chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old given Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given Moderna Covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given Moderna Covid-19 vaccine). On 18-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that a 17 year old patient was administered with the 1st dose of the Moderna Covid-19 vaccine at their facility.  No treatment information was provided.
Background: the pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, they always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
She woke up with pain, swelling, and warmth at the injection site. She also had an elevated heart rate. After visiting a provider, she was given ice and ibuprofen.
Onset of symptoms within a few hours: aches, chills, fever (to 103F), foggy thought processes (trouble articulating thoughts), flushed face, minor cough with wheeziness.
This spontaneous report as received from a medical assistant refers to a 42 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 30-JUL-2014 the patient was vaccinated with an expired dose of M-M-R II lot # H012572, expiration date 29-JUN-2014 (strength, dose and route were not reported). The reporter stated that this was patient's first dose of M-M-R II series. No adverse effect reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Intermittent, sudden, strong, bursts of pain in Right  eye and also Left lower side of that back of my head. These subsided after about 8 hours. I had been alternating between Advil and Tylenol for treatment.
Information has been received from a physician concerning a 16 year old male patient with cefaclor allergy and no pertinent medical history who on 18-AUG-2011 was intramuscularly vaccinated in the right arm with 0.5 mL of the first dose of GARDASIL (Lot# 667165/1167Z, expiration: unknown). Secondary suspect vaccine included VARIVAX (Merck). Concomitant therapy included HAVRIX. Physician reported that the day after administration of GARDASIL the patient experienced pain in his right arm, on 19-AUG-2011. On 20-AUG-2011 the pain became worse. On 21-AUG-2011 the patient also experienced general malaise, muscle spasms, dystonic movements, and severe pain in his arm. On 22-AUG-2011 the patient had to leave school early because he was experiencing muscle spasms of his arms, neck, back, and legs. On  23-AUG-2011 the patient slept all day. On 24-AUG-2011 the patient began having severe muscle spasms of the neck and torso. He was examined in the emergency department. Physician reported that the patient was treated with BENADRYL and ATIVAN intravenously for tonic/clonic movements and tremors. Movements resolved 15 minutes after ATIVAN was administered but started one hour later. Second dose of ATIVAN was administered and patient was admitted to the hospital. On 24-AUG-2011 the patient experienced dystonic movements and severe pain every 6 hours. Patient was treated with ATIVAN intravenously and was still currently in the hospital. He was still experiencing dystonic movements. The movements were of shorter duration (5-10 minutes) and decreased frequency, but with same intensity. The morning of 25-AUG-2011 his legs were "drawing up" and he could not walk. A CBC was performed with normal limits as result, also a blood glucose was performed with 145 as result. The patient sought medical attention via hospital. At the time of reporting the patient was recovering. Pain in right arm, general malaise, muscle spasms, dystonic movements, muscle spasms of arms, neck, back and legs, slept all day, severe muscle spasms of neck and torso, tonic/clonic movements, tremors, dystonic movements, drawing up and could not walk were considered to be disabling. Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: patient called stated arm hurt and having some discomfort of moving the arm-Medium, Systemic: Joint Pain-Medium, Additional Details: Inform patient to seek medical care at urgent care or emergency room
Received immunizations at another facility. Mom noticed mucus threads in stool with streaks of blood. Followed closely in office, repeat fecal occult blood (-) on 6/11/07. No issues after that.
pain and immobility moved down to right leg, then over to left leg, and finally to right arm; difficulty moving; pain and swelling in the right arm and hand; pain and swelling in the right arm and hand; immobility moved down to right leg, then over to left leg, and finally to right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain and immobility moved down to right leg, then over to left leg, and finally to right arm), INJECTED LIMB MOBILITY DECREASED (difficulty moving), VACCINATION SITE PAIN (pain and swelling in the right arm and hand), VACCINATION SITE SWELLING (pain and swelling in the right arm and hand) and MOBILITY DECREASED (immobility moved down to right leg, then over to left leg, and finally to right arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain and immobility moved down to right leg, then over to left leg, and finally to right arm), INJECTED LIMB MOBILITY DECREASED (difficulty moving), VACCINATION SITE PAIN (pain and swelling in the right arm and hand), VACCINATION SITE SWELLING (pain and swelling in the right arm and hand) and MOBILITY DECREASED (immobility moved down to right leg, then over to left leg, and finally to right arm). At the time of the report, PAIN IN EXTREMITY (pain and immobility moved down to right leg, then over to left leg, and finally to right arm), INJECTED LIMB MOBILITY DECREASED (difficulty moving), VACCINATION SITE PAIN (pain and swelling in the right arm and hand), VACCINATION SITE SWELLING (pain and swelling in the right arm and hand) and MOBILITY DECREASED (immobility moved down to right leg, then over to left leg, and finally to right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications were not provided.
I was fine but at ten at night I begin to feel tired and sleepy.  I went to bed on 11DEC2022 at five aM I was very very hot and I was frighttend, I took my tenperature it was one hundred degrees I took Tylenol and went back to bed my fever upon waking up had spiked to onehundred one hundred and I was positive for COVID-19.  A couple of hours later my fever continued  to rise and my coughing started, a second test showed a clear positive result.  A drive through PCR test also resulted in a positive.  Fatigue for months was a factor.
MORNING AFTER: FELT FAINT, FEVER, POSSIBLE CHILLS. SLEEP RELIEVED SYMPTOMS. INJECTION SITE: SWOLLEN, RED, SORE.
extreme chills lasting  2 hrs followed by vomiting for 12hrs will body aches and headache. following those symptoms the following day was diarrhea with general tiredness and headache.
plantar fasciitis pain disappeared; hit hard as if flu; teeth are particularly sensitive to cold; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular route on her left arm on 06Jan2021 (lot number: EL1823) at 15:45, and first dose via an unspecified route of administration on an unspecified date; both at a single dose for COVID-19 immunization. Medical history included hypothyroidism and tooth recession. Concomitant medication included levothyroxine. The patient previously took amoxicillin and experienced allergies. The patient's plantar fasciitis pain disappeared so she thought that her body was too busy responding to vaccine. She was hit hard as if flu. One notable side effect was that teeth were particularly sensitive to cold. She used Sensodyne for periodontal recession and they were really, really uncomfortable to cold. All occurred on 07Jan2021 at 15:00. Outcome of the events was unknown.
COVID vaccine breakthrough case. Moderna 4/3/21 018B21A, 5/1/21 040B21A and boosted 12/4/21 - NO LOT # AVAILABLE
Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: I had him lie down on the exam table. He was coherent the whole time. Was conversing, Was NOT diaphoretic. I took his BP 3 times. It was all 128/80. HR was in the 80s. He denied chest pain or shortness of breath. He was unsure if this is a reaction to the vaccine or a panic attack. I monitored him for 15 minutes, he drank water, I gave him an ice pack. He felt fine after 15 minutes. stated no longer dizzy and no blurry vision. He left with his father
1515-Vaccine administered-Employee was monitored for 15 min and returned to work.  1600- Employee developed hives, reported to occupational health and benadryl administered. APRN present in Occupational Health. Patient stated he felt that his throat was swelling. Epi-Pen was administered while an ambulance was called, employee was transported to ER.
After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   None of the reported symptom were experienced by patient. Concomitant product use was not provided by the reporter.   No treatment information provided.
husband got breakthrough COVID after receiving the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BREAKTHROUGH COVID-19 (husband got breakthrough COVID after receiving the vaccine) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included COVID-19 (COVID-19 positive on 15-APR-2022) on 15-Apr-2022.   In September 2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 16-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced BREAKTHROUGH COVID-19 (husband got breakthrough COVID after receiving the vaccine). On 07-Oct-2023, BREAKTHROUGH COVID-19 (husband got breakthrough COVID after receiving the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Patient had previously received Moderna vaccines first dose on 13-MAR-2021, Lot no. 001B21A, second Dose on 10-APR-2021, Lot no. 038B21A third Dose on 12DEC2021, Lot no. 031H21A fourth Dose on 7-MAR-2022, Lot no. 004M21A fifth Dose on 17-NOV-2022, Lot no. 020H22A. It was reported that patient received flu shot one week after Spikevax 2023-2024.  Question 9 was left unanswered since the applicable option was not available in the decision tree.   This case was linked to US-MODERNATX, INC.-MOD-2023-745333 (E2B Linked Report). This case was linked to MOD-2023-745962 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2023: Live significant follow up received. Reference numbers added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745333:Wife case
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored PROQUAD (dose, route not reported, lot # K009470 with expiration date 03-JAN-2016, lot # K010211 with expiration date 17-JAN-2015). Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
headache; This is a spontaneous report from a contactable consumer via Medical Information Team. A female patient of an unspecified age (Age: 88; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The concomitant medications included cetirizine hydrochloride (ZYRTEC), naproxen sodium (ALEVE), paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN), alprazolam (XANAX) and melatonin; all were taken for an unspecified indication, start and stop date were not reported. The patient experienced headache on an unspecified date. The clinical outcome of the event was unknown.  Information on Lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
sore right arm; Dizziness; Feeling of dehydration; Fatigue; This is a spontaneous report received from a contactable reporter.A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 13:00 (Lot number: EW0173) at the age of 38 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "pregnant" (unspecified if ongoing); "Anal Fissure" (unspecified if ongoing), notes: Verbatim: Anal Fissure; "Know Allergies: Hornet stings" (unspecified if ongoing), notes: Know Allergies: Hornet stings. Date of last menstrual period: 02Feb2021. The patient was 13 weeks pregnant at the time of exposure to bnt162b2. The patient was 13 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 09Nov2021. Concomitant medication(s) included: MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; VIT D3; NIFEDIPINE. Vaccination history included: Bnt162b2 (Dose number: 1, Product: COVID 19 , Brand: Pfizer, Lot number: EW0161, Lot unknown: False, Administration date: 16Apr2021, Administration time: 01: 00 PM, Vaccine location: Left arm, ), administration date: 16Apr2021, for COVID-19 immunization, reaction(s): "sore left arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08May2021 06:00, outcome "recovered" (2021), described as "sore right arm"; DIZZINESS (non-serious) with onset 08May2021 06:00, outcome "recovered" (2021), described as "Dizziness"; DEHYDRATION (non-serious) with onset 08May2021 06:00, outcome "recovered" (2021), described as "Feeling of dehydration"; FATIGUE (non-serious) with onset 08May2021 06:00, outcome "recovered" (2021), described as "Fatigue". Therapeutic measures were not taken as a result of pain in extremity, dizziness, dehydration, fatigue.  Additional information: Reporter stated after shot 2 experienced sore right arm and could not sleep due to soreness. Then next day dizziness, feeling of dehydration and fatigue was noted. Lasted about 24 hours. Other vaccines in four weeks, COVID prior and post vaccination were none.  No follow-up attempts are possible. No further information is expected.
Erythematous macular rash surrounding injection site beginning 1 day post injection with increased warmth. Maximum size to date 9 cm x 7.5 cm. Not tender, no itchiness, non fluctuant. BENADRYL given to patient. Unknown outcome at this point.
Fever, chills, body aches for 2 days then some chest pains the Monday morning after
This spontaneous report as received from nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot# was not reported) and RECOMBIVAX HB (lot# was not reported). The reporter reported GARDASIL and RECOMBIVAX HB were improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 24-OCT-2014 the patient was vaccinated with PROQUAD (Merck) (0.5 ml, subcutaneous, lot # K005195, expiry date: 10-OCT-2015) which underwent a temperature excursion prior to being administered. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial report received from a registered nurse at a health center on 21/Apr/2006. A 29-year-old male patient developed bouts of diaphoresis lasting a short time, a fever, heat and swelling at the injection site with pain in the right axillary node area the day after receiving the injection (route not reported) of TD, lot number U1703DA in the left deltoid and the intramuscular injection of Pneumococcal vaccine (manufacturer Merck), lot number L048P in the right deltoid on 19/Apr/2006. Per reporter the patient had no illness at the time of vaccination. The patient's symptoms began the day after vaccination, on the 20/Apr/2006 in the evening. On 21/Apr/2006 the patient's temperature was 98.6 degrees Fahrenheit. He was seen by a physician. No treatment was reported. The patient's recovery status was unknown at the time of this report. He is scheduled for a recheck on 24/Apr/2006. A new version was created, on 06/Jun/2006, to amend the product screen to Decavac. Decavac was the product administered, not TD ADS Adult as previously recorded.
Six days after I received the second booster and for 6 weeks following, I had severe pain in both of my shoulders, my left hip, and my tailbone.  Only after receiving a regular steroid injection for my long term back pain did I receive ANY relief!
13x13 indurated warm fluctuant area w/ assoc. erythema, warmth, tenderness, decreased ROM secondary to edema & pain. 3 visits to clinic. Tx 1 gm ROCEPHIN IM then BACTRIM 875/105 BID x 10 d.
Patient received Moderna vaccine on 5/14/21 and 6/23/21. Presented to ER on 12/29/21. She was COVID negative at the time. presented with unresponsiveness at home. Initial Blood glucose was <20. GCS was 3, intubated. Subsequently extubated without difficulty. Large ascites- required paracentesis. GI consulted. TIPS recommended, done by IR on 01/07/2022. Recurrent ascites continues, s/p multiple paracentesis. AKI-Creatinine 2.4, Nephrology consulted. possible hepatorenal syndrome  metabolic acidosis. Nephrologist-plan was hemodialysis. On 1/19/22- abdominal x-ray suggestive-COVID pneumonia. COVID test came positive. Started on dexamethasone and remdesivir. Anemia Hb 6.3, s/p PRBC on 1/19/22. Worsening short of breath, lethargy. transfer to larger hospital on 01/20/2022. NG bleed. Coagulopathy. Oxygen requirement worsening. Discussed with brother. Code status changed to no CPR select on 01/20/2022. Patient mentation improved on 1/21/22.  Discussed with patient and brother/POA. Opted for comfort care on 1/21/22 morning.  Patient passed away at 04:33 AM on 1/22/22.
Information has been received from a healthcare worker (also a medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K023363 with expired date 20-MAY-2016, lot# L010142 with expired date 24-SEP-2016, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.