chrisvoncsefalvay/vaers-outcomes huggingface dataset:
iron infusion; ulcerative colitis flare ups; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 23Nov2021 (Lot number: 1155994) to 23Nov2021 at 160 mg (160 mg citrate free (1 in 1 once)), second regimen subcutaneous from 07Dec2021 (Batch/Lot number: unknown) to 07Dec2021 at 80 mg (80 mg citrate free (1 in 1 once)) and third regimen subcutaneous since Dec2021 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg citrate free (1 in 7d)) for colitis ulcerative. Relevant medical history included: "ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 2021, outcome "recovering", described as "ulcerative colitis flare ups"; MINERAL SUPPLEMENTATION (non-serious), outcome "unknown", described as "iron infusion". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events Colitis ulcerative aggravated and Iron supplementation are assessed as unrelated to the suspect product BNT162B2 administration.
Got in car, started car, felt dizzy and light-headed. Turn car off. Leaned back against chair. Passed out. Then came to put self back into chair and ask daughter for cell phone. Was sweating, called someone to transport me home. Got sick. A follow up report received 7/1/2002 adds: Vomiting x2.
Per pt's caregiver, pt has been experiencing severe sleepiness/drowsiness following administration of covid (pfizer) vaccine. Caregiver reports pt is not coherent and presents with slurred speech.
c/o feeling "foggy" and left hand tinging and numbness 30 minutes after dose(1040 am)..  Pt took own Benadryl tablets(2)  BP 189/90, HR 55  Speech clear, A & O x 4. .  15 minutes later (1055), c/o "tongue swelling" and took another Benadryl tablet.  No swelling observed, speech clear, no airway impairment.  BP 170/90, HR 54, oxygen saturation 98%.  1110, c/o left thumb feeling "numb".  1120, tongue swelling sensation resolved.  1130, patient ambulated with RN, took additional Benadryl tablet.  Stated hand numbness was resolving.  "I'm going to be okay".  1155, pt escorted to vehicle.
This spontaneous report has been received from a 81-year-old female patient reporting on herself. The patient did not have any relevant medical not drug reactions/allergies. The concomitant therapies included an unspecified high blood pressure medication. On 11-SEP-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot number, and expiration date were not reported) intravenously (IV) for shingles prevention. Other suspect therapy included sterile diluent (DILUENT MRK). On approximately 25-SEP-2016 (reported as "two weeks after receiving ZOSTAVAX"), the patient developed itching on her back and shoulders. The patient spoke with a couple of doctors on unspecified dates and she was given treatment for itching on her back and shoulders. There were no laboratory diagnostic tests performed. At the time of this report, the patient had not recovered from itching on her back and shoulders. The causality assessment between itching on her back and shoulders and ZOSTAVAX was unknown. Additional information is not expected as no contact consent was provided.
A nurse reported that a 14 year old female pt experienced itching, redness, swelling, difficulty breathing and throat swelling during treatment with RabAvert therapy. The pt's medical history included allergies to PCN and bee stings. She began her post exposure vaccination series of RabAvert 1 ml IM on day 0, 07-SEP-2001. The pt received her first and second shots without any reported problems. She received her third shot on 14-SEP-2001. On 16-SEP-2001 the pt developed severe itching and redness around the face and neck area as well as some swelling around the eyes. On 17-SEP-2001 the pt was hospitalized for difficulty breathing and throat swelling. She was treated with epinephrine and adrenaline and the symptoms subsided. She was discharged on 19-SEP-2001. the pt was scheduled to receive her fourth dose of RabAvert on 21-SEP-2001, instead she received HDCV on 22-SEP-2001. The pt again experienced throat swelling and difficulty breathing and was treated with epinephrine and adrenaline. As of 26-SEP-2001 the subject had discontinued RAbAvert and the symptoms had resolved. The pt is scheduled to visit and allergist and a dermatologist. the physician assesed this event as possibly related to RabAvert.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 20-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) 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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    No relevant concomitant medications were reported. Route of administration was reported as BI. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
tachycardia heart valve regurgitation observed on echcardiogram in March 2021 (not present on ecocardiogram done in June 2020) wildly vacillating oxygen saturation from 99 to 83 (after very limited exertion, such as emptying dishwasher) wildly vacillating pulse from 70 - 152 (after very limited exertion, such as emptying dishwasher) shortness of breath extreme fatigue and exhaustion no endurance poor sleep poor appetite Absolutely NONE of these symptoms present prior to second Moderna injection
This spontaneous report was received from a pharmacist referring to a 19 year old patient of unspecified gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unspecified date in August 2017 (reported as: ''about a year ago''), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, frequency, lot# and expiration date were not provided) for prophylaxis. On 30-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, route, frequency, indication, lot# and expiration date were not provided) for prophylaxis. No adverse effects were being reported. No product quality complaint was filed. And no further information provided.
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a heath care professional (MA). This case involves a six months old female patient who was inadvertently received 0.4% NaCl diluent and not the powder, while she received vaccine ACT-HIB.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 14-Nov-2018, the patient received a dose of 0.6 ml of only diluent of suspect HIB (PRP/T) VACCINE (lot number: U6074AAand expiry date: 27-Oct-2019) via intramuscular route in the left thigh. It was a case of actual medication error due to Product preparation error and overdose. No known symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Site pain, swelling, chills, body aches 6hrs and by next day.  4 days later- bellyache, cramps, burning diarrhea, nausea, lack of appetite, more fatigue. Last symptoms hard to shake. Better and then back.
Severe vertigo, tinnitus, nausea, painful lymph nodes, paraesthesia
Patient was underage at the time of vaccination. Vaccine center attempted to reach patient with number on file but no contact was made.
Pt recvd PNE-Imune on 20NOV90; then devel redness, swelling up & down arm w/pain into jaw; tx ice & DPH;
DOS. 12/10/16. Fever, rash. TX: Cephalexin, Ibuprofen.
Patient has had persistent shoulder pain in left (injection site) shoulder. Has not improved in the 7 wks since.
Fever (down to 100F); Bone infection in finger; A spontaneous report  was received from a consumer concerning a 74-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bone infection in finger and fever down to 100 F   Medical history or concomitant product use was not reported.   On 06-Feb-2021, the patient received his first of the two planned doses of mRNA-1273 (batch number: 043L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 15-Feb-2021 patient diagnosed with a probable bone infection in finger with fever 100 f. Treatment information was not provided.   The action taken with mRNA-1273 in response to the events was unknown.   The outcomes of the events developed bone infection in finger and fever down to 100 F were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The diluent was not added properly. The medical assistant said she only added 0.22 ml instead of 2.2 ml.  The amount drawn and given to patient was 0.2 ml but not sure if medical assistant added diluent or if she did not add enough.
have not been able to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (have not been able to get the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not been able to get the second dose). In March 2021, PRODUCT DOSE OMISSION ISSUE (have not been able to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
11-6-08 0920 TWINRIX 1.0 ml vaccine given IM R deltoid lot AHABB128AB, Exp. 7-18-10.  Immediately became pale, c/o whole body feeling warm.  Lightheaded.  BP 30/42 L p.60 T 97.8 degrees. R. 16. No itchiness, no SOB, no rash.  Assisted to cof. 0950 BP 100/60, p.60 6pm.  Respiration nonlabored 12-16.  0935 BP 102/64 p. 60 6pm. O2 per NC @ 2-4 6pm X 5min.  0940-0945.  IM sitting BP 90/60.  Color pink. Skin WID. had some diaphoresis 0950. 1020 feeling fine.
Extreme fatigue, headaches, and muscle aches for about 48 hours after I got the vaccine. I got the vaccine on the 13th, slept for 20 hours straight on the 14th and had a slight fever on the 15th. I took Tylenol for the entire time which provided some relief but that's about it.
Narrative: A 37-year-old B. Male with PMH of shoulder pain, bursitis, palpitation, chronic sinusitis, male hypogonadism, Migraine, anxiety, obesity, hyperlipidemia, thiamine deficiency, steatosis of liver, vitamin D deficiency, constipation and chronic PTSD on April 6. 2021, he was reported with a historical Johnson and Johnson covid-19 Vaccine induced fever, chills headache and body ache, which occurred on April 3, 2021, x1-2 days after the vaccine.
On same night, my BP was high. Checked BP and it was high 204/89 BP & and daughters went emergency with daughters. Medication to bring down. It took an hour for BP to go down.
PATIENT BEGAN EXPERIENCING ITCH, RASH, REDNESS IN THE RIGHT ARM A FEW HOURS AFTER VACCINATION.
Vaccine given out of local facility - reported by patient. J96.11- CHRONIC HYPOXEMIC RESPIRATORY FAILURE- 2/10/2022; J96.90- RESPIRATORY FAILURE, UNSPECIFIED ACUITY- 11/9/2021; R09.02- HYPOXIA- 10/26/2021
Tested positive for COVID-19, 3 months aver receiving 5th dose. Called doctor and was given the option to take PAXLOVID, but decided not to.
Hospitalized (11.5.21 -discharged 11/14/21; COVID-19 positive (11.4.21); Fully vaccinated  HOSPITAL COURSE: Patient is a 36 y.o. female with a known history of COPD, asthma, recurrent pancreatitis related to hypertriglyceridemia, type 2 diabetes uncontrolled, anxiety, depression, PTSD and morbid obesity who presented to the ED with three days of epigastric pain on 11/4/21. In the ED, she was tachycardic with VS otherwise stable. Labs notable for Na 127, glucose 318, TG 2540. COVID PCR was positive. CXR showed no acute pathology. CT abd/pelvis showed inflammatory process in the distal duodenum, pancreas head and uncinate process with a fluid collection. Patient was given 1L IVF and admitted for abdominal pain 2/2 possible pancreatitis.   Upon admission, she was evaluated by the GI team who recommended treatment of hypertriglyceridemia with insulin gtt as well as ongoing IV hydration.  She remained on insulin drip for several days with improvement triglycerides. She was converted to BBI per DGMS recs and blood glucose remained stable. At discharge DGMS recommending resuming home insulin and oral antihyperglycemic regimen.   Regarding COVID, patient received monoclonal antibodies while on room air.  She was thought to be nearing discharge when she began to require supplemental oxygen up to max of 6L.  There was concern for hypervolemia due to the amount of IV fluids she had received, but BNP was normal and CXR without evidence of pulmonary vascular congestion.  Patient was started on remdesivir and Decadron. Completed 4 days of therapy. Oxygen was able to be weaned off completely during the day but she continued having mild desats at night on overnight oximetry study. She is in process of being diagnosed w/ OSA and has follow up sleep study scheduled. Home Oxygen was prescribed for NC 2L at night. Patient discharged with instructions to follow up with DGMS and PCP outpatient. Patient in agreement with discharge plan and discharged in stable condition.   CONSULTS / RECOMMENDATION:     Consult Orders (From admission, onward)                   CONSULT TO DIABETES & ENDOCRINOLOGY      Provider:   DO        CONSULT TO GI      Provider:   MD
The patient signed up to receive the Updated Bivalent booster but was accidentally given the Origianl Pfizer vaccination instead. No adverse reaction was reported.
Pt recv vax on 12/21/98; on 12/22/98 pt exp sore vax site w/ redness, hard, warmth; tx=Benadryl, ice, Cetaflexin
Pt developed symptoms of Henoch Schonlein purpura 48 hrs after vaccine.
High blood sugars, unable to control when my sugars are normally under control.  I usually run in low 100s, sugars up into 300s unexplained.  At this point, two weeks later they are starting to come down some.  I have talked with others and 4 others I know have had similar issues.
Covid-19; Covid-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Jun2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Lot number: 013M2A), in left arm, on 10Mar2021 as dose 2, single (Lot number: 026A21A), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Jun2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 04Nov2023 to 09Nov2023. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300369161 same patient, different drug/event;
Blood clots in her lungs; blood clots in legs; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY THROMBOSIS (Blood clots in her lungs) and THROMBOSIS (blood clots in legs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 042B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PULMONARY THROMBOSIS (Blood clots in her lungs) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (blood clots in legs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in December 2021 due to PULMONARY THROMBOSIS and THROMBOSIS. The patient was treated with RIVAROXABAN (XARELTO) at an unspecified dose and frequency. At the time of the report, PULMONARY THROMBOSIS (Blood clots in her lungs) and THROMBOSIS (blood clots in legs) outcome was unknown.            No concomitant medications were reported.  Company comment- This is a spontaneous case concerning a 74-year-old female patient with no medical history reported who experienced the serious (hospitalization and medically significant) and unexpected AESI thrombosis and pulmonary thrombosis 2 weeks after a booster dose of mRNA-1273 vaccine was administered. Patient was in the hospital with blood clots in her lungs and legs and was treated with Rivaroxaban. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no medical history reported who experienced the serious (hospitalization and medically significant) and unexpected AESI thrombosis and pulmonary thrombosis 2 weeks after a booster dose of mRNA-1273 vaccine was administered. Patient was in the hospital with blood clots in her lungs and legs and was treated with Rivaroxaban. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient reports approximately 1 week after vaccination noticing tingling sensation to right upper lip. This was mild and persisted for a few days. He noticed a few days later that when he went to drink water it drippled down his right cheek, as if he could not close his lips completely on the right side. This continued for 1 day, then improved and has now resolved. Never had any other facial paralysis and was able to completely close his right eye. He did not seek medical attention for this. He went for his follow up vaccination dose and was turned away when he brought up these symptoms, and made appointment with myself at his PCP office.
Extreme tiredness/fatigued within the hour.  A few hours later, chills and dull headache.  By evening, severe body aches. Middle of the night, woke up extremely thirsty (dehydrated), and with a slight fever of 100.7.   Took two Advil at the time.  Following day, body aches, slight temperature (99.7), and intermittent headache.  Dehydrated.  No chills. Took two Advil by mid afternoon.  Started to feel better by early evening, but still feeling sluggish; tired.
2-3 hours after receiving vaccine developed tightness in chest, coughing, zero wheezing or edema in face, throat.  Seen in ED, no treatment. Fine 24 hrs later.
Information has been received from a Registered Nurse concerning a 66 year old male patient with asthma, chronic obstructive pulmonary disease and no drug reactions/ allergies, who in 2005 was vaccinated subcutaneously with one 0.5 ml dose of PNEUMOVAX 23. On 27-APR-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # 665400/1315Y). On 29-APR-2010, the patient called the office because she was experiencing an injection site reaction involving itching, swelling and pain. The patient was told to treat the area with ice and over-the-counter anti inflammatories. On an unspecified date, the patient recovered. No laboratory diagnostics studies were performed. Additional information has been requested.