chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clots; Felt like they had flu/ symptoms for long Covid but never had Covid; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Blood clots) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 THROMBOSIS (Blood clots) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Felt like they had flu/ symptoms for long Covid but never had Covid). At the time of the report, THROMBOSIS (Blood clots) and INFLUENZA LIKE ILLNESS (Felt like they had flu/ symptoms for long Covid but never had Covid) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient reported that it's really awful, that none of the medical department will talk to those that had really bad permanent issues because of the booster shots. Patient underwent all kinds of tests and blood work and doctors determined that it's from shots. She had a feeling that many more other people had these issues. Treatment information was not reported. Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected AESI thrombosis. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient reported that she is not the only one having issues from these shots. There are people who are experiencing the same she is. They have blood clots and feel like they have flu every day, or symptoms for long COVID but never had COVID. There are people who are having long term problems. The benefit-risk relationship of the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-705410 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2023: Follow-up received and added patient initials, gender, updated event verbatim and updated narrative. On 18-Jul-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705410:Other people case
Severe elevation in Blood pressure; elevated heart rate; difficulty swallowing; dry mouth; severe thirst; jitters; chills; numbness in face and mouth; nausea; diarhea; headache; cold, blue hands.  Rushed to Urgent Care Clinic; Directed to go to the ER immediately; Rushed to  the Emergency Room at local hospital.  Fluids, bed rest, monitor, do not continue usage of medication; most symptoms have subsided in about 24 hours of the initial event. However, body has not returned to normal state.
Headache, nausea, extreme fatigue/tired, felt unwell. I slept for four hours in the afternoon and then got up to eat dinner and went back to sleep early. Felt like an absolute champ in the morning with no lingering side effects.
Patient was called to schedule her second dose, at which time she reported the following: Starting approximately 2 days after receiving her 1st dose, she developed itchy red hives. She reported this to her clinic via telephone, and a clinician (nurse?) advised her to treat them with hydrocortisone cream. She treated the spots with hydrocortisone, which greatly reduced the itching. All spots were limited to the truck and arm of her left (vaccinated) side.  She didn't recall how long it took for the spots to go away. The itchiness resolved with the hydrocortisone, at which point she stopped paying attention to them. Based on the potential for a heightened immune response, we advised her NOT to receive her second dose at the pharmacy, though she could pursue at a clinic or after a work-up from an allergy specialist.
After the first Shingles vaccine on Sept 23 I developed fever, chills, pain in the injection site, muscular pain generally, headaches, fatigue.  But the worst thing is that it adversely impacted my emotional state significantly.  I became easily angry, suspicious, paranoid and unable to control impulses.  The emotional and psychological adverse impact was completely unexpected and quite severe.  Knowing that I had this adverse impact when I had the second shot in the shingles series (it was administered on December 17, 2021) I planned for the adverse effects.  But was shocked at yet another psychological/emotional/perceptive effect.  My peripheral vision was almost non-existent.  I was driving, went to the supermarket and had to will myself to pay attention to things that were around me.  It was an incredibly odd and disconcerting adverse impact.  Something I had never experienced before.  I went home and tried to sleep it off and spent a few days in bed.  Surprisingly and perhaps unrelated - but if related then very significant to note - I started feeling like I had a cold.  A standard cold.  Nothing special.  I used over the counter medication.  Then on about 9/26 I administered the Binax Now test and surprisingly for my very first time and after being fully vaccinated it came up positive.  I then had a PCR test to confirm.  Its very likely this was Omicron because it was only upper respiratory, rather mild (except for meaningful hearing problems), no impact on taste and smell and ended in about 6 days.  I quarantined and have home tested multiple times since and always negative.  I do not know if taking the Shingles vaccine made me more susceptible to Covid but I have been traveling, going to events, wearing masks, vaccinating properly, taking Vitamin D daily - I never got Covid except shortly after taking the Shingles vaccine.  There may be a cause and effect here that I suggest you look into.  And PLEASE look into the emotional and cognitive adverse impact of the Shinglex vaccine.  I have spoken with quite a few friends about it and it is amazing how often they reported they had sever and unexpected adverse reactions to it.   This is a completely voluntary vaccine.  I would absolutely not have had it if I knew these were possible side effects.  Please look into this!!!  I had the flu vaccine the same day as the first Shingles vaccine.  I report this on the next page but I do not know which Flu vaccine I was given so I clicked on the first one.
1 MONTH AFTER VACCINE ADMINISTRATION PATIENT CAME INTO OFFICE ARM LOCALIZED SWELLING AND STRENGTH WHEN EVALUATED WAS 4/5, NO FEVER AND NO OTHER SYMPTOMS NOTED
Awoke approx 6AM. Took daily synthroid went back to sleep woke up feeling nauseous and dizzy went to bathroom felt like I needed to sit down next I remember I woke up on the floor with cut over my left eye.
Initial report received on 07 July 2008 from a health care professional. A 57-year-old female patient, who has a past medical history of "blood clotting disorder" and palpitations, had received an intramuscular left deltoid injection of ADACEL (Lot # C2767AA) on 17 June 2008. Two days after vaccination, the patient experienced redness and swelling the size of an orange at the injection site, and leg pain which lasted for seven days. The patient was treated with antihistamines and ice. No relevant diagnostic tests/laboratory data were performed. The patient subsequently recovered (date of recovery not reported). Follow-up information received on 21 August 2008 from a health care professional. The patient had a history of heterozygous Leiden mutation. She was not taking any concomitant medications. The patient was evaluated by a physician and no diagnosis was made. The patient recovered from her symptoms on 20 July 2008.
COVID 19 Treatment; COVID 19 Treatment; Pfizer - Dose Number: 5; Moderna - Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 07May2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 030L20A), in left arm, on 26Feb2021 as dose 2, single (Lot number: 031M20A), on 31Oct2021 as dose 3 (booster), single (Lot number: 076CYA), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Basel cell cancers" (unspecified if ongoing); "overactive bladder" (unspecified if ongoing); "constipation" (unspecified if ongoing); "Known allergies: Adhesive on tape" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ, start date: 22Dec2022. Past drug history included: Declomycin, reaction(s): "Known allergies: declomycin"; Bacitracin, reaction(s): "Known allergies: bacitracin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "not recovered", described as "Pfizer - Dose Number: 5; Moderna - Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid treatment from 14Aug2023 to 18Aug2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out considering interchange of vaccine.
Patient came in complaining of a bruise along the entire upper arm. Did not have signs or symptoms of continuing bleeding and claims the bruising has started to recede.
This spontaneous case, was initially received on 28-Sep-2017, from other health professional (pharmacist) concerning a 28-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with the FLUCELVAX QIV (dose: 0.5 ml, batch number: 195213 (reported as 1925213), expiry date: 31-Mar-2018, anatomical location, route of administration: not reported). On 28-Sep-2017, after 2 days of vaccination, the patient experienced redness, warmth on touching and swelling at the vaccination site. At the time of this report, the patient had not recovered from the events. The reporter assessed the events as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (195213) was captured in the case form and narrative was amended accordingly.
pt recv vax 5APR96 & 12APR96 pt exp h/a;23APR96 pt exp h/a;No further details were provided;
This spontaneous report was received from a doctor of pharmacy concerning an approximately 61 year old female patient with no drug reactions or allergies. Current condition of the patient included hypertension. On 29-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J002693 and 07-JUN-2014 respectively, dose unspecified), subcutaneously. Concomitant medication included an unspecified blood pressure medication. On 31-AUG-2013, the patient began to experience injection site reactions like local irritation, warmth, and redness. The patient sought medical attention. The pharmacist noted that no rash had occurred. No treatment was given. No lab tests were performed. The patient was not recovered from the events as the patient was still experiencing these injection site reactions when she called the pharmacy at the time of reporting (09-SEP-2013). The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
This is a hospice patient under the care of Hospice at an affiliated nursing home. Pt received the vaccination around noon on 2-16-21 by a representative from Pharmacy.  The following afternoon 2-17-21 at 14:45 the pt started to experience severe SOB resp rate 36, audible wheezing and use of respiratory accessory muscles. BP180/80, 113 pulse temp 98.  Pt was given morphine and ativan.  The respiratory distress was eased however pt never returned to baseline and died 2-22-21 around 4am.
patient was given Moderna for dose 2 instead of Pfizer due to miscommunication at vaccination site
Loss of balance for 4 or 5 days. Fussy, fix stare, jerking body seizures that last about 5 second, back was sweating.
mom noted swelling a day after immunizations were given in right leg. Hives and itching developed in right thigh area where MMR and IPV were given. Localized reaction noted.
severe diarrhea; burn sensation from insertion of needle; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burn sensation from insertion of needle) and DIARRHOEA (severe diarrhea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Food allergy (Mushroom) and Drug allergy (Amoxicillin). Concomitant products included ADALIMUMAB (HUMIRA) for Immunosuppressant drug therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) and METOPROLOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BURNING SENSATION (burn sensation from insertion of needle). On 22-Feb-2021, the patient experienced DIARRHOEA (severe diarrhea). On 12-Feb-2021, BURNING SENSATION (burn sensation from insertion of needle) had resolved. At the time of the report, DIARRHOEA (severe diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous prospective pregnancy report as received from a physician assistant refers to a approximately 27 year old female patient with no drug reactions/allergies. The patient's medical history included positive ppd test for tuberculosis. On 02-OCT-2012 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number and expiry date not provided), .5 ml, subcutaneous. The patient received the first dose of VARIVAX (Merck) (lot number and expiry date not provided), .5mml, subcutaneous on 07-AUG-2012. The Concomitant therapies included in INH. The patient became pregnant with LMP of 12-Aug-2012 and EDD of 19-May-2013. The pregnancy outcome was pending. On an unknown date the patient became pregnant. On 02-OCT-2012, a pregnancy test prior to administration of VARIVAX (Merck) was negative. An ultrasound performed on 21-DEC-2012 revealed a pregnancy of 14 week gestation. Follow up information has been received from Registered Nurse on14-JUN-2013 concerning female patient who on 02-OCT-2012 was vaccinated at private medical doctor (MD) office/hospital with second dose of VARIVAX (Merck) (lot number H011724, expiry date not provided),0.5 ml and on the same date was vaccinated with the second dose of M-M-R II (0.5 ml, route not reported (lot number H012140, expiry date not provided). The patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. The patient became pregnant with last menstrual period (LMP) on 12-AUG-2012. Estimated date of delivery (EDD) was reported as 20-JUN-2013. The patient had 2 full term deliveries and 2 previous pregnancies. No defect, stillbirth, miscarriage in previous pregnancies. Prenatal testing included: ultrasound (unrecognizable date) with normal result ultrasound to estimate due date (reported as 21-DEC-2013) and Maternal Serum Alpha-Fetoprotein Screening (MSAFP) performed on 25-JAN-2013 (on patient request) with normal result. It was unknown if the patient experienced local reaction at vaccinated site or if the patient developed varicella or Herpes Zoster symptoms post vaccination. Additional information has been requested.
ulcerative colitis/the flare started again very aggressively/t was the longest flare I have ever had in my life; I had blood in my stools/blood in my feces; diarrhea; I had a very bad time; This is a spontaneous report from a contactable Pharmacist (patient). A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 21Feb2021 at 12:30 (at the age of 38-year-old), as single dose for COVID-19 immunization at the Hospital. Medical history of the patient included Colitis ulcerosa. Patient did not receive any other medications in two weeks or any other vaccine in four weeks of suspect vaccine. Patient had no known allergies. Patient did not have covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266) via an unspecified route of administration on 31Jan2021 at 13:00, as single dose for COVID-19 immunization and experienced a flare up of ulcerative colitis. On an unspecified date in 2021, patient had blood in feces and diarrhea every day, 7-10 times a day and three days after second dose on an unspecified date in Feb2021, patient experienced that flare started again very aggressively (ulcerative colitis). The second flare lasted 4 months until it went away, it was the longest flare that patient have ever had in his life. Patient had to take mesalamine, high two prednisone, dicyclomine and had a very bad time. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. On 01Mar2021, patient underwent lab test for COVID-19 (PCR-nasal swab test) which came negative. Treatment received for the adverse event included Mesalamine, prednisone and dicyclomine. Outcome of the event ulcerative colitis was resolved with sequel on an unspecified date in 2021 and for other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events of  ulcerative colitis ,haematochezia and suspect drug BNT162B2 cannot be excluded   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.
At about 7:00 p.m. on 1/21, I began to feel chills and feverish. I checked my temperature and it was at 99.8. By the time I went to bed around 11:00 p.m. my temperature was 100.6. When I woke up on 1/22 around 6:30 a.m., my temperature was 100.3. I blacked out as I was walking to the bathroom and feel very nauseous. Whenever I stand up for more than a few minutes, I feel like I am going to black out again.
She had her 1st shot then got COVID; She had her 1st shot then got COVID; This is a spontaneous report from a Pfizer sponsored support from a contactable consumer. A patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st shot then got COVID in 2021. The patient was in hospital and had since recovered but now in physical rehab. Wanted to know when she should get a second shot. Outcome of events was recovered on unspecified date in 2021.  Information on lot/batch number has been requested.
Arm bruised and was bleeding as soon as injection was given had swelling. I was told to rub the area by 7:30 PM injection area was red and sore and itching. By morning it was a large area swollen  and red.
12/16/21 headache started that night 13/17/21 redness and swelling at injection site treated with ibuprofen, Tylenol, ice pack, Benadryl 12/18/21 redness and swelling increased 12/20/21 redness and swelling increased down arm seen by PCP treated with steroid shot, Claritin, Pepcid, Benadryl  12/21/21 redness hot to the touch and swelling continues headache has never gone away
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 12-FEB-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to four temperature excursion, one for a sum of 48 hours with a lowest temperature recorded as 1 degree C; other for a sum of 72 hours with a highest temperature recorded as 9 degree C; another for a sum of 24 hours with a lowest temperature recorded as -1 degree C; and the last one for a sum of 16 hours with a lowest temperature recorded as 0 degree C. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
a 3 month old patient missed their 2 dose of VAXELIS in the series; This non-serious spontaneous safety report, with reference number 2023SA055146 (and inquiry number 01494959), was received by a partner on 16-FEB-2023 and forwarded on 17-FEB-2023, from a non-HCP.  Due to the nature of the event the causal relationship between Vaxelis and "a 3 month old patient missed their 2 dose of VAXELIS in the series" was not applicable.    Further information is expected.
Fever of up to 101.2 Fahrenheit; Chills; muscle soreness; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Jan2021 11:00 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history was none. The patient had no known allergies. Concomitant medication included ibuprofen (IBUPROFEN). The Historical Vaccine included product=COVID, brand=Pfizer, lot unknown=False, administration date=22Dec2020, administration time=10:30 AM, vaccine location=Left leg, dose number=1. The patient experienced fever of up to 101.2 fahrenheit, chills, muscle soreness on 12Jan2021 23:30. The patient underwent lab tests and procedures which included body temperature: 101.2 fahrenheit on 12Jan2021 23:30. No treatment was received. The event outcome was recovering. The events reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Had 2 days of arm ache, chills, muscle aches & joint aches until 2/14/21.  Then on 2/17/21 experienced severe joint ache & muscle aches to the point of tears, lasted until 2/19/21, then back to baseline late Friday into Sat. 2/20/21.  Self treated with rest, heating pad, and Aleve.
Patient states soreness at the site of injection persisting 2 weeks post administration. No swelling or redness.