chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Several months after receiving the Moderna Covid-19 vaccine 2nd booster the patient developed Urticaria), RASH (Caller says as soon as she put the Benadryl cream on her husbands rash the rash would disappear and then pop up somewhere else/caller said that her husband's Dermatologist called this a "running rash") and RASH PRURITIC (Rash was extremely itchy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Controlled hypertension and Hypercholesterolaemia (controlled). Concomitant products included PREDNISONE and HYDROCORTISONE for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced URTICARIA (Several months after receiving the Moderna Covid-19 vaccine 2nd booster the patient developed Urticaria). On an unknown date, the patient experienced RASH (Caller says as soon as she put the Benadryl cream on her husbands rash the rash would disappear and then pop up somewhere else/caller said that her husband's Dermatologist called this a "running rash.") and RASH PRURITIC (Rash was extremely itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash and Itchy rash, at an unspecified dose and frequency. At the time of the report, URTICARIA (Several months after receiving the Moderna Covid-19 vaccine 2nd booster the patient developed Urticaria), RASH (Caller says as soon as she put the Benadryl cream on her husbands rash the rash would disappear and then pop up somewhere else/caller said that her husband's Dermatologist called this a "running rash.") and RASH PRURITIC (Rash was extremely itchy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications also included blood pressure medication, cholesterol medication and medication for prostate. This case was linked to MOD-2022-638947 (Patient Link).
Vaccine was expired, no temperature excursions occurred and Moderna determined the vail "maintained the activity necessary to portect against he SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
FEELING COLD; DIZZINESS; BODY ACHES; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling cold, and dizziness, and had not recovered from body aches, tiredness, and headaches. This report was non-serious.
Early 3rd dose; Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAB (Twinrix adult) (batch number 797f9, expiry date 30-DEC-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix adult) (batch number 327e3, expiry date 14-MAY-2025) for prophylaxis.   Previously administered products included Twinrix adult (1st dose was received in June 2017 with batch number: b9h95 expiration date was unknown).   On 08-AUG-2023, the patient received the 3rd dose of Twinrix adult. On 07-APR-2023, the patient received the 2nd dose of Twinrix adult. On 07-APR-2023, not applicable after receiving Twinrix adult and an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 08-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long were 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: 17-AUG-2023 The pharmacist reported that the patient received 1st dose of Twinrix adult in June 2017, 2nd dose on 7th April 2023 and 3rd dose on 8th August 2023. The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Twinrix adult, earlier than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Headache; Sorearm; Low grade Fever; Coughing; blood when she spits; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Sorearm), PYREXIA (Low grade Fever), COUGH (Coughing) and HAEMOPTYSIS (blood when she spits) in a 28-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Sorearm), PYREXIA (Low grade Fever), COUGH (Coughing) and HAEMOPTYSIS (blood when she spits). At the time of the report, HEADACHE (Headache), MYALGIA (Sorearm), PYREXIA (Low grade Fever), COUGH (Coughing) and HAEMOPTYSIS (blood when she spits) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.  Husband stated that she had headache, sore arm, low grade fever. It lasted for few days. Then she started coughing and when she spits there is blood in spit. This happened after the 1st shot as well. After 1st shot it lasted for few days and then it was fine   This case was linked to MOD-2021-089371 (Patient Link).
Information has been received from a registered nurse concerning a 23-year-old female, with no pertinent medical history, who failed to seroconvert after getting two doses of varicella virus vaccine live (Oka/Merck). On 09-Apr-2002, she was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). On 14-May-2002, the patient received her second dose of varicella virus vaccine live (Oka/Merck). On 14-Mar-2007 her titer was 0.26. Unspecified medical attention was sought. On 03-Apr-2007, the patient received a booster dose of varicella virus vaccine live (Oka/Merck). The patient will have another titer done in June. No product quality complaint was issued. Additional information has been requested.
Information has been received from a medical assistant concerning a 14 year old female who on approximately 05-MAY-2007 was vaccinated with a dose of Gardasil. On approximately 05-MAY-2007 five minutes after vaccination the patient experienced convulsions. Unspecified medical attention was sought. At the time of the report the patient had recovered. Upon internal review, convulsions was considered to be another important medical event. Additional information has been requested.
Initial report was received from a health care professional on 23 February 2011. A six month-old male patient who had received 2 previous doses of PENTACEL on the proper schedule (lot number, route, site and dates of administration not reported), became very sick. The patient was reported to be in severe respiratory distress. He was intubated and hospitalized in the intensive care unit (dates not reported). Laboratory studies were positive for Haemophilus B-Biotype III. Treatments were not reported. The patient had no illness at the time of prior vaccinations and it was unknown if he had any adverse events following the prior vaccinations. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
5 year old patient was given PENTACEL because she was behind with her vaccinations with No adverse event; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 5 years old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] because she was behind with her vaccinations with no adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]).  On 03-Jan-2023, the 5 years old patient received total 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: U7198AA, expiry date: 28-Jan-2023) via intramuscular route in the right arm for Immunization (Immunisation) because she was behind with her vaccinations with no adverse event (product administered to patient of inappropriate age) (latency: same day)   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event 5 year old patient was given pentacel because she was behind with her vaccinations with no adverse 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.
Lymph nodes were swollen I needed steroids.. migraine neck pain. Red swollen face
Full body rash, extreme chills, fever, fatigue, joint pain, loss of some hearing in left ear, headache, muscle cramps, nausea, pain at injection site, difficulty moving injection arm, pain in right side of neck, muscle cramps
Shingles or herpes zoster; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 30-JUN-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On 18-JUL-2012, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for the long-term prevention herpes zoster or shingles. Subsequently, to the patient's Zoster Vaccine Live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles or herpes zoster.  Then, on an unknown date, the patient was hospitalized due to the event. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not linted to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries including but not limited to cost for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. At the reporting time, the outcome of herpes zoster was not provided. The reporter considered the event herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Pt. received second vaccine, complains immediately after heart is racing.  Pt. states she did not eat breakfast. Pt. cleared by EMS to finish observation and then pt. exited facility.
Reporter indicated that pt has become aware of 4 new pts who did not seroconvert;
I gave the pt the shingrix shot-- She came back the enxt day with a raised raise at the site of injection
A nurse reported that a 70 year old male received an injection of Pnu-Imune 23 on 5/23/01. On 5/24/01, he developed an injection site reaction characterized by redness, swelling and heat. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 472209.
Information has been received from a nurse practitioner concerning a 13 year old female who on 23-AUG-2007 was vaccinated at 11:15 am with the third dose of Gardasil. Afterwards, the patient experienced dizziness for a couple minutes. She sat down, had a cup of water and walked to the waiting room. About 5 minutes later, she passed out. She was cold, clammy, and pale. When she finally came to, the patient was watched for about 20 minutes. The patient felt nauseated. She received no other vaccines that day. She had eaten breakfast. When she left the office, she still felt nauseous. No further details were provided.  This is one of 2 reports from the same source (WAES 0708USA04690).  Additional infromation is not expected.
A non-serious spontaneous report of FLUMIST administered to patient with history of egg allergy, rash over body and hives over body has been received from a non-health professional concerning a six-year-old female, subsequent to FLUMIST. The patient's past medical history included egg allergy in 2007 and milk allergy in 2008. The patient was not ill at the time of vaccination. No concomitant medications have been reported for this patient. The patient received FLUMIST on 20-Sep-2011. The patient had previously received FLUMIST in 2009 and 2010. On 21-Sep-2011 at 6:30 PM, the rash and hives began then at 7:00 PM diphenhydramine was administered. On 22-Sep-2011 at 7:00 AM, the rash subsided. The outcome of FLUMIST administered to patient with history of egg allergy, rash and hives was resolved on 22-Sep-2011.
2mm X 3mm papules, especially on trunk. Started with just a few on 10/10/00 and then progressed from there.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 11:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 11:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.20.  Concomitant products were not provided.  On 12-Feb-2021, Excursion time was 10 AM and 11 AM, temperature was 35 and 35 respectively, total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vials was sent to clinic. Vaccine BUD dates was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
R09.02 HYPOXIA 7/19/2022 HEART FAILURE W REDUCED LVEF 31-40%, UNSPECIFIED ACUITY
HEADACHE STARTED 17 HOURS POST VACCINATION TOOK TYLENOL,IBUPROFEN AND FIORCET (IT WENT AWAY 24 HRS LATER).  BODY ACHES STARTED 29 HOURS POST VACCINATION (WENT AWAY  48 HOURS POST VACCINATION) FEVER 100.4 AND CHILLS STARTED 52 HRS POST VACCINATION AND WERE GONE BY 36 HOURS.
Information has been received from a medical assistant concerning a 20 year old female patient with diabetes and hypothyroidism who on 05-AUG-2008 was vaccinated with the first dose of GARDASIL, lot # 660620/0571X, 0.5 mL, intramuscularly; and on 31-OCT-2008 was vaccinated with the second dose of GARDASIL, lot # 661044/054f8X, 0.5 mL, intramuscularly. Concomitant therapy included insulin Novolog and insulin Levemir. It was reported that the patient on 31-OCT-2008 experienced pain and redness at the injection site of the left upper arm after receiving her second dose of HPV vaccine. The pain was increased and the area formed a large, firm lump surrounded by a red ring. The patient had difficulty lifting the left arm. Patient not recovered. She was scheduled for an office evaluation on 28-NOV-2008. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Follow-up information from her physician indicated that the patient was a female student (152 pounds, 67.5 inches) with diabetes, hypothyroidism and celiac disorder who reported redness, swelling and decrease of mobility in arm after being vaccinated. The patient was seen on 29-NOV-2008 with erythema (2 cm thick) at site of injection, mobility within normal limits. Therapy with nonsteroidal anti-inflammatory drug (unspecified) was prescribed. Patient recovered on 19-JAN-2009. Additional information is not expected.
Patient presented for COVID Bivalent Booster.  Vaccine administered by the RN.  Afterwards patient reported feeling left mid sternal discomfort.  Not radiating, no SOB, dizziness or nausea.  Chest discomfort did go away but then returned.  Rating pain as a 3-4. 911 called and patient was taken to Hospital for evaluation.
AN ERROR WAS MADE, PATIENT WAS 11 AT TIME OF VACCINATION, GUARDIAN REPORTED THEY WERE 12, PATIENT RECEIVED MODERNA 1ST DOSE FOR 12 + YEARS AND UP
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: cellulitis-Mild
Acute cerebellar ataxia onset 4SEP90 started w/head twitching,loss of balance, then was unable to walk.  Admit hosp 7Sep90 & D/C 10Sep90, still under treatment.
Rash around the injection site; Soreness of the injection arm; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 26th January 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 27th January 2021, the patient experienced injection site rash. On 27th January 2021, the outcome of the pain in arm was recovered/resolved. On 28th January 2021, the outcome of the injection site rash was recovered/resolved.   The reporter considered the injection site rash and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, the patient received Shingrix vaccine approximately ten days ago. On the dayof vaccination the patient had soreness of the injection arm and the day after the vaccination, had a rash around the injection site. The symptoms have resolved. The reporter consented to follow up. This case was lined with case US2021030895, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021030895:same reporter
loss of taste; Sleepy , slept for 4 hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) and SOMNOLENCE (Sleepy , slept for 4 hours after vaccination) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste) and SOMNOLENCE (Sleepy , slept for 4 hours after vaccination). At the time of the report, AGEUSIA (loss of taste) and SOMNOLENCE (Sleepy , slept for 4 hours after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
I am not sure if this is caused by the vaccine, but I think it is worth to mention that I didn't have my period for a over year (menopause) and since the last vaccine, I've had my period at least 5 times.
DIARRHEA; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) 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 numbers No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.
High fever, 102 deg F. Erythema at site of injection worse on L side.