chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weak; flu like; felt really bad; shivering; sore arm; feeling tired/ very tired; achy; fever; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 12th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, tiredness, pain, fever, shivering and feeling bad. On an unknown date, the patient experienced weakness and influenza like illness. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On 14th April 2019, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the tiredness and weakness were not recovered/not resolved and the outcome of the fever, shivering, influenza like illness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, pain, fever, weakness, shivering, influenza like illness and feeling bad to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix and next morning of Friday the patient arm was sore and through the day she started feeling tired and achy and her arm got more sore. By the time, the patient got home from work she felt really bad, was shivering and she had a fever, which was 102 degree F at its highest. The patient took some Ibuprofen and Benadryl and fell asleep and when the patient woke up her fever was down to 100 degree F. On Saturday, the patient felt very tired and achy and did not do anything all day. On Sunday she felt okay since she did not have to do any activities. But now today, Monday, the patient was back at work and feels weak and tired on the date of reporting, like the patient had the flu for several days.  The patient had no longer achiness and her arm was lot better.
Subsequent to receiving vax, the pt was diagnosed with influenza A virus infection confirmed by nasal swab.
Redness and itching around area of injection. Area is about 2.5 inch long and 1 inch wide. Reaction started 1 week after injection.
chest and heart pain; Short of breath; chest and heart pain; sore arm; tremendous pain; The chest pain is pinching and tightening like a poking of a needle or tightening of the chest; This is a spontaneous report from a contactable consumer. This consumer reported for an 18-year-old female patient (reporter's daughter). An 18-year-old female patient received BNT162b2 (BNT162B2), first dose, intramuscularly, administered in arm left on 11Jul2021 15:30 at the age of 18 years old, at 0.3 ml single dose for covid-19 immunisation. Medical history was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient's Mother in law has a heart problem, the patient's brother was born with a hole in his heart. There were no concomitant medications. There was no other vaccine in four weeks. The patient experienced chest and heart pain on 12Jul2021, short of breath on 12Jul2021, sore arm on 11Jul2021, tremendous pain in Jul2021, the chest pain is pinching and tightening like a poking of a needle or tightening of the chest in Jul2021. The reporter was calling on behalf of his daughter. The vaccine didn't sit right with the patient. The patient had chest and heart pain and was short of breath. The patient went to her primary care provider and they checked her out and gave them a cardiologist's name to go see tomorrow. The doctor prescribed some ointment to rub on the chest. The doctor recommend that the patient not get her second shot because there was a heart condition that runs in the reporter 's wife's side of the family. The cardiologist was going to do an ultrasound on the patient. The patient was going through tremendous pain and colleges are requiring the vaccine, which was why she got it. The chest pain started Monday (12Jul2021) night at midnight. First came the chest pain and then the shortness of breath. The patient had arm pain and they recommended that she take Tylenol. Tuesday (13Jul2021) the patient had chest pain and took Tylenol and recommended that she see a cardiologist. The patient took Tylenol for her sore arm. The chest pain was pinching and tightening like a poking of a needle or tightening of the chest. The patient is going to be getting an MRI and sonogram tomorrow at the Cardiologist. The doctor is not advising the patient to take the second shot because the symptoms are worse with the second shot. The outcome of the events chest and heart pain, short of breath was not recovered, of the event sore arm was recovering, of the other events was unknown.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Information has been received from a nurse referring to a 33 year old female patient. On 05-FEB-2015 the patient was vaccinated with a dose of GARDASIL  injection, 0.5 ml, intramuscularly. The patient was 36 weeks pregnant at the time of reporting on 06-FEB-2015. The patient was pregnant with Last Menstrual Period (LMP) of 29-MAY-2014 and Estimated date of delivery (EDD) of 05-Mar-2015. No adverse effect reported. The pregnancy outcome was pending. Additional information has been requested.
PT WAS GIVEN TDAP AND TD ON THE SAME DAY. NO MANIFESTATIONS OF ADVERSE REACTION PRESENT. PT DENIED ANY PAIN OR DISCOMFORT AT THE INJECTION SITE.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 12-year-old female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis. On 24th October 2013, the patient received the 1st dose of Meningitis ACWY vaccine (potential MENVEO). In October 2013, 1 day after receiving Meningitis ACWY vaccine (potential MENVEO), the patient experienced injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction. On an unknown date, the outcome of the injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction to be related to Meningitis ACWY vaccine (potential MENVEO). Additional details were provided as follows: The case was reported by the mother of the patient. The patient got a meningitis vaccine to cover group A about 5 years ago. The mother does not know the brand name. The patient had pain at the injection site and a lot of swelling at the injection site. The patient developed a large red lump on her arm at the injection site. The lump was the size of a golf ball and very warm to the touch. It stayed like that for a couple of weeks. She started having those symptoms the next day after the injection. Reporter believed that her daughter had to go back to the office for a booster dose at 16 years.
Onset of fever and "fall" off chair 15 hrs after immunization of Hep A. Also nasal sx.
Neurological problems. Difficulty speaking and opening my jaw. Unable to write or say more than one word at a time. I also had some visual disturbances. These episodes  came in waves, lasting 15-30 mins at a time. They happened 3 days in a row. Each episode was followed by fatigue and diaphoresis.
About 4-5 minutes after GARDASIL vaccine the pt. fainted in the office.  It lasted only for few seconds.  She was fine in a minute or so & went home after 15 to 20 minutes.
ONE OF FOUR PTS WHO EXPERIENCED EPISODE CONSISTING OF FAINTING AND/OR SHORTNES OF BREATH, INCREASE IN PULSE REAT, DEAPHORESIS AND LIGHT-HEADNESS FOLLOWING IMMUNIZATION.
Severe rash. Difficulty breathing. Tightness of chest. Hives. Numbness or tingling of the hands and feet.
Headache.  I got a headache the day of my first & second shot. I very rarely ever got a headache.  Ever since my 2nd shot I have had a headache at least  four days out of a week.  Sometimes dull but sometimes its a really bad headache that (2) extra strength Tylenol doesn't  touch.  When I get a bad headache it feels like my head is in a vice.
Flublok vaccine to her 13 year old child/no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 11-year-old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number QFAA1905 via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
This report was received from GlaxoSmithKline and was assigned manufacturer report number A1025426A concerning an infant (also reported as child) patient around 2 months of age of unspecified gender. On an unknown date the patient was vaccinated with the first dose of PEDVAXHIB (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). Other concomitant vaccines included the first dose of all below, ROTARIX oral, PREVNAR and PEDIARIX (lot #, expiration date, dose, route and anatomical location unspecified for all). On an unknown date and an unspecified time after vaccination with the first dose of PEDVAXHIB, ROTARIX, PEDIARIX and PREVNAR, patient experienced seizure. On an unspecified date, around 4 months of age, patient received second dose of PEDVAXHIB, ROTARIX oral, PEDIARIX and PREVNAR (unknown details for all). The physician reported that the patient got their normal schedule of pediatric vaccines (2,4 months schedule). The physician reported that on an unspecified date, 4 days after vaccination with second dose of all vaccines, the patient experienced diarrhea and rotavirus infection. Relevant test results included a stool sample of the diarrhea. The "stool sample showed child was positive for rotavirus". At the time of the report, the outcome of convulsion, diarrhea and rotavirus infection was unknown. Upon internal review the case was considered to be medically significant because of convulsion. This was originally reported by a physician. Additional information has been requested.
A few mins after administration of vaccine pt experienced lightheadedness and was pale and clammy. Had pt sit for several mins. We o/c checked BP 102/65. Felt OK to go home was with parent (mother). Called to follow up a hr later patient said she's OK and lying down on couch.
Vaccine injected into right arm too high/too forceful.  High level of pain at time of injection in shoulder.  Experienced patient in receiving injections, Dr. did not properly identify location markers.  Shoulder pain (not arm) still exists.  Dr (who administered vaccine) needs to measure twice before injecting.
APPROXIMATELY 24 HOURS AFTER ADMINISTRATION, THE PATIENT NOTICED A RASH ON THE FRONT OF HER BODY FROM NECK TO TOES. THE RASH WAS NOT PAINFUL NOR DID IT ITCH. SHE DID TAKE DIPHENHYDRAMINE 25MG EVERY 4 HOURS FOR 24 HOURS AS A PRECAUTION. SHE DID NOT SEEK MEDICAL ATTENTION. THE RASH RESOLVED WITHIN 36 HOURS.
This spontaneous report was received from a registered nurse concerning a patient of an unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 20-AUG-2014, the patient received (Oka/Merck) VARIVAX lot number J014400, expiration date: 13-NOV-2015 (dose and route were not provided), which was improperly stored on 05-AUG-2015 at 11:18 am for 3 hours 10 minutes. Other suspect and concomitant therapies were not reported. No adverse symptoms were reported. The temperature excursion for the (Oka/Merck) VARIVAX was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report received from a consumer on 13/Oct/2005. A 66 year old female patient reported that approximately three years ago she developed local pinkness and warmth at the injection site which went down to the wrist area, 24 hours after receiving the injection of Fluzone. Lot number, route and site of administration not known by the patient. The patient reported symptoms lasted two to three days. She was diagnosed by a physician as having a thimerosal allergy. The patient recovered.
Approximately 4 hours post vax pt became somewhat fussy and had a spell. The spell consisted of the entire body stiffening, and pt spit up some white, thick, milky substance and stuck out her tongue which was very stiff to the touch. Pt appeared to gasp for air and parent thinks that pt may have had some periorbital cyanosis. The pt repeated the stiffening posture 3-4 times over the next few minutes. The pt awoke and appeared confused at which time she was taken to the ER. Pt was placed on seizure precautions while in the hospital which included cardiorespiratory monitoring and cushioning of her crib. Pt was observed overnight and did not experience any repeated episode. The differential diagnosis could include reflux or possible seizure.
Patient was given first shot for covid vaccine. She was sitting in the chair for her 15 min wait time. Her mom was observing her child that fainted and slumped down in the chair. Mom caught the daughter and gently put her on the floor. She yelled out help the intern and the pharmacist went out to help with the situation. We moved the child to her side in case she's had seizure or choked in something. Child did lose consciousness for 15 seconds, but then she regained consciousness and was breathing properly. The intern called emergency services and took patient to the local HCF.
Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient asked if they had shingles and year later had 1st dose of Shingrix vain nine and experienced all the worst side effect of it. The patient asked if they should go ahead and get second dose of Vaccine. It was unknown if the reporter consented to followup.
Received vaccine 6:30pm 4/8/08. At around 9:30 patient states she noted rapid heartbeat then following day felt weak, lightheaded and intermitted to nausea. Symptoms have been on and off for past week. Called 4/15 to report symptoms. Seen 4/16-
A few minutes after Tdap vaccine, patient had abrupt syncope and generalized tonic clonic seizure that lasted for < 30 sec. IV started and bolus given. Patient transported by EMS to ER. Pt lacerated chin, broke upper front teeth and lacerated lip in fall.
This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (numbness in their hand, whole hand being numb, it is only the pinky, ring finger and later side of injection site arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HYPOAESTHESIA (numbness in their hand, whole hand being numb, it is only the pinky, ring finger and later side of injection site arm). At the time of the report, HYPOAESTHESIA (numbness in their hand, whole hand being numb, it is only the pinky, ring finger and later side of injection site arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment related information has been reported.
EXTENSIVE REEDNESS AND PAIN BEGINNING THE DAY AFTER THE SHO PERSISTING OVER HEREE WEEKS.  iTCHING BEGAN 5 OR 6 DAYS AFTER THE VACCINE RESULTING IN A RASH SHORTLY THEREAFTER WITH SMALL ERYTHEMATOUS APULES AND OCC VESSICLES
Rash (face, body, arm) puffy eyes 5 minutes after given the 3 shots and Rotavirus by mouth. Given steroid right away 2mg/kg/dose and 1 dose of TYLENOL -> VS - stable, F.U Q 5-10 min: rash improved, swollen eyes, SPO2 normal HR 130/min.
Terrible pain; Throat swollen; cough; muscle spasm neck moving to front; muscle spasium leg, back, arm left side,neck moving to front; vomit; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasium leg, back, arm left side,neck moving to front), PHARYNGEAL SWELLING (Throat swollen), MUSCLE SPASMS (muscle spasm neck moving to front), COUGH (cough) and PAIN (Terrible pain) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Central vision loss and Sleep apnoea (c pap). Concurrent medical conditions included Drug allergy (to opioids).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VOMITING (vomit). On 25-Jan-2021, the patient experienced MUSCLE SPASMS (muscle spasium leg, back, arm left side,neck moving to front). On 26-Jan-2021, the patient experienced MUSCLE SPASMS (muscle spasm neck moving to front). On 29-Jan-2021, the patient experienced PHARYNGEAL SWELLING (Throat swollen) and COUGH (cough). On an unknown date, the patient experienced PAIN (Terrible pain). On 24-Jan-2021, VOMITING (vomit) outcome was unknown. On 27-Jan-2021, MUSCLE SPASMS (muscle spasium leg, back, arm left side,neck moving to front) outcome was unknown. On 29-Jan-2021, MUSCLE SPASMS (muscle spasm neck moving to front) outcome was unknown. At the time of the report, PHARYNGEAL SWELLING (Throat swollen), COUGH (cough) and PAIN (Terrible pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was reported R/T: (Oxy 98 percent) Treatment :Applied heating pad   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: New event was added
Narrative:  Pt received two doses of pfizer/biontec vaccination in Jan/Feb2021, contracted COVID-19 on 10/12/2021. LAB RESULTS: Date Test Name Result 10/12/2021@02:15 COVID-19 PCR DETECTED 09/28/2021@14:35 COVID-19 PCR NotDetected 09/25/2021@01:59 COVID-19 PCR NotDetected 09/22/2021@11:35:05 COVID-19 PCR NotDetected The patient has early acute COVID-19 infection without overt symptoms and meets the criteria for monoclonal antibody infusion (bamlanivimab/etesevimab) therapy to prevent further decompensation of COVID-19 infection, if the patient is able to provide informed consent. Risk factors: - Hypertension - Prior CVA - Hyperlipidemia Symptoms: & COVID-19 infection Treatment: BAMLANIVIMAB (EUA) , BAMLANIVIMAB/ETESEVIMAB (EUA) etesevimab
By next day, my arm had a red ring around site of needle. it was hard and itchy and lasted over a week. Also, from that day on, I had pain, sometimes intense, coming from the muscle of left arm.
The same day after the shot the patient experienced disorientation, double vision, shaking. The patient was tired, has a poor apetite, and is nauseous. States these have resolved and she has severe pain and little motion in her right arm.
COLD THEN HOT; CHILLS; FEVER 102.7F; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced cold then hot. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever 102.7f. Laboratory data included: Body temperature (NR: not provided) 102.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102.7f, chills and cold then hot was not reported. This report was non-serious.
Pain on left side of clavicle and muscle  attached to left side across top of shoulder toward left upper arm.
Nausea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional information received on 2 May 2021: updated the outcome of the events from unknown to recovering/ resolving. Denied to Follow up again.
Patient complains of left neck muscular soreness minutes after vaccination. Denies chest pain/pressure, shortness of breath, lip/tongue swelling, dizziness. On physical exam, has mild muscle spasm at left sternocleidomastoid muscle, normal neck ROM,  normal cardiac & pulmonay exam, vitals stable. ECG earlier this AM w/o ischemic changed. Advised rehydration & topical/OTC treatments of muscle soreness. Labs ordered to eval for cramping. Symptoms improved by 30 min.
I got the shot in my left arm to avoid a reaction to my right injured shoulder. About 5hrs after injection the left arm started hurting first (general soreness) and about an hour later my right shoulder started hurting badly. Pain was consistent w my bursitis diagnosis (nerve pain) plus soreness. Pain progressed for the next 24 hrs or so and affected being able to do normal activity.
Sore arm, redness, rash, and itchy arm where flu shot was administered for 3 days.