chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to ER 3 days after vaccine was administered with superimposed cellulitis and blistering. After the vaccine mother noticed redness in right arm where the vaccine was given. With time the redness spread, worsen, and the arm became indurated, and blistering develop. Patient was treated with clindamycin every 8 hours and IV Benadryl every 8 hours. Patient was discharged home with clindamycin by mouth every 6 hours and Benadryl as needed.  Pt came to the office and right upper arm had mild erythema no induration, not warm to touch and no blisters.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles shot a day before reporting and experienced sore arm. The patient wanted to know how long her arm would be sore. The patient did not have time for providing additional details. This case has been linked to the case US2018GSK216567 (husband's case), reported by the same reporter.
Initial unsolicited report received from pharmacist on 19-Sep-2018. This case involves an unknown age and gender patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UI977AC, expiration date: 03-Sep-2019, site of administration: arm and route was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to syringe leak (needle in the arm, pushed on it and stuff came out). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
pt recvd vax;exp flu like virus sx w/ fever,chills,muscle aches & palpitations;additionally,almost fainted on 01sep94;mom reported that pt felt ill & fatigued;2sep94 MD spoke w/ pt & seemed much better;
I broke out in a cyst like rash all over my left side shoulder, neck and back on Saturday morning following the shot. I have also had severe bloating and stomach issues since Saturday.
Awakened by severe leg cramps in both legs, upper and lower, front and back. Pain so intense it? brought tears to my eyes and I woke my husband with my moaning. It lasted about 15-20 minutes. I have never had muscle cramping like this before or since.
Patient states that she woke up in the middle of the night and was shivering and had chills and upon waking up she noticed a blister near her eye.
Normal/expected side effects occurred during the first 24-36 hours after receiving my second dose. Those side effects went away, and then 5 days after (on 4/7/21), I began to experience pain and tingling (pins/needles feelings) in my legs and feet. I was unable to sleep for two nights and pain medication did not alleviate any of the symptoms. I went to urgent care on 4/8/21 and the ER on 4/9/21. The ER ran labs and gave me fluids. Nothing abnormal was found on my labs, so I was discharged without being admitted. The nerve pain also seemed to move around to different parts of my body, including chest and upper extremities. During the week of 4/12/21, I experienced some mild chest pain and later constipation that prevented me from eating. The tingling nerve pain subsided a good amount after about a week from the onset date, but it was many weeks before it fully went away.
Generalized fatigue and severe back pain lasted for more than 72 hours.; Generalized fatigue and severe back pain lasted for more than 72 hours.; I developed a severe headache; Spiked a fever of 104 approximately 10 hours after third dose infusion. I continued to run a fever between 100 and 104 for 48 hours.; This is a spontaneous report from a contactable reporter (healthcare professional). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 12Feb2022 at 10:15 (Lot number: FM0698) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa medications. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EK9231), administration date: 27Dec2020, when the patient was 56 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EL3248), administration date: 17Jan2021, when the patient was 56 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 12Feb2022, outcome "recovering", described as "I developed a severe headache"; PYREXIA (non-serious) with onset 12Feb2022, outcome "recovering", described as "Spiked a fever of 104 approximately 10 hours after third dose infusion. I continued to run a fever between 100 and 104 for 48 hours"; FATIGUE (non-serious) with onset 12Feb2022 at 22:00, outcome "recovered" (an unknown date in Feb2022), described as "Generalized fatigue and severe back pain lasted for more than 72 hours"; BACK PAIN (non-serious) with onset 12Feb2022 at 22:00, outcome "recovered" (an unknown date in Feb2022), described as "Generalized fatigue and severe back pain lasted for more than 72 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, fatigue and back pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
local pain at the injection site after vaccination; post vaccination induration; post vaccination itchiness; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves female patient [age unspecified] who experienced, local pain at the injection site (vaccination site pain), post vaccination induration (vaccination site induration) and post vaccination itchiness (vaccination site pruritus), while she received FLUZONE HIGH DOSE [INFLUENZA VACCINE TRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE TRIVALENT [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious local pain at the injection site (vaccination site pain), post vaccination induration (vaccination site induration) and post vaccination itchiness (vaccination site pruritus) unknown latency following the administration of [INFLUENZA VACCINE TRIVALENT]  It was reported that, worsening of the condition if she ate eggs and wondered if patient was experiencing an egg allergy reaction.  Details of laboratory data not reported.   It was reported that, it was not sure patient should be treated with steroids.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the batch number for this case.
I experienced chills, headache, fever of 100, muscle aches, body aches, pain, exacerbation of Tarsal tunnel syndrome, and these symptoms dissipate. These symptoms lasted for 2 days before they resolved. I took Tylenol for my symptoms until it resolved. I have been in physical therapy for the chronic tendonitis, and I had not had this type of tendonitis prior to beginning this vaccine series. Each dose of the vaccine causes a flare up of my symptoms. I have not fully recovered.
My husband had shingles shots & still got shingles/Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My husband had shingles shots & still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-MAR-2023 The case was received from the patient's wife interactive digital media. The reporter stated that her husband had shingles shots and still got shingles in one eye and one side of his head.  The reporter stated that it had been a nightmare. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Nausea, vomit x 2, overall fatigue/malaise} 10 hours after injection. Diarrhea 2 days after injection. Tenderness to right arm from elbow to armpit/shoulder-since injection given Monday 9-19-16. Localized reaction: hot to touch, tight skin, swelling, lumpiness.
leukocytoclastic vasculitis reported in a pt receiving flu vax; pt recvd fluogen OCT93 & 4 days later devel palpable, papular purpura on lower legs; pt's MD made a dx of leukocytoclastic vasculitis;
No Adverse Event; Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No Adverse Event) in a 41-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022).    No concomitant medications were reported.   It was reported that Moderna COVID-19 Bivalent were administered with BUD 17-Dec-2022 (lot number 019H22A) on 20-Dec-2022 to 3 patients and BUD 16-Dec-2022 (lot number 015H22A) on 19-Dec-2022 to 4 patients. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-692428, US-MODERNATX, INC.-MOD-2022-692431, US-MODERNATX, INC.-MOD-2022-690257, US-MODERNATX, INC.-MOD-2022-692423, US-MODERNATX, INC.-MOD-2022-692429, US-MODERNATX, INC.-MOD-2022-692430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692428:same reporter US-MODERNATX, INC.-MOD-2022-692431:same reporter US-MODERNATX, INC.-MOD-2022-690257:same reporter US-MODERNATX, INC.-MOD-2022-692423:same reporter US-MODERNATX, INC.-MOD-2022-692429:same reporter US-MODERNATX, INC.-MOD-2022-692430:same reporter
For the first dose ONLY:  Approximately two hours after injection, I noticed overall body aches, plus fatigue set in.  The fatigue and body aches lasted ~18 hours.  I had no adverse events for the 2nd dose.
Itchy; Hot arm; Arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), FEELING HOT (Hot arm) and PERIPHERAL SWELLING (Arm swelled up) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PRURITUS (Itchy), FEELING HOT (Hot arm) and PERIPHERAL SWELLING (Arm swelled up). At the time of the report, PRURITUS (Itchy), FEELING HOT (Hot arm) and PERIPHERAL SWELLING (Arm swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by Reporter.  No treatment information provided.
Received 1st dose of Pfizer vaccine on Thursday.  Started experiencing left-sided facial droop (eye and mouth) Friday morning.  No improvement on Monday morning.  Difficulty closing left eye and severe left-sided mouth asymmetry.  Patient denies any extremity weakness. Presented to Emergency Department Monday morning for evaluation on 2/22/21.  Discharged to home.  (Assessment:  Bell's Palsy).
Individual awake at night and went to use the bathroom.  After washing his hands, individual was found by family members on the floor of the bathroom.  Individual appears to have passed out.  Individual had symptoms of slight fever, myalgia, profuse sweating while sleeping, and dehydrated.
The day after the immunization, most of patient's left bicep muscle was red, hot and itched. She had a fever of 103 degrees. The second day after the immunization her tongue also itched. Mother was told to give ibuprofen and BENADRYL. About 5 days later she was back to normal.
I had a heart attack on 4/8/21 after my vaccine a couple weeks earlier. I had no risk factors and no prior heart problems. They were unable to put a stent in because it appeared to be a tiny vessel ghosting on the heart cath. They gave me a statin, blood thinner, and blood pressure medicine with a rescue nitro prescription when I was discharged. They were unable to fix the heart vessel.
This spontaneous report was received from a nurse prescriber referring to a 6 month old female child patient. The patient's medical history, concurrent conditions, drug reaction or allergies and concomitant therapy were not provided. The nurse reported that on 23-JAN-2017, a 6 month old child received a dose of GARDASIL 9 intramuscularly (dose, lot # and its expiration date were unknown) for prophylaxis. No adverse effects were noted. No product quality complained was involved. Additional information has been requested.
Swelling/lump on lower, inner arm which looks like hives possibly; Lump between her elbow and wrist - left arm - size of silver dollar; Giant lymph node reaction from the vaccine - size of quarter; Redness at injection site; Slight fever; Chills; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SWELLING (Swelling/lump on lower, inner arm which looks like hives possibly), PERIPHERAL SWELLING (Lump between her elbow and wrist - left arm - size of silver dollar), LYMPHADENOPATHY (Giant lymph node reaction from the vaccine - size of quarter), VACCINATION SITE ERYTHEMA (Redness at injection site) and PYREXIA (Slight fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01322OA or 011522OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ZOLPIDEM and DOXYCYCLINE for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced SWELLING (Swelling/lump on lower, inner arm which looks like hives possibly), PERIPHERAL SWELLING (Lump between her elbow and wrist - left arm - size of silver dollar), LYMPHADENOPATHY (Giant lymph node reaction from the vaccine - size of quarter), VACCINATION SITE ERYTHEMA (Redness at injection site), PYREXIA (Slight fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling/lump on lower, inner arm which looks like hives possibly), PERIPHERAL SWELLING (Lump between her elbow and wrist - left arm - size of silver dollar), LYMPHADENOPATHY (Giant lymph node reaction from the vaccine - size of quarter), VACCINATION SITE ERYTHEMA (Redness at injection site), PYREXIA (Slight fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Treatment for the event included extra strength Tylenol.  Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Updated information on events received.
Red, swollen arm day after Pneumovax.  Presented to ER two days after Pneumovax.  Treatment unknown.
Pt was reported dead to us by mom this morning.  She stated death was around 4:00 am.  5/9/08 Autopsy report states COD as sudden unexplained death in infancy.  Autopsy report also states patient was found in prone sleeping position on soft bedding w/soft pillow partially covering mouth/nose.  Had been placed in bassinet on back on a soft pillow.  Patient was large for his age weighing 19.6 lbs. Patient had seen PCP approx 11-12 days prior for ear infection & had finished his antibiotibcs.  No problems noted on day of vaccination or afterward.  PCP had noted that patient was overweight & parents counseled to reduce feeding.
Patient called pharmacy at 6 pm on 8/18/20 to report that she had extreme arm soreness related to vaccine that she states inhibited her from lifting her arm. At this time she was counseled to take OTC pain relief and ice vaccination site. She was instructed to call doctor or pharmacy if pain worsened. Followed up with patient today 8/19/20. She states that after talking on 8/18/20 that pain continued to  worsen and inhibited her from sleeping well due to being uncomfortable. She states that she has taken tylenol and ibuprofen periodically throughout today and feels that it is continuing to improve. She states that she is able to move arm more than previous day but is still restricted due to the pain. She stated that she has not called doctor yet.
Initial unsolicited report received regarding an unsolicited valid non-serious case from other health professional on 13-Nov-2018. This case was linked to 2018SA315878, 2018SA315888, 2018SA315885, 2018SA315886, 2018SA315887, 2018SA315882 and 2018SA315884 (same reporter). This case involves a 65 years old male patient who was vaccinated with a dose of FLUBLOK QIV, (lot QFAA1815, expiry date: 30 Jun 2019) via intramuscular route in the right deltoid, on 07-Nov-2018. The patient's medical history was not reported. Concomitant medication includes PREVENAR 13 on 07 Nov 2018. It was an actual medication error due to incorrect product storage as vaccines were exposed to a max temp of 52 F for 27 hours. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Pain at injection site X 2 days. Redness, swelling from injection site on upper arm to elbow X 5 days
Breakthrough case admission after 2 vaccines Moderna 2/19/21 Lot# 023M20A;   Moderna 3/19/21 Lot# 007B21A
1. Injection site of second doese started to have pronounced discoloration after day 2 that looks like a bruise.  The site had a little bleeding as the male nurse adminiter the dose.  Redness faded but circular yellowish discoloration about 2 inches in diameter is still visible on left arm after 7th day.   2. Eyes started itching the first shot and left eye had itchy corner like dry skin or something.  Itchiness faded then came back again after second shot.  Same reaction, itchy eyes the next day and the left eye corner started itching and drying up.  Applied 1% cortizone to relieve itchiness and dryness on 3rd day.  Seem to have releived the itchiness and dryness but still monitoring it.   Will report this reaction with my provider when I see them next week,
pt recv vax 26JUN96 & 11JUL96 pt devel chicken pox lesions on forehead & arms, his testicles were covered w/pustules;tx w/DPH & colloidal oatmeal (aveeno bath);reporter felt that pt exp was probably r/t vax;
18 days after vaccine patient developed vaccine induced chicken pox including rash, fever, headaaches and neckstiffness. No clinically improving.
It has been more than 36 days and the patient did not receive the second dose; very swollen lymph nodes from head to toe; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days and the patient did not receive the second dose) and LYMPHADENOPATHY (very swollen lymph nodes from head to toe) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days and the patient did not receive the second dose) and LYMPHADENOPATHY (very swollen lymph nodes from head to toe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days and the patient did not receive the second dose) had resolved and LYMPHADENOPATHY (very swollen lymph nodes from head to toe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.