chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 31-JAN-2017  at 09:13, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000411:  US-009507513-1704USA000412:  US-009507513-1704USA000413:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000437:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000428:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704USA000454:  US-009507513-1704U.
Covid-19 breakthrough. 1st vaccine received 7/20/2021. Patient presented with epigastric pain and acute pancreatitis.  Covid-19 + 12/28/2021.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 22-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 0.55 C for 712 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Arm soreness, 3 days later 11/11/2020 red area on arm size of palm below the shot site 3-4 dime sized areas very red and other area pink flesh toned areas. Harden, very firm areas underneath skin in flesh colored red and pink areas more so in redden area. Discoloration still visible today 11/18/2020 in moderation. 11/12/2020 Left shoulder joint tender in certain positions.
Got mine at least a month ago. Always have a bad reaction; Initial information received on 22-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional via social media.  This case involves patient (unspecified gender and age) who got at least a month ago. always had a bad reaction (adverse drug reaction), while he/she received vaccine Influenza Vaccine.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got at least a month ago, always had a bad reaction (adverse drug reaction) (non-serious).  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown. There will be no information available regarding batch number in this case.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed rash underneath the left arm), PRURITUS (It started as localized area of itching), BURNING SENSATION (burning), FEELING ABNORMAL (very moist and was feeling very uncomfortable) and ERYTHEMA (finally the area turned bright red in color) in a 67-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.     The patient's past medical history included No adverse effect. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and GLIPIZIDE for an unknown indication.    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 RASH (developed rash underneath the left arm), PRURITUS (It started as localized area of itching), BURNING SENSATION (burning), FEELING ABNORMAL (very moist and was feeling very uncomfortable), ERYTHEMA (finally the area turned bright red in color) and RASH (noticed its getting bigger and bigger and moving down the arm.). At the time of the report, RASH (developed rash underneath the left arm), PRURITUS (It started as localized area of itching), BURNING SENSATION (burning), FEELING ABNORMAL (very moist and was feeling very uncomfortable), ERYTHEMA (finally the area turned bright red in color) and RASH (noticed its getting bigger and bigger and moving down the arm.) outcome was unknown.        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.   No treatment medication was provided
Information has been received from a certified medical assistant (CMA) referring to a patient (4) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant  medications was provided. On 14-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34F (Min) and 37.9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Flu-like symptoms, minus the fever.  Body aches, extreme fatigue, headache
This spontaneous report was received from a registered nurse refers to 2 patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L015048, expiry date of 29-APR-2017 and M-M-R II lot # L002873, expiry date of 27-JAN-2017. No adverse effects were reported. Additional information has been requested.
All over body rash (hives) starting 5 hours after receipt of vaccines on 9/26/03. Denies difficulty breathing, etc. Still with rash on 9/29/03. Referred to PMD for treatment.
5pm 1/28/2021  developed headache, low grade fever, chills and severe pain at the injection site
No adverse event; Primary series vaccine expired 03/30/23 and was administered today 04/03/2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Primary series vaccine expired 03/30/23 and was administered today 04/03/2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Primary series vaccine expired 03/30/23 and was administered today 04/03/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Primary series vaccine expired 03/30/23 and was administered today 04/03/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Primary series vaccine expired 03/30/23 and was administered today 04/03/2023).    No concomitant medication was reported.    No treatment information was reported.
Day after: nausea, fever (99.5 F), rash at injection site, lower back pain, muscle aches, skin sensitivity (lower back, legs, arms), headache  2 days after: eye infection, rash remains
Patient started to shake without control and felt like he had no control over arm.  He then became very pale in color and had a sore neck from shaking without control for several minutes.  He then complained of a tight throat for a few minutes.
COVID19 Vaccine (1st in series) - 2/12/2021  Positive early pregnancy test - 2/21/2021  Suspected date of conception - 2/7/2021  Due date - 11/1/2021  COVID19 Vaccine (2nd in series) - 3/5/2021  Date of birth -   (normal vaginal birth at 40+1 with no complications)  Seizure-like episode with cyanosis in baby at 6.5 months old - 5/22/2022  Vomiting at similar cyanotic episode in baby at 7 months old - 6/7/2022  Hospitalized overnight with EEG, ultrasound, and MRI - 6/8/2022-6/9/2022  Abnormal MRI findings on 6/9/2022 MRI CONSULT IMPRESSION NOTE BELOW: Bilateral fairly symmetric areas of T2 hyperintensity in the subcortical parietal white matter are nonspecific. No associated diffusion restriction or enhancement seen. These may reflect vasogenic edema of indeterminate etiology. Dysmyelinating diseases are also included the differential diagnosis. Lack of volume loss speaks against gliosis. Unmyelinated brain parenchyma may also be considered, but the T2 signal is higher than expected for this and the distribution is not typical.   Tested for Leukodystorphy with the Invitae panel, VUS found but nothing that would be indicative of the MRI results.    part of a clinical study - NO FINDINGS TO REPORT.  Consults with a local clinic and a second Clinic, and leading expert in Leukodystrophy MRI imaging Dr. contacted for impressions on MRI.  All providers concluded diagnosis was NOT Leukodystrophy.  Baby is lower on weight, head size, and height percentile, but developing normally.  No diagnosis. No explanation. Vaccine received by mother (me) while baby was in early and essential development stage in utero (the first 6-8 weeks).
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No relevant concomitant medications were reported.  It was also reported that there was potentially a second lot number that was expired on 28 Feb 2023 and was administered to patients on 3 Mar 2023, but HCP did not had any details on that event at that time. The vial size was reported as 10 dose vial.  The vial had not  undergone any temperature excursions. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Matster case
Very sore shoulder/ arm at injection site starting almost immediately. Extreme fatigue  starting about 3 hours after injection and lasted about 24 hours. Shoulder still in pain 36 hours later.
Had Syncopal episode lasting 5 seconds immediately following injections (3). Brief shaking associated with syncope. PMH - similar episode when treated for ingrown toenail.
101.1; shivering; experience the entire list of Shingrix vaxx side effects; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, shivering and adverse drug reaction. On an unknown date, the outcome of the fever, shivering and adverse drug reaction were unknown.   It was unknown if the reporter considered the fever, shivering and adverse drug reaction to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced 101.2 degrees C, Shivering like at end. The patient mentioned that you experience the entire list of Shingrix vaccine side effects and it was dramatically better than getting shingles again. At least this was his/her 2nd dose so done.
Information has been received from a RN concerning an unidentified female patient who was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the patient developed a couple of vesicles. The patient sought unspecified medical attention. Additional information has been requested.
3 days after rash,nasal congestion,runny nose and cough. 6 days after rash,cough,fever
Patient states that approx 24 hrs following ZOSTAVAX, she developed a red round rash with 'tiny bumps' at the injection site, (RT) upper arm, with mild burning and tingling which resolved in 3-4 days. Patient without symptoms on 6/5/12 at our office and without rash/skin lesion of either upper extremities.
Reported by NP who administered the vaccine.  She got her vaccine, she had them sit there for about 15 minutes for a reaction.  She had no anaphylaxis.  Arm next day was red, swollen, painful and itchy.  The pain is 8/10 and the arm is pretty much from her vaccine site down her elbow and wraps around .  It is red, warm and swollen.  She said she did Aleve for the pain, but that was it.  The patient was given a fact sheet brochure.
11/11/09 generalized rash. 11/16/09 seen ER off balance, fever, dizzy. 11/18/09 fever hands achy.
Throwing up,; bone aches; nausea; headache; stomach craming; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Apr2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient previously had penicillin for unknown indication on unknown date and experienced penicillin allergy. The patient had received other medication within two weeks of vaccination which included her regular prescriptions for unknown indication on unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 09:00, the patient experienced throwing up, bone aches, nausea, headache, stomach craming. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events throwing up, bone aches, nausea, headache, stomach craming was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
It started a few minutes after with a nauseous but that happened with the first two doses. About four five hours after.  Extreme fatigue rash two lumps under my left arm pit ringing in my ears. As the day progressed and into Thursday Friday really bad fever chills achy bones tightening in my chest and a pain on the right side of my back. Early Thursday morning I almost went to the ER but decided to wait it out. Around Sunday symptoms started to lesson but still experienced very exhausted and little fever. As of Tuesday 1/11 still experiencing fatigue lumps have gone down not painful my ears are ringing less only when I lay down and my chest is still a little tight of and on. I had to take three sick days from work. With the second dose I was so nervous I went to the dr to check. This dose (booster) symptoms was worse than the first two.
I cant walk. My walking is very bad./I am having a hard time walking/why I can't walk; I just feel bad/I don't feel good. I didn't feel good yesterday; My left side is weak/I get extremely weak/left arm is more weaker than it normally is/my left arm isn't functioning/every time I move around, I get extremely weak and I can't function; 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 female patient received bnt162b2 (BNT162B2) (Lot number: EW0202) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine, reaction(s): "My walking is very bad".  The following information was reported: GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "I cant walk. My walking is very bad./I am having a hard time walking/why I can't walk"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "I just feel bad/I don't feel good. I didn't feel good yesterday"; ASTHENIA (non-serious), outcome "not recovered", described as "My left side is weak./I get extremely weak/left arm is more weaker than it normally is/my left arm isn't functioning/every time I move around, I get extremely weak and I can't function. I make myself get up".  Additional information: Patient had a Pfizer COVID shot 2 days ago and she didn't feel good. She didn't feel good yesterday but it's worst today, it's like she cannot walk. She was having a hard time walking and her left arm is more weaker than it normally was. Her walking was very bad. her left side was weak. She just felt bad. Patient reacted to other vaccines like flu vaccines. A month getting form that one she had that experience. She was on a walker. After receiving the Pfizer COVID vaccine, the side effects seem to be hanging on. She can't get things accomplished because every time she move around, get extremely weak and can't function. She make herself get up because if she don't, wont be able to get up. She had vaccines before with the flu and sometimes had a reaction, but she don't react like everybody else.  Follow-up attempts are completed. No further information is expected.
Three days after the first injection I noticed an itching sensation in my genital region. Upon closer inspection I noticed blister like bumps just under the head of my penis and down my scrotum. Initially I tried lotion, then Neosporin and finally Cortisone to stop the intense itching. When I shower with hot water it intensifies the itching. I went to the doctors on 4-26 and Dr. prescribed Prednisone. He's trying to get me into the dermatologist but the earliest is May 7th.
Swelling of right arm, extending below elbow 2 inches, right arm warm and red to touch, difficulty moving arm also.
Approx a day after vaccination (or <24 hrs) pt. falls forward or occasionally feel down after walking (ataxia), unusual as per mom.  Started walking 4-5 wks ago.    2/19/08 Reviewed hospital medical records which reveal patient experienced difficulty walking x 1 day, falling backwards whenever standing up.  Also emesis x 2.  Admitted 1/10-1/11/08. FINAL DX: Ataxia, post viral vs post vaccination.
This case was reported by a physician via call center representative and described the occurrence of thymus enlargement in a 76-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included lymphoma (with treatment, most of it resolved except for a spot on thymus). On 4th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced thymus enlargement. On an unknown date, the outcome of the thymus enlargement was not recovered/not resolved. It was unknown if the reporter considered the thymus enlargement to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient received SHINGRIX in the left arm. After receiving SHINGRIX, his next PET scan showed that the thymus was increasing in size. The healthcare professional was not sure if it was caused from SHINGRIX. He did not have vaccine information since he got it done at the pharmacy.
Pain in arm, at injection site, joint pain in shoulder, neck pain and headache.  Took Advil and applied heat and massage to area.  Next day, broke out mid morning in facial rash with red raised bumps on checks, nose and chin.  Pain in arm worsened with more stiffness when moving arm.  Took Benadryl with Advil for pain.
Throbbing tinnutis within 2 hours of the first dose of Moderna vaccine. It sounded like a rushing noise in my ears that followed my heartbeat. Boom boom boom. I called the pharmacist to report it and they said they were sorry to hear I had experienced the side effect. The boom boom boom rushing tinnutis subsided after 2 weeks but now I have a high-pitched "hum" ringing in my ears that has never subsided, I hear it all hours I am awake.