chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of painful l arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2022, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced painful l arm. On an unknown date, the outcome of the painful l arm was not recovered/not resolved.   It was unknown if the reporter considered the painful l arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that the left arm still hurts 15 days after shingles shot. No further information was provided.
Patient had syncopal episode approx. 7-10 minutes post vaccination while sitting in waiting area. Partner reports patient had seizure-like episode and was shaking. Duration is unknown, partner reports about 30 seconds. Then notified clinic staff. Patient was brought into clinic room and had return of consciousness. She was diaphoretic, with cool and clammy skin. Kept laying inclined on patient on exam table for post monitoring. A/Ox3, vital signs stable. She reports hx of fainting in past post blood draw but has not experienced with vaccination. Skin tone returned to normal. Patient reports feeling better after post monitoring. Partner will transport home via personal vehicle.
Extremely exhausted starting the next morning 1/19/22 about 0800.  Shortly after that neck very stiff, and a headache started and the base of my skull.  Low grade fever of 99 degrees. (my normal temp is 97 degrees)  Then about 1:00pm, started getting nauseous and vomited 6 times about 2:00pm.  Whole body started aching shortly after.  Went to bed at 4:45pm with fever of 100 degrees, nauseous, stiff neck, entire head was throbbing, tightness in left chest, resting heart rate was 79 bpm (my normal resting is 60 bpm).   Was unable to take ibuprofen until 9:30 pm when nausea subsided.  Took 400 mg ibuprofen.    1/20/22 update: fever gone, headache gone but neck is still very stiff.  Still have a slight tightness in my chest, and this morning I am coughing.
she reports that she has this "phantom smell "after she had the second dose of COVID-19 vaccination.  Patient reports that maybe the symptoms started about a week after she got the second dose of the vaccination.  Patient reports that she had Moderna vaccination and after the second dose she has noticed random smells that is not present and she calls them "phantom smell ".  Patient reports that at times she smells smoking and burnt wax when there are no such items available around her.  No other symptoms available.  We discussed about getting connected with neurology to see if she should be getting any further COVID-19 vaccination.  Patient reports that she does not want any further evaluation at this time since she is uninsured and she will reluctantly know when she is ready.  She will think about it after she gets insurance.
patient only e liquid DTAP- IPV portion of Pentacel without mixing it with the powder Hib portion; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who recieved only e liquid dtap- ipv portion of pentacel without mixing it with the powder hib portion, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Sep-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number - U6138AB in left Vastus Lateralis.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was a case of actual medication error due to Inappropriate reconstitution technique.  No adverse event reported as none symptoms 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.
< 5 mins after received Hep A #2, HPV #2, MCV #1, pt c/o dizziness and became unresponsive slumped in chair. LOC about 30 secs, briefly awoke, then 2nd LOC x few seconds.
Diarrhea, fever, nausea and vomiting began 11 days MMR vaccine, 6 days after Varivax vaccine. The discharge summary states abdominal pain. Also states gastroenteritis and Crohn's disease.
pt recvd vax; pt cried for 4 hrs; pt was drowsey;
Pregnant female received LAIV H1N1 at flu clinic. Interpreter present. Not discovered until 10/30 when pt seen in MD office. 11/2/09:  Prenatal records received for dates of care 7/20/09 to 10/30/09.  Dx:  Pregnant woman received LAIV H1N1 Influenza Vaccine. Assessment:  Pregnant woman at 33 weeks gestation reported to her physician that she had received the LAIV H1N1 Influenza Vaccine at a mass flu clinic.
night sweats; irregular heartbeat; itchy; large welts/hives/hives on trunk of my body,and back of legs; Rash across my chest and rash all over my trunk and up and down my leg; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), HEART RATE IRREGULAR (irregular heartbeat), PRURITUS (itchy), URTICARIA (large welts/hives/hives on trunk of my body,and back of legs) and RASH (Rash across my chest and rash all over my trunk and up and down my leg) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (BP) since 1996 and Drug allergy (Allergy to Sulphur). Concomitant products included IRBESARTAN from an unknown date to 23-Jun-2021 for Blood pressure high, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), VITAMIN B12 NOS and HYDROXYZINE HCL for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced NIGHT SWEATS (night sweats), HEART RATE IRREGULAR (irregular heartbeat), PRURITUS (itchy), URTICARIA (large welts/hives/hives on trunk of my body,and back of legs) and RASH (Rash across my chest and rash all over my trunk and up and down my leg). The patient was treated with METHYLPREDNISOLONE ongoing from 17-Feb-2021 for Allergy, at a dose of 4 milligram; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 17-Feb-2021 at a dose of 10 milligram twice a day; OMALIZUMAB (XOLAIR) for Chronic idiopathic urticaria, at a dose of 300 milligram, 3 doses; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Jun-2021 for Hives, at a dose of 1 dosage form once and DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) on 15-Jun-2021 for Hives, at a dose of 1 dosage form once. At the time of the report, NIGHT SWEATS (night sweats), HEART RATE IRREGULAR (irregular heartbeat), PRURITUS (itchy), URTICARIA (large welts/hives/hives on trunk of my body,and back of legs) and RASH (Rash across my chest and rash all over my trunk and up and down my leg) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Full blood count: normal normal. On 31-Jan-2021, Urine analysis: high wbc count abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 20-Jul-2021. Events, patient information, treatment, and batch number updated.
exposed to chicken pox by sibling & came down w/chickenpox on 22MAR97;
Shortly after patient recieved vaccine she started complaing about itching in the lower forarm area on the same side of the vaccination site. a few hours later I called patient to check on her and she informed me that she had started to get numbness in her tongue and lower face, she had congestion and a headache and felt like when she was walking ar doing things around the house that her breathing was labered. she also stated that he had pain in her (R) ear for about an hour
Patient got dizzy, his skin was pale and clammy. He had itchy throat and cough. These symptoms happened about one hour after receiving the vaccine.
approx 10 mins p/vax pt fainted & hit the lt side of forehead on counter top as fell; pt went to ER & MD ofc where received sutures;
Redness and swelling at site of vaccine, rapidly progressing.  ER visit x 2, office visit x 1, admitted for IV antibiotics for cellulitis right thigh.
expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Neurological side effects.; So debilitated; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program. A young female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer covid vaccine in Feb2021 and she was so debilitated after the vaccine. Six months later she had neurological side effects. The events were reported as non-serious. The outcome of both the events was unknown.  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-202100951798 same reporter/ drug, different AE/ patient
7 days following the shot I had extreme fatigue, shortness of breath, GI issues, chest pain, sharp headache and extreme leg pain. Symptoms started about 6am and got increasing worse through the day. At night when I was in bed at about 6pm my legs and chest hurt so bad I couldn't take it, so that by 11pm I went to the ER.  Because of where we live in and it was a hot day, I suggested that I was dehydrated and never thought about the shot or that it might be side effects. I was treated with IV fluids and paid meds, I have given chest Xrays and it was determined I had inflammation in my chest. Once my PVCs were under control (I had been in bi-Gemini) I was released with Zofran and Tramadol. I have felt extremely tired since. And I am unsure if I should contact a health care provider.
Patient is 8 years DTap for 6 years and under should have got Tdap instead.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case pertains to the 123rd patient of the total 190 patients.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
01/05/23 presents with "cough, diarrhea". PMHx of "dementia, CKD, HTN, DM, psoriasis"
Puffy Lower Jaw; This spontaneous case was reported by a consumer and describes the occurrence of OSTEITIS (Puffy Lower Jaw) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced OSTEITIS (Puffy Lower Jaw). At the time of the report, OSTEITIS (Puffy Lower Jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. Treatment was taken with cetirizine and loratadine.
didn't feel the needle go in/no pin prick; This spontaneous case was reported by a nurse and describes the occurrence of MEDICATION ERROR (didn't feel the needle go in/no pin prick) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No adverse event history reported.  Concomitant products included LORAZEPAM (ATIVAN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MEDICATION ERROR (didn't feel the needle go in/no pin prick). On 18-Mar-2021, MEDICATION ERROR (didn't feel the needle go in/no pin prick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.; Sender's Comments: Very limited information has been provided for the event at this time.
Late onset soreness and 3 inch diameter swelling at injection site. Swollen, firm and warm to touch. No redness. No spread. Unresolved since onset (1.5 weeks).
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 10-weeks-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 25-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Constant dull aching pain in stomach and severe burning pain after eating anything; major bloating, gas, burping.
Horrible very loud high pitched tinnitus.  Its constant 24/7 it never stops
Since the middle of November, I've had post-menopausal uterine bleeding. I experienced heavy bleeding and clots. We were in another state for six weeks. During this time, I started feeling bad. When we got home, I laid low and stayed home. I felt tired. About a month ago, I continued bleeding heavily. Then, about January 13-14th, I was basically hemorrhaging. I tried to contact my Primary Care Physician. The next available appointment was April 4, 2023. I went to Emergency Room. They said I was severely anemic. They did a physical exam. The ER doctor found what she thought was a tumor on my cervix. I was also dehydrated. They gave me IV fluids. They contacted a GYN Oncologist for follow-up care. They also told me to contact my Primary Care Physician. The Oncologist did an exam and a biopsy of the mass. She scheduled me for a PET Scan and MRI. The biopsy showed the mass was a Uterine Serous Carcinoma. I have an appointment tomorrow to discuss further options. I'm still anemic, but I'm eating foods to try to help fix that.
Tues Nov 12-Following injection, patient talked with nurse and started to work. Patient began to fell bad-similiar to patient's twice a year sinus infections. As soon as patient got to work around 11 am, all patient could do was hand my sick leave request that just read "I feel terrible." Patient went home and stayed there. Patient was weak sick Tues, Wed, Thurs, Fri. Patient saw their doctor on Thurs Nov 15, patient physician diagnosed bronchitis. Antibiotic helped slowly. This was as bad as the flu.
chicken pox rash; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was unknown by the reporter.  On an unknown date, when the patient was 12-month-old, he was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, once, administered as routine vaccination (prophylaxis) (route of administration, lot number, and expiration date were not reported).  On an unknown date in 2023 (also reported as last week), he experienced chicken pox rash (varicella) which was initially thought to be a chiggers rash or poison oak rash since the patient was on a camping trip. On 02-AUG-2023, it was confirmed by the health care professional (HCP) that he patient experienced varicella. It was not reported if the patient received any treatment, or if he had laboratory diagnostics or studies performed for this adverse event. At the reporting time, the patient had not been vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX).  The outcome of the event, and the causal relationship between the event and the suspect vaccine were not reported.
Tightness in throat.  Swallowing a ?lump? feeling.  Breathing feels restricted.   Swelling & redness in vaginal area.
Lost of taste and smell.  I was negative for a COVID 19 test.  Severe body aches.
Fever Breast Discomfort/Pain Breast Mass. Sore to the touch.
Pt noticed the morning after the injection that her arm was very sore and lost range of motion. On 11/29/2014 the patient presented back to the pharmacy, still with very limited range of motion in the left arm and experiencing significant amounts of pain.
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in an unspecified number of the patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2016-2017 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2016-2017 season. Additional details were provided as follows: The age at vaccination was not applicable for this report. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for influenza were not provided. The healthcare professional reported that they found the patients who received flu vaccine early last year got the flu later in the season verses the ones who waited to receive it. No additional details provided by the nurse except that they were using GlaxoSmithKline flu vaccine last year.
Blood clot in her legs; This is a spontaneous report from a contactable other healthcare professional. A 40-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), oral from 2020 (Batch/Lot number was not reported; Expiration Date: 28Feb2023) to 2021, at 11 mg, 1x/day for psoriatic arthritis. It was unknown if the patient was pregnant. The patient medical history was not reported. Concomitant medications included metoprolol succinate, rivaroxaban (XARELTO) (20 mg tablet) and paracetamol (TYLENOL) (325 mg tablet). On an unspecified date in May2021, the patient experienced blood clot in her legs. The patient reported that she developed blood clots in her legs, went to the emergency room in early Jun2021. She further stated that she has been followed by vascular MD that currently have her off all her prescription medications except the anticoagulants. She also stated that the doctor said it was hard to tell what caused the clots since she was taking birth control, xeljanz and also had her covid vaccine around the same time. She was off xeljanz until cleared by vascular MD. Prescribing MD aware. The clinical outcome of the event was reported as not recovered.  Follow-up attempts are needed. Information on the lot/batch number has been requested.