chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cold sores; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The misdirected consumer reported that the patient received Shingrix about 8 weeks ago and 48 hours after receiving the injection he had a terrible reaction. He later states that he has been dealing with ongoing cold sores. The patient was a perfectly healthy person until he received the vaccine. He stated that he was at the time of reporting had plagued with sores and his physician completed blood work including a metabolic and everything was fine. The reporter did not consent to follow up. Related to Patient. The consumer declines to provide any further information stating he already reported all of this to another department at GlaxoSmithKline.  The reporter declined to provide his contact information.      Lab Comments: lab test performed on uknown date
spent 3 days in the sun and got burned and wanted to knowif it was due to Xeljanz or her COVID vaccine; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program XELSOURCE.   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation and tofacitinib citrate (XELJANZ XR 11 mg), via an unspecified route of administration from an unspecified date and ongoing, at 11 mg unknown frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated she spent 3 days in the sun and got burned on an unknown date and wanted to know if it was due to tofacitinib or her covid vaccine. The outcome of the event was unknown.The action taken for tofacitinib citrate was dose not changed.No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a 28 year old female patient with allergic reaction to aspirin when take extra strength and no medical history who on an unspecified date was vaccinated with the third dose of GARDASIL. There was no concomitant medication. Shortly after vaccination, the patient started experiencing severe, increased motions with an increase of menstrual flow. She also stated she felt body temperature increased along with getting more headaches. The patient could not give specified dates of when she took the vaccine. She simply stated her last dose was given a couple of years ago before her 26th birthday. No medical attention was sought. At the time of the report, the patient had not recovered. No further information is available.
artificial joints in my neck feeling very stiff; feel tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (artificial joints in my neck feeling very stiff) and FATIGUE (feel tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Joint arthroplasty (due to an accident years ago).   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (artificial joints in my neck feeling very stiff) and FATIGUE (feel tired). At the time of the report, MUSCULOSKELETAL STIFFNESS (artificial joints in my neck feeling very stiff) and FATIGUE (feel tired) was resolving.            No concomitant information was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: event start date added, outcome updated from unknown to recovering
This spontaneous report was received from a office manager regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On an unspecified date, the patient was vaccinated with one dose of improperly stored VAQTA INJ 25/0.5 (lot# reported as ED72D and expiration date 07-SEP-2018) (1 dose, route of administration and anatomical location unknown). The detail of the storage was a temperature excursion to 29 Fahrenheit(F) for 1 hour 27 minutes, 31 Fahrenheit(F) for 2 hours, 30.2 Fahrenheit(F) for 1 hour 45minutes, 32 Fahrenheit(F) for 1 hour 52 minutes and 32 Fahrenheit(F) for 33 minutes. No adverse effect was reported. Additional information is not expected as the reporter denies consent to be contacted for further information.
pt recv vax 25APR97 & OCT97 pt devel varicella;pt had recovered;
Initial report received from a nurse (who is the patient's  mother) in the USA on 19, December 2006. A 15 year old, female patient experienced dizziness, three hours after she received 0.5 cc of Act-HIB (lot number UE994AB, route of administration not reported) in the left shoulder on 13, December 2006. The patient received the vaccine because her "titers were low" No fever was noted. On Friday, 15, December 2006, the patient was seen by a pediatrician. On Monday, 18, December 2006, she was seen by and ENT since the dizziness was still persisting. The patient continued to experience dizziness, severe headaches and nausea and was taken to the emergency room on Tuesday, 19, December 2006. In the ER, blood work was drawn and a CAT scan and MRI were completed; the results were not provided. The patient was treated with fluids and anti-nauses medication Phenergah and was released. As of 20, December 2006, the patient is still tired.
Arm felt heavy prior to leaving drug store but did not report to clinic worsening sx, joint pains, cramping, terrible headache, BP elevated, 102 temp, skin red and burning, eyes red and burning. Had shocky feeling. Ativan given in ER. After Ativan didn't feel 100% better until today. Weak feeling all over. Gave Rx Xanax, last night diarrhea but only once - feels 100% better today. 11/4/08-ED records received for DOS 10/15/08-presented with C/O tightness like band in chest since day before, shaking onset today, nausea, shortness of breath, dizziness and cough. Headache. Upper back and neck pain. Pedal edema.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, Pain/Redness/Swelling/Rash @ injection site Narrative:
within 24 - 48 hours: Malaise, fever, muscle pains, labored breathing, general weakness, bedridden
Patient instantly felt faint, dizzy, and cold upon administration. Blood pressure was taken immediately and had dropped to 65/47. Blood pressure taken a minute later with same result. We offered to call the ambulance for car and patient refused. Patient laid down on the pharmacy bench and started to feel better. Blood pressure was taken 5 minutes later and had risen to 95/67.  Patient sat down for 10 minutes and instantly felt better once she rest.
12 days post vax pt developed a red, raised, scabbed, pruritic rash only around the injection site.
Gross hematuria, nausea, swollen lymph nodes- supraclavicular and axillary, fever (102.3 F), fatigue, joint pain, headache, dizziness, abdominal pain.
Breakthrough case of Covid 05/21/2022 positive test date. Sx began 05/20/2022, I started to get really tired, it felt like I had a cold or allergies. I progressively got more and more tired, I slept for 12 hours and woke up on 05/21/2022 tired still. That afternoon after a nap I took a home test that was positive. That afternoon I spoke to the nurse from my insurance company and was prescribed PAXLOVID which I started on 05/22/2022. Sx were mainly tiredness, cough, possible fever in the nights but I was not able to document it. I never documented a fever, but I woke up sweating, but every time I took my temp it was fine. I still have a cough that is still hanging around, but it was a very mild case, it was not super bad.
Information was received from a medical assistant concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 16-MAY-2017, the patient inadvertently received a second dose of ZOSTAVAX (lot #M024700, expiration date 18-JUL-2017) (route of administration not provided), reconstituted with sterile diluent (MSD), after receiving the first dose of ZOSTAVAX in July 2016. No adverse effects reported. No additional information was provided. Additional information has been requested.
Rash started small area on my right arm (opposite arm of injection) - like eczema red; raised; itchy spot. As a couple of days went I got more and more spots. Sent pictures to my Dr - Pityriasis Roseola - Went to see dermatologist - he diagnosed me with the same thing (January 19th). He gave me cream for it - it was all over my entire body by the time I saw him. It was like a red petechiae rash over my whole body. I usd the cream as instructed per doctor. The following week on that Monday, I was short of breath and not feeling right and I worked. But next day I only worked a couple of hours and went home. I started having vomiting and diarrhea - I went to the ER twice - 1st time they diagnosed - Viral infection - and they discharged me and didn't give me anything but told me to rest and they pushed fluids. The second time I went - they gave me medication and they said it might help with the pain in my  abdomen. They didn't do much. I had gone to ER - was there for four and half hours waiting to be seen but didn't get seen. Two days after second ER visit - I went back to the hospital  on January 26 and was admitted for heart failure and that is when cardiac symptoms occurred.
Patient received dose two / late / First dose 12.28.20 - Second dose 4/23/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 28th December 2020).   On 23rd April 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported the patient received dose two of Twinrix longer than recommended interval, which led to lengthening of vaccination schedule. Lot number and expiration date for dose 1 of Twinrix were not provided. The reporter consented to follow up.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, subcutaneous, 0.5ml). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The patient is deceased; Nausea while eating; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (The patient is deceased) in a male 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Nausea while eating). The patient died on 11-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, NAUSEA (Nausea while eating) outcome was unknown.            No concomitant medications were reported.   It was reported that nausea would go away for a few hours and would come back while eating again. The patient was already in supplemental oxygen but was using more since he received the vaccine. The patient had been experiencing the events for four days.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal cannot be ruled out for the event of Nausea and is unlikely for the event of Death. The event of Oxygen therapy is invalid as it is a pre-existing condition.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 includes serious event death.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal cannot be ruled out for the event of Nausea and is unlikely for the event of Death. The event of Oxygen therapy is invalid as it is a pre-existing condition.; Reported Cause(s) of Death: unknown cause of death
Patient was brought to hospital by EMS was breathing and able to respond to some questions when leaving the facility
Approx 12 hrs after shot began with headache, fever:102.5, chills,ache, nausea, abdominal gas,.  Lasted with some fever for 4 days.  Back to normal after about a week. Treated first with acetaminophen at first.  Switched to ibuprofen after 2 days.
"Fever > 100.4:Y, 101.4evening past 3 nights. @ 8-9 pm. Subjective fever: Chills:Y Rigors:N Myalgias:N Headache:N Sore throat:N Diarrhea:N Nasal congestion/rhinorrhea:N  Additional symptoms:No rash No fatigue no dysuria Onset and duration: 3/3/2021"
Was standing in line 5-10 minutes after the injection making an appointment when she lost conciousness and suffered tonic clonic movements for 30 seconds and then did not respond completely with alertered conciousness.
Pt reported a lump the size of a quarter on the left side of her neck near the hairline, below her ear. Reporting occurred 12 days after vaccine; unclear when lump developed
I received the second dose on the Moderna vaccine on Thursday (4/22), and I had some bad symptoms the following day (yesterday, Friday, 4/23). I fainted twice when I tried to get out of bed and stand up. When I stood up, I got really nauseous, my face got hot, my vision went black, and my legs just gave out (I don?t think I hit my head)
Extreme fatigue, chills, fever. Started approximately 3 hours after second dose. Fatigue was intense for 36 hours.
Woke the next morning with hives, swollen lip and throat. My doctor prescribed methylprednisolone 4mg 21s and Benedril and I started taking Saturday afternoon. The next morning the hives and swelling had gone down
Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Dec2020 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Dec2020, the patient experienced headache, nausea, tiredness, injection site swelling and injection site pain. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache, nausea, tiredness, injection site swelling, and injection site pain were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Erythematous, macular rash on face temp to 104.7 Ax; taken to Hosp ER & later to MD office started on ATB; dx OM & tonsillitis & rxn to MMR; recovered in 2.5 days;
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 01-JAN-2014, 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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical facility for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
After my first shot I experienced mild left-ear tinnitus.  Three weeks later, I got my second shot.  The next morning I awoke with EXTREMELY LOUD tinnitus in both ears.  A few weeks later I had a 5-day course of oral steroids to see if it might help to resolve the tinnitus.  The right-ear tinnitus subsided some, but the left-ear tinnitus remains  to this day and is severe and life-altering.  I also developed hyperacuity/sensitivity to noise.  I have had a hearing test which verified hearing loss in my left ear.
pt recvd vax & start screaming & shaking for 6 hrs 24 hrs after vax; pt cont jerking x 1 mo; 01aug94 stopped breathing; was stiff; eyes rolled; called 911 ; 12aug94 turned blue; stiffened; progressed convuls; taken to ER;
1230 sitting in general observation area and is itching right arm. States she did not have any problems with the first dose. States she has her EPI pen with her for anaphylaxis reaction to bee stings. States she is not having any trouble breathing. Tongue examined and not swollen. Taken to private observation area. Noted red blotchy flat rash on right arm, neck, and front of chest. Itching constantly.  1232 gave Benadryl 25 mg, two tablets by mouth for itching. Husband is present.  1235 noting rash is progressing to left arm.  1240 HR 91, BP 166/88; O2 sat 99% on room air. Denies throat discomfort or itching in throat. Drinking water without difficulty.  1245 gave ice for itching. Mild redness noted bilateral thighs.  1255 BP 162/93; HR 72. No throat or tongue swelling. Respiration even/ regular.  Redness of rah subsiding, still itching but less. States she is anxious as well and thinks her BP may be from anxiety. Husband present and will be driving. Patient states this is nothing like her anaphylaxis and feels well enough to go home. Ambulated without difficulty to POV Rash redness subsiding
On 9/30/21 patient developed frequent emesis and inability to keep food/liquids down. She experienced some shortness of breath and was also febrile. The fever persisted through 10/2. This abdominal issue transitioned on 10/1 am to persistent abdominal cramping and frequent diarrhea which continued through 10/2. Bowel movements were multiple times/hour and abdominal pain was moderate to severe. On 10/2, the patient sought medical treatment in the Emergency Room. Investigation revealed concerns for free portal venous air, compromised intestinal perfusion, and suspected intestinal necrosis on CT scan with contrast. The patient proceeded to emergency abdominal surgery and an 8-10 inch section of ileum was found to be affected. This area was resected and an end to end anastomoses of the ileum occurred. The specimen was sent to the pathology lab. The patient's fever resolved following surgery with administration of ketorolac and perioperative antibiotics. A nasogastric tube was placed to suction and the patient was made NPO. This NG tube remained in place until 10/4 when feeding was reintroduced. The patient was discharged to home on 10/6 with 6 weeks lifting of restriction and prescribed enoxaparin and treatment doses. This is to be followed up by Hematology in 2 weeks after discharge. The patient is a breastfeeding mother who has a 3.5 month old infant. This unexpected severe complication occurred ~4 weeks after the patient received her second Pfizer Covid 19 vaccine on 8/27 on 10 after she received an influenza vaccine. On 10/11am this patient experienced severe abdominal pain, rapid breathing, and lightheadedness when attempting to stand. She described the pain as similar in severity to when she required surgery. She was transported by ambulance to the same hospital. A repeat abdominal CT scan with contract identified no source for the new onset increase in pain. She was readmitted to the hospital at the date of this report.
Case number PHEH2016US029292, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 47 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX Quadrivalent at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 20 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error (incorrect product storage).
pain Narrative:  swelling, pain, fatigue, swollen lymph nodes under left arm (symptoms lasted 4 days). nerve sensitivity all over body (lasted 24 hrs)