chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Minor receiving Moderna booster dose; Receiving booster 5 months after receiving 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor receiving Moderna booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving booster 5 months after receiving 2nd dose) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Previously administered products included for COVID-19: Pfizer Vaccine (Patient received two doses of the Pfizer COVID-19 vaccine.) on 08-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor receiving Moderna booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving booster 5 months after receiving 2nd dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor receiving Moderna booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving booster 5 months after receiving 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No Treatment information was reported.
Patient felt dizzy, had muscle aches, and had a fever of 100.5 the day following the Pfizer booster dose. Patient continues to have a red mark on his arm on the second day following the dose. Note that the patient had no effects after doses one and two.
Several leg cramps; Pain in my right leg; Was so ill; Fever; Chills; Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Several leg cramps), PAIN IN EXTREMITY (Pain in my right leg), ILLNESS (Was so ill), PYREXIA (Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Several leg cramps), PAIN IN EXTREMITY (Pain in my right leg), ILLNESS (Was so ill), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, MUSCLE SPASMS (Several leg cramps) outcome was unknown, PAIN IN EXTREMITY (Pain in my right leg) had not resolved and ILLNESS (Was so ill), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) was resolving.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. On an unspecified date, an ultrasound was done.
Chills/ Rigor, vomiting X 1  and head ache- Took Tylenol x3 . Symptoms resolved by 03/15
Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/11/2022 Discharge Date: Dec 14, 2022 COVID positive Date 12/12/2022 PRESENTING PROBLEM: Weakness [R53.1] Failure to thrive in adult [R62.7] Low blood glucose measurement [E16.2] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 65-year-old male with a past medical history of coronary artery disease s/p PCI in 2019, pulmonary embolism, T2 Diabetes, diabetic neuropathy, Parkinson's disease, stage 3 chronic kidney disease, GERD who presented from an outside living facility after episodes of hypoglycemia and a witnessed fall without loss of consciousness.   On arrival to the emergency department, he was found to be febrile with a temperature of 38.3°.  Glucose was low at 66, left otherwise within normal limits.  He was without leukocytosis.  Imaging, including pelvis x-ray, chest x-ray, and head CT were negative without any signs of acute abnormalities. On routine screening he was found to be positive for COVID, and was subsequently admitted to medicine for management of hypoglycemia in the setting of COVID infection.   Patient's hypoglycemia was thought to be due to poor oral intake, and he was started on a D5 LR infusion.  After approximately 12 hours, his blood sugars normalized in the mid 150s to 200s, and the infusion was subsequently stopped.  Patient did have intermittent episodes of confusion and hallucinations throughout his hospital stay.  Spoke with patient's son, who requested discontinuation of Artane, who stated he had given patient hallucinations and confusion in the past.  Despite discontinuation, patient continued to have persistent episodes of confusion, agitation, and hallucination.  He received p.r.n. Seroquel during these episodes.  It was arranged for him to return to his care facility despite his COVID 19 positive status, and he was subsequently discharged with plans for PCP and neurology follow-up.
12APR93 exp high pitch screaming lasted almost 24 hrs; no fever; no redness no swelling;
The injection site was sensitive for 2-3 days after the injections. There was a tight feeling when moving the arm, which seemed to go away.  On Sunday, 03/07/2021 I woke up with a pain in the arm near the injection site. By the afternoon  a red inflamed patch of about 7 inches in diameter developed. The patch had raised edges. There was a tight feeling on the muscle and a pain when moving the arm. The skin was very hot to the touch. I applied topically hydrocortizone cream and an ice pack, which seemed to calm down and reduce the heat. On 03/08/2021, I went to my doctor's office, and was prescribed an antibiotic( Cephalyxine). I applied ice packs 4 times during the day, and hydrocortizone in the evening.
8/9/2021- A few hours after I received vaccine, I had tenderness on my left arm and a headache. I took Tylenol but the headache didn?t go away. That same night I had trouble sleeping, I felt like my chest was stacked with a ton of bricks. I couldn?t sleep on my left side or stomach. I missed work on 8/10 because I had fever, body aches , fatigue and my chest still hurt. I slept in and out that day. I contacted my healthcare provider and they suggested i go to the ER if I felt like I couldn?t breathe. I wanted to fight it off, so I decided to stay home. On 8/11 , I missed work again because all of my symptoms were still present except for the fever. I was starting to notice I was having trouble getting my thoughts together and getting brain fog. I rested some more and started taking Ibuprofen for the pain. My chest pain was still consistent. On 8/12 I returned to work but left after 4 hours. I couldn?t think straight at work and i felt as if i was going to faint. I went to urgent care where they performed an an EKG. The results came back normal. I asked the doctor why my chest still hurt and why I feel worse on the 3rd day and they suggested it was anxiety. Today is 8/13 and I feel the same. My chest pain is more consistent, I have rashes all throughout my body, there?s a tingling sensation throughout my left side, my headache has not gone away. I feel as if I haven?t slept for days. I now have a weird pain on the left side of my throat
She felt very hot then she felt very cold; Temperature like she has a fever; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (She felt very hot then she felt very cold), HEADACHE (Terrible headache) and PYREXIA (Temperature like she has a fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced HEADACHE (Terrible headache). On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (She felt very hot then she felt very cold) and PYREXIA (Temperature like she has a fever). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (She felt very hot then she felt very cold), HEADACHE (Terrible headache) and PYREXIA (Temperature like she has a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter said patient taking other medications.  No treatment information was reported by reporter.
Information has been received from a nurse concerning a 22 year old female with no medical history or allergies, who on 28-MAR-2007 was vaccinated intramuscularly with a first 0.5mL dose of Gardasil (lot#656049/0187U). There was no concomitant medication. The patient reported that on 28-MAR-2007 the roof of her mouth felt swollen for about 24 hours after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
Fever to 101, abdominal pain, nausea and vomiting within 36 hours of vaccine.
About 3 months after the Pt had the second dose of Moderna Covid vaccine he started with extreme join pain, carpal tunnel syndrome, malaise, stiffness.
I was doing a rotation in the emergency department that day. I started to feel like I was going to faint. I tried to get some water and ended up fainting. I was already in the emergency department, so I was treated by the doctors there who did blood work, chest x-ray, urine analysis, and an EKG and found nothing suspicious. They sent me home and I tested for COVID-19 when I got there, and my test came back positive.
Patient reported she had developed a rash about 20 minutes after vaccine.  We gave her a 1ml dose of diphenhydramine 50mg/ml.  After about 25-30 minutes, pt reported she was feeling better and left.  Her husband would drive her home.
Patient received the Pediatric dose of Engerix-B as a first dose.  Patient did not complain of any symptoms.
fever 101.7 degrees, right shoulder slightly tender, appetite poor, both lower legs were achy and slightly weak, body shook
Information has been received from a physician concerning a 64 year old retired female with hypertension, arthritis and mild scoliosis who on 10/31/05 at 1:45pm was vaccinated IM in left arm with a second dose (first dose was 20 years ago) of Pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Concomitant therapy included estrogens, conjugated (Premarin), ramipril (Altace), and acetaminophen + propoxyphene napsylate (Darvocet N). On 11/1/05 at 8:00 am, the pt developed severe swelling of left upper arm to approximately twice normal size, redness, no fever and itching. The pt visited the Dr's office. The events gradually resolved over the next 6 days. It was reported that the pt recovered on 11/7/05. No further information is available.
He had sciatica for 10-12 days; He was unable to stand or walk.; He was worse when he was lying in bed; It was impossible to get into bed without having pain.; It was impossible to get into bed without having pain.; This is a spontaneous report from a contactable other-HCP (patient reported himself). A male patient of an unspecified age received second dose of BNT162B2 (Covid-19 vaccine, Formulation: Solution for injection, Lot Number: EL3302, NDC number/Expiry date: Unknown) via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medication was not reported. Historical vaccine details included first dose of BNT162B2 (Covid-19 vaccine, Lot Number: EL3302) via an unspecified route of administration on 22Jan2021 at single dose for Covid-19 immunization. Caller previously reported side effects with the Covid-19 vaccine on 25Jan2021 or 26Jan2021. He received the first dose on 22Jan2021. He received a form with some follow up questions on it. The form was requesting the batch or lot number. He might have provided it with the first call. The lot from the first vaccine is EL3302. He added that the handwriting was sloppy. He received the second dose on 12Feb2021. Lot EL3302. He added that the lot for the first dose could have been EL3302, but it was written sloppy. The form was also asking if the patient provided information regarding the reported adverse events with the use of the product. Caller is an Optometrist. He was reporting on himself. Caller confirmed there were no new events. Caller added that maybe some of the side effects were still lingering. He had sciatica for 10-12 days. He was unable to stand or walk. He was worse when he was lying in bed. It was impossible to get into bed without having pain. He was unsure if dozens of people had this or just him. Outcome of the events was not recovered.
FOLLOWING JANSSEN COVID VACCINE, PATIENT COMPLAINED OF ANXIETY AND MENTIONED HISTORY OF ASTHMA. PATIENT WAS GIVEN ALBUTEROL HFA INHALER AND ALL THE VITALS WERE NORMAL. HOWEVER, CALL 911 TO FURTHER ASSESS THE PATIENT. PARAMEDIC CONFIRMED PATIENT WAS HAVING ANXIETY BUT ALL THE VITALS WERE NORMAL . SPO2 99%, HR 90-94, BP 100/70. AFTER PARAMEDIC ASSESSMENT, PATIENT STARTED TO RELAX AND FEELING BETTER AND LEFT WITH HER HUSBAND.
injection site redness; injection site tenderness; injection site swelling; Underdose; Vaccine Administered at Inappropriate Site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2019) for prophylaxis.   On 14th April 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 14th April 2019, unknown after receiving Shingrix, the patient experienced accidental underdose and intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site erythema, injection site tenderness and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site swelling, accidental underdose and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema, injection site tenderness and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The nurse reported that some vaccine was loss during administration to the patient, less than 0.5 mL, health care professional was unaware of how much was actually lost as she did not administer the vaccine, which led to accidental underdose. After administration, less than a year after receiving Shingrix, the patient reported localized redness, swelling and tenderness at the injection site. The health care professional reported that the dose was administered more towards the back of the arm, and might have been injected subcutaneously on an unknown arm, which led to intramuscular formulation administered by other route. No additional details provided. This case was linked to case US2018203376 reported by same reporter.
PATIENT RECEIVED MODERNA FOR  HER SECOND DOSE INSTEAD OF PFIZER. THE LOT NUMBER OF THE PFIZER VACCINE THAT HE FISRT RECEIVED ON MARCH 03-2021 WAS EN6202. PATIENT HAS NO ADVERSE REACTION SO FAR
50 mins post vaccination pt reported light headedness Vitals: 157/94, 66, 16 Pt stable and released from the vaccination site
AFTER THE PATIENT HAD BEEN SITTING IN THE WAITING AREA ABOUT 8-10 MINUTES I LOOKED UP FROM DRAWING MORE VACCINES TO DISCOVER THE PATIENT'S HUSBAND HOLDING THE PATIENT WHO WAS SLUMPED IN HER CHAIR.  WHEN HE SAW ME LOOKING HE WAVED HIS HAND AND SAID SHE'S OK , SHE'S FINE.  I DROPPED WHAT I WAS DOING AND WENT OUT TO CHECK ON HER. HE STATED SHE DOES THIS ANYTIME SHE GETS A SHOT AND SAID SHE'D BE OK IN A MINUTE.  I ASKED IF HE WANTED ME TO CALL AN AMBULANCE TO CHECK HER OUT.  HE SAID NO, YOU JUST HAVE TO GIVE HER A MINUTE.  HE STATED HE'D BEEN THROUGH THIS WITH HER MANY TIMES BEFORE.  I GOT HIM A DAMP PAPER TOWEL AND AND CARD TO FAN HER WITH, SINCE SHE WAS SWEATY.  THE PATIENT PERKED UP IN A FEW MINUTES.  SHE SAID SHE FELT OK AND I THEN HAD MY TECHNICIAN TAKE HER SOME WATER.  I FOLLOWED UP WITH THE PATIENT THE FOLLOWING DAY AND SHE STATED SHE WAS DOING FINE BUT THAT THE VACCINE HAD KIND OF "ZAPPED" HER.  SHE STATED SHE HAD A COUPLE OF THE EXPECTED SIDE EFFECTS HEADACHE AND  FATIGUE.
4/13-c/o abdominal pain, headache, lightheadedness, nausea since 4/8/21 evening. Caller reports blood sugar was "normal" yesterday but has not checked it yet today.  Called her PCP and they recommended she get a Covid test. Recommended to caller to monitor blood sugars, increase fluid inake, OTC pain relievers as needed. Caller verbalizes understanding. She also asked if symptoms could be r/t taking melatonin last night. She takes it PRN. Informed caller symptoms may be related to a combination of factors.
11/1/2021 I received my vaccine. On 01/05/2022 I started feeling body aches, high fever, sore throat, fatigue and  night sweats. I was diagnosed with COVID on 01/07/2022. The symptoms lasted approx. 10 days. since then i have became diagnosed with diabetes around 4/18/2022.
A report was received from a health care professional on 09Dec02 concerning a 80 year old female vaccinee who inadvertently received a dose of Fluvirin on 20Nov02 and 08Dec02. On 20Nov02 and 08Dec02 the vaccinee received vaccinations of 0.5ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment.
Patient is fully vaccinated. COVID positive 12/27/2021. ED visit 12/31/2021.  Patient presents to the ED secondary to cough. Patient reports dry nonproductive cough, chest discomfort, shortness of breath, occasional nausea but no vomiting. Also reporting diarrhea. Positive for fever, headache, myalgias, rhinorrhea.  BP 140/87  | Pulse 80  | Temp 98.7 °F (37.1 °C) (Oral)  | Resp 20  | SpO2 99% EKG normal, CXR: Patchy bilateral interstitial opacities, Treatment:  decadron, toradol, robitussin, fluid. Discharged home.
fluzone hd that has been administered twice no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 86-year-old male patient and influenza quadrival A-B high dose HV vaccine [Fluzone High-DOSE QUADRIVALENT] that has been administered twice no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 19-Sep-2023, the patient received a 0.7 ml (frequency: twice) dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form: unknown) (lot: UT8057PA, expiry date: 30-Apr-2024) via intramuscular route in right side for immunization and fluzone hd that has been administered twice no reported adverse event (extra dose administered) (latency: same day).  Reportedly, Patient got the first dose on 12SEP2023 and got another dose today, 19SEP2023. No adverse reaction was reported by the patient.  it was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  Outcome: unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient developed redness and swelling around the injection site. Her arm become red and warm.  Condition continued for 4 to 6 days. condition began showing improvement after 5 days. Patient, who a healthcare nurse,  was asked if she she had taken Benadryl or place ice on the site. Patient had not taken any healthcare measures  .  Patient was encouraged to take these  measures to help symptoms subside. Patient will be followed up after 7 days.
Patient was experiencing a high fever and was diagnosed with a urinary tract infection and COVID-19 at an outside facility on 7/18/2021. He was instructed to go to emergency department for further management on 7/21/2021. He presented with a cough and mild shortness of breath. He was treated with supplemental oxygen, dexamethasone, and remdesivir.  His symptoms improved and he was discharged from hospital on 7/27/2021.
Client fainted after receiving the COVID-19 vaccine.  Attending nurse administered ammonia inhalant.  Client woke up.  Fire Rescue arrived to evaluate.  Clients vitals all within normal limits.  Client showed no other signs of distress.   No further evaluation needed as per Fire Rescue.  Client was released to home at 10:05am.
patient called pharmacy on 2/26/2021 to report that on 2/21/2021 arm became "really sore, red, swollen, itchy and warm to the touch" and she had a fever and chills; patient states she took Tylenol for the fever and applied Benadryl gel for the itching; patient states color is back to normal today (redness lasted until 2/25/2021), slight itch (1 on scale of 1 to 10) remains today
I began having severe migraines on 05/22/2021, when I woke up I had numbness in my left leg on my whole left side of my body. I figured since I slept in the chair when I woke up Sunday morning I still felt the numbness. I thought it was because I had fell asleep in the chair when I was driving to work that Monday I went to the ER it showed that I had a stroke. I felt brain fog I could never focus on anything.  I still have numbness in my left foot.
The evening after receiving the vaccine, c/o fever 102 degrees F, vomiting x1 and muscle aches, joint pain-
1045 Pt reports not feeling well. C/O itching, nausea and dizzy.  Appears calm.  Color good-not pale, lips pink and not diaphoretic.  Water bottle given.  Pt drank a 1/3 of bottle without difficulty.  Remained seated in chair.   1048  Pt reports still not feeling well.  Pt reports "still the same".  Ambulated to examination/medical evaluation area.  Pt ambulated independently, steady gait and no difficulty.  No SOB, CP or itching noted. 1049 132/80 Calm, sitting. EMS contacted to come to assess per pt request.  Report given to EMS. Pt stable and talking without difficulty. -FNP
began crying w/in 3 hrs, high fever, began screaming, having sz, extremely high fever 105.4; APAP did not help, sz became more frequent so took to ER;
I experienced heavy menstrual bleeding, nose bleeds.  This lasted for 24-48 hours.  It had completely gone away on 02-05-2021.
10/21/02 mother reports that pt's arm went numb for several hours post receiving vaccine and then became very painful. Mother did not look at arm on Thurs. or Fri. On Saturday, pt was still complaining of his arm hurting. Mother states that pt had a large red wheal above and below injection site approx. size of a tangerine and very hot to touch. Pt was seen by MD who is ER doctor. MD told mother this was a reaction to the vaccine and advised her to report it to the HD. MD wants to see pt again on Tues and may give pt Rx for antibiotics at that time per mother. 10/22/02 talked to mother states when she picked up child from school yesterday that site now looks looks like a mosquito bite. Dx-allergic reaction per mother. MD recommends tetanus only in future dose.
slightly raised rash around site of injection; red and warm 4" x 2" began ~ 3 days after injection and persisting 10 days after injection