chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had CVA on 3/28/08.  Started with L hand & facial numbness which progressed on that 1/2 of body, went to ER. Oral contraception.  4/30/08-records received for DOS 03/28/08-Presented to ED with C/O right sided facial swelling right arm 'asleep' feeling, hand numbness. Symmetrical smile able to raise eyebrows. Medications: birth control pills.  8/29/08-DC summary received for DOS 3/28-4/2/08-DC DX: Acute cerebrovascular accident.  New onset of slurred speech and right arm weakness more than right leg weakness and positive finding is decreased attention, decreased affect, dysarthria, decreased memory, slightly reduced nasal labial area fold and right arm weakness 3-4/5 and plantar was extended and sensory was reduced on right side.  Follow-up: Pt dx M.S. 3/08.
This spontaneous case, initially received on 18-Sep-2018, from other healthcare professional, concerns a 34-year-old, adult female patient. The patient had no medical history. The patient's concomitant medications included: calcium and fish oil for unknown indications. On 18-Sep-2018, the patient was administered expired FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195245 and expiry date: 20-Jun-2018). The patient was observed and revaccinated. At the time of this report, no adverse events were reported. The reporter assessed the case as non-serious. Non-significant follow up received from the reporter on 08-Oct-2018: The route of administration of the vaccine was confirmed as intramuscular. No new information was received.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 24-NOV-2015 at time- 24-NOV-2015 08:56, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose,#, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 2.9 (units unspecified) for 1 hour 4 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
on week latter a red spot 1&1/2 inch tall and 2inchs wide developed  around the injection site and is warm to the touch -slight swelling (?) maybe.
I have a temp of 100; feel tired; arm is really sore; achy; This is a spontaneous report from a contactable consumer, reporting for herself.  A 78-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 78 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included restless legs, high blood pressure, and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 27Jan2021 at 08:00, the patient experienced temperature of 100, feels tired and achy plus the arm is really sore. The patient did not receive treatment for the events. The clinical outcome of temperature of 100, feels tired and achy plus the arm is really sore was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
High fever, extremely painful muscular pain from administration site through to chest plate, large, hot red rash growing after 03/02/2012.
awfully sick; chest pain; nausea; fever; headache; Dizziness; itching; diarrhea; Stabbing pain in ear; arm swell; haven't been able to eat; shivering; hot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness, chest pain, nausea, fever, headache, dizziness, pruritus, diarrhea, ear pain, swelling arm, unable to eat, shivering and feeling hot. On an unknown date, the outcome of the sickness, chest pain, nausea, fever, headache, dizziness, pruritus, diarrhea, ear pain, swelling arm, unable to eat, shivering and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the sickness, chest pain, nausea, fever, headache, dizziness, pruritus, diarrhea, ear pain, swelling arm, unable to eat, shivering and feeling hot to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient got first Shingle shot on Wednesday and had been awfully sick, chest pain, nausea, fever, headache, dizziness, itching, diarrhea, stabbing pain in ear, arm swell to softball have not been able to eat much, shivering and hot. The patient still not over it.  The patient stated, he/she scared to get the next one.  The patient asked have anyone else had bad symptoms.
Swelling at injection site. 6cm X 2cm. Some itching. Instructions given to apply cold compress for swelling, return to office if swelling worsens or persist.
Fatigue, muscle aches stiff joints pain at injection site chills the first night and next day after both injections. Took tylenol and advil and just stayed home and rested.
pt/vax pt noticed rash in lt axillary area about 2 or 3PM;rash was reddened & itchy that noc in bed;pt felt nauseated & feverish;next Am noted that rash was on entire lt arm & on lt side of torso down to waist;rash still present on 8OCT97;
Initial report was received 29 May 2008 from a health care provider. A 74-year-old female patient with a history of shingles (March 2008) and diverticulosis, had received a left deltoid intramuscular injection of ADACEL, lot number C2766AA on 22 May 2008, and five days later, she developed itching, redness and swelling. She was evaluated by her physician on 29 May 2008 with symptoms which consisted of a red swollen left arm, 11cm by 6cm in size which extended 6-8 cm below the left deltoid injection site. Corrective treatments were not reported. At the time of the report, the symptom of itching had resolved but the symptoms of redness and swelling persisted. The patient had not recovered from the event. Follow-up information was received 01 August 2008 from a health care professional in the United States. The reporter indicated that the event consisted of a local reaction "11 x 6 cm area of erythema, plus induration, the left upper arm". The patient received corrective treatments with t.i.d BENADRYL plus 1cc of CELESTENE. At the time of the report, the patient had not recovered from the event.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # reported as 1012038, expiry date 17-APR-2017) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
her mother died recently due to Covid; her mother died recently due to Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "her mother died recently due to Covid". The patient date of death was unknown. The reported cause of death was covid-19, drug ineffective. It was not reported if an autopsy was performed.  Additional information: Pfizer Covid 19 Vaccine Start date and Stop date was unknown. Medical Information: No any unaddressed medical questions referred or forwarded to Medical Information. Customer and/or medical inquiry was NOT forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: her mother died recently due to Covid; her mother died recently due to Covid
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 047B21A and 001B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medicine were reported. Lot number 004M21A, expiration date 13Jul2022, Date of administration of vaccine were -26Jul2022 (40 doses), 04Aug2022 (1dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medicine were reported.   This case was linked to MODERNATX, INC.-MOD-2023-704260, MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-704260:(Master case) MODERNATX, INC.-MOD-2023-704260:
Arm was sore after 1st shot... 3 days after second shot shoulder joint became sore and still is. Hard to move the joint without pain
Pain in one eye - Right. Rash on forehead - one side - Right. Headache.
Pt experienced tightness in chest, no SOB, just felt tight. Nausea, loss of appetite, couldn't eat, general malaise, slept more than usual 10-12 hours a day. Pt took Tylenol twice the day of vax. Symptoms began 24 hours after receiving shot and lasted 14 days.
Needle injury. My husband and I went together to get our annual Flu shots. We noticed the pharmacist seemed clumsy while getting out supplies, but didn't know there could be a serious problem since we had never had problems with a vaccine before. The pharmacist gave me a shot first. It felt like he had done it too hard. Then he gave my husband a shot and blood was dripping down my husband's arm and the pharmacist was slow to do anything about it. When someone has been well trained or has lot of experience their movements are smooth and quick. They have the cotton ball ready to go and the bandaid, but he was klutzy. My arm hurt then but I thought it would go away in a couple of days. Instead it kept hurting so I took some OTC pain pills. Then I noticed that certain movements of my left arm (where the shot was given) hurt so much I stopped making those movements. Straight movements were ok but nothing to the side or back or up, as when putting my hair in a ponytail. I couldn't pick up my toddler grandkids anymore. I now wear shirts that button down the front because it hurts too much to put my arm thru a sleeve with an upwards and sideways motion. When I would roll onto my left side in bed it hurt, and I am a left-side sleeper. This keeps waking me up throughout the night. After 2 months of thinking it would get better on its own, thinking if he had hit a nerve there wouldn't be much that could be done anyway, I did some Internet research and found that it has been given a name: SIRVA. I read accounts of women who experienced what I was going through. I still gave it a few more weeks since some of the women said nothing had helped. Then with the pain still bad and certain movements very painful I went to see my primary care doctor. We ruled out a blood clot with an ultrasound, then after a second visit also did an xray of the left humerus, then an MRI of the humerus. This MRI showed degenerative changes of the shoulder so I then had an MRI of the shoulder. The MRI of the shoulder showed a partial thickness tear of the supraspinatus tendon. At time at my desk job I have pain up and down my arm, and I avoid the movements that are very painful. I take 5 ALEVE a day. If I don't take ALEVE even just holding my arm straight I can feel pain, sometimes a deep ache. I have to try to put my arm on an extra pillow in a certain way to try to get sleep. I use heat daily to help with the discomfort and have iced the upper arm/shoulder a few times also. A friend who is a physical therapist showed me 2 exercises/stretches to do telling me I couldn't stop using my shoulder completely or it would be even worse. I have now scheduled an appointment with an orthopedist. I don't know if I will eventually need surgery or not. This all started with the Flu shot. It was not the vaccine; it was his use of the needle. In one of the article I read it mentioned that most of the people this has happened to are women who are not very big. I weight 125 lbs. Articles about this state that the pain can last for months or years.
Slight fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Slight fever) and FATIGUE (Fatigue) outcome was unknown.            The patient is reporter's mother and had received booster vaccine 5 days ago.  No concomitant medication were provided.  No treatment medication were provided.
Deltoid swollen with prominence noted, warm with erythema, reporting numbness, tingling along outer arm at ulna into fingers with throbbing discomfort and difficulty lifting arm.
Pain and erythema at site, myalgias, arthralgias, low grade fever, fatigue. States sx began approx. 7-8 hours after injection. Worsened the next day. Slight improvement in constitutional sx on 2nd day but continued erythema and pain at site of injection. States similar sx in 2015 and 2016 but not as bad.
This is a spontaneous case, initially received from other healthcare professional (nurse) on 27-Nov-2017, concerning a female patient of an unspecified age. The patient's medical history and concomitant medication were not reported. On 10-Nov-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF30306 and expiry date: 28-Jun-2018). On the same day (10-Nov-2017), evening after vaccination, the patient developed swollen lymph nodes on the left side, where the shot was given. It was reported that, after a week, the patient felt little sore on the area, but the swelling went down. At the time of this report, the patient was recovering from the event lymphadenopathy and had not recovered from the event injection site pain. The reporter assessed the events as non-serious. Follow-up received on 27-Feb-2018: It was reported that, 3 attempts were made to contact the reporter to obtain information but there was no response. Hence, this case was considered as lost to follow-up. Significant case correction received with the IRD 27-Nov-2017: The LLT of the event "Lymphadenopathy" was changed from lymphadenopathy to swollen lymph nodes.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-JUL-2009, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-AUG-2010, he was treated at a physician office for onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt states that about 5 days after receiving the vaccines he developed hives all over his body and his lips even swelled. He said he took BENADRYL for this reaction. It lasted for about 7 days.
IT TOOK AWAY THE PAIN IN SHOULDERS AND ARMS BECAUSE OF DIABETES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent condition included: diabetes. The patient was previously vaccinated with Covid-19 vaccine ad26. cov2.s. (manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported), (dose number in series 1) 01 in total, administered dose was not reported for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, (dose number in series 2) 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient took Johnson & Johnson vaccine and it took away the pain in shoulders and arms because of diabetes (Unexpected therapeutic benefit) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of it took away the pain in shoulders and arms because of diabetes (Unexpected therapeutic benefit) was unknown (dose number in series 2). This report was non-serious.
feels sluggish; had a little bit of fever yesterday; Warm feeling shooting in head; developed a warm feeling in his head that turned into a headache; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9899), via an unspecified route of administration (arm left) on 16Dec2020 at single dose for precaution for front line worker. The patient's medical history included blood pressure abnormal, blood cholesterol abnormal, diabetes, enlarged prostate, sleep disorder, on anticoagulant therapy, and migraine. Concomitant medications included lisinopril, simvastatin, metformin hcl, tamsulosin, dutasteride, zolpidem, aspirin [acetylsalicylic acid], and melatonin. It was reported that the patient experienced warm feeling shooting in head on 16Dec2020. It was further reported that the patient developed a warm feeling in his head that turned into a headache on 16Dec2020. The patient also experienced slight fever on 1Dec2020. The patient received the vaccine on Wednesday afternoon (16Dec2020). The patient stated, "initially it felt weird; for a couple of minutes, it felt ok and then he felt a warm feeling shooting in his head, like when you take strong medications or do MRI. It gives you that strong feeling. It was cold or warm but shoots in head. He felt it, so he went to occupational health and it went away. He went home early and did not finish his shift. Then he got a headache and it did not go away and it is not severe. He feels sluggish and had a little bit of fever yesterday and took Tylenol and it went away. He still had a headache and it bothers him. He cannot remember the name of the medication that he got the warm feeling shooting in his head, but he believed it was when they did a dye for an MRI. He does not have the name and did not have a lot or expiration. He works at a hospital but not as a healthcare provider. He got the vaccine a few day ago and later stated it was Wednesday, 16Dec2020 warm feeling started an hour after getting the vaccine. As soon as he went to occupational health, it went away and improved. He did not have the headache yet. He did not work his full shift. He got home at night and felt not too bad of a headache. He has a history of migraines and he can feel somehow, he is starting to have a headache. It is not severe though. The headache started that night and it is still there. It is not so severe, but it bothers him. When he had a slight fever, it is gone after taking Tylenol. He never actually checked his temperature, he just felt warm. He takes medications every day, so he took medications the night before and did not take other medications since then. He wanted to find out if there was any interaction with the vaccine before taking them again. The outcome of event fever was recovering, events warm feeling shooting in head and headache was not recovered, and the event feels sluggish was unknown.
Soreness, decreased mobility, pain - has continued since 4/15.  Asked his primary physician regarding this...he had no explanation.
Site: Pain at Injection Site-Mild, Systemic: heart racing, palpitations-Medium
Patient in clinic with redness to lt deltoid site of injection.  States began having this 9/21/03 in the am.  Area warm to touch.  Area of redness the size of an orange.  Patient states had "kernal" under  lt arm pit that had sorness beginning 9/21/03 until 9/23/03.  Notified patient sPMD instructed to have patient take benedryl or zyretic and may come in to see her clinic for injection id needed. also instructed patient to apply warm compresses to area.