chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inability to concentrate/focus; nose bleeds; Sore arm; nausea; overall feeling of out of sorts coming in waves; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 (Lot number: EW 0168) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; METOPROLOL taken for hypertension. Past drug history included: Iodine for Known allergies, notes: Iodine. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 13Aug2021 18:00, outcome "recovering", described as "inability to concentrate/focus"; EPISTAXIS (non-serious) with onset 13Aug2021 18:00, outcome "recovering", described as "nose bleeds"; PAIN IN EXTREMITY (non-serious) with onset 13Aug2021 18:00, outcome "recovering", described as "Sore arm"; NAUSEA (non-serious) with onset 13Aug2021 18:00, outcome "recovering", described as "nausea"; FEELING ABNORMAL (non-serious) with onset 13Aug2021 18:00, outcome "recovering", described as "overall feeling of out of sorts coming in waves". Therapeutic measures were not taken as a result of disturbance in attention, epistaxis, pain in extremity, nausea, feeling abnormal.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility COVID-19 vaccine was administered at Doctor's office/urgent care.  No follow-up attempts are possible. No further information is expected.
9 x 5 cm area of raised redness and pain left arm starting on on day 8
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Beginning sometime in June 2017, the patients were vaccinated with improperly stored ROTATEQ (lot # M035452, expiration date 04-APR-2018, lot # M041815, expiration date 28-JUN-2018) orally for prophylaxis. The vaccines were improperly stored in 1.3 degrees Celsius for 117 hours. There was no previous temperature excursion. No data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA012809: US-009507513-1708USA001216.
Days 1-3 arm soreness and swelling  Day 7: notice arm is still swollen  near injection site Day 8 and 9: itchiness and redness near injection site, swelling is still there, area near injection site is very very warm to the touch
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported). Concomitant therapies were not reported. The pharmacist reported that she heard from the patient when she came in for a flu shot that on an unspecified date she came down with shingles even after vaccination with ZOSTAVAX. The pharmacist did not have the patient's information since she was not her regular patient but she came in just for flu shot. The outcome of the event was reported as recovered on an unspecified date. The causality between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient complaining of numbness and tingling of extremities, muscle aches, lymphadenopathy. States neurologist diagnosed as "neuro/CNS reaction". Also diagnosed decreased sensation in feet, legs and arms and tingling. Patient also seen at ED and released without hospitalization.
Pt received Hep B #1 in her left arm at 1500 on 6/23/09.  The pt waited in the clinic 15 min (felt fine) and drove home (which is very close to the clinic).  The pt felt "kinda dizzy" but okay.  Within 45-60 minutes the dizziness was worse so the pt lled down.  Within 15 minutes she noted an intermittent, dry, hacky cough.  Within 30 minutes the cough was more constant and the pt felt that her throat "was itchy".  This prompted the pt to continually attempt to clear her throat.  She denied skin rash, itching, angioedema, SOB.  The pt decided to go to hospital ER.  She arrived at 5p.  According to the pt her VS were taken (and were stable), her o2 Sat was normal as were her breath sounds.  The pt was examined about 45 minutes later.  She symptoms were stable.  She was given BENADRYL 50mg IM.  After 15 minutes all of the pts subsided and she was discharged home.  Past medical history reviewed with patient.  The patient has not history of adverse events with prior vaccinations.  The pt has a history of skin rash when exposed to latex and swelling of the genitalia after the use of CERVADEL during labor.  Pt does take BENADRYL 25 mg for seasonal allergies (rhinorrhea, itchy watery eyes).  The pt had taken a BENADRYL at 0900 the day of the Hep B vaccination (6/23/09) The pt does not recall any exposure to new personal care products, new cleaning/laundry products or new clothing.  she had a cheeseburger, fries, onion rings and soda for lunch around noon,.  Symptoms:  Dizziness, Cough, dry, Pain.
2 patients received an expired flu from  last year, no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves two patients of an unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] expired from  last year on an unknown date (dose, route and site of administration, expiry date not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At the time of reporting, 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 holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
9FEB91 developed rash x 3 days, fever x 2 days; 11FEB91 given Penicillin inject for throat infection;
pt recv vax & approx 24 hr p/vax exp a vesicular eruption on the tip & sides of tongue;eruption subsided on approx 3NOV95, then reoccurred;it is now subsiding;
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Joint and muscle pain stiffness. Pain/stiffness  in arms and  hands delayed start after vaccination one week after
BlurredVision, Headache, Arthralgia, Fever, ErythemaMultiform, arm pain, Narrative:
Information has been received from a RN concerning a 58 day old female who was vaccinated with a first, second, third and fourth dose of hepatitis B virus vaccine rHBsAg (yeast) on 13Sep04, 10Nov04, 18Jan05 and 11May05 (lot645506/0309N), respectively. On 12May05 the pt developed a fever of 103F and hives. Unspecified medical attention was sought. At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 18-APR-2015, the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot # was not reported), 0.5 ml, subcutaneous (site of administration was not reported). (Merck) VARIVAX was exposed to -10.82 C for 7 hours. No concomitant medication was reported. No adverse effects were reported. Additional information has been requested.
Patient received dose #2 of Pfizer vaccine on 6/6/2021 @ Vaccination CLINIC and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/21/2021 as recommended. No adverse reactions identified on site.
Red rash, 2" in diameter, around injection site. Itchy; warm; firm. Muscle soreness near injection site.
Didn't affect her too badly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Didn't affect her too badly) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Didn't affect her too badly). At the time of the report, VACCINATION COMPLICATION (Didn't affect her too badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   This case was linked to MOD-2021-076591 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up information was received on 2 Jun 2021: included no new information.
Left armpit lymph node swelling; This is a spontaneous report from a contactable nurse. This 38-year-old female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL 3249) via an unspecified route of administration from 27Jan2021 at 09:00 am to 27Jan2021 at 09:00 am at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported as hospital. Patient was 38 years old and not pregnant at the time of vaccination. Patient's medical history included Grave's disease, factor 5 Leiden, Hashimotos, known allergies: PCN (dates unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EJ1685) via an unspecified route of administration from 06Jan2021 at 08:30 am to 06Jan2021 at 08:30 am at single dose (dose number; 1) on right arm for Covid-19 immunisation. Patient's concomitant medications (other medications in two weeks) included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), acetylsalicylic acid (ASA) and Vitamin D nos (therapy dates unspecified) for an unspecified indication. If other vaccine in four weeks; no. Patient experienced left armpit lymph node swelling on 28Jan2021 at 08:00 pm. Treatment received for adverse event was reported as no. Patient did not have covid-19 prior vaccination and was not tested for covid-19 post vaccination. The outcome of event was not recovered.
Rash and extreme itching over entire body (except for face and feet) blisters on tongue and inside cheeks.  It is starting to resolve today (Tuesday June 1) after starting oral Benadryl and topical hydrocortisone 1%/
Swollen lymph node at neck/shoulder of right side; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 23Aug2021 at 07:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 24Aug2021, the patient had swollen lymph node at neck/shoulder of right side. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node at neck/shoulder of right side was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
massive hair loss;instant loss of sections of hair approx 10 days p/vax;
pt recvd flu vax & devel non-serious self-limiting pericarditis & was adm to hosp;
Chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via intramuscular route of administration, on 22Dec2020 at 03:00 PM (at the age of 23 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Dec2020, at 03:00 PM, the patient developed chills, headache, fatigue 24 hours after the 1st dose. Treatment was received for the events chills, headache, fatigue 24 hours after the 1st dose included one Advil standard dose with relief. The outcome of the events chills, headache, fatigue 24 hours after the 1st dose was recovered on unknown date. Since the vaccination, the patient had been tested for COVID-19 (via saliva COVID test) on 30Dec2020 with negative result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Aug2021 12:00 (Batch/Lot number: unknown) as dose 1, single and administered in arm, administration date 12Aug2021 (Lot number: Ew0183) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: EAR DISCOMFORT (non-serious), VERTIGO (non-serious) all with onset 19Aug2021 12:00, outcome "recovering" and all described as "Vertigo, re occurs Vertigo with left ear discomfort". The event "vertigo, re occurs vertigo with left ear discomfort" and "vertigo, re occurs vertigo with left ear discomfort" was evaluated at the physician office visit. Therapeutic measures were taken as a result of ear discomfort, vertigo.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Device Date: 19Sep2021. The treatment received for the adverse event was Anniversary and deltasone.   Follow-up attempts completed. No further information is expected.
A few moments after the vaccine was given, pt began to faint and lose consciousness. After a few minutes, pt began to respond to questions, but appeared drowsy. He was also pale. He had not eaten all day and was given something to eat and drink.
He got his vaccine, had no symptoms, but then a week or so later he noticed hand swelling.  As time progressed he noticed rashes coming up in spots popping up on his hands (still there), a few on his legs.  He had a very bad itching on the top of his legs.  It even spread to his foot.  Then progressed to all over his body, and won't go away.  He is a shaved man and he now has darkness and spots on his head as well, as well as discolorations.  These are still present as well.  His hand cleared up some but nothing else has cleared.  He went to his doctor and they did not give him anything as they did not much and the vaccine had not been approved and told him to call us.  They told him to take pictures and just to tell us what happened to him.    His symptoms started with his hands with the first vaccine, and after the 2nd one is when the rest of his body was affected.  He did not take the booster due to his reaction.
Headache, 101 fever, large welt like looking thing about 2 to 3 inches below the injection that is very painful
This spontaneous report as received from a nurse refers to a 16 year old patient of an unknown gender. On 03-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
red spots over body; Itching; lips swollen; face swollen; hands swollen; red on cheeks; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH PAPULAR (red spots over body), PRURITUS (Itching), LIP SWELLING (lips swollen), SWELLING FACE (face swollen) and PERIPHERAL SWELLING (hands swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH PAPULAR (red spots over body), PRURITUS (Itching), LIP SWELLING (lips swollen), SWELLING FACE (face swollen), PERIPHERAL SWELLING (hands swollen) and RASH ERYTHEMATOUS (red on cheeks). At the time of the report, RASH PAPULAR (red spots over body), PRURITUS (Itching), LIP SWELLING (lips swollen), SWELLING FACE (face swollen), PERIPHERAL SWELLING (hands swollen) and RASH ERYTHEMATOUS (red on cheeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
was in the fridge for a couple of days before administration; received Shingrix instead of the intended Flu Shot; patient was 20 years old and not immunocompromised but inadvertently received Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 20-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-AUG-2023, the patient received Shingrix (left deltoid). On 24-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: received Shingrix instead of the intended Flu Shot) and inappropriate age at vaccine administration (Verbatim: patient was 20 years old and not immunocompromised but inadvertently received Shingrix). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: was in the fridge for a couple of days before administration).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and incorrect storage of drug were unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 A pharmacist reported that a patient was administered the reconstituted Shingrix after it was in the fridge for a couple of days before administration which led to incorrect storage of drug.  After gathering age for safety report, pharmacist reported the patient was 20 years old and not immunocompromised but inadvertently received Shingrix instead of the intended Flu Shot which led to wrong vaccine administered and inappropriate age at vaccine administered. The reporter wanted to know what happens after the 6 hours of the reconstituted Shingrix and did it break down or something.  The reporter did not consent to follow-up.
pt c/o numbness, finger tingling & pain in deltoid muscle in lt arm p/hep B; feeling nauseated, joint, dizzy, clammy, cold & looked very pale; stated just didn't feel good;
Patient complained of nausea and "feeling hot" 1/2 hour after self-reported first time flu vaccine. Asked to be seated and remove coat. Slightly diaphoretic. VS - 97/2 - 124/86 - 80/20. No vomiting, SOB, c/o itching or hives. After 30 min. pt. insisted on return to work. No exacerbation s/s. Instructed to call Dr. or go to ER with increase signs and symptoms. Pt. verbalized an understanding.