chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea) in an 80-year-old male patient 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 DIARRHOEA (Severe diarrhea). At the time of the report, DIARRHOEA (Severe diarrhea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Stool analysis: normal (normal) normal.         no treatment and concomitant medication was provided by the reporter   This case was linked to MOD-2021-076873, MOD-2021-042580, MOD-2021-040930, MOD-2021-107944 (E2B Linked Report).; Sender's Comments:  MOD-2021-076873:Same reporter/different patient (wife 1st dose) MOD-2021-042580:Same reporter/different patient (wife 2nd dose) MOD-2021-040930:Same reporter/different patient (husband case) MOD-2021-107944:Same reporter/different patient (50s male)
Given a 5-11 pfizer vaccine at 1:40 pm.    At 1:50 HPM was called over to first aid station where pt had been taken. She c/o jaw pain and feelings of fear stating "Is something bad going to happen to me?".  HPM instructed pt to lay down on cot. 1:55 pm: HR = 110; RR = 22 BP 106/80; O2 sat 99% Alert and oriented, Respiration unlabored, Skin warm and dry, facial paleness, no rash noted, capillary refill <2 secs.  HPM reassured child that she was being taken care of and other clinic RN encouraged regular steady breathing. Jaw pain subsided and pt started to c/o upper left thigh pain which subsided when she bent her leg with knee to ceiling.  Mother reports that pt has anxiety around unknown situations such as the vaccine clinic and has experienced similar symptoms of increased fear in the past. Observed for 30 minutes during which pt continued to voice concern stating "I'm really scared, am I going to be o.k. Voice clear and strong, c/o headache stating "this always happen to me when I get scared".  Mom speaking calmly and quietly to child which was effective in bringing anxiety down. Mom verified verbally that pt gets a headache when she is upset.  2:20 HR = 92  BP 102/72.  Skin warm and dry, facial paleness resolved, no rash noted. No further complaints of pain. Walked family to car and gave instructions about when to be concerned, when to call MD (anxiety continues), when to go to ER (rash, concerned), when to call 911(swelling of tongue, throat, trouble talking, drooling, trouble breathing, loses consciousness). Mom verbalized understanding.
Patient complained of immediate pain in deltoid muscle after injection. Ongoing discomfort in left arm. Here for evaluation 1 month later.
pt started vomiting on 7/21 for 3d, then had cramps, abd pain w/blood in stools; cont vomiting & stools w/blood - on palpation a midline mass was noted; dx intussusception
Information has been received from a nurse practitioner concerning a 22 year old female who on 21-NOV-2006 received her 1st 0.5 ml dose of GARDASIL vaccine (yeast) intramuscularly (lot# 654540/0800F). The nurse practitioner noted that on 22-Jan-2007 the patient developed heavy bleeding. The patient has received all 3 doses of GARDASIL vaccine (yeast) (lot # 654540/0800F, 653937/0637F, 655618/0186U respectively). The patient was concomitantly taking drospirenone (+) ethinyl estradiol (YASIN) at the time of the vaccination. The patient received unspecified medical attention. Per the nurse practitioner, the patient recovered from excessive menstrual bleeding. Additional information has been requested. This is one of several cases, from the same source.
admitted with an ileus; pain 10 out of 10; 9-15 Tingling in abdomen and down both legs within minutes of injection; abdominal Cramps; nausea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: FE3592), dose 1 via an unspecified route of administration, administered in left arm on 15Sep2021 14:15 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19. No known allergies. Concomitant medication included venlafaxine hydrochloride (VENLAFAXINE SR) at 75 mg, 1x/day. No other vaccine in four weeks. On 15Sep2021, the patient experienced tingling in abdomen and down both legs within minutes of injection, abdominal cramps, nausea. Abdomen cramps and nausea continued and worsened throughout evening. On 16Sep2021, woke up with pain 10 out of 10, went to ER, CAT scan: admitted with an ileus. The patient was discharged on 18Sep2021. Continued abdominal pain, cramps and nausea since discharged. Follow up appointment with GI provider. MRI of abdomen with, without contract is now recommended. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization from 16Sep2021 to 18Sep2021, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events which included NG placed, IV, pain meds. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Narrative: Patient is an 83 yo male with PMHx MDS (on chemo, requiring blood transfusion Q2 weeks), CKD3, h/o large lt sided pleural effusion, obstructive lung disease, CAD s/p PCI, HTN, and HLD, who presented to medical facility 6/28/21 with fall and progressive SOA. He was admitted for further workup and treatment. Per Dr. consult note 7/11/21, he became more short of air on the floor and was transferred to the icu; he has been intermittently agitated and is presently on a precedex drip and sedated; a daughter is at the bedside; the patient was more alert this morning and told another daughter that he was tired and wanted to stop aggressive treatment. Palliative medicine was consulted for goals of care discussion, and per family's wishes, patient was transferred to hospice inpatient unit on, 7/11/21. Pt died on 7/12/2021. Per MD note, death was caused by Multisystemic organic failure. It appears death was unrelated to covid vaccinations.
PATIENT REPORTS NO ALLERGIES TO FOOD, MEDICATION OR LATEX. VACCINE INJECTION TOLERATED WELL. PATIENT PHONED  TO REPORT THEY DEVELOPED SMALL HIVES THAT WERE ITCHING. ASSESSED AIRWAY INVOLVEMENT, NONE REPORTED TO BE PRESENT. THE HIVES APPEARED 2 HOURS AFTER THE ADMINISTRATION OF THE DOSE.  ADVISED PATIENT TO ADMINISTER BENADRYL 25MG Q4 HRS FOR THE NEXT 24 HOURS AND SEEK EMERGENCY TREATMENT IF THEY EXPERIENCE DIFFICULTY BREATHING, SWELLING IN LIPS, TONGUE OR THROAT. ADVISED PATIENT TO CONSULT PHARMACY BEFORE NEXT YEARS FLU VACCINE TO PRE-TREAT WITH BENADRYL.
Mom came to office on 1-9-19 approx 10:20am without child to state that her daughter is having a reaction to Men B shot. She "can not function today and was awake all night". Offered office visit and declined. Went home to speak further to adult child. Called office back on 1-9-19 at 11:41am to state that child is very fatigued, pain at site. Not red but swollen. No fever. No SOB.
Student claimed on form prior to vaccination and verbally that she had not received a prior vaccination.  When went to enter the vaccination in registry , it stated that she had a Moderna vaccine on 2/11/2021 at pharmacy.  When I contacted her after checking registry, she admitted that she did get the other shot but, ". I didn?t have the chance to take the second dose of Moderna, and I lost my COVID card."   I instructed her to watch for significant side effects and how to report them.
Low grade generalized itching without rash beginning approximately 5 hours after injection; injection site soreness within an hour of injection
Pin worms. Over the counter medicine ( Reese?s pin worm treatment.) due to pregnancy. whole family was treated with albenazadole.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic Hypersomnia" (unspecified if ongoing); "POTS" (unspecified if ongoing); "known allergies: Fragrances only" (unspecified if ongoing). Concomitant medication included: DEXTROAMPHETAMINE [DEXAMFETAMINE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Treatment of COVID-19 included Paxlovid from 22Feb2023 to 27Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M036296, expiration date 14-NOV-2017) for prophylaxis (dose and route of administration were not reported). It was verified that ZOSTAVAX was reconstituted with a sterile diluent (manufacturer unknown), which did not undergo an excursion. The storage temperature was in the range 15 Fahrenheit (°F) to 46°F (32°F) and the excursion lasted for 7 hours and 15 minutes. Information was obtained from a digital data logger. There were no previous temperature excursions and no adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
day 8 I had a very strong positive on rapid test.; day 8 I had a very strong positive on rapid test.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gluten intolerance" (unspecified if ongoing); "high BP" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin"; Erythromycin, reaction(s): "known allergies erythromycin"; Penicillin, reaction(s): "known allergies Penicillin"; Levaquin, reaction(s): "known allergies levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "day 8 I had a very strong positive on rapid test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had a very strong positive on rapid test. Congestion headache and fatigue remain and it is now Day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient seem to have had a rebound of COVID after taking Paxlovid. This was her first infection and she had two am doses of Moderna vaccine and one of Pfizer as her booster. Her symptoms were abating on day 6 and 7 and then on day 8 she had a very strong positive on rapid test. Congestion headache and fatigue remain and it is now Day 17. Perhaps a longer course of Paxlovid is needed! Thank you.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left arm was tender all along, but on the 17th, it got redder and more tender and firm, and had a line of demarcation measuring about 4 inches across.  The inside of my upper lip on the left side also became very sore.  And my inner labia on the left side became very sore and itchy.  On 01/18, I examined those areas and found a large blistered area on my inner lip.  On 01/19, in addition to the red, painful area on my inner labia, there were multiple blisters. I have a history of HSV-1 in the genitals. I take Valtrex 500 mg daily. I had an appointment with my GYN?s NP on 1/20.  They ordered Valtrex 1 GM for 5 days, and to repeat that when I get my second dose, which is scheduled for 2/7/21. The blisters are now resolving.
suspected vaccination failure/had 3 shingles and get shingles; shingles; had 3 shingles vaccine; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 3 doses of Shingles vaccine and still had shingles. The patient received 3rd dose of Shingles vaccine which led to extra dose administered. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the time to onset and laboratory test confirming shingles were unknown at the time of reporting.
- Patient is a 39yo female with a past medical history significant for autoimmune thyroiditis and previous zoster infection who experienced a severely pruritic facial dermatitis and general pruritus with onset 4-5 hours after receipt of post exposure prophylaxis RabAvert rabies vaccine #2 which was self treated with benadryl 75 mgs with partial benefit. The bite was deemed high risk and the animal was not found. Given rabies is uniformly fatal, completion of the post exposure protocol was indicated, however additional evaluation was warranted for safety. The reaction is less suggestive of IgE induced urticaria due to the later onset and continued duration, however, due to the extremely pruritic nature of the symptoms indicating allergic response and the symptom onset at the tail of typically accepted window for anaphylaxis response after vaccine, out of an abundance of precaution  the  decision was to defer vaccination and evaluate for allergy via prick testing and to change to Imovax brand.Prick skin testing was  performed to full-strength vaccine. Appropriate positive and negative controls were identified at the appropriate time interval. Results of the skin test were interpreted approximately 15 minutes after placement. After prick skin testing was determined to be negative, the patient underwent further evaluation with a 1:100 dilution of the Imovax brand rabies vaccine intradermal with appropriate controls. The patient tolerated the procedure well without any immediate adverse reactions. Both prick skin tests and intradermal skin tests were interpreted as negative, supporting the dermatitis was not IgE mediated and there is no identified risk of anaphylaxis. The patient was subsequently vaccinated with full dose Imovax vaccine and observed for 1 hour post vaccination. The patient tolerated the vaccination well without evidence of adverse reaction. The initial topical dermatitis was mostly resolved after 3 days of topical steroid. and oral fexofenadine. the dermatitis did not recur with next two Imovax doses.
Developed Covid after vaccinataion; Developed Covid after vaccinataion; This is a spontaneous report received from contactable consumer (patient himself) reported that a  a male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after the first dose, the patient experienced what he thought were side effects. He developed Covid after vaccination and wanted to know if this will affect efficacy and the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
nausea, headache, night sweats, insomnia, congestion, abdominal cramping, back pain, knee pain, fatigue, right arm pain and weakness, neck pain  took 1000mg tylenol every 6 hours, provided relief
7:00 PM began low appetite and fussiness, expression of soreness and fatigue; woke at 6:00 AM 06/26/2014 with soreness, and by 8:00 AM was resistant to walking; by 1:00 PM stated she was unable to walk, and urinated self while unable to hold it or maneuver to toilet; 4:00 PM arrived ER (on instruction of on-call physician), and exhibited palsy-like loss of control over body from waist-down; unable to take even a step, even with support (but was able to stand with assistance); hip x-rays clear but was admitted for observation around 7:00 PM due in part to family history of vaccine reactions/proximity of home to hospital; treated with ibuprofen, fever all sub-100, "loopy" and slurred speech; discharged from hospital able to take a few shaky steps at a time, but without full muscle control.
the adverse event its a error on administration. Patient comes to the clinic for his 4th dose (4th booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine (0.25 ml administered), the administered vaccine was past of the date of use by 3 days (expiration date: 11/22/22), no temperature excursion for this vaccine. We are waiting responses of the immunization system and from the manufacture (moderna) to see how proceed with the patient, if we need to revaccinate the patient(s) or what else we can do.
Per Employee, presented to Center stating he was here for his 2nd dose. Per Employee, she looked up the client on Vaccination system and the client did not have an appointment. Employee stated she looked at the back of the client's vaccination card and noted that the card was not legible and damaged. Client was insistent that he was scheduled for his second dose today. Employee added client as a walk in for 2nd dose. Client proceeded to vaccination table with Vaccinator and Center. Client received received a 2nd dose of Pfizer COVID Vaccine (Lot#EW0187, EXP 06-28-2021) on 06-03-2021 at 1:15pm. Supervisor (myself) was notified by Lead that notified her that a client was added as a walk in for 2nd dose, but might have been too early. Supervisor determined name of client through participation forms and searched client on Vaccination system. RN reviewed vaccination system appointment and vaccination doses. On Vaccination system, client first dose documented on 05-22-2021 and second dose documented on 06-03-2021. Supervisor alerted Vaccinator that vaccinated client incorrectly. Supervisor reviewed vaccine administrations with inclusion of verifying client, DOB, right date, right time, right dose, right date, right route, and allergies with Vaccinator. Furthermore, Supervisor reviewed eligibility dates for Pfizer second dose. Supervisor reviewed with Ancillary the eligibility dates and  the need to relay any concerns regarding vaccination cards, appointments, walk-in, and previous COVID-19 vaccinations prior to sending client in to get vaccinated to Lead or Lead Vaccinator. VERP completed. Site Coordinators alerted and event elevated for further evaluation.
Patient received duplicate therapy of Pfizer Bivalent Updated Booster. Patient received first dose of Pfizer bivalent in September 2022 from a different pharmacy and patient received a second dose of Bivalent in March 2023. Patient was not aware that they were not supposed to get two doses of Bivalent.
Information has been received from a licensed practical nurse concerning an adult female with an intolerance to codeine who was vaccinated with MMR. There was no concomitant medication. Subsequently the patient did not show immunity to mumps. No symptoms were reported. Medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
I developed a swollen lymph node in my arm pit. It is sore and a lump.; I developed a swollen lymph node in my arm pit. It is sore and a lump.; I developed a swollen lymph node in my arm pit. It is sore and a lump.; I've experienced bodyaches; chills; slight fever; nausea; This is a spontaneous report from a non-contactable other health care professional (patient). A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration, administered in the right arm on 08Feb2021 01:00 PM (at the age of 33-years-old) as dose 2, single for COVID-19 immunisation at a workplace clinic. Relevant medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in the right arm on 18Jan2021 03: 00 PM as dose 1, single for COVID-19 immunisation. The patient previously took doxycycline (reported as doexyclimine) and experienced allergy. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination. The patient experienced bodyaches, chills, slight fever, nausea on 09Feb2021 03:00 AM and a swollen lymph node in her arm pit, it is sore and a lump on 11Feb2021 01:00 PM (reported as after about 36 hours. No treatment was received for the events. The patient underwent lab tests and procedures which included COVID-19 test (Nasal swab): Negative on 10Feb2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt felt dizzy, lightheaded, body aches, hot and cold, fatigue right after getting the vaccine. Also some slight nausea but is slowly going away. She is still feeling symptoms about an hour after dose was given.