chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE INDUCED CIDP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 09-OCT-2021, on the following morning post vaccination, woke up with a burning sensation in feet, which over the course of days and weeks spread to upward. The patient had followed numerous emergency room and medical appointments, patient was diagnosed with vaccine induced CIDP (chronic inflammatory demyelinating polyneuropathy). The patient reported that 1.5 years later, patient still had constant pain (intense burning, numbness, tingling) and only with great difficulty able to walk and climb stairs.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine induced CIDP. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230226361- vaccine induced CIDP. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED ACUTE RESPIRATORY FAILURE CARDIOGENIC SHOCK 3/4/2023  &  3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient complaining of tenderness/soreness in the injection site and radiating around to the back of the shoulder beginning shortly after receiving the vaccine and continuing x 1 month, recommended he follow up with primary care provider for evaluation.
Patient has pain radiating down arm and into neck that began 3 days after vaccination. Patient took Tylenol which did not alleviate the pain. Patient is still experiencing arm/neck pain 3 weeks later.
Vaccine (mandatory for my employment) given left arm at 1:10PM by nurse manager while on duty as an RN in hospital. During administration warmth was felt down arm but I was not worried. Within 10 minutes following I experienced numbness and cold sensation to left hand, arm, shoulder, neck, scalp, face, lips, inside mouth and throat. Strange taste to left side of mouth as well. I reported to ER at the instruction of supervisor and employee health at 2:00PM where I received an IV and 3 medications to treat allergic reaction at 2:15PM. Symptoms resolved by 3:00PM and I was discharged to home with 7 day course of all the 3 medications to prevent reaction from returning.
From the chest down patient was itchy; Second covid vaccine and booster caused aches and pains and flu like symptoms; Second covid vaccine and booster caused aches and pains and flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (From the chest down patient was itchy), PAIN (Second covid vaccine and booster caused aches and pains and flu like symptoms) and INFLUENZA LIKE ILLNESS (Second covid vaccine and booster caused aches and pains and flu like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ankylosing spondylitis.    No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced PAIN (Second covid vaccine and booster caused aches and pains and flu like symptoms) and INFLUENZA LIKE ILLNESS (Second covid vaccine and booster caused aches and pains and flu like symptoms). On an unknown date, the patient experienced PRURITUS (From the chest down patient was itchy). In 2021, PAIN (Second covid vaccine and booster caused aches and pains and flu like symptoms) and INFLUENZA LIKE ILLNESS (Second covid vaccine and booster caused aches and pains and flu like symptoms) had resolved. At the time of the report, PRURITUS (From the chest down patient was itchy) had not resolved. Not Provided          It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sore arm, cannot lift left arm; Heart beat accelerate; Very drowsy; Headache; Brain fog Chill;
Brittle nails; brain fog; lack of appetite; exhaustion; 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 ONYCHOCLASIS (Brittle nails), FEELING ABNORMAL (brain fog), DECREASED APPETITE (lack of appetite) and FATIGUE (exhaustion) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ONYCHOCLASIS (Brittle nails), FEELING ABNORMAL (brain fog), DECREASED APPETITE (lack of appetite) and FATIGUE (exhaustion). At the time of the report, ONYCHOCLASIS (Brittle nails), FEELING ABNORMAL (brain fog), DECREASED APPETITE (lack of appetite) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants was not reported.  No treatment medication was reported.  Patient had experienced  brittle nails, exhaustion, brain fog, lack of appetite.
Admission Date: 9/6/2022 Discharge Date: Sep 9, 2022  PRESENTING PROBLEM: Diabetic ketoacidosis with coma associated with type 2 diabetes mellitus (HCC) [E11.11] DKA, type 2, not at goal (HCC) [E11.10]   HOSPITAL COURSE: ICU Course: 30 year old male w/PMHx of HTG induced pancreatitis, HTN, and uncontrolled DM II who presented to the ED w/nausea and vomiting. On arrival to the ED, patient was noted to be tachycardic, hypertensive, and tachypneic. VBG 6.8/22/51. Other labs notable for mild hyponatremia, hyperkalemia, bicab of 3, hyperphosphatemia/magnesemia, elevated lipase, betahydroxybutyrate >9, leukocytosis, and lactic acidosis. Positive COVID PCR. ECG w/sinus tach w/PVC's. CTA thorax eval was limited, however, no central PE noted. CT abd/pelvis with pancreatitis and and peripancreatic fluid collection. Patient was given 2L IVF, started on Endotool, given Rocephin and Azithro, then transferred to ICU for ongoing care and evaluation.    Hospitalist Course: Pt had hypokalemia- aggressively replaced. For his DM II - Insulin drip briefly stopped due to persistent hypokalemia and later transitioned to Lantus. Transferred out of MICU on 9/8. His symptoms improved and electrolytes stabilized. On 9/9 - patient was tolerating diet, had no respiratory concerns and felt at baseline. He was placed with electrolytes, completed 4 days of IV Redmesivir for COVID infection.   His Diabetes medications were adjusted. Patient is discharged home in stable condition. He was directed to stop taking Jardiance.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 17:45 (Batch/Lot number: unknown) at the age of 35 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "mild pain and soreness due to the breastfeeding" (unspecified if ongoing), notes: mild pain and soreness due to the breastfeeding. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; IRON. The following information was reported: BREAST PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 11Mar2021, outcome "not recovered" and all described as "had mild pain and soreness due to the breastfeeding but after the vaccine, my pain aggravated in both breasts. had constant burning pain in both breasts"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Mar2021 17:45, outcome "unknown" and all described as "Breastfeeding since 4 months". The event "had mild pain and soreness due to the breastfeeding but after the vaccine, my pain aggravated in both breasts. had constant burning pain in both breasts" and "had mild pain and soreness due to the breastfeeding but after the vaccine, my pain aggravated in both breasts. had constant burning pain in both breasts" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast pain, condition aggravated. Additional information: List of any other medications the patient received within 2 weeks of vaccination: Prenatal Multivitamins, Vitamins, Iron 65mg and vitamin C. On an unknown date in Mar2021, the patient's ultrasound of breasts was nothing showed up in the ultrasound. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2021308283 baby case.
Right arm still hurts from shot; Blurienest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 10:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE, Lot number: Not reported, Vaccination Time: 10:00), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Apr2021, outcome "not recovered", described as "Right arm still hurts from shot"; VISION BLURRED (non-serious) with onset 28Apr2021, outcome "recovered" (29Apr2021), described ".  Additional information: Right Arm still hurts From shot - - as gone Away after one day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain with movement of my arm. I can't lift it without help from my other arm or in a controlled manner. It woke me up 3 times in the middle of the night just throbbing.
Just arm color and sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 12:15 (Lot number: EW0185) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2; Batch/Lot Number: Unknown; Location of injection: Arm Left), administration date: 20Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose 1; Batch/Lot Number: Unknown; Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "Just arm color and sleepy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence.  Additional information: The patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported just arm color (not specified) and sleepy. The patient had been tested for COVID-19 post vaccination he underwent Nasal swab (sample) test on 19Sep2021 with negative result.  No follow-up attempts are possible. No further information is expected.
patient was given 0.5ml of the liquid component of the Pentacel vaccine with no AE; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who received 0.5ml of the liquid component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ406AA, expiry date: 09-Oct-2021) via unknown route in the right thigh on 18-Nov-2020 for prophylactic vaccination (product preparation error).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and Rotavirus vaccine  It was an actual medication error due to Active ingredient not added to diluent (latency same day).  At the time of report, no adverse event was reported.  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.
A report was received from a health professional on 09Jan03, concerning a female vaccinee of unk age who was inadvertently administered Fluvirin instead of Tuberculin PPD ID while pregnant on 09Jan03. On 09Jan03 the vaccinee inadvertently received 0.1ml Fluvirin ID instead of Tuberculin PPD when pregnant. The vaccinee did not exhibit any signs or symptoms of an adverse reaction. There was insufficient information to determine the reporters causality assessment. Update 1 07Apr03: A report was received from a health care professional indicating that the 36 year old vaccinee  was 8 weeks and 3 days pregnant at the time of vaccination.
Hives, chills, hypertensive, bradycardia, pallor, felt like she was going to pass out
Information has been received from a certificated medical assistant also reported as "Office Supervisor", referring to 8 unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in June 2017 (reported as "from June 1, 2017 through June 30, 2017"), the patients were administered with improperly stored vaccines of ROTATEQ administered orally, lot # M038724 with expiration date on 24-APR-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. The vaccines has a temperature excursion of 35.1 Fahrenheit (F) during a time frame of 3 hours. It was confirmed that no previous temperature excursions occurred or a digital data logger was involved. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1707USA008450:
Patient called on 9/25/14 to report dizziness after receiving flu vaccine that had continued off and on for almost 24 hours.
Information has been received from a physician concerning her daughter who was vaccinated with a dose of VARIVAX (Merck). On an unspecified date the patient broke out in chickenpox. Subsequently, the patient recovered, unspecified medical attention was sought. Additional information has been requested.
Red, itchy, circle 2" diameter. Warm to the touch. Started 8 days after injection.
Reduced blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (Reduced blood pressure) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (Reduced blood pressure). At the time of the report, BLOOD PRESSURE DECREASED (Reduced blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Patient reported "I am 50 hours post thejab and am at mid 90's".  No treatment information was provided.
sore arm; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as unknown single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sore arm, sinus-type headache, and  fever  for approximately 7 hours.
Initial unsolicited pregnancy report received from nurse on 29 Mar 2016. This case involves a 33-year old female patient who was vaccinated with a dose of ADACEL (batch number: U5316AA, expiry date: 30 Apr 2018, site of administration not reported) by intramuscular route on 22 Mar 2016 while she was pregnant. Pregnancy information included last menstrual period: 06 Aug 2015, estimated delivery date: 27 May 2016 and pregnancy trimester: third and gestational period at exposure: 30 weeks. Medical history and Concomitant medications were not reported. It was reported that the patient had no health issues (current pregnancy history). At the time of this report, the patient had not experienced any adverse events. Pregnancy outcome was not reported. Follow up information received from nurse on 17 Jun 2016 and 20 Jul 2016. Patient's demographics were updated. It was reported that 0.5 ml ADACEL (frequency: once) was administered intramuscularly in right buttock. Pregnancy information: It was reported that patient did not have any history of previous pregnancy and this was her first pregnancy. Patient was healthy during pregnancy until 37 weeks of gestation. The patient had medical history of depression, obesity, Factor V Leiden, former smoker and alcohol user. Illness at the time of vaccination was reported as none. No other vaccines given within four weeks prior to vaccination. Patient did not experience any adverse event following prior vaccination. Concomitant medication included ASCORBIC ACID/BIOTIN/MINERALS NOS/NICOTINIC  CID/RETINOL/TOCOPHEROL/VITAMIN B NOS/VITAMIN D NOS (PRENATAL VITAMINS) once daily orally from first trimester to throughout delivery. On 30 Apr 2016, one month after vaccination, the patient developed gestational hypertension. Vaccine administered at inappropriate site and product use issue were considered as the vaccine was not administered in recommended site. Routine second trimester OB ultrasound on 06 Jan 2016 was performed and result was normal. Relevant laboratory tests for event and corrective treatment were not reported. The outcome of event gestational hypertension was not reported. Pregnancy outcome: Patient delivered a healthy female baby (weight- 3.825 kg, Apgar score 08/09 (at 1 and 5 minutes respectively) via caesarean section (LTCS - due to gestational hypertension and arrest of descent) without complications. No congenital anomaly or birth defect in the baby. Documents held by sender: none.
Left side numbness from face to lower extremity of vaccine arm. EMT noted no facial drooping, and reported symmetry. Patient reported as very anxious with uncontrolled HTN and anxiety. Pt with history of Bell's Palsy, denies SOB or lip/tongue swelling. EKG WNL. Transported per patient request.   See chronic conditions section for list of existing conditions.
Itching skin; Red rash on hand,Red rash on wrist; Fever 101.4 on Saturday, Fever 102 on Sunday, Fever of 100 on Monday; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching skin), RASH (Red rash on hand,Red rash on wrist) and PYREXIA (Fever 101.4 on Saturday, Fever 102 on Sunday, Fever of 100 on Monday) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M020A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no medical history provided). Concomitant products included ADALIMUMAB for Psoriasis, DULOXETINE HYDROCHLORIDE (CYMBALTA), GLIMEPIRIDE (AMARYL), FOLIC ACID, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), LEVOTHYROXINE, DULOXETINE, CITALOPRAM, POTASSIUM CHLORIDE, GLIMEPIRIDE, METFORMIN, METOPROLOL and CLONIDINE.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PYREXIA (Fever 101.4 on Saturday, Fever 102 on Sunday, Fever of 100 on Monday). On 02-Feb-2021, the patient experienced PRURITUS (Itching skin) and RASH (Red rash on hand,Red rash on wrist). At the time of the report, PRURITUS (Itching skin) and RASH (Red rash on hand,Red rash on wrist) outcome was unknown and PYREXIA (Fever 101.4 on Saturday, Fever 102 on Sunday, Fever of 100 on Monday) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
I had my vaccination on 10/08/2022. On 01/2023 I was on a cruise and I started sneezing with my nose running like a faucet. I tested COVID-19 Positive on 01/22/2023. I was prescribed Paxlovid. I did have COVID-19 in 2021 in which I was hospitalized and loss a lot of lung function. My hemoglobin is at 10 and I get tired really easily. I am still getting infusions and I am slowly recovering from the internal bleeding. My arthritis is flaring up as they have taken me off the blood thinners.
Information has been received from a physician concerning a 13 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (Dose #, lot #, site and route were not reported).  The patient was "shaking a little and then collapsed" after receiving the vaccine.  The patient sought unspecified medical attention by calling the office.  No additional information was provided.  Additional information has been requested.
1 day post vax-1 side of pt face not acting right-2wk later mom took pt to MD dx w/mild bell's palsy;pt had no prev head trauma or other event;mom feels side effect of hep B
Pt came to pharmacy on 4/13/19 and informed me that he had a reaction to SHINGRIX. He experienced chills, fever, muscle soreness. BP was 134/68, HR - 80 (on 4/12/19) on 4/13/19 - only soreness. 4/19/19 - contacted pt - did not experience any symptoms in a few days. No medical help. Tried to reach pt few times-no answer.
Pt has redness at site of injection and fever to 104.1 for 2 nights. The pt also has vomiting, diarrhea and anorexia. Supportive care was given.