chrisvoncsefalvay/vaers-outcomes huggingface dataset:
There is a like a red bruise thing that formed around where I got my shot; around where I got my shot and it hurts when I touch it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (There is a like a red bruise thing that formed around where I got my shot) and VACCINATION SITE PAIN (around where I got my shot and it hurts when I touch it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (There is a like a red bruise thing that formed around where I got my shot) and VACCINATION SITE PAIN (around where I got my shot and it hurts when I touch it). At the time of the report, VACCINATION SITE BRUISING (There is a like a red bruise thing that formed around where I got my shot) and VACCINATION SITE PAIN (around where I got my shot and it hurts when I touch it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-7-2021 contains no new information.
Rapid heartbeat, shortness of breath. heaviness in chest, headache, fatigue, soreness at injection site
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a four-years old male patient who was administered QUADRACEL twice. This was the case of actual medication error due to extra dose administered. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccination was given. On 25-Jul-2018, the patient received a fifth dose of 0.5 ml of suspect QUADRACEL lot C5248AA, exp date: 21-Aug-2019, via unknown route in unknown administration site. On 27-Jul-2018 the patient again received a dose of QUADRACEL lot C5248AA, exp date: 21-Aug-2019, via unknown route in unknown administration site. It was not reported if the patient experienced any adverse event. This was medication error case. Lab data and corrective treatment: not applicable. Event outcome: not applicable. 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. Documents held by sender: none.
PATIENT REPORTS BEGINNING TO FEEL PAIN IN THE LEFT ARM FROM THE SAME DAY OF THE VACCINE AND THE PAIN WAS INCREASED, FEELING THE HOT AREA AND ON THE THIRD DAY PERSISTENT PAIN, EDEMA, ERYTHEMA
Caused fatigue that I feel contributed to workplace seizure 2 weeks later. Resulting in need for medical evaluation. Other factors contributed to the fatigue.
Diarrhea - still on going @ 11:15AM. Chills, sweats, muscle aches, pain, headache.
approx 2-3hr post vax pt c/o soreness & redness @ the site;this cont x 2 days when MD was consulted;pt was placed on keflex & advised to use hot packs to arms;was told that it was cellulitis;
PROBLEMS WITH MEMORY AND TROUBLE REMEMBERING; FELT LIKE HE IS IN A CLOUD; SWEATING; CHILLS; VERY TIRED/FATIGUE; FEVER; This spontaneous report received from a parent concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced sweating. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced very tired/fatigue. On 25-MAY-2021, the subject experienced fever. On 27-MAY-2021, the subject experienced problems with memory and trouble remembering. On 27-MAY-2021, the subject experienced felt like he is in a cloud.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever on 27-MAY-2021, had not recovered from very tired/fatigue, and problems with memory and trouble remembering, and the outcome of felt like he is in a cloud was not reported. This report was non-serious.
Approx 24 hours after receiving Varicella and Tdap vaccine woke up with pain and neck stiffness and headache on left side - pain remained constant for over 48 hours but somewhat relieved (a lo'-relieved) with 1st dose of Advil; All symptoms gone by 2/10/08
Chronic tinnitus starting 11/3/2021 through 12/21/2021
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked with case 2019SA267191; 2019SA267208 ; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193 (same reporter)  This case involves a female patient (elderly) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this Flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccine was administered.  It was a case of actual medication error due to incorrect product storage.  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.  Documents held by sender: none.
pt recvd 1 dose of Engerix-B & 2 hrs p/vax exp generalized achiness, sore throat & fatigue;
post 24 hrs after administration , severe urticaria in head, face and neck and eyes with mild swelling to bilat eyes. took benadryl x 2 tabs during day and Claritin 1 tab. symptoms resolved later that night. no SOB
After 2nd dose of Pfizer at 8:30 pm on April 24 2021  I developed seizures  Taken to hospital via ambulance given Ativan to stop seizures, kept in hospital for 5 days
pt recv vax & approx 21 days post vax,devel greater than 200 lesions;pt recovered;antibody response to vax was unk;
I experienced pain at the injection site that lasted approximately 3 days. I also experienced body aches, fatigue, and diarrhea that lasted approximately 36 hours.
About 30 min after shot, experienced mild numbness and weakness in right hand that later spread to right foot that evening. Remained a mild sensation. The next day, Sunday, started spotting. Was not due for menstruated cycle and have never spotted like that. It lasted 5 days. Have continued to feel fatigued since. Has improved a bit. Have also had what I think to be brain fog and worsened anxiety.
Breast feeding; Sore arm; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tired). On 12-Mar-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tired) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   The patient stated that she was currently breastfeeding a 5 month old baby boy.   Treatment information was not reported.
Gums began swelling and bleeding on both doses. Lasted 4-7 days.  Constant headache that goes in and out of a migraine as well, after 2nd dose. Started day of vaccine and still continuing (2nd dose on 4/22, it is now 4/27). Flu symptoms from 2nd dose beginning about 5 hours from receiving vaccine, and lasted just about 48 hours.
Patient presented to the pharmacy to receive their Covid-19 Moderna booster vaccine, and communicated they had received their second dose on 8/13/21 on their consent form. At the time of their booster dose, it had been just over 4 months since they received their second dose. Staff didn't communicate to the patient that they needed to wait until 6 months after their second dose to receive their booster dose, and the booster dose was administered. No known side effects have been observed.
Pt stated to mother after leaving facility-she immediately felt a rush on left side of neck and head and vision in both eyes became blurry, Right eye cleared, left eye blurry all afternoon, Severe headache (took 3 ibuprofen tabs), nausea. Pt had not eaten breakfast.
This spontaneous case was reported by a consumer and describes the occurrence of MASS (She has a red clump), PRURITUS (Her left arm got itchy) and ERYTHEMA (Her left arm got red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (She has a red clump), PRURITUS (Her left arm got itchy) and ERYTHEMA (Her left arm got red). At the time of the report, MASS (She has a red clump), PRURITUS (Her left arm got itchy) and ERYTHEMA (Her left arm got red) outcome was unknown. Concomitant medication list was not reported. Treatment information was not reported
Morning dizziness (vertigo) starting 8 days post vaccine; Morning dizziness (vertigo) starting 8 days post vaccine; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 22Feb2021 at 10:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT) for unknown indication from unknown date and unknown if ongoing. 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 vaccination. The patient experienced morning dizziness (vertigo) starting 8 days post vaccine on 03Mar2021. It was unknown whether therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event morning dizziness (vertigo) starting 8 days post vaccine was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
the very next day and I am still little itchy; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number: EN6198) via an unspecified route of administration on 20Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number: EN6198) via an unspecified route of administration on 26Feb2021 (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation and experienced itchy rash all over her body and then another patch on her arm that actually black, patient had rash, red spot, or other rash all over her body and it was most severe on her right arm. On 21Mar2021, after second shot, the very next day, patient was still little itchy, the patch on her right arm appears to be getting better, that was improving. Patient's husband had some Lotrimin [corrective treatment], patient put that on there and that helps it. The outcome of event was recovering.  No follow-up attempts are possible. No further information was expected.
Petechial eruption started 2 days after MMR. Platelets decreased (thrombocytopenia). Checking labs weekly, platelets increasing weekly. Pt is expected to recover completely.
vaso response  . bp came up from70/30 to 110/60 . paramedics released pt to wife
Patient came to pharmacy on 09/27 and said she developed a rash after the flu shot & she had a rash covering upper right thigh. (from groin to knee ), flu like symptoms, chills. Fatigue.
Patient got both the vaccination at the same time on the same arm. After getting the shots as she was walking away she felt dizzy and lightheadedness. The patient has to sit on the floor with the help of her son and another customer also helped her. After sitting on the floor for about 10 minutes, she told she was getting better. Then the patient was helped to move to a bench nearby and she sat there for about 15 minutes. She told she is getting better. Then she went home with the help of her son.
Redness and inflammation at/near injection site. Pain at site on left arm. Benadryl Elixir and Tylenol.
experienced a sore arm; redness at the injection site which resolved; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site erythema to be related to Shingrix.  Additional details were provided as follow: The age at vaccination was not reported. The patient reported that after 1st dose of Shingrix, on an unknown date, she experienced a sore arm and redness at the injection site which was resolved.   The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2021015599.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021015599:Same patent 2nd dose, same reporter
No adverse event; 12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    No concomitant medications were reported.  No other adverse events had been reported. Date(s) of administration of vaccine on 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient).  The patients involved were all over the age of 65.   No treatment medications were reported.  This case contains information for the 3rd out of 12th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient 1
PATIENT RECEIVED MODERNA VACCINE AT 17YO. MODERNA IS APPROVED FOR AGES 18YO AND UP.
Face was sore and noticed drooping left side, tongue went off to the left, went to the hospital  where she got a stoke. TPA through IV.
Breakthrough COVID-19 infection in fully vaccinated individual;  covid + approx 4/25 per pt  (no result avail, no vaccine info avail), worsening fever, cough, chills, SOB for past week;
!st noticed a lump under her skin at TD injection site (left gluteus) on Saturday morning Oct 1/05. Began itching on Sunday Oct 2, ON examination of site red area 10 cm x 3 cm noted with dark purplish area in center about 1cm in diameter. Non tender to touch but itchy. Induration of 2 cm. Also noted. No other complaint (systemic). Also examined by Dr. Warm compresses at 15 - 20 min intervals. Benadryl PRN itching.
Parkinson's disease; This case was reported by a other health professional via patient support programs and described the occurrence of parkinson's disease in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced parkinson's disease (serious criteria GSK medically significant). On an unknown date, the outcome of the parkinson's disease was unknown.   It was unknown if the reporter considered the parkinson's disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date for Shingrix were unknown to the reporter. The patient experienced Parkinson's disease and had difficulty in receiving the 2nd dose of Shingrix for him and his wife. The patient asked for help as he had illness and was due for the 2nd dose of Shingrix in June 2019. The reporter did not agree to have GSK's safety team to follow up via postal mail.
Morning of 9-20-2014 started being very sore. Cannot sleep on that arm,. Slightly warm to touch. Yellowish bruise near arm pit. Red blotchy patches in right arm around admin site.
Headache, Myalgia, Fever,  chills, cold feet Cold feet, headache, chills, fever 106, myalgia; resolved 48 hours.
A serious spontaneous report of positive salmonella culture in blood and stool, bloody diarrhea and fever was received from a physician concerning a six-year-old male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received one dose of FLUMIST on 01-Oct-2008. The patient received a total of one dose before onset of the events 10 days later. On 11-Oct-2008 the physician reported her patient had symptoms of fever and bloody diarrhea. On 18-Oct-2008 the patient was hospitalized and noted to have positive blood and stool cultures for Salmonella. The patient was placed on intravenous antibiotics. it was reported that the patient is improving but remains hospitalized. The causality of the events to FLUMIST was not reported.  11/7/08 Reviewed hospital medical records of 10/18-10/23/2008. FINAL DX: salmonella gastroenteritis; bacteremia, resolved; diarrhea, resolved. Records reveal patient experienced HA, myalgia, fever & diarrhea x 7 days; developed bloody stools 10/13 & seen by PCP.  Peds ID consult done.
Patient received Proquad vaccine on 9/26. On 9/27 patient broke out in rash and was told to go to the ED. Patient was given steriods to take at home and was given dexamethasone at the hospital. Patient was seen at office four days later and was diagnosed with urticaria.
Swelling, redness, tender to touch, itching with distinct margins on right upper arm.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 19-year-old male patient who received MENVEO (batch number 151501, expiry date unknown). On 23 June 2016, the patient received MENVEO .5 ml. In June 2016, less than a week after receiving MENVEO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to MENVEO. Additional details were provided as follows: The healthcare professional reported that a number of patients received the MENVEO vaccine and experienced severe pain at injection site in the arm. The healthcare professional only had information for 3 patients, they all reported to have pain up to a week after administration. No expiration date was provided for the vaccine. This case has been linked with cases US2016099029 and US2016GSK102324, reported by the same reporter.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult female patient who received SHINGRIX for prophylaxis. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tiredness, weakness, injection site pain and headache. On an unknown date, the outcome of the tiredness, weakness, injection site pain and headache were recovered/resolved. It was unknown if the reporter considered the tiredness, weakness, injection site pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm and she experienced pain at injection site, headache, weakness and tiredness which lasted for total of 1 day. The patient had denied permission to contact their physician. The patient was referred to her physician. No further details were provided. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK192996.