chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The rash was itchy; Rash here and there on her body; feet were stinging; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (The rash was itchy), RASH (Rash here and there on her body) and PAIN (feet were stinging) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041220A) 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 19-Jan-2021, the patient experienced PRURITUS (The rash was itchy), RASH (Rash here and there on her body) and PAIN (feet were stinging). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 4 pills a day. On 19-Jan-2021, PAIN (feet were stinging) outcome was unknown. At the time of the report, PRURITUS (The rash was itchy) and RASH (Rash here and there on her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Benadryl upto 4 pills a day and Benadryl creams. Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up received on 20-JUN-2021 contains No new information.
Patient stated that a few hours after receiving shot her arm started hurting really bad.  The next day it got worst so patient went to ER and followed up with PCP on 11/14/16.  Came to us on 11/14/16 saying her arm hurt and she was having trouble moving it.
Got my 1st dose got a bad reaction felt like had a bad flu.; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR092900   Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got his/her shingles vaccine and got the bad reaction. It felt like he/she had a really bad flu.  The reporter stated that, he/she was glad that he/she got the vaccine.  The reporter further stated that, he/she rather suffered a few days than getting the shingles. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR092900, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR092900:Same Reporter
Fever of 101 w/malaise for 4 days; sl nausea for 2 days & local reaction characterized by redness, painful to touch, swelling, warmth & itching for 72 hrs;
approximately 14 hours after second Moderna vaccine, developed severe shaking chills, low grade fever, nausea and fainting
JANSSEN COVID-19 VACCINE EUA 12PM Sore deltoid left side up the neck BY  2PM lightheadedness, dizziness, nausea, headache, fatigue BY 4PM Dry cough and chills, BY 6PM Muscle soreness on the entire left side of body By 10PM 101 fever, aching in every joint of body, trouble breathing By 2AM hot and feverish. All symptoms continued through Sunday, many abating by Monday. However, I am still fatigued, coughing, lightheaded, dizzy, and nauseous since then to even now 3/19/2021. Headache comes and goes and slight difficulties in breathing from the normal. COVID rapid result test came back Negative today from facility.
This case was reported by a healthcare professional and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX in an unknown deltoid. Within one day of vaccination, the subject experienced a local reaction at the injection site with injection site redness and injection site pain. Drowsiness was also reported. At the time of reporting the outcome of the events was unspecified. The nurse reported that 7 employees of the nursing home received FLUARIX and experienced a local injection site reaction within one day from vaccination. The local reactions ranged from local redness and pain at the injection site to left arm pain which radiated to the chest in one subject and left arm pain which radiated down the arm in another subject. No additional information was provided at the time of reporting. Linked cases include A0809349A, A0809357A and A0809359A through A0809362A.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-172135 (Patient Link).
Mild fever. Soreness at site (L arm). Hives/rash - legs & ankles. Stable no other SX.
Vaccination-induced adenopathy: grossly enlarged axillary lymph nodes near injection site; onset 3 weeks post-injection.
pt recv vax 16MAY94 & 18MAY94 pt devel arthritis, arthralgia, chills, fever 101.2, myalgia, cephalgia; presented to MD & recovered 20MAY94; No further details were provided;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 5th February 2019, the patient received the 2nd dose of SHINGRIX. On 5th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The patient received SHINGRIX vaccine on left arm and was 5 days past her six month period. The patient experienced soreness at the injection site after receiving SHINGRIX vaccine.
No adverse reaction observed during the monitoring period before discharge. Staff contracted for the vaccination clinic at our site vaccinated this patient under the age of 18 in error.
Dull with occasional sharp pains behind the left ear.  Started on Sunday 11/21/2021 in the evening.
There is a significant area of redness around the injection site (about 1" all around the site). The patient has also complained of the injection area being very tender as well as having some swelling and tenderness of the neck, and mild swelling of lips. The patient took 650mg of Acetaminophen for pain with very limited improvement.
Fainted to the floor; Dizzy; Too dizzy, hot and sweaty; Nausea; A  little vomit; sweaty; A spontaneous report was received from a non-health professional who was a 40-years-old, female patient who received Moderna's COVID-19 vaccine and fainted, was dizzy, felt hot, had nausea and vomiting, and sweaty.  The patient's medical history included a propensity for fainting and low blood pressure. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 12 Jan 2021, after receiving the vaccine, the patient got dizzy, had nausea, a little vomit, and fainted to the floor. She reported feeling dizzy, hot and sweaty.  Patient did not take medication to treat her symptoms.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, fainted, dizziness, felt hot, nausea and vomiting, and sweaty were unknown.; Reporter's Comments: This case concerns a 40-year-old female patient with medical history of propensity for fainting and low blood pressure who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the unlisted event of Syncope which was considered medically significant. Additionally, the patient experienced the non-serious listed events of Nausea and Vomiting, and the non-serious unlisted events of Feeling Hot, Dizziness and Hyperhidrosis. Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. We would note that the patient's history of propensity for fainting and low blood pressure could be also contributory.
Seen by provider 9/12/11 at 9:45am for itchiness and reddening 2" > 5" left upper outer arm, warm to touch, non tender to palpation. Possible allergic reaction. Treatment - BENADRYL.
Dizziness; Soreness; Feeling unwell; foggy head; This is a spontaneous report from a non-contactable consumer, the patient. An adolescent female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced dizziness, soreness, foggy head and felt unwell. The clinical outcome of the events dizziness, soreness, foggy head and felt unwell were unknown at the time of  this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got the shot on the 17th of Dec. Feet started hurting so went to doc who took blood test. Kidneys were up to 2.9. By new years eve they were 7.
Information has been received from a nurse referring to a currently 3 to 4 years old patient. On an unknown date, the patient was vaccinated with PEDVAXHIB (2 months for dose 1, 4 months for dose 2, 6 months for dose 3, dose, frequency and lot number not provided). No adverse effects were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
reported bad headaches on the day following the vaccine--did not see the doctor--later died.  the coroner reported that the preliminary autopsy showed an enlarged heart and liver
After administering the vaccine into the patient's arm, the needle retracted back into the syringe forcefully and the vaccine squirted out back toward the nurse giving the dose.  After the nurse looked at the syringe there was still liquid inside the syringe and leaking out the bottom of the syringe.  It appeared that the vaccine did not enter the patient's arm.  After discussing what happened with the patient, the patient decided to receive a second dose.  After administering the second dose the patient stated that she could feel the vaccine enter her arm where as she did not feel it with the first shot.
Pt seen in ED on 1/19/22 for generalized weakness and tested positive for COVID-19, was discharged.  Came back to the ED for increasing SOB on 1/23/22 and was admitted for COVID pneumonia.87yo female with PMH of HTN now with COVID PNA, diagnosed on 1/19, vaccinated. Pt is currently on Bipap 12/6 100% FiO2 with O2 sat 100% and very comfortable. Since pt will be made DNR, there is no current need to bring her to the ICU for respiratory management. As for open anion gap with lactic acidosis, it is likely due to a starvation ketosis as pt has had poor PO intake over the past few days. Additionally she is hypovolemic with concentrated urine spec grav and hyponatremic/hypochloremic. Would resuscita  given CXR appearance and start SSI and initiate meds per COVID protocol.  XR Chest 1V [Auth (Verified)] (01/23 1252): FINAL IMPRESSION: Diffuse bilateral mixed infiltrates. Findings could be on the basis of infectious or edema. Patient was discharged to Hospice on 1/26/2022.  Patient previously vaccinated with Pfizer 8/5/21 & 8/26/21.
Rash to face, neck, upper arms. Treatment with Benadryl, Hydrocortisone, and keep skin temperature cool.  To monitor.
Sudden onset clusters of vesicles which evolved into painful, chronic mouth sores which lasted 5 months
Administered 7/15/2011. Patient suffered pancreatitis October (mid) 2011. Required admission and treatment.
all of us started experiencing headaches; he couldn't go to work, exercise or anything because he would kind of like fainting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "all of us started experiencing headaches"; DIZZINESS (non-serious), outcome "recovering", described as "he couldn't go to work, exercise or anything because he would kind of like fainting". Therapeutic measures were taken as a result of headache, dizziness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe body aches, joint pain, body chills, high fever (102 F), headache, severe pain in kidneys, nausea and vomiting
shoulder pain, back pain, numbness and tingling of fingers, dizziness, acute renal failure, hyperkalemia
FEVER; CHILLS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophyalctic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
The patient reported having a grape-sized, painful, swollen area around the injection site the night of the injection. She experienced difficult moving her arm because of the soreness. She self-treated with Tylenol and Motrin. She reported the area of swelling moved to an area distal to the initial area and that the swelling was approximately the size of an orange. She is now taking Tylenol and Aleve and will follow-up with her primary care physician if the condition worsens.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild
Patient reported abnormal burning while getting injection, she said about an inch below injection site, she had swelling and her arm was red, also reported having bad red and hot knot and these symptoms lasted about 1 week.
Patient said after he received the shot he felt a sharp pain in his left arm (non vaccinated arm) that he felt went down his arm and up into his heart. His arm then went numb for a short time and then he said he didn't feel any pain at all and everything felt normal.
Local reaction to right thigh only. Redness and swelling surrounding injection site. Fever noted by parents last night and vaccines were given yesterday. Per grandma child has been eating well, not fussy and overall happy, general appearance.
7-10 days after being around a child that developed chickenpox. Mom reports child had about 8 spots which lasted 4-5 days without fever.
Pt received her Tdap, MENACTRA and HPV vaccines on 7/2/18, her parents noticed some slurred speech intermittently within a few days and saw me in the office on 7/9/18. Multiple lab tests were normal, brain MRI/MRA and EEG. Her exam was also normal both by me and Neuro. Seems to have resolved after 2-3 weeks.
Injection-site pain/discomfort Narrative: Per COVID-19 Screen note 12/17/20at23:12: No side-effects noted other than verbalization of some discomfort to right upper arm. Offered pain med but said no. No redness, no swelling noted to site. 12/18/20 COVID-19  Screen note at22:51 has addendum at23:11: pt reported still w/ discomfort to right deltoid site. Offered pain med but declined. 12/19/20 COVID-19 Screen note at03:37 states patient denied pain/discomfort.
16yo F with known history of syncopal episodes after injections who had a witnessed syncopal episode and LOC for 30s. Pt was evaluated by medical staff and EMS, provided with oral hydration and nutrition. Pt improved after 20min of observation and was released.
Woke up in the middle of the night on 6/8/2021 around 2 AM ET and felt like the room was spinning. Felt like I might pass out, rapid heart rate. Felt 'vibrations' in L arm.  Thought something serious was wrong. Arrived at ED.  Had a loss of balance and coordination. Vomited. Was treated with Meclizine, zofran, and potassium drink. Diagnosed with benign positional vertigo. Went to PCP later that day. Confirmed diagnosis and recommended taking migraine medication (Excedrin) immediately. Resolved within 2 days. Never experienced Vertigo before in lifetime - new since vaccination.
This case was reported by a other health professional via regulatory authority and described the occurrence of fatigue in a adult female patient who received Meningococcal ACWY Vaccine (potential MENVEO) for prophylaxis. Concomitant products included valsartan, Levothyroxine Sodium and sertraline hydrochloride. On 18th June 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular). On 24th June 2009, 6 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced fatigue (serious criteria disability and other: as per reporter), shallow breathing (serious criteria disability and other: as per reporter), memory loss (serious criteria disability and other: as per reporter), nausea (serious criteria disability and other: as per reporter), headache (serious criteria disability and other: as per reporter), weight loss (serious criteria disability and other: as per reporter) and decreased appetite (serious criteria disability and other: as per reporter). On an unknown date, the patient experienced malaise (serious criteria disability and other: as per reporter) and dizziness (serious criteria disability and other: as per reporter). On an unknown date, the outcome of the fatigue, shallow breathing, memory loss, nausea, headache, weight loss, decreased appetite, malaise and dizziness were recovered/resolved. It was unknown if the reporter considered the fatigue, shallow breathing, memory loss, nausea, headache, weight loss, decreased appetite, malaise and dizziness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The patient received concomitant (drug name unknown) for Arthralgia. The patient received Valsartan for hypertension, Thyroxine sodium for hypothyroidism and Sertraline hydrochloride for depression. The age at vaccination was not reported. The patient experienced extreme fatigue. Correction done on 26 November 2018, following an internal QC. This case downloaded from Agency was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
After the dose, patient was asked to stay for 15 minute observation and he experienced syncope by falling off chair. Patient regained consciousness  within 1 minute and then felt fine
Covid vaccine booster given  8 days before the 5 month.  First dose: 12/30/2021 Second Dose 01/21/2022 Booster given 06/13/2022 it was due 6/21/2022 or after
Pt was inadvertently given the Monovalent Booster instead of the Bivalent Booster (Moderna)  Pt experienced no adverse event.  He is scheduled to return 2 months from date of this vaccination to receive the Moderna Bivalent Booster
Patient refers feeling dizzy, looks pale and blurry vision. Paramedics take her vitals and is transported to ambulance for evaluation. Pressure 80/50, Dxt 100, P67, sat. Doctor was called and indicates to elevated legs, to keep in observation for 30 minutes and give patient a candy for stimulation.
Pt received the Janssen covid vaccine. During the 15 minutes post-vaccination observation period, pt started not feeling well. He experienced dizziness, sweating, swelling of the lips and tongue, and shortness of breath. Pt was non-responsive. Rph administered an Epipen and staff called the ambulance. At this time, pt was becoming more responsive in response to the Epipen. EMS came and checked the pt's vitals. Vitals were within normal range. Pt was not sent to the hospital. EMS advised the family to monitor the pt and call EMS if  symptoms worsen. Pt is doing okay.
After receiving the first dose, she experienced just a sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After receiving the first dose, she experienced just a sore arm for a couple of days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergies to Cedar tree). Concomitant products included CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (After receiving the first dose, she experienced just a sore arm for a couple of days). On 07-Apr-2021, PAIN IN EXTREMITY (After receiving the first dose, she experienced just a sore arm for a couple of days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment drug information was provided.   This case was linked to MOD-2022-485374 (Patient Link).
Pt became limp after receiving 4 vaccines. Became limp, slumped down in chair & body began trembling. Called for help. Attempted to stop pt from sliding out of chair. Pt regained composure, reports he is fine, he felt med. go through his body & got sleepy. Help arrived, father arrived. Both deny hx of seizures. Pt denies any other help (referred to E.R.), states he is hungry, & left with father. Received VIS with instructions.
APPROXIMATELY 10 MINUTES AFTER INJECTION, PATIENT BEGAN FEELING DIZZY, SWEATING AND FELL IN THE BACK OF THE AISLE WHILE GRABBING HIS MOTHER TO SIT WITH HIM. I SAT PATIENT DOWN AND ASKED WHAT SYMPTOMS HE WAS EXPERIENCING. HE SAID HE HAD ABSOLUTELY NO TROUBLE BREATHING AND JUST FELT LIGHT HEADED, SOME FLOATERS IN HIS EYES AND SWEATY. I IMMEDIATELY TOOK HIS BLOOD PRESSURE WHICH WAS LOW AND OFFERED HIM WATER, AND GATORADE. PATIENT DID NOT WANT US TO CALL EMS BUT DUE TO LOW BLOOD PRESSURE, EMS WAS CALLED. ALL VITALS WERE CHECKED ABOUT 10-15 MIN LATER BY EMS AND EVERYTHING CHECKED OUT OK. PATIENT DECLINED SERVICES AND TRANSPORATION TO HOSPITAL AND STATED THAT HE FELT MUCH BETTER. FOLLOWED UP WITH PATIENT AN HOUR LATER VIA PHONE AND PATIENT WAS FEELING MUCH BETTER AND WAS JUST RESTING; CALLED AGAIN AT 6:30PM AND PATIENT SAID HE FELT 100% AND I COUNSELED HIM ON VISITING THE ER ASAP IF ANY SYMPTOMS, OR FEELING ILL RETURNED.