chrisvoncsefalvay/vaers-outcomes huggingface dataset:
84 years old was vaccinated with Menactra, no AE; Initial information received on 02-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 84 year old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Exp. Date not reported) via unknown route in an unknown administration site for prophylactic vaccination in 2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that a patient who was 84 years old can have a second vaccination with Menactra, if his first (at another pharmacy) was done less than 30 days ago. He was at increased risk due to an infusion of Soliris he has to have 0.5 ml Menactra.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Vaccine administered on 8/7/06.  Next day, 08/08/06, under side of arm at injection site very sore requiring motrin.  On second day 08/09/06 patient awoke with swelling in armpit of injected arm and soreness in armpit so severe she could not rest her arm at her side and so was prevented from attending ballet camp.  Visited pediatrician on 08/09/06 and was advised to use hot compresses and take pain reliever.  Now 08/10/06 soreness and swelling have NOT abated.  Still requiring pain reliever which only reduces pain slightly.
sz activity noted by mom, including turning of the head neck to one side, rolling of eyeballs, flickering of eyelids for 10-15 seconds occurring 3-4times per day;also associated w/excessive sleepiness & diminished activity;sibling died SIDS
Pt recvd 3 vax of Hep B the 3rd of which was Engerix B & tested negative for anti hepatitis B surface antigen
Pt recvd vax & exp malaise, chills, weakness, tingling in lt hand, flu-like sx, nausea, loss of appetite, aching in arms, loss of strength in arms, irritability, agitation, inc HR, pain & soreness in chest, difficulty breathing & bronchospa
grand mal sz following vax #1 12noon;#2 3:30PM;#3 7PM;#4 930PM infant placed on phenobarbital;
upset stomach; Headache; fatigue; swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts and avocado allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (ADVIL) started on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 21Apr2021 at 22:30, the patient experienced upset stomach, headache, fatigue and swollen lymph node in left armpit. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The clinical outcome of the events upset stomach, headache, fatigue and swollen lymph node in left armpit was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Rash appeared on patient's upper torso right and left, underarms and on arms on 23 December 2002.  Patient received shot 21 Dec 2002.  Patient was seen by doctor and he recommended Allegra for possible histamine reaction.
01/06/2022 instant test and came out positive Called doctor for virtual visit and question for symptoms and called in antibodies in case she has an issue with discharge green from lungs of and infection cause of infection. Also called in nebulizer and inhaler that was not needed. Day in a half felt better and never ran fever. Runny noise, a sore throat, chest congestion, bad head ache, nausea and fatigue and lose bowels. Blood pressure was up and oxygen lever drop from 99 down to 90. Then in evening it raised to 95.
Swelling from shoulder to below elbow, erythema, hot started Thursday evening worsened on Friday. Pt applied ice and did not contact us until Monday, when symptoms were almost gone.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received Bexsero for prophylaxis. On 12th September 2018 10:00, the patient received the 1st dose of Bexsero (intramuscular). On 12th September 2018, less than a day after receiving Bexsero, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. It was unknown if the reporter considered the injection site pain to be related to Bexsero. Additional details were provided as follows: The case was reported by the patient's mother. The reporter stated that her daughter received a dose of Bexsero and was experiencing soreness at injection site. The patient's mother had denied permission to contact their physician. No further details were provided.
Child administered DTAP on 3/14/06.  According to mother, child developed redness and swelling the next day.  Redness and swelling increased over several days and Mother took child to Emergency Room.  Mother states her son was in ER for seven hours and then was able to return home.
Approx. 2min after vaccine was administered to the left deltoid, swelling/redness developed  (4cm diameter) at injection site. Patient was imediately given 50mg of diphenhydramine, the swelling/redness decreased in size, to 3cm, within 30 min. Patient sent home w/ 50mg diphenhydramine q6h x2d w/ 600mg ibuprofen q6h prn pain. Followed-up 3 days later, patient stated arm was still tender, slightly swollen and a bruised color; patient did not take any OTC pain medication or seek any other medical attention. Followed-up 5 days later, patient stated arm was still tender and turning a yellow color, pain was tolerable and she did not need to take any over the counter pain medication.
Patient arrived at emergency department 10/19/2022 with lower extremity weakness and difficulty with coordination. Patient was diagnosed with ischemic stroke, basal ganglia.
This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm shoulder on 08Feb2021 at 14:00 (at the age of 39-year-old) as dose 1, single to protect his family and himself from COVID/ COVID-19 immunisation. The patient's medical history included ongoing vertigo. He has had vertigo in the past due to concussion, but that was a while back. Maybe 7 or 8 years ago. Concomitant medications was none. Family medical history relevant to adverse events was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. It was reported that, patient confirmed vaccine as COVID-19 vaccine. He received it at Pfizer site. It was reported that, he just had vaccine yesterday the first dose. Pfizer vaccine. He was calling to report side effects. After the injection on 08Feb2021, within an hour, he started feeling like his body was hot. Then he started feeling dizzy, vertigo around four hours after vaccination on 08Feb2021. Vertigo was worse today. Dizzy was reported as worsened. Weight was 170 to 180 pounds. The adverse events did not require a visit to emergency room and physician office. No investigation assessment. The outcome of the event body was hot was resolved on 08Feb2021 and not resolved for the other events.  Follow-up attempts completed. No further information expected.~
Broke out in hives on shins, neck, scalp, upper back and forearms. The hives started after the first vaccine and got much worse after the second.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EPG955) via an unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 59-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included estradiol, norethisterone acetate (ACTIVELLA) from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 10:00, the patient broke out in hives on shins, neck, scalp, upper back and forearms. The hives started after the first vaccine and got much worse after the second. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of broke out in hives on shins, neck, scalp, upper back and forearms and included treatment with topical anti itch ointment and oral histamines. The clinical outcome of broke out in hives on shins, neck, scalp, upper back and forearms was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt was waiting in the exam room for the after vaccine period of observation. Pt reported at 1:20 pm (APPROXIMATELY six minutes after sitting in the room), that he had some numbness in his tongue and swelling of his lips. There was no prior history of this happening before. Pt was brought into the exam room and had a set of vitals taken with a quick examination. The mother of the patient expressed concern for the swelling in his lips. Patient was evaluated and given 50 mg of diphenhydramine.  Vitals were taken every 5-10 minutes.  Symptoms resolved about 20 minutes after the antihistamine was given. Patient obsrved for an hour.  No vital signs concerns.  No other symptoms.  Discharge instructions provided. No questions. Has remaining diphenydramine at release. Normal vitals. No problem breathing, swallowing and had resolution of his lip edema and tongue sensation concern resolved. Follow up if ANY concerns. HA are aware and will check with the patient later. D/C to home.
No adverse effects were reported; the patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant, regarding a 12-month-old patient of unknown gender.   The patient's pertinent medical history, and previous drug reactions or allergies were not reported.   On 11-NOV-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (product storage error), as prophylaxis (lot number: S021925, expiration date:15-JUL-2021; strength, dose, route of administration and anatomical location were not provided). A properly stored sterile diluent was used to reconstitute the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX).   The aforementioned vaccine underwent a temperature excursion from 6 Fahrenheit (F) degrees to 14 F degrees (14F) for 5 hours; and from 15 F degrees to 46 F degrees (15.3F) for 1 hour and 15 minutes, as recorded by a data logger. There was no previous temperature excursion. No product quality complaint was involved. No adverse effects were reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004612:
could not walk, had to be carried to the vehicle; oxygen level had dropped to 85; felt weak; extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk, had to be carried to the vehicle), OXYGEN SATURATION DECREASED (oxygen level had dropped to 85), ASTHENIA (felt weak) and CHILLS (extreme chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack, Weight loss and Bypass surgery (15 Stems). Concurrent medical conditions included Diabetes.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk, had to be carried to the vehicle), OXYGEN SATURATION DECREASED (oxygen level had dropped to 85), ASTHENIA (felt weak) and CHILLS (extreme chills). At the time of the report, GAIT DISTURBANCE (could not walk, had to be carried to the vehicle), OXYGEN SATURATION DECREASED (oxygen level had dropped to 85), ASTHENIA (felt weak) and CHILLS (extreme chills) outcome was unknown.            Patient state they take around 20 different pills a day because of their heart condition (had a heart attack, a triple bypass and 15 stems) and diabetes, but were generally in good shape, and even lost weight intentionally for the diabetes.   This case was linked to MOD-2022-440706, MOD-2022-440854 (Patient Link).
Hello i gave the pfizer vaccine to a patient and they said their face hand and back felt numb; This is a spontaneous report from a contactable pharmacist. This contactable pharmacist reported for an unknown patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, pharmacist reported that after giving a Pfizer vaccination to a patient, patient complained their face hand and back felt numb for an hour until they left the clinic. Reporter urged them to go to urgent care, but they refused. Pharmacist wanted to know the protocol for numbness. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
C/o injection arm "numb. Upset stomach. Observation X 10 hours.
expired vaccine Injected to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine Injected to patient) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine Injected to patient). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine Injected to patient) 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.   No concomitant medications were reported by the reporter.  The reporter stated the patient was vaccinated with a dose from a punctured vial of Moderna COVID-19 Vaccine that had been sitting at room temperature since 11-May-2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up information contains no new information
Warm dark pink, light red rash left arm to the side of vaccine site 2 days after vaccine
LOCAL ERYTHEMA AND SLIGHT EDEMA AT VACCINE SIGHT. HARDENED AREA 3"-4" IN DIAMETER WITH ITCHING.
Patient claimed on 12/2/2017 that for a few days she had pain, swelling and redness at injection site  and arm. Slight flu like symptoms. It lasted a few days.
experienced a rash in her neck then in her chest and belly / new areas; This case was reported by a physician via call center representative and described the occurrence of rash zosteriform in a male patient who received Herpes zoster (Shingrix) (batch number NE49X, expiry date 23rd August 2022) for prophylaxis.   On 4th March 2021, the patient received the 1st dose of Shingrix. In March 2021, 72 hrs after receiving Shingrix, the patient experienced rash zosteriform. On an unknown date, the outcome of the rash zosteriform was not recovered/not resolved.   It was unknown if the reporter considered the rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's spouse. The patient received 1st dose of Shingrix and experienced rash on back, chest and belly on 7th Mar 2021. The patient stated that, the rash was ongoing, getting in new areas and looks like shingles.  No further information reported. The reporter consented to follow up
P/receiving dose of Td, pt exp sore arm which became red, swollen, & warm to touch @ inject site; lump size of a walnut devel @ site; since 2JAN90, pt devel multitude of sx-chest pain, h/a, sore throat, dizziness, malaise, arthralgias, temp
Patient's guardian provided inaccurate information regarding Patient's date of birth. The date of birth provided on the consent form, and subsequent identity verification steps, was incorrect. The correct date of birth was actually a year later making Patient only 11 years old, and an ineligible candidate for the Pfizer covid-19 vaccine. Patient received her first dose on 5/15/2021 and the second dose on 6/5/2021. No adverse effects were reported to my knowledge.
I was vaccinated with the 2nd dose of the vaccine at 3:25 pm on 4/3/2021. Later that day, maybe around 5pm, my lips and the inside of my mouth started to feel itchy with a very slight tingling sensation. This went away after about 3 minutes. When going to bed around 11:30pm, my mouth again felt itchy. I went to sleep and woke up at 3:10 am and the tip of my tongue felt numb with a fizzing sensation. It was more intense than what was previously felt before. The end of my tongue had both numbness and tingling. This subsided and went away after about 10 minutes. When I woke up in the morning the next day around 8am, I still had lingering feels of tongue tingling that have come and gone intermittently throughout the morning. My tongue also appears different than usual with it being slightly larger in size and with new ridges/grooves along the side of the tongue, bilaterally. Also noted was the slightest tongue deviation to the left along with subtle right sided facial droop, hardly perceptible.  Body aches and general malaise also present.
Felt "jittery" and experienced light sensitivity. Was evaluated and released. Two days later presented with acute upper respiratory infection symptoms. The following day experienced onset of urticarial that have persisted to present.
I95.89 CHRONIC HYPOTENSION 11/25/2022 ACQUIRED ARTERIOVENOUS FISTULA I95.9 HYPOTENSION 11/16/2022 ACQUIRED ARTERIOVENOUS FISTULA
12/22/21 Provider used HPI and A/P to determine LOS.  Physical exam limited given Telehealth, and was by observation only Has been feeling terrible chills, diarrhea Fever yesterday headache No cough Today  Is better Was able to eat today
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Physician. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization, first dose (Lot number: EW0162, expiration date: 31Jul2021) on 24Apr2021, second dose (Lot number: EW0168, expiration date: 31Aug2021) on 15May2021. Medical history included: diabetes, high blood pressure, cholesterol. Concomitant medications included: atorvastatin, glimepiride, lisinopril, hydrochlorothiazide, metformin. The patient was tested positive for COVID-19 after taking the vaccine on 17Jul2021. The reporter assumed that its delta variant but didn't know for sure. The patient was sequencing DNA sample.; Sender's Comments: The possibility of COVI-199, Vaccination failure, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Fever,  joint pain,  headache,  aches, burning eyes,  no taste,  lethargy
arm on the injection site was red; arm on the injection site itch a lot.; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm on the injection site was red, arm on the injection site itch a lot,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) arm on the injection site was red. arm on the injection site itch a lot.  Treatment details included not able to gather more information..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm on the injection site was red, arm on the injection site itch a lot,  was unknown.