chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness on the whole left side of body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness on the whole left side of body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation.     The patient's past medical history included Stroke.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on the whole left side of body). At the time of the report, HYPOAESTHESIA (numbness on the whole left side of body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Per mother approx. 2 days after receiving Hep B3, child complained of headaches, temp on 5-12-03 99. Need to report symptoms to family doctor. 5-16-03 PC to mother, child having no more problems with headaches.
Fatigue, nausea X 24 hours.  Redness and pain at injection site starting about 12 hours after injection, with worsening redness extending around upper arm and into armpit over the next couple of days and lasting through May 30th.  Also, golf ball sized swelling under arm started about 24 hours after injection which lasted about five days.
From initial information received on 19May05 from a RN regarding an adverse event occurring, it was reported that a 5 yr old male pt received his fourth dose of Ipol, lot number Y0265, admin IM in the right thigh, as well as a dose of Daptacel, lot number C2184AA, administered IM in the left thigh on 09May05. An unspecified amount of time later, the pt developed a rash on his right leg. He was treated with oral Duricef. The pt was seen in the emergency room on 14May05 with possible cellulitis. The Duricef was discontinued and the pt was started on oral Bactrim. At the time of this report, the pt had not recovered from these events. The reporter of this case is the same as for case 200500970.
Pt experienced numbness on the left arm and left side of face, started 10 mins after getting the vaccine and lasted for 2 hours
High fever pain and soreness at injection site, chills, severe muscle aches especially legs and chest, rash on arm
neuropathy; stabbing pain in the right foot; arthritis type of pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient received the second dose of the Pfizer Covid vaccine on last Friday (26Mar2021) and experiencing stabbing pain in the right foot, it's like neuropathy, since 2 am yesterday morning (28Mar2021). On Sunday morning (28Mar2021) at 02:00, the patient woke up and he was getting a stabbing pain in the top of his foot, like kind of neuropathy or it could be a arthritis type of pain; he don't know but he was just wondering if that was the side effect of the vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected. Information about lot number cannot be obtained.
My right arm started hurting around 8pm. Could not get comfortable in bed, hurt to move arm . When I woke up the next morning still hurting just as bad & can?t really use it because it hurts. I did not have this issue with 1st shot. If I had known this shot would hurt this bad, I would never have gotten this shot. The pain is bad & I can barely use my arm.
Itching at injection site urthen 1 hr.  Progressed to diffuse edema & erythema from elbow to distal deltoid.  Some mild tenderness.  Hard slightly numb no previous allergies.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 16-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
Fever of 100.9 achy arm head ache joint pain pain in back across lungs nausea  tired
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 08-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained. Sender's Comments: US-009507513-1611USA004113.
Fever/Chills for approximately 72 hours after vaccination. Flu-like symptoms - ongoing (6 days so far)
Tested positive for covid 1/05/2022.  Experience severe pain in right side 1/14.  Diagnosed with appendicitis.  Emergency surgery 1/15/2022 - perforated appendix .
Beginning on the evening of April 8th, my ability to taste lessened. This morning, April 9th, I cannot smell or taste anything. I have tried eating potent candied ginger as well as raw onion and cannot taste either one. I asked a family member, who is an RN, and she advised this is most likely just a temorary side effect as I am quite healthy otherwise. I always wear my mask, wash my hands often and thoroughly, and have stayed home whenever possible. I am unaware how long it will last, but hopefully it will go away soon.
PT EXP AN INJECTION SITE REACT WHICH INCLUDED SEVERE PAIN WITHIN 24 HRS AFTER IMMUN. ALSO, PT EXP A FEVER OF 101. REACTION RESOLVED 4 DAYS AFTER IMMUNIZATION WITH NO RESIDUAL SEQUELAE.
Information has been received from a physician via a company representative referring to a 68 year old female patient. On an unknown date the patient was vaccinated with one dose of ZOSTAVAX (dose, route and lot# unknown). On an unknown date the patient was diagnosed with a mild case of shingles after receiving ZOSTAVAX. The patient made office visit on an unspecified date and received acyclovir (unspecified dose/frequency and manufacturer) as treatment. Outcome of shingles was reported as recovered on an unknown date. This is one of two reports received from the same reporter. Additional information is not expected as the physician refused to be contacted.
7/19 - significant pain on administration 7/20 - expected warmth, swelling and soreness at  injection site  7/21 - extreme pain to area around right deltoid, right clavicle and right scapula. Persistent ache 7-8/10, intermittent sharp pain 8-9/10.  Pain unresolved, 6-7/10 for @ 1 hr with OTC ibuprofen 800mg.  7/22 - visit with chiropractor, beemer and laser therapy.  Ongoing OTC ibuprofen 800 mg every 8 hrs and ice pack every 2-3 hrs. Minimal to mild relief with ibuprofen. Mild relief with ice pack. 7/23 - on going OTC ibuprofen, rest and ice pack. Persistent pain range 5-8. Cough, sneeze or laugh spikes stabbing pain to 10. 07/25 - MD appointment . Full exam, ROM and labwork. Diagnosis SIRVA
Headache, NauseaVomiting, Localized pain; lightheaded, short of breath with minimal exertion  Narrative:
24 hours of fatigue, low grade fever, nausea and vomiting, heartburn, body aches, chills, headaches.  Treated with Advil and rest. Completely gone after 24 hours from start of symptoms
Arm numbness, weakness, tingling. Worse when sleeping. Cannot sleep in side I received the injection.
Patient reports swelling in lower extremity noticed over the weekend on 08/07/21. He went to Family Practice and was diagnosed with Deep Vein Thrombosis per Dr. on 08/11/21.  Moderna COVID-19 Vaccine
second dose Covid 19 vaccine administered 2 months after first dose; This is a spontaneous report from a contactable other healthcare professional (registered nurse). A 56-year-old male patient received second dose of BNT162B2 (Pfizer, Solution for injection) intramuscularly in left deltoid on 09Jul2021 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) (at the age of 56-year-old) at 0.3 mL as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 08Apr2021 (NDC number: Unknown, Lot number: EP7533, Expiration date: Unknown) (at the age of 56-year-old) for Covid-19 immunization. On an unspecified date, 2 months after first dose, the patient received the first dose of the Pfizer Covid-19 vaccine. Stated that the dose was not delivered. It was not their vaccine, so they did not have any further information. It was a diluted vaccine that had been stored in the syringe longer than 6 hours. Had discussed that with a medical doctor and was thinking of re vaccination because they were not sure if the vaccine was viable at that time. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
the one unspecified 1 year old patient went to the physician office on 16-JUL-2019, and was diagnosed with "chicken pox"; This spontaneous report has been received from a nurse via a company representative, concerning a 1 year old male patient.      The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 11-JUL-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (frequency, anatomical location, lot number and expiration date were not reported) as routine 12 month vaccination (prophylaxis).  Other suspect therapies included sterile diluent (MERCK STERILE DILUENT), which was used to reconstitute the vaccine (dose, frequency, route, lot number and expiration date were not reported).  On 16-JUL-2019, the patient went to the physicians office and he was diagnosed with chicken pox (varicella). The nurse stated that "it was unclear as the cause of the chicken pox as the child had been around other children and it may be that the child was exposed to the chicken pox from other children or possibly from receiving the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine. Therefore, the patient received "standard treatment" for the event. At the reporting time, he was stable, however he had not recovered from the event. In addition, no other adverse effect was reported.   The causal relationship between varicella, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and other suspect therapy: sterile diluent (MERCK STERILE DILUENT), was not reported.
#1 - chills body aches, nausea, headache , sick in bed for 2 days , runny nose  #2 so far- ringing in left ear, runny nose.
shingles; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about November 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
14 1/2 yr old male with history of reaction to varicella.  6 cm x 3 cm red swollen area - Rx BACTRIM x10 days.
The day after the vaccinations, patient had fever of 100.5 F, tiredness, redness at the local site. Her daughter took her to Urgent Care.  Her daughter called us to report on 11/2/20
Lt arm Redness and hot to touch from shoulder to elbow.  Swollen at injection site an more at the site about the size of silver dollar.
No issue until exposed to COVID with travel to (withheld) and Stayed in house with known COVID positive person who was isolating and then ST and AG positive x 2 on 22Mar2022; No issue until exposed to COVID with travel to (withheld) and Stayed in house with known COVID positive person who was isolating and then ST and AG positive x 2 on 22Mar2022; Exposed to COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Nov2021 (Lot number: FF2589) at the age of 25 years as dose 3 (booster), single, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Mar2022, outcome "unknown" and all described as "No issue until exposed to COVID with travel to (withheld) and Stayed in house with known COVID positive person who was isolating and then ST and AG positive x 2 on 22Mar2022"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 22Mar2022, outcome "unknown", described as "Exposed to COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Mar2022) positive, notes: Covid test name post vaccination: Home Ag; (22Mar2022) positive, notes: Covid test name post vaccination: Home Ag. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, exposure to sars-cov-2.  Clinical course: Facility where the most recent COVID-19 vaccine was administered was workplace clinic. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
she noticed that her arm was itchy so she removed the bandage. then she noticed it was red and slightly swollen on down her arm. It was slightly warm to the touch.
Developed Herpes Zoster without having known primary varicella infection. Given varivax on 10/29/96 at 1 year old.
Other than lethargy, a headache, mildly achy muscles and swelling (large knot) at the injection site, the primary problem was with a lymph node at center of left collar bone.  It became very swollen and painful and was warm to the touch.  The pain has gone away and the swelling is far less than in the first several days, but is still present.  I did not seek medical attention as I read this could be a side effect.  I am concerned that the lymph node has not returned to normal over a week since injection.  I will be seeing my primary care physician as soon as I can get an appointment.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 240 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Generalized body urticaria with itching within 30 minutes Treated with steroids and antihistamine None - rash/urticaria still resolving
Patient with dementia - incidental finding in asymptomatic patient due to trauma - mechanical fall admitted to Hospital
Chills during the night after having received the vaccine Fever of up to 102.3 during the next day Sore throat Tired Fever ended before the end of that day Sore throat continued into the following day
After my second vaccine, I continue to have breakthrough bleeding. I had my menstrual cycle 11 days after my second dose vaccine. I  went to se my gynecologist who performed an Ultrasound but could not find anything wrong. Since my first vaccine, my menstrual cycle has been out of sync and still out of sync with my second dose vaccine. It is very concerning to me since I am planning for embryo in the future.
i asked the nurse if she stuck the needle all the way in she said yes, i say no; Blister with fluid in it on TBE outside if the injection site/ blister dime size at the injection site / Blister is liquid filled; This case was reported by a consumer via call center representative and described the occurrence of injection site blisters in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included disability and aortic dissection.   On 27th April 2021, the patient received Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced injection site blisters. On 27th April 2021, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site blisters and wrong injection technique were unknown.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the dose of Shingrix and experienced fluid filled blister of dime size at the injection site. The nurse stated that she stuck the needle all the way in however patient stated that needle was not went in, which led to wrong injection technique. No other information was reported.
COVID arm. Circular red patch at injection site with swelling and itching. Started 7 days after injection and increased in size and swelling for 2 days. Swelling began to go down some on day 3.  This is day 3 3/15/2021.
RIGHT UPPER THIGH ERYTHEMA, BLOTCHY, BLANCHING RASH. NO HARDNESS, TENDERNESS OR WARMTH
Initial information has been received from the patient's family member concerning an approximately 62 or 63 years old male patient with an unspecified pertinent medical history or drug reactions/allergies, who last year, in approximately 2011, was vaccinated with ZOSTAVAX (dose, route, indication and lot were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that 2 or 3 weeks ago, approximately in October 2012 the patient developed a painful rash on his legs that feels similar to poison oak. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
DIZZINESS; SHAKY; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative 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: Unk) dose was not reported, administered on 2021 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. On 2021, the subject experienced dizziness. On 2021, the subject experienced shaky. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, shaky, chills, headache, and fever on 2021. This report was non-serious.