chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
4 days after immunization - severe pain in bones, back, hips, shoulders, neck, left wrist, knee and fluid in joints. No fever, no itching, no rash. Reports BP elevated and lightheadedness.
Case number PHHY2011US41580 is an initial spontaneous report received from a health care professional on 02 May 2011. This report refers to an adult female patient. She was given only the CYW-135 liquid component of MENVEO (batch number 090901, expiry date: Aug 2011) on an unspecified date. No other adverse reaction was reported.
Sick; Aches; Not feeling well; Tired/Fatigue; Fever; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Sick), PAIN (Aches), MALAISE (Not feeling well), FATIGUE (Tired/Fatigue) and PYREXIA (Fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), PAIN (Aches), MALAISE (Not feeling well), FATIGUE (Tired/Fatigue) and PYREXIA (Fever). At the time of the report, ILLNESS (Sick), PAIN (Aches), MALAISE (Not feeling well), FATIGUE (Tired/Fatigue) and PYREXIA (Fever) was resolving.        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.   Treatment information was not provided.
Within 2 hours of receiving shot her arm and shoulder started burning.  By that evening her entire arm was sore.  The next morning she had nausea and vomited twice.  She had a fever of < 100 degrees.  The following day she had no more nausea but still had severe pain in her arm.  The third day after the shot her entire arm turned red and she went to her doctor.  Now, all symptoms have resolved.  Her physician told her that most likely she had an allergic reaction to one of the vaccine components.
Flu-like Sx's, headaches, neck pain, stiff neck, shoulder pain, joint pains, jaw prob's, numbness, difficulty in pronouncing words, pain in knees, arms, balance lost, dizziness, foot pain.
Chills; hot flashes; headache; tiredness; inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11May2021 at 11:45(at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient medical history included allergy to bell pepper. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Apr2021 at 10:30(at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 12May2021 at 02:30, the patient experienced chills, hot flashes, headache and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event chills, hot flashes, headache and tiredness were recovered on unknown date in 2021 at this time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
high fever arms & legs turned blue on 19AUG93 & again on 21AUG93;
Received the Vaccine on a Monday morning,  Next day started with a bad cold.  By Tuesday night I had to use my inhaler, take cold/cough medicine to help me stop coughing.  By Wednesday Had a bad cough, tightness in the chest,  and lots of congestion.  Left arm was very sore.  Called work who told me to go to the ER for covid test.  Tried to get into my doctor's office who would not see me and told me to get a covid test.  Tried to get into Facility who told me I would require two appointments.  One to see a doctor and another to get a Covid test.  Also, it would be a three to four-hour wait.  Felt so sick that I took myself to an ER in order to be seen.  Mysaturation was good in the ER but HR was in the 120s.  They did an EKG, gave me an albuterol inhaler, IV fluids, IV steroids, and a chest X-ray.  They did a Covid test which was negative as well as other bloodwork.   Then sent me home.  My husband also started with a cold the Sunday night before my vaccine so I do not know if that might have been where I got sick?
Approximately, one week after my 2nd dose started to experience dizziness and feeling faint on and off.  (started this past Sunday, today is Weds).  Also general feeling of 'wigginess' making it tough to concentrate.       Also minor feeling of 'chills' on and off throughout my body.   Also VERY cold hands (not on and off but constant).   None of this has  abated yet -- as of today, Wednesday.
Received vaccine on 4/13/09- symptoms began morning of 4/18/09, severe headache - 2 reddened areas R shoulder; one just above acromion process irregularly shaped - reddened with pinpoint open area in center - reports clear drainage and itching, approx 1 1/2" below and to the right area approx 2 1/2" L x 3/4" wide with scattered small scabs - area reddened. T 98.8 degrees F.
Pt recvd 1 dose of Engerix-B & 4 hrs p/inject devel h/a & tingling hands; tingling hands lasted 12 hrs; h/a lasted 16-18 hrs; tx none;
felt he had a fever, did not take his temperature, chills headache initially, next day was light headed, disoriented & freezing cold
fainted, seizure (grand mal) for 30 seconds, dyspnea, sweating. came to feeling weak, drank water and started feeling better
Poss HSV, Outbreak set off by 3rd dose. COVID vaccination. Valacyclovir has stopped new lesions from forming. Gabapentin for pain- may need to take for 1-2 mths.
had both shots and had shingles twice/Suspected vaccination failure; Shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The patient self-reported this case. The patient had both doses and had shingles twice. Follow-up would not be possible as no contact details available. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
2/17/2022 I went in for a regular Dermatology visit. The doctor discovered I had Frontal Fibrosing Alopecia. I am losing my eyebrows and my hair from my sideburns back. My scalp is red and itchy. The follicles are being attacked by my body which causes the hair to fall out and not grow out in that particular follicle. There is no cure, but the medication prescribed to me is supposed to slow it down. The medication I was prescribed finasteride, a steroid solution to put on my scalp, RETIN A to use on my forehead for the bumps. I also was to start on ROGAINE. I was recently prescribed doxycycline. I stopped taking finasteride and doxycycline because of the side effects and the fact that this condition continues to progress. I am still using the topicals.
A 2nd dose of hepatitis Engerix B vaccine 10mcg given mistakenly to a newborn that had first dose given 6.5 hours before. No apparent IU effects.
No additional AE reported; HCP reported an adverse event. Caller explained PROQUAD was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.     ?    Names of vaccines involved (including lot/exp): PROQUAD lot W0065; This spontaneous report was received from medical assistant and refers to an identifiable patient with unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W006585, expiration date: 23-AUG-2023, administered for prophylaxis (strength, dose, and route of administration were not provided).  The vaccine was stored at the temperature that was reported as 1.6 degrees of Celsius for 2 hours and 10 minutes. There was no previous temperature excursion reported.  No additional adverse event was reported.
Developed headaches the week of vaccine, especially Saturday, 12/26/2020.  Experienced body aches on 12/26/2020, intermittent in nature and fatigue.  Called Nurse to report symptoms and confirm clearance to return to work on 12/28/2020 and was instructed to complete potential vaccine reaction.
PATIENT REPORTED EVENT TO US ON 10/13/23, BUT STATES REACTION STARTED WITHIN A COUPLE HOURS OF RECEIVING FLU VACCINE ON 10/11/2023. SHE HAD AN EXTREMELY SORE ARM THAT DEVELOPED REDNESS AND LARGE AREA OF SWELLING INCHES BELOW THE ACTUAL INJECTION SITE. SHE SAID THE AREA OF REDNESS/SWELLING WAS VERY HOT. SHE ALSO DEVELOPED LEFT SIDED NECK PAIN/WARMNESS IN THE LEFT SIDE OF HER NECK.  THESE ISSUES ARE STILL PERSISTING AS OF 10/13/2023. SHE DISCUSSED REACTION WITH HER DR.
Hot burning feet, arms jerking, eyelid twitching. Sharp pain on head, arms, chest, abdomen, feet, toes, hands, fingers, rectum, testicles, face, back, both body sides, under armpits. Vibrating and twitching around whole body as well. Right elbow muscle did tighten up too. Right leg went to sleep and hard to raise up.
Pt traveling to Africa and received vaccines 1/10/07 and 1/17/07.  On 1/17/07 pt received TD. Menommune and Pneumococcus vaccines.  1/19/07 pt called clinic and reported red and swollen arm down to elbow, was instructed to go to MD's office. Received antibiotics on 1/24/07 pt stated she was doing much better.  MD told pt it was likely due to Pneumococcus vaccine. Patient stated she had problems w/Pneumo vaccine the other time she received it (she forgot about receiving pneumo vaccine prior to vaccination 1/17/07)
I had minor difficulty swallowing 6 hours after vaccination. This lasted about 12 hours. No swelling of tongue, lips or face.
Patient was given a PCV13 vaccine which was not due. Local Health department informed and parent and provider informed.
He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating; he fell flat on the floor; felt really tired; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; arm feels like it was punched by a gorilla/his arm was sore/muscle sore; He couldn't hardly move it sore; tingling, kind of like ants crawling up his leg; This is a spontaneous from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via intramuscular route of administration on 13Jan2021 at 19:05 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Hepatitis B vaccine that is supposed to last for 10 years (which was administered for about three years ago) and flu vaccine. On 13Jan2021, patient received the vaccine and felt really tired, his arm feels like it was punched by a gorilla, it was sore. He couldn't hardly move it sore, like a muscle sore, so he went to bed. His arm was really, really sore, he's just kind of avoided using his arm. He woke up twice. He initially woke up at 5 am on (14Jan2021) and that is when he experienced  his legs are actually numb. He also woke up sweating. He didn't know his legs were numb until he literally got out of bed, and he fell flat on the floor because he could not feel them. He went to bed again and woke up at 7:20. On an unspecified date in Jan2021, he feels the tingling, kind of like ants crawling up his leg. It's not as bad as it was, it's like a feeling one gets when sitting on top of your legs. He wanted to know could these be side effects of the vaccine. The patient took Advil for arm feels like it was punched by a gorilla/his arm was sore/muscle sore. The patient underwent lab test which included COVID-19 PCR test with negative result on 10Jan2021. The outcome of the events arm feels like it was punched by a gorilla/his arm was sore/muscle sore, he couldn't hardly move it sore, numbness in leg was not recovered; sweating was recovered on an unspecified date, while unknown for the other events.
On day one of vaccine, injection site indurated sl. and reddened and tender. Resolved in 2 days. Very tired all week after vaccine. C/O slightly stiff neck on day 3 and then resolved. On day 6 after vaccine, began with nausea; On day 7 began with severe headache ( said 8 on scale of 1-10; photosensitive and asked me to come home from work ( highly unusual for this 18 y.o.) (forehead not occiput location of H/A )and nausea and fever of 101 degrees. sleeping much; Vital signs normal other than temp. Has not been ill in over a year; no other friends or family have been ill with anything resembling this Sx picture. I am monitoring Sx and have not called our physician on call seeing as it is the weekend and Sx are not intensifying. I will if Sx worsen or continue beyond a day.
Aching, fatigue, chills, diarreha , upset stomach; Aching; Aching, fatigue, chills, diarreha , upset stomach; Aching, fatigue, chills, diarreha , upset stomach; Aching, fatigue, chills, diarreha , upset stomach; sick; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue, pain, chills, diarrhea, upset stomach and sickness. On an unknown date, the outcome of the fatigue, pain, chills, diarrhea, upset stomach and sickness were unknown.   The reporter considered the fatigue, pain, chills, diarrhea, upset stomach and sickness to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose two months ago and got sick with aching, fatigue, chills, diarrhea, upset stomach. The reporter wanted to know was it likely that would get sick again on the second dose.
Information has been received from a pharmacist concerning his 6 year old son with no pertinent medical history or drug allergies who on an unspecified date and on approximately 01-MAR-2005 was vaccinated with his first and second dose of MMR II. There was no concomitant medication. At that same time, the patient was diagnosed with autism. The pharmacist mentioned there were "signs before vaccination" and that "things were not getting better." The patient was seen by a psychologist who performed "a battery of tests." The pharmacist also mentioned he does not feel that MMR II was related to his son's autism. There was no product quality complaint. No further information is available. Autism was also considered to be disabling by the reporter. Additional information has been requested.
Patient c/o itching, redness, rash, swelling, and pain at injection site. Symptoms began the same day vaccine was administered. Symptoms got better with OTC pain medication (ADVIL) but injection site was still red the next day.
COVID arm. Started on day 9, still having soreness, heat at injection site, rash and itching all over, especially eyes, nose and hands
This vaccine was given at the wrong age, patient was 8 and should not have had this vaccine after age 6
Fatigue; sore arms; This is a spontaneous report from a contactable consumer (patient) received via a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and patient's concomitant medications were not reported. The patient experienced fatigue and sore arms on an unspecified date, after receiving the first shot. The patient has concerns about getting the second shot because he heard of side effects from the second dose. The outcome of events fatigue and sore arms was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed localized redness, swelling, and tenderness over her L deltoid (MenACWY and MenB injection sites) 3-4hours after injections.  Patients arm was swollen, warm, tender and pt had low grade fever (as high as 100.9F). Seen in ER.
Patient had temp of 104 on the 20th. Was given instructions to rotate TYLENOL and MOTRIN until fever comes down.
25Nov91 indicated pt had large oblong area of erythema the size of 50 cent piece or larger, hardness & reddness of area.
Patient called with swollen arm from neck to hand, states it started this morning after receiving Pfizer Covid-19 booster in his right arm yesterday. Yesterday he had chest pain, heart pounding and headache that went away then he woke up this morning with arm swelling. I recommended he call his MD office and go to urgent care for further assessment.
Redness and swelling of inner arm, going towards axilla. Immediate injection site. Differential here allergic reaction VS cellulitis, treated for cellulitis as a precaution. See attached clinical note.
A week after my second shot,  on 2.13.21 I got hives on my neck, face, arms, ears, back of head, back, and stomach. The hives come and go I am still getting them. on 2.16.21 I started having trouble swallowing in the AM. Went to urgent care and given steroid shot and told to take Benadryl and Pepcid and Zyrtec. I was also given steroids to take at home. Hives decreased in intensity but have not gone away completely. Today 2.18.21 I also had issues with swallowing and had some reflux. I do not have any underlying condition.
Friday: profound fatigue and dizziness. Saturday: rt arm numb, headache, fatigue, dizziness with nausea. Sunday: headache with pulsation, vision impacted, chest pain. Monday: headache with pulsation persisted, nausea with emesis.
Fever, Chills, Muscle pain (flu like symptoms) lasting 24 hours (5 am on May 23 to 5 am on May 24).
Pt presented to the ER on 1/4 2021 with worsening sob, found to have  acute ST elevation MI  and new rapid atrial fib with RVR. He tested positive for covid 19 requiring new oxygen and received his first pfizer vaccine on 12/31. He was acutely transferred to rochester general hospital. He progressed to multiorgan failure, sepsis, mrsa bacteremia and died on 1/14/2021
Patient woke up this morning with intense intermittent sharp back pain. Feels like he slept wrong but very intense and growing in intensity and making it difficult to walk and move around.  Patient tried to use a brace but has not provided relief, ibuprofen has also not helped.
Breakthrough case admission after three vaccines Moderna 2/18/21 Lot# 011M20A;  Moderna 3/18/21 Lot# 003B21A;  Moderna 10/28/21 Lot# 025D21A
shoulder pain and soreness; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68-year-old female patient who had shoulder pain and soreness after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient had no medical history, concomitant disease or risk factor.  On 30-Sep-2023, the patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine, suspension for injection in pre-filled syringe (strength; batch number; expiry date unknown) via intramuscular route in unknown administration site for Annual flu shot (influenza immunization).  On 30-Sep-2023 the patient had shoulder pain and soreness (arthralgia) (same day latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Patient claimed the vaccine administrator administered the fluzone HD too high on the shoulder which then led to ongoing shoulder pain and soreness.  Patient did not experience any additional symptoms/events.  There were no lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (shoulder pain and soreness).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event shoulder pain and soreness.