chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feverish; Felt fatigued; mild body aches; headache; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In January 2021, the patient received Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season. In January 2021, less than a week after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever, fatigue, general body pain and headache. On an unknown date, the outcome of the fever, fatigue, general body pain and headache were unknown.   The reporter considered the fever, fatigue, general body pain and headache to be possibly related to Shingles vaccine. It was unknown if the reporter considered the fever, fatigue, general body pain and headache to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered Shingrix at the same time as the flu vaccine. The patient was feverish with mild body aches and a headache. The patient felt fatigued when took the shingles vaccine, which had similar side effects. The patient stated that a third of people who take the shingles shot have flu-like feelings. But it was definitely better than getting shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001249:Same reporter
Information has been received from a physician concerning a 15 year old female who on 22-AUG-2007 was vaccinated with a first dose Gardasil.  There was no concomitant medication.  On 23-AUG-2007 the patient experienced hives.  Unspecified medical attention was sought.  Subsequently, the patient recovered from hives.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a physician concerning a 15 year old female who on 22-AUG-2007 was vaccinated IM in the right deltoid with a 0.5 ml of a first dose of GARDASIL (Lot # 0210U). On 16-AUG-2007 the patient had been vaccination with the first dose of MENACTRA. On 23-AUG-2007 the patient experienced hives one day post vaccination of the first dose GARDASIL. She was treated with BENADRYL. Unspecified medical attention was sought. Subsequently, on an unspecified date the patient recovered from the event. Additional information has been requested.
Severe hives covering entire body. Raised red welts, round with clearly defined ?rings.? Especially concentrated on inner thighs, hands, and feet. Bruising was left behind by the hives as the welts faded. Hand and feet were so swollen and painful that walking and holding objects was barely possible. After the worst of the hives subsided, still suffering from dermotographia daily.
Exposed to COVID from a friend who did not realize he had it. Cold like symptoms started 3 days later.  Contracted COVID. Treated with Paxlovid regimen. Felt fine for a few days after completing Paxlovid regimen. Cold like symptoms returned more severe than before. Yesterday morning took rapid test which was negative. Took PCR test in the afternoon which came back positive.  Still have cold like symptoms but not as severe.
Complained of tingling in hands and arms, ie "like you lay on your arms and they fall to sleep and are now trying to wake up" tingling in lips and face
13 days p/vax had flushing & itchy face; 14th day-gen pinpoint pruritic rah, t99.7, sore (mildly inflamed) throat
A patient who has missed their third dose of GARDASIL 9; No other adverse event; This spontaneous report was received from the administrator on behalf of the costumer concerning a child patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 09-JUN-2017, at age 11, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On 17-AUG-2017, the the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) both vaccines for prophylaxis. The frequency was planned as 3 doses: 0, 2 and 6 months (dose, route of administration, anatomical location, lot number and expiration date were not provided for none of the vaccines). The patient did not came back in for third dose. No other adverse event.
Arm from shoulder to hand swollen 3x normal size. Vomiting night that immunization was given. Notified of symptoms on 5/4/16 by other dr. office.
chest hurting; Sneezing; Running nose; had a bad headache; Body ache; Feeling bad and being a little restless; Feeling bad and being a little restless; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 31Jul2021 (Lot Number: FC3180) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first vaccine and had like chest hurting, sneezing, running nose, had a bad headache, body ache, feeling bad and being a little restless on an unspecified date in 2021. The outcome of the events was unknown.
Information has been received from a physician concerning a 11 year old female with a history of attention deficit disorder and no allergies who on 03-NOV-2007 was vaccinated subcutaneously with a first dose of VARIVAX (Oka/Merck) (lot #658762/1340U). Concomitant therapy included Clonidine and RITALIN. On 11-JAN-2008 the patient was vaccinated subcutaneously with a second dose of VARIVAX (Oka/Merck) (lot #658522/1252U). Recently, the patient developed varicella rash of over 100 lesions (most of the lesions were on her trunk) and she also had a fever and itching. The patient was treated with OTC BENADRYL, TYLENOL and oat meal baths. At the time of report, the patient was recovering. Additional information has been requested.
Vaccine injection site:  red circle (three inches across) and has increased diameter daily since 1-14-2021; swollen; itchy
Significant swelling of (L) arm from above shoulder to elbow. Entire area red, hard, hot. Pt. guarding (L) arm.
Patient had a vasovagal response. He became pale and felt nearly fainted. With the assistance of his wife, he laid down in the floor and put his feet up in a chair. His wife wiped his face with a cool paper towel until he felt better. After about 10 minutes, he sat up against the wall for another 10 minutes until he felt completely fine. The entire event lasted approximately 30 minutes. He states that this often happens when he gets immunizations.
Approximately 75 percent of circumference of the left upper arm is warm and erythematous and mildly edematous. Erythema extends beyond the shoulder and approximately 25% of the way across the scapula posteriorly. Erythema is at the elbow crease. Full range of motion of the arm and lungs clear to auscultation.
On 6/14/99, the pt awoke with pain and inflammation with red/purple dime sized areas on the balls of both feet. Examined by physician and dx with significant vasculitis involving the metatarsal region of both feet; possible serum sickness. Treated with Trentil for 4 weeks, rest, and Motrin.
This spontaneous report as received from a consumer, the father of the patient, refers to a 16 year old patient. Patient experienced fainting (unspecified date) after receiving with a first dose of GARDASIL (intramuscular, strength, formulation, lot#, dose/frequency and duration were unspecified) on an unknown date. The patient recovered quickly in the physician office. Additional information is not expected.
Runny nose and eyes 6 hrs after shot. Extreme diarrhea about 10-12 hrs after the flu shot. Violent shaking about 12 hrs after the shot lasting for about 3 hrs. Couldn't catch my breathe, shaking so hard couldn't put on my glasses or hold a pen. No fever.
Lower extremity weakness. Physical and occupational therapy. Dx: Guillain-Barre. Electrodiagnostic Study consistent with GBS. 78yo active male with PMHx of HTN presenting with BL LE weakness that started this AM. He was in his usual state of health yesterday and walked 2 miles without problems. Today he awoke without issues and ate a grapefruit for breakfast. Shortly after he was walking around his house and his legs felt weak like his knees were going to buckle. He sat in his chair and watched some football and when he tried to get out of his chair he couldn't get up. His legs felt like they just couldn't support him. He is no longer able to stand. He has some mild toe numbness but nothing significant. He is able to lift BL LE off of the bed during eval. He denies inciting event or back pain. No sciatica symptoms. No problems with bladder/bowel issues, no saddle anesthesia, no fevers, rash, change in medications, or trauma. Labs at the local ER were essential normal. Neurology asked me to evaluate and admit for them tonight. He denies chest pain or shortness of breath. He did receive pneumococcal vaccine about 1.5 weeks ago.
Woke up MN last night screaming & acted like he was in a great deal of pain; Lasted 30-45min; Can last 10min-30min (shaking); Has been sleeping a lot; does not lose consciousness when shaking; Advised to notify PMD;Shaking lasted 2 days;
Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021.
09/07 about 2 hours after vaccine began having chest pressure and pain and chocked it up to indigestion. 09/08 began having chest pressure throughout the day that increased through the day and became chest pain in the evening. Also had tightness in throat. 09/09 symptoms where the same throughout the day. That night the symptoms increased and I had a full blown panic attack with sweats and shaking. 09/10 symptoms continued with an increased since of panic. I went into the ER and they did blood work, EKG, and cat scan all normal. 09/11 symptoms continued. 09/12 Went into PCP and they found nothing but put me on LEXAPRO. Over the next two months, I continued to have panic attacks for a short time after beginning the medication but they slowed and then stopped.
Vaccine leaked out of syringe while giving vaccine.  Was not able to see how much vaccine went into patient.
This spontaneous report as received from a physician via company representative refers to unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with GARDASIL 9 (lot # reported as M036059, expiry date: 03-JUN-2019), (route: oral) (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F at a time frame of 15 hours. No adverse effects reported. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA010855.
Client contacted clinic on 6/13/2022 to report symptoms.  States the evening she received her vaccines, she experienced fever, chills, pain, muscle aches.  By Saturday, June 11, her left arm began to hurt and she noticed one thick, red streak from her shot site moving up toward her shoulder.  Over the weekend, she took hot showers and used the heating pad to assist with the body aches.  States no relief; states Monday morning (6/13/22) took Tylenol (states, even though I'm not supposed to, I took a dose of Tylenol).  States she reviewed the VIS statement that were provided during the vaccine visit.  Reviewed again during phone call.  Explained that most of the symptoms she was explaining are common, even the sore arm, however, a red streak is not and instructed client to contact her PMD for evaluation and guidance.  Voiced understanding. Client is receiving vaccines for pre-liver transplant needs.
Patient stated he felt a tingling sensation and really hot about 5 minutes after receiving the vaccine.  Patient received Benadryl Liquid at 10mL (25mg) about 2 minutes later (4:07).  At that time he stated that the tingling had stopped but he still felt hot.  5 minutes later (4:12) patient stated that he no longer felt hot and thought that it may have just been nerves about the vaccine.  Patient left the pharmacy at 4:25 with no symptoms.
dizziness; elevated B/P of 189/99; headache; sore left arm with difficulty moving her left hand; not feeling well; I was sick for a week; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced dizziness, elevated b/p of 189/99, headache, sore left arm with difficulty moving her left hand, not feeling well and i was sick for a week. The patient underwent lab tests and procedures which included blood pressure increased: 189/99 on 17Apr2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After the vaccine, I was tired, and on the back part of the lungs I felt like ice/water giving off, like a hot flash, inflammation and the muscles were hurting and itching ears, I have a dry cough, since then I feel tired. I do yoga to alleviate the pain, I have a headache. All this discomfort is on the right side and I have to get up on the left side so it doesn't hurt.  When I move my hands or I bend down, my back hurts, in my lung.
This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M045546, expiration 12-JUN-2018, oral, for prophylaxis. No adverse effects reported. Sender's Comments: US-009507513-1707USA004891.
female patient received a pediatric dose; female patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up. Note: There is a discrepancy regarding the reported suspect vaccine information, query was raised for the same and meanwhile suspect start date, batch number and expiry date was kept blank for Engerix B as all information seems to be for Havrix.
Pharmacy personnel prepared a dose of COVID vaccine for inpatient without reconstituting the vial as per the manufacturer instructions.  1.8 mL NS should have been added to vial prior to withdrawing dose.  RN administered dose at 2:30 PM on 8/27/2021.   Contacted RN who administered dose - she informed me that patient had reported no side effects after dose administered and was already discharged.  Contacted patient after discharge and informed him of the potential for local and systemic adverse events and to be seen in ED if he experiences severe side effects. As of approximately 6 PM on day of discharge, patient reported no side effects experienced since discharge from hospital.  Contacted the patient 24 hours later - he stated he experienced chills and dizziness the evening of the vaccine administration.
Pt felt dizzy and fainted in chair within 5 minutes of vaccine administration (head tilted back, eyes closed, breathing stopped for 1 sec).  Regained consciousness within 1 minute, was given glucose tabs, water, crackers and recovered by 30 minutes waiting.
SWELLING ON ADMINISTRATION SITE STARTED, IN THE NIGHT RASHES AND SMALL ELEVATED SPOTS NOTED ON NECK, GROIN, FACE, AXILLA, UPPER EXTREMITIES THE AREAS OF RASHES GETTING BIG AND ITCHING STARTED, SUBSIDED WITH BENADRYL ONE DOSE IN ER, NEXT MORNING FOUND BIG AREAS OF ELEVATION ON FACE, SCALP, NECK, GROIN, SWOLLEN RED KNEES, WRIST
4/11/21 pt with pleurtic chest pain and worsening hypoxia.  chest x-ray w/ bilateral pulmonary infiltrates. covid pcr + 4/11.  pt admitted to hospital on 4/7 for alcohol withdrawal, minimal o2 requirements on admit.  on 4/10 pt with low grade temperature and 02 requirements were increasing then, started on azithro 500mg daily x 3 days, patient did have chest ray that day with bilateral opacities.
Developed body rash and large reddened area at injection site. Benadryl 50 mg IM, Solumedrol 125 mg IM, Prednisone ta per dose.
Began with small rash under armpit on left side.  First noticed around 8am on Sunday June 26.   Rash is now also on left cheek and left back.  Looks like hives
SEVERE RIGHT SIDED LOWER BACK PAIN; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced severe right sided lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe right sided lower back pain. This report was non-serious.
patient "passed out"; woozy; faint; stomach pain; This spontaneous report was received from a physician via company representative and refers to a male 'possibly adolescent' patient of unknown age. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug allergies and reactions was provided.  On an unknown date in 2020 (reported as 'couple of weeks ago'), the patient was vaccinated with unknown series of dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot # and expiry date were not provided) for prophylaxis.  After vaccination, the patient 'passed out', was 'woozy' and faint. The physician watched the patient for an hour and the patient was sent to the emergency room (ER) as he was still faint. The patient received fluids (unspecified) in the hospital. He was discharged from the hospital on an unknown date in 2020, but had complained of stomach pain. It was reported that at the time of the report the patient was doing okay.  The causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, loss of consciousness was considered to be medically significant.
Headache, CoughWheeze, shortness of breath exhaustion Narrative: On 8/20/21, he experienced exhaustion, shortness of breath, cough, and headache for 5 days. Evaluated by employee health.
Pt. states that after receiving the 1st dose of Moderna 08/22/2021, started experiencing symptoms 09/01/2021 of a rash on the left arm, hot to the touch, and itchiness. Primary Telehealth visit recommended Steroid cream. Still continuing to experience symptoms.
Light headed/vertigo sensation w/balance disturbance due to vestibular weakness (suspected), fuzzy head feeling, difficult to concentrate
About a week later from both shots I experienced extreme dizziness that lasted 5 seconds   A total of 4 dizzy spells that totally frightened me. I went to the ER had MRI and multiple tests done for stroke, heart attack mass. All perfect! Thank God It?s been 5 weeks after second shot and at times I still feel at times unsteady and fearful it will happen again.  I am a very healthy person exercise not overweight and eat healthy.
Sore in injection arm - hurt to move arm at all.  Ran a low fever or a couple of hours.  Had a headache for about 24 hours.  All symptoms gone within 24 hours of onset.
tingling of the lips/Lips tingled; Throat got tight; This is a spontaneous report from a contactable other hcp(patient).  The 49-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration at left arm on 21Dec2020 at single dose for COVID-19 immunization. There were no concomitant medications nor medical history.  Patient got first dose of the COVID vaccine and experienced her lips tingled/ tingling of the lips and her throat got tight, both on 21Dec2020, led to medically significant, lasted about 20 minutes. They observed her and she did not need any further treatment. Outcome of events was recovered in 21Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of her lips tingled/ tingling of the lips and her throat got tight cannot be excluded, considering the plausible temporal relationship and the known adverse event (anaphylactic adverse reaction) profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
This medically confirmed report (initial receipt 06-Aug-2012) concerns a male patient, approximately 75 years old. The patient had previously received flu vaccine (unknown manufacturer) on an unknown date and developed Guillain Barre Syndrome. He was paralysed from the waist down (see case 2012033040). On an unknown date, the patient received influenza vaccine (manufacturer and batch number not specified). An unknown time later, the patient developed Guillain Barre Syndrome. He had a milder case (compared to the first episode). The patient recovered after each case of GBS (Guillain Barre Syndrome). Reporter's comment: On 20-Aug-2012 the pharmacist commented that the patient's GBS following vaccination with an unspecified flu vaccine occurred approximately 7 years ago. She had no idea which flu vaccine the patient received approximately 7 years ago. Follow up (20-Aug-2012): reporter's comment.
Random period in the middle of birth control cycle  But your system doesn?t even know it is JOHNSON & JOHNSON  - NOT JANSSEN
Pt. c/o dizziness, sensation of falling, headache, cramping, holding her head, pain, nausea and vomiting. 2:40PM Pt. given injection of epinephrine.  3:05pm given benadryl 30ml po. Vital signs:  2:50pm  120/82 92 13 O2 99%;  3:00pm  110/78 84  O2 99%;  3:05pm 108/72 91 O2 91%; 3:10p  100/70 78 O2 99%;   **Pt. advised for safety reasons, ambulance would be called to assess symptoms.  Pt. was agreeable to  Nurse's assessment.
On January 12, one week after receiving the vaccine I noticed ringing in my ears. I didn't connect the two until a few months later (still have it) that I recalled sitting down to do a Calm app meditation where you rate your experience at the end and I remembered was the first time I noticed it. I didn't complete the meditation because the ringing was bothering me and I rated it with a "frowny face". When I went to the app to check, it was the week after the vaccine.