chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; FLU-LIKE SYMPTOMS; This spontaneous report received from a physician concerned a 15 year old female. 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: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 03-APR-2021, the subject experienced flu-like symptoms. On an unspecified date, the subject experienced drug administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 04-APR-2021, and the outcome of drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Itchiness and Rash:  Multiple body areas:  between and under breasts, lower back area, under arms.  It was also on my left arm around the injection site but that has gone away.   Date of 1st dose:  1/8/2021 - ELO140 Date of 2nd dose:  1/29/2021 - EJ1686
Pt reports that 3 hours after receiving her vaccine she experienced rash to the upper extremities, chest, and cheeks.  As of 11/9/2021 she reported resolved course.  She denied any angioedema or difficulty breathing.
After my 15 min wait, I ate a yogurt and then my throat started feeling funny. A coworker told me I had hives. I couldn't swallow, couldn't feel my lips. I went back to where I received the vaccine and was given Benadryl. I waited 30 min and my throat closed again. I was given more Benadryl and I had to wait again. I eventually went home and slept the rest of the day. I woke up feeling like  I was hit by a bus. I was sweating with chills for two days.  I slowly got better. The muscle ache took longer to go away and I was eventually able to return to work on Monday. I was having problems with my throat. The allergy specialist had me doing breathing exercises and it eventually got better.
Sore arm and headache for 2 days Metallic taste in mouth for at least 3 days (not yet resolved)
admitted to hospital for COVID pneumonia, tested covid positive on 7/10/22.  started on remdesivir and steroids
Client received janssen vaccine and was dizzy after receiving the vaccine. Client was lowered to the ground with legs elevated.  clients vitals observed.  Clients vitals was within normal limits and client started feeling better. client position changed to upright and then on to chair. Client then complained of chest heaviness. Client was breathing and awake.  EMS was called. EMS arrived at 11:30am and client left with EMS at 11:40 am along with her parents.
Night of vaccines DTaP/HIB DOV 103 degrees irritability Next evening afebrile. NL exam happy playful.
no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 14-year-old female patient. The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was 02-AUG-2023 via Left Deltoid.     This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2309USA000746: US-009507513-2309USA000747: US-009507513-2309USA000744: US-009507513-2309USA000743: US-009507513-2309USA000745: US-009507513-2308USA001806:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-NOV-2014, an expired dose of ZOSTAVAX (lot # 0168AE, expiration date: 13-SEP-2013)(Dose and route not reported) was inadvertently administered to the patient. No adverse effects were reported. Additional information has been requested.
rashes and hives over his body; rashes and hives over his body; fatigue; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (rashes and hives over his body), RASH (rashes and hives over his body) and FATIGUE (fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included ROTIGOTINE (NEUPRO), CARBIDOPA, LEVODOPA (SINEMET) and LEVODOPA for an unknown indication.    On 15-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced URTICARIA (rashes and hives over his body), RASH (rashes and hives over his body) and FATIGUE (fatigue). At the time of the report, URTICARIA (rashes and hives over his body), RASH (rashes and hives over his body) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Burning, swelling, redness, itching in baseball size area of injection. Cortisone cream Sunday & Monday - Triamcinolone cream thereafter - did not use.
Patient received MMR/VARIVAX on 12/27/10 he developed fever of 10-102 on 1/3/11. Diffuse rashes (macular) started on 1/4/11. Rashes became generalized.
pediatric patient received an adult dose of Havrix; pediatric patient received an adult dose of Havrix; received / on March 25th, 2021 / first dose was given on November 2019; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-year-old male patient who received HAV (Havrix adult) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received in November 2019).   On 25th March 2021, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 25th March 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, adult product administered to child and drug dose administration interval too long. On an unknown date, the outcome of the overdose, adult product administered to child and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter stated that the pediatric patient received adult Havrix dose, which led to overdose and adult product administered to child. The patient received 2nd dose of Havrix, later than the recommended interval, which led to lengthening of vaccination schedule. No further information was reported. The reporter consented to follow up.
OBSTRUCTIVE SLEEP APNEA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Initial spontaneous report received from a consumer on 21 October 2013. A female received FLUZONE (Lot # and expiration date unknown) in 2013. Within 2 hours of vaccination, the patient had pain from shoulder bone to fingers and cannot pick up things. Documents held by sender: none.
Since early October, I have been having daily migraines along with feelings of nausea. It feels as if there is a pit in my throat that comes and goes throughout the day. A general feeling of uncomfortableness. The migraines are unbearable and frequent.
High fever ranging from 102-104, Lethargic, Pain, and Swelling. Treated with Children's Tylenol, did not bring relief.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot#, route and dose not reported). No concomitant medications were reported. No symptoms were reported. It was unspecified if the patient had sought medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Patient is a 84 y.o. female patient of a MD with history of breast and colon cancer, HTN, neuropathy who presented to a local Medical Center with generalized weakness and COVID-19 .   Covid-19 Virus Infection Date of onset of symptoms: 4 days ago Symptoms present on admission: cough, dyspnea on exertion Date of covid positive test: 7/23/2023 at 1701 Vaccination status: vaccinated Imaging: CTA - bilateral basilar infiltrates, however this was also seen on CT in 2013 Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: not indicated Consultants following: e-consult to ID for paxlovid Anticipated special isolation end date: evening of 8/2/2023 Discontinued Discontinued paxlovid as patient with hallucinations/paranoia Mentation back to baseline 7/26 Generalized weakness Pt having great difficulty walking over the last week, uses a walker at home Likely exacerbated by COVID-19 infection PT/OT and CM consulted; plan for HH Fall precautions   Ocular irritation Suspect dry eyes No vision impairment Artifical eye drops ordered Suspect this is due to paxlovid paranoia Resolved after discontinuing paxlovid 7/26   Abnormal CT abdomen History of breast and colon cancers Heterogenous enhancement of liver seen on CTA Completed treatment for breast CA in 2008, colon CA in 1992 per daughter Liver MRI without suspicious lesion   Hypokalemia K 3.3 Replaced and will follow   Primary HTN Continue home Dyazide, propranolol  As needed hydralazine ordered
Headache, chills, fever 103, joint pain, muscle aches, diarrhea. Treated at home with fluids, cool compress, rest, sleep. Still having symptoms.
Stomach still bloated, Stomach still gassy; Abdominal pain on her right side; diarrhea; Arm soreness; Redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (Abdominal pain on her right side), DIARRHOEA (diarrhea), ABDOMINAL DISTENSION (Stomach still bloated, Stomach still gassy), VACCINATION SITE PAIN (Arm soreness) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), AMLODIPINE, TURMERIC [CURCUMA LONGA RHIZOME] and MULTIVITAMIN [VITAMINS NOS].    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE PAIN (Arm soreness) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 10-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain on her right side). On 11-Jan-2021, the patient experienced ABDOMINAL DISTENSION (Stomach still bloated, Stomach still gassy). On 09-Jan-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain on her right side), ABDOMINAL DISTENSION (Stomach still bloated, Stomach still gassy), VACCINATION SITE PAIN (Arm soreness) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not 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.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: No specific follow-up information recorded.; 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.
Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unspecified dates, the patients were administered improperly stored VAQTA (lot # reported as L004559 with expiration date of 01-JUN-2017, strength, dosage, frequency and route unspecified) for prophylaxis which was reconstituted with sterile diluent. Sterile diluent was not involved in the temperature excursion. No adverse effects were reported. Temperature was from 9 to 25 degree C (9.7 degree C) for 30 minutes (refrigerated vaccine). There was no previous excursion. This is one of 4 cases received from the same reporter. Lot#L004559 is not valid for VAQTA. Sender's Comments: US-009507513-1708USA003787: US-009507513-1709USA001896: US-009507513-1709USA001897.
Pt noted redness and induration of (L) deltoid area 4 x 4 cm. Warm but not tender.
excessive thirst; experienced some arm soreness like all the previous doses; diarrhea; lost of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 23May2022 at 14:15 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "experienced some arm soreness like all the previous doses"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "experienced some arm soreness like all the previous doses"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): "experienced some arm soreness like all the previous doses". The following information was reported: DIARRHOEA (non-serious) with onset 24May2022, outcome "unknown", described as "diarrhea"; THIRST (non-serious) with onset 24May2022, outcome "unknown", described as "excessive thirst"; PAIN IN EXTREMITY (non-serious) with onset 24May2022, outcome "unknown", described as "experienced some arm soreness like all the previous doses"; DECREASED APPETITE (non-serious) with onset 24May2022, outcome "unknown", described as "lost of appetite".  Additional Information: Question: Call was transferred from another Dept. Caller states that she received the second booster dose Pfizer BioNtech covid vaccine on monday around 4:15 and experienced some arm soreness like all the previous doses. However she has also been experiencing other side effects such as excessive thirst, diarrhea and lost of appetite (she did not have these side effects with previous doses) and would like to know if its normal and if it was how she can treat it. Question: Caller would like to know how she can treat the diarrhea. Reporter related to a study or programme was reported as no. Other Conditions was Not Provided. Investigations was Not Provided. Other Products was Not Provided. Additional Context: Caller stated that she received the Covid 19 Pfizer booster second one on Monday afternoon. Stated that she was not sure that some of the side effects of getting diarrhea. Stated that she did not get this before and wanted to know how long does it last. Wanted to know if this was a normal side effect, how long it lasts and how to treat it. Stated that she had major loss of appetite. Stated that she had the vaccine at 14:15 on Monday and had no side effects until last night. Stated that she had all other Pfizer vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a little bit pink\ raised\ tiny bumps starting to appear on top of my shoulder; sore arm; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling), PAPULE (a little bit pink\ raised\ tiny bumps starting to appear on top of my shoulder) and MYALGIA (sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced PERIPHERAL SWELLING (swelling) and MYALGIA (sore arm). On 17-Aug-2021, the patient experienced PAPULE (a little bit pink\ raised\ tiny bumps starting to appear on top of my shoulder). At the time of the report, PERIPHERAL SWELLING (swelling), PAPULE (a little bit pink\ raised\ tiny bumps starting to appear on top of my shoulder) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment medications were reported.
Patient received vaccines on 09/28/2022 around 1:00 PM. Dad called and reported to Unit that pateint was having swelling and redness around his eyes with itching. Dad states that he starting complaining about itchy eyes around 09/28/22 around 8-9 oclock that night. Stated that throughout the next days he started having swelling and redness around his eyes. Dad gave him benadryl around 1:30 PM on 09/29/22 and ibuprofen later that night. States that he gave him another does of benadryl this morning on 09/30/2022. Patient continues to have symptoms.
Approx 40 minutes after given injection, developed rash on same arm and hand that had the H1N1 injection. BENADRYL given. Red and itchy.
Pt received varicella vaccine on 1-25-17. He noticed diffuse rash 10 d later on 2-4-17. Diagnosed with varicella by lab work.
Large red patch visible several hours after vaccine and persisting, still viable and itching 2 days from vaccine admin.  On the second day after dose, woke up with the red patch itching.  I have never had any reaction to annual flu vaccine since I started receiving them approx 13 yrs ago, including the high dose started 2 yrs ago.  I was previously dosed with Pfizer COVID Vaccine, 2nd dose in mid Feb 2021 height bruise at injection site for first, fatigue and aches 2nd dose) and dose of Pneumovax 23 vaccine (no reaction) in mid April 2021, 1st dose of Prevnar 13 In March 2020. (No reaction).
Ten patients were administered with the Moderna Vaccine that had suffered a temperature; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine that had suffered a temperature excursion (mRNA-1273) (product storage error).   The patients' medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not provided route of administration :unknown ) for prophylaxis of COVID-19 infection.  The vials that were affected due to the temperature excursions(product storage error) and there were 10 patients administered the vaccine (product storage error).  Treatment details Information Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of product storage error was recovered.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # unknwn with no associated AEs.
numbness on her right wrist and hands; tingling on her right wrist and hands; tightness of throat; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on her right wrist and hands), PARAESTHESIA (tingling on her right wrist and hands) and THROAT TIGHTNESS (tightness of throat) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Prochlorperazine Allergy). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced HYPOAESTHESIA (numbness on her right wrist and hands), PARAESTHESIA (tingling on her right wrist and hands) and THROAT TIGHTNESS (tightness of throat). At the time of the report, HYPOAESTHESIA (numbness on her right wrist and hands), PARAESTHESIA (tingling on her right wrist and hands) and THROAT TIGHTNESS (tightness of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.
Has history of tics-after the vaccines were given-within a few hours was having increased tics, tics almost were constant.
An 11 year old female pt with no significant medical history had received a dose of Menactra, lot number U1893AA, and a dose of Tetanus Toxoid vaccine, lot number AC52B006BA, on 6/26/06. The routes and sites of administration were not reported for either vaccine. The pts parent contacted the physicians office by phone and reported that the pt had developed a headache, malaise, low grade fever, lower extremity weakness and one day post immunization. The recovery status of the pt was not reported.
Immediate facial flushing, minor difficulty breathing that lasted approximately 48 hours.  Injection site pain, small (quarter-sized) rash right next to injection site.  1 week after injection, I developed lymph node pain, mostly in both underarms.  I had spotting the week prior to my menstrual cycle for (so far) two cycles.  Fatigue began about 2 days after the injection, and continues to linger.
No additional AE.; vaccine was administered after expiration; This spontaneous report was received from a medical assistant referring to a 7-week-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (strength was not provided), 2 milliliter, lot #1821791, expiration date: 26-JUL-2022, administered orally for prophylaxis (Expired product administered).  Product was not involved in any temperature excursions. No additional adverse event (AE) or product quality complaint (PQC). The vaccine was not available for return due to disposed. The adverse event was previously reported to doctor and manufacturer.
it hurts; it's itchy; My arm is turning red, it appears to be spreading; It's hot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (It's hot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (It's hot). At the time of the report, VACCINATION SITE WARMTH (It's hot) outcome was unknown.        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.   Patient's primary care physician told him to take Benadryl and put cortisone ointment on the injection site.
shortness of breath, some chest pain after each shot.  Received vaccine 2/17, 3/11, 9/25/2021.  Heart Cath performed with diagnosis of small artery disease.