till today.
no adverse event. moderna  confirmed 216K22A was viable until 2/21/23 despite beyond use date of 1/22/23
pt recvd vax 30AUG93 & on 31AUG93 approx 730AM achy & drowsy small bruise noted lt deltoid area; no redness; bruise size of nickel; approx 5 PM 31AUG93; started having chills, pain in lt arm & neck area; t103; arm sore; redness noted lt arm
--Days 2-3 after vaccine: fever, chills, nausea, loss of appetite, felt like skin on fire; --Days 4 after vaccine: slight reprieve, no fever, still loss of appetite, skin no longer felt on fire --Days 5-6: extreme nausea, vomiting, diarrhea -- Taken by ambulance to hospital on 4/13/21; admitted due to acute renal failure --10 day hospital stay: First 7 days with extremely low potassium and magnesium levels, put on telemetry due to low electrolytes.  BP fluctuated up and down.  Lactic acid & hemoglobin extremely high upon admission. I have all lab reports if necessary to provide. In fact, discharged with potassium at bare minimum of safety.  Released with 3.5 potassium level. --Unable to control nausea: Zofran & Phenergan ineffective.  Eventually put on IV Phenergan piggy back through IV with oral Diclegis given every 8 hours, eventually change to every 6 hours.  Pain felt in upper right quadrant and lower abdomen due to multiple bowel movements (extreme diarrhea). --Tests performed in hospital showed nothing abnormal: CT Scan, Ultrasound, Endoscopy, MRI with and without contrast --Immediate follow-up with GI doctor on 4/23/21.
When receiving vaccine. Armed was swelled and hurt for weeks.  Was very sick for 24 hours, flu like symptoms for both shots. Within a month, joints started to hurt and numbness was in both arms and hands.  It has been over a year, still joint pain in fingers, knees and feet. Numbness still occurs. Activity makes it worse. Went from being healthy to having many issues.
Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a female patient. On 04NOV2013 the patient received ZOSTAVAX and experienced an adverse reaction (not further specified). The reported lot # J003798 and expiration date of 28JUN2014 was valid. Additional information has been requested.
After receiving her 2nd dose she was feeling dizzy, ears clogged and had blurred vision for a few minutes while was in the post vaccine waiting area. After a few minutes, she started feeling better and left the pharmacy.
Mom states parent developed very uncharacteristic high pitched "animal cry" for several hours after immunization.  Was unconsolable.
A lot of liquid running down the front and back of her arm; concerned there was a leak around the hub around the needle; concerned there was a leak around the hub around the needle; A spontaneous report was received from a consumer, who was also a 67-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  There was a lot of liquid running down the front and back of arm (exposure via skin contact) and the patient was concerned that there was a leak around the hub around the needle (device connection issue, underdose).  The patients' medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (batch number: 013L20A) on 16 Jan 2021.  On 13 FEB 2021 at 1 pm, the patient received their second dose of mRNA-1273 (batch number: 039K20A) for prophylaxis of COVID-19 infection.   During the second dose, there was a lot of liquid running down the front and back of the patient's arm.  She was concerned that there was a leak around the hub around the needle.  The patient asked if she would have the same immunity effect if she did not receive the full second dose.   Treatment information was not provided.  The action taken with mRNA-1273 in response to the events was not applicable.  The events, there was a lot of liquid running down the front and back of arm and concerned that there was a leak around the hub around the needle, were considered recovered/resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of Underdose due to a leak around the hub around the needle for mRNA-1273, lot # 039K20A with no associated AEs.
i prepared the vaccine, got verified, then administered the vaccine. a couple hours later i went to document and it was expired.
About 2 days after administration of Gardasil pt reported onset of intense itching under armpit same side, has now been present for about 3 weeks, not improving.  Possibly reaction to Gardasil vs fungal infection -avoid any irritants, no creams of soaps or deodorants -fungal cream twice a day -will report this as adverse event to Gardasil -reeval in 1 week  Medications Added to Medication List This Visit: 1)  Ketoconazole 2 % Crea (Ketoconazole) .... Apply twice a day
Myalgia, Arthralgia, Fever, CoughWheeze, Diarrhea, Chills, Narrative:
Information has been received from a registered nurse concerning an 11 year old male who on 22-OCT-2008 was vaccinated with a dose of GARDASIL vaccine, IM. No problems reported. Follow up information was received from a physician who reported that the patient came into the office for Tdap vaccine (unspecified), MENACTRA and VARIVAX (Oka/Merck) and he mistakenly received GARDASIL. The physician reported that the child experienced some soreness in his arm and weakness, but nothing adverse. The physician stated the the child was fine. Additional information has been requested.   This is in follow-up to report (s) previously submitted on 11/14/2008.  Information has been received from a registered nurse concerning an 11 year old male who on 22-OCT-2008 was vaccinated with a dose of GARDASIL 0.5 mL, IM.  No problems reported.  Follow up information was received from a physician who reported that the patient came into the office for MENACTRA and VARIVAX and he mistakenly received GARDASIL.  The physician reported that the child experiened some soreness in his arm and and weakness, but nothing adverse.  The physician stated that the child was fine.  Additional information has been requested.
Woke up  by epigastric pain, radiating to chest. Associated with nausea. Went to ER with persistent chest pain. Ruled out cardiac cause.  Nausea persisted after discharge from ER leading to another ER visit for hydration. Pain and nausea improved 24 hours later.
PATIENT WAS INADVERTENTLY GIVEN INTRADERMAL FLU VACCINE AND IT IS ONLY APPROVED FOR USE IN ADULTS AGED 18 THROUGH 64 YEARS OLD. PATIENT IS 11 YEARS OLD.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805424 was crossed linked to original cases 201804863 due to same reporter.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Fatigue, tachycardia, Vertigo, nausea, muscle aces, chills, sweating, coughing, sneezing, shortness of breath, chest pain on exertion, dizziness, weakness, muscle tremors
13 year old patient administered 10 mcg dose of pediatric formulation 5-11 years.
Information has been received from a registered nurse concerning a 7 year old male who was vaccinated on 5/27/97 with a dose of varicella virus vaccine live (lot number was unavailable). The patient was seen in April 2003 with a few pox. The child was noted to have chicken pox breakthrough. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live and developed chicken pox breakthrough/shingles (WAES0404USA00205, 040USA00418, 0404USA00419, 0404USA00420, 0404USA00421, 0404USA00422, 0404USA00423, 0404USA00424, 0404USA00425, 0404USA00426, 0404USA00427, 0404USA00428, 0404USA00429, 0404USA00430, 0404USA00431, 0404USA00433, 0404USA00434, 0404USA00435, and 0404USA00436). No further information is expected.
lip swelling for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip swelling for 3 days) in a 22-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (lip swelling for 3 days). At the time of the report, LIP SWELLING (lip swelling for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Did not take any medication. No known allergies. Patient received the 1st dose of the Moderna vaccine last month. Then she had a swollen lip that lasted for 3 days.
COVID PCR: 02Dec2021 positive; COVID PCR: 02Dec2021 positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 08Jan2021 (Lot number: EL3246) at the age of 39 years as dose 2, single and intramuscular, administered in deltoid left, administration date 18Dec2020 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 01Mar2013 (ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism, start date: 2013 (ongoing); ORTHO TRI-CYCLEN LO taken for contraception, start date: 2017 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Dec2021, outcome "unknown" and all described as "COVID PCR: 02Dec2021 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Dec2021) positive. There was no family medical history relevant to adverse event. On 28Jan2022 at 21:00, the patient experienced non-stop coughing and on 29Jan2022 patient experienced violent vomiting at 09:00, diarrhoea at 10:00, fever-103, chills at 12:30. Patient was recovered from non-stop coughing, violent vomiting, diarrhoea and fever-103, chills. Patient required to visit physician office for non-stop coughing, violent vomiting, diarrhoea and fever-103, chills. Treatment was not received for non-stop coughing, violent vomiting, diarrhoea and fever-103, chills. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods of Lot EK5730 and EL3246. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch were within specifications. The patient received third dose on 28Jan2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully excluded.
1 1/2 hrs p/vax pt became pale, sleepy & wouldn't wake up; seen in office; appeared grayish & drowsy, t98.8, PB 80systolic; HR 130/min; color returned 15-20mins; vomited had diarrhea;
Patient was seen in clinic this morning for Tdap and Pneumovax vaccination. She called just now and stated that her upper arm has a large welt on it the size of a softball. It is painful even when she doesn't move her arm and extremely painful when she moves it. States she is barely able to lift her arm without throbbing pain. Slightly warm feeling to her. No redness, no feverish feeling although she has not taken her temperature. States she has had adverse reaction in the past but never this severe.
she is not completely well; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a 99-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was not recovered/not resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by the son/daughter of the patient. The age at vaccination was unknown, as patient could be 98 years or 99 years old at the time of vaccination. The patient had her first Shingrix shot six months ago. The patient was planning on getting her second shot at the time of reporting, but she was not completely well. The reporter asked if she could get one shot and not the second shot.
Information has been received from a physician concerning a 17 year old female who on 23-APR-2008 was vaccinated with the third dose of GARDASIL. The physician reported that after the patient's last dose of GARDASIL the patient experienced skin warts that were all over her body cleared up. Biopsy of skin warts were performed. The patient sought unspecified medical attention. Additional information has been requested. 6/24/09 CDC spoke with Provider who stated that all warts started PRIOR TO HPV4 vaccine. Pt was treated with interferon, freezing and drugs and none of these cured the warts that were all over the body. Then given HPV4 vaccine on the following dates: Oct. 2007, Jan 2008 and 4/23/08. All warts had cleared up after receipt of # 3 dose of HPV4. 7/20/09 Consultant records received DOS 7/26/06 to 1/31/07. Assessment: Warts. Warts on legs, feet, arms, hands, face; treated by laser, intralesional injection, topical ointments. Dry peeling skin on face. History of tonsillectomy, myringotomy. Endometriosis. Multiple nevi. \ksk 9/29/09 PCP records received.  Warts cleared up by 9/2008.
Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 39-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.