chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A HCP reported post vaccine pt developed an injection site reaction characterized by 2cm palpable area of swelling and tenderness. Pt was treated in the ER and diagnosed with cellulitis, a moderate amount of pus was removed from the right arm an Penrose drain was inserted and sutured in place.
Sore arm; arm hard to move; chills; fever; couldn't lift arm; does not feel good; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPOKINESIA (arm hard to move), FEELING ABNORMAL (does not feel good), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age 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 event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (does not feel good). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HYPOKINESIA (arm hard to move), CHILLS (chills), PYREXIA (fever) and MYALGIA (couldn't lift arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPOKINESIA (arm hard to move), FEELING ABNORMAL (does not feel good), CHILLS (chills), PYREXIA (fever) and MYALGIA (couldn't lift arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment  reported: ice and heat
Received Shingrix vaccine. I had no reaction to the first in the series of two. However, the next day following the 2nd injection, I had a fever, body weakness, shivering, disorientation, and pain in my right flank.
PT RECEIVED MODERNA VACCINE ON 3/10/21 (LOT 048A21A)_ + 4/12/21 (LOT 036B21A). S/O BEGAN 9/21/21, TESTED + 9/28/21
Vaccine was administered IM to patient in right arm and nurse noticed right arm swelling, below the vaccine site.  Cool compress was provided.  Patient stated they previously had vaccine and never experienced this reaction.
started with itching then welted after 1 week. Welt lasted about 2 weeks, then when I move my arm back to far or forward to far , sharp hot pain shoots from the injection site up my should, no care
Pt received the Anthrax vaccine within x14 days of receiving the COVID vaccine. Pt notes that he received the 1st COVID-Pfizer vaccine on 29Apr2021 and the 2nd dose of Anthrax on 19Apr2021. Pt notes the night of COVID vaccine he developed 99.5 and HA, today he continues to have HA, dizziness and stomachache.
The patient reported that she woke up during the night following the vaccine with pain, burning/ hot sensation in her arm and face.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Information has been received from an 84 year old female consumer with congestive heart failure, high blood pressure, diabetes and a penicillin allergy who on approximately 31-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  In November 2007, "a couple of days after getting ZOSTAVAX (Oka/Merck)" the patient developed a red rash under and on the front of her arms, on her face, stomach and rear-end.  The patient contacted the physician by phone for medical attention.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested. 03/26/2008 Folow-up information has been received from a physician, dermatologist and medical records indicating that the 84 year old female nursing home patient had a drug hypersensitivity to simvastatin (MSD), who on 25-OCT-2007 was vaccinated IM with a dose of ZOSTAVAX (Oka/Merck) in the deltoid. There was no illness at the time of vaccination. Concomitant drug therapy included famotidine, ZRYTEC, LOTENSIN, ZOLOFT, LIPITOR, LASIX, trazodone HCl, EFFEXOR and potassium chloride. In November 2007, a couple of days after vaccine, the patient developed a red rash. At the doctor visit the physician described the patient's event as a macular eruption in heat areas (concentrated in the arms, lower back, axillary, intra-mammary and neck). On 15-NOV-2007 the dermatologist described the rash as scattered non-blanchable macules on arms, chest with minimal itch for the past month. The dermatologist also observed a cayenne pepper staining on the chest, upper back, with no scaling or palpable lesions. On the left proximal forearm the patient developed a 1 mm pustule. The physician's assessment was a combination of capilaritis and miliaria. Lab diagnostic studies included a CBC, UA, and an ASO titer. The patient was treated with SARNA OTC PRN, CETAPHIL cleanser. The patient was recovered. It was also noted that the dermatologist doubted that the events were correlation to vaccination with ZOSTAVAX (Oka/Merck). Additional information has been requested.
Nausea, then non-stop vomiting from 11:30 pm until 3:30 am.  Non stop watery diarrhea from 1:00 pm 31 Dec until 9:00 am 2 Jan 2010.  Fever 101 degrees until 9:00 am 2 Jan 2010.   Took Tylenol extra strength once vomiting stopped.  Everything normal by 9:00 am 3 Jan 2010.  Except I lost 5 pounds in 3 days.
swollen spot at the injection site; red spot at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (swollen spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No patient medical history was provided.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swollen spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site). At the time of the report, VACCINATION SITE SWELLING (swollen spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator. No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-090662 (E2B Linked Report). This case was linked to MOD21-081731, MOD21-081735 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090662:Same reporter
seizure; This is a spontaneous report from a contactable physician. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced seizure in May2021 with outcome of recovered.    Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
pt seen 2 days after vaccine with redness with harder core at injection site total area of redness > than softball size started on cephalexin for ? cellulitis
Dose administered after manufacturer date of expiry; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were initially stored in the refrigerator on 09-Apr-2022 and moved from freezer to Room Temperature at time of vaccination. The eight patients received expired Moderna COVID-19 vaccine beyond the manufacturing expiration date.  4 patients received their first shot, 2 patients received booster and 1 patient received the 2nd shot. Lot number was 060H21A and manufacturing expiry date: 28MAR2022 On 09-Apr-2022, the vial was initially stored in the refrigerator for patient 2, 3 and 4.  The vial did not undergo any temperature excursion. Patient did not have any adverse reactions. No treatment  medications were reported.
Half of the vaccine spilled on her arm; A spontaneous report was received from a Consumer concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine and half of the vaccine spilled on her arm (vaccine under dose).  The patient's medical history was not included. Concomitant medications included aliskiren fumarate and amlodipine.  On 27 Feb 2021, prior to onset of the events, the patient received their dose of mRNA-1273 (Batch number: 031L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient noticed that half of the vaccine spilled on her arm (vaccine under dose). No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event vaccine spilled on her arm (vaccine under dose) was considered recovered.; Reporter's Comments: This report refers to a case of under-dose for mRNA-1273.  There were no reported adverse events associated with this case.
47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd dose of COVID 19 vaccine.  Patient denied experiencing any SOB, difficulties breathing and difficulties swallowing.  She described abdominal pain as sharp with sudden onset following vaccine.  Pt does have a history of abdominal pain and is currently followed by GI.  At that time, RN contacted provider for consult.  Patient was evaluated by provider and 25 Mg PO Diphenhydramine ordered and given at 1533 Log: 502213 EXP: 3/31/21.  Pt V/S at that time were: BP 144/90, HR 98, 02 99, Temp 98.1.   Patient was observed by RN for an additional 15 minutes.  V/S at 1545 - BP 129/79, HR 83, O2 99, temp 98.1.  Patient facial flushing had visibly improved and her husband was contacted to pick up.  Per provider, patient was released to self care with ER instructions if symptoms return/worsen provided.
shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The nurse reported that the patient developed shingles 4 days after receipt of Shingrix. The reporter consented to follow up. No further details available from nurse at the time of reporting but she was agreeable to recontact.  Email address was provided.
Case previously recorded as MA2009-3969. Initial case report received from a nurse via MedCom on 06 NOV 2009. A 9-month-old male patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 102044P1) i.m., on 06 NOV 2009. MedCom reference no.: NA09-007775.
The day after, starting to have burning sensation from the chest down to the the bottom of feet.  No burning on head, neck, fingers or toes. Pt can tell it's not her normal arthritic pain. Burning worse at bedtime. That's when noticed more. During the day too busy to notice. 3 days out and burning still the same.
Started having jerks (later found out they were seizures). Were around 15 at a time.
On August 6th around 3 am I woke up with the sensation of pins and needles in my left hand along with difficulty opening and closing my fist. After forcing my fist to open and close for a few minutes it went away. Then on August 9 around 4 am, I woke up with pins and needles sensation in my right forearm and hand, but after clenching a fist a few times it also went away.
Behavior change.  Sleepy day after vaccines.  A few days later, more resistant behavior in this easy going toddler- irritable, clingy, decrease appetite, finicky - no fever or rash.
9/25/13 pt received AFLURIA at 10:10AM. Pt came back at approx. 7:00PM with raised bumps approx. 8mm in diameter on forearms and 1 one neck. Pt stated itching on head and back as well. Pt went to (on 9/26/13) immediate care, received Rx for prednisone and ZYRTEC (filled on 9/27/13).
This case was reported by a healthcare professional, via Merck, and described the occurrence of lab test abnormal in a subject of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of PEDIARIX (details unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced lab test abnormal. The subject developed titer a hundred times the normal. The titer was not specified and no further information was provided. At the time of reporting the outcome of the event was unspecified. No further information was available.
Pt is a 65 yo male, hyperlipidemia, cluster headaches, GERD, BPH who developed fever 102, chills 16 hours after vaccines given. Pt drink a lot of water and then developed decreased mental status. On exam cellulitis of (L) arm - triceps arm was noted.  10/23/07 Received pneumo lot #.  VAERS database updated w/same.  10/23/07 Received hospital medical records which reveal patient experienced swelling of left biceps with fever, chills, lethargy & altered mental status.  Admitted 10/13-10/15/2007.  Nephrology consulted for low Na & ID consult done.  Tx w/IV antibiotics.  Progressed well & d/c to home on oral antibiotics. FINAL DX: Cellulitis of left biceps, hyponatremia.
Patient had been fussier this day, at around 1p she began to look pale and vomited.  It was different and more than regular spit up.  She nursed a little more and vomited again.  She fell asleep on my chest and felt warm although I didn't take her temp, she was unusually sweaty.  She woke up around 2p and had two instances of vomiting a bile like substance.  Then her color appeared back to normal and she ate and slept per her usual for the rest of the day and Sunday.
Sore arm for a day or two; Hand swelled a little bit; Right arm got red too in some parts; Left arm developed a big red area that went from the vaccination area down to the rest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a day or two), PERIPHERAL SWELLING (Hand swelled a little bit), ERYTHEMA (Right arm got red too in some parts) and VACCINATION SITE ERYTHEMA (Left arm developed a big red area that went from the vaccination area down to the rest) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for a day or two), PERIPHERAL SWELLING (Hand swelled a little bit) and ERYTHEMA (Right arm got red too in some parts). an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Left arm developed a big red area that went from the vaccination area down to the rest). At the time of the report, PAIN IN EXTREMITY (Sore arm for a day or two) had resolved and PERIPHERAL SWELLING (Hand swelled a little bit), ERYTHEMA (Right arm got red too in some parts) and VACCINATION SITE ERYTHEMA (Left arm developed a big red area that went from the vaccination area down to the rest) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Additional concomitant medications included unknown water pill.  Treatment information was not provided.   This case was linked to MOD-2021-245639 (Patient Link).
Rash/hives  Welts  on upper thighs and right forearm arm and wrist.  Excessively itchy! Like it?s on fire!  Treating clobitosol ointment.  Taking antihistamine to help reduce itching.   I had the same reaction after the first vaccine and after the H1N1Vaccine in 2009.
I was given the Pfizer vaccine by mistake. I originally received the Moderna for my first round of vaccinations and was told upon scheduling that this site would be administering the Moderna vaccine.  However, after my second vaccine was administered I was informed that I was given the wrong vaccine.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 60-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805497 was crossed linked to original cases 201804863 due to same reporter.
Information has been received from a registered nurse concerning a male student who on 02-APR-2009 was vaccinated with VAQTA 1 ml IM (lot # 663507/1603X). On 09-APR-2009 the patient was diagnosed with encephalitis. The patient was hospitalized at an unknown facility and no details of the hospitalization were available. The patient's encephalitis persisted. Encephalitis was considered to be immediately life-threatening and disabling. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
all his COVID vaccinations he has got in the past have been Pfizer/diagnosed with COVID; all his COVID vaccinations he has got in the past have been Pfizer/diagnosed with COVID; 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 71-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "all his COVID vaccinations he has got in the past have been Pfizer/diagnosed with COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Headache, Myalgia, Fever, NauseaVomiting,  Chills Narrative:
AFTER RECEIVING THE VACCINE THE PATIENT BECAME PALE, SWEATING, AND WITH RIGID UPPER EXTREMETIES, TREMBLING, AND COLD TO THE TOUCH. WAS ACCOMODATED IN SUPINE POSITION WITH ELEVATED LEGS. PULSE AND BLOOD PRESSURE WAS TAKEN: P (42) B/P (100/60). DR. WAS CONSULTED. THE PATIENT'S FATHER INFORMED THAT IT'S NOT THE FIRST TIME IT HAPPENS. THE DR INDICATED THAT IT WAS A VASOVAGAL REFLEX. IT WAS ADVISED TO THE FATHER TO TRANSFER THE PATIENT TO THE EMERGENCY ROOM BUT HE REFUSED AND SIGNED THE RELEASE FORMS. THE PATIENT LEFT THE HOSPITAL. THE FATHER WAS LATER CONTACTED AND INFORMED THE PATIENT WAS WELL. IT WAS AGAIN RECOMMENDED TO TAKE THE PATIENT TO BE EVALUATED.