chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022; patient received Moderna Covid-19 vaccine  31 days after the vaccine was placed in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine  31 days after the vaccine was placed in the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine  31 days after the vaccine was placed in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine  31 days after the vaccine was placed in the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jun-2022 at 10:38 pm and the vaccine was administered on 11-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 11-Jul-2022, the patient received second booster dose.  Date the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM.The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-606336, US-MODERNATX, INC.-MOD-2022-606349, US-MODERNATX, INC.-MOD-2022-606361 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-606336:Same reporter US-MODERNATX, INC.-MOD-2022-606349:Same reporter US-MODERNATX, INC.-MOD-2022-606361:Same reporter
This spontaneous report as received from a nurse via company representative refers to an 8-year-old patient of an unknown gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient was vaccinated with the two doses of GARDASIL 9 (dose, route and site of administration, lot number and expiration date were not reported). No adverse effect was reported.
20 minutes after receiving the 3 vaccines & while leaving the office building, patient told her mom, I don't feel good, turned very pale & fainted, once laying down she was conscious, smiling but very pale, mom said that she didn't eat breakfast.
arm is in great pain well below the injection site; I am feeling very sick; feeling ber; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2020, the patient received the 2nd dose of Shingrix. On 21st May 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, malaise and feeling abnormal. On an unknown date, the outcome of the pain in arm, malaise and feeling abnormal were unknown.   It was unknown if the reporter considered the pain in arm, malaise and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was fine after first dose of Shingrix. On 21st May 2020, the patient received 2nd dose of Shingrix and felt very sick and arm in great pain well below the injection site. The patient asked is this a normal reaction. The reporter did not consent to follow up.
The following day felt a little off mentally. Had a slightly elevated temperature (for me) 98.9  At around 4:30 began to feel very confused and unable to work. Went home and experienced great disorientation, had difficulty with balance - had to hold onto furniture and walls to walk.  It was almost like hallucinations. I was in and out of sleep and had nightmares.  I was not in any condition to make a logical decision to take my temperature, or do anything else for that matter, or call for help.  Did not eat or drink much water.  On 4/9 I woke around 9 am, still felt moderate  disorientation. Elevated temperature - 99.3.  Not until 4 pm did I start to feel almost normal.  Not much appetite, 4/10 Still slight disorientation all day.  No fever.  4/11 slept most of the day on and off.  Right now I feel okay, but not back to normal.  never contacted health care provider nor went to ER. (I did not mention in the medications section that I take insulin: Lantus 1x day, Novolog 3x day, Trulicity 1x week.)
This medically confirmed spontaneous report (initial receipt: 05-Oct-2012) concerns a 59-year-old male patient. On an unknown date the patient received flu vaccine (manufacturer, brand name and batch number were not provided). Concomitantly he also received PNEUMOVAX (batch number: H010515) and Tdap. After vaccinations, the patient developed swelling at the injection site. The event outcome was not reported.
starting COVID-19 treatment. Did you/the patient previously receive a COVID-19 Vaccine?: Yes; starting COVID-19 treatment. Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK5730), on 22Jan2021 as dose 2, single (Lot number: EL3246) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF841) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 30Apr2022, stop date: 05May2022; ESCITALOPRAM, start date: 30Apr2022, stop date: 05May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "starting COVID-19 treatment. Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative at day 9 after symptoms; Positive, notes: Now am testing positive with symptoms on day 15. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Vaccine administered 24 hrs after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up document received contains No New Information
Became very ill after vaccine ( fever, chills , nausea, vomiting) lasted 3 days.   A few weeks later I experienced more aches, skin sensitivity, rash and severe nerve pain.  Dr. diagnosed I have shingles virus on 10/26/22.   This vaccine in conjunction with flu vaccine depleted my immunity which caused shingles virus to surface.   I also just finished a strong antibiotic for UTI infection which could have possibly lowered my Immunity prior to vaccines.   This should be documented and noted as possible side effect.    No,  I didn?t get the Shingrex vaccine.  Was planning to once  All COVID vaccines were complete.    Please reach out to me with any questions.
Initial unsolicited report received from non-healthcare professional on 13-Oct-2015. This case involves a 58-year-old female patient who was vaccinated with an intramuscular dose of ADACEL (batch number- U5278AA, expiry date- 25-Feb-2018 route and site of administration were not reported) on 02-Oct-15. It was reported that patient had scratched her leg on rusty nail on the day of vaccine administration. Patient had medical history of Arthritis, GERD, Hypothyroidism and Sleep Apnea and concomitant medications were not reported. On 06-Oct-15, four days after vaccination, patient had experienced redness, swelling, having difficulty raising arm, weakness of the arm which Physician had considered as cellulitis. Patient required ER/doctor visit. Lab tests included CBC, CRP which were being ordered today (at the time of report). Patient was placed on antibiotics as corrective treatment. Outcome of the event was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: cellulitis. Documents held by sender: none.
shot on Thursday & Friday PM sore throat, swollen glands, joint achiness, throat, chest, asthma, URI & sinusitis; still has some illness; still coughing p/ 2 wks; very tired had ATB for sinus;
muscle damage; nerve damage; This case will be deleted because as per narrative patient got Shingrix vaccine and experienced muscle damage, nerve injury and it was not mentioned after which vaccine dose the patient experienced AE, we will keep 1 valid US2023AMR031879 with blank dose number.
STATES AWOKE NAUSEATED AT MIDNIGHT, NOTED SWELLING TO RIGHT SHOULDER W/ TENDER LYMPH NODES NOTED UNDER RIGHT CLAVICLE.  ENTIRE RIGHT ARM TENDER. NO SWELLING NOTED TO INJECTION SITE.
Immunisation given at clinic on 4/8/2014. Pt seen in office 4/10/14 for complaint of mild pain on palpation and edema, erythema and warmth to (LT) arm start date 4/10/14. (App. 15cm x 12cm) area to upper (LT) arm. Using arm in play. Afebril TX with Ibuprofen and cool compresses PRN.
17 year old patient received 1 dose of Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1 dose of Moderna COVID19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1 dose of Moderna COVID19 vaccine). On 06-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1 dose of Moderna COVID19 vaccine) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "known allergies: Bone" (unspecified if ongoing), notes: known allergies: Bone. Concomitant medication(s) included: MYLAN ATORVASTATIN, start date: 01May2022, stop date: 21Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was yes. Paxlovid, Other medication in 2weeks was yes. Anti Viral details was product: COVID 19 Treatment brand was Pfizer, treatment start date was 21Nov2022, reatment stop date was 25Nov2022 and indication was treatment of COVID-19.   Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
At 11:13 AM, patient reports diziness. Patient denies shortness of breath. No rash; no complaints of itching, burning, or pain. Patient was placed in seated position and given P100 apple juice to drink. Patient swallowed without complication. Color good; no diaphoresis. At 11:30, patient ambulated with steady gait noted. Patient discharged at 11:38 AM.
Pt vax w/ 3 doses Recombivax; antibody response was 3.1.  2 Engerix-B doses given & antibody response was 3.2.  2 addit doses given & antibody response was 6.8.
Pt. given school immis x 4 at 2:25 PM. Mom states child had tightness of chest 15 min post injections. Went to Dr office, observed x 30 min and they gave him epinephrine inj.
Dizziness; disoriented; Burning pain starting from the injection site upto her neck around ears head and all over the face; Brain fog; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), CONFUSIONAL STATE (disoriented), PAIN (Burning pain starting from the injection site upto her neck around ears head and all over the face) and FEELING ABNORMAL (Brain fog) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was reported.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced CONFUSIONAL STATE (disoriented), PAIN (Burning pain starting from the injection site upto her neck around ears head and all over the face) and FEELING ABNORMAL (Brain fog). On 21-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 21-Mar-2021, DIZZINESS (Dizziness) and CONFUSIONAL STATE (disoriented) had resolved. At the time of the report, PAIN (Burning pain starting from the injection site upto her neck around ears head and all over the face) and FEELING ABNORMAL (Brain fog) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.
had a sharp twinge in the upper back muscles/all over the upper back muscles; had a sharp twinge in the upper back muscles/all over the upper back muscles; This is a spontaneous report received from a non-contactable consumer (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 at single dose for COVID-19 immunization. Medical history included neuropathy. Concomitant medications were not provided. Received vaccine the day before and overnight on 09Mar2021, the patient had a sharp twinge in the upper back muscles, it was all over the upper back muscles and then went away. Patient thought that her neuropathy was affected by the vaccine. This report is non-serious. It was unknown if the patient diagnosed with COVID-19 prior vaccination, unknown if the patient had been tested for COVID-19 since the vaccination. No treatment for the events. Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Symptoms-6 hours later- felt chills, did not measure temp and felt some pain at site of Varivax injection. Outer aspect left deltoid. Approximately 12 hours later noted red streak 3/4" by 6" proximal to Varivax injection site and area was tender and warm. Approximately 26 hours later- site observed by shool instructer who recommended client be seen by MD for cellulitis. Approximately 28-29 hours later went to ER and DX with cellulitits and started on Augmentin and Vicodin.
Treatment of COVID-19; Treatment of COVID-19; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "PFO" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Addition information: Start date of treatment for COVID-19 was 02Jul2022. Stop date of treatment for COVID-19 was 06Jul2022. Adverse event: Rebound case a week after testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was about nine days after getting the shot and I came home from getting my radiation treatment. That night I had chills and all my joints were achy, and the next day my hands all broke out in the rash. Saturday I couldn't get warm, and I couldn't eat. Monday I couldn't go in for treatment, and so Tuesday I went to the ER. I had a 100 degree fever. They did some tests. The ER doctor gave me prednisone treatments.
Narrative: Patient received Moderna Vaccine on 3/23/2021. The patient experienced diarrhea approximately 15 minutes after receiving the vaccine. The patient also experienced muscle weakness, dizziness, and flushing. The patient was treated with diphenhydramine and symptoms resolved approximately five days later.
Lost appetite approximately 11 hours after ADACEL injection developed chills, headache, and vomited. Fever of 102.3. Also sore throat.
little bumps-papular vesicular rash all over entire body; occurred p/2nd dose;
Information has been received from a RN concerning a 38 year old female RN with asthma who on 28Mar2003 at 10:45AM was vaccinated SC in the left upper arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 04Apr2003, 7 days later, the pt developed redness at the injection site (left upper arm) and a facial rash. Unspecified medical attention was sought. Follow up information received from a RN indicated that on 04Apr2003 at 10:45AM the pt developed redness and itchiness at the site of the injection. She also developed an elevated area over her body with itchiness, which was on her back, sides, and neck. On 11Apr2003 the pt was evaluated and recovered 2 weeks after breakout. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccinations of the pt or her siblings. No further information is expected.
It feels like have a metallic taste on and off; the sides of my tongue feel ulcerated, but my tongue looks normal; I have also felt fatigued ever since my second shot; I have been having ongoing burning tongue syndrome; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the right arm on 13Jan2021 at 08:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hearing impaired and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), ascorbic acid (VITAMIN C), vitamin d nos (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the left arm on 23Dec2020 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 13Jan2021 at 13:00, since the second shot about 5 hours after, the patient had been having ongoing burning tongue syndrome. It felt like had a metallic taste on and off. Also the sides of the tongue felt ulcerated, but the tongue looked normal. The patient had also felt fatigued ever since she got the second shot. The events resulted in doctor or other healthcare professional office/clinic visit and the patient had seen her primary care physician (PCP), ENT and Periodontist. Therapeutic measures were taken as a result of reported events and included treatment with Nystatin, metronidazole, omeprazole and acyclovir. Since the vaccination, the patient had been tested for COVID-19. On 19Apr2021, the patient underwent lab tests and procedures which included PCR test for COVID-19 (Nasal swab) and tested negative. The clinical outcome of the events ongoing burning tongue syndrome, metallic taste on and off, sides of the tongue feel ulcerated and felt fatigued was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.