chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling fatigued; achy with lymphadenopathy; achy with lymphadenopathy; This is a spontaneous report from a contactable nurse reported for herself. A female patient of an unspecified age received the second 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. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. After receiving the second dose of the vaccine, she reported feeling fatigued, achy with lymphadenopathy. Event took place after use of product. The outcome of events was unknown.   Information on batch/lot number was requested.
Chief Complaint Patient presents with ? Generalized Body Aches     Pt presents via EMS c/o DOE, dry non-productive cough, subjective fevers Tmax 101.9, decreased appetite, aches since testing + for COVID on 1/5.   Patient is a 50 year old male with PMH of Crohns/MS on fingolimod presenting to the Hospital for fevers, shortness of breath and weakness. Patient received COVID vaccine on 12/29. Patient had initial left arm discomfort though has had worsening weakness, cough, shortness of breath and fevers since that time. Patient tested positive for COVID19 on  Patient has shortness of breath with exertion that is relieved by rest. Patient denies N/V/D. Patient has taken tylenol at home to attempt to alleviate symptoms.
19 yo female received her Twinrix vaccine this morning at 0950.  Pt Pt rereported she did not like getting shots. Pt reported not feeling very well, and was told to have a seat. Mild syncope episode.  Pt denies any previous episodes. Pt mentions this has happened before when she gave blood. Cool packs applied to the axillary regions, and upper trunk area. Transferred to gurney for monitoring of vital signs.
Mucousy severe diarrhea within 48 hours of vaccination lasted more than 1 wk, had to try different formulas, now on Nutramigen.
Dizziness started 1 day after vaccination, getting better every day but not feeling 100%
12 hours after injection I developed several muscle aches. Extreme shivers and chilling. Fever. Headache unmanageable. Teeth, neck, jaws, eyes, shoulders all throbbed with extreme pain. Frontal lobe irritation! Loss of appetite. Sought Drs. Care after 12 hours. Meds for pain given. In bed and immobilized. Meds did help headache pain.. Injection of toradol then APAP/butalbital/caffeine every 4 hours. Head pain was a 10 of 10! Down to 5/10 with meds. I'm at the 48 hour mark with no let up in sight.
A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Seasonal allergy and Immune thrombocytopenia (No change in condition) since 1996. Concomitant products included PREDNISONE, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced FATIGUE (A little fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fatigue, at an unspecified dose and frequency. On 31-Jan-2021, FATIGUE (A little fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient not had COVID  positive test or diagnosis. The patient didn't receive no other vaccines 1-month prior receiving Moderna COVID-19 vaccine. The patient didn't seek medical care. No   This case was linked to MOD-2022-498749, MOD-2022-498874 (Patient Link).
This spontaneous report has been received from a physician, via a company representative concerning a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of GARDASIL intramuscular injection, (lot #, expiration date, strength, dose number and dose were not provided) for prophylaxis. On an unknown date, the patient experienced fatigue and "slept for three days". It was unknown by the reporter if treatment was given for the adverse events. The physician had stopped therapy with GARDASIL and it was unknown if therapy would be resumed for the patient. No additional adverse events had been reported. At the reporting time, the outcome of hypersomnia and fatigue was unknown. The causal assessment between the events and vaccination with GARDASIL was not reported. Additional information has been requested.
Joint pain in-hips, knees, elbows, shoulders, hands; muscle aches/everything hurts; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in-hips, knees, elbows, shoulders, hands) and MYALGIA (muscle aches/everything hurts) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOMEFLOXACIN HYDROCHLORIDE (LOMAX [LOMEFLOXACIN HYDROCHLORIDE]), APIXABAN (ELIQUIS), METOPROLOL, ALPRAZOLAM and ATORVASTATIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain in-hips, knees, elbows, shoulders, hands) and MYALGIA (muscle aches/everything hurts). At the time of the report, ARTHRALGIA (Joint pain in-hips, knees, elbows, shoulders, hands) and MYALGIA (muscle aches/everything hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: TCR form received and it contains no new information.
SICK; COVID-19 SYMPTOMS (NAUSEA ,COUGHING, FATIGUE, COULD NOT FEEL TASTE OR COULD NOT SMELL); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced sick. On JUL-2021, the subject experienced covid-19 symptoms (nausea, coughing, fatigue, could not feel taste or could not smell). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and had not recovered from covid-19 symptoms (nausea, coughing, fatigue, could not feel taste or could not smell). This report was non-serious.
improperly stored ROTATEQ was administered; This spontaneous report was received from a medical assistant, referring to a 6-month-old patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-AUG-2021, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1691141, expiration date 01-NOV-2021; strength and dose detail were not reported) orally for prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 12.1 degrees Celsius for 1 hour. There was no previous temperature excursion.
Approximately 24 hours after receiving both his booster dose of COVID vaccine along with his influenza vaccine, he developed angioedema to his face, most significantly around his eyes. No lip swelling or airway involvement. Also with mild pruritus to his face in general. Has not had reaction to either vaccine individually in the past. Denies any other known exposure to allergens/triggers.
Booster shot that was given to the patient expired 30 days ago/the vial was initially stored in the refrigerator- 26OCT2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster shot that was given to the patient expired 30 days ago/the vial was initially stored in the refrigerator- 26OCT2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster shot that was given to the patient expired 30 days ago/the vial was initially stored in the refrigerator- 26OCT2021). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster shot that was given to the patient expired 30 days ago/the vial was initially stored in the refrigerator- 26OCT2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The booster shot that was administered to the patient was expired 30 days ago. The Date the vial was initially stored in the refrigerator 26-OCT-2021.  No concomitant medications reported.  No treatment information was provided.
No additional adverse events.; Caller is nurse reporting administration of expired dose of PROQUAD.; This spontaneous report has been received from a nurse regarding a 4 years-old female patient. The patient's concurrent condition, concomitant therapies, historical condition, drug allergies and reaction were not reported.   On 05-APR-2022,  the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA), lot # T031825, expiration date reported as 16-MAR-2022, subcutaneous (dose and frequency were not reported) in the right deltoid for prophylaxis.No temperature excursions reported. No additional adverse event reported, no further information provided.
patient slumped in chair after 5 minutes of receiving the vaccine. I shook patient and he woke up and had some orange juice. he then was resting for about 10 minutes when he passed out again and was more unresponsive than the first episode so we called 911. he was awake before paramedics arrived but very pale. he was checked out by paramedics and a family member came to pick him up
This is a spontaneous report received from noncontactable consumer or other non-healthcare professional. A 56-year-old female patient received the third (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty), for COVID-19 immunisation; and had reaction(s) of chills, total body aches and shaking. The patient reported immunization/booster shot, chills/feeling chilly and  fatigue, all with outcome of unknown. Additional information: The patient shared that after second Pfizer COVID-19 shot, she experienced shaking chills and total body aches and milder symptoms (feeling chilly, fatigue) after Pfizer COVID-19 third (booster) shot. Optional information: Unknown patient history, medications and underlying conditions. Adverse events took place after use of product. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-202101772839 same patient and drug, different dose and similar event.
8 patients received doses after the 30-day Use By Date; No Adverse Event; 8 patients received doses after the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) in an adult 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. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, 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 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) 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 (8 patients received doses after the 30-day Use By Date) and PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date).    Concomitant products were not provided. Treatment medication were not reported. It was unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vials were 2.5 ml size taken from  open carton 4. It was initially stored in the refrigerator on 5 Dec 2022. Vials did not undergo any temperature excursion. This case contains information for the 4th of 8 patients described by the report.; Sender's Comments:  MODERNATX, INC.-MOD-2023-695798:Patient 1 out of 8 Patients MODERNATX, INC.-MOD-2023-696048:Patient 2 out of 8 Patients MODERNATX, INC.-MOD-2023-696086:Patient 3 out of 8 Patients MODERNATX, INC.-MOD-2023-696088:Patient 5 out of 8 Patients MODERNATX, INC.-MOD-2023-696089:Patient 6 out of 8 Patients MODERNATX, INC.-MOD-2023-696090:Patient 7 out of 8 Patients MODERNATX, INC.-MOD-2023-696091:Patient 8out of 8 Patients
Shot - Mon, Wed afternoon spread to baseball size (8 x 10cm) redness, Thurs -> still large red, itching & hot. No rash. BENADRYL 25mg Thurs & ice.
I had injection site discomfort, about 4-6 hours after vaccination. I  had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site.   I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
Immediate cough; shortness of breath; racing heart; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Immediate cough), DYSPNOEA (shortness of breath) and PALPITATIONS (racing heart) in a 64-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 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Dec-2022, the patient experienced COUGH (Immediate cough), DYSPNOEA (shortness of breath) and PALPITATIONS (racing heart). At the time of the report, COUGH (Immediate cough), DYSPNOEA (shortness of breath) and PALPITATIONS (racing heart) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had immediate cough, shortness of breath, racing heart from 07-Dec-2022 and still pressent. Much testing done. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
17 year old patient received Proquad combination dose instead of MMR and varicella. Patient had no adverse reaction upon observation for one hour. Client informed of nurse error and agrees to return 10/30/2023 for administration of approved vaccines.
Some soreness in right upper arm where shot was given for 30 hours. However, by the next morning (Nov. 8) I suffered from a general tiredness and malaise which lasted most of the day.  I had the same experience when I had the first shot (Aug. 24, 2018) at a different pharmacy (hence a different batch).
Information has been received from a nurse, who is the mother of the patient, concerning her 16 year old daughter who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine. On 10-JUN-2008, she was vaccinated with the second dose of GARDASIL vaccine, (lot # not reported), IM. Concomitant therapy included MENACTRA. The nurse reported that her daughter developed headache, muscle aches and pain on 25-JUN-2008. On 29-JUN-2008, she had taken her daughter the patient to a urgent care facility because she still wasn't feeling well. The nurse reported that her daughter had blood work performed and it was determined that she had a low white blood count; it was suspected she could have a virus, but they were not sure. No further information was provided. Additional information has been requested.
Rash and urticarial pruritus. Ranitidine 150 mg bid, methylprednisolone, fluocinolone.
pregnant patient was given Adacel  that was in freezing temperatures for 4 days with a low of -0.2F, NO AE; pregnant patient was given Adacel  that was in freezing temperatures for 4 days with a low of -0.2F, NO AE; Initial information received on 15-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 42 years old female patient who received booster dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6612AA and expiry date: 19-Mar-2020) via intramuscular route in the left arm, On 13-Jan-2020, while she was pregnant.  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was reported as 20-May-2019.  The estimated due date is 24-Feb-2020. Gestation period at onset was 34 weeks.   Medical history, medical treatment, vaccination and family history were not provided.  It was the case of vaccine exposure during pregnancy.The patient was pregnant when she received vaccine.  It was also a case of actual medication error due to incorrect product storage as vaccine was in freezing temperatures for 4 days with a low of -0.2F. The product was unopened. Out of range for 4 days. The lowest temperature was negative 2 degrees Fahrenheit.  The patient did not experience any adverse effects as a result of the vaccination.   Pregnancy outcome was unknown at the time of report. Baby not delivered yet.
left arm erythema, warmth and induration.  fatigue.  left arm lymph node swelling, fatigue, headache, swelling of hands, and mild rash.
Shortness of Breath diabetes, hypertension presenting by ambulance for left lower quadrant abdominal pain.  Patient reports that the pain is intermittent when he gets "strong" he feels short of breath.  He denies URI symptoms.  No chest pain.  Denies fever.  Noted to be febrile here however.  No urinary symptoms.  No diarrhea. Hospital Course and Significant Findings: Patient was a 65-year-old male vaccinated for Covid-19 (tested positive for Covid-19 on 10/9/2021), type II diabetic, hypertension admitted on 10/20/2021 with worsening shortness of breath. Asthma   Hospital course: -In emergency room--- > presented with ST elevation/DKA.  Insulin drip protocol started and patient taken to Cath Lab: 100% LAD occlusion/received DES -Admitted to ICU: Started on remdesivir/Decadron, insulin drip continued (thrombocytopenia noted/consistent with DIC and no TOCI given)/requiring high flow oxygen--- > transferred out of ICU -(10/21/2021) echocardiogram showing LVEF 20-25%, DVT ultrasound showing right distal femoral to entire popliteal DVT (started on enoxaparin -(10/23/2021 developed A. fib/RVR-initially treated with digoxin and then amiodarone drip/more shortness of breath-transferred to ICU/then downgraded to med telemetry on 10/24/2021 in early a.m. -(10/24/2021) CT angiogram chest showing bilateral lower lobe pulmonary emboli/consolidations bilaterally/bilateral pleural effusions--- > started on Eliquis/ongoing high flow oxygen needs. -(10/25/2021) repeat echocardiogram with similar LVEF: 25% -(10/26/2021) started on empiric ceftriaxone/doxycycline -(10/28/2021) transferred to ICU for work of breathing/hypoxia (intolerant of BiPAP)/pt able to come off Bipap in evening to high flow O2--- >able to take in some po's   During the course of the night, patient experienced deasaturations despite Bipap. After D/W patient, he was intubated.   Unfortunately patient exp'd PEA arrest later in am. Despite several rounds of CPR, patient expired at 3:05 am.
pt recv vax 16AUG96 & devel a fever & swelling of lt parotid gland on 3SEP96;
Pt. develop a reaction to 1st dose of covid-19 vaccine.  Symptoms described as having elevated heartrate and headache and blurred vision.  Pt. current medications cytomel and levothyroxine, also pt. in remission for cancer with a thyroid of 4/14/21 removal.  V/S: 123/71, 73 P.  Pt. verbalizes feeling better and recovered .   No hospital provided.
Pt developed a red and swollen left and right leg. No appetite, fever of 100.5F, left leg skin peeling and (3cm induration). Went to ER.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received an injection of Engerix B (lot 2712A2) on 4/18/99. He also received injections of hep B vaccine (manuf unk) 6/18/99 and 12/16/99, DTaP (manuf unk) 6/18/99, 10/18/99, and 10/18/00, Tetramune 8/17/99, and haemophilus influenzae type B conjugate vaccine (manuf unk) 6/18/99, 10/18/99 and 4/18/00. The subject's attorney alleged that "As a result of the mercury in the Thimerosal-containing vaccinations that the subject received he now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." The attorney further alleged that the subject "has developed severe neurodevelopmental disorders with associated high mercury exposure levels as a result of the vaccinations he received, and has suffered serious permanent injury." Onset and treatment of the events were not specified. The mercury poisoning in this report, with resultant neurodevelpemntal disorders, is considered medically serious (OMIC).