chrisvoncsefalvay/vaers-outcomes huggingface dataset:
So there is something going on with my stomach, I woke up one morning and went to the restroom and my urine was really dark. I went to ER and they said I was severely dehydrated. When I went home I used the bathroom and it was burning and hurting really bad so I went to the DR again. They did some tests and the DR thinks it is an ulcer. Next I am looking for a gastroenterologist to see. They gave me some nausea medicine to help me be able to eat. My stomach is so sore and I am not really getting around and overall not feeling well.
Pt recvd 1 dose of Engerix-B & pt also recvd immune serum globulin; between 24-48 hrs p/dose had fever, abdo cramps, flu-like sx, nausea, vomiting;
This spontaneous report was received from a physician via company representatives referring to a patient of an unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 240 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient states that he had pain in the first days after vaccination, ranging up to an 8 out of 10. He is still having pain now, over a month later, but it is less severe. If his arm is at rest, he has no pain up to a 1 out of 10. When using his arm, especially lifting it up, he has pain described as a 5 out of 10. He has taken ibuprofen and used ice, to some result. He was seen by his doctor, who noted that there is no swelling, redness, infection, or anything else notable.
Patient noted erythema and urticaria within 5 minutes after vaccine. Given Zyrtec 10mg and water. Currently feeling better at this time.
Major swelling at injection site, warm to touch, swelling and down left arm, across shoulder & up neck to below ear. Steroid treatment started on 10/26/11.
I noticed a rash on my left front thigh about 1 day after vaccine. It then spread to my left front thigh. No itching or pain. It is one week later and it is almost gone. I was not sure if it was related to the shot as I had been doing yard work during that time. Then I saw an article this morning which described the rash accurately.  So it is probably related, however that being said, given the choice, I would take it again. Had no pain at injection site, no other issues, and I feel safer for the experience. Pharmacy sent text.
pt came to pharmacy with redand irritated injection site from pneumovax 23 vaccination 12/7/21. it was healing and looking better per pt but states red and inflamed almost like allergic reaction.
Information has been received from a healthcare worker concerning a 76 yr old female with hypertension. On 27Oct05 the pt was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot649913/0577P). Concomitant therapy included unspecified therapy reported as several other medications. On 27Oct05 the pt developed swelling at the injection site and area surrounding the injection site. The pt sought unspecified medical attention. At the time of this report, the pt was recovering from the event. Additional information has been requested.
severe joint aches; muscle spasms; severe diarrhea; severe pain in his knees; pain in his shoulders; cold; chills; fever; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support from a contactable consumer or other non HCP (patient) via medical information team. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 01May2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 08Apr2021 with no problems. The patient's medical history and concomitant medications were not reported. On 02May2021 the patient reports severe joint aches and muscle spasms and severe diarrhea. He says that he bent down at work and was in severe pain in his knees, and they didn't even want to push me back up and that he can be sitting, watching TV and if he moves, he can hear his knee joints grinding. He also reports pain in his shoulders. Patient experienced cold, chills and fever. He's been seen by his HCP and tested negative for Covid infection. The doctor told him that it will go away in 72 hours. He also asked the pharmacist at local store, and he was told that other people had cramps. He called in to know if it is normal and when it will go away or if other people experience the same. First dose of the vaccine was given 08Apr2021. He also mentioned that after the first dose he felt that he did not have the shot. The patient underwent lab tests and procedures which included body temperature results into fever on 02May2021, sars-cov-2 test results as negative on 03May2021. The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills, 101.5° fever, vomiting, pain and swelling in area of injection, body aches. Pain in arm lasted 3 days. Fever and body aches lasted 24 hrs after they started. No treatment received.
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. Anatomical location of administration was reported as left. It was unknown if patient had allergies to medication, foods and other products.  It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergone any temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains updated reporter details
Headache; low fever; nausea; fatigue; loss of appetite; general discomfort; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm right on 27Apr2021 at 10:30(at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy like allergy to walnuts, apples and many stone fruits. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and naproxen sodium (ALEVE) since an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm right on 06Apr2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 02:00, the patient experienced headache, low fever, nausea, fatigue, loss of appetite, general discomfort and sore arm. It began approximately 14 hours after injection and easing 28 hours after injection and completely gone within 40 hours but still had sore arm. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, low fever, nausea, fatigue, loss of appetite and general discomfort were recovered on an unknown date in Apr2021. The clinical outcome of the event sore arm was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Low fever,  nausea,  fatigue,  headache, night sweat,  chills, loss of appetite
Mom reports pt spiked a t103 early eve 27MAR92; pt was pale & lethargic; mom also reports pt quivered; mom reports pt had similar sx w/1st vax, but did not report that incident; mom became concerned when occurred a second time;
About 5 mins after vaccine was received patient started wheezing, felt like her throat was closing. Difficulty breathing
ARM SORENESS CONTINUING FOR 1 MONTH AFTER IMMUNIZATION. NO RELIEF FROM OTC PRODUCTS.
administration of an expired dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number c9gm4, expiry date 15th November 2021) for prophylaxis.   On 2nd January 2022, the patient received Shingrix. On 2nd January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 68 or 69 years. The patient was given an expired dose of Shingrix. No further events were reported . The reporter agreed to follow up. This is one of three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002050:same reporter US-GLAXOSMITHKLINE-US2022002051:same reporter
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-AUG-2013 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-SEP-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster accompanied by Ramsay Hunt Syndrome (a condition brought on by a shingles outbreak that interferes with facial nerves and causes facial paralysis and hearing loss, secondary to zoster infections.) On or about 30-SEP-2014, the patient sought subsequent treatment from the physician for ongoing symptoms of Herpes Zoster Oticus and Unilateral high frequency sensorineural hearing loss. The patient sought ongoing treatment for these conditions, but will experience hearing loss that is likely permanent and irreversible due to the interferences she has experienced from zoster complications with her ears. The patient has been prescribed VALTREX and prednisone for management of her painful and bothersome symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Unilateral high frequency sensorineural hearing loss was reported to be disabling. Upon internal review Ramsay-Hunt Syndrome and unilateral high frequency sensorineural hearing loss were considered medically significant events. Additional information has been requested.
Hives & itching- all over body, bottom of my feet and in bilateral groins.
Diagnosed with COVID after receiving first dose of COVID-19 Vaccine; Diagnosed with COVID after receiving first dose of COVID-19 Vaccine; This is a spontaneous report from a contactable nurse (patient).  A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number PAA156051, expiration date unknown), via an unspecified route of administration on 15Dec2020 16:00 at a single dose at the right arm for COVID-19 immunization. The patient has no medical history, no family medical history and no concomitant medications.  The patient is a nurse in the Emergency Room. She had a first dose of COVID-19 vaccine on 15Dec2020. She was diagnosed with COVID after receiving first dose of COVID-19 vaccine on 23Dec2020. Due for second dose of COVID-19 vaccine on 04Jan2021. She wanted to know if she should go through with second dose if her symptoms subside. The COVID swab was done in the Emergency Room and was not admitted to hospital.  The outcome of the event was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Patient has an area 3 cm x 3cm of induration and 1 cm of redness surrounding the injection site at the R deltoid. She is experiencing pain wanted to know if this normal.   The patient was being treated for a skin infection with ciprofloxacin 500 mg one P.O. BID.
Patient waited 15 mins after covid vaccination on Wednesday 3/3, cleared by EMT to leave.  I was notified by nurse at the senior building where patient resides that she had expired Thursday evening at   home.  Paramedics were called.  No other additional information.
Information has been received on 01-DEC-2016 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient reported he never had chicken pox or shingles prior to 2010. In 2010, the patient received ZOSTAVAX (lot number not reported) vaccine.  In 2014, the patient began to develop shingles. The patient subsequently began to develop a skin rash on his hands, arm and back. This spread to his entire left hand and developed into nerve damage. As a result of this injury, the patient has lost 60-70 percent of the use of his left hand, and had to retire early from his job. As a direct and proximate result of his use of ZOSTAVAX, the patient continues to experience ongoing symptoms,  including loss of use of his left hand, which is believed to be caused by damage to his nervous system. The patient'  symptoms have resulted in physical limitations not present prior to use of ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of his use of ZOSTAVAX, the patient sustained serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient's wife has been the patient's primary caretaker since his illness began in 2014. Shingles, loss  of use of left hand/nerve damage and damage to his nervous system were considered to be disabling. Additional information has been requested.
This spontaneous report has been received from a certified medical assistant regarding to a 4-year-old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 13-FEB-2019, the patient was vaccinated with a dose of RECOMBIVAX HB (lot # R006746 and expiration date 09-NOV-2020) (dose number and anatomical location of vaccination were not reported) and PEDIARIX (anatomical location of vaccination was not reported) (Inappropriate dose of vaccine administered); both administered for prophylaxis. No adverse effect was reported.
On March 7th, the day after receiving the vaccine, I woke up with a stomach ache. It lasted all day and was sometimes very uncomfortable. It felt like a bad case of constipation, but it was not. I still had it when I went to bed, but it was gone the next day.
Pt had a positive COVID test 8/7/22; was hospitalized 4x within last month of life; last hospitalization, pt was dehydrated and hypotensive; family opted to transition pt to comfort measures and pursue hospice; pt admitted to Hospice where she passed away; death report shown as CHF complicated by COVID 19
Initial report received froM a healthcare professional on 28 Dec 2009: This patient,with an unknown medical history was vaccinated with 0.5 ml FLUVIRIN, intramuscularly on 28 Dec 2009. No further information was provided.
Severe dizziness with nausea and vomiting  for multiple days. Bed rest
2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: severe abdominal pain; low backahe; headache--aleve and rizatriptan 2/21/2020 through 2/25/2020 severe stiff neck; headache; aleve X4 pills  Only a sore arm from the fist vaccine.
experienced a reaction; Initial information received on 22-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who had experienced a reaction after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date 2019, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (form, batch number and expiry date unknown) via unknown route in unknown administration site for immunisation. Information on the batch number was requested.  On an unknown date the patient experienced a reaction (immunisation reaction) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced a reaction).  At time of reporting, the outcome was Unknown for the event experienced a reaction.
Initial unsolicited report received from a healthcare professional on 3 August 2015. A 59-year-old male patient had received a first dose of ADACEL (batch number, route of administration not reported) in right deltoid on 8 July 2015. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none and concomitant medication were reported as none. On 17 July 2015, nine days after vaccination, the patient developed a red scaling rash that had spread starting from his head progressing to his face and then full trunk. It both itches and burns. The patient was diagnosed with pityriasis rubra pilaris. Reporter consider it as a life-threatening illness. The patient required ER visit. The patient had tried triamcinolone cream without success as corrective treatment and was concerned that this may lead to more serious physical conditions such as liver and spleen enlargement. The patient's blood work is pending and he is being seen as a case at a symposium this week for evaluation and treatment. Laboratory investigations were reported as 'labs'. At the time of this report, the event outcome was not recovered. Documents held by sender: none.
Previously undiagnosed, sensorineural hearing loss - symmetric.  Specialist thinks pattern is consistent with congenital insert, however, mom feels child's hearing was excellent before Gardasil series.  09/10/2008 PCP records received including 2 ENT and audiological evals with DX:  Sensorineural hearing loss-symmetric.  Deafness. WCC 6/4/07 with normal exam. RTO 7/2/08 with c/o hearing problems after failing school hearing test. Did not pass audiogram given in office.  Refered to ENT.  ENT visit 7/15/08. Pt states first noticed a change in hearing approx 2 yrs ago. Occasional ringing in ears. ENT PE WNL. 1/26/2010 Had hearing loss-possibly due to GARDASIl hearing has not recovered.
Her eyes were sensitive to the light; they don't feel right; nausea again; it was the worst day; a very bad nausea; Splitting headache; Backache; Muscle ache; Didn't have any appetite; she began with symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (a very bad nausea), HEADACHE (Splitting headache), BACK PAIN (Backache), MYALGIA (Muscle ache) and DECREASED APPETITE (Didn't have any appetite) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica and Sjogren's. Concomitant products included HYDROXYCHLOROQUINE, VALSARTAN, HYDROCHLOROTHIAZIDE and FAMOTIDINE for an unknown indication.  On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION COMPLICATION (she began with symptoms). On 20-Feb-2021, the patient experienced NAUSEA (a very bad nausea), HEADACHE (Splitting headache), BACK PAIN (Backache), MYALGIA (Muscle ache), DECREASED APPETITE (Didn't have any appetite) and FEELING ABNORMAL (it was the worst day). On 23-Feb-2021, the patient experienced PHOTOPHOBIA (Her eyes were sensitive to the light), FEELING ABNORMAL (they don't feel right) and NAUSEA (nausea again). On 22-Feb-2021, NAUSEA (a very bad nausea), HEADACHE (Splitting headache), BACK PAIN (Backache), MYALGIA (Muscle ache) and DECREASED APPETITE (Didn't have any appetite) had resolved. At the time of the report, PHOTOPHOBIA (Her eyes were sensitive to the light), FEELING ABNORMAL (they don't feel right), VACCINATION COMPLICATION (she began with symptoms), FEELING ABNORMAL (it was the worst day) and NAUSEA (nausea again) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included Excedrin: Aspirin /Paracetamol /Caffeine.
Fever up to 103 for 2 days, headaches, muscle aches, cold sore started after 2nd day which hasn't resolved yet, pain at injection site
very tired. noticeable about 3 months after vaccination and seems to be getting worse. now 6 months after second shot and i am extremely tired daily, needing to take a nap in the afternoon.