chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number adult patients who received SHINGRIX. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that many of his patients had reported various adverse events following SHINGRIX. They reported soreness that kind of thing. The healthcare professional did not have any detailed information about specific lot numbers and expiry dates or even specific patient data or an estimate of how many patients might had been affected. The healthcare provider just stated that he heard these sort of nebulous complaints regularly regarding SHINGRIX.
Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.; Around 9am on November 2, 2021, she began to feel stomach pain; Around 9am on November 2, 2021, she began to experienced diarrhea; Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.; Chills; Felt unusually warm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING HOT (Felt unusually warm), ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea), FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) and CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced FEELING HOT (Felt unusually warm) and CHILLS (Chills). On 02-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea) and FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.). On 03-Nov-2021, the patient experienced CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.). At the time of the report, FEELING HOT (Felt unusually warm), ABDOMINAL PAIN UPPER (Around 9am on November 2, 2021, she began to feel stomach pain), DIARRHOEA (Around 9am on November 2, 2021, she began to experienced diarrhea), FLATULENCE (Was very gassy for the entire day but couldn't pass any bowel movement./oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.), CONSTIPATION (Was very gassy for the entire day but could not pass any bowel movement/oday, on November 3, 2021, she has not passed any bowel movements and is very gassy.) and CHILLS (Chills) outcome was unknown.            No concomitant medication was provided No treatment received by the patient
Clinical course at hospital indicative of the development of sepsis and TTP-HUS (thrombotic thrombocytopenia purpura with hemolytic uremic syndrome).  Pt received dose 5 booster shot on 10/15/2023 (LOT #GJ6665).  Dose number 6 was given on 10/21/2023. Pts husband reported pt started feeling unwell the night of 10/21/23.  Pt presented to the ED on 10/25/23 C/O abdominal pain and rectal bleeding. Pt was Dx with Colitis and D/C with Bactrim PO ABX.  Per Pts husband pt continued to deteriorate at home. Pts husband called 911 on the morning of 10/29/2023 stating that pt did not recognize him and was nearly unresponsive.  Upon admission to the hospital Pt was in renal failure and had no purposeful neurologic movement. Pts husband moved to comfort care on 10/30/2023 when PT was rapidly deteriorating and was moving towards needing intubation and ICU level of care. The need for Plasmapheresis was being discussed when she moved towards comfort care.  Final diagnosis was not achieved because all of the diagnostic labwork was not able to be obtained.  however what was obtained was highly abnormal and leaning towards TTP-HUS.  Source of sepsis was unknown at the time she was moved to comfort care. The majority of labwork was hard to obtain because it was all coming back hemolyzed.
Severe muscle pain and fatigue, followed about 12 hours later by fever, chills and body pain. Fever lasted 5 hours. Fatigue lasted 24-48 hours. Muscle pain at injection site persisted for over 72 hours and has abated somewhat.
Muscle cramps in legs and feet., Buttock pain, Fatigue Symptoms came and went but now it is fully resolved. Started using cane because felt unsteady on feet
frontal h/a persisting daily x 3 wks some temporary relief w/APAP only pt did not contact MD:
Approximately 24 hours after injection, 50 + mm raised area, red and hot to touch, pain, down arm and up shoulder, neck stiff, hip and knee joints achy x 72 hours. Temp 102 x 48 hrs. Fatigue, H/A. Took Benadryl x 24 hrs and Ibuprofen q 4 hours.
Patient called on 4/12/21 and reported that starting 2 days after her second dose she experienced changes in vision, She said she feels like her distance vision has changed significantly.  She was directed to vsafe as we were uncertain whether this was a reported side effect.  I told her I would report the issue for documenting  purposes.
Arm was sore first two days, then about six days later was red, hot, itchy like poison ivy and has got worse since - larger, itcher, redder, hotter - this is 8th day since vaccine.
Nightmares; Nausea; Tired; Headache; Jumbled speech and crying; Jumbled speech and crying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). A 54-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 11:45 (Lot number: EN6208) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Bnt162b2 (First dose, Lot number: EN6200), administration date: 15Feb2021, when the patient was 54 years old for Covid-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 08Mar2021, outcome "recovered" (10Mar2021), described as "Nausea", FATIGUE (non-serious) with onset 08Mar2021, outcome "not recovered", described as "tired", HEADACHE (non-serious) with onset 08Mar2021, outcome "recovering", described as "Headache", SPEECH DISORDER (non-serious), CRYING (non-serious) all with onset 08Mar2021, outcome "recovered" (08Mar2021) and all described as "jumbled speech and crying", NIGHTMARE (non-serious) with onset 10Mar2021, outcome "recovered" (10Mar2021), described as "Nightmares".  Additional Information: The reported stated that the patient had normal side effects, tired, headache and nausea, states he got the vaccine around 11:45AM, states around 8:45 AM he had fallen asleep and when he woke up a few minutes later he was talking and saying things that did not make any sense, his speech was jumbled, saying things like socks is box and even wrote down the same phrase, does not remember himself having this episode, episode has not happened sense. Then all of a sudden, he started crying, states he has not cried in 20 years. States three days after he was having nightmares.  No follow-up attempts are possible. No further information is expected.
This report describes the occurrence of developmental delay in a female child who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manuf unk) for prophylaxis. This report was received from the subject's grandmother and has not been verified by a physician or other healthcare professional. The subject's medical history and concurrent conditions were not reported. Reportedly, the subject received no concurrent medications at the time of vaccination. Reportedly, the subject experienced no adverse events following "other" immunizations. The grandmother reported that in March 2000, the subject received her first injection of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manuf unk). The grandmother reported that the child experienced increased tone (rigidity) in May 2000. She stated that the subject "started developing problems within two days after the injection but they didn't know what it was. The child would wake up out of a sound sleep and her arms would go straight above her head and she goes very stiff. her eyes roll back." The grandmother thought the infant was having a bad dream. "She was having them five to seven a day. It wasn't until she was five months old that they were diagnosed as seizures. The child is now on medication for seizures." It was reported that the subject experienced increased tone (rigidity) in May 2000. Reportedly, at an unknown time post-vaccination, the child experienced developmental delay characterized by the inability to walk, talk, and sit on her own; she is currently at the 6 month level of development. The grandmother stated that in April 2002, the child experienced hip displacement. The child was reportedly hospitalized for an unspecified period of time. The grandmother stated that the subject had "undergone numerous tests NOS and no underlying causes can be found for her symptoms." The events were reportedly treated with Trileptal, and baclofen. The events reportedly persisted as of 1/8/03. Additional information was received from the grandmother on 5/20/03. She stated that the subject did not receive any vaccine manufacturered by GSK. The manufacturer of the vaccine administered to the subject was not identified. Since no GSK vaccine was administered, this report has been voided.
Patient was Admitted with history of falls and worsening hypoxia.  Tested positive COVID-19 infection.  Patient had COVID-19 infection with pneumonia.  Patient condition slowly declined.  On 2/2/22, Patient wanted to stop all aggressive medical measures as she was having significant symptoms of dyspnea.  Patient placed on lorazepam and morphine  For symptom control.  Overnight patient condition has declined further.  Patient is appropriate for admission to inpatient hospice.
Cluster of bumps (rash) on back and thigh.  Rash is not  itchy , red or painful . Patient describes as raised bumps
Patient tested positive for COVID-19 on 07/01/2021. Developed symptoms on 06/30/2021
pt recv vax 16JAN97 & same day pt exp angioedema;ER or MD visit was required & was treated w/DPH;event resolved;pt was referred to an allergist;
ITCHY; HIVES - RED RAISED BUMPS ON MY BODY; PAIN ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced itchy, hives - red raised bumps on my body and pain on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives - red raised bumps on my body, itchy and pain on the injection site was not reported. This report was non-serious.
pt. vax'd w/ 1st dose of hepatitis B vac & exp. swelling of hands,SOB,diaphoresis,flushing, T99.2 & agitation.
In October 2021 I was diagnosed with Giant Cell Arteritis. Since it is an autoimmune system, my pharmacist recommended that I report it in case there were other similar cases that could be correlated to the vaccine. It is equally possible the disease is not related to the vaccine.
admitted to hospital, on room air, did not receive remdesivir or MAB. Symptoms included headache, dizziness, weakness for several days, did not qualify for outpatient treatment
There was a series of adverse events. Initially I was unable to move my head. I woke up and my head was locked. I saw my doctor on December 9th. It may not be related but it is one of the things that went on since then. I started getting. There was x-ray done on February 02 related to the issue with my head. On January 23rd I saw my doctor after having several days of swelling on the right side of my face. I also had neuropathy. The doctor completed blood work at that time and I received the results on January 27th and it indicated that it was positive for IFA-immunofluorescence assay. I am seeing a rheumatologist next week.
Little red spots on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Little red spots on injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Little red spots on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Little red spots on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recvd vax;8 days later,devel red face,persisted several days;then devel eczema;21mar94 pt recvd DT & again devel eczema;
Systemic: Tinnitus-Severe, Additional Details: Pt received Pfzier Booster shot on 11/20/21, and she has experienced tinnitus on her right ear (her left ear was deaf after receiving J&J vaccine on 5/18/2021). She also has dizziness and nausea and vomiting from the vaccination. She said that she experienced tinnitus on her right ear in which she never experienced before. She has not recovered from the tinnitus since
Arm red  raised; Arm  itchy raised; Faint outline; Injection site red, like a bullseye, Red mark; It itches a lot/itchy,raised/itched for two days; Raised mark/faint outline; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site red, like a bullseye, Red mark), PRURITUS (It itches a lot/itchy,raised/itched for two days), SCAR (Raised mark/faint outline), ERYTHEMA (Arm red  raised) and PRURITUS (Arm  itchy raised) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since 01-Mar-1970, Epilepsy since 25-Jun-1968, Cholesterol and Blood pressure high. Concomitant products included ATENOLOL from 16-May-2000 to an unknown date for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR OD) from 18-Apr-2001 to an unknown date for Cholesterol, PHENOBARBITAL SODIUM (PHENOBARBITAL [PHENOBARBITAL SODIUM]) from 15-Sep-1999 to an unknown date and TOPIRAMATE (TOPAMAX) from 12-Feb-2001 to an unknown date for Epilepsy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site red, like a bullseye, Red mark), PRURITUS (It itches a lot/itchy,raised/itched for two days) and SCAR (Raised mark/faint outline). On 02-Sep-2021, the patient experienced ERYTHEMA (Arm red  raised), PRURITUS (Arm  itchy raised) and SCAR (Faint outline). On 28-Aug-2021, VACCINATION SITE ERYTHEMA (Injection site red, like a bullseye, Red mark) and PRURITUS (It itches a lot/itchy,raised/itched for two days) had resolved with sequelae. On 03-Sep-2021, ERYTHEMA (Arm red  raised) and PRURITUS (Arm  itchy raised) had resolved with sequelae, SCAR (Faint outline) had resolved. At the time of the report, SCAR (Raised mark/faint outline) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The consumer stated that one week after getting the shot, she woke up with the injection site red, like a bullseye. It itched for two days and cleared except there was a faint outline.   The consumer stated that one week later it happened again, but only lasted for a day and the faint outline for a day.   The consumer stated that her events resolved with Residual effects- Circle visible.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: The follow up document was added and had significant information. Added events- Vaccination site erythema, Erythema, Pruritus, scar, concomitant medications. Updated Vaccine facility information, Events outcome, events start date and stop date, relevant history,Patient's demographic. On 07-Sep-2021: The follow up document was received and had no new information
A male patient of unspecified age with a medical history of emphysema and asthma experienced cramping and diarrhea 10-15 minutes following eating, duration 4 days, the day he received influenza vaccine (Fluzone SV 2005-2006) lot no:U1871BA in an unspecified arm on 17-Nov-2005. The event began in the evening at 06.00 PM of the vaccination. Signs and symptoms still persisted at the time of the report in relation to eating. Follow up information received on 212/Mar/2006. The initial reporter advises that the patient did not received the flu vaccine at their facility. However, he has no additional information about the case and no contact information for the patient or his physician. Additional information is not expected in this case.
Developed hives after KINRIX immunization. Came into office 7/16/09. Put on BENADRYL 1 1/2 tsp TID and  PERIACTIN 1 tsp TID, no fever or distress.
I received my 2nd (booster) shot of Zoster Vaccine (RZV) on 7/24/2018 at approx. 6:00pm by the pharmacist. By the next day (Wednesday), my entire arm was sore with redness at the injection site. By evening of 7/25/2018, I had fever, chills, achiness, headache, joint pain, nausea, and could barely move without feeling dizzy. My fever spiked to 102.3. I drank mostly water throughout the night. By morning, my fever was gone and I am feeling much better. My arm is still a little sore with redness at the injection site. I did not have this reaction with the first dose, only the 2nd dose. I've never had such a reaction to vaccines before. It lasted about 24 hours and now is mostly subsided.
Neck Node Enlargement Both times. Severe R Knee pain & swelling  could hardly walk
Developed a huge area of redness and swelling in the right thigh approximately 20 x 10cm in dimensions.  Resolved with Benadryl and warm compress after 4 days.
Systemic: Fainting / Unresponsive-Mild, Additional Details: The patient was reaaly terrified about getting the Vaccine but mom decided to go ahead since his older brother got it and was fine. After the vaccination patient was fine and I moved her to the waiting area. it was at this point she fainted and fell to the ground. she did hit her head on the floor before I could catch her. I called the paramedics and after evaluations she checked out ok and all her vitals were great. Mom opted to take the patient home instead of going to the hospital
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 09-FEB-2015, the patient was vaccinated with improperly stored VAQTA (strength: 25/0 (unit  unspecified), lot # K005323 with expiration date of 10-FEB-2017; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
left arm swollen, red (2"x2" area) and itchy; can't sleep
When pt got shot, first instinct was stiffness on arm immediately. After 3-4 hrs of the shot, pt noticed there's bruises underneath the skin, it's getting darking everyday. Pt's on blood thinner (EFFIENT 10mg). Stiffness last about a day, and now stiffness is gone but bruises underneath skin is getting darker each day. Pt got flu shot before w/o any problem.
Information has been received from a 50 year old female nurse assistant with allergies to codeine and monosodium glutamate and a history of shingles who on 14-DEC-2006 was vaccinated SC with a dose of Zostavax. Concomitant therapy included vitamins (unspecified). Subsequently she developed "blisters" on the lateral part of her tongue. She also experienced a shingles lesion on her eyebrow. Unspecified medical attention was sought. She was being treated with VALTREX. At the time of the report, the patient had not recovered. There was no product quality complaint involved. No further information is expected.
Low-grade and genuine malaise the next day and increasing temperature to 106F with chills. Pt is a kidney transplant pt on cyclosporine and prednisone.
Approximately 7 days after vaccination, notice grey-ish dot at injection site.  Injection site began to act irritated, initially feeling itchy.  Progressively became more itchy, rash-like around injection site, general area of arm where shot was given.  Turned red, blotchy, warm to touch and some swelling.  Irritation has continued (4 days), but is not getting worse.
Significant right arm pain - almost 30 days - had the flu vaccine at the same time in the same arm. Very sore, immobile in the morning. Anti-inflammatories help, I'm a nurse and this is very unusual.
5/13/21 around 11:30 am Patient received vaccination.  Patient directed to post exposure waiting area. Patient after sitting down under a minute  started to slouch and fainted. Fell on floor with side of head hitting floor. Patient passed out and then  less then 10 seconds later gradually became alert. Patient  did not want to lay on floor and was positioned in chair.  911 Call placed and EMS responded approximately 8  to 10 minutes later. Patient declined  being sent to hospital. EMS took blood pressure and made sure patient was okay. Patient signed waiver with EMS
Right shoulder with decreased motion after receiving flu shot. History of chronic shoulder pain and history of steroid injections in the past. Pain with flexion and abduction
A few minutes after received vaccines, he felt a little dizzy ("woozy") but did not faint or lose consciousness. Asked for a glass of water & felt fine afterward. Observed in office for several minutes & reported no further symptoms.
I started feeling pain in my shoulder/bursa area. I couldn't lift my arm, or rotate it. I had trouble putting clothes on, holding anything or hanging my purse off of it. I couldn't reach across my body or lift it over my head. I couldn't raise my arm in front of me or to the side due to pain and muscle weakness. This occurred in November, December, and into January.