chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Moderna Covid-19 vaccine administered to patient. More than 12 hours after vial has been punctured.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to patient. More than 12 hours after vial has been punctured.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to patient. More than 12 hours after vial has been punctured.). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to patient. More than 12 hours after vial has been punctured.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. No lab data has been provided by the reporter.
Arms became achy and wasn't able to lift it. Extreme Fatigue, Headache and chills
pain at injection site; tenderness; arm very sore down to the elbow; arm feeling weak; stiffness in the arm, cannot lift without discomfort; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak) and MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy (Patient has a history of epilepsy that has been stable) and Polycythemia vera (polycythemia vera which is in remission).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak), MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) and DISCOMFORT (discomfort). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, VACCINATION SITE PAIN (pain at injection site), TENDERNESS (tenderness), PAIN IN EXTREMITY (arm very sore down to the elbow), MUSCULAR WEAKNESS (arm feeling weak), MUSCULOSKELETAL STIFFNESS (stiffness in the arm, cannot lift without discomfort) and DISCOMFORT (discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
pt recvd vax & 2wks later the parent devel a severe case of shingles;parent (physician) had no history of chicken pox;the vaccinated child did not devel vesicular lesions;parents lesion were cultured & were neg;
Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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, the patient experienced HEADACHE (Really bad headache). At the time of the report, HEADACHE (Really bad headache) outcome was unknown. Not Provided           The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
On day 8 after the vaccine he was very lethargic. Then he got sick. That night he had an extraordinary high fever which broke. He urinated all over himself and the bed and was covered in sweat. I called the Ped office listed above to record the reaction.
The patient called about 30-60 min after receiving the 1st dose of shingrix saying her lips were tingling and asked if there was penicillin in the vaccine. The pharmacist told her there was no penicillin and to take benadryl and if it were to get worse to go to the emergency room. The pharmacist tried following up several times on 7/2/19 but the patient did not answer. On 7/3/19 the pharmacist called and the patient said she continued taking benadryl on 7/2/19 and her lips had a slight tingling sensation but not enough to medicate.
local reaction to injection site. Large area of diffuse redness , warmth and mild itching. Treated with topical steriod and oral antihistamine
She took the vaccine on 12/28/2020.  She reports she was sick that day and 3 days after with headache, nausea, chills and extreme fatigue. She took Tylenol for her symptoms. Did not seek medical treatment. Symptoms have resolved except for fatigue.  She noticed  that her right arm was still sore on 1/10/2021 and she reports a red area that is very hot to touch.
Numbness in arms after 1 hour starting to feel discomfort in the neck after 1 hour.
Fetal demise within 24 hours of vaccination. Required emergency D&E 1 week later.
Flu symptoms (fever, severe aches and pains) for a day and a half...could barely move or get out of bed
lost strength right arm and she cannot hold up a skillet; soreness to right arm extends between elbow and wrist worsened /pain to entire right arm 24/7/she has pain from where the shot was given past her elbow to mid arm; Stated that her arm is tender to touch; numbness to right arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in Deltoid Right on 24May2021 13:00 (age at vaccination 56-year-old) at dose 2 0.3 mL single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) in right deltoid on 03May2021 (age at vaccination 56-year-old) for COVID-19 immunisation and she had no side effects. Patient stated that she had her last dosage of Pfizer on 24May and had numbness to right arm on 25May2021 08:00 and soreness for a week that continued and got worst. Stated that she lost strength in her arm, cannot hold up a skillet on 28May2021 12:00, that if she lifts her arm up to reach that she has pain from where the shot was given past her elbow to mid arm on 28May2021 08:00. Stated that her arm was tender to touch and she has pain throughout her entire arm 24/7 on 28May2021 08:00. Stated that it has been going on into two months and not subsiding. Wanted to know if she was supposed to sit in pain or get an X-ray to see what was going on with the muscle or tendon in her arm. Later clarified that it was her right arm. Stated that she had no side effects from the first dose. Stated that the soreness to her right arm that has worsened to where it extends between the elbow and the wrist. Stated that her friend told her to try an anti-inflammatory. Stated that she had Ibuprofen did not work. Stated that her friends gave her balm oil, Avoniki balm, that did not work. Stated that the Motrin did not work. Stated that was about three weeks ago. Later clarified that it was Motrin and not Ibuprofen that did not work. Patient did not require a visit to emergency Room or physician Office. Prior Vaccinations (within 4 weeks) were none. The outcome of the events was not recovered.  Follow-Up (03Aug2021): Follow-up attempts are completed. No further information is expected.
-sore arm of injection site -shivering/shaking at night time -body aches -sweating (on 12/11/2019 and 12/14/2019)
Was sitting in observation room, felt dizzy and put his hands on his head, then passed out. Hit head on carpeted surface. LOC less than 10 seconds.
I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 3/22/2023 ACUTE ST ELEVATION MI, INFERIOR WALL I21.19 ACUTE ST ELEVATION MI, INFERIOR WALL 3/22/2023 WEAKNESS
Patient received 0.5mL dose vs 0.25mL dose for the booster.
Patient received Moderna vaccine on 1/26/21, 2/26/21, 7/8/21 and 8/17/21. Was 25 weeks and 6 days pregnant (G5P3003). Presented to hospital on 6/19/22 and found to be COVID positive.  c/o lower right abdominal pain, vomiting, and a chest cold x2 days. Denies LOF or decreased fetal movement.  States she had light pink spotting when she wiped yesterday but none today. Admitted for only 3 hours. Presented to hospital again on 6/27/22 with abdominal pain. She was 25 weeks, 6 days pregnant . Found to be covid positive on 6/19/22. She presented to Labor and Delivery via EMS after a delivery of baby at home this morning. Patient was feeling pressure and thought she had to have a bowel movement, she subsequently delivered over the toilet; estimated time of delivery is 4:14 when EMS was called. Pregnancy has not been complicated with hypertension.  Pregnancy has been complicated by Breech presentation, and Hepatitis B. Fetal growth restriction at 5%, patient saw MFM. Ultrasound showed single umbilical artery, and EIF with possible left axis deviation. Admitted and discharged on 6/28/22.
Myalgia, Fever, UrticariaPruritus, NauseaVomiting,  PAIN INJECTION SITE; CHILLS; FEVER; MYALGIA/ NAUSEA  NARRATIVE:  DAY 1-4 PAIN AT INJECTION SITE; DAY 5 ITCHING AT INJECTION SITE DAY 2: CHILLS; FEVE; MYALGIA; NAUSEA DAY 3: MYALGIA; NAUSEA DAY 4-5 NAUSEA
hives on my neck and scalp that I cannot seem to line up with a food or medication; This is a spontaneous report from a contactable healthcare professional. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 13Apr2021 at 17:30 (at the age of 29-year-old) as a single dose for COVID-19immunisation. The medical history included autoimmune reaction to gluten(not celiac), chronic gastro intestinal (GI) issues (GERD (Gastroesophageal reflux disease), chronic gastritis, bile reflux, SIBO (Small intestinal bacterial overgrowth)) and allergic to soybean oil. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included eszopiclone (LUNESTA), alprazolam (XANAX), ondansetron (ZOFRAN), probiotic (unspecified), hyoscyamine sulfate (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. On 28Apr2021 at 21:00, the patient experienced hives on her neck and scalp,  that she cannot seem to line up with a food or medication. The patient received treatment for the reported event which included Benadryl. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives on the neck and scalp was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
some symptoms right after the first dose and they got worse after the second one: continuous itching on the back of his shoulders, down his spine, on his upper chest, center of his forehead and cheeks. It doesn't look irritated, but feels irritated,; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (some symptoms right after the first dose and they got worse after the second one: continuous itching on the back of his shoulders, down his spine, on his upper chest, center of his forehead and cheeks. It doesn't look irritated, but feels irritated,) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026A21A) for COVID-19 vaccination.     no medical history information was history.  Concomitant products included AMLODIPINE for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (some symptoms right after the first dose and they got worse after the second one: continuous itching on the back of his shoulders, down his spine, on his upper chest, center of his forehead and cheeks. It doesn't look irritated, but feels irritated,). The patient was treated with CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (some symptoms right after the first dose and they got worse after the second one: continuous itching on the back of his shoulders, down his spine, on his upper chest, center of his forehead and cheeks. It doesn't look irritated, but feels irritated,) had not resolved.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Sumptoms started May 15, the morning after I received the shot. Symptoms include: Extreme Headache Tired Dizzy Fever of 101 degrees F, 24 hours after dose administered.  Fever got up to 104.4 degrees F,  32 hours after dose administered Sore & redness, in shoulder dose was administered in
11/9/16 body aches, 11/25/16 all over body aches, loss of coordination and balance, 11/29/16 difficulty walking, referred to Neuro, 12/1/16 Neuro study Dx Guillain Barre Syndrome.
Initial report received from a health care professional on 23 January 2014. A patient had received a dose of FLUZONE ID (batch number: UT4719AA, dose number and site of administration not reported) intradermally on an unspecified date of December 2013. The patient had no illness at the time of vaccination and had no known drug allergies. On an unspecified date, the patient's upper arm became swollen, inflamed and sore. Symptoms developed on the same day as vaccination was administered. No laboratory tests were performed and corrective treatments were not reported. The patient had recovered on an unspecified date. Documents held by sender: none
Pt recieved smallpox 14 Jul 10. Pt went to ER 24 Jul 10 for itching, redness, pain, and swelling in his left lower and upper eyelid. Pt thinks he may have touched his smallpox site then rubbed his eye. Pt was seen by an opthalmogist, pt was Dx with possible ocular vaccinia.  Pt was treated with Viroptic, Vigamox, and erythromycin eye drops. Pt did not have any visual changes or blurring he was 20/20 in both eyes. Pt f/u with primary Dr. 27 Jul 10 and was Rx oral amoxicillin.  Pt f/u with opthalmologist 28 Jul 10 and primary Dr. 29 Jul 10.  On his 29 Jul visit the patient's upper eyelid had improved greatly but his lower eyelid had become worse. He was put on 72 hr quarters and Rx Darvocet for the pain.  Pt was supposed to travel to foreign country, 31 Jul 10 but according to the opthalmogist's recommendation the patient may not travel until his clear of symptoms for 2 weeks.
Expired dose of Heplisav-B administered to patient; Initial Report Received on 15-May-2019 and 21-May-2019  A practice manager from a healthcare practice reported that a female patient (age and race not provided) was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was an expired dose.   The patient had no relevant medical history or allergies. Concomitant medications were not provided.  On 15-May-2019, a medical assistant administered the patient with an expired dose of HEPLISAV-B (lot #1032912, expiration date 20-Mar-2019). The practice manager stated that she would call back after determining what further information she could provide about the incident. No further information was provided.    At the time of the report, the outcome of the event was unknown.  The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
DIZZY 5/10 1000  BLOOD PRESSURE 105/70, HEART RATE 50, OXYGEN SATURATION 97. PATIENT COMPLAINS OF DIZZINESS PATIENT IS SPANISH SPEAKING ONLY. DAUGHTER IN LAW IN CAR WITH PATIENT.  PAIENT IS ALERT AND ORIENTED X3. GAVE PATIENT AN ORANGE AND BOTTLE OF GATORADE. PATIENT DENIES ANY DIFFICULTY SWALLOWING OR SHORTNESS OF BREATH. SAT WITH PATIENT FOR 10 MINUTES. 1015 PATIENT WAITED 15 MINUTES. PATIENT STATES SHE IS GOOD TO GO HOME. DAUGHTER IN LAW IS DRIVING AND IS TAKING PATIENT HOME TO EAT.
on Friday after injection developed sore arm at site and worsened as the day went on. Hours later arm and neck and left side of body felt like lead balloon and have been beat up and had no energy and couldn't lift arm or legs. very lethargic, overnight couldn't sleep because of pain and developed a fever that went up to 100.5 and took Advil. fever lasted on and off until Sunday night, Also developed nights sweats and chills lasted until early Monday morning (1/18/21)
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's current conditions medical history and concomitant medication were not reported. On 02-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ (therapy type - digital data locker, lot # L013206 and expiry date 29-JAN-2017). Temperature excursion was 30.1 F and time frame was 67.78 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
A nurse reported that a 4 year old male received his 5th dose of Acel-Imune, as well as, MMR (Merck) and IPV (Aventis Pasteur SA) vaccines on 4/11/00. On 4/13/00, he developed an injection site reaction characterized by blotching, swelling and redness measuring an area greater than 5cm. He recovered.
FELT DIZZY ABOUT 20-25 MINUTES AFTER SHOT, GIVEN GATOR AIDE AND REMOVED MASK IN AREA WITH NO OTHERS ...FELT LIL BETTER ITS BEEN ABOUT AN HOUR AND HALF STILL FEELING LIL DIZZY OR OUT OF IT BUT OTHERWISE OK.
3 cases of Zoster Sine Herpete in 9 months since vaccine administered. First of the 3 episodes (left side V 3)  resulted in hospitalization with viral vestibular neuritis, which has caused ongoing significant disequilibrium.  2nd of 3 was in right face V3 & V4 nerve tracts with complete resolution. 3rd of 3 was in same nerve tract as 1st (left V3) and has not completely resolved after 14 days of valacyclovir treatment. I had received a high strength flu vaccine 2 days before episode 3.  Prior to Shingrix I had mild, rare (every few years) episodes of ZSH with no significant symptoms and no ongoing problems related to the ZSH.
High pitch cry,difficult breathing.Has been hospitalised since then.  11/15 and 11/16/09 Medical records received. Multiple procedure results and ICD9 codes for date range 66/11-7/27.  Infant (approx4-5 months old) in resp failure of unknown etiology. Born at 32 weeks.  L basilar atelectasis. Muscle weakness. CVM titer high. Hematuria.  Endotracheal tube placement. Cytopath showed no viral inclusions. Many acute inflammatory cells.  ICD9 Codes: 789.0, 486.0, 789.3. 518.81 , 511.9, 765.1, 585.2, 348.0, 518.0, 486, 729.5, V50.02, V58.82, V58.81, 786.09, 406.0, 706.09786.05
pt recvd vax & became flushed & sleepy 5min later; pt was also desoriented for 6-8 hrs;
HEADACHE, NAUSEA, INTESTINAL DISTRESS, FATIGUE. LASTED TILL AROUND 10 AM, RETURNED ABOUT NOON AND LASTED TILL SLEEP.
Information rec'd from RN states pt with an allergy to Cefaclor that results in a rash. Immediately post vaccine pt developed injection site redness. It was noted the area was approximately 10cm x 4cm and was described as blotchy. It was also noted that the pt may have an active infection with hepatitis B.
Extreme chills and high fever starting approximately 12 hours following vaccination. 14 hours after vaccination had high fever, profuse sweating, leading to heart palpitations and two syncope episodes resulting in hospitalization. CT scan and xrays, ekg and blood tests, all normal, sent home on fluids. 76 hours after vaccination presented axatia, slurred speech, confusion, dizziness, resulting in rehospitalization. MRI, EEG, EKG, blood, and urine tests all completed and normal. Sent home on steroid.
MMR given 2/20/13. Phone call from mom 2/25/13. Fever of 103.7 on Saturday 2/23/13 no other symptoms per mom but dad wondering if he saw a seizure for a few seconds while he had the fever, eyes were open, flailed his arms/legs no problems since. No rash.
Symptoms were shortness of breath that exacerbated upon exercise, and mild chest pain. The diagnosis was atrial fibrillation. I was prescribed Xarelto 20mg daily, diltiazem 240mg daily. I went to my GP and he sent me to the cardiologist listed. I went about a month of two with those meds and then he added valsartan 80mg daily, and flecainide 50mg 3xday. Those are what I'm currently taking now. And I still have the atrial fibrillation, it didn't resolve. The symptoms resolved when I started the meds in December.
Breakthrough infection, includes hospital admission that appears unrelated to COVID 19. Patient reported to the hospital with right sided numbness of the face. Patient had an MRI that was negative for acute stroke.
Rash on the forehead / Shooting pain on the head; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shooting pain on the head/ headache, rash on the forehead/ rash, shingles/ herpes zoster.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event shooting pain on the head. On 9 Feb 2021, the patient experienced the event rash on the forehead. On 10 Feb 2021, the patient experienced the event shingles.  Treatment details included Valacyclovir 1000mg three times daily for 7 days.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   The outcome of events, shooting pain on the head, rash on the forehead, shingles was unknown.
Patient presented to ED at on 11/20/21 with complaints of increasing shortness of breath. PMH of MS (currently on Ocrevus infusions, follows with neurology), HLD, OSA. Patient was seen on 11/19 for symptoms suggestive of COVID, found to be positive, CTA neg for PE though did note GGO concerning for COVID. Was only requiring 2L and was discharged home from ED with atarax. Unfortunately pt continued to decline from a resp standpoint and re-presented to the ED for re-evaluation. Previously fully vaccinated and boosted with Pfizer on 5/9/21, 6/3/21, and 8/24/21. Admitted to facility on 11/20/21 and discharged 12/14/21.
With in 30 minutes experienced nausea, vomiting, extreme itching and headache
08:15 AM - FEVER OF 100.3 GIVEN TYLENOL. 05:00 PM - FEVER OF 102.9 GIVEN TYLENOL. 09:00 PM - FEVER OF 102.3 GIVEN MOTRIN. 02:30 AM - FEVER OF 102.2 GIVEN TYLENOL.