chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 31 years old female patient with no known pertinent medical history and no known drug allergies. On 21-JUN-2012, the patient was vaccinated subcutaneously with the first dose of 0.5 ml VARIVAX (Merck) (lot # not reported) on 21-JUN-2012. No concomitant medications were reported. It was reported that the patient was subsequently determined to be pregnant. The last menstrual period (LMP) was approximately on 31-MAY-2012 and the estimated date of delivery (EDD) of approximately 07-MAR-2013. A pre-natal ultrasound on 19-JUL-2012 revealed 7 week gestation. No problems reported. No treatment information was reported. The patient sought for medical attention via an office visit. It was reported that VARIVAX (Merck) was discontinued on 21-JUN-2012. Follow up information has been received from other nurse on 01-FEB-2016, who stated that the patient delivered a male infant. The patient had a vaginal delivery and the baby was normal. Additional information is not expected as no further information is available.
Had ringing in her ears; Has trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Had ringing in her ears) and INSOMNIA (Has trouble sleeping) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced TINNITUS (Had ringing in her ears) and INSOMNIA (Has trouble sleeping). At the time of the report, TINNITUS (Had ringing in her ears) and INSOMNIA (Has trouble sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
vesicles on child's back, abd, behind ears, on both rt & lt eyelids one under rt eye;t100;rx APAP, DPH, aveeno bath, calamine lotion;
dull pain and pressure near my heart/ sore,painful heart muscle; chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (dull pain and pressure near my heart/ sore,painful heart muscle), CHILLS (chills) and ARTHRALGIA (Joint pain) in a 79-year-old male 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 CHEST PAIN (dull pain and pressure near my heart/ sore,painful heart muscle), CHILLS (chills) and ARTHRALGIA (Joint pain). At the time of the report, CHEST PAIN (dull pain and pressure near my heart/ sore,painful heart muscle) and CHILLS (chills) outcome was unknown and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.      Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: significant follow up-Medical History Is updated On 16-Jul-2021: Follow up received contains no new information so consider it as NNI
Headache, Myalgia, NauseaVomiting, FATIGUE, NASAL CONGESTION,
got sick; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demographics) who got sick (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) right after the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
w/in 18-24 hr p/vax several pt devel inj site rxn characterized by a 3-4inch area of warmth, itching & induration;pt given APAP & hydrocortisone cream;reporter unable to specify # of pt who exp this event;addtl reports will be generated;
Guillain-Barre symptoms after injecting Prevnar 13; This is a spontaneous report from a contactable physician via Pfizer sales representative.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation .  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Guillain-Barre symptoms after injecting Prevnar 13 with outcome of unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: There is no plausible mechanism to implicate PREVENAR 13 to the occurrence of the serious event "bloody Guillain-Barre symptoms" due to the information currently available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Fatigue; headache; Aches; Nausea; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills) and the first episode of FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m2ua) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), THYROID, VALACICLOVIR HYDROCHLORIDE (VALTREX) and NALTREXONE for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills), the first episode of FATIGUE (Fatigue) and HEADACHE (headache). In April 2021, the patient experienced the second episode of FATIGUE (Fatigue). In March 2021, PAIN (Aches), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, last episode of FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 (High) Mild fever.         No treatment medications were reported.   This case was linked to MOD21-077286, US-MODERNATX, INC.-MOD-2021-079767 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up was received on 17-MAR-2021. Additional events- chills, headache and pain were added.; Sender's Comments:  MOD21-077286:follow up US-MODERNATX, INC.-MOD-2021-079767:2nd dose
Adverse Event NOS; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse Event NOS) in a 36-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Feb-2021, the patient experienced ADVERSE EVENT (Adverse Event NOS). At the time of the report, ADVERSE EVENT (Adverse Event NOS) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Large red area on arm near injection site that spread around the arm.  Original area was approx 2" x 2" and was initially red, slightly swollen and warmer than rest of the area.  By day two the area spread down and around the arm to about 1/3 the circumference of my arm.  Since starting it is gradually fading but is still visible.  The original itching was stopped by the use of an over the counter itch cream.  Primary doctor thought I should report since he had not seen this in any of his other patients who had shot #2.
This case was reported by a other health professional via call center representative and described the occurrence of fatigue in an unspecified numbers of adult patients who received SHINGRIX(batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Couple of people in our office felt very fatigued and very run down for a day or two" following vaccination with SHINGRIX. This case has been linked with US2018153831, reported via same reporter.
Dermatoma rash along the nerve path; This case was reported by a nurse via call center representative and described the occurrence of rash in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   On 14th January 2020, the patient received Shingrix. In January 2020, 1 week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The patient experienced dermatoma rash along the nerve path after vaccination. The reporter asked how to proceed with 2nd dose and any information on the type of reaction lasting so long. The reporter did not consent to follow up.
Chills, fever of 100.8, headache, throwing up, body aches and stiffening, lethargic, trouble breathing/coughing.
This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received PREVNAR 13 (lot number: S51635, expiration date: 31Oct2018), via an unspecified route of administration at deltoid left on 26Oct2017 14:00 at 0.5 ml, single dose for she was told anyone over 65 should get the pneumonia vaccine and influenza vaccine (manufactured by Sanofi Pasteur, lot number: UI883BA, expiration date: 25May2018), via an unspecified route of administration at deltoid left on 26Oct2017 at 0.5 ml, unknown frequency for it is that time of year when everyone is told to get it. Medical history included ongoing high blood pressure and ongoing gastrooesophageal reflux disease (GERD); both diagnosed a long time ago, maybe 20-30 years. The patient had no family history and relevant tests. Patient was taking other medications. On 27Oct2017, the patient experienced black and blue mark at site then on 30Oct2017, she experienced pain in her armpit and on 31Oct2017, patient noticed redness and is starting to have quite a large rash at the injection site, armpit gland is swollen and she felt a little itch. It was further reported that patient noticed redness and is starting to have quite a large rash at the injection site and her armpit gland is swollen. The patient asked if that could be a delayed reaction or something else. It was reported that the patient got senior flu shot at the same time so it could be the flu shot but the patient thought that the pneumococcal injection was the top one which the site where she was having the reaction. Patient has a black and blue mark at the site then redness started. It was reported that the black and blue mark is persisting and going through the normal progression, turning red then yellow. Patient just noticed the redness and rash about an hour or two ago. She felt pain in her armpit but noticed the swelling in morning. Patient just wanted to know if it was common 4 days later or she just thought any reaction would happen immediately. Outcome of the event felt a little itch was recovered on 31Oct2017 while outcome of other events was not recovered.
My period started two days early on 02Jun (which by itself is not an issue) but I have not stopped bleeding since then and am still passing actual tissue/clots almost daily.; I have not stopped bleeding/ am still passing actual tissue/clots almost daily; This a spontaneous report from consumer (Patient).  A 47-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration on 29May2021  (at the age of 47)(at 11:30 AM), as dose 2, single in left arm for covid-19 immunization at vaccine clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient medical history was not reported and ha d no allergies to medications, food, or other products. Device Date was reported as 15Jun2021. The patient's concomitant medications included lexapro (escitalopram oxalate) and collagen powder(collagen hydrolysate). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) via unspecified route on left arm on 01May2021 01:30 PM for COVID-19 Immunization. On 02Jun2021 (at 12:00PM), patient experienced her period started two days early on 02Jun (which by itself is not an issue) but she has not stopped bleeding since then and still passing actual tissue/clots almost daily. The outcome of the events was not recovered.
pt recv vax 25JUL96 & 31MAR97 pt devel numerous, spreading erythematous lesions predominately on back;there were no vesicles noted & pt was afeb;atypical chickenpox was suspected;
Itchy rash on trunk of body, on back and chest. No fever.  Rash lasted longer than 24 hours.
Allergic reaction 15 minutes after 1st dose; March or April 2021 she received her 1st dose of the Moderna /second dose not yet taken; Headache; Developed rash in front of chest/Developed rash in upper back/Rash in the front and back of her neck reoccurred/Rash in front of chest reoccurred/Rash in upper back reoccurred/Developed a rash in the front and back of her neck; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction 15 minutes after 1st dose), PRODUCT DOSE OMISSION ISSUE (March or April 2021 she received her 1st dose of the Moderna /second dose not yet taken), HEADACHE (Headache) and RASH (Developed rash in front of chest/Developed rash in upper back/Rash in the front and back of her neck reoccurred/Rash in front of chest reoccurred/Rash in upper back reoccurred/Developed a rash in the front and back of her neck) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    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 ALLERGY TO VACCINE (Allergic reaction 15 minutes after 1st dose), PRODUCT DOSE OMISSION ISSUE (March or April 2021 she received her 1st dose of the Moderna /second dose not yet taken), HEADACHE (Headache) and RASH (Developed rash in front of chest/Developed rash in upper back/Rash in the front and back of her neck reoccurred/Rash in front of chest reoccurred/Rash in upper back reoccurred/Developed a rash in the front and back of her neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, ALLERGY TO VACCINE (Allergic reaction 15 minutes after 1st dose), HEADACHE (Headache) and RASH (Developed rash in front of chest/Developed rash in upper back/Rash in the front and back of her neck reoccurred/Rash in front of chest reoccurred/Rash in upper back reoccurred/Developed a rash in the front and back of her neck) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (March or April 2021 she received her 1st dose of the Moderna /second dose not yet taken) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
COVID-19; COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of the first episode of COVID-19 (COVID-19) and the second episode of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.   Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Patient had 5 shots and and all were Moderna.). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced the first episode of COVID-19 (COVID-19). In January 2023, the patient experienced the second episode of COVID-19 (COVID-19). At the time of the report, last episode of COVID-19 (COVID-19) had resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  The patient said that they got COVID in December 2022 and January 2023. The symptoms were mild.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-717679 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717679:Husband case
had the vaccine, came down with shingles/suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In May 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-May-22 Reporter's comment: The case was received from the patient via interactive digital media. The patient self-reported this case. The patient stated that although he/she had the vaccine and came down with shingles last week. It was the most painful experienced he/she had ever endured. The patient reported that they said that when you took the vaccine, the break out was not as bad. The patient stated that if that's the case, the patient was glad to had the vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Faint several minutes after vx; This case was reported by a nurse via sales rep and described the occurrence of fainting in a patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, several minutes after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was recovered/resolved.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.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: 14-APR-2022 Reporter's Comment: The reporter had no further information about the vaccine, demographics of the patients, or the event itself.  The reporter reported that, the patient faint several minutes after receiving Bexsero.  The patient was fine and recovered quickly from the fainting spell.  The reporter consented to follow up. Additional Supportive Information: The case had been linked to US2022065232, reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065232:Same reporter. Pt 1.
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) 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 assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    Concomitant drugs were not reported. It was reported that 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. For the past month, reporter had been giving 0.25 ml instead of 0.5 ml. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Hives, dizziness, runny nose, nausea, swelling of arm (severe), itching. Treated in ER with with Benadryl, Pepcid, and later, steroids.
Left Axia Swelling Narrative: Left axilla swelling developed after corona virus vaccine. vaccine given on 03/13/21, patient seen by PCP on 04/02/21. Rx'd for Medrol dose pak and diphenhydramine PO. Has since resolved. Patient was f/u on 04/06 with PCP. Swelling resolved. No longer on diphenhydramine or Medrol dose pak.