chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Across upper torso a little itchy; rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body; rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Across upper torso a little itchy), URTICARIA (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body) and RASH (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (cillin medications) and Hashimoto's thyroiditis.    On 19-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body). On an unknown date, the patient experienced PRURITUS (Across upper torso a little itchy) and RASH (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; LORATADINE (CLARITINE) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Across upper torso a little itchy), URTICARIA (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body) and RASH (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Histamine level: more active/increased (High) more active/increased.         No concomitant medications were reported. Patient's date of birth mentioned.   The patient had allergy to poison ivy. She did not have seasonal allergies and had not added any new foods to diet. Moderna 2nd booster dose Lot number was reported as 027L21A or Z1A. The patient suspected hives and rash were due to vaccine in combination with having hashimotos. She experienced hives and rash had been going for weeks and saw doctor. The rash and hives happened through the day, histamines were more active at night.  Treatment with Benadryl, Claritin, prednisone made that worse.  The patient had not experienced a similar event in the past.
SLEEP AFTER GETTING VACCINE; 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, start therapy date were not reported 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 an unspecified date, the patient experienced sleep after getting vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sleep after getting vaccine was not reported. This report was non-serious.
CONFIRMED CLINICAL VACCINATION FAILURE; POSITIVE PCR CONFIRMED COVID-19 VACCINE AFTER BOOSTER DOSE OF JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a 47 year old male. The patient's height and weight were not reported. The patient had no significant medical history. The patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 23-AUG-2021) dose was not reported, 01 total was administered on 23-MAR-2021 on left arm for prophylactic vaccination (dose number in series 1). The reporter had not reported any adverse events following vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, 01 total was administered on 17-NOV-2021 on left arm for prophylactic vaccination (dose number in series 2). No concomitant medications were reported. On 29-NOV-2021 or 30 NOV-2021 (exact date not mentioned) the patient tested self (rapid test) found negative as his wife started to show symptoms to Covid. On 02-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), the patient had cold like symptoms, little/light cough, feeling cold. On the same day, the patient reported a positive coronavirus disease (COVID)-19 test for himself on self (rapid) test when he retested after he began experiencing loss of smell. On 04-DEC-2021, laboratory test was performed and he had positive polymerase chain reaction (PCR) confirmed covid-19 vaccine after booster dose of Janssen covid-19 vaccine (confirmed clinical vaccination failure). He reported that, the lab result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was detected abnormal (Ab). He was treated with zinc, vitamin C, multivitamin and reported that he always wore a mask, prior to and after vaccination whenever leaving the house. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from positive PCR confirmed covid-19 vaccine after booster dose of Janssen covid-19 vaccine and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case was associated with product quality complaint (PQC): 90000205848. This case, involving the same patient is linked to 20211220582 and 20211217118, 20211217766 (wife's case).; Sender's Comments: V0:20211217227-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Extreme nausea and vomiting starting 12 hours after the shot and lasting for 16 hours
Information has been received from a nurse concerning a female (age not reported) with diabetes who on approximately 12-MAR-2007, "last week", was vaccinated with Gardasil. Concomitant therapy included insulin. On approximately 12-MAR-2007, the patient experienced blood sugar out of control for 48 hours after receiving Gardasil. The patient sought unspecified medical attention. On approximately 14-MAR-2007, the patient from blood sugar out of control. Additional information has been requested.
Client received #3 HPV on 6-12-08 at 3:15 PM, no problems. At 9:30 PM - client started shaking x 45 minutes - then developed headache -face flushed then fever 99 took to ER. Doctor gave her Tylenol. 4 AM - at home awoke with 102 - muscle cramps - stomach ache, dizziness, nausea.
Pt devel chills, low-grade fever, muscle pain, joint swelling hands, fatigue soon p/recvd flu vax; pt exp weakness, fatigue, & joint pain, devel autoimmun response; vertigo; pt antinuclear antibody titer was elevated;
5 hrs post PCV 23 #2 yesterday 8/7/19 developed sever local reaction with pain, swelling, warmth, decreased ROM left deltoid and (L) shoulder
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated improperly stored doses of PROQUAD (dose route, frequency, lot number and expiration date were not reported) for prophylaxis. Information regarding concomitant therapies were not reported. The vaccines were stored at 39F degrees during 10 hours. This information was registered in a digital data logger. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000689:
This case was reported by a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (unknown). Forty-two days after vaccination with the 3rd dose of Engerix B, the subject experienced not responding to therapy. A product complaint was associated with this event. The sales representative received an email from a doctor's office. Vaccine was purchased through a company and 42 days after all seven subjects were given the 3rd dose of Engerix B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representatives reported the event as "lack of effect."
Kinrix administered to a 3 years-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th May 2010, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th May 2010, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: Kinrix dose was the patient's 5th DTap and 4th IPV. The reporter did not consent to follow-up. Additional Supportive Information: Patient received Kinrix vaccine 7 days prior to 4th birthday,which led to inappropriate age at vaccine administration.
Patient tested positive at hospital of Covid on 11/28/2021.  No charting of symptoms or pre-existing conditions listed.
No Adverse event; We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.) and NO ADVERSE EVENT (No Adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced INCORRECT DOSE ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (We gave 2 doses of Covid-19 Vaccine (Monovalent) instead of the Moderna covid-19 Vaccine Bivalent.). No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679877 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679877:same reporter
Dizziness, blurred vision, clammy hands, head pressure.  Monitored for an hour.  Sent home.
Increased fussiness, fever, not eating. Seen in local ER. Abd U/S done. Had concerns for intussusception. Was transferred to another Hospital on 02/26/2018.
DIARRHEA; VOMITING; CHILLS; FEVER; SHAKING; EXCRUCIATING PAIN ON LEFT SHOULDER; ACHEY; PAIN IN JOINT; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shaking. On 10-APR-2021, the subject experienced excruciating pain on left shoulder. On 10-APR-2021, the subject experienced achey. On 10-APR-2021, the subject experienced pain in joint. On 10-APR-2021, the subject experienced fever. On 10-APR-2021 03:00, the subject experienced chills. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced vomiting. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, excruciating pain on left shoulder, chills, and fever on 11-APR-2021, was recovering from achey, and pain in joint, and the outcome of diarrhea and vomiting was not reported. This report was non-serious.
First day: severe chills (extreme body shaking), and body temperature alternating between overheating and moderate/severe chills every several hours. Body fatigue, temperature varying from low 99 F up to 101.3 F. These symptoms subsided after about 2 days. Also developing during this time was an asthma attack, characterized by wheezing, coughing, and difficulty breathing. Patient has had life-long history of asthma, moderate, well-maintained with albuterol inhaler (life-long) and Qvar redihaler (beginning in early-mid 2020). However, after the common symptoms subsided, the asthma attack prolonged for over a week (2nd injection on 22 Apr 2021, and present as of reporting (03 May 2021). Albuterol inhaler would ease the wheezing, but no effect on mitigating the coughing / difficulty breathing. Qvar redihaler had no effect. Asthma attack would alternate in waves (approximately every hour up to 4-6 hour cycles), of breathing mostly clearly (some difficulty persisting), and severe attacks when extremely difficult to breathe.
pain at injection site; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain  The patient's medical history was not provided by the reporter.  Concomitant product use was not reported.  On 14 Jan 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #: 0013L20A) intramuscularly for prophylaxis of COVID-19 infection.    The patient's symptoms included pain at injection. Treatment included acetaminophen (one a day), warm cloth and cold compress.   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, injection site pain, was unknown.; Reporter's Comments: The reported event is consistent with the known safety profile of mRNA-1273 vaccine and temporarily associated with the product use, hence a causal relationship cannot be excluded.
After the flu vaccine patient took advil for the injection pain within 4 hours after the vaccination, patients sclera turned bright red and dry.  The next morning, she developed flu like symptoms and tearing eyes, she took Benadryl by mouth, symptoms improved. Sclera still red.  Patient has had no prior reaction to flu vaccine.  No medical allergy.
Error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 168 doses were given from LOT 048C21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received
Patient reported having metallic taste in mouth about 15 minutes after receiving the immunization and wanted us to report it. She also said that she had a metallic taste after the first shot.  Patient had anxiety about the shot and was not sure if she had a little trouble swallowing because of the shot or the anxiety.
Low testosterone; Test: Covid-19 Antigen/Result: Positive; Test: Covid-19 Antigen/Result: Positive; cough; Sore throat; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Sep2021 11:30 (Lot number: 301358A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Skin health" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 25Sep2021; RETIN-A taken for skin disorder, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Date: 13Jan2021, Time: 09:30, Anatomical site of injection: Left deltoid, Route of administration: Intrmuscular, Batch/Lot Number: EL3248), administration date: 13Jan2021, for COVID-19 Immunization, reaction(s): "Low testosterone"; Bnt162b2 (Dose: 2, Date: 03Feb2021, Time: 10:00, Anatomical site of injection: Left deltoid, Route of administration: Intrmuscular, Batch/Lot Number: EL9269), administration date: 03Feb2021, for COVID-19 immunization. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), VACCINATION FAILURE (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Test: Covid-19 Antigen/Result: Positive"; COUGH (non-serious) with onset 31Dec2021, outcome "recovered" (07Jan2022), described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "recovering", described as "Sore throat"; BLOOD TESTOSTERONE DECREASED (non-serious), outcome "not recovered", described as "Low testosterone"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovering", described as "Fatigue". The patient underwent the following laboratory tests and procedures: blood testosterone: (unspecified date) low; sars-cov-2 test: (28Dec2021) negatie; (04Jan2022) positive; (04Jan2022) positive, notes: second confirmatory positive test; (07Jan2022) positive; (08Jan2022) positive; (09Jan2022) negative; (10Jan2022) negative, notes: second confirmatory negative test. Therapeutic measures were taken as a result of cough, oropharyngeal pain, blood testosterone decreased included ibuprofen, Dextromethorphan Br, Guaifenesin, Phenylephrine HCL. Therapeutic measures were not taken as a result of fatigue.  Clinical course: Ondansetron/Zofran oral 30Dec2021-30Dec2021 for post surgery nausea.Cefadroxil oral 31Dec2021-07Jan2022 for post surgery infection prophylaxis.Mucinex Fast-Max severe (Dextromethorphan HBr/Guaifenesin/Phenylephrine HCL) oral 31Dec2021-07Jan2022 for cough.  Follow-up attempts are completed. No further information is expected.
Boostrix was inadvertently administered instead of Kinrix - child received TDap instead of DTap which was not appropriate for age. The child experienced no complications with administration or following administration.
Large swelling at shoulder warm, painful, welting. Described as multiple golfballs size.
Adverse event experienced was hives from the chest, arms down to ankles. Duration a week. Treatment used was antihistimine Alegra.
Debilitating muscle soreness; This spontaneous case was reported by an other and describes the occurrence of MYALGIA (Debilitating muscle soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Debilitating muscle soreness). At the time of the report, MYALGIA (Debilitating muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products was provided by the reporter.  No treatment information was provided by the reporter.
Two series of Janssen COVID-19 Vaccine Second series: COVID19(Janssen), Janssen, 201A21A, Intramuscular, Arm side unknown One dose recommendation. Individual received two doses All vaccines in block 17 administered on 09/21/2021