chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Shingles; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (diagnosed with Shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HERPES ZOSTER (diagnosed with Shingles). At the time of the report, HERPES ZOSTER (diagnosed with Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported.    Treatment medication included Acyclovir from 20 Jan2021 to 29 Jan 2021.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
second dose of Shingrix 30 days after her first; pain at the injection site / after receipt of the second dose.; malaise / after receipt of the second dose.; dizziness after receipt of the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 3XR3X, expiry date 12th September 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 19th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, malaise and dizziness. On 19th September 2020, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the injection site pain, malaise, dizziness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site pain, malaise and dizziness to be related to Shingrix.  Additional details were provided as follows:  The patient received second dose of Shingrix 30 days after her first, which lead to shortening of vaccination schedule. The patient experienced malaise, pain at the injection site and dizziness.
Joint pain; injection site Itching; Pain and itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain and itching at injection site), ARTHRALGIA (Joint pain) and INJECTION SITE PRURITUS (injection site Itching) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain and itching at injection site) and INJECTION SITE PRURITUS (injection site Itching). On 26-Mar-2021, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, INJECTION SITE PAIN (Pain and itching at injection site), ARTHRALGIA (Joint pain) and INJECTION SITE PRURITUS (injection site Itching) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.  Action taken with mRNA-1273 in response to the event was unknown
difficulty breathing; difficulty swallowing; swelling of her throat; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of bnt162b2 (Solution for injection, Lot number: EN6204, Expiration date Jun2021), intramuscularly administered in Arm Right on 10Mar2021 08:30 (at the age of 47-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications was not reported. She got the vaccine because her son had a multiple organ transplant. She wanted to get it and be able to get back to work. She wanted to protect herself and her son. The patient experienced difficulty breathing, difficulty swallowing, swelling of her throat on 10Mar2021. Emergency Room visit on 10Mar2021 at 15:00 and The Emergency Department gave her Benadryl and let her go home that same day. Therapeutic measures were taken as a result of difficulty breathing, difficulty swallowing, swelling of her throat. On 10Mar2021, the clinical outcome of the events was resolved.   No follow-up attempts are possible. No further information is expected.
Pt received 2nd dose of Gardasil vaccine on 7/17/12. On 7/21/12 pt had a generalized tonic clonic seizure.
I started having very vivid good dreams the 2nd day after the 2nd shot; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: ABNORMAL DREAMS (non-serious), outcome "unknown", described as "I started having very vivid good dreams the 2nd day after the 2nd shot".  Additional information: It was reported that patient had a weird experience with her 2nd dose of the Pfizer Covid19 primary series. She started having very vivid good dreams, with the 2nd day after the 2nd shot was administered and it lasted approximately 6 weeks and happened almost every night. Caller stated that she did not experience this with the booster doses. She also stated that she don't normally have dreams that she remembered and these dreams were very vivid and specific, but not scary. Nobody she talked to had that side effect but she did not have the headaches. She didn't know, it was approximately six weeks, it was a long time and almost every single night. 6 out of 7 nights every week. She never had dreams that she could remember that specific but nothing was getting her upset and it wasn't scary stuff. Nobody else she talked to had this particular experience. It was also reported that maybe its a coincidence, maybe its connected, she didn't know. The only difference was the shot. She didn't take other medicine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I tested positive for Covid-19 on March 22, 2023 I experienced runny nose, fever of 100.0, sneezing, coughing, exhausted. I was taking Tylenol for my symptoms.
Right arm tingling finger numb, right arm swollen, red, hot to touch from shoulder to elbow. Severe pain with movement in elbow. Feels strained unable to lift any heavy items. Ibuprofen 800 MG taken and ice applied at home.
This spontaneous report was received from an unknown age female patient reporting on herself. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PENUMOVAX23 (dose and lot number were not reported). Concomitant medication was not reported. On an unknown date, after receiving PNEUMOVAX23, the patient experienced extreme diarrhea. The outcome of experiencing extreme diarrhea was unknown. Causality was not reported. Additional information is not expected.
Positive for Covid-19; Received the Moderna Covid 19 vaccine after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Positive for Covid-19) and EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 017F21A, 026L20A and 026L20A) for COVID-19 vaccination.     Patient had no known drug allergies.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry). On an unknown date, the patient experienced COVID-19 (Positive for Covid-19). At the time of the report, COVID-19 (Positive for Covid-19) and EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive for Covid-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported.  Number of doses/vials: 26 doses some were primary doses and some boosters. The vial was stored in the refrigerator on 17-May-2022. The vial did not undergo any temperature excursion. The patient had not reported side effects.  No information on treatment medications was reported.  Company Comment: This is a Spontaneus case concerning  69-year-old patient of an unknown gender with no previous relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date and the patient received the fourth dose of mRNA-1273 for COVID-19 vaccination. Expired product administered was also reported with the same dose. Clinical course with treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This is a Spontaneus case concerning  69-year-old patient of an unknown gender with no previous relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date and the patient received the fourth dose of mRNA-1273 for COVID-19 vaccination. Expired product administered was also reported with the same dose. Clinical course with treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Mother called into office today concerned that pt broke out in widespread chickenpox rash. Pt has chickenpox on her back/face/neck/legs/belly/hands/feet. Started the night of 6/27/06.
9 days post rotavirus received pt. developed bloody - gel like diarrhea. Admitted to hospital for 2 days. Dx: presumed intussusception.
Administered Bexsero instead of Menactra; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 20-APR-2022 Reporter's Comments: The nurse reported that patient came in to clinic saying she needed meningitis vaccine. Nurse administered Bexsero because there was no immunization record indicating patient had ever had any meningitis vaccine. The patient's mother called wanted to know why the school said it was the wrong vaccine, that she should have received the 2nd dose of Menactra. The reporter consented to follow up. Additional Supportive information: The patient received Bexsero instead of Menactra which led to wrong vaccine used.
Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 26-SEP-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint was involved. Additional information is not expected.
No adverse event; Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7647B and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 10-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 01-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On 10-Jul-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 01-JUN-2023 and Dose 2: 10-Jul-2023).    Concomitant medication was not reported.  The route of administration of suspect Moderna bivalent dose 1 and 2 was reported. No adverse effects were noted.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Rcvd flu vaccine 10/13/16. Continued w/discomfort on 10/22/16. No redness, no swelling, full ROM (R) arm. Seen 10/25/16 by PA, for continued pain. Taking NSAID. Seen 11/1/16 with some improvement-continue NSAID and ROM.
This case was reported by a physician via call center representative and described the occurrence of anaphylactic reaction in a 16-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Influenza vaccine (yearly without difficulty or reaction). Concurrent medical conditions included multiple allergies (has number of basic allergies) and egg allergy (unknown reaction). On an unknown date, the patient received the 1st dose of FLULAVAL QUADRIVALENT. On an unknown date, 1 day after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), tonsillar hypertrophy, difficulty breathing, throat swelling and documented hypersensitivity to administered product. On an unknown date, the outcome of the anaphylactic reaction, tonsillar hypertrophy, difficulty breathing and throat swelling were recovering/resolving and the outcome of the documented hypersensitivity to administered product was unknown. The reporter considered the anaphylactic reaction, tonsillar hypertrophy, difficulty breathing and throat swelling to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient's concomitant medication was unknown. The physician reported that day after vaccination the patient was picked up from the school and reported to have difficulty breathing, swollen throat and tonsils. The patient was going to be taken to be seen, however it was reported back to the physician that the patient was doing better and treatment was not required. The physician did not see the patient. The physician noted that she did not plan to use FLULAVAL for this patient in the future. It was noted to the account manager that the physician was going to file a report, but the representative was unaware if that was to GSK or VAERS.
This spontaneous report was received from a nurse refers to a 24 year old no pregnant female patient without any pertinent medical history or drug reactions/allergies. The vaccination history was unknown. On 08-APR-2015, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, subcutaneously, (strength, frequency and anatomical location were not reported), (lot # K014833, expiration date: 14-SEP-2016). Other suspect therapies were not reported. There was not concomitant therapy. On approximately 25-APR-2015, the patient experienced rash, which began on her fingers and spread to the inside of her elbows, hips bilaterally and the front and back of her knees bilaterally. The patient sought medical attention on 28-APR-2015 through office visit. No treatment was given for the adverse event and no lab diagnostics studies were performed. The outcome of rash was reported as not recovered/not resolved. The relatedness between rash and therapy with M-M-R II was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Vaccine was expired on 22-SEP-2021 and patient administered on 29-DEC-2021; Vaccine administered to 44th patient of 45 patient past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 44th patient of 45 patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccine was expired on 22-SEP-2021 and patient administered on 29-DEC-2021) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 44th patient of 45 patient past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 22-SEP-2021 and patient administered on 29-DEC-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 44th patient of 45 patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccine was expired on 22-SEP-2021 and patient administered on 29-DEC-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date.  Date the vial was stored in standard freezer 31-Mar-2021 (2 degrees F high    -1 degrees F low). The BUD reported as on 22 S ep 2021.     No treatment information was reported.  This case is of 44th of 45 patients.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 ( lot #L019836, expiration date 24-MAR-2017 (dose and route of administration were not reported). The reporter was unable to confirm if the expired doses were administered after their expiration date. There was no adverse effect reported. There was no adverse effect reported. Administered doses of PNEUMOVAX 23 from 32 to 35 degrees Fahrenheit for 8 hours and form 47 to 77 degrees Fahrenheit for 8 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001092: US-009507513-1707USA001093: US-009507513-1706USA010602:
Patient had some expected side effects the day of the vaccine which included weakness, headache, body aches.  At 24  hours post vaccination, patient been to feel worse and passed out. She woke up on the floor and had hit her head.  She felt weak and dizzy and stayed in bed until 8 PM that night.
A skin issue; This case was reported by a consumer via call center representative and described the occurrence of skin disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin disorder. The patient was treated with antibiotics nos (Anti-Biotic (Drug Name Unknown)). On an unknown date, the outcome of the skin disorder was not recovered/not resolved.   It was unknown if the reporter considered the skin disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  Patient received the dose of Shingrix and experienced skin issue. The reporter stated that, he/she was due for the 2nd dose of Shingrix. The patient took anitbiotics for the skin disorder.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
35 minutes after vaccination a rash appeared on forehead and inner forearm.   Took 12.5mg of Benadryl.  Rash resolved 15 minutes post administration of Benadryl.  No further symptoms reported.