chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Hallucinating; Sick; Frozen shoulder; Being able to sleep only one to two hours; Soaking wet whit sweet; no appetite; Pain in the arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinating), ILLNESS (Sick), PERIARTHRITIS (Frozen shoulder), INSOMNIA (Being able to sleep only one to two hours) and HYPERHIDROSIS (Soaking wet whit sweet) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroiditis, Blood pressure and Cholesterol. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced HALLUCINATION (Hallucinating), ILLNESS (Sick), PERIARTHRITIS (Frozen shoulder), INSOMNIA (Being able to sleep only one to two hours), HYPERHIDROSIS (Soaking wet whit sweet), DECREASED APPETITE (no appetite), VACCINATION SITE PAIN (Pain in the arm) and PYREXIA (Fever). On an unknown date, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, HALLUCINATION (Hallucinating), ILLNESS (Sick), PERIARTHRITIS (Frozen shoulder), INSOMNIA (Being able to sleep only one to two hours), HYPERHIDROSIS (Soaking wet whit sweet), DECREASED APPETITE (no appetite), VACCINATION SITE PAIN (Pain in the arm), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter.   Additional treatment medication include were thyroid condition, a blood pressure condition and doctor recommended to stop using ice packs in the arm that is in pain, and start using hot Packs.  Company's comment:This case concerns am 86-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected event of hallucination. The event occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient had frozen shoulder, arm pain, unable to sleep, had no appetite and was hallucinating from the pain, chills and fever after the booster dose. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns am 86-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected event of hallucination. The event occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient had frozen shoulder, arm pain, unable to sleep, had no appetite and was hallucinating from the pain, chills and fever after the booster dose. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Systemic: Allergic: Difficulty Breathing-Mild, Additional Details: after injection moderna bivalent and flu shot, patient complained about chest discomport and breathing problem. called emergency services and help to have a deep breath for 1 min. patient was recovered in a few minuits and paramedic arrived and took care of her.
Pt chose to have both shots in the same arm.  She reports leaving pharmacy, going shopping and within an hour feeling very cold.  She says her temperature went up to 104.1 at the highest that first night hours after the immunizations.  She has been treating it with acetaminophen and it has come down some, but remains over 100 degrees.  She also reports feverish, red, painful area on arm at site of injections.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014, unspecified number of patients were vaccinated with a dose of ROTATEQ, (lot number, Expiry Date, dose were not reported), route default to oral, that was improperly stored in April 2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 2 weeks after receiving the vaccine I had extreme pain in my lower right pelvis area - it felt like it was in my right ovary.  The pain was sharp and intense and unrelenting. I went to urgent care but they didn?t do anything. The pain lasted about two or three evenings and was better during the day (more like a consistent dull ache). After about 5 days the pain went away and I have not had any pain since.
Chills, fatigue, myalgias and headache,  during the evening hours of 3/17/2020. Developed fever 103.2 on 3/19/2020
tenderness in left underarm/axillary area; lymph nodes tender; feeling tried; fever; having a headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-OCT-2023, the patient received the 2nd dose of Shingrix (left deltoid). In OCT-2023, 2 days after receiving Shingrix, the patient experienced lymph node tenderness (Verbatim: lymph nodes tender), tiredness (Verbatim: feeling tried), fever (Verbatim: fever) and headache (Verbatim: having a headache). On 29-OCT-2023, the patient experienced axillary pain (Verbatim: tenderness in left underarm/axillary area). The outcome of the axillary pain, lymph node tenderness, tiredness, fever and headache were not resolved.   It was unknown if the reporter considered the axillary pain, tiredness, fever and headache to be related to Shingrix. The reporter considered the lymph node tenderness to be related to Shingrix.     It was unknown if the company considered the axillary pain, tiredness, fever and headache to be related to Shingrix. The company considered the lymph node tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-OCT-2023 The reporter received her 2nd Shingrix vaccine and one day later she developed tenderness in her left underarm / axillary area.  The reporter believed her lymph nodes are tender due to the Shingrix Vaccine.  And also reports being feeling tired, having a fever, and having a headache 2 days after receiving her 2nd dose of Shingrix.  All symptoms are not resolved. The reporter consented to follow up.
massive pulmonary embolism; This is a spontaneous report received from a contactable physician. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (at age of 48 years old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient was not pregnant at time of vaccination. Medical history included asthma and menorrhagia. No past drug.  Concomitant medication(s) the patient received within 2 weeks of vaccination included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, start and stop date were not reported.  The patient experienced massive pulmonary embolism on 10Apr2021 with outcome of recovering. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for massive pulmonary embolism for 30 days.  catheter-directed thrombolysis received for event. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of pulmonary embolism due to temporal relationship.  However, the concomitant medication of ethinylestradiol, norgestimate may have contributed to the development of the PE.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including VQ scan, pulmonary angiogram results and coagulation panel, and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
PATIENT RECEIVED VACCINE AT 230PM, AROUND 240PM, SHE APPEARED PALE AND SWEATING. PT STATED SHE FELT AS SHE WAS GOING TO FAINT. FAINTED MINUTES LATER. PROVIDED A INSTANT COLD PACK TO COOL PT, PT WOKE UP AND LAID DOWN, WHICH SHE STATED HELPED HER FEEL BETTER. EMS ARRIVED TO EVALUATE PT, PATIENT LEFT 30 MINUTES OR SO AFTER THE EVENT ALERT AND FINE
Headache; Muscle pain; Chills; Nausea; Swollen lymph nodes; Decreased appetite; Dizziness; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: elo142), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: egg" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, single, lot number : EN5318, vaccine location: left arm), administration date: 10Jan2021, for Covid-19 immunization; Covid-19 vaccine (dose 2, single, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (dose 3 (booster), single, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); DECREASED APPETITE (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); DIZZINESS (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); HEADACHE (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); MYALGIA (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Muscle pain"; NAUSEA (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022); LYMPHADENOPATHY (non-serious) with onset 16Sep2022 at 06:00, outcome "recovered" (Sep2022), described as "Swollen lymph nodes". Therapeutic measures were taken as a result of headache, myalgia, chills, nausea, lymphadenopathy, decreased appetite, dizziness.  Additional information: The patient did not receive other vaccine in four weeks. Facility type vaccine was Public Health Clinic/ Administration facility. The patient received apap 1000 mg Q 6-8 hours, Pepcid treatment for AE. The patient did have covid prior to vaccination. The patient did have covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170341 Same reporter/ patient/ vaccine, different dose numbers/ events;
Member presented to staff immunizations with orders requesting Anthrax, and needed 2nd dose of HPV. Member received HPV in right arm and Anthrax in left arm at 1200. At 1203, pt stated he "wasn't feeling good". Member became pale, slid down into chair, and was unresponsive. Staff was called and became overseeing provider. 1207, pt vitals were taken with BP: 80/54 and HR: 57 with SPO2 98%. At 1208, pt began to wake up and respond fully. 1209, vitals retaken BP: 96/64 and HR: 73 with SPO2 at 99%. Pt states he is feeling much better, and has color returned to his face. Pt walked back to treatment room by staff for vitals and observation. At 1245 pt was discharged and went home with no complaints.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 16May2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Nov2021 as dose 3, (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "low hemoglobin (possibly mild Thalassemia)" (unspecified if ongoing). Concomitant medication(s) included: NUVARING; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks: Yes; Anti viral details: product=COVID 19 Treatment, treatment start date=02Jul2022, treatment stop date=06Jul2022, indication=Treatment of COVID-19. Other medication details, other medication in 2weeks product=Nuvaring, other medication in 2weeks product=B12 supplements. Known allergies: no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt started feeling weak, deep dry  cough 6 hours after vaccination,  pt took robitussin dm to help, fever low grade, increased fluid intake, muscle/joint aches , cough worsened, pt tried Mucinex to try and break up mucus if there was any,  sweats, next day mucus was beginning to loosen,  fever low grade, pt also had to take Aleve twice daily to help with symptoms, body aches, flu like symptoms
"feeling out of it"; Fatigue; Numbness in toes on both feet; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in toes on both feet), FEELING ABNORMAL ("feeling out of it") and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HYPOAESTHESIA (Numbness in toes on both feet). On 23-Feb-2021, the patient experienced FEELING ABNORMAL ("feeling out of it") and FATIGUE (Fatigue). At the time of the report, HYPOAESTHESIA (Numbness in toes on both feet) had not resolved and FEELING ABNORMAL ("feeling out of it") and FATIGUE (Fatigue) had resolved.            Concomitant medication not provided. Treatment medication not provided   This case was linked to MOD-2021-071488 (E2B Linked Report).; Sender's Comments:  MOD-2021-071488:
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient came in 10/10 and said she had rash on right arm--felt some burning--She went home and took a benadryl and said it was getting better and almost resolved.  patient did not call md
Minor denied sexual activity prior vaccination. MMR and Varicella were administered. A pregnancy test was performed and came back positive. Minor stated 9/12/22 was her LMP.
Gave a 2nd dose of Flulaval quadrivalent vaccine 12 days after 1st dose given on 10/13/2022
Chills, sneezing, coughing, sore throat, flu like symptoms.  Onset was the evening of 10/27/07 and was full blown by 10/28/07 in the evening time.  11/30/07 Reviewed ER hospital records which reveal patient experienced nausea, abdominal cramping pain, sore throat & bilious vomiting.  Seen in ER on 11/1 & dx w/viral syndrome, d/c to home.  Symptoms continued to worsen & developed cough, congestion, diarrhea & returned to ER.  Exam revealed hypotension & dehydration.  Admitted 11/2-3/2007.  Tx w/IVF & pain meds. FINAL DX: no d/c summary available.  D/C date obtained verbally.  Nausea & vomiting.  Non-obstructive left ureteral stone.
Got the shot but he got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot but he got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that the patient got the shingles shot which was 90 percent effective but he got shingles within 6 months.  The reporter further stated that she believed this was rare, fortunately. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
The morning after receiving the vaccine (06/18/2009) she woke up with severe body aches, felt like the flu, and Rt. deltoid warm and tender to the touch. The next day she noticed a raised rash distal to the injection site on the deltoid and still warm to the touch for three days following that. All symptoms gone as of 06/21/2009
patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 4:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was 64.67 years. Concomitant products were not provided.  On 20-MAR-2021, Excursion time was 9 AM, temp was 34 , total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were moved to clinic. Vaccine BUD date was 08-Apr-2021.  Vial was stored on cooler 1 , on 27-FEB-2021, Excursion duration At  9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4 PM: 40 and 5PM: 43   It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a Doctor of Pharmacy concerning his approximately 8 month old daughter, a twin born premature, who in approximately November 2007, was vaccinated in the leg with a dose of COMVAX (lot 657380/0377U). The patient was concomitantly vaccinated with unknown multiple vaccines at the same office visit. Subsequently, the patient developed a red area at the injection site that lasted 4-5 days. Subsequently, the patient recovered. Additional information has been requested.
Pt reported exposure to Covid + person, reported symptoms starting 7/17/2021, unknown what symptoms experienced.
I had been taking an antibiotic (Biaxin XL) for 2 days because of a throat infection. I mentioned this to the nurse before she gave me a Hep-B shot and shed said that was no problem. I started to feel sick that afternoon and stopped taking the Biaxin XL. Two days after the shot, I became very weak, itchy, very dark urine, had no appetite, very sick. Lasted 10 days. Blood work revealed that I had hepatitis.
10:50  Pt c/o "severe itching", mostly on extremities, but some "mild itching" on tongue. Denies shortness of breath, difficulty breathing throughout episode, observed unlabored breathing, appropriate verbal responses
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 13-year-old female subject who was vaccinated with Engerix B for prophylaxis. Prior vaccinations included Engerix B for prophylaxis given on 02 February 1999, 05 March 1999 and 10 September 1999. In November 2006, 7 years after these vaccinations with Engerix B, the subject did not have antibodies to Hepatitis B. On an unspecified date within or after November 2006, the subject received a 4th dose of Engerix B (20 mcg). On 14 May 2007, at an unspecified time after vaccination with the fourth dose of Engerix B, the subject's Hepatitis B antibodies test were again found to be negative. At the time of reporting the event was unresolved.
Our office did NOT administer the vaccine She received the vaccine at another location and 2 months later mad me aware of her symptoms as follows: The same day of her first vaccine, she had visual changes (half of her face looks very yellow)   and auditory (hearing a  radio). Subsided after a few hours. No further symptoms or changes  She did not notify me at the time so we did not have OV or eval dedicated to this