chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a runny nose; headache; rash on her left breast, chest, and abdomen; flu-like symptoms; Pain in extremity; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (a runny nose), RASH (rash on her left breast, chest, and abdomen), HEADACHE (headache) and PAIN IN EXTREMITY (Pain in extremity) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis NOS (The patient stated that she has sinuses.). Concurrent medical conditions included Allergy.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN IN EXTREMITY (Pain in extremity). On 30-Jan-2021, the patient experienced RASH (rash on her left breast, chest, and abdomen). On 24-Feb-2021, the patient experienced RHINORRHOEA (a runny nose) and HEADACHE (headache). On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), RASH (rash on her left breast, chest, and abdomen) and PAIN IN EXTREMITY (Pain in extremity) had resolved. At the time of the report, RHINORRHOEA (a runny nose) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included 1 tablet of a Benadryl taken on 01 Feb 2021.
Left arm pain, including down the left arm, the armpit, the upper left back, and left shoulder. Temp 101F oral. Elevated heart rate into the 130s. BP 140/100. All over body aches. Chills. Ice pic headache to the left temple. I went to the ER around 2pm Friday, 24 hours post vaccine. My temp spiked around 8pm Friday night to 101F oral. I had labs done. 2am on Saturday my temperature broke. I still have a sore left arm, and dull headache to the back of my head, and it?s Tuesday morning.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves adult patient who was vaccinated with PENTACEL (batch number: C5439AA, expiration date: 29-Jun-2019, route was not reported, in left side) instead of a FLUZONE HD, on 30-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt experienced shortness of breath and urticaria with watering and redness of the eyes, about 20 minutes post vax.
This spontaneous report as received from a 71 year old female patient regarding herself. Patient's current conditions included occasional migraine headaches, psoriasis-like rash on her lower back, dermatitis, headaches and also patient was allergic to sulfur. On 22-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) in the arm. On the same day, the patient also received influenza virus vaccine (manufacturer unknown) at an unspecified Pharmacy. Concomitant therapies included FIORINAL. On 22-SEP-2013, the patient experienced headache which has continued "most days" since administration. The patient also reported breaking out with a reaction on and around the injection-site, in the form of "itchy-pink" small bumps that tend to spread and sting when scratched, sometimes extending over the breast area and into the underarm area since 22-SEP-2013, also straight pink "lines" or "streaks" on her stomach and stated that any touching or bumping of her skin seemed to lead to an outbreak of these bumps, which emerged and then disappeared. Patient sought medical attention for the same (had appointment with physician). No treatment was provided. The outcome of all the reported events was not recovered/not resolved. Additional information has been requested.
5 min after shots, had pain in lower back , tingling in legs and face and leg weakness. Pain got progressively worse for 5 minutes then began to abate. After 30 min symptoms mostly gone. Only slight feeling of weakness.
Patient received flu vaccination on 11/3/08. Patient called the Tele-nurse line on 11/4/08 complaining of generalized itching over most of her body after receiving the flu vaccination. The itching subsided on 11/3/08 but patient developed aches all over with some chills on 11/4/08. She has taken the flu vaccination in the past without side effects. She denied any other symptoms. Nursing line referred the information to her PCP. Patient instructed to drink at least six 8-ounce glasses of fluid a day unless on a fluid restriction diet. She was also instructed to take her usual pain/fever medications as per label instructions. Patient also told to call the Tele-nurse back if symptoms did not improve by Thursday, 11/06/08, if her symptoms worsened, or if she developed new symptoms.
Had injection approx. 3:30pm on a Friday afternoon: Pain in LEFT arm, more severe than expected, lasted thru evening.  Headache started about 5pm on LEFT side; became more severe thru the evening.  Difficulty sleeping, my brain felt like it  was "buzzing"..... I feared that my brain function had been affected, or that I may have a stroke.  Pain on Left side migrated down Left side of neck, shoulder & upper back thru the night.  By next day, pain developed into Migraine, affected BOTH sides of head. Then followed the same course down my Right side of body & settled into my lower back.  Back pain became severe & called Doctor on Monday (3 days later). He prescribed a Pain medication & heat/ice & suggested I report these side effects to VAERS.  Body pain & migraines continued for about 5 days, with nausea.  Then, got better as days went on; however, did not feel well for  about 2 weeks, with weird "buzzing" in head at night, continuing.   It has now resolved itself.
Muscle spasms starting a few hours post first injection - back, facial, neck and persistent for 6 weeks. Second dose was not administered.
Information has been received from a nurse practitioner concerning an 18 year old female who in May 2008, was vaccinated with the second dose of GARDASIL. Subsequently, in May 2008, the patient experienced nausea, fever and back pain. Subsequently, the patient recovered from nausea, fever and back pain. The patient contacted a physician. Additional information has been requested.
Approximately 24 hours following receipt of the second dose of the Moderna COVID-19 vaccine, patient developed a red, itchy rash around the injections site that was 3 inches in diameter. The rash persisted for several days before eventually subsiding but remained itchy for an additional week thereafter. Other symptoms included fatigue, soreness at the injection site, and feeling faint.
very vaque complaints of "strange feeling in stomach"    Thinks it may be related to not having eaten since early this morning - only 6 small crackers & tea"  no other c/o what so ever.     conversant & pleasant.  Given bottled water.  Remained in observation lot x 20 mins.  Drives off lot by spouse with plan to get late lunch.
Shoulder pain; woke up with the double size if the shoulder; can not lift my arm because of the terrible pain, i have to help that arm with the left one¨; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (woke up with the double size if the shoulder), MOBILITY DECREASED (can not lift my arm because of the terrible pain, i have to help that arm with the left one¨) and ARTHRALGIA (Shoulder pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PERIPHERAL SWELLING (woke up with the double size if the shoulder) and MOBILITY DECREASED (can not lift my arm because of the terrible pain, i have to help that arm with the left one¨). On 19-Mar-2021, the patient experienced ARTHRALGIA (Shoulder pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (woke up with the double size if the shoulder), MOBILITY DECREASED (can not lift my arm because of the terrible pain, i have to help that arm with the left one¨) and ARTHRALGIA (Shoulder pain) outcome was unknown.            No concomitant medications were reported. Action taken with mRNA-1273 in response to events was not applicable.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling (serious criteria other: serious as per reporter). The patient was treated with Corticosteroid (Trade Name Unknown). On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient experienced a large swelling at the injection site and she went to the emergency room (ER). The ER physician told the patient to put ice on the swelling and prescribed corticosteroid. This case has been linked to US2018GSK142280, for unspecified number of patients reported by the same reporter.
As the vaccine was being injected, my arm immediately began going numb and I felt pins and needles going down my left arm. My left index finger and thumb were numb for over an hour after. I was monitored by the doctor on site and sent home around 11am. After arriving home, I vomited once and fell asleep. I woke up about every 2 hours very nauseous, vomited once each time, and fell back asleep. At 9pm, I woke up shivering and having a very hard time breathing because my teeth were chattering so quickly. I felt so cold and all I could think to do was take a hot shower. In a daze, I walked to the bathroom and started vomiting uncontrollably. I got in the shower and kept vomiting. Thankfully, I was able to breathe more easily at that point, yet kept vomiting. After about 1 hour of continual vomiting, I noticed blood in the vomit. I immediately notified my parents and we went to the ER around 10:30pm. In the ER, I kept vomiting constantly and the nurse took me back right away. I was given an IV and 3 bags of fluids over 4 hours. I kept vomiting even with the fluids. I was given Zofran through the IV but it didn't help and I kept vomiting. I was also given 1 other anti-nausea through my IV that started with an "A", but I don't remember the name. Then I was given more Zofran through the IV but still couldn't stop vomiting. Finally, I was given Compazine through the IV and I was able to stop vomiting for 30 minutes. This was all over the course of 4 hours. I was ultimately sent home after that because it was 3am and my dad was exhausted. Over the next two days, I slept constantly and was unable to stay awake for longer than 20 minutes. After those two days, I felt completely back to normal and like nothing happened.
Severe joint pain, fevers, severe headaches, cough, severe fatigue, the first week. Second & 3rd week -Positive D dimer,low o2 sat.s. high fevers and body/joint pain. 4-6 week-Hemoptysis, Systemic inflammattory response syndrome, sepsis, acute bronchitis, uveitis and vertigo. Info below is for answer 21 1 admissions to Hospital was 4 days 2nd admission to Another Hospital. 6 day stay Most of the treatment was antibiotics, oral steroids, steroid drops for my eyes and breathing treatments to open my airway.
Extreme mood swings. Wanted to curl in bed and cry, wanted to laugh hysterically, wanted to punch people for making me angry.
Pt. had local reaction at injection site. Area became swollen, and red, the next day. No treatment required.
chills; fever; joint pain; soreness to the injection site; A spontaneous report was received from a health care professional concerning a 30-years-old, female patient, who received Moderna's COVID-19 Vaccine and who experienced soreness to the injection site, chills, fever 101 Fahrenheit (F) and joint pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 JAN 2021 at 11:40 AM, the patient received the first of two planned doses of mRNA-1273 (batch number: 025L20A) intramuscularly left deltoid for prophylaxis of COVID-19 infection.  On 01 JAN 2021, the patient experienced soreness to the injection site. On the same day at 11PM the patient reported chills, fever of 101 F and joint pain. On 03 JAN 2021, she still had low grade fever of 100.4 F, joint pain and woke up with chills. The patient stated that fever, chills, joint pain were resolved after taking acetaminophen, but the injection site was still painful.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, chills, fever 101 F and joint pain was resolved on the 03 JAN 2021. The event soreness to the injection site was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of chills, pyrexia, arthralgia and vaccination site pain, a causal relationship cannot be excluded.
81 year old female, history of migraines, history of dementia, like primary progressive aphasia. On October 23, 2023 she received the following vaccinations from Pharmacy: Prevnar20 Lot#HF1068 Spikevax 2023-24 Lot#30320086 Fluad quad 2023-24 (Seqires) Lot#371626 On October 24, 2023 approximately 01:00 the patient experienced two episodes of vomiting. The next day she complained of severe fatigue. She also experienced aggravation of underlying disorder: increased confusion, migraine triggered. She required help to avoid falling due to unstable gait.
Severe nausea and vomiting for 6 hours Headache, body aches 12 hours +
Shortness of breath, chest pain, extreme fatigue. Diagnosed with multiple pulmonary embolisms in emergency room. Transferred to Hospital, where they performed the EKOS procedure to dissolve clots. I survived but am on blood thinners for at least 6 months, maybe life.
suffers cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp via social media.  This case involves a 16 year old and unknown gender patient who suffered cardiac arrest while receiving 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 and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a football player and on an unknown date the patient suffered cardiac arrest (cardiac arrest) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (suffers cardiac arrest).  At time of reporting, the outcome was Unknown for the event suffers cardiac arrest.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 16 year old patient of unknown gender who suffered cardiac arrest after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history, concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
"On January 28, 2021, I received the 2nd COVID  vaccine.  Later in the day, I started feeling general malaise, chills, then during the night I felt like I couldn't get warm and ran a fever up to 101.2.  Later that night when I was going back to my room, I felt very weak and dizzy and I ended up passing out.  I don't remember anything until I woke up around 9:00 a.m. the following day.  I felt back to myself by around 4:00 p.m. January 29th, 2021."
I started to bleed from the nose; Spit blood; Chest pain; Fatigue; Fever; Chills; Horrible headache; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset Sep2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Sep2021, outcome "unknown", described as "Horrible headache"; MYALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "Muscle pain"; EPISTAXIS (non-serious) with onset 10Sep2021, outcome "unknown", described as "I started to bleed from the nose"; HAEMOPTYSIS (non-serious) with onset 10Sep2021, outcome "unknown", described as "Spit blood"; CHEST PAIN (non-serious) with onset 10Sep2021, outcome "unknown", described as "Chest pain"; FATIGUE (non-serious) with onset 10Sep2021, outcome "unknown", described as "Fatigue".  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
severe Bladder urgency and pain blood in urine. Was treated for uti even though there was no bacteria in urine. symptoms went away but came back a month later worse than before. went to er but again found no bacteria. both times there was blood in urine. was referred to urologist. Urologist found no bacteria and Vesicare was prescribed for Over active bladder. I never had these symptoms before this vaccine.
"More than normal" soreness was noted approximately 2 hours after the injection. 10 hours after the injection, patient had a low grade fever, and her left arm was red and warm to the touch. The inflamed area was approximately 3" by 2.5" and was near the area of injection. 18 hours after the injection, the patients eyes also itched and burned. All symptoms resolved after approximately 3 days.
usually experience very brief loss of consciousness but upon injection i lost consciousness immediately and proceeded to have a mild seizure lasting approximately 10 seconds followed by numbness in my legs for 10 minutes after injection.
Guillain-Barre syndrome was ultimately diagnosed Following information was described by patient:  Typical symptoms started during the night of the vaccination on 12/20/21 as sore arm that became to move,  then gradually the symptoms became worse and she developed a rash, nausea,  and generally didn't feel well.  She eventually went to the hospital on 12/31/20, at which point she was treated for her symptoms and released.  By 1/7/21 she felt absolutely awful, she managed to get herself into a vehicle to leave the house to be medically evaluated but by the time she arrived she couldn't get out of the car, she reports her BP was 185/135 and she couldn't walk.  At the ER they did a lumbar puncture and that's the last thing she remembers until Monday 1/18/21.  At some point was admitted to ICU paralyzed with what was diagnosed as Guillain-Barre syndrome and she said they weren't sure she would make it.  She is now alert and making a slow recovery now at a rehab facility and called the pharmacy today to report the incident to us now that she is able to speak again.
have little natural immunity from catching the variants/only immunity is from the original vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "have little natural immunity from catching the variants/only immunity is from the original vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This case was reported by a healthcare professional and described the occurrence of stinging during injection in an unspecified number of subjects of unspecified ages and genders who were vaccinated with Havrix (GlaxoSmithKline).  On an unspecified date the subjects received unspecified dose of Havrix (unknown).  The reporter stated that approximately one-third of patients were "screaming and saying that the Havrix injection stings."  The nurse believed that the event "may be due to the reformulation".  At the time of reporting the outcome of the event was was unspecified.
Pt was given Hiberix as ordered by her doctor bc she is having a splenectomy.  When processing the paperwork and entering the lot/exp. we discovered that the product expired on 4/1/2023.  I called the manufacturer (GSK) and they said since there is no data with studies on product expired more than 30 days that the dose should be repeated.  They also said there haven't been any adverse reactions reported from use of expired Hiberix.  I talked to the patient and let her know what happened.  I told her the recommendation per GSK/CDC is to get another dose and could be given same day and that clinic has it in stock (she is a patient there).  I contacted her doctor's office and spoke with (nurse) to let her know what happened.  She said the doctor would probably want her to go ahead and get another dose rather than wait until after her surgery and that she would talk to him.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue, Chills Narrative: