chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Traveler's diarrhea; A spontaneous report was received from a pharmacist on 02NOV2023 regarding a male patient of unknown age who had "traveler's diarrhea" (PT: Diarrhoea infectious) following the administration of oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 26OCT2023, the patient took the first dose of Vivotif and then had traveler's diarrhea. Reportedly, the patient stopped Vivotif during the weekend.   The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was withdrawn.  No additional information was reported.  Company comment: It was reported that a male patient received first dose of Vivotif for immunisation and then had traveler's diarrhea. Vivotif was stopped in response to the above event. Considering the above information and strong temporal association, the causality of the above event is assessed as possible to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a male patient received first dose of Vivotif for immunisation and then had traveler's diarrhea. Vivotif was stopped in response to the above event. Considering the above information and strong temporal association, the causality of the above event is assessed as possible to Vivotif. The case is considered non-serious as per medical assessment.
BODY GOT LOCKED UP; NERVE PAIN IN LEGS; TINGLING IN HANDS/FEETS/ IT WOULD GO  UP TO MY HIP IN MY ARMS IT WAS ONLY IN FINGERS/HANDS/ IT TRAVELS  UP LEG/TINGLING GETS WORSE; WENT TO SLEEP AND WOKE UP EARLY AND LIKE ON SPEED/COCAINE (MORE  THAN COFFEE); ARM SORENESS; CRAZY HUNGRY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal stenosis, and artificial disc in neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 5905029 and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the patient experienced crazy hungry. On 30-MAR-2021, the patient experienced arm soreness. On 31-MAR-2021, the patient experienced went to sleep and woke up early and like on speed/cocaine (more than coffee). On 13-APR-2021, the patient experienced nerve pain in legs. On 13-APR-2021, the patient experienced tingling in hands/feets/feet it would go up to my hip in my arms it was only in fingers/hands/ it travels up leg/tingling gets worse. On JUN-2021, the patient experienced body got locked up. On SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, EMG (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy hungry, and went to sleep and woke up early and like on speed/cocaine (more than coffee) on 31-MAR-2021, and arm soreness, had not recovered from tingling in hands/feets/feet it would go up to my hip in my arms it was only in fingers/hands/ it travels up leg/tingling gets worse, and nerve pain in legs, and the outcome of body got locked up was not reported. This report was non-serious.; Sender's Comments: V0:  Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Local red raised hive at site of injection.Later that night pt screamed in high pitched, unusal cry for 2 hrs-after 1st vax.After 2nd vax used acellular petussis vax only and local red hive reaction was noted.
black spots over the skin,; shingles; This spontaneous report was received from a consumer and refers to a 55-year-old female patient. The patient concurrent condition included hypertension. There was no information about the patient's medical history provided. Concomitant therapies included enalapril (ENALAPRIL). On an unknown date in 2015 also reported as "it happened 24-AUG-2015, started a couple months after the shot", the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On 24-AUG-2015, the patient developed shingles, she had skin discoloration, black spots over the skin, caused by her bathing suit and the pool water, and it stayed for about 1.5 years, she was using a cream. lt was maybe 2 years before it disappeared. The outcome of skin discolouration was reported as recovered/resolved. The outcome of shingles was not reported.  Causality assessment between the event of shingles and the suspect therapy was reported as related (attributed). Causality assessment between the suspect therapy and the event of skin skin discoloration, black spots over the skin was not reported.
patient had near syncopal episode  after vaccines. patient  had orthostatic hypotension.  patient did not eat before vaccines, found to have accu-check 78.  Felt better after poptart. Patient  went with EMS  since was not able  to stand  without feeling  symptomatic & dizzy.
2/01/00- Pt received an MMR for college, on 2/15/00, pt experienced and elevated temperature and slight sore throat. On 2/16/00, a rash developed. On 2/23/00, pt experienced a red confluent rash on feet and legs that vary in size and color from a red to a purple hue, larger than an apple. No pain, no itching and no other symptoms were experienced. FU received 4/2/02 states pt was seen again on 3/5/00 with dark reddish circles varying in size from about 10MM to at least 40MM just on legas where rash appeared on 2/16. Pt states he has been unable to work since 2/25. Tentative diagnosis of hypersensitive vasculitis, leukocytoclastic vasculitis, or allergic vasculitis.
not been feeling very well - lasted a couple of days; headaches-sporadically today worse than other days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not been feeling very well - lasted a couple of days) and HEADACHE (headaches-sporadically today worse than other days) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced MALAISE (not been feeling very well - lasted a couple of days) and HEADACHE (headaches-sporadically today worse than other days). At the time of the report, MALAISE (not been feeling very well - lasted a couple of days) and HEADACHE (headaches-sporadically today worse than other days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment with Tylenol was provided by the patient.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Since 08-MAY-2015, the patient were vaccinated with improperly stored doses of MMR II (dose and route were not reported, lot # K011188, expiry date 12-AUG-2016, albumin status unknown). Concomitant medications were not reported. No adverse reactions were reported. Additional information has been requested.
pt recv vax & 10 hr later exp hives & itching all over body;MD visit was required;pt was treated w/DPH;clusters of hives cont;pt is not taking deltasone daily;sx cont;
SHORTNESS OF BREATH (FEELING CONSTRICTED BUT NOT COMPLETE LOSS OF BREATH); LEFT NECK LYMPH NODE SWELLING (NOW DECREASED IN SIZE, STILL PALPABLE AND INFLAMED); FEELS HYPOSTATIC; LIGHT HEADED; FEELING BACKED UP; CLOUDINESS IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included fever, tinnitus, and drug induced hypertension, and concurrent conditions included autoimmune disease -psoriatic arthritis, and other pre-existing medical conditions included the patient had experienced many adverse experiences with other vaccines/medications in the past. the patient had received steroids that resulted in bright pink torso and was aware about the steroid allergy. the patient thinks he had covid-19 back in december because he loss his sense of smell for 2 to 3 weeks. patient received a vaccine 10 years ago that gave him a fever for 10 days straight. The patient experienced hypertensive when treated with salbutamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, and expiry: 05/AUG/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced cloudiness in urine. On 21-MAY-2021, the subject experienced shortness of breath (feeling constricted but not complete loss of breath). On 21-MAY-2021, the subject experienced left neck lymph node swelling (now decreased in size, still palpable and inflamed). On 21-MAY-2021, the subject experienced feels hypostatic. On 21-MAY-2021, the subject experienced light headed. On 21-MAY-2021, the subject experienced feeling backed up. On 01-JUN-2021, Laboratory data included: Blood test (NR: not provided) all clear. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 111/63. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (feeling constricted but not complete loss of breath), left neck lymph node swelling (now decreased in size, still palpable and inflamed), feels hypostatic, light headed, cloudiness in urine, and feeling backed up. This report was non-serious.
an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.  Reporter stated that an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose. The patient received Moderna for their 1st two doses.
12 hours in began feeling like I had overworked muscles. An hour later I became violently ill. Vomiting, high fever, extreme blurred vision, sever pain in leg and back muscles, fainting, dizziness, confusion, difficulty speaking and thinking, lasting into the 34th - 38th hour after shot. today is the 3rd day after the shot and I'm having extreme constipation, pressure migraine, couching, stuffy and or runny nose, and allergy like symptoms.
I had fatigue, severe headaches, weakness in the body and body aches, also heaviness of the vaccination site. I contacted my DR and had a visit several times in Jan/Feb/March/June 2021. I do not know the exact dates right now as I am working. My DR said I am a long hauler with Covid and have to use Advair inhaler to try and help. My DR made arrangements for me to see a Cardiologist and they did a work up during my visit.
swelling,redness,warmth and pain to touch x1 day in rt upper deltoid and down to posterior/ antrior bicept.
A non-serious Spontaneous report of administration of expired dose was received from a health professional concerning a 12 year-old female. The patient's medical history was not reported. On 18 Aug 2009, the patient inadvertently received FLUMIST that expired on 05 Apr 2009. There was no adverse event associated with this medication; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Started with itching - generalized, no rash c/o not feeling well. 7 days later - c/o twitching to eyes - Referred to ER/Primary  on 10/16 - with twitching/unable to close Lt eye.
Tested positive for oxycodone after getting 2nd dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DRUG SCREEN POSITIVE (Tested positive for oxycodone after getting 2nd dose of the vaccine) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DRUG SCREEN POSITIVE (Tested positive for oxycodone after getting 2nd dose of the vaccine). At the time of the report, DRUG SCREEN POSITIVE (Tested positive for oxycodone after getting 2nd dose of the vaccine) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
Patient given Varicella to left post. upper arm subcutaneously tolerated well. Patients arm immediately started to turn red 5.5 cm x 4 cm area with red blotches as well.
next day at approx 1030 felt fatigue, temp 103.6, temp today 99.5 had taking anipyretic at 0630. still have malaise/fatigue. Negative COVID 1/6.
82 Y male with history of prediabetes, hypertension, emphysema, infrarenal abdominal aneurysm, who presented with positive home COVID test and subjective dyspnea in the setting of progressive decline in exercise tolerance, admitted for acute hypoxemic respiratory failure due to COVID pneumonia.   # Acute hypoxemic respiratory failure  # COVID pneumonia / History of emphysema Presented after having positive home COVID test in the setting of progressive decline in exercise tolerance for months. No other symptoms including fevers/chills, cough, chest discomfort. Confirmed to be COVID positive 12/29. Initially hypoxemic to 86% and required 2L NC on admission. Received IV remdesivir and IV Decadron 6 mg on 12/29. Also found to have elevated D-dimer (~3) but CTA chest negative for PE. Received SQ Lovenox for VTE prophylaxis. Passed ambulatory trial 12/30 (oxygen saturation 95-97% with ambulation on room air). No home oxygen ordered. LFTs within normal limits. - Monitor for progression of symptoms - Continue isolation for 20 days (until 1/18/2022) - Continue tessalon perles 100 mg TID PRN for cough   # Prediabetes Last HbA1c 5.8% in 04/2021.  - Follow up repeat HbA1c   # Hypertension - Continue PTA atenolol 25 mg daily - Continue PTA aspirin 81 mg daily   # Hypothyroidism - Continue PTA levothyroxine 150 mcg daily   # Hyperlipidemia - Continue PTA lovastatin 20 mg QHS
no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 09:53 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023645 and expiration date on 03-MAR-2022 at a dose of 0.5 mL intramuscularly (IM) on the left tight (LT) and with an improperly stored dose of rotavirus G1 P1 vaccine live (89-12) (ROTARIX) oral route and lot # Y5CN5, diphtheria toxoid, and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; for prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008884: US-009507513-2008USA008882: US-009507513-2008USA008889: US-009507513-2003USA002275: US-009507513-2008USA008879: US-009507513-2008USA008883: US-009507513-2008USA008885: US-009507513-2008USA008886: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008876: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2008USA008890: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008911: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008887: US-009507513-2008USA008919: US-009507513-2008USA008890: US-009507513-2008USA008890: US-009507513-2008USA008890: US-009507513-2008USA008922: US-009507513-2008USA008923:
Placental abruption (with heavy bleeding) occurred two days short of week 36 in first pregnancy (which was achieved via IVF with PGS-tested embryo), resulting in stillbirth on 5/6/2021; baby was 4lb 8oz upon delivery. Due date was June 4, 2021.
Rash ~ 2.5x2.5 inch below the injection site, itchy, tender to touch, a bit swollen, a bit warm
This spontaneous report has been received from a Registered Nurse and refers to an unspecified amount of unspecified patients of an unknown age and gender. Patients medical history, concurrent conditions and concomitant therapies were not reported. From 21-OCT-2017 to 30-NOV-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N013863, expiration date 31-OCT-2018 and VARIVAX lot # N010107, expiration date 18-MAR-2019, for prophylaxis (doses, routes, routes of administration and anatomical locations were not reported for any vaccine). The administered dose of the vaccines experienced a temperature excursion 6 to 14 degrees Fahrenheit for 2 hours, as recorded by a data logger. The sterile diluent was stored properly. No adverse effects were reported. Albumin status for PROQUAD lot number N013863 is rHA. Follow-up information was received on 02-MAR-2018. An inbound call was received from the registered nurse who informed that there was a temperature excursion for the past 30 minutes. No further information was available. Sender's Comments: US-009507513-1712USA001796.
Admitted 7/29/21. Received both doses of Pfizer vaccine, the last on 3/29/21. Presents with diarrhea x5 days, weakness and SOB. Tested positive for COVID on 7/27/21. Patient treated with COVID protocol, antibiotics, remdesivir, BiPAP. Patient responded poorly to treatment and condition declined. On 8/9/21 pt discharged.
heart rate dropped; blood oxygen dropped; blood pressure dropped; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included her 8th surgery from an unknown date. The patient's concomitant medications were not reported. The patient experienced heart rate dropped, blood oxygen dropped, blood pressure dropped on an unspecified date. She stated a week after the vaccine she had a skin graft surgery on the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy, that she had in October that a doctor screwed up. After the surgery in October a week into it her foot went purple and brown and she was in a boot and her foot went numb for 5 days. They went in and did a compartmental surgery. then they sent her to a vascular doctor and it was not vascular and then sent her to a wound care specialist and started doing hyperbaric treatments that did not do a thing. The two toes were turning black, gangrene, and after a second opinion had to have 2 toes amputated right before holiday. Later, a third toe amputated where they put cadaver skin on it. She had a skin graft a week after the vaccine to replace this skin with skin from her thigh. In this surgery she was not sure if it was due to it being her 8th surgery or the anesthesiologist using something she had never ever used that she ended up having to be intubated because her heart rate dropped, and her blood oxygen dropped. She was fine. They did echos on her heart and kept a heart monitor on her for a week. After the surgery her blood pressure dropped, or is staying at a good rate, without any blood pressure medication within the last week and a half. She stated she wasn't even having to take her diabetes medication while she was in the hospital. She stated she was back to her for her diabetes but does not take shots. No other issues that she was out of surgery. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure dropped, bunion operation: foot issues (the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy), heart rate decreased: heart rate dropped, investigation: foot issues (the top of her foot from where she had issues from a previous Lapiplasty, bunionectomy, oxygen saturation: her blood oxygen dropped) on an unspecified date. The outcome for all events was unknown.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
19JAN94 small sz in middle of noc; 20JAN94 vomiting all day, lethargic; 21JAN94 small sz middle of noc; 22JAN94 2 major sz middle of noc in ER;
Needle bent at 90 degree angle when attempted to administer Flu shot. Vanish Point syringe 3 cc 25G x 1" Lot: A790A. No vaccine was administered w/ this needle. New needle and new vaccine administered.
I received my second dose 2/4/21.  Approximately 24 hours following this dose I had a 102 fever, chills, head ache and stomach ache.  Went to be and woke up the following day (2 days after the second dose) at 80% recovery and the next day (3 days after the second dose) at 100% recovery.  A low grade head ach persisted for the next 7 days.
Fever, soreness, aching, knot at injection site, redness and itching at injection site, chest pain
p/vax pt exp fever; vomiting & dehydration; hosp for dehydration; pt rehydrated on 8/31, alert, active, playful and discharged & recovered.
16Mar15 patient reported to work area to show reaction to injection site on left arm (deltoid area). Large/red/raised area noted (2.5 x 3.5). Patient reported rxn started approx Saturday (3/14/15) night after injections. BENADRYL taken. Patient instructed to report to local hospital for evaluation. Patient en route for evaluation. Updated MEDPROS "MR".