chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a 8 week old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 10-OCT-2018, the patient was vaccinated with improperly stored doses of ROTATEQ lot number: N030150 (expiration date: 29-AUG-2019), orally, for prophylaxis (strength, dosage and frequency were not provided) and PEDVAXHIB lot number: N031492 (expiration date: 02-MAY-2020), for prophylaxis (strength, route, dosage and frequency were not provided). There was digital data logger involved. No adverse effects were reported. The storage characteristics were the following: Temperature: 0°C to 1°C (0.9°C) for 30 minutes. Previous temperature excursion: 0°C to 1°C (1.4°C) for 7 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA003268.
No additional adverse effect reported.; patient was administered an expired dose of GARDASIL 9.; This spontaneous report was received from a medical assistant referring to a 12 years old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not provided.   On 21-JUL-2020, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N023952, expiration date 12-JUL-2020, strength, exact dose and route were not provided) for prophylaxis. No additional adverse effect reported.
1208 Patient received vaccine and was in her 15 min. wait  time when she began to taste a metallic taste and flushing skin / hot flashes.EMS was on site and present with the patient. 1208-  147/85,81,20, 97%. rescue drugs were not given.  1217 -147/78,84,18. 97% patient feeling better and symptoms resolved. 1225-  147/85,85,89,18,98%. Again all symptoms have resolved. Patient was released and instructed to call 911 if symptoms come back.
Patient begun having flu like symptoms the evening of getting the vaccine, and had an episode of syncope.
Fever, Stroke like symptoms,   Sent to hospital for evaluation, admitted.  (In house hospice)
2 days after varicella and Menactra developed red, indurated, hot 14cm x 7cm area at area of chicken pox vaccine. Subjective fever reported. Started on Keflex 500mg BID x 10 d.
pt recv vax on 27MAY94 & since then tremors are more visible & ankles are more affected & pt seems to tire earlier;
I got my shot around 345 pm on 3/13/21. I didnt have any pain until I woke up at 12:30am on 3/14/21 with head, back and shoulder ache which lasted all day even after taking Tylenol until going to bed at 11pm on 3/14/21.  I woke up on 3/15/21 with no pain at all.
14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    Concomitant product use was not provided by the reporter.  It was reported 14 doses of the Moderna COVID-19 vaccines were administered after the 30-day BUD between 15-May-2023 to 10-Jun-2023. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 9th out of 14 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1808USA002487: US-009507513-1808USA002489: US-009507513-1808USA002490: US-009507513-1808USA002491: US-009507513-1808USA002453.
Office Visit 5/22/2021 Urgent Care - town Med Asst Encounter for screening laboratory testing for COVID-19 virus Dx Progress Notes Med Asst (Medical Assistant) ? ? Encounter Date: 5/22/2021 ? ? Signed    Patient being seen for loss of taste and smell. States that he has received both of his COVID vaccines, but recently started having symptoms. Requesting COVID test but does not wish to see provider today. Patient was swabbed for COVID and order placed in chart. Patient aware that results will be back in 24-48 hours and that he can view these on the portal. No questions or concerns at this time.
Measles like rash. Fever and headaches and abdominal pain taking its course like 4 weeks after vaccination
Patients lymph node under armpit got swollen day after shot. She got the shot on Friday 11/19/2021 by monday it was feeling better. Pharmacist spoke to patient said it was a normal reaction some people get with vaccines and to check with her prescriber just to make sure everything is ok.
Throat feels tight upon breathing; This is a spontaneous report from a non-contactable pharmacist (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular, administered in Left Arm on 09Mar2021 (Batch/Lot Number: en6199) as dose number unknown, single for covid-19 immunization. Medical history included ongoing anxiety. The patient was not pregnant at vaccination. Facility where the most recent COVID-19 vaccine administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included alprazolam (XANAX) taken for anxiety; start date and stop date was not provided. In 2021 the patient experienced throat feels tight upon breathing. The patient was not hospitalized. The outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
Two weeks prior to 03/20/2010 started with fever, weakness, fatigue took acetaminophen & ibuprofen, tested for mononucleosis and negative for Hepatitis A, B, C, weakness progressed to paralysis in legs, arms, hands admitted to Medical Center. Required respirator, feeding tube, 6 plasma removal treatments. Diagnosis Guillain-Barre' Syndrome. 9 days in intensive care, 3 day regular hospital care, 4 weeks in rehab.
pt recvd MMR vax on 14AUG91 & devel a rash on 23AUG91; no further details were provided;
Injection received in left upper arm.  Injection site was quite low on the arm.  Redness, swelling, and warm to touch.
On 11/22/06 client developed hives on left cheek red raised area, very itchy, she had stated she was very stressed at her job, on 11/23/06. Woke up to find approx 10-12 water blisters that broke open and oozed. Cleansed area with Bactine and applied Benadryl cream and antibiotic ointment. 11/27/06 areas are drying up and fading client did not see doctor.
Adverse event:  Guillain-Barre syndrome presenting on 11/18/2004 in conjunction with Beta-hemolytic streptococcal pneumonia.  Individual was also post-op from craniotomy for meningioma on 11/09/1998 and had been continuously treated with IV Decadron and Mannitol since that procedure for ongoing cerebral edema.  Yeast was also present in tracheal aspirates at presentation; not cultured for campylobacter yersenia nor tested for CMV.  He developed ARDS and sepsis and despite treatment with plasmapheresis and IVIG died 66 days after presentation with multiple organ failure. Manufacturer of vaccine was Connaught, lot 0980530 or possibly 0986530.  Influenza vaccine givne IM left deltoid.  Exp 06/99.  He had had influenza vaccine for at least the preceeding 3 years.  Nurse follow up on 07/26/04 states: "atrial fib, renal failure, hypotension."
This spontaneous report was received from a consumer via company representative regarding an adult(early 50s) female patient. The patient's concomitant medications and drug reaction/allergies were unknown. The patient's past drug included PREVNAR 13. On 15-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 1 injection in her arm (dose, route, lot# and expiry date were unknown) for prophylaxis. On the same day 5 hours after vaccination, the patient had horrible reaction to vaccine. The patient experienced painful injection site redness(vaccination site pain & vaccination site erythema) and swelling in the upper arm by the top of the shoulder (vaccination site swelling). The patient also developed a fever of 100.6 degrees of fahrenheit (pyrexia) and experienced seizure like symptoms (seizure). The reporter did not know if the patient visited an emergency room because of her symptoms. No further adverse event information was provided. On an unknown date in December 2018 (3 or more days after vaccination), the outcome of seizure, pyrexia, vaccination site erythema, vaccination site pain and vaccination site swelling was reported as recovered. The causality assessment of the events was not provided with PNEUMOVAX 23. No product quality complaint was involved. Upon internal review, seizure was determined to be medically significant.
Information has been received from a nurse via a company representative referring to a female patient of unknown age. On unknown dates, the patient was vaccinated with the first and the second dose of GARDASIL 9 (lot#, dose and route not reported). The patient experienced headaches after the first and second doses of GARDASIL 9 on unspecified dates. The headaches went away within the next few days after the GARDASIL 9 was administered (specific dates unknown). The outcome of the events were reported as recovered. The therapy of GARDASIL 9 was continued. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 43-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP6955), at the age of 43, via an unspecified route of administration, left arm, on Mar 27, 2021, at 10:45, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included unspecified prenatal vitamins for unspecified indication (from unknown date and unknown if ongoing). Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Information on allergies to medications, food, or other products: not applicable. On Apr 12, 2021, at 15:00, patient found out in annual check-up her platelet count was low (108K/ul); normal range was 150- 450K/ul). Her previous platelet count was 198K/ul on unknown date in Feb 2021 (before the vaccination on Mar 27, 2021). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The outcome of low platelet count (108K/ul): unknown (at the time of report). No follow-up attempts needed. No further information expected.
Nausea and dizziness began approximately 45 minutes following vaccine administered at 11:40 a.m.  At 3 p.m. I began experiencing moderate abdominal cramping pain. It is currently 5 pm and the pain has not subsided.
Moderate fever; chills; spasms at injection site; severe  muscle pain; lymph node pain; sore throat; fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in her left arm on 17-MAR-2021 at 10:45 AM (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Type 2 diabetes, hypertension, high cholesterol, sleep apnoea, obesity. The patient past drug history was not reported. Concomitant medications included Amlodipine (MANUFACTURER UNKNOWN), Losartan (MANUFACTURER UNKNOWN) and Janumet (MANUFACTURER UNKNOWN) Lantus (MANUFACTURER UNKNOWN) Crestor (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 17Mar2021 6.00 PM the patient experienced moderate fever, chills, spasms at injection site, severe muscle pain, lymph node pain sore throat, and fatigue. The patient did not receive treatment for the reported events. The clinical outcome for Moderate fever, chills, spasms at injection site, severe muscle pain, lymph node pain, sore throat, and fatigue. was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Patient started feeling dizziness, feeling hot, paased out 20 secs. Legs raised, alert and active, no seizure.  BP 94/76, P- 70 1:03 Has M/O feeling dizziness when she wakes up in the morning at times. No signs of stridor, no seizures, no vomiting or nausea.  1:14 82/68, P- 70 Alert, active, sweating, color is pink, no change in color, no Shortness of breath, no stridor 1:23 104/76 P-70 Alert, Oriented x 3 1:28 110/80, P-70 1:32 cold and sweaty 1:35 sitting on chair, feel well. Alert, active, oriented x 3 1:42 92/68 P- sitting position chair 1:46 103/72 P-64 lying down 1:50 Vomiting, feel better afterwards 2:01 105/82, P-65
11/26/12: treated with MEDROL DOSEPAK for asthma; by 02/11/13 on ADVAIR, but consulting neurologist recorded she was also using methylprednisolone as of 02/13/13. 02/11/13: Received ZOSTAVAX vaccination (apparently in setting of methylprednisolone use). 02/13/13: Headache that afternoon, followed by right hemiparesis from left hemispheric CVA Question possible VZV vasculitis after ZOSTAVAX as precipitant on background atherosclerosis? See PMR case. Also, case reports on retinal necrosis post VZV vaccine.
TD was given 09/04/2001. On 09/11/01, The patient noticed large, edematous, red , warm and itchy area over the injection site. Prescribed ice compress. On 09/12/01, came in this AM. site was 12 x 7 cm with 2 small satillites over elbow. No body rash, no systemic reaction, no fever.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient received the 2nd covid vaccine, and 5 minutes later, I witnessed the patient fall to the floor near the pharmacy. she regained consciousness within a couple of minutes, but we called 911 to be sure. the paramedics assessed the patient, but patient and her mother declined visit to er. blood pressure taken by paramedics was 100/60.
11-29-12 at 1530 called HD and reported that she was feeling dizzy, nausea, tingly in right arm and just felt "weird". Was advised to go to ER but waited until AM on 11-30-12 and went to ER and was told to go to regular doctor on Monday. Went to regular MD on Monday 12-3-12 symptoms were not better. 12-4-12 Went to Neurologist, 12-16-12 - ER.
Pain and numbness in the left arm, itching in the body, joint pain, swelling in vaccination area, neck and chest, faster than usual heartbeat, and still, after 6 days I feel the symptoms.
The day after the shot developed a light mucus, continuous cough, which has been lessening, but still persists.
Hospitalized;  COVID-19 positive (8.26.21) - after being fully vaccinated   Admission Date: 8/26/2021 Discharge Date: 8/30/2021    Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus 08/26/2021 Yes ? ESRD (end stage renal disease) on dialysis (HCC) 07/31/2019 Yes   HOSPITAL COURSE: 68 year old man with hx of CAD, pacemaker in place, NIDDM2, HTN, ESRD on HD on compassionate dialysis program.  He was dialyzed on 8/23/21 and felt well. Developed cough, sputum, shortness of breath over the past 3 days.  He developed a fever.  Denied any weight gain or pedal edema or chest pain. His appetite has been down.  He presented to the ER on 8/26/21. In the ER, he had a fever 38, 76 bpm, 95% on RA, CXR showed bilateral infiltrates, COVID PCR was positive. He will be admitted for further treatment of COVID pneumonia. CRP 64.6. D-dimer 1130. He is previously vaccinated, Pfizer COVID-19 vaccine: 3/18/2021, 2/23/2021. He was started on Decadron 6 mg po daily and received 5 doses, he needs 5 more days. Should stay in isolation until he finish Decadron 6 mg daily. He was evaluated by the dr. and was found to needs 2 l/m at all times. Airway Oxygen will deliver portable tank to room for DC home.    ESRD on hemodialysis, he had 2 hemodialysis while in hospital. Should continue compassionate hemodialysis as before. He had mild thrombocytopenia with Plt. Count of 110 at discharge. PCP to follow.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored PEDVAXHIB (lot #, expiration date and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Explosive diarrhea for hours and hours, coating the walls of my bathroom unfortunately. I thought I was finished, but after 3hrs of constant pooping I pooped even more.   I chugged two bottles of Pepto Bismal and had 4 anti-poop pills. Didn't help much
DTaP immunization 01/21/05.. Next day 01/22 left arm swollen almost to elbow. Father states child had 100.3 temp. Gave Benadryl began to get better the next day 1/23/05. Child no c/o any problems other than arm sore. Eval at HD 01/24 and referred to MD for further eval. Returned f/u call 1/26 and mom states swelling is gone and all is fine.
Body aches and chills. Muscles aches. Fever between 101-99.5. Been 24 hours since vaccine and still occurring.
left arm swollen on the wrist area,could not strech her arm; soreness at the injection site, could not lay down on that side; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (left arm swollen on the wrist area,could not strech her arm) and VACCINATION SITE PAIN (soreness at the injection site, could not lay down on that side) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 004M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness at the injection site, could not lay down on that side). On 10-Nov-2021, the patient experienced JOINT SWELLING (left arm swollen on the wrist area,could not strech her arm). On 07-Nov-2021, VACCINATION SITE PAIN (soreness at the injection site, could not lay down on that side) had resolved. At the time of the report, JOINT SWELLING (left arm swollen on the wrist area,could not strech her arm) outcome was unknown.            No Concomitant medications were provided  No treatment medications were provided.
Vaccination given in afternoon on 10/3/2010. At 5 am on 10/4/2010 had severe chills and elevated temperature. By 1300 on 10/4/2010 adverse event had resolved. Took MOTRIN 400mg on 10/4/2010 at 1000 am. Pt missed one day of work.
sick; after 48 days patient still trying to schedule the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (after 48 days patient still trying to schedule the second dose) and ILLNESS (sick) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (after 48 days patient still trying to schedule the second dose). On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (after 48 days patient still trying to schedule the second dose) and ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication Information  were reported. No Treatment Information was Reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Event sick Updated and Declined for further FU.
I honestly think these two things may have just happened at the same time. A few hours after receiving his vaccine on 12/10/2022, he developed a 103-degree fever that night. The next morning, he was complaining of an earache. We took him to a local hospital where they diagnosed swimmer's ear and prescribed medicine. That Tuesday, I realized his throat was hurting because he was only wanting to eat popsicles. That night, he had a vomit with mucus. That Thursday, he was itching and broke out in hives. That Friday, we went to see his physician who stated that he had a virus that resulted in hives and recommended we treat the hives. We gave him BENADRYL for around three days and the hives went away and he has been fine since then.
Pt reported cough and scratchy throat 30 minutes after vaccination. The day after severe weakness, extreme muscle weakness, blurry vision and difficulty breathing.
29AUG91 fever noted in afternoon, by nighttime temp up to 103-104; vomited several times; APAP given also gave cool bath; 30AUG91 temp lower, not gone, vomiting occasional; 31AUG91 temp normal, no further vomiting;