chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From ER Report "On 12/10 patient  woke up with heart palpitations. Mom was unable to count her heart rate. She was also having abdominal discomfort, nausea & sore throat.  Symptoms progressed to where she continued to feel nauseous and she looked pale and she felt like she was going numb in her legs and arms and so mom called 911 to have her evaluated.  Mom  also reported that she did experience some body aches yesterday, 12/9."
Pt recvd 3 doses of Engerix-B 1 1/2 yrs ago; just had titers drawn; did not sero-convert; 1APR92 recvd 4 dose (booster); pt now immune;
a sizable sac of fluid developed under the skin, just below the bicep on the front of the left arm, below the injection site, on the day after the vaccination.   On the next day, the sac of fluid had migrated down the arm, to the elbow.  On the following day, the sac of fluid had migrated to below the elbow.  The following day, the sac of fluid got smaller.  On the following day, the sac was nearly gone.  On the following day, the sac was not noticeable.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; We had patients who were administered the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 5:48 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 5:48 PM, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The vial undergone temperature excursions for 1 month. On 19-Nov-2021, vials went from the super cold freezer to the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. No treatment medications were provided.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: PT FAINTED 3-5 MINUTES AFTER VACCINE WAS ADMINISTERED.
Loss of appetite; This case was reported by a consumer via interactive digital media and described the occurrence of appetite lost in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced appetite lost. On an unknown date, the outcome of the appetite lost was unknown.   It was unknown if the reporter considered the appetite lost to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-Nov-2022 Reporter's Comments: This case was received from consumer via  interactive digital media. The reporter stated that Shingrix cause loss of appetite.  Additional Supportive Information: The follow up would not possible as no contact details were available.
Initial loss of consciousness, skin very hot to the touch, extensive sweating.  Epi-pen administered into left outer thigh.
Pt vaccinated /w HIB titer developed culture pos. Hflu bactermia 3 days p/ HIB.  F/U 05Nov90 Fever, decreased appetitie, vomiting X1, neg PE
Mild aches at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild aches at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild aches at injection site). At the time of the report, VACCINATION SITE PAIN (Mild aches at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were provided Treatment medication was not provided.   This case was linked to MOD-2021-117995 (Patient Link).
Approx 1 week after receiving vaccines pt began to ache at the yellow fever injection site, it was sore to touch and some bruising at the site was noted. This ache progressed to involve the entire arm shifting from upper scapula, shoulder to hand and thumb. At one point making use difficult, this went on for 2 days. Swelling in left armpit "tender" and "quite large" lasting 1 week.
Shingles; Mild to moderate achiness; Tiredness; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), HERPES ZOSTER (Shingles), PAIN (Mild to moderate achiness) and FATIGUE (Tiredness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high (No medical history reported), Macular degeneration and Cold sores. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and L-LYSINE [LYSINE] for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), PAIN (Mild to moderate achiness) and FATIGUE (Tiredness). On 06-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, ABDOMINAL PAIN (Abdominal pain), HERPES ZOSTER (Shingles), PAIN (Mild to moderate achiness) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication: Centrum Silver Vitamin   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non-significant TCR FU - Consent declined.
UrticariaPruritus Narrative:  Brought into exam room about 10 minutes after receiving her fist vaccination w/complaints of "spots of itchiness." States experiencing localized areas of itchiness over left bicep, left hand, and right anterior thigh. All areas described as less than baseball sized. No associated swelling. There was a very faint blanchable erythematous rash over about a 2x2cm area of her left hand where she c/o itchiness. Otherwise skin exam normal and no swelling noted. She denied any immediate allergic reactions sx or current adverse effects. She has a h/o allergic rhinitis and contact dermatitis, for which she typically takes a prn Zyrtec or Claritin (states obtaining relief from past episodes of sporadic itchiness from these rx). She does not typically take Benadryl. Discussed immediate allergic reactions and when to seek urgent/emergent care, which included advise regarding if she were to experience progression of sx. Advised to take a Zyrtec or Claritin this evening and call EOH if there are any further issues. She was monitored for another 10 minutes with no further progression of sx and then excused from the clinic.  Other Relevant History:
Patient was seen in my clinic with reports of "flare" of psoriasis after having her second COVID vaccine.  She has a history of well controlled psoriasis BSA 2-3%, today she a rash that is not consistent with psoriasis.  Rash presented within 12 hours of vaccine administration. Additionally, she reports within the first 12 hours of second vaccine administration she developed extreme anxiety, shortness of breath, anxiety, and heart palpitations that lasted intermittently for 2 days.  She did not seek medical attention.  On exam she is alert/oriented, no visible distress. Pending skin biopsy results.
Pulmonary embolism: vaccine shot 2 administered 3/8, symptoms (shortness of breath, rapid heart beat) began 3/10, diagnosed at medical center 3/12. (Also experienced typical"flu like" symptoms beginning 12 hours after vaccine and lasting ~48 hours.) Being treated with anticoagulants.
Child was lethargic and could not keep her balance -- she kept falling over and seemed weak. Later, a rash started on her trunk and spread to her face, head, neck, arms, and legs.  Child seemed to be in considerable pain and was inconsolable.  She had trouble sleeping.  The rash lasted for one week but other symptoms went away more quickly - in 4-6 days.
Day 8 began having nagging headache that will not go away.  It is not the most severe headache I have ever had, but, with the pause due to clots and my age group, I am worried.  Has not ended after 24hrs.  Pain is in back of my neck.
Woke up next morning nauseous, vomited, headache, extremely tired.  I slept for most of the day and was fine by the evening.    I am only reporting for record keeping and metrics.
Suspected vaccination failure; Get vaccinated if you want the Shingles had the shot and got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that, get vaccinated if you want the Shingles. The patient had shingles 50 years ago and was told that it could come back. The patient had the shot and got the shingles. This case has been linked to US2021AMR178370, reported by the same reporter. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.  ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178370:Same reporter
Case number PHEH2015US019971, is an initial spontaneous report from a consumer (patient) received on 30 Sep 2015. This report refers to 68 years old female patient. Medical history was not reported. Concomitant medications included B12 injection and other unspecified medications. The patient was bitten by a bat on the left foot. The patient was started with post exposure prophylaxis of RABAVERT (batch number: 556011A, expiry date: Feb 2018) into left arm on 25 Sep 2015. The vaccination did not hurt and it was not thick. On the same day the patient also received HRIG (batch number: unknown, other manufacturer) into left deltoid. As per the patient the HRIG was very thick and syrupy and it "liked to kill" her because it was very painful. The patient reported that it took about 15 seconds for the nurse to administer the full dose and she felt it all the way down her arm to her thumb nails and through her whole body. The patient stated that the nurse even at one point mentioned that she "thinks she did it backwards". The patient stated that the pain continued for some time and throughout the day. The arm pain was so bad that she thought that she was having a heart attack. On 26 Sep 2015 the patient began having flu-like symptoms described as aches and headache which progressively got better but still occurs. The patient stated that currently she does not feel great but is "functional". No hospitalization or ER/doctor visits were necessary. The patient went back for her next dose of RABAVERT on 28 Sep 2015 and that was when she really realized that her original dosing was incorrect. Outcome of vaccination site pain was recovered on 25 Sep 2015. Outcome of aches and headache was improving. Causality of the events of vaccination site pain, aches and headache was reported as almost certain. The outcome and causality of flu like symptoms was not reported. Seriousness criteria were not reported. Seriousness assessment of vaccination site pain was upgraded based on information in the source document.
This is a spontaneous report from a contactable physician via a Pfizer Company representative. This physician reported events for four patients. This is for the first patient of four. A 17-year-old male patient of an unspecified race received the second dose of TRUMENBA, (lot R56655) for Immunization at single dose via intramuscular route in the deltoid on 24Jan2017. Concomitant medications, history and testing were unknown. Patient had to go to the hospital for a sports checkup and the patient experienced an Electrocardiogram which was abnormal. The ER physician wanted to admit the patient, but the primary care physician said to not admit, he was given a dose of BENADRYL in the ER. The physician said it looked like it was some sort of tachycardia. The patient was sent home soon after on the same day. Sender's Comments: Linked Report(s): US-PFIZER INC-2017421632 same reporter/product, different patient/event; US-PFIZER INC-2017422119 same reporter/product, different patient/event.
Dizziness, Myalgia, ErythemaMultiform & Diarrhea
Initial: redness, heat and swelling at injection site with induration 10 cm. Weakness of arm/hand grip. Late: Following morning: dizzy, diaphoresis, followed by syncope. Fell and injured ankle.
She tested positive for the flu on 11/26/22. She had a fever, cough, stuffy nose, and fatigue. This lasted for about 2 weeks. She was not prescribed medications, but she took over-the-counter MOTRIN and TYLENOL. She still has a little bit of a cough and stuffy nose, but it has improved tremendously.
Limited active range of motion initially (L) shoulder. Pain base of (L) neck, (L) trapezius radiating to upper back, pain (L) shoulder, pain (L) upper extremity. Numbness/tingling (L) upper extremity.
New onset PVCs (bigeminy, trigeminy), non-sustained ventricular tachycardia.
I experienced a breakthrough case of COVID-19 with sore throat, nasal congestion, fever, coughing and insomnia.
patient received an expired VARIVAX; This spontaneous report was received from a nurse regarding a 4-year-old female (child) patient. There was no information about concomitant medication, pertinent medical history and drug allergies or reactions.   On 17-APR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot# unknown) which got expired on 16-APR-2019 for prophylaxis (expired product administered).
Since the vaccine was administered on 1/30/2021 the resident was complaining of tiredness. On 2/9/2021 she complains more than usual with fatigue, a lot of fatigue so they make the decision to transfer her to the hospital.  In the hospital she was informed that the pain was from a  gallbladder stone,  also that she has a lung condition and a compromised kidney.  A Dr.  from Hospital  tells POC that the patient was not responding to treatments and was compromised thus prolonging the hospital stay.
pain in arm immediately and lasting at least 3 days, headache, fever, queasy stomach, blotchy rash covering arms and legs
Information has been received from a pharmacist concerning a 70 year old female with allergies to alendronate sodium (MSD) WAES # 0902USA04457 and penicillin allergy who on 16-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number 663638/1706X). On 18-FEB-2009 the patient experienced redness, swelling and increasing pain at the injection site (location of injection site unknown). The patient's redness and swelling and increasing pain at the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 1/27/21 lot# El9264;  Pfizer 9/26/21 lot# FF2588;
She is not feeling well; Chills; Sweating; Fever; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer reported for her daughter. A female patient of an unspecified age received her dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter She mentioned that the patient got her vaccine this morning and unfortunately the patient was experiencing some side effects or symptoms. The patient who was a nurse who just received the vaccine, the Pfizer vaccine yesterday from the hospital where she worked. And today she was not feeling well, she got chills and she was sweating, and just not well. It sounded like she was having some side effects 30 percent (Further clarification was unknown), to get the Chills and fever, 15 percent of (incomplete sentence). The reporter asked how long they had to wait if someone was feeling unwell from the shot. The patient got to start her 12 hours shift and should she be going back to work and doing 12 hours shift, if she was not feeling well with fever, she had got chills. The reporter asked how long it anticipated her feeling like this. The outcome of the events was unknown.    Information about Lot/batch number has been requested.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.  Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date.  Patient received dose from lot 042J21A with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received: Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Left deltoid onset started at time of injection and the same evening she started having swelling at site & it continued to swell. She started having shooting pain on Frid. noc - 11-30-12 intermittently & then the pain became constant on Sat. thru present. OV today - 12-3-12 lump at site 5 x 2.5 cm with 1 cm of pinkness states redness at site this AM was the size of a "quarter", fever 99.7-100 over the weekend.
I had an upset stomach accompanied with diarrhea, I also had chest congestion with wheezing. I made appointments to see my doctor, it took three different visits.  I was tested for COVID-19, Influenza A and B, had a chest x-ray for pneumonia. All came back negative.  I was put on an antibiotic to help clear up viral chest infection. I do still have some wheezing and coughing, mostly bothers me at night now.
Pt called and complains of vomiting, dizziness, arm swelling and pain of the right side, can't pick up arm.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Admitted for COVID pneumonia. Fully vaccinated. Supportive treatment with zinc, singulair. No indication for steroids or remdesivir. Did not require O2. Discharged home.
On 12/30/2023, I tested for COVID-19 because my wife wasn't feeling well and had already tested positive. My symptoms were very mild. I did lose my sense of smell for three days. I had no fever or headaches. I just felt under the weather. It did take 10-12 days for me to test negative, but overall, it was a mild case. I called my primary care doctor to inform them of my positive results. She advised that we just rest and see how it goes. We never required any treatment.
Vaccine  date  lot#  exp date Pediatrix 09/27/04 AC21A001AA 09/05 Hib   09/27/04 0092P   10/06 Prevnar  09/27/04 A83578R  07/06      Pediatrix 11/23/04 AC21A008AA 10/05 Hib   11/23/04 0805P   10/06 Prevnar  11/23/04 A79659B  08/06      first seizure seen 12/21/2004     admitted to hospital 01/06/2005     seizure free 04/06/2005 - 04/26/2005  Prevnar  04/21/05 A67188A  01/07 Pediatrix 04/21/05 AC21A05AA 01/06      04/26/2005 seizures returned  No vaccines given for 4th set of shots. Seizure free since 05/17/2005  Follow-up Info Diagnoses:(1)Suspected symptomatic infantile spasms (2) Development Delay decreased muscle bulk as wellas decreased tone. He is hypotonic HIB 0082P  9/27/04-Wyeth HIB 0805P 11/23/04-Wyeth