chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt very sick could not get out of bed. Then I started to have chest pain. On June 10th i had a stent out in my LED. Freak incident with no explanation
itching at injection site; stinging; joint pain/ she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; she was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms, and had headaches.; headache; pain at injection site; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Left on 24Jun2021 16:50 as a single dose for covid-19 immunization. Medical history included anaemia -diagnosed in 2017 or 2018. She really wasn't taking anything, her doctor had put her on allergy pills, but had not been taking it the two weeks leading up to the second dose. He has iron pills, but clarifies she's been off of them, and hasn't been having to take them now, for about four weeks. She clarifies the anemia has been on and off, severe, since maybe 2017 or 2018. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took iron. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:43 as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks and no AE(s) following prior vaccinations. She clarifies arm kind of itches, and she is wondering if she can put some alcohol on her arm. On 25Jun2021, Saturday (24-hour clock, unknown time, earlier in the day), she had joint pain and a headache, and it's a little better. She was having pain throughout her body, a shooting pain in her wrist, feet, shoulders, arms and pain at injection site. On 27Jun2021, now at the site where she had the shot, it's itching, she almost feels like she wants to scratch her arm. She has experienced itching at injection site, and "feels like it's stinging" at injection site. Caller was asking if she can put alcohol on her left arm for complaints of itching and stinging. The patient was treated with a BC Powder, a packet of powder, individual packet, took it on 25 Jun2021 for the pains throughout her body and headache. The adverse event did not require a visit to emergency room and physician office. Therapeutic measures were taken as a result of headache and stinging (pain). Outcome of the event stinging, itching at injection site was not recovered; headache, arthralgia was recovering; pain at injection site, pain in extremity was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Charlie horse; It's almost like when you get stung and have an allergic reaction; didn't sleep the whole night; red splotchy; headache; temperature of 101; not feeling good; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), NECK PAIN (neck ache), MUSCLE SPASMS (Charlie horse), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction) and INSOMNIA (didn't sleep the whole night) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced MALAISE (not feeling good), NECK PAIN (neck ache), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction), INSOMNIA (didn't sleep the whole night), RASH MACULAR (red splotchy), HEADACHE (headache) and PYREXIA (temperature of 101). On an unknown date, the patient experienced MUSCLE SPASMS (Charlie horse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of before and after receiving that dose and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling good), NECK PAIN (neck ache), MUSCLE SPASMS (Charlie horse), VACCINATION COMPLICATION (It's almost like when you get stung and have an allergic reaction), INSOMNIA (didn't sleep the whole night), RASH MACULAR (red splotchy), HEADACHE (headache) and PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No history of organ transplant or immunocompromised condition was reported. She was on blood thinners.   This case was linked to MOD-2021-359999, MOD-2021-359904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received on 22-0ct-21 contain No new information since reporter was not able to open Follow up letter paper clip.
received 3 doses ofGARDASIL 9, on unspecified dates, that were all outside of the recommended schedule; No additional adverse event reported; This spontaneous report was received from a pharmacy intern and refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On an unknown dates, the patient received 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis, which were all outside of the recommended schedule of the prescribing information. No additional adverse event was reported.
Client is 15 years of age who got vaccinated. Clientt had no symptoms, side effects or adverse effects immediately after vaccination. Due to her age, client should not have been vaccinated with vaccine.
it really started on the 21st when I felt fatigue, wiped out ,runny nose, sore throat, and now I have a dry cough and I still feel it today 12/24/2020, I went to the dr on the 21st and they did not prescribe anything to me
She reported taking her Pfizer COVID shots and 2 booster, with second booster on 10/28/2021. At optometry visit 11/11/22, she was found to have vision loss in her left eye and have now progress to worsen in the right eye as well. This can potentially be one of the long-term adverse effect or complication after receiving the vaccine.
Received Novavax 17-OCT-2023; tested positive again 02-NOV-2023; Developed a cough; Tested positive for COVID-19; On 02-NOV-2023, this serious, initial spontaneous safety report was received from a consumer via a pharmaceutical company, and was received by Novavax on 07-NOV-2023.  An individual of an unspecified race, age, and sex was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 5 on 17-OCT-2023 at 11:00 AM.  Medical history included Drug hypersensitivity.  The individual was not taking any concomitant medications.  On 17-OCT-2023, the individual experienced vaccination failure (PT: Vaccination failure).  On 01-NOV-2023 18:00:00, 15 days after vaccination, the individual developed a cough (PT: Cough). On 02-NOV-2023, 16 days after vaccination, the individual tested positive for COVID-19 (PT: COVID-19), resulting in vaccination failure (PT: Vaccination failure) (Serious: Medically significant) on 17-OCT-2023. Treatment of COVID-19 included Paxlovid (nirmatrelvir, ritonavir) from 23-OCT-2023 to 27-OCT-2023.  Relevant lab tests included a negative SARS-CoV-2 test on 29-OCT-2023 and 30-OCT-2023, and a positive SARS-CoV-2 test on 02-NOV-2023.  On 17-OCT-2023, the event of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Cough and COVID-19 were unknown.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This individual of an unspecified age and sex experienced: Vaccination failure, Cough and COVID-19 after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Vaccination failure was assessed as serious. The events Cough and COVID-19 were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
The patients arm swelled up light a ballon. Immediately after the shot. Monitored for 10-15 minutes swelling went down and was advised to take a Benadryl
Patient was injected with saline.  Pharmacist on duty diluted empty vial with saline, then gave injection.  No Adverse reaction reported
Numbness and tingling throughout entire left arm; Tingling throughout entire left arm; Noticeable temperature drop in left arm; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 13Apr2021 at 06:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient did not have any allergies to medications, food, or other products. Concomitant medications included dexmethylphenidate (MANUFATURER UNKNOWN) since an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021 at 06:15, the patient experienced numbness and tingling throughout entire left arm and a noticeable temperature drop in left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events numbness, tingling and temperature difference in arms was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
CHILDS DOB LISTED ON CONSENT DOES NOT MATCH DOB IN DATABASE. CHILD POSSIBLY UNDERAGED FOR VACCINE.
Post vax, the pt developed dizziness, weakness, and nausea immediately after the vax and then the injection site became red and itchy in about 6 hours. Pt also complained of having a low-grade fever and felt like a lump is in her throat. Pt sought medical attention and was treated with Triamcinolone cream and Loratadine.
Breakthrough case after 4 vaccines  Moderna 3/13/21 Lot# 044A21A;  Moderna 4/10/21 Lot# 007B21A;  Moderna 11/22/21 Lot# 069F21A;  MOderna 11/4/22 Lot# 015H22A
I received dose #1 of COVID and planned to walk through the store to shop. While walking passed the observation chair, I began to feel dizzy and decided to sit down. After I took a seat, I immediately began to feel numbness in my arm which spread to my entire body. I was also feeling a piercing headache with ringing in my ears and my dizziness was extreme. At this point I called for help to the individual who had administered my shot as I had feared I would have fainted. I was in this extreme state for approximately 3-5 minutes. The individual at the pharmacy then checked in on me, gave me a bottle of water and after drinking it I began to feel better. I was then able to walk around and buy some food. Approximately 20 minutes after that event and eating and drinking some food, I felt like I was back to normal. I am writing this 5 hours later, and I currently feel normal, with some soreness in my arm I received the vaccine in.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (dose and route were not reported), lot # M020103 and expiry date: 15-FEB-2018 for prophylaxis. The vaccine was exposed to a temperature of 47.8 Fahrenheit for a time frame of 7 minutes. The call was because of a data logger and there were no previous temperature excursions. No adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Contusion - Patient inappropriately given 3rd shingles  vaccines without indication, and with secondary development of deep tissue contusion likely from vessel rupture
After 1.5-2 hours, my right ear start to pop every time i would swallow food/liquid. After about a week every morning ears started fealing stuffed and post 2'nd week right ear started to ring non-stop. It has been 11 days now my ears are continuously ringing
Site: Pain at Injection Site-Mild, Additional Details: The patient's skin and muscle were a little tough and when my intern went to adminster the vaccine the needle bent a little and was not able to admnister the vaccine.  I drew up a new dose with the vanish point needle and syringe and admnistered the vaccine to the patient.
4 month received Pediarix, Prevnar, Hib on 11/9/06. Then developed fever for 1 day followed by a diffused papular rash. Fussy but no upper respiratory infection symptoms.
Pt recvd 2nd dose of vax 3DEC92 & on 9DEC92 devel edema in rt upper arm; pt seen by MD & placed on unspecified meds;
Paralysis of right side of face. Unable to lift right brow. Unable to close forcefully right eyelid. Unable to lift right lip. Numbness of right cheek. Throbbing pain in back of ear, behind right neck close to skull, pain below right jaw, right cheekbone. Has not been treated. Pain has tamed down.
1) Fat necrosis-right thigh, 2) Superficial afebrile abscess, requiring incision and drainage (right thigh).
COVID-19 symptoms started on 04/15/2022, and I tested positive on 04/17/2022. It started out with post-nasal drip I thought was allergies, and then on the 17th it was a little worse and I took the antigen test to be sure and it showed positive and then I did a PCR and it was positive. On the 19th, I felt I had flu-like symptoms for 24 hours and 3-4 days following I had cold symptoms but no fever, but I did have congestion and tiredness. I tested negative on 04/27/2022.
patients that were vaccinated with this vaccine after the excursion; No adverse event; patients that were vaccinated with this vaccine after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On 10-Oct-2022 at 11:25 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Oct-2022 at 11:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion), POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patients that were vaccinated with this vaccine after the excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients that were vaccinated with this vaccine after the excursion).    No concomitant medication was reported.  No treatment medication was reported.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 01-APR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. The previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
During vaccine observation period, patient reports "heaviness of legs" and vision difficulties RN.  RN instructed to put patients seat back to rest and removed patient's seatbelt.  Patient began to convulse and was unresponsive to verbal stimuli for <1 min.  EMS was immediately called and arrived shortly after.  EMS assessed the patient who was AO x 4 after encounter with EMS.  EMS plan of care is have her take uber/lyft home.  Arrangements are made to pick car up next day at vaccination site.  Patient left without further incident.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. An elderly female patient of an unspecified age (above 65 years), race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date post vaccination the patient experienced redness and swelling around the vaccination site. Outcome was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016574242 Same reporter, suspect product, events, different patient.
Goose Egg; This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a adult 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 swelling. On an unknown date, the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The healthcare professional stated that, the patient had a goose egg that lasted for 2 to 3 days. The reporter did not consent to follow up. The healthcare professional declined to provide any additional information. The healthcare professional declined follow up regarding the case. This case is 1 of the 2 linked cases, reported by the same reporter.
Feeling tired, muscle aches, nausea, vomiting, difficulty breathing, dizziness, weakness, heartburn Medications given:  NaCl 0.9 %, ondansetron (ZOFRAN)  Rx for ZOFRAN ODT
I have had a very large red rash around the injection site for two weeks.  It is not painful, not itchy.  It is more pronounced sometimes than other times.  It is currently some 4 inches in diameter.  Yesterday it looked like a bullseye rash, pale in center, but today back to being  all red.
Patient Denies any Symptoms, Signs such as nausea, vomiting, headache, fever or allergic reaction.
HIVES X 2 WEEKS, TREMORS IN LEFT LEGX3WEEKS
This spontaneous report was received from a registered nurse concerning an unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 27-OCT-2016 (also reported as "after that date"), the patient were vaccinated with an unspecified number of doses of improperly stored of PROQUAD lot number L030584, expiration date: 10-FEB-2017 (strength, dose and route were not reported) for prophylaxis. It was reported that the sterile diluent (manufacturer unknown) did not undergo a temperature excursion. The temperature of excursion with  PROQUAD was 6 to 14 Fahrenheit degrees during 5 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by data logger. No adverse effects were reported.; Sender's Comments: US-009507513-1709USA008827:
Right arm completely swollen all the way to the fingers.  Whole hand on right side swollen for over 8 days.
Discharged. 91 year old female with past medical history of demential, HTN, hyperlipidemia, depression, afib, PVD, thyroid cancer who presented to ED, lethargy and hypoxia in setting of known COVID. Family elected to pursue comfort measures on admission and chose hospice and had meeting 1/25. Discharge back to community with hospice support arranged.
Six days post vax the pt developed 15 skin lesions and was afebrile.
PATIENT CAME IN TODAY FOR COVID VACCINE BOOSTER. REVIEWED PAPERWORK WITH PATIENT AND ADMINISTERED VACCINE. UPON DATA ENTRY, REALIZED PATIENT'S SECOND COVID VACCINE WAS ADMINISTERED 011122. PATIENT CHANGED D2 DATE WRITTEN ON FORM BY CHECK-IN TECHNICIAN TO 011121.
Stomach cramping and diarrhea, vomiting, couldn't stay awake, vertigo, falling, couldn't walk. Impending doom. I really felt I was going to die. Also, nothing got rid of my migraine that lasted 10 days.
Rash the size of a silver dollar at the injection site; It itches sometimes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash the size of a silver dollar at the injection site) and VACCINATION SITE PRURITUS (It itches sometimes) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-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 SITE RASH (Rash the size of a silver dollar at the injection site) and VACCINATION SITE PRURITUS (It itches sometimes). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 3 milligram. At the time of the report, VACCINATION SITE RASH (Rash the size of a silver dollar at the injection site) and VACCINATION SITE PRURITUS (It itches sometimes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.