chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of blood sugar increased in a 56-year-old male patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. Concurrent medical conditions included diabetes. On 8th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th February 2019, less than a day after receiving SHINGRIX, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was not recovered/not resolved. It was unknown if the reporter considered the blood sugar increased to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in right deltoid. The pharmacist reported that the patient had trouble to keep his blood sugar under 300 units. The patient followed-up with his physician.
Fainting (witnessed) the morning after the vaccine.  Vaccine was given at 1330 4/20/2021, fainting occurred the following morning at 0830. Difficulty sleeping
Had preschool immunizations 06/07/04, next day site left arm (face of muscle) about 1 day after had redness, warmth, shoulder to elbow, gone by 4 days.
Information has been received from a pharmacist, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included an sterile diluent(manufacturer unknown). On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N007930 with expiration date on 08-MAR-2019 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 35 Fahrenheit (F) during a time frame of 30 hours. It was also reported that previous temperature excursions occurred of 22 F during 22 hours and a digital data logger was involved. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA005581: US-009507513-1709USA008139:
Fevers x2 days, poor appetite, eyes burning.  Patient received IPV & DTAP on Left Deltoid.  Site of injection is swollen, hot to touch, area not hard; is reddened.  Patient not acting same, less active 05/16/2003.
Hurt arm/little sore legs; Knees getting up and down; Hardy wake from the bad; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurt arm/little sore legs), MUSCULOSKELETAL DISCOMFORT (Knees getting up and down), FATIGUE (Hardy wake from the bad) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FLUOXETINE and DULOXETINE for an unknown indication.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Fever). On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Hurt arm/little sore legs), MUSCULOSKELETAL DISCOMFORT (Knees getting up and down) and FATIGUE (Hardy wake from the bad). The patient was treated with PARACETAMOL (TYLENOL) for Pain in extremity, Discomfort in joints, Fatigue and Fever, at a dose of 1 dosage form. On 14-Mar-2021, PYREXIA (Fever) had resolved. On 15-Mar-2021, PAIN IN EXTREMITY (Hurt arm/little sore legs), MUSCULOSKELETAL DISCOMFORT (Knees getting up and down) and FATIGUE (Hardy wake from the bad) had resolved.            Concomitant medications also included CHOLESTEROL MEDICATION and HIGH BLOOD PRESSURE MEDICATION.   This case was linked to MOD-2021-046214 (Patient Link).
On 6/8/01, 1 day post vaccine, the pt developed redness and swelling at the injection site and was admitted to the hospital with cellulitis. The MD reported that 3 other pts had received vaccinations from the same vial w/out incident. Cultures done were positive for infection. As of 6/12/01, the pt remained hospitalized. On 6/14/01, the MD reported that there was only 1 positive blood culture (previously reported as 2) showing bacterial growth. As the growth was now identified as coagulase negative staph aureus and the concurrent WBC count was only 5.300, this was regarded as a contaminant. Therefore, there are no positive blood cultures. It was reported that the pt was discharged from the hospital and was placed on oral cephalexin (Keflex). The reporter expressed a concern with the lot #. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Addtl info has been requested. Follow-up info indicated that the pt was hospitalized from 06/08/2001 until 06/13/2001 with a discharge diagnosis of cellulitis. Subsequently the pt recovered. It was reported that the physician was not convinced that the pt's diagnosis was associated with pneumococcal vaccine 23 polyvalent. No further info is available.
The injection site is raised, red, warm, swollen, and hard. It just happened, and therefore, I have not recovered as yet. I am going to try putting ice on it.
Swollen Arm; Arm Hurt; Bruise at site of shot; muscle aches; Rash in arm; Body Chills; Nausea; Fever; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Swollen Arm), PAIN IN EXTREMITY (Arm Hurt), INJECTION SITE BRUISING (Bruise at site of shot), MYALGIA (muscle aches) and INJECTION SITE RASH (Rash in arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypersensitivity. Previously administered products included for an unreported indication: Influenza (reaction- high fever for several days, throwing up and body aches) in 2014. Concurrent medical conditions included Autoimmune hypothyroidism since 2018, Hashimoto's disease since 2018, Fatigue (Using energy med from doctor (started in last few weeks)) since 2020, Chronic sinusitis since 2008, Skin rash (Poison ivy spread and blistered over a month over both arms) since 04-Jun-2021, Skin rash (tick bite caused rash for up to 6 inches for about a week) since 28-May-2021, Drug allergy and Drug allergy. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (ORTHO TRI-CYCLEN) for Birth control, LEVOTHYROXINE for Thyroid disorder NOS.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen Arm), PAIN IN EXTREMITY (Arm Hurt), INJECTION SITE BRUISING (Bruise at site of shot), MYALGIA (muscle aches), INJECTION SITE RASH (Rash in arm), CHILLS (Body Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen Arm), PAIN IN EXTREMITY (Arm Hurt), INJECTION SITE BRUISING (Bruise at site of shot), MYALGIA (muscle aches), INJECTION SITE RASH (Rash in arm), CHILLS (Body Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Ice pack and cream for rash were used for treatment.   This case was linked to MOD-2021-118796 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non-Significant Follow up Appended - NNI.
Fever 103F (oral) 06:00 on 4/26/06. Rash, urticaria all over torso, limbs with little change 4 hours after 50mg Benadryl. Onset about 02:00 on 4/26/06. Treated with 5 days of Prednisone due to severe "itching" with the rash. History of Pertussis Reaction as infant, OK after DT, MMR, OPV, Hep-B.
5 year old male seen 11/19/05 for well child exam. Exam included DTaP and Influenza vax in right upper outer arm. Plus left arm IPV, MMR, Pneumoccol 23 vax. 11/21/05 seen for redness and blistering right arm 11/22/05. 5 x 3 cm area of blistering 10 x 10 area of heat, redness and swelling.
A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving FLUMIST. FLUMIST started on 06-Dec-2012. The patient experienced INADVERTENTLY GAVE EXPIRED FLUMIST TO PATIENT which started on 06-Dec-2012. The outcome of the event of INADVERTENTLY GAVE EXPIRED FLUMIST TO PATIENT is unknown. Inadvertently gave expired FLUMIST to three patients. The report was considered to be non-serious.
Vomited; Hot or dying of heat; Weakness; could hardly stand up; Cold or freezing; 2nd dose received 11th August 2020; Headache; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 17th January 2020, for tolerance refer US2020158083).   On 11th August 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th August 2020, less than a day after receiving Shingrix, the patient experienced asthenia, difficulty in standing, feeling cold and drug dose administration interval too long. On 12th August 2020, the patient experienced vomiting and feeling hot. In August 2020, the patient experienced headache. On an unknown date, the outcome of the vomiting and drug dose administration interval too long were unknown and the outcome of the feeling hot, headache, asthenia, difficulty in standing and feeling cold were recovering/resolving.   It was unknown if the reporter considered the vomiting, feeling hot, headache, asthenia, difficulty in standing and feeling cold to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left deltoid. The patient received 2nd dose of Shingrix and on same day and weakness as in she could hardly stand up and Cold or freezing. The patient received 2nd dose which was recomended her in past month which led to lengthening of vaccination schedule.  On 12th August 2020, the patient was hot or dying of heat and she vomited. She then took a nap and felt better. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020158083:same reporter
Information has been received from a physician concerning a male in his early 60's with pertinent medical history and drug reactions/allergies reported as unspecified who on an unspecified date was vaccinated with Pneumovax 23 (lot #651400/0618F).  Concomitant medication was reported as unspecified.  Subsequently on an unspecified date, the physician reported that the patient experienced "swelling in the entire arm" after Pneumovax 23 was given.  Subsequently on an unspecified date a couple of days later, the patient recovered from swelling in the entire arm.  Additional information has been requested.
w/in 24hr pt exp body aches, fever (no temp taken by parent) swelling of upper arm w/redness & tenderness;inc sleeping;
very bad arm and leg lump getting bigger and bigger; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). This female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 on an unspecified date for COVID-19 immunization. Patient experienced very bad arm and leg lump getting bigger and bigger after taking the 2nd dose of the vaccine last Tuesday (Jan2021). Outcome of the event was unknown.  Information about lot/batch number has been requested.
3 days post immunization pt. c/o wheezing with exhalation.  The Monday following 11/10 she came down with flu-like symptoms + fever 101 degrees.  She saw her personal physician given Z Pack.  2 additional episodes in December + January treated with Z-Pack + OTC cold med CXR-negative in February.
Body/Joint ache,  Red hives, very itchy arms, legs, ankles, swollen face, hands, feet. Injection site stung after shot.
Patient c/o dizziness, presyncopal symptoms and paleness.  Patient exhibited s/sx of vasovagal symptoms. 1458: BP 98/64, HR 62 and SPO2 98%; 1503: 92/54, HR 58 and SPO2 98%; BP: 108/72, HR 70 and SPO2 98%
Pt recv vax on 10/15/98; on 10/17/98 pt exp hot, red area of vax site.
Suspected vaccination failure'; got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and a few months later got the shingles. The patient further stated that it was awful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Parent reports ongoing, intermittent headaches and dizziness since child received HPV 9 (8-30-2017).
I HAD COVID IN NOVEMBER AND HAD A FEVER FOR 10 DAYS AND AN ACHY BODY. WHEN I GOT THE VACCINE I HAD THE SAME SYMPTOMS FOR 2 DAYS AND FELT TIRED FOR ANOTHER 2 DAYS
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash very itcy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash very itcy). At the time of the report, RASH PRURITIC (Rash very itcy) had not resolved. Concomitant medication use was unknown. Treatment information was unknown. This case was linked to MOD-2021-193828.
Swollen arm, red, hot, burning sensation, a few small red spots all on cheek and face; very achy joint in replaced knees and hip, chills, headache.
heart is messed up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart is messed up". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266051 same patient/vaccine/event, different vaccine dose;
pt recvd vax for prophylaxis & devel discomfort in arm,neck & shoulder;2 wks p/ vax exp n, abdominal discomfort w/out association of v;pain extended to elbow & to trapezius; tx:observation only;no subsequent problems;
PT states she felt itchy and light headed before she developed rash on her arms legs and face. PT took Benadryl 25mg to relieve the itching but symptoms just progressed.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 29-MAY-2014, the patient was vaccinated with ZOSTAVAX at a pharmacy  as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-SEP-2015, the patient was treated by physicians assistant at urgent care clinic for a vesicular outbreak that was diagnosed as severe shingles. 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, pain and suffering, and other damages.  The outcome of shingles was not recovered. Additional information has been requested.
Booster dose of Pfizer monovalent vaccine (0.3mL) was administered instead of Bivalent booster. Patient contacted to come back and receive Bivalent dose in 2 months per head of Immunization Dept. Scheduled to come back 2/2/23
This spontaneous report was received from a nurse practitioner via a company representative referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patients started GARDASIL series with GARDASIL (strength, dose, route, lot # and expiration date were not reported) for prophylaxis and completed the series with GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (Interchange of vaccine products). No adverse symptoms reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 77 year old female with hypertension, diverticulitis, osteoporosis, arthritis, and a sulfa allergy who at 1:15pm on 1/4/06 was vaccianted intramuscularly in the left arm with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Concomitant therapy included alprazolam Xanax, amlodipine besylate Norvasc, Telmisartan Micardis, ranitidine HCL Zantac, risedronate sodium Actonel, vitamins and acetaminophen Tylenol. Approximately 15 to 20 minutes after injection, the arm became tingling and itchy. Within a hour of vaccination, the patient developed swelling, hardness, redness and itching to her upper left arm. On 1/5/06 the patient went to the ER with worsening symptoms. There she was diagnosed with cellulitis and was treated with levofloxacin Levaquin. the patient was evaluated in the physicians office on 1/9/06. At that time, her left inner upper arm was red, warm, swollen and hard down to her fingers. Doppler studies completed on 1/9/06 were negative. Impression, No evidence of acute deep venous obstruction of the left upper extremity. The physician discontinued levofloxacin and started the patient on Cephalexin Keflex 500mg twice daily. The nurse reported that the patient was seen in follow up on 1/11/06. The patient still had a small red bump at the injection site, but was considered recovered from the event. Additional information received via medical records indicated that the diagnosis at the ER included hypersensitivity reaction of the left arm. The patients cellulitis was considered an other medical event (OMIC). No additional information is expected.
Hospitalization for acute exacerbation of COPD, Acute hypercapnic respiratory failure, COVID positive on dates 7/25/2023- 7/30/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
SHINGLES(NEVER HAD IT EVER)..THE DOC SAID IT WAS THE WORST CASE HE HAD EVER SEEN
diarrhea; Vomiting; sore throat; sore shoulder; sore neck; blood in her diarrhea; feeling icky; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8735), administered in left arm, on 28Apr2021 at 13:00 (at the age of 20-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included bipolar disorder, bipolar depression, anxiety and depression. Family medical history relevant to the adverse events was reported as none. Concomitant medications included ongoing citalopram (provided as CELEXA, clarified that she took the generic citalopram) taken from an unspecified date (has been taking for about 4 years, as reported) at 40mg orally daily for anxiety and depression, ongoing lamotrigine (provided as LAMICTAL, clarified that she took the generic lamotrigine) taken orally from an unspecified date (had been taking for 2-3 years, as reported) at 150mg twice daily for bipolar disorder, ongoing lithium taken orally at 300mg twice daily for bipolar depression. No prior vaccinations (within 4 weeks) were received, no history of all previous immunization with the Pfizer vaccine was considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. The patient experienced blood in diarrhea and sore neck on 30Apr2021, diarrhea, vomiting, sore throat, sore shoulder on 30Apr2021 at 01:00, feeling icky on 29Apr2021 at 18:00. The events did not require emergency room and/or physician office visit. The reporter stated that the patient was fine until 29Apr2021 around 6 pm when she started feeling icky. She woke up at 1 am with diarrhea and vomiting, sore throat and sore shoulder. The patient was having blood in her diarrhea. The last time she threw up was around 7:30. Her daughter developed a sore throat and sore shoulder late last night of the reporting day or early the morning of the reporting day. Reporter added that her daughter also had a sore neck that started late last night of the reporting day or early the morning of the reporting day. No relevant tests were performed. The patient had not recovered from diarrhea, sore throat, sore shoulder and sore neck, had recovered from vomiting on 30Apr2021 at 07:30, the outcome of the other events was unknown.
ringing in his ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in his ears). At the time of the report, TINNITUS (ringing in his ears) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment product information was not provided.  Concomitant product use was not provided.