chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up feeling dizzy, like I had vertigo; woke up feeling dizzy, like I had vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", VERTIGO (non-serious), outcome "unknown" and all described as "woke up feeling dizzy, like I had vertigo". The event "woke up feeling dizzy, like i had vertigo" and "woke up feeling dizzy, like i had vertigo" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness, vertigo.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient felt chest tightness was given 2 benadryls and water and felt better after observation, 30 minutes, possible allergy, unsure
client presented today at health department with concerns regarding shingrix injection site. area visualized to have mild puffiness, with an area approximately 4inches length by 2 inches  on inner aspect of right upper arm. client denies any fever or malaise, denies any shortness of breath, or throat closure,  but does state the area is "itchy". No angioedema visualized during this visit, client is communicating well and no acute distress noted. Encouraged client to apply cool compress to site, and to take otc antihistamine for the itching if her physician  approves and acetaminophen or Ibuprofen as her physician recommends for any discomforts she may have. client verbalized understanding.--rn
High Fever and chills starting at 10:30pm, 6.5 hours after receiving vaccine.  Fever broke about 12:30 after ibuprofen  Experienced insomnia, Muscle aches, and Headache until about 3 the next day.  Low grade fever next morning around noon. Managed with more ibuprofen.
swelling in the arm; red; hot; hard; swollen; I think it is a drug interaction between the vaccine and Methotrexate; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm), ERYTHEMA (red), HOT FLUSH (hot), MUSCULOSKELETAL STIFFNESS (hard) and PERIPHERAL SWELLING (swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METHOTREXATE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in the arm), ERYTHEMA (red), HOT FLUSH (hot), MUSCULOSKELETAL STIFFNESS (hard), PERIPHERAL SWELLING (swollen) and DRUG INTERACTION (I think it is a drug interaction between the vaccine and Methotrexate). On 19-Jan-2021, PERIPHERAL SWELLING (swelling in the arm), ERYTHEMA (red), HOT FLUSH (hot), MUSCULOSKELETAL STIFFNESS (hard), PERIPHERAL SWELLING (swollen) and DRUG INTERACTION (I think it is a drug interaction between the vaccine and Methotrexate) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No specific follow-up information recorded.
Pt was given flu shot first in upper left arm. No problems. Pt was given HAVRIX in same arm about 2 inches lower. After RPh removed the syringe, he stated "that made me light headed". He stopped talking and started to slump in chair. RPh immediately called for help, another RPh entered the vaccine room. He was unresponsive for about 30 seconds and got very pale. As the RPh's rubbed his back and tried to rouse him, he seemed to be coming around, but still confused for several minutes. He then pointed to trash can, and vomited. Afterward, he seemed less confused and his color returned. We offered water and paper towels. He sipped on the water and seemed to be recovering. Offered to call his wife (who was in the car). He denied. We checked his BP and it was about 140/85 and pulse was about 90. He stayed in clinical room about 10 minutes total. RPh walked him to his car and asked his wife to drive him home. He stated he was feeling "fine".
her mother died in her 70's following multiple injections of PNEUMOVAX23; This spontaneous report was received from the patient's daughter, referring to a 70 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 0.5ml, once, every 5 years, for vaccination (strength, route, lot# and expiration date were not reported).   On an unknown date, the patient died. The cause of death was not provided. It was unknown if an autopsy was performed.  The causality assessment between death with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA001947:
Within 12 hrs of the shot awoke at midnight with dizziness, chills, fever, myalgias, headache, backache, arm soreness.  Those sxs resolved in 24hrs.   But 24hrs+ later ,  lightheadeness, vertigo, dizziness and ataxia.  Those sxs resolved in 6 days.  But,  Same sxs recurred 3 weeks later although not as severe, and ever since, waxing and waning sxs of grogginess, dizziness, lighthead, borderline vertigo with exacerbation of my  tinnitus and rarely feel like I can't concentrate well.  Some days it feels like the sxs are gone or almost gone only to return a day or few days later.  In general, perhaps the sxs feel like they are slowly improving, but NOT yet resolved.
Extreme chills, body aches, nausea, headache, fatigue.  Symptoms lasted 24-48hrs after 1st dose, symptoms persisting past 4 days on 2nd dose.  2 weeks after 1st dose positive ANA titer was found after an episode of Raynoud?s that had never been experienced previously.
sinus headache, nonproductive cough, fever, chills, body aches, sinus congestion, nasal congestion, wheezing, sneezing, itchy eyes for few days. . starting 12/10/21
Pain, Redness and swelling of arm. Had 6" X 6" hardness and swollen arm, shivering, fatigue, mild fever, severe muscle and joint paint. Almost unable to walk for 2 days. I was unable to do regular activities for 3 days.
RASH ON INJECTION SITE, BIGGER RASH; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rash on injection site, bigger rash. On 31-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on injection site, bigger rash, and sore arm. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious
Two days following Twinrix vaccine on 4/15, client's upper lip began to swell. Swelling continued for several days. Client visited primary care physician on 4/20 and received prescription for hydroxyzine for allergic reaction. He is also scheduled to meet with allergist on 4/28. After two doses of hydroxyzine, swelling has reduced slightly but lip is still swollen one week later.
extreme pain at site of shot, entire body hurt (like the flu x 100) this went on for at least 36 hrs. Fever/Chills then throat became swollen, nausea
Mederna 1st  shot March 8, 11:15.  Second day after : chills, headache, fever, nausea, body aches.  Second day 7:00am woke to Vertigo ( side to side), Migraine and tingling through my body (like electricity) to my extremities.  I had had Covid at the end of November.  I had a TDAP vaccine on 02/16/2021.  All within the guidelines laid out for the Vaccine.
pt recv vax 11FEB98 & between 15-16FEB pt c/o inc redness, swelling & hot to touch @ the site of inj towards elbow;
50 years old female with past medical history of hypertension.  Patient presented with chief complaint of chest pain associated with nausea and vomiting.  She was found to have a inferior ST elevation.  Code heart was called.  Patient was taken to Cath Lab.  Mid RCA was occluded and one drug-eluting stent was placed.  Patient tolerated procedure well.  She was transferred to the ICU for the further management.
Patient reports frozen neck muscles and radiating intense pain 10/10 on pain scale. Saw PCP for treatment. Still seeing physical therapy, using tens unit and heat to control pain. Is now 7/10.
shingles; blisters; pain in hip; arm with red spots; arm itching; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), BLISTER (blisters), PRURITUS (arm itching), PERIPHERAL SWELLING (swollen arm) and ARTHRALGIA (pain in hip) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044I21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (arm itching), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (arm with red spots). On 16-Mar-2021, the patient experienced HERPES ZOSTER (shingles), BLISTER (blisters) and ARTHRALGIA (pain in hip). At the time of the report, HERPES ZOSTER (shingles), BLISTER (blisters) and ARTHRALGIA (pain in hip) had not resolved and PRURITUS (arm itching), PERIPHERAL SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (arm with red spots) had resolved.            Treatment details included Icdalacyclovir hcl 1000mg 3x a day and ice.  .Action taken with mRNA-1273 in response to the event was not applicable.
Felt like I was developing fever but head was cool to touch; Made it difficult to raise right leg or push leg behind butt, get up out of chair or bed, run, go up/down stairs, get into and out of car/ Could only jog at half of normal pace in 2 races 4/24, 4/25 after being able to run normally 4/22; Urinating much more frequently up to every half hour/hourly from 4/23 to 4/25; Also chills on 4/14, less severe chills on 4/23; Arm soreness from 4/14 to 4/17/Soreness, pain at or near right groin area/thigh area (but not right buttock) experienced on waking up on Friday,April 23.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 13Apr2021 at 17:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies. 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 did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 23Mar2021 at 16:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021, the patient experienced arm soreness till 17Apr2021 and chills; less severe chills on 23Apr2021. On 23Apr2021 at 06:00, the patient had soreness, pain at or near right groin area/thigh area (but not right buttock) experienced on waking up, made it difficult to raise right leg or push leg behind butt, get up out of chair or bed, run, go up/down stairs, get into and out of car, felt like he was developing fever but head was cool to touch, urinating much more frequently up to every half hour/hourly from 23Apr2021 to 24Apr2021. He could only jog at half of normal pace in 2 races on 24Apr2021 and 25Apr2021, after being able to run normally on 22Apr2021. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event soreness was recovered on 17Apr2021. The clinical outcome of the events soreness, pain at or near right groin area/thigh area (but not right buttock) experienced on waking up, made it difficult to raise right leg or push leg behind butt, get up out of chair or bed, run, go up/down stairs, get into and out of car, felt like he was developing fever but head was cool to touch, urinating much more frequently and could only jog at half of normal pace in 2 races was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Staff member at nursing home vaccinated at mass vaccination event on 12/18/2020 for residents and staff. Developed headache, chills, diarrhea- muscle aches, joint aches on 12/29/2020 and tested positive for COVID-19 on 12/30/2020. Uneventful course isolating at home.
This spontaneous report was received from a consumer refers to herself as a 60 year old female patient. The patient was allergic to Penicillin (manufacturer unknown). On an unknown date in August 2013, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date in 2013 (also reported as 2-3 weeks after) the patient experienced measles lasting about 3 weeks. On an unknown date in 2013 (also reported as about 13 days later) the patient experienced shingles lasting about 6-7 weeks. On an unknown date in 2013, the patient experienced psoriasis on her knees. The outcome of the event measles and shingles was reporting as recovering. The outcome of the event psoriasis on her knees was unknown. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
medicine squirted out underneath the skin with no AE; Most of the vaccine squirted out underneath where the needle was attached to the shot, so I don't think the patient got much of it with no AE; pharmacist confirmed that the vaccine was leaking where the needle was attached with no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who reported medicine squirted out underneath the skin (Exposure via skin contact), most of the vaccine squirted out underneath where the needle was attached to the shot, so i dont think the patient got much of it (Underdose) and pharmacist confirmed that the vaccine was leaking where the needle was attached (Syringe issue), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot: UJ251AD Expiry date: 01-May-2020) via unknown route used for prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of FLUBLOK HIGH DOSE VACCINE, patient reported that medicine squirted out underneath the skin (Exposure via skin contact), most of the vaccine squirted out underneath where the needle was attached to the shot, so i did not think the patient got much of it (Underdose) and pharmacist confirmed that the vaccine was leaking where the needle was attached (Syringe issue).  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was not applicable.  At the time of the report, no adverse event was reported.   No further information was reported.
Approximately 6 hours after the injection, pain and stiffness occured in my left arm. As the days continued the pain worsened and range of motion lessened. Hot showers helped relieve some of the pain and improve mobility. After one week pain was only present when trying to fully extend the arm. After 3 weeks there was roughly 80% range of motion. The 2nd Covid shot on May 7 seemed to release something in the muscle. There was minimal pain at the injection site that only lasted 12 hours and mobilty improved to 90%. This was reported to my PCP at my annual physical on June 25. I was encourage today to report the side effect.
Information has been received from a licensed practical nurse concerning a female adolescent patient who within the last two weeks (in August 2010) was vaccinated SC with a dose of VARIVAX (Merck) (lot number not provided). The nurse reported that the patient experienced cellulitis (in August 2010). The nurse reported that the patient required an injectable antibiotic to treat cellulitis. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Neck rash and itchy, swollen and burning eyes which lasted about 2 weeks since the vaccine. Pt saw her Primary Care Physician who recommended diphenhydramine oral caps for her eye symptoms and hydrocortisone cream for her neck rash. There was still evidence of swollen eyes and neck rash when she came in to the pharmacy a couple of days ago. Her Dr said it could be her allergies (seasonal or allergic rhinitis) or allergy to vaccine.
Fever, injection site tenderness,  body aches, joint pain, severe headaches, fatigue
This spontaneous report as received from a 55 year old female consumer with Th1 immune deficiency syndrome refers to herself. On 28-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J005071, expiry date: 19-JAN-2015 (also reported as 19-FEB-2015), dose and anatomical location was unknown). The reporter stated that the physician suggested this vaccine because her "Sil-R" levels were low and to boost her levels the vaccine was given. No concomitant medications were reported. Approximately on 04-SEP-2014 (reported as 1 week after vaccination) the patient experienced strep throat and low grade fever. No treatment was given for the events. The patient spoke to physician and sought medical attention. The event did not cause hospitalization or prolongation of hospitalization. The outcome of the events was reported as recovered/resolved. The causality was unknown. Additional information has been requested.
This case was reported by a physician and described the occurrence of not responding to therapy in a 51-year-old male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included arthritis and crohn's disease.  Concurrent medications included Infliximab (Remicade), Paroxetine hydrochloride (Paxil) and Iron supplements (Iron supplement).  On 20 April 2007, 17 November 2006 and 20 October 2006 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (20 mcg, unknown).  Three months after the third vaccination with Engerix B, 8 months aftersecond vaccination with Engerix B, 9 months after the first vaccination with Engerix B, the subject experienced not responding to therapy and decreased response for hepatitis b virus surface antigen.  At the time of reporting the outcome of the events were unspecified.
Symptoms: Rash Treatment: Ibuprofen 800 mg TID take one table by mouth three times a day as need for arm pain, cephalexin 500 mg TID take one capsule by mouth three times a day
Redness and Swelling at the injection site; redness and swelling at the injection site; Redness and Swelling at the injection site; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 4 patients (unknown age and gender) who experienced redness and swelling at the injection site and redness (vaccination site inflammation) while they received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, 4 patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot number UJ237AB and exp date 30Jun20 via unknown route in unknown administration site.  On an unknown date, (unknown latency) 4 patients developed a non-serious redness and swelling at the injection site (vaccination site inflammation with symptoms vaccination site swelling and vaccination site erythema) following the administration of ENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED vaccine.  (Other relevant lab test was not reported).  Final diagnosis was redness and swelling at the injection site and redness and swelling at the injection site.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for redness and swelling at the injection site and as unknown for redness and swelling at the injection site.
Starting one week after vaccination (August 21) symptoms started to appear. Small, redness at injection site.  On August 27, major symptoms started to appear. A large purple area, which is warm to the touch.  Swollen, and minor stiffness.  Patient states  may have been bitten by a bug, but unsure.
Bell's palsy; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose; This is a spontaneous report from a contactable pharmacist. A 72-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose via intramuscular in left arm on 28Sep2021 as single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient previously received BNT162B2, the first dose on 12Jan2021 (Dose Number: 1, Batch/Lot No: Unknown. Location of injection: Arm Left, Route of Administration: Intramuscular) and the second dose on 02Feb2021 (Dose Number: 2, Batch/Lot No: Unknown. Location of injection: Arm Left, Route of Administration: Intramuscular), both at the age of 72 years old for COVID-19 Immunization. The patient experienced Bell's palsy on 29Sep2021. Unknown if received treatment for this event. The patient had physician office visit due to this event. The outcome of the event Bell's palsy was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The event Bell's palsy was considered related to suspect drug based on strong temporal association and known safety profile of the drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.