chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue, 4 light orange/yellow spots developed below injection.  Approximate size of quarter each. Lasted a couple days
This spontaneous report was received from a physician via field representative refers to a 19 year old female patient. On an unknown date the patient was vaccinated with GARDASIL dose 1 for prevention of hpv (Human Papillomavirus). On an unknown date the patient experienced twinges and muscle spasms within a few days after receiving the first dose. The twinges had continued so that, when the patient presented for the second dose, it was withheld until the patient could be referred to a neurologist. It was noted that the spasms began in the arm in which GARDASIL had been administered, but had traveled to other, unspecified areas of the body. No treatment was received for the events, however sought medical attention (referred to specialist). The events were reported to be not recovered at the time of the report. Reporter's causality was not provided. Additional information has been requested.
On day 7 after vaccine, pain and stiffness in both knees had not resolved. Sought medical evaluation. On day 10,, symptoms completely resolved. :) Starting on eve of vaccine, had widespread body pain traveling through all joints and muscles. Fever for couple of hours. Severe fatigue, light sensitivity. Missed 3 days of work.  I have a history of osteoarthritis as well as history of severe mononucleosis from decades ago. Felt very much like a faster moving case of mono body pain and fatigue. No sore throat or lasting fever.  I am glad I got the Pfizer booster to be protected at a higher level against covid. I am very pro vaccine and my experience does not alter my thinking about the good of the vaccine!!!  In the scope of medical events, this was a minor situation.
Shortly after shot, 104 degree fever, nausea, fatigue, extreme aches, did not immediately seek treatment (live in rural area). All of those things have persisted, 102 fever every night, 100 fever.  Kidneys shut down since April 1st. Blood pressure and breathing difficulties (especially bad because living at elevation)
Child with hx of epilepsy well controlled on topramax had reoccurrence of seizures on 5/17 am. Increasing in frequency through evening progressing to status epilepticus late on 5/17 that needed IV Cerebyx for control. 06/07/2006-received 1 page office notes and 6 page medical record from hospital to include consultation report and lab results.  Consult of 5/17/2006 documented 12 year old with history of seizures, history of migraine headache until recently after pertussis immunization and her usual menstrual cycle time that she had breakthrough seizure. She had 3 seizures possibly due to encephalopathy after pertussis immunization. During exam did not have any focal neurological signs. Treated with Cerebyx.
After waiting here 15 minutes she got up to walk back to her apartment. She began to feel a little light headed, dizzy, and and warm. She felt like she needed to sit down immediately. Her temperature and BP were check; both were normal. We gave her some water and cold towel to put on the back of her neck then had her sit down for a while longer till she was feeling better. She said she felt immediately better after the water and after a while a facility staff member came to take her home.  As I talked to her she did tell me that she has a history of passing out so this may have played a part in the event.
receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 040B21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to bactrim), AFib, Diabetes and Drug allergy (oxybutynin allergy). Concomitant products included APIXABAN for AFib, METFORMIN for Diabetes, FLUOXETINE, HYDROCORTISONE and OMEPRAZOLE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 12:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 12:45 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022 at 12:45 PM, EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    The patient did not experience a similar event in the past. There were no other potential causes reported. The patient did not experience any associated adverse events. It was reported that, per Moderna, the vaccine will maintain the necessary effectiveness against COVID-19. The patient did not seek medical care for the event.
15-20min p/arrived home from vax-started vomiting 7x's & diarrhea 5-6x's;reported to clinic 2PM;advised to call family MD;330PM t101.5 po;vomitus 4x's w/in 1 1/2hr as well as 2-3 diarrhea stools;pt given APAP & anti-diarrhea med by mom;
under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER) and 2022SA448075(CLUSTER).  This case involves a 22 years old female patient who was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 15-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a total dose of 0.7 ml once (lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 15-Oct-2022, the patient who was under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 the 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 spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 27-MAR-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M036056 with expiry date 18-MAY-2019 (exact dose and route of administration were not reported). The dose was exposed to the temperature between -3 and 0 degrees Celsius for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003053: US-009507513-1704USA003054: US-009507513-1704USA002166:
This spontaneous report as received from a registered nurse refers to a 4 year old patient.The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Pts right upper arm got very red and a little swollen and very tender and sore starting the day after the shot and lasted 4 days before it resolved.
About 20 minutes after shot my shoulder started hurting & swelled my arm all the way to my fingers. 6 hours after shot I started vomiting.I took Ibuprofen &iced my arm& went to bed.Sunday 5/2/2021I was in excruciating pain took extra strength Excedrin & continued to do ice & heat nothing helped the pain but the swelling did go down a little so Monday5/3/2021I went to Patient first I was seen & they sent me to hospital to rule out DVT & thank goodness I do not have a blood clot
Dizzy, weak, sleepy, low grade fever, vomit, after 2nd dose of HPV.
I had gotten Pneumonia and went to 2 different emergency rooms even though I had the pneumonia shot on 9/28/2021, 1st ER on 11/25/2021 and then the 2nd emergency room & ended staying overnight in the hospital on 11/27/2021. I was sick earlier that week with a sore throat and felt bad. Both ER visits checked for covid and the flu and all 4 tests was negative.
Dizziness, nauseous tinnitus hearing loss - diagnosed with SSHL (sudden sensorial hearing loss)
Post herpetic neuralgia / which lasted 6 months; This case was reported by a physician via call center representative and described the occurrence of post herpetic neuralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was recovered/resolved.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient had shingles or post herpetic neuralgia. At the time of vaccination the post herpetic neuralgia had completely resolved. The day after her first dose of Shingrix she experienced a recall of her post herpetic neuralgia in the exact same area, which lasted 6 months. The reporter consented to follow up.
Redness and swelling distal injection site. Reported fatigue following day. Next day reported feeling of flu.
Received the shot 5/6 and very unexpectedly died 5/15, autopsy was not performed because foul play was not suspected and family could not pay to have it done
Fatigue is still bad; Now taking naps, has never in 30 years of marriage, had to take a nap,took a two hour nap after work; Really bad weakness for 8 weeks; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Now taking naps, has never in 30 years of marriage, had to take a nap,took a two hour nap after work), ASTHENIA (Really bad weakness for 8 weeks) and FATIGUE (Fatigue is still bad) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced SOMNOLENCE (Now taking naps, has never in 30 years of marriage, had to take a nap,took a two hour nap after work). On 09-Jun-2021, the patient experienced FATIGUE (Fatigue is still bad). In 2021, the patient experienced ASTHENIA (Really bad weakness for 8 weeks). On 08-Jun-2021, ASTHENIA (Really bad weakness for 8 weeks) had resolved. At the time of the report, SOMNOLENCE (Now taking naps, has never in 30 years of marriage, had to take a nap,took a two hour nap after work) and FATIGUE (Fatigue is still bad) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up information received on 20 Jul 2021 contains non-significant information.
Numbness of insertion site, sore and pain at the upper arm. Tiredness and sleepiness. Slept the entire day/night of 3/25/21 & half day of 3/26/21.
Redness, pain, and swelling of injection site, hot and cold flashes, and body aches. Symptoms for about 3 days, controlled with OTC acetaminophen 1000mg q6 hours. Symptoms then resolved completely with no long-term effects.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 46-year-old male subject who was vaccinated with ENGERIX-B (GlaxoSmithKline) for prophylaxis. The subject's medical history included mental retardation and seizure disorder. On an unspecified date in 1983 the subject received "the hepatitis B vaccination series" with an unspecified number of doses of hepatitis B vaccine (unknown manufacturer). On an unspecified date after 1983 and before November 2005, a hepatitis B surface antibody titer was positive. The healthcare professional reported that, "for some unknown reason," the subject again was vaccinated with three subsequent doses of Engerix-B on an unspecified date in November 2005, an unspecified date after November 2005 and on or before 04 May 2006, and 04 May 2006. On 16 November 2006, 6 months after vaccination with the last dose of Engerix-B, a hepatitis B surface antibody titer was negative. Follow-up information received on 26 February 2007 indicated that there was no change in the subject's seroconversion. The subject was receiving multiple concurrent medications at the time of vaccination.
On 07/06/2006 Per mother, son blacked out for 30 seconds immediately after Tdap, he told her he had blurry vision and ringing in ears. Went to ER for shortness of breath, tremors, and teeth chattering. Went to cardiologist on 07/10/06 normal tests, mom's concern is he wakes up at night with shortness of breath. Concerned vaccine causing reactions.
Started with mild nausea and chilling on morning of 10/30/21.  Then, by the afternoon, I had a fever of 101.4, severe lower back pain, and sharp stomach pain.  Then, by Sunday morning, I had developed hives on my trunk, thighs, and right forearm.  I also still had a fever of 100.4.
Sore arm, fever (99.5-100.1 F) , muscle ache, night sweats and chills. Symptoms started about 9 hours after receiving the vaccine; persisted for the next 24 hours.
Left are from the elbow down is numb. Where the shot was injected the arm is in pain. The symptoms started a couple of hours after the shot and has persisted for weeks since. Also chest pains started a couple of hours after the shot and kept going.
Red rash surrounding sites of vaccination. Rash also radiated towards torso of the body.
Complains of right sided numbness/weakness for few "weeks/months"  in clinic slumped  in chair
pt recvd immun & over next 48 hrs had some anorexia & was sleeping longer than usual;
Fever to 39.9 C several hours after imms given. The hospital discharge summary received on 1/15/04 states immunization reaction.
T78.40XA ALLERGIC REACTION, INIT 4/3/2023 SWELLING OF LEFT LEG T78.40XD ALLERGIC REACTION, SUBSEQ 4/13/2023 SWELLING OF LEFT LEG T78.40XA ALLERGIC REACTION, INIT 4/3/2023 UTI (URINARY TRACT INFECTION) T78.40XD ALLERGIC REACTION, SUBSEQ 4/13/2023 UTI (URINARY TRACT INFECTION) T78.40XA ALLERGIC REACTION, INIT 4/3/2023 IRON DEFICIENCY ANEMIA T78.40XD ALLERGIC REACTION, SUBSEQ 4/13/2023 IRON DEFICIENCY ANEMIA T78.40XA ALLERGIC REACTION, INIT 4/3/2023 ACUTE CHOLECYSTITIS T78.40XD ALLERGIC REACTION, SUBSEQ 4/13/2023 ACUTE CHOLECYSTITIS
now day 11 with the flu. Horrible; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who was on day 11 with the flu  after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of now day 11 with the flu, horrible (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (now day 11 with the flu. Horrible).  Outcome: Unknown
Pt. received HPV vaccine in the morning. That evening noticed large red, swollen area on deltoid area anterior to injection site. After 5 days pt. came to Health Services was 9x4 cm area of irreg shaped lesion, red/brown in color with no swelling. Returned for recheck 11/27/18- darkened area with slight swelling noted on (L) upper arm. Small area of flaking at edges noted. We will continue to monitor the patient.
pt recvd vax 20APR94 & 430PM mom called to report that pt was unresponsive & having convuls-hospitalized; fever 103 x 2 days; CBC, Blood culture, Urine screen, CXR nl; rx'd Amoxicillin; No further szs; discharged 4MAY;
Had COVID on 2/7/21- Feverish feeling x 1 day, fine after.   Tested negative 2/17/21.   One half hour after receiving the vaccine, onset of hoarseness. Severe hoarseness persists until today.  Eyelids pink, swollen slightly, persisted 2 weeks.  Did not feel well. 4/15/21 -Hospital Emergency Room.  Chest pain. Elevated blood pressure. COVID test positive. Disharged with azithromycin, zinc sulfate 220mg, ProAir. High blood pressure, new onset. On 4/6/21 BP 160/120 both arms.  4/7/21 Hospital ER. MRI, CT brain showed Dural Venous Thrombosis. To ICU for anti coagulation, until 4/14/21. MRV done.  Now on floors, started coumadin. 9 days hospitalization so far. CT done again 4/15/
I got the 2nd shot 10 am at the store location which is a  3 1/2 hr drive from my house.  After the 15min waiting period with no issues. I was able to get in the car and head home. The injections site did not bleed and the nurse didn't need to use a band aid. My wife and I went to an outdoor restaurant and had dinner I came home and everything was fine. I went to bed and when I  woke up, I was  very lethargic and out of it. Sometime during the day, I noticed my 3 middle fingers on each hand and the middle knuckle on those hands were painful and stiff. On my right hand the middle knuckle was swollen and noticeably large. These symptoms lasted for about a week or two. The pain and swelling in the middle knuckle lasted the longest. I was advised by my doctor I have slight arthritis but it does not prevent any of my daily activities.  I noticed several weeks later around the 1st week in May as I would wake up in the morning, a pain would shoot throughout my entire right leg. I would get up and the pain would be gone for the rest of the day, The pain got progressively worse during the first 2 weeks of May. By the third week of May the pain had gotten so bad I could hardly walk. I made an appointment with my orthopedic surgeon with the idea I may need hip replacement surgery. Then I noticed during that 3rd week the pain completely went away. I called to cancel my appointment with my orthopedic surgeon.  Around the last week of May and the first 3 weeks of June I would wake up in the morning I would have to run to the restroom because I had a lot of gas and some diarrhea. On the 17th of June my wife and I took a trip and as we walked around the town, I noticed there was something going on with my digestion and we rushed back to the hotel. During this period of time I would have to go to the restroom 2-4 times in the morning and maybe 1-2 times in the afternoon, This was mostly caused by gas with a bowel movement happening in small amounts throughout the day.  I've noticed that these adverse reactions are impacting areas the body where I have may have been compromised  previously.
very painful where injection site was (both doses).    2nd dose produced overall severe fatigue, headache, muscle weakness, vertigo.  Vertigo still lingering 4 days later
severe joint pain in her arm; so severe that she can't move her arm; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date in 2021, the patient experienced severe joint pain in her arm and so severe that she can't move her arm. The patient had never experienced something this severe before in her life. The outcome of both the events was unknown.  No follow-up attempts are possible. No further information is expected.
Extreme pain in neck, shoulders, arms, joints and legs. Feeling of malaise lasting for several weeks after each vaccination and recurring off and on without warning, often now. First original Lyme dx discovered by a spinal tap in a hospital. Had 2 additional Lyme vaccinations on 4/15/00 and 4/15/01. Slight fever. Malaise and joint discomfort "comes and goes" Pt unsure if this is permanent. Fever has abated. Left carpal tunnel was diagnosed 02/2001 and surgically corrected.
After the vaccine I had joint pain and a really bad headache. I got my cycle and it was extremely heavy. I went to the doctor and I had blood work done on 09/14/2021, my TSH was elevated, they prescribed me Synthroid. I saw another doctor on 09/24/2021 and I got an antibody test and they were elevated. Positive thyroid antibody test. My TSH was elevated again. On 09/24/2021 they diagnosed me with Hashimotos disease.
I was fine until 9 days later. My arm was extremely painful, very swollen and hot to the touch. The doctor gave me an injection of antibiotics and prescription of pills as well. It started going down that night, but by the next day it had gone down quite a bit. I was referred to an allergist and after looking at the photos, she said I was probably had too many histamines and need antihistamines instead antibiotics. I told her I was worried about the 2nd dose, so she told me to take Claritin the day before and continue on it for 10 days.   After the 2nd dose, I had the same arm issues, along with an unusual feeling in my head. My BP was higher than it's ever been at 184/88. About