chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen and tendered arm; swollen and tendered arm; nerve pain; sore gut; blisters due to shingles; Severe case of shingles; abdominal pain; kidney pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Severe case of shingles) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 08-Apr-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 19-Apr-2021, the patient experienced HERPES ZOSTER (Severe case of shingles) (seriousness criterion medically significant), ABDOMINAL PAIN (abdominal pain) and RENAL PAIN (kidney pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen and tendered arm), TENDERNESS (swollen and tendered arm), NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles). At the time of the report, HERPES ZOSTER (Severe case of shingles), ABDOMINAL PAIN (abdominal pain), RENAL PAIN (kidney pain), PERIPHERAL SWELLING (swollen and tendered arm) and TENDERNESS (swollen and tendered arm) outcome was unknown and NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles) had not resolved. Not Provided          No concomitant medications were reported. On 20APR2021, patient went to the emergency room. Patient is currently taking famciclovir 500 mg for his symptoms.  Company comment This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-81574, MODERNATX, INC.-MOD-2021-089399 (E2B Linked Report).; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-81574:Wife case MODERNATX, INC.-MOD-2021-089399:Husband case
Report received from a pharmacist on 10-Dec-2009. A 74 year-old female patient received H1N1 on approximately 07-Dec-2009. On 10-Dec-2009, 3 days after vaccination, the patient developed chest pain, weakness of the lower extremities, and transverse myelitis. The patient was hospitalized on 10-Dec-2009. Awaiting further information.
Received Dtap and Varivax on 3-4-2008.  Patient went to ER via ambulance on 3-14-2008. Triage assessment states Fever x 1 day (102.3 @ home). Febrile seizure. Per mom lasted 5 min. Pt turned blue. Pt now alert. Tested ordered are: CXR, CBC w/diff, CRP, UA, RSV and influenza screen & blood cultures.  CXR neg, UA normal, negative RSV & influenza A & B, CRP 1.3, blood cultures pending.  Dx Acute febrile illness and Febrile seizure. Pt had follow up appointment 3-15.  Dr ordered strep screen, all negative. Note- patient had prior febrile seizure on 2-8-2008. Had gone to ER and dx given was influenza and febrile seizure.
BACK OF THROAT FELT SWOLLEN, SCRATCHY/ITCHY AFTER 30-45 MINUTES (BENADRYL 25 MG AND COLD DRINK HELPED) AFTER 4-5 HOURS, DEVELOPED ABDOMINAL CRAMPING, NAUSEA, MUSCLE/BODY ACHES, FATIGUE, LIGHT-HEADEDNESS (TOOK ZOFRAN AND TYLENOL FOR SYMPTOMS)  THROAT FELT BETTER AFTER A FEW HOURS; OTHER SYMPTOMS LASTED 3 DAYS; STILL EXPERIENCING FATIGUE/WEAKNESS ON DAY 4 BUT GENERALLY FEELING BETTER OVERALL
Migraine; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 09:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy (PCN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified birth control medication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 07:00, the patient had a 48-hour (as reported) migraine 5 days after the shot. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included a chiropractic adjustment. The clinical outcome of the event migraine was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Chills, sore arm, coughing, muscle pain, nausea, headache, extreme fatigue
rash outbreak on his face which spread down to both his arms and legs.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 18-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after the vaccination (approximately in 18-NOV-2015), the patient suffered a rash outbreak on his face which spread down to both his arms and legs (widespread rash). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition.  The outcome of the event was considered unknown.  The event was considered related to zoster vaccine live (ZOSTAVAX).  Widespread rash was considered to be disabling.  Additional information has been requested.
neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain and swelling in arm pits.  currently have increased paresthesia arms, hands, legs and feet
Information was received on 15-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 16-SEP-2009 at a medical facility, 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 16-DEC-2013, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir (manufacturer unknown) for management of her painful breakouts. 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. Additional information has been requested.
Second booster of covid vaccine was given at 11:55am on 4/11/22. Swollen lymph nodes in left armpit first noticed early morning on 4/13/22. Swelling gradually worsened and lymph node gradually increased in size all day 4/12 and 4/13. Throbbing pain in upper left arm began around noon on 4/13/22 as well.  Went into the doctor's office today (4/15/22) and was diagnosed with Lymphadenopathy caused by my covid vaccine.
patient developed a pericardial effusion post vaccination; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: PERICARDIAL EFFUSION (medically significant), outcome "unknown", described as "patient developed a pericardial effusion post vaccination". The patient underwent the following laboratory tests and procedures: Biopsy: patient developed a pericardial effusion, notes: Physician reports that his patient developed a pericardial effusion post vaccination. They have done a biopsy and he is getting paperwork for some possible compensation.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new 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.
Rashes developed on chest one day after the Modern bivalent Covid booster shot. Doctor confirmed shingles due to reduced immunity.  All symptoms of shingles developed after the doctor visit including clusters of rashes on one side of upper body, painful blisters filled with liquid, sensitive skin, stabbing pain etc. Now on medication, Valacyclovir 1 gm, for the fourth day.
60 hrs after receiving 2nd Moderna vaccine, rash began to emerge all over body from head to toe including palms & webs of fingers, arms, legs & trunk of body. The rash was extremely itchy & since this happened on wknd, took doses of  chlortrimaton every 4 hrs for 3 days until new rash sites stopped erupting.
Weakness; Dizziness; anxious; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness) and ANXIETY (anxious) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD, Emphysema and Reye's syndrome. Previously administered products included for Product used for unknown indication: Flu shot (Previously he had worse reaction to Flu shot). Past adverse reactions to the above products included Adverse reaction with Flu shot.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness) and ANXIETY (anxious). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness) and ANXIETY (anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
A physician reported that a 2 month old infant received an injection of Prevnar (first dose) on 11-OCT-2001. Subsequently, the pt was hospitalized and on 14-OCT-2001, the infant died. No further information was available at the date of this report. This is 1 of 2 pts from this facility who died after receipt of Prevnar lot 475-385. Cause of Death as per autopsy report was SIDS. Initial autopsy showed no cause of death. Final results were not received. The reporter noted that this was the healthier twin.
Local site reaction, approximately 1 and 1/2 inch redness, hot and swollen.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI SADDLE PULMONARY EMBOLISM ACUTE DVT OF LEFT FEMORAL VEIN ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 9/16/2022,  9/20/2022,  11/24/2022,  3/13/2023 -- RECURRENCE OF SAME SYMPTOMS
SEVERE UNRELENTING EXTREMELY LOUD TINNITUS RATING 8 TO 10 ON A SCALE WITH EPISODES OF HEAD AND EAR PRESSURE FOR THE FIRST 7 MONTHS AFTER THE INJECTION FOLLOWED BY CONTINUED EPISODIC HEAD AND EAR PRESSURE AND CONTINUED TINNITUS OF  VARIABLE VOLUME RANGING 3 TO 6 ON A SCALE OF 1 TO 10.   IT IS NOW 14  MONTHS POST VACCINATION.   TREATED WITH SOME STEROIDS WITH NO EFFECT.
15 minutes after vaccination. Pt complained of bilateral lower forearm itching. Pt was further assessed and monitored for 1 hour. No signs of redness, swelling or hives were noted during the time-frame. No reports or signs of itching anywhere else on the body. Pt given PO diphendyramine 20 mL.  Followup 8 hours later pt reports almost all symptoms gone and still complaining of slight itching. Pt's mother reports only in lower bilateral forearms.
Congestion; Cough ongoing; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Aug2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 23Aug2021 at 10:30, the patient experienced congestion and cough ongoing. The events resulted in doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 01Sep2021, the patient underwent COVID test via nasal swab and the result was negative. Therapeutic measures were taken as a result of events which included treatment with unspecified antibiotic for bacterial infection. The clinical outcome of the events congestion and cough ongoing were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a consumer concerning her 60 year old female friend with no pertinent medical history who on 24-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Additional suspect vaccination administered at the same time included pneumococcal 23v polysaccharide vaccine (MSD). The patient had a respiratory illness the day she received the vaccines. Subsequently, on 25-MAR-2008 the day after vaccination the patient became very sick with a fever, malaise and soreness in her arm. It was unspecified if medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information is not expected.
Fatigue, nausea, dizziness, heart palpatations, afib. Went to bed: took baby aspirin and heart medicine.
Attendee received vaccination at about 04:30 and was sitting in observation area. At 4:43, attendee waved to observer that she was feeling like she was going to throw up.  Several staff members assisted attendee. EMT present on site and were summoned and were at attendees side within  1-2 minutes. Attendee having dry heaves, coughing, c/o of feeling hot. Vital signs at 4:45pm--temp 98.2F, pulse 112, resp 20, blood pressure 135/92, O2 sats 99-100% on RA with mild scattered wheezing. EMT continued with evaluation of attendee and moved attendee to ambulance, started at IV and administered 50mg Benadryl IV, and albuterol 2.5ml inhalation x2. Attendee then transported at approximately 5:00pm  to Hospital and presented to waiting room ED.  EMT reported attendee left in waiting room in good condition and waiting to see dr.  At 5/1/2021, 11:38am, this writer called attendee to check on her status, left message to please return call.
9:22 Reported to observer felt heaviness in chest; transferred to care tent; VS:  BP: 122/72 Left arm  O2: 95% on Room Air;  Temp:  98.0 temporal; HR: 92; Rapid response called; while waiting reports difficulty catching breath but able to speak through interaction; transferred to ED at 9:37; outcoume unknown;   HX of Covid in April 2020
received the second Covid vaccination and developed immediately blood in their hands and fingers underneath the skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 Immunization. The following information was reported: HAEMORRHAGE SUBCUTANEOUS (medically significant), outcome "unknown", described as "received the second Covid vaccination and developed immediately blood in their hands and fingers underneath the skin". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201046298 Same reporter/product/event, different patient;
5 days afterwards  i had a grandmal seizure  for unknown cause.  No history of seizures.  No symptoms prior to this event.
Patient received the booster on 10.29.21. Patient said he had extreme fatigue, loss of taste, shortness of breath, and chills the following evening. Patient was tested for COVID at PCP visit on 11.1.21, negative test. Patient is still experiencing SOB today (11/4), but says it has improved.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history, concurrent condition and concomitant medications were reported. On 09-APR-2018, the patient was vaccinated with improperly stored dose of PROQUAD (lot # N025718, expiry date 17-MAR-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (lot number and expiry date unknown). No adverse effects reported. The vaccine was exposed to the temperature of -14 degree Celsius to -10 degree Celsius (-10.5 degree Celsius) for 1 hour. Previous temperature excursion included exposure to -9 degree Celsius to -8 degree Celsius (-6 degree Celsius) for 1 hour. A digital data logger was involved. No product quality complaint was present.
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by a physical therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up was received and included no significant information
Clinical dx varicella made 1/2/12 but sx onset was on 12/30/11. Child had been IZ'd on 12/5/11 & started chemo for undifferentiated sarcoma of (R) orbit on 12/7/11. Started with fever 1/1-1/2/12, classic rash, PCR (+) VZV. Treated with acyclovir 1/2-7/12.
an expired dose of PENTACEL was administered to a patient with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient of unknown age and unknown gender and it was reported an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant and family history were not provided.  On 08-Mar-2023, an expired dose of 0.5 mL of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] suspension for injection (1X; batch/lot number: UJ658AAA and expiry date: 31-Jan-2023; strength, route: unknown) in unknown administration site for immunization was administered to a patient with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Day 1, 2 and 3: chills, body aches, weakness Day 2, 3, 4 rash of small read raised bumps on entire back and buttock.  It started on sacrum area first across to each posterior superior iliac spine but then migrated up back.  Rash is extremely itchy.
cried for 3hr, erythema & induration of thigh;never sought med care until 18DEC97;
started having generalized weakness on 1/21/21, fatigued., nausea/vomiting.  went to doctor on 1/25/21 with complaint of sore throat, cough, and felt congested.  Went to ER on 1/25/21 with complaints of increased shortness of breath, worsening nausea and vomiting.  started on oxygen for sats of 87%.  admitted on 1/25/21.  On 1/26/21 needed intubated, CXR showed worsening consolidative change right lung at right hilar level. Echocardiogram showed ejection fraction 35-40%, left atrium is moderately dilated.
I had a sore throat, sinus pressure, eye and ear pain, a little cough, low grade fever of 99.8, and a lot of mucus. I tested positive for COVID-19 at home. I texted my doctor and she prescribed me PAXLOVID.