chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of rash in a 67-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was the physician stated that one of her friends (patient) received the SHINGRIX vaccine and reported a rash at a remote location that was still cropping up at the time of reporting.
Patient called 10/29/21 and said she started itching on 10/28/21 and that she had a knot on arm by left breast and was red.  This was not at injection site.
patient received the vaccine and was not of age yet.  No know adverse reaction, will be reaching out to physician to notify.
Received the QUADRACEL in (L) arm 12:20pm. Mom noticed redness from his shoulder to his elbow. On 9/26/18 mom noticed severe swelling from shoulder to elbow - his lightweight cotton short sleeve is tight on that arm. Area is hot, hard, painful.
he is 5 years old; Having little chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 10Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 10Nov2021, outcome "unknown", described as "he is 5 years old"; CHILLS (non-serious) with onset 10Nov2021, outcome "unknown", described as "Having little chills".  Additional Information: my son is having little chills and he is sleeping.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: COVID infection following COVID vaccine series 02/26, MODERNA, dose#1 03/26, MODERNA, dose #2 08/27 COVID swab, result: detected 08/27 SARS-COV-2 Variant Sequencing RESULT: pending 08/25 pt cc: fatigue, headache, myalgias, rhinorrhea exposure: unknown
We followed protocol: check website, had pt complete pre-vaccination checklist and reviewed chart. There was nothing in his chart to suggest he had received vaccine. After administration of vaccine, MA gave pt his white vaccine card. pt told MA, "I have one of those white cards at home."  Patient received dose #1 at OUR FACILITY on 4/15/2021. HOWEVER, there was no documentation in website , patient's chart, and patient WROTE "no" to all of our prevaccination questions.  We informed pt and called him afterwards.
Began with itching immediately upon infection. Later, the area surrounding the injection site was reddened and swollen. The injection site itself seemed to be bruised
The resident resides in an independent living facility/apartment. The reporter at the center was informed by his daughter he was not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020 and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the reporter indicates his daughter reports his test was positive.
I don't think this is significant, but my husband encouraged me to report it anyway.   Slight headache started evening of March 25 p.m., took 2 aspirin and was fine after.  Felt O.K. next morning, March 26, but tired.  Went to gym as normal, did a light workout.  Came home, didn't do much.  Hands felt cold - not normal for me.  Went out to dinner around 4:30 p.m., came home around 6:00 p.m. and was tired and freezing,  Laid down for a while with two blankets, slept a little.  Got up, took my temperature - 100.3.  Took 2 aspirin and went to bed.   Today, March 27, got up around 9:00 a.m., feeling normal!  Temperature is 98.6.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2020, couple of hours after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient had her first shot in February or March. She developed a sore arm several hours later but it resolved in a day or so. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020160502.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160502:same patient
Approx 40 minutes after injection became excessively tired. Brought back to office for MD assessment. Vital signs - WNL - kept in office to observe for 1 hour.
No adverse event; Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658075. This case was linked to MOD-2022-658197 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658075:patient 2( dose 2)
Post vax, the patient developed a fever, rash, and a large, painful cold/cankor sore on her chin. Additional information has been requested.
On day after vaccine I experienced fatigue, nausea, headache, and myalgia.  On the 9th day after Vaccine.  I was taken by ambulance, evaluated in ER and admitted for four days.
Localized reaction to Pneumovax placed 1/24/06. Pt seen 1/27/06. Erythema upper L arm. No weeping, tenderness. Swelling. Rx'd Medrol dosepack Benadryl. 1 week followup.
Per ER record, LLE extremely red and swollen from hip to knee RLE also swollen and red but not as much as LLE. Also has rash all over the body. Pt was given Tylenol, Benadryl and Prednisone in ER.
Fever 100.4 F/ Fatigue/ Headache/Body ache/ Chills.
Something getting his eyes red; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for himself. An male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that patient took both doses of Covid vaccine and first dose did not do any good for him, something getting his eyes red. Patient administered a lot of eye drops and further Inquiring if he could get a booster shot. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
After vaccination, patient started to experience trouble breathing within 2 and a half minutes. I injected the patient with 1 Epipen and patient started feeling better. Emergency services soon came and brought her away. At that time patient was alert and had no difficulty breathing.
couldn't eat; Vomited; Very weak/felt so weak; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (couldn't eat), ASTHENIA (Very weak/felt so weak), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder NOS (two autoimmune diseases, one in eye). Concomitant products included METHOTREXATE for an unknown indication.   On 15-Feb-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. On 16-Feb-2021, the patient experienced ASTHENIA (Very weak/felt so weak), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 21-Feb-2021, the patient experienced DECREASED APPETITE (couldn't eat) and VOMITING (Vomited). On 17-Feb-2021, HEADACHE (Headache) had resolved. On 21-Feb-2021, VOMITING (Vomited) had resolved. At the time of the report, DECREASED APPETITE (couldn't eat), ASTHENIA (Very weak/felt so weak), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received on 29-jun-2021 contains email address updated
AFter the injection of the second dose, patient complained of headache, heavy feeling, and hypotensive. Was sent to treatment room for fluids. Then presented to ER with same symptoms at 3 AM. Admitted to observation for telemetry and hydration.
First / dose in 2020 but never received / second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Pharmacist did not have any further details such as the patient's initials or date of birth. The reporter consented to follow up.
Pt reported feeling very achy; very tired; "feverish" and "horrible headache" evening and night of 7/22/14. On 7/23/14 AM pt had temp of 101.6 oral upon awakening. Slept most of day. In office 7/24/14 for PPD read. Pt reports feeling back to normal, but says had low grade temp, and neck and lower back soreness up until bedtime 7/23/14.
3 days p/vax pt reported that devel an inj site rxn characterized by redness, swelling, & tenderness;also reported devel gen body aches & joint pain;
99.7 degrees - 99.9 degrees fever, normal temps 97. Neck pain, general achiness and tingling both hands. Notified LPH 2 days post vaccine. Saw MD 1-13-06 fever remained at 99.7. Used Tylenol and Motrin to ease symptoms did not get total relief. Achiness in neck persistent until 1-18-06.
On 09-10-15 broke out with a burning red rash. 3 spots on each side and back. On 09-11-15 broke out with a itching, burning red spots from shoulders to between my toes this lasted 8 days.
I had hives/rash around 4 days after my second dose; starting with my stomach, then spreading to my arms and then to my legs. Inflammation all over my body over the course of a week. They are now no longer inflamed or red but seeming to form scars, especially around the calf and ankle areas.
Heart palpitations began within the hour and have lasted all evening (about 9 hours so far). Have not sought medical attention.
Localized redness about 6cm below site of injection. Likely mild allergic reaction to a product within either the MMR, Considered infection/cellulitis, but I think it is less likely at this time given location away from injection site. -advised continued use of Ibuprofen and tylenol. Advised to take Benadryl or Zyrtec. - return precautions given for worsening symptoms, to which patient gave understanding and agreement.
Symptoms at site of yellow fever vaccine inj. Seen in our office 1/17/12 for vaccines for trip. Returned for other vaccines on 1/25/12. At that time noted redness & swelling & warmth at yellow fever injection site. Referred to PCP. On 2/16/12 returned for further immunizations. Stated PCP had treated him for cellulitis. No redness/swelling/warmth currently.
Pt presented in v-fib arrest.  V fib arrest thought to be secondary to hyperkalemia from DKA.  Pt w hx of pre-diabetes w hub A1c 6 for years ( not on meds) but came in w blood sugar 1386.  C-peptide levels checked and undetectable.  Anti-GAD-65 Ab came back positive
Pt fainted, possibly because of mother's hold on the child and because child was holding her breath. Resolved after 5 minutes.
Shot at 9 Left facility at 9:15  Around noon had a headache and was extremely nauseous-took 2 Advil Woke up at 3pm with enlarged lips and tongue on the right side.  Had bitten my tongue while asleep and was bloodied/bruised.  Called PCP, said if I could breath call 911 Took temperature, No fever Had some Pepto and Soda, continue To feel weak, with nausea and Swollen lips, but I can breathe and my headache went away.
1.  Stroke in the Cerebellum 2.  Transverse Myelitis at the top of my spine
no adverse event; expired drug administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 29-JUL-2020, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) lot # S007769, 0.5 milliliter for prophylaxis (route and site of administration were not reported), which had expired on 24-JUL-2020 (expired product administered).   The product had never had a temperature excursion.  There were no adverse events reported.  There was not any PQC reported.  The product was supported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007769; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a health professional concerning a female who was vaccinated intramuscularly with the first dose of GARDASIL. Per the reporter the patient experienced flu-like symptoms for 10 days. The patient sought unspecified medical attention. Subsequently, the patient recovered from their flu-like symptoms. No additional information was reported. Additional information has been requested.
itchy; tiny little bumps on different areas of my body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (itchy) and RASH (tiny little bumps on different areas of my body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy) and RASH (tiny little bumps on different areas of my body). At the time of the report, PRURITUS (itchy) and RASH (tiny little bumps on different areas of my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
and the results came back negative; This is a spontaneous report from a non-contactable consumer. A non-contactable consumer (patient):A female patient of an unspecified age received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH)dose 2 via an unspecified route of administration on 11Feb2021 as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported.The patient's concomitant medications were not reported. You may not have ever had COVID-19. Talk with your healthcare provider about your test result and the type of test you took to understand what your result means. Some people may take even longer to develop antibodies,and some people who are infected may not ever develop antibodies."and The patient experienced and the results came back negative on an unspecified date with outcome of unknown.
Information has been received from a registered nurse concerning a 7-year-old male with attention deficit/hyperactivity disorder, allergy to milk protein and fluconazole (DIFLUCAN) who on 08-MAR-2000 was vaccinated with an inflammatory dose of Varivax (Lot number possibly "14640" but not the nurse was not sure because the "o" was unclear). On 04-DEC-2006, the patient experienced breakthrough chicken pox; he had less than 50 lesions. Medical attention was sought and he was treated with acyclovir 400 mg once a day for five days. No laboratory or diagnostic tests were performed. The outcome was recovering at the time of the laboratory or diagnostic tests were performed. The outcome was recovering at the time of the report. No further information to report. There was no product quality complaint involved. No additional information is expected.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 18-Oct-2021, the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2022-491837 (Patient Link).
11:15 AM patient received 3 vaccines (TDAP, MCV, HPV). After receiving MCV vaccine I noticed his head was down. When I turned around pt. was leaning forward. I caught pt. and had pt. lay down. Soon after he started shaking. I carried him to the trauma room.
Initial and follow-up information has been received from a registered nurse and a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with a history of urinary tract infections, kidney infections, a previous pregnancy with an elective abortion, and an "abnormal pap with cryo" in December 2006, who on 14-NOV-2007 was vaccinated with her first dose of GARDASIL.  On 21-JAN-2008, the patient was vaccinated with her second dose of GARDASIL.  There was no concomitant medication.  Subsequently, the patient became pregnant.  No adverse symptoms were reported.  The registered nurse stated that the patient was 12 weeks pregnant as of 18-Mar-2008.  On an unspecified date, the patient took a urine pregnancy test which was positive.  The date of last menstrual period was 23-DEC-2007 and the estimated delivery date was 28-SEP-2008.  On 19-MAR-2008, the patient had a pelvic ultrasound with the normal result.  On 25-MAR-2008 the patient had a maternal serum alpha-fetoprotein test for first trimester screening which was negative.  On 26-APR-2008, the patient had an ultrasound for "anatomy" with "Echogenic Fetal Kidneys", results not provided.  The dose of GARDASIL were administered at another site while the patient attended college.  The patient sought unspecified medical attention in the office.  On 10-OCT-2008, the nurse practitioner reported that the patient had her baby at the end of September or beginning of October.  She did not have the patient's chart available at the moment so she wasn't sure of the exact date.  She also reported that "nothing ever came of that" about the echogenic fetal kidneys that were seen during the 18 week 1 day anatomy scan on 26-APR-2008.  The patient had undergone some genetic counseling/testing but everything was normal with the baby.  There were no congenital anomalies and the baby was healthy when it was born.  Follow-up information has been received from a completed questionnaire from a Certified Registered Nurse Practitioner.  Other medication used during pregnancy includes metronidazole (manufacturer unknown) for bacterial vaginitis on 11-APR-2008, COLACE for constipation on 11-APR-2008, and nifedipine (manufacturer unknown) for pre-term labor at 31 weeks on 31-JUL-2008.  On 06-MAY-2008, ultrasound follow-up, for echogenic fetal kidney - anatomy screen resulted cero problems.  A serum alpha fetoprotein test was performed resulting within normal limits.  There were no complications during labor/delivery.  On 26-SEP-2008, she delivered a normal and healthy male, 40 weeks from last menstrual period (previously reported as at the end of September or beginning of October).  There were no congenital anomalies.  Additional information is not available.
PT NOTICED REDDENED AREA AROUND INJECTION SITE APPROX 30 HOURS AFTER INJECTION.  SHE CIRCLED RED AREA.  THE NEXT MORNING, THE SITE HAD MORE THAN DOUBLED IN SIZE, FELT HARD AND WARM TO TOUCH.  PT WAS LOOKED AT BY ONE OF THE PROVIDERS IN THE OFFICE (PT IS EMPLOYED AT PEDIATRIC OFFICE).  MAY BEGIN ANTIBIOTICS FOR POSSIBLE CELLULITIS
One morning, I noticed I had very hard skin on my neck. A couple of days later, my whole body was darker than normal. It looked like I had a suntan. I went to my PCP. She said I should see a Rheumatologist. I also have Raynaud's disease. My fingers turn white when I get cold. I've had Raynaud's disease for over ten years.
Localized reaction after MMR vaccine 4/12/04 area on left upper arm area with raised macular papular hives. No drainage noted. Employee complains of itching.