chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 15-FEB-2016, the patient was vaccinated with an improperly stored ROTATEQ 2 ml oral injection (lot# L008997, expiry date 04-DEC-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 488 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius) and the second one lasting for 152 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm with mild swelling, starting 2 hrs after administration, lasting 36 hrs Generalized muscle aches and fatigue, starting 4 hrs after administration, lasting 36 hrs Shaking chills but no fever starting 6 hrs after administration, lasting 10 hrs
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer, took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
left arm extremely sore and throbbing Narrative:  staff had allergy shots in the left and right arm the evening 0f 2/10.
patient had metallic taste in mouth when drinking pepsi about 1 hour after then later in the night noticed she cannot wink her right eye. Patient can close both eyes at the same time, can close left eye only, but can not close right eye only.
R09.02 HYPOXIA 5/18/2021 UTI (URINARY TRACT INFECTION)
Pt vaccinated w/DT/OPV/MMR/HIB developed fever began Sunday -103-104 couldn't bring down, unconsolable to ER- WBC done exam by MD all neg poss MMR rxn, Monday fever spiked to 105.3 back to ER sp tap/CXR - neg home w/supportive measures.
My mother passed away recently, following her 2nd Covid booster shot. She got the shot on May 17th, 2022, at her annual well-visit, from which I have a copy of her normal lab results. She became increasingly ill, short of breath, and exhausted each day afterwards.  She contacted her primary care physician a few days later, complaining of pain in her upper back, thinking it was stress-related (in hindsight, most likely caused by inflammation in her lungs). She was taken to the emergency room and admitted to the hospital on May 25th. She was tested for COVID-19 twice in the hospital; both times the result was negative. She was transferred to the ICU on May 26th, due to her increasing need for oxygen. She was tested for various types of atypical viral pneumonias via Clinic; all results were negative. She was tested for bacterial and fungal pneumonia; she had neither. Neither antibiotics nor steroids helped her lungs clear up. She suffered a severe heart attack the morning of June 2nd, while on a ventilator, and died.
5/5 Began apx 8h after inj of vaccine - -> polyarthralgia, severe, retroperitoneal/flank pain, fever, chills, extreme gastric pain, malaise, fatigue, polymyalgia, lethargy, tremulousness. 5/5 lasted for apx. 24 hours.
Within 5 minutes of receiving the flu vaccine, patient told mom she didn't feel good. She got tense, with eyes wide open and body was stiff. Patient was placed flat on floor until symptoms improved. EMS was called. BP=92/60, P=84, T=98.4, PO2=98%. Pulse increased to 103. EMS and parent agreed patient had a vasovagal reaction. EMS did not transport to hospital, patient was feeling better and left clinic at 5 PM with parents.
A little under the weather; Loss of appetite; Achy Left Arm; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (A little under the weather), DECREASED APPETITE (Loss of appetite), PAIN IN EXTREMITY (Achy Left Arm) and VACCINATION SITE PAIN (Sore Injection Site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DISCOMFORT (A little under the weather), PAIN IN EXTREMITY (Achy Left Arm) and VACCINATION SITE PAIN (Sore Injection Site). 06-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite). On 09-Mar-2021, DISCOMFORT (A little under the weather), DECREASED APPETITE (Loss of appetite), PAIN IN EXTREMITY (Achy Left Arm) and VACCINATION SITE PAIN (Sore Injection Site) had resolved.            No concomitant medication information was reported. No treatment information was reported. On follow-up, the patient stated she didn't report adverse events and was doing good. Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: TCR was attached and does not contain any new information
LLR to Vvx #2, about 4x5cm swelling, redness
EXTREME DISTENSION OF THE STOMACH. NO RELIEF. THEN VOMITED AND DIARRHEA. EXTREME PAIN IN STOMACH TRAVELING TO THE RIGHT AND BACK. SHIVERING AND SWEATY!
difficulty breathing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and COUGH (coughing) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing) and COUGH (coughing). At the time of the report, DYSPNOEA (difficulty breathing) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Patient received (0.5ml)  full dose from a red cap vial for the 2nd booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received (0.5ml)  full dose from a red cap vial for the 2nd booster) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 939905, 030M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient received (0.5ml)  full dose from a red cap vial for the 2nd booster). At the time of the report, ACCIDENTAL OVERDOSE (Patient received (0.5ml)  full dose from a red cap vial for the 2nd booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd Booster dose on 04-APR-2021. No concomitant medications was provided. No treatment medications was provided.
27 weeks pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (27 weeks pregnant) in a female 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 (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (27 weeks pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 30-Dec-2020, EXPOSURE DURING PREGNANCY (27 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Fever of 102 when he work up.  Started on Tylenol.  Fever by the evening was 103-104 at times. Very lethargic and throwing up.  No appetite.
Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD; Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2023 and dose was administered after BUD).    No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023,8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023.  Vial size was reported was 0.4 ml per vial. Vial did not undergo any temperature excursions.  No treatment information was provided.  This case was reported for patient 41 of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
4/13/21 - Day after, started fever, chills, tiredness for 36 hours 4/18/21 - Period started [2 weeks after last period]
had a COVID test on Monday/test came back positive; had a COVID test on Monday/test came back positive; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a first dose of the Pfizer COVID-19 vaccine on Sunday and then had a COVID test on Monday as part of a pre-surgery test and her test came back positive but she does not have symptoms. She would like to know if the vaccine can cause you to test positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccines were administered on 9-9-14 and patient had fever on 9-12-14 and 2 seizures on 9-15-14 along with irritability. Seen in ER and prescribed KEPPRA and DIASTAT PRN.
The first symptom of a reaction was an acute pain at the base of my skull; then a sense of dizziness and "brain squeeze". It passed, and I began to feel slightly feverish. When I rose to walk out at the end of a 2 hour-class (sitting with 1 break an hour earlier when I walked easily) I had difficulty getting easily to my feet. I had to shuffle my feet to walk. No pain, but great stiffness. On the 30 minute drive home I suddenly began shivering and my teeth chattering; felt very cold, even though it was a warm evening. As soon as I got home I took my temperature (no fever) had a hot bowl of chicken rice soup, with a lot of soda crackers and the shivering slowed and stopped. I slept very soundly. Even though I could walk without shuffling, overall stiffness continued for about 7 weeks. The injection site continued to be painful, then very tender when touched through June 12.  Although I don't know if these are at all related, I add them here; perhaps new issue with my neck is related. August 4 I was diagnosed with a kidney infection at ER. (Was referred to ER I was in abdominal pain and it was late in the day.) August 8 I checked myself into the ER because I had pain in my abdomen that I thought was due to a recurred kidney infection. Test results for the infection were negative, however I felt increasingly anxious; enough to check myself back in after release given all clear on kidney infection. (I started to see double while driving, so I went back to ER.) The ER doc suspected vagus nerve interactions. My GP subscribed a current XRay of my back and neck and a course of physical therapy which seems to be helping with pain, cramping and dizziness/anxiety.
Information has been received from a registered nurse concerning a 9-tear-old white female with asthma and NKDA who on 02/25/1997 was vaccinated with a first dose of Varicella virus vaccine live SC in the right arm. There was no illness at the time of vaccination. On approximately 03/05/2001, the pt experienced chicken pox that included "15 maculopapular vesicular lesions and no other symptoms" Unspecified medical attention was sought. In follow-up, the registered nurse learned on 03/26/02, that the pt was seen by the school nurse. The pt had 15 lesions but "was already better". No further information is expected.
Feeling dizzy; both legs are hurting from the hip down not including the feet; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), PAIN IN EXTREMITY (both legs are hurting from the hip down not including the feet) and HEADACHE (headache) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced DIZZINESS (Feeling dizzy), PAIN IN EXTREMITY (both legs are hurting from the hip down not including the feet) and HEADACHE (headache). At the time of the report, DIZZINESS (Feeling dizzy), PAIN IN EXTREMITY (both legs are hurting from the hip down not including the feet) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.
Skin reaction - 5x3 cm hard, sore, raised, red area at injection site.  Cleared on its own.
Pt developed presumably vaccine-related herpes zoster on right thigh and superior buttock starting about 6 months after receiving the varicella vaccine (rash first noted 10/17/17). He has no known Hx of wild type varicella.
heart attack from Myocarditis ejection fraction extremely low, heart medications, mobile defibrillator.
This is a 74-year-old gentleman that presents with concerns regarding left-sided facial numbness, right-sided numbness/paresthesias to his tongue as well as an episode of ataxia and vertiginous symptoms yesterday.  This is in the context of the recent diagnosis of COVID-19.   The patient does have a background history significant for severe chronic fatigue that has been present over the last 6 months and had fairly thorough investigations.  He did have an episode of ITP approximately 6 months ago which he states has resolved but the symptoms of chronic fatigue have not improved.   The patient denies any other significant neurological symptoms on examination.  His cranial nerve exam is otherwise unremarkable apart from paresthesia and numbness to the left side of his face and tongue.  His visual fields are all intact and he is no longer ataxic and able to walk steadily.   The patient is compliant with his anticoagulant.  In addition he has been recently started on digoxin with vital   Because of the patient's concerning symptoms a workup for possible CVA particularly posterior CVA was considered and a CT head as well as CT angiogram head and neck were performed to exclude any intracranial hemorrhage or large vessel occlusion.   I did discuss with stroke neuro Dr., she suggested based on the patient's symptoms that he should be admitted for an MRI brain with and without contrast to exclude CVA as above imaging does not exclude posterior CVA particularly well. Because of the patient's other nonspecific symptoms and thorough workup including EKG showing atrial fibrillation controlled rate as well as routine labs showed normal kidney function negative urine as well as a normal digoxin level.  I do not find any alternate cause for the patient's symptoms.   The patient was agreeable for admission and discussed with the hospitalist here who will admit to facilitate MRI and continued observation.
Red spotted rash, approximately 3"x1.5". Itching and swelling noticed during the first night. Itching continued for a day and a half. Swelling still ongoing. Redness of rash diminished, but still evident, after 2 days.
This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Tiredness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-May-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 an unknown date, the patient experienced VERTIGO (Vertigo), DIZZINESS (Dizziness), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Tiredness). At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown.   No concomitants were reported. No treatment was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Joint pain increasingly got worse over the ensuing 3 weeks and got so severe that Dr. prescribed prednisone and processed blood work.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with GARDASIL 9 (lot #: L048237, expiry date: 08-MAY-2017) that had been improperly stored at a temperature of 47 F for a time frame of 74 hours (incorrect product storage). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
pain at the injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site (left arm)) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A, 050C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain at the injection site (left arm)). At the time of the report, VACCINATION SITE PAIN (pain at the injection site (left arm)) had not resolved.            No concomitant drug details were reported. No treatment details were reported.
After 24 hours, patient felt sharp, throbbing pain, inflammation, hotness, and sharp pain.  The symptoms travelled up the patient's upper shoulder and lower neck area with severe pain and discomfort.