chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; muscle pain; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received Shingrix. In May 2019, less than a day after receiving Shingrix, the patient experienced fever, muscle pain and chills. On an unknown date, the outcome of the fever, muscle pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the fever, muscle pain and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient had the Shingrix shot and during the night the patient experienced chills, fever and muscle pain.  The patient wanted to know how long does the side effects last.
This case was reported by a physician and described the occurrence of arthralgia in a adult patient who received FLUARIX (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX. On an unknown date, unknown after received FLUARIX, the patient experienced arthralgia. On an unknown date, the outcome of the arthralgia was unknown. It was unknown if the reporter considered the arthralgia to be related to FLUARIX. Additional information: Physician updating previous report of shoulder arthralgia in 10 patients following vaccination with FLUARIX QIV, with lot number and expiration date info. He was unable to obtain more information on the patients, though he states that they were all adults.
This spontaneous report was received from a medical assistant, refers to 4 year-old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications include sterile diluent. On 13-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018, albumin status: rHa) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. The outcome of events was unknown. This is one of 11 reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001467: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820: US-009507513-1708USA001338:
Patient received his first dose a and then came here to receive the "second" dose on 4/16/2021.  he received a dose on 4/7/21 also.  Because the facility does not bill insurance the claim went through with us.  Typically if someone would have gotten 2 vaccines previously it would reject since they can only have 2 doses in 300 days.  We had no idea that he had received a previous second dose since he never revealed that.
Within 10 mins I had Hives on my chest and back. My face and ears started turning bright red and swelled a little. Then for a week I was itchy. I took Benadryl and hour after the incident. The EMS monitored me while It was happening and since I was still breathing ok  I decided to leave and get Benadryl since they didn't have any.
A non-serious spontaneous report of runny nose has been received from a non-health professional concerning a 31-month-old female, subsequent to FLUMIST. This case will be submitted to accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 25-Aug-2011. On 26-Aug-2011, the patient developed a runny nose. The Patient did not receive any medical attention for the symptom. The outcome of the event was unknown.
VACCINATION FAILURE; POSITIVE COVID-19 TEST RESULT; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimotos ,Allergic to antibiotics allergy, socially alcohol user, and non-smoker. On 26-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported,1 total administered  possibly on left arm for prophylactic vaccination. Concomitant medications included levothyroxine sodium/ Synthroid 125 mcg for thyroid, pantoprazole sodium sesquihydrate, and pravastatin sodium/ Pravacol. On 09-May-2021 or 10-May-2021, the patient was unsure about the exact date of symptom onset, since symptom onset coincided with allergy season, the patient experienced shortness of breath and extreme tiredness. On 12-MAY-2021, the patient tested positive for Covid-19 on 15 minute rapid test ( Binax 15 minute rapid test).  The patient reported that she did not had any reaction or side effects post vaccination. The patient questioned if her lack of reaction post vaccination was  correlated to reduced effectiveness of the vaccine. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the positive covid-19 test result and vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210523305-covid-19 vaccine ad26.cov2- vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Pt presented on 4/5/06 with left parotiditis, labs drawn. Pt was immun elsewhere. Pt new to our practice, HX of MMR vaccine on 6/8/05. Pt was rechecked on 4/10/2006 no parotid swelling.
30 min after vaccination, got a big itchy welt, another one popped up further down on arm size of a nickel, chills, fever, rash on inner right ankle size of palm, itchiness on back
Patient became pale and slouched in chair for approximately 5 seconds. Aroused to name when called. CRNP made aware. Orange juice, peanut butter crackers given and tolerated well. Cool RA placed to forehead. Gave water to sip on and patient laid down. BP 103/63. Then 10 minutes later BP 108/70, P-100, R-24, and temp 36.4.
pt had low grade temp monday-elevated to 102 on Tuesday, low grade 100-101 on Wednesday, temp elevated to 104-105 on Thursday w/emesis x 2;hosp thru ER Friday;given APAP & Bactrim & APAP & cont fever;
PAIN IN ARM/MINOR PAIN IN RIGHT ARM (BOTH SIDES) NEAR ELBOW; PAIN IN TOE/MEDIUM PAIN IN BOTH TOES AND SECOND TOE ON LEFT FOOT; HOT/HOT FLUSH; BRUISE ON LEFT ARM; HEADACHE; FAINT; PAIN IN PELVIC AREA; ABDOMINAL PAIN; BUBBLING SENSATION AS IF THERE WAS A VIRAL INFECTION OR STOMACH FLU; DIARRHEA; VOMITING; SWEATING; SLIGHTLY WEAK; VEINS PROTRUDING FROM LEGS AND ARMS MORE THAN USUAL; Throbbing pain in knuckle of right hand; This spontaneous report received from a patient of unspecified age and sex reporting on self. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085031 and expiry: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced minor side effects the day of minor pain in right arm (both sides) near elbow (pain in arm), medium pain in both toes and second toe on left foot (pain in toe). The toe pain continued for a few days. On 23-MAR-2021 (mentioned as next week), the patient noticed veins protruding from legs and arms more than usual (dilated veins). The patient mentioned no pain, however and throbbing pain in knuckle of right hand (throbbing pain). On 24-MAR-2021 and 25-MAR-2021 (also mentioned as next week), the patient had pain in pelvic area (pelvic pain), abdominal pain (bubbling sensation as if there was a viral infection or stomach flu (abdominal noises)), diarrhea, some vomiting, hot/hot flush and sweating, slightly weak (weakness) and faint all symptoms on same day. The patient took Pedialyte to help with vomiting and to restore energy. On next day, 26-MAR- 2021, the patient was feeling much better. Most symptoms were gone. But there continues to be hot flashes as had been all along (but this may be due to hormones). On 26-MAR-2021, headache continued as well.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, and headache, and the outcome of pain in arm/minor pain in right arm (both sides) near elbow, pain in toe/medium pain in both toes and second toe on left foot, veins protruding from legs and arms more than usual, throbbing pain in knuckle of right hand, pain in pelvic area, abdominal pain, bubbling sensation as if there was a viral infection or stomach flu, diarrhea, vomiting, hot/hot flush and sweating, slightly weak, faint and bruise on left arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210352411-covid-19 vaccine ad26.cov2.s-Faint. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
acute hypoxic respiratory failure, COVID-19 infection, Possible aspiration pneumonia versus community-acquired pneumonia, acute encephalopathy
Runny nose started maybe an hour or so after injection.  Felt slight nausea around 6:30PM until I went to bed. Woke up at about 1:30AM with mild nausea. Within about 30 minutes I experienced chills.  I hydrated and tried to go back to sleep.  In the morning I had a fever of 100.3 degrees.  Took 1000 mg of Tylenol and hydrated, another 500 mg 4 hours later. Chills came on and off throughout the day.   Added layers of clothing to stop the chills. Ate breakfast and lunch. Drank G2 to hydrate. Temp bounced between 99.6 and 100.8 throughout the day.  Experienced heartburn for several hours in the afternoon. Took a  nap at 3:30 for 2 hours, ate, rehydrated and removed some layers to clothing and put on a cool towel on my forehead to try to reduce.  Took 1000 mg of Tylenol and went to  bed. Slept well. All symptoms were gone by morning.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 01-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (Lot # L045956; Expiration date 17-NOV-2017), (dose and route of administration were not reported). It was reported that the vaccine was exposed to a temperature of 50 F for 26 hour. There was no previous temperature excursion, data logger or product quality complaint involved. No adverse symptoms were reported. Additional information has been requested.
After a few hours, I started itching at my injection site, and had some pains. I also have a really big bump and rash around my injection site.
Pt from home 5/24 with vomiting and diarrhea x5 days. Pt presents A&OX4 and hypotensive. Generalized pain, denies abd pain. Patient was admitted, found to have acute kidney injury. Found to be COVID positive 5/24.  Not on supplemental oxygen.  No cough, chest pain, or any shortness of breath. Remains on IV fluid infusing well. Patient reports generalized pain and weakness, tylenol little relief. Patient also requesting something for cough 5/26. Pt is AOx4, on RA not in distress, complaining of back pain, Toradol ordered, with N/V noted, metoclopramide given, remains on IV fluid infusing well, with ocassional cough, taking orally well, continue with the plan of care. Discharged to home on 5/27.
Runny nose and eyes-minimal-2-3 days, extreme tiredness-3 days, achy joints-2 days, low grade fever-2 days, throbbing headache-3 days.
I, Pharm.D., gave Fluzone HD vaccine to the patient in the Deltoid muscle and a great deal of blood filled all the barrier bandage. I kept it on for a minute then took it off, the blood stopped coming out but it looked the area was swollen up under the skin, I placed a gauze pad with a gentle pressure for a minute in case more blood may start coming out but none came out and it was apparent at this point the area was swollen about 1.5 inches in diameter and 1 cm in height around the shot area. I kept the patient waiting for about 10 more minutes and asked him questions. He said that he never had allergic reaction to a shot before and he had a flu shot every year for decades. The skin color stayed the same for the entire period (normal skin color) and the swelling went down slightly after him being in the booth/kiosk for 15 minutes. Since he didn't have any concerns and was not feeling ill or dizzy, he was ok in leaving the pharmacy area. I called the patient 1.5 hours later and he said that he is still feeling fine and there are no concerning issues.
PATIENT WAS ERRONEOUSLY GIVEN PFIZER BIVALENT VACCINE ON 9/12/2023  after FDA ended the EUA on September 11, 2023 and an email was sent notifying clinics to discontinue use of that vaccine.
Rcvd flu vax. at 10:19 AM at pharmacy. At 8 PM severe chills and shakes started. I put on a heavy winter coat and got under a blanket. This helped but didn't make them stop. Fever started and peaked at 102 degrees at 1100 PM. Chills and shakes gone by 12 midnight. Fever subsided. Next morning, very weak. All symptoms gone by 12 noon.
Acute pain in left elbow (tendinitis) followed by stiffness in left shoulder; joint achy/stiffness in left wrist, ankle and knee.  By morning, left arm stiff and painful
who are fully vaccinated who tested positive; who are fully vaccinated who tested positive; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Right on 27Apr2021 (at the age of 44-years-old) as DOSE 1, SINGLE and dose 2 bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration, administered in Arm Right on 18May2021 (at the age of 44-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included crohn's disease from 2018 and ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Inflectra 400mg infusion every 8 weeks for crohn's disease and Azathioprine 50mg daily for crohn's disease. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient was tested positive for Covid 19. Reported as: who are fully vaccinated who tested positive. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101095688 same reporter/drug/AE, different patients.
Sweating, dizzy, history of vasovagal reaction. Vitals wnl, given water.
A report has been received from consumer concerning a 46 year old female patient. No medical history provided. The patient has no health problems in general. The patient had been receiving unknown influenza virus 120 for influenza immunization started on 23-OCT-2013. The patient experienced urticaria. Reporter had quite a few hives attack after the flu vaccine, subsequently caused swelling in the mouth , huge swelling around the left eye and huge swelling on the right ear. So uncomfortable that she had to call in sick because she firstly looked terrible and secondly it was so incredibly uncomfortable. The patient had not been treated for the adverse reaction. The patient had been admitted to hospital because of adverse reaction. No investigation conducted nor was any laboratory test taken. Action taken with the suspect was unknown. At the time of reporting the event of ear swelling, urticaria, eye swelling, to swelling and swollen mouth was ongoing. The reporter considered the case to be non-serious.
After receiving HRIG and initial dose of Rabies vaccine on 08/13/04, that evening pt had swelling of her tongue and went to the ER. Pt having extreme anxiety and panic attack.
On 11/19/2022 in the morning 02:00-02:30AM I started feeling pain, sweating, severe stomach pain, and chills. On Saturday 11/19/2022 in the afternoon I went to the ER. They did ultrasound, and full blood work. I had blood in my urine. They prescribed me with cephalexin every 4 hours. I had blood clot on both of my lungs. They gave me vitamin K and something for nausea. Right after all the medication I felt better in 5 minutes.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received 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 influenza-like symptoms, stomach discomfort and headache. On an unknown date, the outcome of the influenza-like symptoms, stomach discomfort and headache were unknown. It was unknown if the reporter considered the influenza-like symptoms, stomach discomfort and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms, stomach discomfort and headache after SHINGRIX.
Rash appeared  around injection site nine days after injection.. Approximately 2 1/2 X 1 inch  Redness, small pustules and very hot, itchy and painful.  Also itchy rash appearing on hands and feet with out pain.
Near end of 15 minute observation she developed hives on lower neck/upper chest. Some slight throat fullness - no history of shortness of breath, dysphagia. Vital signs obtained by EMS - Benadryl 50mg po given - hives faded some. Watched for additional 20 minutes and sent home. Informed patient she needs clearance from doctor if she wants dose #2.
Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for several days and it went to my chest.  I  Medicated with: Mucinex and Advil sinus - but wasn't working. Telehealth call to DR. and He prescribed C-Pac - 250 mg - 5 day dose and decongestant: Guaifenesin 100 mg - 5 mg liquid - 10 ml every six hours by mouth as needed for 10 days and I took that decongestant for 6 days. Felt better at this point. Never had had this before.
Reporter is family member of pt. Pt recv vax & exp measles & mumps. Fever 103f. Rash & swelling of the salivary glands. Recovered 4-5 day p/onset.
developed a rash on left arm; different arm due to rash on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (developed a rash on left arm) and PAIN IN EXTREMITY (different arm due to rash on the left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (different arm due to rash on the left arm). On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (developed a rash on left arm). At the time of the report, VACCINATION SITE RASH (developed a rash on left arm) and PAIN IN EXTREMITY (different arm due to rash on the left arm) had not resolved.            No information about concomitants was provided. No information about treatment medication was provided.   This case was linked to c (Patient Link).
Patient called early February 2022 and complained her arm was very painful. She thinks we injected her incorrectly. She has seen her doctor and he/she does not know what the problem is but they would do an MRI. Patient said pain started slowly but increased to the point of it being excruciating.
Spasms in leg and arm muscles, unable to stand and hard to eat. Symptoms were much diminished at 10:30 pm and he slept from about 12:30 pm to 10:30 pm and then through the night.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age who were enrolled in study. Pertinent medical history was unknown. The reporting physician stated that they also given PNEUMOVAX 23 (dose, route of administration and anatomical location was unknown) to smokers under 65. Concomitant medications were unspecified by reporter. The outcome of the event was unknown. Additional information has been requested.
07/05/2021 Swelling and hard lump in right submandibular gland was observed by patient/self.  08/20/2021 fine-needle aspiration and core biopsy pathology showed a malignancy 09/08/2021 neck dissection pathology showed a carcinoma in the submandibular gland, 3 lymph nodes, and invaded the nerves. Radiation and medical oncology treatments are scheduled. In Feb - May of 1996 I saw an oncologist for a pea-sized lump in the same location.  Because it did not change in size over the 3 month observation period, cancer was all but ruled out. I, my dentists, and dermatologists have been observing this mass for 25 years and this was the first time it was observed to have increased in size.
An hour after injection my arm became so sore I could not move it and I became extremely fatigued and dizzy. Within a few hours of those I became nauseous and by 2am I was fevering with chills. The next morning around 8am I still had chills and fainted while walking around my apartment. 11/22 I left home a few hours into my shift because I was vomiting bile, fevering and had chills. I have had a migraine since about 7pm 11/20. It is 3:18pm and I am still fevering with chills intermittently, am having an extremely hard time stating about and I have not been able to eat today.
Since February- dizziness, lightheadedness, brain fog, migraines, depression, anxiety, memory loss, difficulty finding words, elevated HR,  palpitations, shortness of breath, incontinence, nausea, vomiting, diarrhea, continuous tremors, muscle spasms, neuropathy, joint pain, swollen lymph nodes
Around 10 PM the day of the shot, started experiencing chills, muscle aches, exhaustion and a low grade fever (99.5).  Symptoms lasted approximately 36 hours.  Treated with tylenol.
30 min after vaccine, pt developed rash on trunk to ext. macular, erythema.