chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ache on bones; Pain; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Ache on bones) and PAIN (Pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 032M20A and 032L620A) for COVID-19 vaccination.     Patient did not have any allergies related to medications, food and other products. Patient never diagnosed with COVID-19 or tested positive. Patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes since 2000, Blood pressure high since 2000, Prostatic disorder, Blood cholesterol abnormal, Unspecified functional disorder of stomach and Anxiety. Concomitant products included SERTRALINE for Anxiety, ATORVASTATIN for Blood cholesterol abnormal, METOPROLOL for Blood pressure high, GLIPIZIDE, GABAPENTIN and METFORMIN for Diabetes, FINASTERIDE for Prostatic disorder, OMEPRAZOLE for Unspecified functional disorder of stomach.   On 29-Jan-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) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Ache on bones) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BONE PAIN (Ache on bones) and PAIN (Pain) had resolved.            Patient received the vaccine on left shoulder.   This case was linked to MOD-2022-604652, MOD-2022-604653 (Patient Link).
Two days after booster, my blood pressure was up and down but always high between 160/95 and 190/0102.  I had a headache, not constant, but pressure headaches behind eyes, ears and back of head. mainly.  I could not stay awake, and had to leave work on Friday and slept from 3pm thru 10:00 am.  I got up because I had an appointment at 11:30, but came home around 2:00 pm and slept until Sunday.  I took my b.p. 3 times a day and finally went to the ER.  My C.A.T. scan, chest X-Ray, EKG, blood work and urinalysis came back good.  I wanted to know if there are other reports of these side affects and if they continue.  I am back at work, so I have not had a chance to take my blood pressure today, but will once I get home.  I am purchasing 1 now to have at work.  I want to know if this is going to be an ongoing problem now with my heart taking all of this pressure?   I have a Dr appt with my primary this week and will go from there.  I never had a problem with this in the past and never had headaches that don't go away.
1st dose before Covid and nowgetting 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (the patient received 1st dose on an unknown date).   On an unknown date, the patient did not received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-June-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient asked what if he/she had first dose of the vaccine before Covid and he/she was just now getting his/her second. The patient wants to know whether need to take another dose. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The follow-up would not be possible as no contact details were available.
9th day after injection, once again have 1.5 inch diameter redness, hardness, itching, warm to touch. Arm again moderate sore. Same reaction after initial shot which cleared up around 5th day.  No other symptoms.
did not return for her subsequent doses of GARDASIL-9 after the initial dose; No adverse effects were reported in the patient; Information has been received from a physician referring to female patient of unknown age. The patient's medical history, drug Reactions/Allergies and concomitant medication were not reported.  On an unknown date, the patient vaccinated with her initial dose HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot#, expiration date, and strength were not reported) for prophylaxis.  At the time of reporting, the physician reported that the patient in the office did not return for her subsequent doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) after the initial dose (Inappropriate schedule of product administration). No adverse effects were reported in the patient.
No adverse event; temperature excursion total time: 25 mins, 3 excursions on dates: 9/9/22 for 9 mins, 9/16/22 for 5 mins, 1/3/23 for 12 mins; This spontaneous report was received from an office manager and refers to a 11-year-old male patient. No information on patient medical history, current conditions and concomitant medications was provided.  On 07-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dosage form, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites and routes of administration were not provided) administered for prophylaxis (product storage error and no adverse event).  Temperature excursion total time was 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day. Patient was vaccinated in private doctor's office/hospital.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:source original: 2304USA002221
Left deltoid redness, swelling and sore arm  for 3 days after second dose of shingrix
Bronchial spasms; Itching on the site; This spontaneous case was received on 25-Mar-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-01069) and concerned an adult female patient. At the time of this report, the patient was 68-year-old.   The patient's relevant medical history and concomitant medications were not reported.   On 01-Oct-2010, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine, dose, route of administration and anatomical location: not reported) for flu prophylaxis. The batch number reported was 111691 (Seqirus batch number unable to be matched), expiration date: 30-Apr-2011.  On the same day, within 10 minutes after receiving Fluvirin, the patient started developing symptoms of itching and bronchial spasms. Itching was severe and at site. These symptoms improved with antihistamines and inhaler.   On an unspecified date, the patient was recovered from events.   The reporter did not provide causality assessment to Fluvirin. The reporter thought it was related to thimerosal, but her allergist did not believe that thimerosal was the reason and preferred to have the list of ingredients.   The case was assessed as non-serious.  This case is linked with case 202102117 (the same patient).  Company comment: An adult female patient was administered Fluvirin. On the same day, within 10 minutes after receiving Fluvirin, the patient started developing symptoms of itching and bronchial spasms. Itching was severe and at site. These symptoms improved with antihistamines and inhaler. Based on provided information, causality is assessed as possibly related for both events, due to plausible chronology.; Sender's Comments: An adult female patient was administered Fluvirin. On the same day, within 10 minutes after receiving Fluvirin, the patient started developing symptoms of itching and bronchial spasms. Itching was severe and at site. These symptoms improved with antihistamines and inhaler. Based on provided information, causality is assessed as possibly related for both events, due to plausible chronology.
A spontaneous report was received from a consumer who is also the 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced blood clots in lung/pulmonary embolism. The patient's medical history was not provided. No concomitant product use was reported. On 10 Feb 2021, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient was admitted to hospital with blood clots in lung. Patient was put on blood thinner. On 26-Feb-2021, the patient was discharged from hospital. Treatment medication included unspecified blood thinners. Action taken with mRNA-1273 was unknown. The outcome of the event, blood clots in lung/pulmonary embolism, was reported as resolved on 26-FEB-2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Pt had never had influenza injections. Pediatric 0.25ML dose was given on 01/03/18. Mother returned with Pt to get 0.5ML dose on 01/04/18 per CDC guidelines.
Prominent redness at injection site, itching and localized discomfort throughout RT upper extremity. Overall feeling of malaise with nausea and vomiting for four days.
12SEP98 10AM dad noticed rash on child face & stomach;pt was c/o sore leg & did not want to ambulate;child MD ordered DPH;by 12PM ankles are red & swollen-rash started spreading all over body;taken to hosp now wrist are red & swollen;
bad peroid; insomnia; drowsiness; sore arm; tired; bad body pains; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and MYALGIA (bad body pains). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and MYALGIA (bad body pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: higher (High) Increased.         Patient mentioned that  Would get tired and then by the time she she gets in bed drowsiness goes away and heart rate will increases preventing her from falls asleep and is no longer tired and took Nyquil and other medications to fall asleep which did not help.
Itching on arms, legs, & back began within  5 minutes of administration. Writer noticed patient itching. No rash appeared.  No additional symptoms appeared. Patient kept for additional observation x 2 hours total. MD also assessed patient, recommended Benadryl 25mg to be given which patient took. Patient reported that Itching continued for about 48 hours and then stopped, never worsening. No rash or any other symptoms.
Pt recvd 2nd dose of vax & exp pain & warmth @ the inject site as well as recurrence of the pain  warmth @ the original inject site; pt then exp palpatations & was subsequently hospitalized in MAY92;
vomitting & fever p/vax; said MD told not to get DTP agian; mom did not comply w/request for documentation of adverse event from MD & diagnosis;
This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. The pharmacist stated that injection site adverse experiences are common with PNEUMOVAX 23. Additionally, she stated that she told her patients that there may be inflammation and pain. At the time of the report, the outcome of injection site reaction was not reported. The relatedness assessment between PNEUMOVAX 23 and injection site reaction was considered as related. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA014939: US-009507513-1705USA009926.
I got scheduled to get CT scan in 05/2021 and a tumor showed up on the scan. On 06/04/2021 I had a biopsy and it was found to be lung cancer. From there on I had surgery to remove one lobe of my left lung.  I took some pain medicines after the surgery and no new medications. I was admitted to the hospital for five days.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient received two dose of COVID -19 vaccine with one additional dose. Only removed a vial from the freezer and put in the refrigerator the day before administered. The vaccines were not in the fridge for more than a day unless patients did not appear for vaccination.  No concomitant medications reported. No treatment reported.
Narrative: 72 yo M that received dose #1 of the Moderna COVID-19 vaccine on 2/26/2021 (Lot#:011A21A: Exp Date: 08/16/2021) and dose #2 of the Moderna COVID-19 vaccine on 3/26/2021 (Lot#: 007B21A; Exp Date:09/08/2021). Most recent A1C prior to COVID-19 vaccination 8.0% on 2/2/2021 and established on metformin 850mg PO BID and glipizide 10mg PO BID. Following non-fasting lab appointment on 3/1/2021, serum glucose=626; provider advised patient to go to local ED or fire station if develops symptoms of hyperglycemia. Note documented on 3/16/2021, Patient presented to the emergency department based outpatient clinic with increased frequency of urination, polydipsia, but no other signs or symptoms of hyperglycemia, found to have hyperglycemia with metabolic acidosis, acute kidney injury and pseudo hyponatremia. At this time patient admitted to hospital for further monitoring, evaluation, and treatment of hyperosmolar nonketotic hyperglycemic state, with mild ketoacidosis and AKI. Pt treated with IV fluid rehydration with normal saline, started on sliding scale insulin. In addition, pt started on basal insulin glargine 10 units every evening. Pt then subsequently discharged (incomplete records). On 3/22/2021, patient obtained non-fasting lab work with serum glucose=504 and A1C=12.5%. Pt has been consulted to endocrinology based on rurality of patient and subsequent management of diabetes.
Sweating more; Chest flutters around heart; Runny nose; This is a spontaneous report from a contactable consumer(patient) or other non-healthcare professional. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186) as dose 1 single, administered in left arm on 07Aug2021 (at the age of 58-year-old) for COVID-19 immunization. The patient medical history included an allergic reaction to when she had the Tuberculosis shot, and there were two medications in one shot. The patient had a bad reaction in her left arm and it was hot to touch. She got the shot when she turned 50 or something as reported. NDC/LOT/EXP Unknown. The concomitant medications were not reported. About a week after she had the first dose the patient experienced chest flutters around the heart, sweating more, and a runny nose. The patient said that she does not know if that was normal or not. The patient said that she was not a sickly person. Never had a flu shot in her life. Patient was sweating more. It began about a week later and has perspiration on her forehead and gets so hot that she must turn the AC up and then she gets too hot. It was up and down. She could feel sweat on her face and not the whole body, just in the head and forehead she was feeling so hot. The runny nose was at the same time as sweating. She did not have a cold or runny nose before the shot. The chest flutter was not constant, comes and goes. Sometimes when it happened, there was a little pinch. The patient's second dose of COVID 19 immunization was due on 28Aug2021. Outcome: It is starting to taper off, it's not as much. The event outcome for sweating more and chest flutter was not recovered, and runny nose was unknown at the time of reporting.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA322127 (same reporter). This case involves female patient who got splashed in the face and eyes with the MENACTRA vaccine due to needle cracked and sprayed the vaccine on them, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a exposed with dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine, lot U6016AA, expiry date- 09-Oct-2019 via eyes and face. It was a case of actual medication error due to Occupational exposure while administering product. It was also a case of needle issue. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
approx 1/2hr p/vax pt devel patches of erythema blotches on upper body & face, especially around eyes & mouth; no c/o discomfort or itching; blotches lighter in color when pt left building; mom states rash was gone by the time arrived;
Dizziness, numbness in legs, nausea, lack of appetite, shoulder pain.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six  patients received the vaccine in question) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit. Vial moved from freezer to refrigerator on 3-MAR-2022. The nurse does not have information on the first two vaccinations. The nurse reports no adverse reactions or side effects to the Moderna COVID-19 vaccine. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 (BNT162B2), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: after initial positive test; (07Sep2023) positive, notes: 4 days after end of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid rebound. 9 days after initial positive test. 4 days after end of paxlovid. Known allergies: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.