chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADR occurred prior to arrival. NKA. PT presented to ED 1/25/21 with nausea, decreased appetite that is documented to have started 2 weeks prior. PT received first Moderna Covid vaccine 1/6/21.  Documentation in ED record notes patient tolerated Covid vaccine fine. No fever or chills, no vomiting or diarrhea. Patient was treated with normal saline bolus and discharged home same day with instruction to follow up with PCP. .PT seen by CNP 2/2. Documentation notes PT ?started prior to vaccines and became more severe after vaccine?. Documentation notes ?rash and then symptoms worsen. Took allergy relief".
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose, refer case US2019042943). On 11th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th September 2018, 8 hrs after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy were recovered/resolved.  It was unknown if the reporter considered the pain in arm, influenza-like symptoms, general body pain, fever, chills and lethargy to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The registered pharmacist reported having a pretty healthy immune system and describes experiencing a sore arm about 8 hours after receiving SHINGRIX and then for about 24 hours she experienced flu like symptoms including body aches, fever, chills, and lethargy. The symptoms were worse with dose 1 when compared to dose 2. The lot number and expiration date not available. The reporter consented to follow up.
(Swelling and hot to touch) Received flu shot on Tues. 1/10/17. Extreme burn was felt when administered. Pain progressed on 1/11/17 to the point my hand and arm was tingling and burning pain shooting to injection site.
MALAISE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included left rotator cuff injury, left rotator cuff surgery, right rotator cuff injury, diastolic heart failure, cervical spine fusion, fell, and shortness of breath, and concurrent conditions included pain and stiffness in all joints, problems with usual activities like laundry, problem in walking longer distances or with stairs, pulmonary hypertension, and fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks from 05-JAN-2021 to 07-APR-2021 for psoriatic arthritis. No concomitant medications were reported. On 2021, the subject experienced fatigue. On APR-2021, the subject experienced malaise. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, malaise, and headache. This report was non-serious.
Sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 19:30 (Lot number: ER8733) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gallbladder removal", start date: 2008, stop date: 2008, notes: Pertinent Details: Organ removal; "gestational diabetes", start date: 2013, stop date: 2013, notes: Pertinent Details: stopped after birth; "gestational diabetes", start date: 2016, stop date: 2016, notes: Pertinent Details: stopped after birth; "Ablation", start date: 2020, stop date: 2020, notes: Pertinent Details: Done. Family history included: "breast cancer" (unspecified if ongoing), notes: Mother died at breast cancer at age 50; "diabetes" (unspecified if ongoing), notes: Father had history of diabetes and heart issues died at age of 76; "heart issues" (unspecified if ongoing), notes: Father had history of diabetes and heart issues died at age of 76. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time (24hr): 07:30 pm, Anatomical site of injection: upper left Arm, Route of Administration: Intramuscular, Batch/lot number: EN6204), administration date: 10Mar2021, when the patient was 43 years old, for COVID-19 immunisation, reaction(s): "Minor heart flutter". The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Sore left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that she only had heart flutters with the first vaccine. Dr. later said it was most likely anxiety induced and not from the vaccine. Second dose of vaccine was given on 31Mar2021 with no side effects except a sore, left arm.   No follow-up attempts are possible. No further information is expected.
After first dose I developed 3 small raised hives 0.5 mm in size on face; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously received MACROBID for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, after first dose, the patient developed 3 small raised hives 0.5 mm in size on face. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event "after first dose the patient developed 3 small raised hives 0.5 mm in size on face" was not recovered at the time of this report. The patient received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.
Serious flu like sypmtons (aka Covid sypmtons) started 6 hours after vaccination.  Severe body ache, headache, slight fever and chills.
BUD 04/07/2022 administered 04/08/2022 Pfizer advised actual BUD 04/09/2022 no further action required. Patient advised per store protocol
left and right  arm  hurts; eye twitch; arm started itching; pain under my right breast; redness at injection site; right arm hurts; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left and right  arm  hurts), MUSCLE TWITCHING (eye twitch), PRURITUS (arm started itching), BREAST PAIN (pain under my right breast) and VACCINATION SITE ERYTHEMA (redness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left and right  arm  hurts), MUSCLE TWITCHING (eye twitch), PRURITUS (arm started itching), BREAST PAIN (pain under my right breast), VACCINATION SITE ERYTHEMA (redness at injection site) and PAIN IN EXTREMITY (right arm hurts). At the time of the report, PAIN IN EXTREMITY (left and right  arm  hurts), MUSCLE TWITCHING (eye twitch), PRURITUS (arm started itching), BREAST PAIN (pain under my right breast) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown and PAIN IN EXTREMITY (right arm hurts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Concomitant medication was not provided.
pt recvd vax & immed redness w/in 20 min; subsequent swelling from elbow to shoulder; no oth sxs; hlthy child;
Large erythematous edematous patch surrounding the smallpox vaccine site, with slightly pustular plaque representing the vaccine site itself. Multiple other erythematous plaques and papules noted on the Upper extremities and lower extremities, and the trunk. On the hands, multiple erythematous targetoid plaques and papules noted on the dorsal and volar aspect of the hands and wrists.  TX- Tylenol for pain; Benadryl for pruritis.
17 Y/O PATIENT GOT A PFIZER BOOSTER WHICH IS ONLY RECOMMENDED FOR 18 Y/O AND ABOVE. PATIENT CURRENTLY HAS NO ADVERSE REACTIONS OR SIDE EFFECTS. WE CONTACTED PFIZER AND PER PFIZER  NO RECOMMENDATIONS RIGHT NOW BUT PFIZER SAFETY DEPARTMENT WILL CALL US BACK IF NEEDED.  PFIZER INTERACTION I.D NUMBER
pt recv vax 18JUN97 & 27JUN97 states was having severe joint pain & noc sweats which believed to be an allergic rxn to the vax;ER or MD visit was needed in response to the events but no treatment given;9JUL97 pt stated that was better;
pregnant received menquadfi with no reported adverse event; Initial information received on 12-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old female patient who was exposed to vaccine meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] in context of pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively.  The date of last menstrual period was Jan-2023. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Jun-2023, the pregnant patient received 0.5 mL dose 1 of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (batch number:  U7616AC; expiry date: 11-Apr-2025) via intramuscular route in left deltoid for Immunization with no reported adverse event (exposure during pregnancy) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event pregnant received menquadfi with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
This spontaneous report was received from a 58 year old female licensed practical nurse, reporting on herself, with asthma, congestive obstructive pulmonary disease (COPD), cramping, diarrhea and flushing all over the body to penicillin, hypothyroidism and drug reaction/allergy to sulfur. On 06-NOV-2014 the patient was vaccinated the second dose of PNEUMOVAX 23 (lot number not reported, expiration date 29-FEB-2016)(dose lot number and route were not reported) in the arm. Concomitant therapies includes bunchu, juniper, parsley, potassium gluconate, BASIC WATER PILL, thyroid, asthma and COPD unspecified therapies. Historical drug includes the first dose of PNEUMOVAX 23 in October 2005. Licensed practical nurse reported she was admitted to the Hospital on 05-NOV-2014, for asthma exacerbation (MARRS 1411USA009421). Licensed practical nurse reported she was due for second PNEUMOVAX 23 shot and was administered it about "5 inches below my deltoid in the biceps area" on 06-NOV-2014. Licensed practical nurse reported the muscle in her arm was"killing her and killing her up her neck, shoulder, and on the left back side of her scapula". Licensed practical nurse reported her arm was swollen and it felt "knotted, intense and hurts really bad". Licensed practical nurse reported pain got worse and worse every day. Nurse reported she was discharged from the hospital on 08-NOV-2014. Licensed practical nurse reported she put ice on the area but it made the pain worse and so she applied heat. Nurse reported TYLENOL and ibuprofen did not help the pain. The licensed practical nurse reported she went to see her nurse practitioner last week who prescribed ULTRAM which did not really help but eased the pain. At the time of the report the outcome was reported as not recovered. Patient did not performed lab diagnostic studies. Patient sought medical attention. This is one (1) of two (2) reports from the same patient. Additional information has been requested.
I had rabies post exposure series - 2 gammaglobulin and 1st rabies 2/17/21; 2nd rabies 2/20/21; 3rd rabies 2/23/21; 4th rabies 3/3/21 - all given by Hospital ER (1st 3) and (last 3). On 8/11/21 I had a "full medical blood test" at which I requested to knowwhat my raboes titer was post injections. I was horrified to see when the results came back (analysed by Clinic) as </=0.1 (>0.5 is required for immunity). Why? The immunity shoud have been for 2y. WORSE, IF the Covid vaccination negated the immunity, MANY Vets and rehabbers nationally and internationally who potentially have no immunity without knowing. CDC, CMC Covid R&D, my GP and vet; waiting call back from Health. No one knows
Dizziness, Headache & Myalgia Narrative:  Other Relevant History:
Headache, Brain fog, disorientation, several hours after first shot. Brain fog and disorientation subsided two weeks after vaccination. Headaches are still recurring. Approximately one week after vaccination ear fullness, and tinnitus developed. Ear fullness has partially resolved. Tinnitus is still present 24/7 high pitch ringing. In both ears and head.
Started as a inch red welt day after injection. Over the course of 5 days has become 3 inches in diameter red welt/ induraction circle. Tender. Warm to touch.  Itching.  Treatments used ibuprofen, Tylenol, Benadryl.
small lump for the first 7 days after vaccine given. on day 8 deltoid that vaccine was given in became red, warm, swollen and itching. no other symptoms
I first felt dizzy, then nauseous, then started sweating. I told the EMT who then got a nurse. I was provided food and water. I then felt better in about 15 minutes.
The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; The patient was administered fluzone high dose quadrivalent accidentally instead of Fluarix, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional (Reference number- 00358654) and transmitted to Sanofi on 15-Nov-2020.  This case is linked to cases 2020SA324634, 2020SA324620, 2020SA324531, 2020SA324529, 2020SA324116, 2020SA323899, 2020SA323872, 2020SA323795, 2020SA323787, 2020SA323614, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 28 years old male patient who was administered 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ552AA, expiry: 30-Jun-2021) once dose via intramuscular route in the left arm for prophylactic vaccination on 05-Nov-2020 instead of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (wrong product administered, product administered to patient of inappropriate age and accidental overdose).  Medical history, medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose accidental (latency same day).  A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days. No adverse events (AE's) were noted and no treatments were administered to any of the patients.  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.
Pain, swelling and stiffness in wrist, fingers, knees and shoulders;  Malaise.
01/01/10 MOTHER REPORTED BY PHONE 2"x3" AREA OF HARD SWELLING, WARMTH & REDNESS AT INJECTION SITE ON LEFT THIGH. PARENT WAS ADVISED BY DR. TO GIVE 1TSP CHILDREN'S BENABRYL P.O. PRN. 01/04/10 PER MOM BY PHONE, AREA HAD INCREASED IN SIZE TO 4"x4" BUT SEEMED TO BE IMPROVING. MOM WILL CONTINUE BENADRYL PRN, BUT COME IN WITH PATIENT THIS WEEK FOR EVAL IF NOT IMPROVING.
started having high blood glucose readings requiring more insulin than previously; This is a spontaneous report from a contactable Other HCP (reported for herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Right leg on 01Jan2021 10:00 am (Batch/Lot Number: EL1284) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration, administered in Right arm on 20Jan2021 10:00 am (Batch/Lot Number: EL9261) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history Type 1 Diabetic on an insulin pump. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products: NKA. Concomitant medication(s) (received within 2 weeks of vaccination) included Insulin Pump, insulin aspart (NOVOLOG) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVAST) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered: Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced started having high blood glucose readings requiring more insulin than previously (non-serious) on 01Jan2021. Treatment was received for the adverse event. Patient stated that I am a Type 1 Diabetic on an insulin pump. I have in the past month started having high blood glucose readings requiring more insulin than previously. This seems to have coincided with the Covid vaccine. This has not been temporary.  Has this been reported by other Type 1 diabetics. Vaccine Facility information available. Ethnicity information is available. Race information is available. The patient underwent lab tests and procedures which included blood glucose: high on 01Jan2021 (high blood glucose readings). The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit intermittently for 120 days and also 15 to 46 degrees Fahrenheit for 1 hour. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected because no consent was given for further contact. Sender's Comments: US-009507513-1703USA013763.
Slight fever; Arm pain; Heart palpitations; Gained weight; Thyroid elevated.
Pain in Arm; Polyps; Hemorrhage of colon (Large intestinal hemorrhage); This is a spontaneous report based on the information received by Pfizer from AbbVie (Mfr. Control No: 21K-163-3835479-00). A contactable consumer (patient) reported for herself that A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8732), via intramuscular on 25Mar2021 (vaccinated at the age of 63 years) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date in 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg, 1 in 2 week for ulcerative colitis. Medical history included ex-tobacco user from an unknown date to 2014, former tobacco use: a pack of cigarette for two days or more (stopped 2014), started smoking in her early twenty's and alcohol use from an unknown date and unknown if ongoing, she started to drink on her late twenty's and a glass of wine four times a week. Concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT) taken for hypertension; lamotrigine (LAMICTAL), ziprasidone hcl (ZIPRASIDONE HCL), both were taken for bipolar; trazodone taken for sleeping; clonazepam (KLONOPIN) taken for anxiety; multiviti (TS NOS) and potassium taken as supplement; tocopherol (VITAMIN E [TOCOPHEROL]) taken for product used for unknown indication and for all Concomitants no start and stop date were reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EN6204) via Intra-muscular route of administration on 04Mar2021 for covid-19 immunisation. The patient experienced hemorrhage of colon (large intestinal hemorrhage) on an unspecified date in 2021, polyps on an unspecified date Mar2021 and pain in arm on 25Mar2021. On 17Mar2021, the patient underwent lab tests and procedures which included colonoscopy: several polyps, 6 polyps removed, humira helped her colon. The report received as, the patient stated that she had a colon bleeding for two weeks and stated that she did not take any medications for it and it just so happened that she already scheduled for routine colonoscopy. The patient stated that she did not missed or stop HUMIRA and just took it three days later after the colonoscopy as per her doctor instruction. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The report assessed as other medically important condition. Causality for event hemorrhage of colon (large intestinal hemorrhage) was not related, for polyps was as per reporter (drug/vaccine) and for pain in arm causality was probable. Outcome of the event pain in arm was unknown, event hemorrhage of colon (large intestinal hemorrhage) recovered on an unspecified date 2021 and polyps was recovered on unspecified date Mar2021.  No follow-up attempts are needed. No further information is expected.