chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High on (R) shoulder must have hit the bone! I shouted "ouch". Bruise size of dime, for over a week w/pain & extreme took ADVIL daily still have pain 10/10/11. Bruise went yellow now gone. Still "though. Have taken over counter sleep pills so can get sleep!
Got my Tdap shot around 10 am on the 11th...the next morning I was awaken by cops and paramedics...I had a seizure and stopped breathing.
Fever, vomiting, chills and sweats, pounding headache, sore/stiff.
She notice redness and soreness on injection site on 02/21/2016, appling a cold compression to the site. MD gave her Cipro 500 mg, twice a day.
Severe muscle pain, bone and joint pain, shooting pains throughout body, vomiting, severe weakness, fatigue low fever
8JUN91 PT recd 1st vax; 6hrs p/inject PT had chills & felt flushed; 9hrs p/inject PT exp'd very severe bitemporal h/a & fever up to 103.6; rx: Tylenol & Ibuprofen & Darvocet N-100 for h/a; PT did not "feel normal" until 17JUN;
(R) arm swollen and red at injection site. Treatment: Given MOTRIN and ice applied to site.
her knee was in "out of control pain"; joint stiffness in this knee for a while now; she has to wear a brace and walk with crutches/ Having to use brace and crutches/Leg giving her lots of problems, couldn't hardly walk; hasn't been able to drive or work for the past 2 weeks; hasn't been able to drive or work for the past 2 weeks; X-rays show she has bone touching bone in her knee; she and her husband were around an asymptomatic covid patient; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 19Mar2021 (at the age of 64-years-old), at dose 1, single for covid-19 immunization. Medical history included preexisting issue with her knee, like arthritis, wasn't bothering her before, just stiff.  The patient's concomitant medications were not reported. On 20Mar2021, the patient experienced her knee was in out-of-control pain, joint stiffness in this knee for a while now, she has to wear a brace and walk with crutches; leg giving her lots of problems. The patient couldn't hardly walk, hasn't been able to drive or work for the past 2 weeks, her x-rays showed bone touching bone in her knee on Mar2021. It was also reported that she and her husband were around an asymptomatic covid patient after first vaccination in Mar2021. The patient underwent orthopedic office twice for the events leg was giving her a lot of problems. The patient underwent lab tests and procedures which included x-ray showed bone touching bone in her knee on Mar2021. Therapeutic measures included: treating her pain with anti-inflammatories, Tylenol and ice, and the pain is improving. The outcome of the event knee pain was recovering, and outcome of other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a field representative which reported that the nurse who is the patient in this case reported to the representative, that on an unspecified date while administering ROTATEQ (route and indication were not provided) part of the dose went into her eye because the infant patient she was administering to spit it back out. Since then the nurse has developed an eye infection, diarrhoea and nausea. The representative also reported "since the infant patient spit the ROTATEQ out the infant did not receive a full dose, no adverse effect were reported. No relevant medical history were reported. Concomitant medications were not reported. All adverse events refers only to the nurse. The outcome of part of the dose went into my eye, nausea, diarrhea and eye infection was reported as not recovered/not resolved. Action taken with the therapy drug were not reported. No further information was provided.
101 fever, horrible body aches, nausea, emesis, fatigue all lasting 24 hours
Prolonged diarrhea, gas, abdominal pain lasting 8 months. Symptoms began to subside after 3 months, but continued intermittantly for another 6 months and stopped at 8 months. No treatment available. This was the first time I had been given the quadrivalent flu vaccine. All past flue vaccines I received had been the trivalent vaccine (approx. the last 6 years). At my annual physical in September, 2019, my PCPs office offered to give me a flu shot at that time. I explained what happened in 2018, they advised the quadrivalent vaccine was too strong for me and instructed to get the trivalent vaccine going forward. Unable to get it this year as it's only available to those ever 65 years of age.
Received 2nd vaccine Monday, 2/8/21 a.m. Called in sick Tuesday, 2/9/21 because at approx. 12:00-0200 woke up dry heaves, sweating, chills, body aches and a low grade fever 100-101 degrees. Around 0800 pressure like headache developed. She had a virtual visit with her MD on 2/9/21. Her MD ordered Ondansetron to help with her vomiting. On 2/10/21 she was dizzy and gagging so her MD ordered Medizine for her dizziness. On 2/11/2021 she's feeling a little better, was able to keep some noodles down from eating last night and some Gatorade. She is waiting for her doctor's office to call her back yet today.
muscle aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Mar2021 (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: Bnt162b2 (product=COVID 19, brand=Pfizer, lot unknown=False,, dose number=1), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 09Mar2021, outcome "recovering", described as "muscle aches". It was unknown if therapeutic measures were taken as a result of myalgia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, slight swelling, and warm to touch to the injected area (right arm). 04/03/2016 - the redness area is about 3cm diameter. Right armpit started have pain on 04/02/2016. Right armpit pain increased and swelling continued on 04/03/2016.
pt recv vax 9JUN97 & 20JUN97 pt devel a temp of 102, rash, sensitivity to light;
No additional AE; Caller reported that PROQUAD that underwent a temperature excursion was administered.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 19-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W010061, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 20-SEP-2023) (dose, anatomical location and route of administration were not reported). The vaccine was administered for prophylaxis after a temperature excursion (temperature of -14 Celsius degrees [°C] up to -10°C [-14.18C] for 0 hours 15 minutes and 0 seconds) (Product storage error). The vaccine did not have previous temperature excursions.  No adverse event was reported.  This is one of three cases reported by the same reporter.
5 days post vax pt devel terrible sore throat-bad cold w/sl temp, chills, feeling sick x 10 day devel into hard cold-a lot of coughing w/mucus;
heart palpitations that lasted for 2hrs 30mins; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations that lasted for 2hrs 30mins) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included Natural Vitamins for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PALPITATIONS (heart palpitations that lasted for 2hrs 30mins). At the time of the report, PALPITATIONS (heart palpitations that lasted for 2hrs 30mins) outcome was unknown.        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.   Treatment information included patient called the doctor about the palpitations and was advised to go to the ER if it persist. Her husband just took cold water and the palpitations went away.
Within 10hours, I was sweating, nausea, vomit, passes out. The next day, I had nausea, fever,body aches. On day 8, large bruise on my right thigh. Day 9-12: burning sensation throughout body, sweating, pain in back. Day 14: still feel terrible and went to doctor.
Pt leaned over and c/o feeling dizzy, having a headache that radiated from the front of head to the back of head. BP was elevated. Rapid Response was called after 40 minutes of continuous increase in BP.
metallic taste, sob, joint pain, cephalea tx: solumedrol 125mg Benadryl 50mg
initial shot was very painful and I noticed a lump in my arm at the injection site next day (more pain than other shots, but not more than I expected).  More than a month later, I still have a lump in my arm, it has descended about an inch or two from the initial injection but when any pressure is applied the lump still aches and I experience tingling through my arm initially, then continued pain near the lump for several minutes after the pressure has been stopped.
hoarse; Trouble swallowing; Trouble breathing; Fever; Shivering; Headache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of hoarseness in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 17th October 2019, please refer the case US2020176185.).   On 27th January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the hoarseness, swallowing difficult, difficulty breathing, fever, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: After receiving the 2nd dose of vaccine, the patient experienced fever, nausea, headache, shivering, trouble breathing, trouble swallowing, and hoarse all at once. The complains almost a year later she was still experiencing all of the side effects.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176185:same patient
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 10-MAR-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # H018987 and expiry date 02-MAR-2014), 0.5 milliliter (ml), intramuscularly. No adverse effect reported. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age with asthma, Gastrooesophageal reflux disease (GERD) and depression. Patient has allergy to KEFLEX, CELEXA and erythromycins. On an unknown date (reported as several months ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant therapies included bupropion hydrochloride (reported as Bupropion) and PREVACID. On an unknown date, immediately after receiving the ZOSTAVAX she developed flu-like symptoms. She did call and reported this to either her physician or the pharmacist (she could not remember which one), who told her that ZOSTAVAX would not cause these symptoms, so nothing further was done about this. The patient states that the symptoms lasted about 3-4 weeks and then resolved. The patient currently had developed on the inside of her right lower calf, muscle pain and joint pain, along with a small red rash that has a burning sensation. She contacted the pharmacist who administered her ZOSTAVAX and informed them about her current symptoms, and she stated that the pharmacist had told her that these were known side-effects that can occur after receiving ZOSTAVAX. These symptoms have resulted in the patient not being able to be on her feet as long as normal (disability). The patient also reported that on an unknown date, she developed a urinary tract infection at the same time she started developing the symptoms in her lower right calf. Patient sought medical attention. The patient recently saw an allergist who performed 'sensitivity testing' on her on an unknown date, and her pulmonologist performed a complete blood count on an unknown date and informed her that her IGE (immunoglobulin E) levels were in the 1500's. The outcome of small red rash that has a burning sensation, developed muscle pain and joint pain on the inside of her right lower calf, not being able to be on her feet as long as normal and developed a urinary tract infection was unknown. Upon internal review the event patient not being able to be on her feet as long as normal was considered to be disability. Additional information has been requested.
Patient states injection site reaction with redness, inflammation and bruising. MD treated with steroids and believes reaction was from BOOSTRIX injection.
fully vaccinated - date given was date of 2nd vaccine dose. Admitted to hospital 8/20/21 for cough and hypoxia and found to be COVID+
Patient is 25 years of age, was incorrectly given pediatric formulation of Hepatitis B vaccine for ages 19 or younger.  Patient noted some nausea immediately after receiving this vaccine and other required vaccines, reported that nausea subsided within 15 minutes.
Those shots are painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Those shots are painful).  The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023. This case was reported by a patient via interactive digital media. The patient stated that Shingles shots were painful but so worth it. The follow-up could not be possible as no contact details were available.
I21.4 ACUTE NON ST ELEVATION MI 7/2/2022 ADENOCARCINOMA, BODY OF STOMACH I95.9 HYPOTENSION 7/2/2022 ADENOCARCINOMA, BODY OF STOMACH
Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022; No adverse event; Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2022 at 10:52 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022).    Concomitant medication information was not provided by the reporter.  The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 13-Sep-2022, vial was removed from the freezer and placed into the refrigerator on 12-Sep-2022. The vial did not undergo any temperature excursion.  Treatment information was not provided by the reporter.
The patient read on his vaccination card that his next dose of the Pfizer vaccine was due on April 21, 2021. During the screening process the screener misread the patient vaccination card that stated the patient was not due for their second Pfizer Covid-19 vaccination until April 27th 2021, resulting in the patient receiving the vaccine 6 days early on April 21, 2021.
Rash on thighs abdomen, back and hips.  Stated looked like a raised, red birthmark.  No individual bumps.  Resolved 24 hours later.  Stated by mother of child, no fever.
Near people who had COVID-19. Had sore throat then took a home COVID-19 test - positive. Had a telehealth appointment and decided not to take any prescriptions. Retested Home COVID-19 test - negative.
blood clot (superficial) developed four days after vacccine.. No prior history of  blood clots.
Information has been received from a nurse practitioner, via a company representative, concerning a female patient in her late teens with a history of hypersensitivity reactions, who on an unknown date was vaccinated with the first dose , 0.5 mL, of Gardasil vaccine (lot # not specified). Subsequently, the patient "had an anaphylactic reaction," and developed hives all over her body, as well as swollen eyelids. The patient visited the emergency room and was administered Benadryl. She recovered from the events, though the duration of symptoms was not specified. Additional information has been requested.
INJECTION SITE RED WITH EDEMA AND HOT TO TOUCH. PAINFUL TO LIGHT PALPATION.
Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an eight-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL; lot number C3980AB received on 23 November 2011, lot number C4045AA received on 23 January 2012 and lot number C4131AA received on 21 March 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 22 May 2012, approximately two months after the last dose. On 23 May 2012, the subject developed a cough and on 25 May 2012 he developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 40 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
on 4/7/98 pt devel a low grade fever & less than 20 pox w/``1 scabbed over''. p/ vax on 3/3/98. not seen by m.d. rpt by RN
stiff neck along and above injection site--started next morning after injection and has continued for 5 days with soreness/stiffness abating somewhat after day 3
Information has been received from a pharmacist concerning an "older" female patient who was vaccinated with a dose of Pneumovax 23.  Subsequently the patient developed a round band of inflammation below the injection site.  The area was warm to the touch.  The vaccination was administered at the pharmacy.  The pharmacist indicated she had never seen anything like it before.  The patient's outcome was unknown.  Additional information has been requested.
IBD worsening - Increased intestinal inflammation (very high calprotectin), still doing tests.  MRI and colonoscopy on the way.  From my first report, my first IBD symptoms started in December after first Covid booster in November 2021. And I also had my first ever flu shot that year in September.  In summer 2022 I also had issues with liver (elevated liver enzymes) after a booster shot in July 2022. Got liver biopsy and diagnosed with Primary Sclerosing Cholangitis. Currently taking Ursodiol and there is no treatment for PSC. Waiting to change medication for IBD because Entyvio doesn?t seem to work. Potentially, my iron supplement might be exacerbating intestinal inflammation. So I?ve stopped taking it.
Warm to touch, red circle on the injection site, and itchiness to the injection site two days after injection was given. Symptoms resolved on its on within a week.
Patient had syncopal episode following moderna vaccination (Dose #1) and fell on face knocking a tooth out.
Myocarditis - started with fever and headaches followed by chest pain on day #3 with elevated troponin and positive CMR as below
Information has been received from a health professional concerning a male with a possible history of clinically diagnosed mumps in his childhood without orchitis, who on 10-NOV-2007 was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient's "childhood immunization history is unclear but is likely to have had measles vaccine alone as a child." On 13-NOV-2007, the patient developed a prolonged course of unilateral orchitis (an ultrasound confirmed inflammatory pattern swelling) with discomfort date onset 3 days after vaccination. "No parotitis was found by treating clinicians at the reporting center." The patient has not had any diagnostic biopsies or aspirates performed to date. The patient remains symptomatic 5 weeks following vaccination at last review. Additional information has been requested.