chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART BEATS FAST; TONGUE HAD A PRICKLY FEELING; BAD CHILLS; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included lymph nodes removed, and concurrent conditions included cancer, congestive heart failure, and heart beats fast. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced heart beats fast. On 02-APR-2021, the subject experienced tongue had a prickly feeling. On 02-APR-2021, the subject experienced bad chills. On 02-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad chills on 03-APR-2021, and had not recovered from tongue had a prickly feeling, heart beats fast, and fatigue. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 52-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
NOTICABLE SWELLING IN UNDERARM AREA OVER INTO LT BREAST,  VERY PAINFUL
Woke up Friday AM with fever 101.7, chills, bodyaches, fatigue, nausea, diarrhea.  Continued fever, chills, bodyaches and body stiffness through Monday night.  Saturday started developing mouth sores and swelling of the gums and the left side of the roof of my mouth extremely swollen.  Called DR and instructed to take a covid test.  Covid test was negative.  Met with my pcp and he started me on steroids, benadryl and magic mouth wash.
This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of LIQUID PEDVAXHIB lot# M027883, expiration date 15-APR-2019 or lot # M036058, expiration date 19-MAY-2019 (dose and route of administration were not reported) were administered to the patients for prophylaxis. On unknown dates, the doses were stored in the temperatures between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 284 hours. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported.  This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA003536:
No additional AEs; Caller reports vaccine administered after temperature excursion; This spontaneous report, as received from a Registered Nurse, refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 03-MAY-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant Human albumin) (PROQUAD), lot # U031560 upon internal validation established to be valid, with expiration date 06-APR-2023 (reported as 05-APR-2022), 0,5 ml administered subcutaneously (SQ) (exact anatomical location was not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 10 degrees Fahrenheit for 10 minutes (Incorrect product storage). There were no previous excursions, product quality complaints or additional adverse events reported (No adverse event).
Sept. 19, my husband, a neighbor and I got our seasonal flu shots at a pharmacy. We three had minor discomfort but 7 to 10 days after the injection, all three of us got pain in the arm and shoulder where the flu immunization was placed. My husband's shoulder still is sore and ibuprofen does not help. My pain went into my neck and shoulder. It was so severe, I had to get an epidural in the cervical spine. I still have considerable pain and numbness in my left hand. My neighbor still has twinges of pain in her shoulder. This is too much of a coincidence. 11/17/2009 ED records for 10/15/2009, patient with c/o's lt sided neck pain that radiates down into lt elbow, also back pain. Tx: triggerpoint injection (DEPO-MEDROL and MARCAINE) Dx back ache. 12/2/09 Medical records received for date 10/19/09. DX: cervical spondylosis, brachial neuritis. Presenting sx: bilat arm pain/numbness, extending down into thumb/fingers.
Systemic: Allergic: Rash Generalized-Medium, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Systemic: Shakiness-Severe, Additional Details: Lasted 28 hours for fever of 101.8. Joint/muscle aches. spasms.
Moderate lower back pain, requiring ibuprofen Moderate headache Gum pain Chills
Received a moderna vaccine and passed out about 5-10 minutes later. She was alert and talking then passed out for about a minute. I went out and she was breathing. Called 911. She woke up and vomited. Stated she felt better. Paramedics arrived and talked to her and took vitals. She opted to be taken to the hospital.
I had dizziness, slight headache, chills, body ache, fever, and severe headache. Then, I got breathing problems. My oxygen level dropped into the 80's. I was fatigue and just not feeling well. These lasted for about 7 days. On Jan 12th, I tested positive for COVID-19.
got sick and tested positive with COVID after getting the first dose of the COVID vaccine; got sick and tested positive with COVID after getting the first dose of the COVID vaccine; This is a spontaneous report from a contactable consumer received from Pfizer-sponsored program Pfizer First Connect. This consumer reported similar events for four patients. This is 3rd of four reports. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got sick and tested positive with COVID after getting the first dose of the COVID vaccine. The outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021013589 same reporter, same product, similar events, different patient.
Nausea, fever, chills, headache, body ache, swollen lymph node under right arm.
VACCINE WAS 2 WEEKS EXPIRED WHEN GIVEN TO THE PATIENT.  MANUFACTURER RECOMMENDATION IS TO REVACCINATE
Patient received flu shot and was counseled to stay and be observed for 15 minutes. Patient was going to area to wait and decided to look at products in the aisle. Within minutes of vaccine administration the patient fell to the floor and "blacked out"/fainted. Called EMS. By the time we reached him he was alert. He had hit his head on a merchandise table and had a small area of bleeding. Kept patient on the floor and put pressure on the cut. Stayed alert and bleeding stopped before paramedics arrived. Paramedics transported to local hospital. Followed up with patieny hours later and he was awaiting discharge from ER. He stated believed to be a reaction from dehydration and low blood pressure.
This spontaneous report as received from an office manager via a company representative refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not provided), for prevention of Human Papillomavirus. On an unknown date, the patient experienced an unspecified adverse event that required hospitalization. The patient recovered on an unknown date. The relatedness between the unspecified adverse event and GARDASIL 9 was not provided. Additional information is not expected, as there was no consent to contact the physician.
Initial sweaty and short of breath with pulse of 126 and oxygen saturation of 99%; rapidly improved with stable vital signs
7-18-08 Here a clinic for vaccines. Father sat out in hallway. 9:30 am while pt received vaccines. After last injection gave he went to stand up and fell to ground, face down. He was slouched over slightly, while sitting in chair before he was able to stand up, he fell forward on to a cushioned mat. Skin color was ashy. Body shook, eyes began to roll back, for approximately 15-20 seconds. Pt stopped shaking and was rolled over onto back and feet elevated on chair. Father came in when he heard nurse calling out for assistance for the immunization coordinator. BP-82/42, P 52, R=14. Eyes open and answering questions correctly, but slowly. BP=94/44, P=56, R=16. Skin color pale, resp easy. Reports ate cereal for breakfast and was not previously feeling ill, father reports pt had stayed up late, until 3 AM this morning. Watching movies. Prior to fall, immunization coordinator reports (L) eye toward bottom
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 PEDVAXHIB for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Additional information has been requested. Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA011858: US-009507513-1708USA011859: US-009507513-1708USA011856: US-009507513-1708USA008820.
My left arm exhibiting significant swelling, when compared with the size of my right arm is almost twice the size.  My entire arm is numb (I do not feel my arm), and I am pain when I touch the injection site and when I try to lift the arm. Additionally, I have a rash all over my body and severe headache that does not go away with over the counter pain medicine.  It is Friday night and I will wait till Monday to see a doctor if I am not back to normal.
Rash; woke up this morning w/itching. The rash appeared shortly after on her arms and back and now (3:24pm) is every where. It's very itchy. Received IPOL IM yesterday at 4:00pm.
This was the second time I had COVID-19. Runny nose, sore throat, headache, sinus pressure, temp increase to 101, joint pain. The symptoms still continue but are better. I still have sinus involvement and drainage. I was given PAXLOVID 5 day course. I was also taking ADVIL and both reacted badly. I would say that NSAIDs and PAXLOVID do not mix at all. As a result of both I got nausea, acidic diarrhea and upset stomach. I'm still tested positive today.
patient called pharmacy to report that she felt numb all over her body, and the symptoms started "about" a week after she got the Td shot.  She went to urgent care to try and get checked out, they gave told her to take Benadryl, which didn't help.  She was further advised to see her PCP for further evaluation.  She states she is looking for one and will make an apt to see her pcp soon.  By further talking with pt to get a better picture, she states that she called her mom and her mom told her she had the same problem when she got the tetanus shot, and advises her to "wait it out".   At our last conversation, pt stated that her symptoms are getting better by the day but still not feeling like herself before getting the shot.
At the end of the day on 7/14/22, I noted that the expiration date of the vaccine that was 7/9/22, which is 5 days past the date it should have been administered.  There was no treatment provided.
mechanical fall during transfer from chair to wheel chair with family assist post vaccine monitoring. Blood noted to right ear . Family states frail skin. EMS assisted. No further follow up required per EMS and family
Left arm "is muscle weakness, hurts to move". Patient feels hot, dizzy cap refill normal, can feel sharpness in finger tips 120/80 18RR 74HR alert:oriented x3.
Information has been received from a physician concerning a 27 year old female who was vaccinated IM with Gardasil. Subsequently the patient had pain syndrome described as myalgia and arthralgia. Additional information has been requested. Follow up information has been received from the reporting neurologist, concerning the 34 year old female patient who in January 2007 received her first IM dose of GARDASIL. The neurologist was not able to report lot number as she had received the vaccination from her OB/GYN. Concomitant therapy included ATIVAN. Within 2-3 days of the vaccination the patient experienced dizziness, headache, and myalgia. The neurologist performed a work up including an EMG, which was negative. In March 2007 the patient received her second dose of GARDASIL. The myalgias, dizziness and headache returned. By May 2007 the dizziness and headache resolved and the patient experienced the myalgia after exercise (and was still experiencing myalgia post-exercise at the time of reporting). Additional information is not expected.
Experienced chills and bodyaches throughout the following day with; Experienced chills and bodyaches throughout the following day with; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2022 at 13:00 as dose 1, single (Lot number: GJ6742) at the age of 53 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), PAIN (non-serious) all with onset 29Sep2022 at 12:00, outcome "recovering" and all described as "Experienced chills and bodyaches throughout the following day with". Therapeutic measures were not taken as a result of chills, pain.  Additional information: The patient had COVID prior vaccination and not tested for COVID post vaccination. No known allergies and no other medical history was reported.
Suspected myocarditis - had onset chest pain with positive cardiac enzymes that were persistent for 4-6 weeks with a drop in LVEF to 39% - catheterization does not show a lesion to account for this
Itching rash swelling in the throat eyes being all watery and goofy,- Treatment three Benadryl, Albuterol tablet
Fever of 101-102, lethargic, dizziness, extreme fatigue, body aches, shivering  Most symptoms subsided a few hours after taking Tylenol at 9pm on 1/7/2021. Body aches and mild lethargy as of 1/8/2021
Suffering from Chronic Lymphoedema for 40 years but after 3 days she got the 1st shot of the Moderna vaccine it went away; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Suffering from Chronic Lymphoedema for 40 years but after 3 days she got the 1st shot of the Moderna vaccine it went away) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Lymphoedema (Chronic Lymphoedema for 40 years).    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 THERAPEUTIC RESPONSE UNEXPECTED (Suffering from Chronic Lymphoedema for 40 years but after 3 days she got the 1st shot of the Moderna vaccine it went away) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Suffering from Chronic Lymphoedema for 40 years but after 3 days she got the 1st shot of the Moderna vaccine it went away) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Patient received a Moderna Covid shot 3 years ago. Treatment information was not reported.
I am still Bleeding/Discharging Blood and this issue has not been resolved.  Have had steroid injection for hips and knees and am currently going to physical Therapy.
Information was received via Poison & Drug Center from a physician concerning a 26 year old female patient who started PROQUAD, once on 12-APR-2017, (lot # unknown), unknown dose and route, for work. Her relevant medical and past drug histories and concomitant medications are unknown. On 12-APR-2017, this 26 year old patient received her first dose of PROQUAD, which is outside of the age-range for this product. On 10-MAY-2017, after received her second dose of PROQUAD (lot #L045678; unknown dose and route), it was noticed that the vaccine expired on 09-MAY-2017. On 10-MAY-2017, at an unknown time and after being told it was okay, the patient received another, unexpired dose of PROQUAD (lot #M039914, expiration date 26-SEP-2018), dosage and route of administration not provided). Lot numbers and expiration dates for the diluents were not obtained. The physician reported that the patient did not experience any adverse events from the expired vaccine or the same-day revaccination. It is unknown if there is any relevant laboratory data. As of 10-MAY-2017, it is unknown if the patient will continue to receive PROQUAD; the patient did not experience any adverse events from the expired vaccine or the same-day revaccination, and the outcome of vaccination outside the age-range for the product is unknown. Lot #L045678 has been verified to be a valid lot number for PROQUAD. Lot #M039914 is an invalid lot number for PROQUAD. Additional information has been requested.
Initial unsolicited report was received on 10 November 2014 from a healthcare professional. A patient (date of birth was not reported) had received on an unspecified day FLUZONE Intradermal (lot number, route and site of administration not reported) and an unspecified amount of time later, experienced a large knot at injection site. The patient was taken to the hospital and was diagnosed with cellulitis. Treatments, concomitant medication and past medical history were not reported. Outcome was unknown. The reporter for this case is the same as for case 2014SA155798. Documents held by sender: none.
Redness about 8 inches in length & 4 inches in width. Very hot skin & painful.
patient states a few seconds  after receiving the vaccine she was light headed, and had a low grade headache. Later on that evening she began to have 1/10 central abdominal pain. C/o coughing spasm in the middle of the night that went away after a few minutes. Also c/o moderate fatigue.
patient received the second dose of Shingrix in June of 2023 and the first dose in July of 2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in July 2022).   In JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the second dose of Shingrix in June of 2023 and the first dose in July of 2022).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 26-Sept-2023 Nurse could not provide patient identifiers, lot numbers, or expiration dates.  The reporter could not provide exact date of administration of either dose of Shingrix.  No additional information was provided. The reporter consented to follow-up. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
This spontaneous report as received from a certified medical assistant (C.M.A.) concerning a 12 months old patient (gender not reported) who on 29-JAN-2013, was vaccinated with a dose of PROQUAD (Lot not reported), 0.5 ml, subcutaneous and VARIVAX (lot number, dose and route not reported) during the same office visit. No adverse effect was reported. Additional information has been requested.
She was freezing after she got the shots whole body hurts, chills. Arm is red and swollen and hot to touch. She arm swollen at injection site (Pneumonia).