chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 1/2 wk p/vax devel jerky eye movements;then progressively devel diff w/movements/twitching & jerking;then emotional lability started;withdrew from fam; seen by MD dx opistohonus myoclonus tx w/med;
Simultaneously to administration of Shingrix vaccine, patient became quiet and his pallor was pale,  noted diaphoresis to forehead, pt states he had experienced this feeling with blood draws but not vaccines in the past.  Pt states he had not eaten lunch, pt requested chocolate.  Pt given pretzels and water.  Pt became nauseated and vomited up food.  Pt denied history of diabetes or history of hypoglycemia.  BP 80/58, Hr   52, pt moved to a supine position and lower extremities elevated, ice packs , no loss of consciousness or confusion, pt monitored for 10 minutes, HR increased to 68, BP increased to 130/58, pallor improving, patient requested to sit up, symptoms subsided; pt stated he felt better, no complaints of dizziness, steady gait, pt assisted back to apartment.  Instructed to notify health care provider of vasovagal episode after vaccine administration.
Sudden onset of severe vertigo starting 48 hours after receiving the vaccine Dizziness, loss of appetite, nausea, fatigue Still experiencing vertigo 2+ weeks later
Both thighs felt like constant restless leg syndrome for about 5 days. I felt periodic pain in two spots: near the knee and in the middle of my left thigh.  My left molar cracked on 03/25/2021. I received treatment for the cracked tooth on 04/07/2021 which required novacaine which resulted in large swelling of left side of face which lasted about 8 days.
Pt is an employee of Hospital.  She reported to Infection Control Representative at hospital on 4-3-03 that she was developing a very large "fever blister" on her lip that was producing a significant amount of drainage.  She saw her primary care physician on 4-4-03 and received antiviral medication (name of medication unknown). The "fever blister" promptly began to heal and is nearly gone now.  No other adverse effects noted, no other treatment treatment was needed.
Immediate sensitivity and soreness at injection site - then within a day or two the tingling and numbness began to move through the upper chest area.  Within a couple more days an upward progression beginning with the feet of tingling, numbness, and finally loss of nerve and muscle ability. He was admitted to Hospital on 11/21 with the diagnosis being Guillain-Barre Syndrome thought secondary to his recent influenza shot.  His symptoms progressed rapidly loss of muscle and nerve function in all parts of his body as well as respiratory failure.  He was immediately placed in ICU and required intubation and mechancial ventilation for 7 days in addition to daily infusions of gammaglobulin.  He was later transferred to InPatient Rehab on 12/3/07 for continued rehabilitation for physical therapy, occupational therapy, Speech and Language Pathology. 4/01/08 Reviewed hospital medical records of 11/21-12/03/2007. FINAL DX: Guillain-Barre syndrome, thought secondary to recent flu shost; HTN; and weakness. Records reveal patient experienced lightheadedness, HA, neck stiffness, weakness & tingling of feet, lower legs & fingers ascending & progressing rapidly over 3 days.  Seen in outlying ER & transferred to higher level of care.  Admitted to ICU.  Continued to deteriorate, developed respiratory failure & was intubated 11/23.  DTRs absent in LEs.  Neuro consult obtained.  Tx w/IVIG & improved  Extubated on 11/27.  Continued to improve w/PT & transferred to inpatient rehab.
Presented with generalized malaise, fever, chills on June 23. Had headache and cough on and off after receving vaccine. On July 8 admitted to hospital with rash concerning for erythema migrans. Positive Lyme IgM. Started doxycycline. Discharged 7/10. Came back on 7/11 with bilateral facial nerve palsy. noted to have severe back pain of unclear cause as well. Started on Ceftriaxone. Discharged again on 7/13. On 7/14 presented to oupatient ID clinic with increasing back pain and numbness on trunk and upper thighs. Sent back to hospital. CT head, MRI thoracic and lumbar spine normal. LP done normal cell count, mildly elevated protein on CSF. Increasing muscle weakness of extremities (proximal muscles of lower extremities first). Impression: Guillain Barre. Started on IVIG
very sick,very sick for atleast a week or more; problems with memory; blurred vision; Brain fog; have lost all since of time space and location; feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine; memory loss; gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines; Pain; Stomach on fire, very bad stomach problems; Chills; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision) and FEELING ABNORMAL (Brain fog) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Very tired). On 07-Mar-2021, the patient experienced PAIN (Pain) and DYSPEPSIA (Stomach on fire, very bad stomach problems). On an unknown date, the patient experienced ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines). At the time of the report, PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), CHILLS (Chills) and FATIGUE (Very tired) outcome was unknown and AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Email On 18-May-2021: Email: New AEs added. Ongoing issues. On 10-Jul-2021: Email included additional events (temporo-spatial disorientation, feeling hot, memory loss, feeling abnormal, abdominal discomfort), outcome of events memory loss and abdominal discomfort.
Pt recv vax on 12/29/98; immediately post vax pt exp knot at vax site; tx=ice
Tingling on lips noticed right after vaccine on 02-25-21 then 02-26-21 reported tired and dizzy when bending over, lips still tingling then on 02-28-21 swelling of lips and inside roof of mouth took Benadryl at 9:30 am and every 4 hours until 11 pm, on 03-01-21 still some lips and mouth swelling but not as bad.
A nurse reported pt received vaccine on 7/19/200 and subsequently developed an injection site reaction characterized by redness, festering, swelling and pain.
There was intermittent itching at the site of vaccination shortly after the vaccine was administered. Itching was localized to the site of administration. Then on Feb 28th, 2021, diffuse itching across the entire body started. The palms, back, scalp, and arms are where the client expresses most itchiness.
Did not respond to two doses of Heplisav-B; Patient Is On Dialysis; Initial Report Received on 08-Jun-2021 and 17-Jun-2021  A nurse reported that an 81 year-old male (race and ethnicity not provided) did not respond to two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history reported included dialysis and no known allergies.  No relevant concomitant medications were reported.    On 08-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot #934599, expiration date 22-Feb-2022 and NDC # not reported), route and site not specified.   On 10-Nov-2020, the patient received the second dose of HEPLISAV-B (Lot #934259, expiration date 25-Sep-2021 and NDC # not reported) route and site not specified.  On 07-Jan-2021, 92 days after having received the first injection, and 59 days after having received the second injection, a titer was drawn which read 1.3 (units not provided).  On 03-Jun-2021, 239 days after having received the first injection, 206 days after having received the second injection, a second titer was drawn, and the results were 3.1.  Company Comment:  The company assessed the events as non-serious. The safety and effectiveness of Heplisav-B have not been established in adults on hemodialysis. For patients undergoing hemodialysis, higher vaccine dosages or an increased number of doses are recommended. Protective levels of antibody developed in 67%-86% (median 64%) of adult hemodialysis patients who received 3-4 doses of current approved vaccines in various dosages and schedules.; Sender's Comments: The company assessed the events as non-serious. The safety and effectiveness of Heplisav-B have not been established in adults on hemodialysis. For patients undergoing hemodialysis, higher vaccine dosages or an increased number of doses are recommended. Protective levels of antibody developed in 67%-86% (median 64%) of adult hemodialysis patients who received 3-4 doses of current approved vaccines in various dosages and schedules.
Large hard area under injection site to left delt. Small 1/4" red area with small scab at injection site. C/O itching.
Developed a high fever, 102. A lot of body aches. Took Tylenol for the fever to little effect. The fever disappeared late the next day but the body aches still remains.
4 days after this updated COVID vax booster injection, onset of cluster of herpes lesions on right buttock; took Rx acyclovir to lessen duration of lesions. (Note: patient has approx. 50-yr Hx of occasional herpes lesion outbreaks on lower back or buttocks, usually occurring after sun exposure or brought on by stressful situation or illness.) This September 2022 herpes outbreak site was the same as after the previous booster dose of COVID vax in October 2021.
Patient's arm has a large area of redness below the injection site. it is not painful but does occasionally itch.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "lupus" (unspecified if ongoing); "sjogren syndrome" (unspecified if ongoing); "APL antibodies" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE], start date: 20Jun2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2022) Positive, notes: Positive; (24Dec2022) Positive, notes: Positive at 9:30 am. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient had no known allergies. Patient received other medication in 2 weeks. The patient received Paxlovid (anti-viral drug) from 12Dec2022 to 17Dec2022 for the treatment of COVID-19. The patient tested positive for COVID on 11Dec2022 and took Paxlovid for treatment of COVID. Did not test negative until 21Dec2022. Symptoms began on 23Dec2022 early evening. Tested positive for COVID again on 24Dec22 9:30 am. Symptoms: fever, cough, congestion, dry mouth, extreme fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cold chills, 104.3 fever, headache, sore throat, rapid heart rate, fatigue, body aches, paleness, hoarseness, cold sores all over, lips, still not completely recovered. (Had swine flu in 1976) -> only flu event ever
On day 7 after the vaccine the injection site was a little itchy and red. On day 8 it is a round red circle about 2? in diameter. My upper arm is warm. It is twice the size it was last night.
The pt was sitting in observation and had a syncopal episode. VS were stable. The pt was very anxious about receiving the vaccine and possibly had a panic attack.
red blood cells were low; This is a spontaneous report from a contactable other healthcare professional. This other HCP reported for a female patient (friend). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Caller stated her friend received the second dose of the vaccine and a couple days later her red blood cells were low. The patient underwent lab tests and procedures which included red blood cell count: low on unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion/ Vaccinated after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 minute excursion in the freezer) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion/ Vaccinated after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 minute excursion in the freezer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion/ Vaccinated after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 minute excursion in the freezer) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medications were reported. It was reported that, the facility had 20 minutes of excursion in the freezer that their Moderna COVID-19 vials were stored in. The excursion was on Sunday and the health care profession was not told about it until the day of the repot. Later, the patient was vaccinated after excursion. No treatment information was reported.This case was linked to MOD-2021-403721 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow-up information received includes patient details and vaccine details  were updated.
PREVNAR 13 administered in (L) deltoid on 5-19-16. Patient reports redness started that PM, most of upper arm became swollen, hot and red. Today 5-25-16 - area below deltoid and above elbow remains red/swollen and warmer to touch c/o being tender and very itchy.
Briefly got chills hours after but went away quickly  2/27-2/28 left arm REALLY sore 2/27-2/28 rash on chest (chest was red) - disappeared by Monday, 3/1 (two days later); took Benadryl
Reaction to immunization; This spontaneous case was reported by a health care professional and describes the occurrence of IMMUNISATION REACTION (Reaction to immunization) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant history).    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 IMMUNISATION REACTION (Reaction to immunization). At the time of the report, IMMUNISATION REACTION (Reaction to immunization) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant product use was unknown by the reporter.
Received vaccine at 14:00. At 14:35, felt dizzy, weak, some tingling of face and upper trunk, tongue felt thick and had difficulty swallowing. No frank urticaria. Given epinephrine, Benadryl and Solu-Medrol and admitted for observation.
Chronic back pain worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Chronic back pain worsened".  Additional information: The patient was asking if she can take Tylenol and her second dose was scheduled on 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) PROQUAD was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 04-APR-2019, the patient was administered improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R020815, expiration date 16-JAN-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA004258: US-009507513-1904USA005130: US-009507513-1904USA005133: US-009507513-1904USA005129: US-009507513-1904USA005627: US-009507513-1904USA005628: US-009507513-1904USA005629: US-009507513-1904USA005630: US-009507513-1904USA005631:
Information has been received from a lawyer regarding a case in litigation concerning a 67 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for long term prevention of shingles and zoster related conditions. In 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-DEC-2015, the patient was treated by a physician for shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An elderly female patient received, on 30Jul2015, at the age of 69 years, PREVNAR 13, Lot. L77777, Expiration date: 01Jan2017) at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain through all the body that caused extreme pain at a level 9 which then impaired walking and even moving the arms much for over 1/2 of a week and was tender in the muscles for even longer. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested.
Fever of 103 degrees F, chills, body ache, joint pain, headache, nausea, vomiting, loss of appetite.
Positive covid home test 5-7-22 with mild symptoms; Positive covid home test 5-7-22 with mild symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 at 12:00 as dose 2 , single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 17May2022 at 06:00, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Positive covid home test 5-7-22 with mild symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: Positive covid home test 07May22 with mild symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: the patient had no Other medication in 2weeks. Anti viral details included product=COVID 19 Treatment and the treatment start date from 09May2022, to 13May2022, for Treatment of COVID-19. Adverse event: Positive covid home test 07May22 with mild symptoms. Prescribed and took 5 day course of Paxlovit. Cold like symptoms mitigated to day 10 after test positive day 0 but same symptoms recurred and persist to day 14. I am athletic male, no medication or health conditions the patient did not received any treatment  and does not have any Known allergies and the patient had no medical history  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative: Patient presented to ED 3 days after receiving 3rd dose of Moderna COVID-19 Vaccine with s/s of swelling and urticaria. Patient was discharged to home without admission.
DAY 1- HEADACHE DAY 2-3 PAIN AT INJECTION SITE DAY 4-6- ITCHING AT INJECTION SITE DAY 7- SWELLING (GOLF BALL SIZE), REDDNESS, ITCHING DAY 8- SWELLING (TENNIS BALL SIZE), REDDNESS, ITCHING, TENDER
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was neg p/2 titer checks;