chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started having left arm/hand numbness the morning after receiving the vaccine.  The next day (Monday), I continued having paresthesia in my left hand, primarily in the ulnar nerve distribution.  Tuesday morning, I woke up with paresthesias in both feet and lower legs, also minor numbness in both hands.  Wednesday afternoon, symptoms were still present, so I went to urgent care.  Still having paresthesias in feet and left hand. Also having some fatigue, nausea, and mild intermittent dizziness.
e I had a flare of my neurological symptoms of CIDP two weeks after my second vaccine.  Dates of Vaccine, 4/5, 4/26.   Unmistakable symptoms of tingling in hands and feet, difficulty walking, weakness in arms and hands preceded by knee weakness, about a week prior.  Weakness in hands and arms such that I could not push up to lift body from mattress to get out of bed normally.   Pain in hip, hands, neck, lumbar and mid-back, feet,  wrist, arms.  Bi-lateral S4 and S5 Steroid Facet Injection with trigger points including right hip on 5/17; led to improved walking hip/lumbar symptoms and some overall.    The following two Hizentra infusions on 5/24 and 5/31 I believe also helped incrementally with overall symptoms.  Some residual wrist and hand weakness remaining.
Seems like Arthritis in both hands, fingers, wrist as well as both shoulders.  No such symptoms before this vaccine
p/ recv vax in 9/97 w/1 dose of varicella that same yr the pt devel an atypical varicella rash. pt also exp lack of response. lab work done on pt: IgG & IgM negative
VSS, Afeb. Received DTAP & varicella on 6/28/11. Today here with swollen (L) upper arm, sl. warm, firm but nontender. Area is red. At times itchy. Tx: BENADRYL if itchy, regular activity. Possibly premedicate with BENADRYL before TDAP at age 10 year. (Swelling at deltoid muscle area). Dad put ice on 6/29/11, seen today by MD 6/30/11.
No adverse effects; improperly stored dose of PEDVAX and ROTATEQ; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reaction/ allergies and concomitant medications were not reported. On 18-NOV-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S006470 expiration date reported as 15-JAN-2021, but upon internal validation established as 15-JAN-2022) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# R029818, expiry date: 09-JUL-2020 (product storage error) (strength, formulating, dose/frequency, route were unknown) for prophylaxis. The vaccines were stored at a temperature of 10.1 degree Celsius for 1hour. There was previous temperature excursion at 10.6 degree Celsius for 15 minutes. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
ear fullness, associated with a dull aching sensation, tinnitus and dizziness / diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and vertigo; ear fullness, associated with a dull aching sensation, tinnitus and dizziness / diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and vertigo; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not provided. On or around 12-MAY-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its indented purpose: the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving the vaccine, the patient suffered ear fullness, associated with a dull aching sensation, tinnitus and dizziness. The patient was diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and with vertigo. As a direct and proximate result of the suspect vaccine, the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of these malfunctions, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX). The events were considered to be disabling. Upon internal review, the event of sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear was determined to be medically significant.
Hep A #2 administered to left arm at 9:30 08/20/2003.  Retured to clinic 10:10AM with red, generalized rash to both arms trunk and legs.  Child not scratching at self.  No rash noted to face.  Grandmother instructed to administer Benadryl liquid 1 tsp to take to ER if child developed any problems with breathing.
Patient reported symptoms started ~15 mins s/p dose. Symptoms reported LUE and LLE numbness/tingling, and notable tachycardia
I haven?t stopped coughing two months in. Also, about 2 weeks after my upper back became extremely knotted up. The muscles are balled up and I can barely move my neck.
Swelling at injection site; Redness at injection site; Itching at injection site; Injection site Pain; Injection site Warm to Touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received in February 2019, for tolerance refer case US2019AMR128501).   On 11th July 2019, the patient received the 2nd dose of Shingrix. On 11th July 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported the case.  Approximately 2 days following the 2nd dose of Shingrix, the patient experienced swelling, redness, itching, pain, and warm to touch, all at the injection site.  The reporter stated, by the third day, all symptoms were resolved. The reporter provided details of the patient's physician for further follow up.
I started having pain in my stomach, the liver and kidney area. I noticed that my stomach was bloated and I couldn't eat due to pain. I felt a burning sensation going up to my heart. I went to the hospital ER and they gave me pain killer through an IV. I went to my primary care physician and she prescribed medication for the pain.
Patient's mother called clinic & stated pt had swelling in left arm and a "pimple" at injection site.  The pimple burst and pus & blood came out.   Mom took pt nearest ER.
Breakthrough case admission after 4 vaccines Moderna 2/9/21 Lot# 015M20A;  Moderna 3/9/21 Lot# 032M20A;  Moderna 8/20/21 Lot# 007B21A;   Pfizer 7/26/22 Lot# FN2908
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a female patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 30th June 2017). On 8th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced nausea, vomiting and hypotension. On an unknown date, the outcome of nausea, vomiting and hypotension were unknown. It was unknown if the reporter considered the nausea, vomiting and hypotension to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported for this report. The other health professional stated that she would call back with details regarding the other two adverse events. This case has been linked with case US2016GSK149943 and US2016GSK149945 as reported by the same reporter.
Initial unsolicited report received from a non-health care professional on 13 November 2015. This case involves an 18-year-old male patient who was vaccinated with a dose of MENACTRA (batch number was unknown, route and site of administration was not reported) on an unspecified date in end of August. Patient denies providing illness at time of vaccination pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medication. On an unspecified date, few days following the vaccination, the patient developed upset stomach sometime then URI (upper respiratory infection) after that. Following the URI he started having "bizarre" headaches with a drunk like feeling, eyes hurt also. The patient was seen several physicians, neurologist, psychiatrist, general practitioner, internal medicine and is going to see neuro surgeon next. Lab data was not reported. The patient had tried several medications including, but not limited, to antidepressants and anti-anxiety. Outcome of events was unknown. Upon internal review, the company decided to consider the event serious because of important medical event: Upper respiratory infection. List of documents held by sender: none.
Leg discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Leg discomfort) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Leg discomfort). At the time of the report, LIMB DISCOMFORT (Leg discomfort) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
WARM AT SITE OF INJECTION; TENDER SORE ARM AT SITE OF INJECTION; BRUISE AT SITE OF INJECTION; 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 concurrent conditions included non smoker, and migraine, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced bruise at site of injection. On 10-MAR-2021, the subject experienced tender sore arm at site of injection. On 11-MAR-2021, the subject experienced warm at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bruise at site of injection on MAR-2021, and had not recovered from warm at site of injection, and tender sore arm at site of injection. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of tingling in a adult male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 2 days after receiving BEXSERO, the patient experienced tingling and numbness. On an unknown date, the outcome of the tingling and numbness were unknown. It was unknown if the reporter considered the tingling and numbness to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. Field representative reported that, a doctor reported an unknown patient experienced severe tingling and numbness in arm up to neck 48 hours after receiving BEXSERO vaccination in arm.
Patient had ZOSTAVAX injection subcutaneously in her right arm and a BOOSTRIX injection intramuscularly in her left arm on 08/03/2016. On 08/05/2016 in the morning, she came into store to let us see the area where the ZOSTAVAX injection was given. The area was red, swollen and itchy. I explained that according to the vaccine information sheet that these are mild problems that can occur. She wanted to know what to do if the site got worse. I told her to call us and we would talk to her about it.
I am unable to perform my job; headaches; excessive sweating; fatigue; overall feeling sick 24/7; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single and administration date Oct2021 (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: IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "I am unable to perform my job"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; HYPERHIDROSIS (non-serious), outcome "not recovered", described as "excessive sweating"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; MALAISE (non-serious), outcome "not recovered", described as "overall feeling sick 24/7".  Additional Information: The patient had the Pfizer flu shot on 30Dec2021. The side effects with this vaccine are closely related to the symptoms of the Pfizer Covid 19 vaccines patient received in Oct2021 and Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection was given in (R) leg and area became red and swollen immediately. Cold compress applied. After approximately 15 minutes after applying cold compress area had begun to get better. Injection was HEP A.
Initially I had all the "usual" vaccine side effects for about 48 hours.  But at the 72 hour mark I experienced significant headaches, earaches, ringing in the ears, & dizziness that persisted non-stop until about 4/21/2021 (for 2 whole weeks).  While these "extra" symptoms are not completely gone I am much better.  Perhaps an inflammatory response of the immune system?  There isn't a lot of information out on dizziness being a side effect & it's particularly scary when the headaches & the dizziness go on for 2 straight weeks (since most information out there states that side effects should go away within 3-4 days).
During the night became almost paralytic (whole body  - which lasted two hours), fever 102.7, no energy, nausea, no appetite. Second day, slight fever, slight appetite, more energy.
This case was reported by a consumer (subject's father) and described the occurrence of diarrhea in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included Hib vaccine; manufacturer unspecified; unknown; unknown given in January 2012; DTaP vaccine; manufacturer unspecified; unknown; unknown given in January 2012. In January 2012 the subject received 1st dose of ROTARIX (oral). In January 2012, less than one month after vaccination with ROTARIX, the subject experienced diarrhea, throwing up, cranky and sleep more hours at night. At the time of reporting the events were unresolved.
On 2021 Mar 01 at 11am I started becoming dizzy and my head spinning. To prevent fainting/falling I had to lie down immediately. I had to stay lying down until 8pm. After that I remained light headed until 2am.; On 2021 Mar 01 at 11am I started becoming dizzy and my head spinning.; I had headaches during the 12+ hours.; I went from being active to lying down in minutes, and could have fainted/fallen.; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Feb2021 at 09:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. 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. On 01Mar2021 at 11:00 the patient started becoming dizzy and his head started spinning. To prevent fainting/falling he had to lie down immediately. The patient had to stay lying down until 20:00. After that he remained light headed until 02:00. The patient had headaches during the 12 plus hours. Onset was fast, with no warning. The patient went from being active to lying down in minutes, and could have fainted/fallen. Therapeutic measures were taken as a result of headache and included treatment with paracetamol (TYLENOL). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started becoming dizzy, remained light headed was resolved on 02Mar2021 at 02:00. The clinical outcome of the event head started spinning; to prevent fainting/falling had to lie down immediately; had headaches during the 12 plus hours; onset was fast, with no warning; went from being active to lying down in minutes, and could have fainted/fallen was resolved an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Under right arm lymph nodes became swollen and tender; Headaches which came and went; Fatigue; Mildly sore injection site.; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Under right arm lymph nodes became swollen and tender), HEADACHE (Headaches which came and went), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Mildly sore injection site.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mildly sore injection site.). On 27-Mar-2021, the patient experienced LYMPHADENOPATHY (Under right arm lymph nodes became swollen and tender), HEADACHE (Headaches which came and went) and FATIGUE (Fatigue). At the time of the report, LYMPHADENOPATHY (Under right arm lymph nodes became swollen and tender), HEADACHE (Headaches which came and went), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Mildly sore injection site.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
A report was received from a health care professional on 11/20/03 concerning an 8 month old male vaccinee who inadvertently received Fluvirin on 11/20/03. On 11/20/03, the vaccinee inadvertently received Fluvirin. The vaccinee had previously received a dose of Fluzone. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/19/04: A follow up report was received from a health care professional indicating that a second dose of Fluvirin was administered on 11/20/04. The vaccinee then returned in one week for 0.25ml of Fluzone. No further medical follow up was ordered by the physician. No adverse experiences were reported that the time of reporting. Update 2/24/04: A follow up report was received from a health care professional indicating that the vaccinee received Fluzone initially, followed by Fluvirin and finally a second dose of Fluzone was given 1 week after the inadvertent administration of Fluvirin. No adverse event had occurred at the time of reporting. No follow up pending, all information received.
Information has been received from a 57 year old male physician who on 03-FEB-2009 was vaccinated IM with a dose of PNEUMOVAX 23. On 03-FEB-2009 the patient experienced severe swelling under and down his arm after receiving a dose of PNEUMOVAX 23. He had another physician look at it and was told it "looked like blood poisoning". He took an unspecified antibiotic and the swelling diminished after 1 or 2 days. At the time of this report, the patient recovered (date unspecified). Additional information has been requested.
broken cold chain until two weeks after the shipment arrived with no reported adverse event; After excursion, vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient and reporter reported broken cold chain for haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] until two weeks after the shipment arrived with no reported adverse event and after excursion, vaccine was administered with no reported adverse event   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 dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength, dosage, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested  Caller reported broken cold chain for haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] until two weeks after the shipment arrived with no reported adverse event (product storage error) (unknown latency) and after excursion, vaccine was administered with no reported adverse event (poor quality product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:Master case
CHILD'S DATE OF BIRTH WRITTEN  AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY PERSON IDENTIFYING AS FATHER. CHILD IDENTIFIED  in system WITH a different DATE OF birth. CHILD TOO YOUNG FOR VACCINE ON 5/14/2021.