chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-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 25-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Consent declined for follow up.
Extensive widespread flare up of eczema covering back and torso and spreading to proximal regions of extremities. This became noticeable by 6 hours after I received the flu vaccine injection and is continuing to increase and spread ten days later. I have been prescribed and am taking 60 mg prednisone (started on 10/19/16) and 1500 mg Cell Cept.
My gums started bleeding when I brushed my teeth and eventually worsened to the point they were bleeding  at random times as well.
Headache, joint pain throughout body, tiredness, and muscle pain throughout arm that received immunization, started day after immunization and headache/pain unrelieved by Advil.
I received my vaccine on Friday, within the first 10 minutes, light headedness, dizziness and headaches.  Paramedic took my blood pressure, I had an elevated BP.  I do not have a history of hypertension.  Within the hour, I started to have body aches and chills. Early the next morning (2 am) Saturday,  the body aches were so bad that I could not get out of bed.  My whole body felt as if I had bloodclots all over, it ached all over and felt very heavy. I started having night sweats, chills and my head was aching badly.  I had to call off from work.  I took Benadryl and drank lots of water and warm tea.  This feeling lasted all day.  I stayed in bed wrapped up the covers. Sunday morning I woke up (6 am ) and was my normal self.
received only the adjuvant component; received only the adjuvant component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 95B23, expiry date 6th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th December 2021).   On 10th May 2022, the patient received the 2nd dose of Shingrix. On 10th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Reporter's Comments: The nurse reported that a patient inadvertently received only the adjuvant component of Shingrix vaccine for her second dose. The invalid dose which was administered on the day of reporting reportedly had a lot number of 95B23 and an expiration of 06th July 2023. However, this did not match anything in salesforce, and the call was not recorded. The nurse declined to provide additional information due to time constraints. Additional information was not available. The reporter did not consent to follow up. Additional Supportive Information: The patient inadvertently received only the adjuvant component of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Two days after the vaccine I started urinating blood that was the color of Coca-Cola. Two days later it stopped.
Waiting 15 minutes with no issues.  Got in car to drive home and after about 5 minutes I got extremely flush and hot.  I then began shaking.  got very dizzy and light headed.  My throat began to get very tight and hard to swallow.  Got to friends house in about 15 minutes.  Took 30 mg of prednisone dissolved in water.  Symptoms did not subside and went to ER.   ER gave me IV benadryl, steroid, and antacid med in IV with full bag of fluids.  Sent home with prednisone prescription sent home.
1.5 weeks after 1st dose I got a red mark in the shape of the bandaid that was placed over the injection site. This only appeared once after a shower and disappeared later that day.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16May2021 13:00 (Lot number: EW0185) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications.  The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovered" (2021), described as "1.5 weeks after 1st dose I got a red mark in the shape of the bandaid that was placed over the injection site. This only appeared once after a shower and disappeared later that day. ". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: Other medication in two weeks included Carbofix. Patient did not take any other vaccine in four weeks of COVID vaccination. It was reported that 1.5 weeks after 1st dose patient got a red mark in the shape of the band aid that was placed over the injection site. Patient was not diagnosed with COVID prior to vaccination and not tested with COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Injection site and a circular area approximately 6-7 inches is red, swollen and febrile.  Urgent care PA and a dermatology NP advise that it appears that the injection was given SubQ (should be administered IM.  Treated with Cold Compress and NSAIDS and was prescribed Augmentin and triamcinolone Acetonide topical cream and mupiricin ointment.  After 24 hours of antibiotics there appears to be no improvement (it looks bigger)
01/06/2021 0900, feeling tired, resting heart rate 94 to 110, normal resting heart rate 74 to 86. A few abnormal heart beats throughout the day....9 PM  cardiac arrhythmia , multiple abnormal beats, irregular rhythm lasting for about 1 to 1 1/2 hours.   went into a regular heart rhythm.   never happened to me before!  01/07. am  very tired, heart rate still 90 to low 100's a few abnormal beats  throughout day, 01/08 am very tired a few abnormal beats, 3 episodes of abnormal beats and irregular heart rate. 01/09 am heart rate 74to 82 no abnormal heart beats and I feel fine now 10:30 pm     feel this events are side effects from Covid Vaccine, afraid to get 2nd dose.
MMR administered 6:15PM 04/19/2005 to pt in left upper outer portion of the arm SQ. No previous allergies reported. Site reddened approximately 4cm with no induration. Benadryl ordered 1tsp STAT per MD and given by RN. Pt discharged home at 6:40 PM with a decrease in redness noted to the area. Spoke with mother this AM and she reports no swelling an no induration.
This spontaneous report as received from a female consumer of unknown age refers to herself. Patient medical history and current condition was not reported. On 05-FEB-2015 the patient was vaccinated with ZOSTAVAX (strength, dose and frequency not reported) vaccination. On 05-FEB-2015, the patient experienced vomiting, aches, shakes, fever and nausea. The outcome of vomiting, fever, nausea, aches and shakes was reported as recovering/resolving. Additional information has been requested.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium
C/O sore left arm at 8am, around 9-10 am Left hot, swollen and red. T99.8.
I literally feel the worst I have ever felt in my life.  Profusely sweating, whole body hurts, practically can?t move my left wrist hurts so bad and insomnia.  I feel like a sepsis patient.
10 days post immunization patient developed high fevers (to 104), viral exanthem, and subsequently mild ataxia and lethargy. Illness lasted 4d & patient has recovered. Please review attached labs. Measles IgM requested - (P).
Constant stomach pains with a continuous loop of constipation and diarrhea. High levels of pain through the left arm and around the injection site.
No adverse event; Vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date).    This case was created for the first patient of the 13 patients involved.  Concomitant medication was not provided. It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with 13 doses being administered. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master case (Patient no. 01 case)
pt recv vax 11OCT96; c/o numbness in that arm, hard, muscle cramps in neck, redness/swellling @ site of inj;started physical therapy on 21OCT96 has been off work since 15OCT96;exp pain in tt arm;pain @ inj site & down lt arm;
Day after immunizations, child developed fever, decreased appetite, inconsolable crying, fever resolved that day. Crying continued for three days.
(06/17/2021) Pressure and pain in chest area, was worse lying down. Progressively got worse as the night progressed. By 4AM on 6/18/2021 went to ER. Was determined was Pericarditis. Ibuprofen 600mg three pills for one day. Felt better and no reoccurring issues after that.
Narrative: Patient received third dose of Pfizer vaccine in December 2021. In October 2022, patient declined COVID-19 vaccine due to reported rash with third dose.
Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 55-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # 025J20-2A. There were no reported adverse event associated with this case of product storage error.
This spontaneous report was received from a 86 year old female patient referring on herself. The patient's medical history and concurrent conditions were not reported. On an unspecified date in February 2016, the patient was vaccinated with ZOSTAVAX injection. The patient's concomitant therapies included ZOLOFT. On an unspecified date in September 2016, the patient experienced shingles for unspecified reason. The patient sought for medical attention in a visit to the physician and she was treated with valacyclovir. At the time of the report the outcome of the event was reported as not recovered. The causality between the event and the ZOSTAVAX was not reported. Additional information is not expected as the patient did not consent for a follow up.
Day after Flu Vaccine was administered, patient's left arm became swollen, red and painful. 3-4 days later, a bumpy, itchy, red rash developed near the injection site and soon spread to right arm. On Nov 02, 2014, rash appeared on front and back of both legs. Patient saw dermatologist on November 2, 2014 and a biopsy was done. Patient received a diagnosis of eczema, acute hyperimmune reaction to the flu shot.
Patient slept from 1PM - 4:20PM and was woken by mother. Mother went to change diaper and baby began gagging and reguritating. She spit copious amounts of mucous out her mouth and nose and could not catch her breath. She became pale then cyanotic. EMS was called. When EMS arrived patient was still cyanotic. She coughed, spit out "a ton of mucous" and then began to breathe and improve. Patient was taken to hospital where she was evaluated and admitted for observation. She was back to baseline by her arrival in the ER and had no further episodes while admitted.
Immediately after i had fast heard rate, flushes, chest pain, sore arm, light headed, headaches, slight stiffness in left arm/singers and had a dizzy spell that night. The next morning I woke up in full body pain. I screamed when my daughter touched my back. I couldn't open my eyes. Once I did, I was very dizzy. I couldn't move. My whole body was stiff The first couple hours after waking up. My husband had to assist me in sitting up. I called my doctor and was told to call the ER. Then I called my rheumatologist and she advised me to take advil and stay home instead.  Eventually I was able to walk to the bathroom hunched over a few hours after waking up. Late in the evening I was able to walk to the kitchen hunched over. I had chills and all over muscle soreness. My lymph nodes all over my body  were the most painful. I had a mild headache and was nauseous. My resting heart rate was also elevated. The following day I was better but shaky and had a headache, diarrhea and vertigo. My symptoms got wore again at night. I had joint and calf pain at night. Day 4 I was able to go to work but I still felt sick. I was nauseous and clammy and light headed. My arm was still in pain and bp was elevated. No fever. Day 5 I still felt the same. Days 8-11 I still felt the same. Day 12&13 my symptoms were a little better. Day 14 I had dizzy spells. I started feeling body/joint pain on 10/3/2021- 10/5/2021 and I had a couch at night. I went to urgent care on 10/7/2021. I was diagnosed with laryngitis. After I took a steroid I felt much better. on 10/8/2021 I had labored breathing at night and congestion. I still have joint pain but most other symptoms have subsided. I have an upcoming appt for acupuncture.
Patient was given vaccine at 0840A. At 0845 patient started having generalized seizures for about 2 minutes. He woke up in 2 min, vomited clear yellow liquid 100 ml and became unconscious.
Pt was administered pediatric/adolescent Havrix vaccine, rather than the adult dose of Havrix vaccine.  No adverse reaction.
Sore/swollen feeling throat, rhinorrhea, headaches, thigh muscle aches
This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Patient reported sore arm (same as previous booster)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient reported sore arm (same as previous booster)). At the time of the report, PAIN IN EXTREMITY (Patient reported sore arm (same as previous booster)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. This case was linked to MOD-2022-629155 (Patient Link).
patient experienced a hive on her wrist after receiving vaccine. of note, she was not sure if it was there prior to being vaccinated. patient was offered to be taken to the emergency room for further treatment/monitoring but she refused. she was monitored for 15 minutes in clinic area and no other hives appeared. patient was instructed to seek medical care if symptoms worsened. patient said she was going to take Benadryl once she got home- unknown at time of submission if that occurred.
Rash, swelling, warmth at injection site. Chills. Muscle pain throughout body.
Total upper arm redness, edema, warmth, soreness. IV Benadryl ordered for pt but has not yet been given at this time to evaluate response/recovery.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age or gender. On 10-AUG-2015 and 23-SEP-2015, the patient was vaccinated with the first and second dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. On 18-AUG-2017, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. The patient experienced interchange of vaccine products, no adverse event, inappropriate schedule of drug administration and off label use.
4 days after being inoculated, my skin began itching all over my body. It was not intense and not distracting, but very present. It continues to this day basically unchanged.
Mom called 7/30/03 and states approximately 7:00 am, child was in high chair, "eyes rolled back in head and he passed out. He came to as soon as I picked him up." Mother didn't take child to doctor.
Incorrect vaccine and dosage were administered. The patient received 0.25 mL of Moderna vaccine approved for ages 6+ (Gray border).  There were no adverse signs or symptoms reported.
Patient stated rash, itching swelling resulting in Dr visit, being treated by antibiotics. On 10/15/18 she developed.
Case number PHEH2013US008353 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 20 Mar 2013. It was reported that the vaccine was stored at 33 to 36 F for 19 days and it was not frozen. No side effect was reported following the medication error. No further information was provided.
Woke the next day with generalized body aches, fatigue and fever. Treated with tylenol and Toradol in the ER. discharged
Pt. spiked fever up to 104 this AM; she then had afebrile seizure. Mother arrived @ home and fever was 105.1. The gave dosage of motrin with improved oral intake and resolution of fever
Cluster of itchy read rash on face, arms, legs, chest and back.  Started 2-3 hours after injections of :  Depo Provera, TD and Hepatitis A/B (Twinrix).  Has not been to MD.  States rash is no better or worse since occurrance.  Referred to MD for evaluation
-Severe shoulder and neck pain within hrs of getting shot - MD diagnosed as polymyalgia rheumatica - On Prednisone (ordered to relieve pain) - Started 30 mg - Down to 10 and pain returned.
No adverse event; Received Bivalent Booster instead of first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Bivalent Booster instead of first primary dose) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Bivalent Booster instead of first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Bivalent Booster instead of first primary dose) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Bivalent Booster instead of first primary dose).    No concomitant medication was reported. No treatment medication was reported.  Patient never had any previous COVID-19 Vaccines.  Reporter states that the patient presented to their pharmacy and seemed to be aware about receiving the Bivalent booster as the first dose.  Reporter stated that the patient requested the Bivalent vaccine from the other pharmacy and was trying to schedule an appointment now to get the primary doses.   Reporter did not allow further contact
J96.00 ACUTE RESPIRATORY FAILURE 6/12/2022 ACUTE RESPIRATORY FAILURE WITH HYPOXIA R09.02 HYPOXEMIA 6/12/2022 ACUTE RESPIRATORY FAILURE WITH HYPOXIA
This spontaneous report was received from a community health worker concerning a 21 year old female patient. Approximately on an unknown date in 2010 (at the age of 18 years), the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and she was in provider office on 14-AUG-2013 to receive her second dose of GARDASIL at 21 years old. No concomitant therapy was reported. No adverse events were reported. Additional information has been requested.