chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of abscess in a patient who received HAVRIX for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis, PNEUMOCOCCAL VACCINE for prophylaxis and FLUZONE for prophylaxis. On an unknown date, the patient received HAVRIX at an unknown dose, dTpa vaccine, PNEUMOCOCCAL VACCINE at an unknown dose and FLUZONE at an unknown dose. On an unknown date, unknown after receiving HAVRIX and dTpa vaccine, the patient experienced abscess, boil, fluid discharge and incorrect product storage. On an unknown date, the outcome of the abscess, boil, fluid discharge and incorrect product storage were unknown. It was unknown if the reporter considered the abscess, boil and fluid discharge to be related to HAVRIX and dTpa vaccine. Additional details were reported as follows: The reporter was worked for the public health. The age at the vaccination was not reported. About 66 to 68 patients, received HAVRIX (healthcare professional believed that it was HAVRIX but still figuring it out), FLUZONE, Tdap, and Pneumococcal vaccine. The all patients experienced severe abscesses and boils that were draining. The reporter believed that, it was due to the injection practices of the clinic that was vaccinating. They were waiting on cultures and this was still under investigation. The clinic also was not monitored the temperatures for the vaccines so the healthcare professional did not even know if the vaccines were viable, which led to possible incorrect product storage. The reporter was still investigating this. The reporter had consented to follow. The reporter was okay with follow-up from safety.
Injection site swelling; Injection site redness; Injection site discomfort; This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site discomfort. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site discomfort were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in her sixties. The patient experienced 7 inches X 4 inch injection site reaction which was described as redness and swelling and this causes discomfort in the patient. All these events resolved within 4 to 5 days. Till the time of reporting, the patient had not received 2nd dose os SHINGRIX. The reporter did not respond to consent request.
Mother reports child developed knots on one side of face and neck 5 days with vaccine administered. States PCP has scheduled for a CAT scan. Is being treated with antibiotic and steroid. PCP told mother symptoms are vaccine reaction. Mother called 10/21/2005.
Upon returning timer to RN at 30 minute post-vaccination, patient reported feeling "itchiness" in her throat. RN assessed patient immediately at 0854. Vital signs were: BP 153/85, HR 61, SPO2 98%. No wheezing was present upon auscultation. No swelling was noted to tongue and no hives were present. Patient reported no other symptoms besides persistent itchy throat. Patient was placed in wheelchair and taken to emergency room immediately by RN and pharmacist. While walking to ER patient was noted to be clearing her throat multiple times. Upon arrival to ED, patient's tongue was noted to have mild changes since previous exam. Patient handoff report was given to to ER nurse at 0900. Of note: patient reported no known history of allergies and no previous vaccine reaction.   Patient was treated in ER with 25 mg IV Benadryl, 125 mg IV Solu-Medrol, and 20 mg IV Pepcid. Patient was observed for another two hours and was ultimately discharged from the ER in stable condition.
DROWSINESS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced drowsiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drowsiness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210744116 and 20210744057.
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: She waited 15 minutes after her shot then came to pharmacist to report her left arm started feeling numb/tingling right after the vaccine was administered. Her & the pharmacist talked for another 15 minutes about the adverse event. She reported feeling a little weak especially in the left arm, and slight tingling in her forehead. Otherwise patient reported she was fine. Pharmacist recommended for her to follow up with DR if numbness doesn't go away & to report to ER/call 911 if it worsens.
This patient had swollen lips, sometimes eyes, hives, tired most of the time, joints in the arms and legs hurt when hives appear and sometimes after.
This spontaneous report as received from a physician refers to 2 patients of unknown age. Patient's medical history and concurrent condition was not reported. On 19-SEP-2014 the patient's were vaccinated with PNEUMOVAX 23 prefilled syringe (dose and frequency unknown). Patient's concomitant medication was not reported. On an unknown date the patient experienced fever and chills. When doctor used the first 2 out of a 10 pack box, both patients broke out in fever and chills. The doctor does not want to use the other eight. The outcome of the event was unknown. Reporter's causality assessment was not provided. Follow up information has been received from the physician. One of two patient was 31 years old female patient with history of gastrointestinal reaction (GI) to MACROBID. The patient was vaccinated on 10-SEP-2014 at 10:47 with first dose of PNEUMOVAX 23 (lot # K009105, expiration date 21-JAN-2016) in left deltoid (dose was not provided). Patient had no illness at time of vaccination. On 10-SEP-2014 the patient experienced fever 103 (unit not provided) for 4-5 days, chills, local soreness for 7 days after immunisation. Patient recovered from the events. Relatedness between fever, chills, local soreness and PNEUMOVAX 23 was not reported. Events of fever, chills and local soreness were considered as disabling by reporter. This is one of the several reports from the same reporter. Additional information is not expected, as all information has been obtained.
On Friday evening I started having fatigue,muscle aches, and fever. This continued through Saturday and Sunday, fever between 99.5 and 101.5. Sunday morning Istarted having severe and sudden onset diarrhea. Today is Monday and i am starting tofeel better, though continue to have some generalized fatigue.
Received 2nd vaccination 22 days apart; Sore left deltoid; Swelling of the lymph nodes on the same side; Tender axilla; Very very slight tender to touch in the pectoral area; A spontaneous report was received from a 56-year-old male physician who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore left deltoid, swelling of lymph nodes on the same side, tender axilla, tender to touch in the pectoral area and second dose vaccine administered 22 days apart.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, fish oil, vitamin B, vitamin D3, zinc, vitamin C, turmeric, sertraline, and encapsulated dried fruits and vegetables.   On 28 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced sore left deltoid, swelling of the lymph nodes on the same side, and tender axilla. On 19 Jan 2021, the patient experienced very slight tender to touch in the pectoral area and second dose of vaccine given 22 days after first dose. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events, experienced sore left deltoid, swelling of lymph nodes on the same side, and tender axilla was considered resolved on 30 Dec 2020. The outcome of the events, slight tender to touch in the pectoral area and second dose vaccine given 22 days apart, was considered resolved on 19 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case of a 56-year-old male patient who experienced second dose vaccine administered 22 days apart (Inappropriate schedule of vaccine administered) and non-serious events of sore left deltoid, swelling of lymph nodes on the same side, tender axilla, tender to touch in the pectoral area after the administration of the mRNA-1273 vaccine (Lot # 012L20A., expiration date-unknown).  The events of sore left deltoid, swelling of lymph nodes on the same side, tender axilla occurred the same day after administration of the first dose of the vaccine and event of tender to touch in the pectoral area occurred on the same day after the last dose and 22 days after the first dose.  No treatment was reported, and outcome is resolved for the event of slight tender to touch in the pectoral area. The reported events of sore left deltoid, swelling of lymph nodes on the same side, tender axilla, tender to touch in the pectoral area are consistent with the known safety profile of the vaccine. Hence, based on the information provided a causal association between the administration of mRNA-1273 and the reported events cannot be excluded The event of second dose vaccine administered 22 days apart is considered not applicable.
large lump in his armpit with a size of a golf ball; light headache; slight fever 98.8F; feeling tired; bad migraine; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (large lump in his armpit with a size of a golf ball), MIGRAINE (bad migraine), HEADACHE (light headache), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, M012M20A and M-13L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Drug allergy (Niscon allergy.). Concomitant products included LISINOPRIL and AMLODIPINE for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation, FINASTERIDE and FENOFIBRATE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced MIGRAINE (bad migraine), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired). On 03-Oct-2021, the patient experienced AXILLARY MASS (large lump in his armpit with a size of a golf ball) and HEADACHE (light headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 03-Oct-2021, MIGRAINE (bad migraine), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired) had resolved. At the time of the report, AXILLARY MASS (large lump in his armpit with a size of a golf ball) and HEADACHE (light headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, Body temperature: 98.8 f (High) 98.8 F.    Indication for use of concomitant medication Finasteride was Prostate and for Fenofibrate was Cholesterol.  Patient's historical vaccine includes Flu shot on 05AUG2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received contains additional race, allergies and medical history  and concomitant therapy dates information.
TOOK ONLY TWO DOSES; This spontaneous case report was received from a pharmacist (PVX2019-521) on 26-Feb-2019. The report described a female consumer who "took only two doses". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took the two doses of Vivotif and then forgot to take the other two doses for about two weeks.   The action taken with Vivotif with respect to the event "took only two doses" was not applicable.  The clinical outcome of the event "took only two doses" was unknown.  Company's Comment: The causality of the event "took only two doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only two doses" was considered as not applicable.
Body Aches; Headache; Fatigue; A spontaneous report was received from a nurse, concerning herself, a female patient of 53-years-old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, headache, body aches and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 14 Jan 2021, intramuscularly, in the right upper arm. On 09 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly, in the right upper arm for prophylaxis of COVID-19 infection.   On 09- Feb-2021, after the second dose of vaccine, the patient experienced, headache, body aches and fatigue. Treatment of the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, headache, body aches and fatigue, was unknown at the time of this report.
pt devel immed swelling w/urticaria & redness @ inject site following the MMR vax;
Moderna COVID-19 Vaccine EUA Noticed hardened, red spot, about half dollar size, at site of injection
Diagnosed with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced COVID-19 (Diagnosed with covid). On 15-Apr-2021, COVID-19 (Diagnosed with covid) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
headache; Cough; SARS-COV-2 test positive; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), COUGH (Cough) and SARS-COV-2 TEST POSITIVE (SARS-COV-2 test positive) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Tremor. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache), COUGH (Cough) and SARS-COV-2 TEST POSITIVE (SARS-COV-2 test positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), COUGH (Cough) and SARS-COV-2 TEST POSITIVE (SARS-COV-2 test positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes medicine for her cholesterol and for her tremors.   This case was linked to US-MODERNATX, INC.-MOD-2021-029065, US-MODERNATX, INC.-MOD-2021-029065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029065: US-MODERNATX, INC.-MOD-2021-029065:
it was reconstituted with sterile water instead of NaCl with no reported adverse event; Initial information received on 13-Sep-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Medical Information (under the reference number- 00766997).  This case involves a patient of (unknown demographics) who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which was reconstituted with sterile water instead of NACl (product preparation error).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (suspension for injection, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product preparation error (same day).  It was reported "Caller reporting they are in the process of researching to determine if these errors occurred, but if it did occur there is no way to identify which 1-2 patients were involved out of 8 patients. Caller did not have any patient data available as they are researching."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.   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 the 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.  There will be no information available on the batch number for this case.
Within 24 hrs onset of fever 101.5F, irritable, erythematous rash - seen by MD on 3/19/01. Fever subsided - rash faint per MD report.
fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 21st July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details provided were as follows: The reporter was patient's mother. Age at vaccination was not reported. The patient got the second dose of the Shingrix vaccine, a day before reporting and next morning at 2 am he started having a fever. The reporter did not consented to follow-up.
blood sugar 162/blood sugar 130; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar 162/blood sugar 130) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar 162/blood sugar 130). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar 162/blood sugar 130) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2022, Blood glucose: 162 162. On 20-Jan-2022, Blood glucose: 130 130.         Concomitant medications were not reported. Treatment medications were not reported. Before she got her booster dose the patient blood sugar was 115.   This case was linked to MOD-2022-456189 (Patient Link).
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20211208442.