chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 08-Sep-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation). At the time of the report, INFLAMMATION (Inflammation) outcome was unknown.     Patient had lot of inflammation and pain with COVID first dose and not as much inflammation with the second shot Booster made patient to stay in bed. But about five days after taking Rinvoq, started to feel little better with her joint pain.  No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624992, MOD-2021-624996 (Patient Link).
the second dose of the vaccine 14 days after the first dose; A spontaneous report was received from a pharmacist regarding a male patient of unreported age that received Moderna's COVID-19 vaccine (mRNA-1273)  that received the second dose 14 days after the first/inappropriate schedule of vaccine administered.    The patient's medical history was not included.  Products known to have been used by the patient were not provided.  On 28 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 11 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   The second dose was scheduled and given 14 days after the first dose.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, the second dose being administered 14 days after the first dose, was considered resolved on 11 Feb 2021.   The outcome of the events, the second dose being administered 14 days after the first dose, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported. Patient received second dose 14 days after the first dose.
I now have ''Occipital'' Neuralgia because of your stupid vaccine; It feels horrible that I am going through; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 21Sep2021 (Lot number: FC3184) at the age of 38 years as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: FD8448), for Covid-19 immunization. The following information was reported: OCCIPITAL NEURALGIA (hospitalization) with onset Sep2021, outcome "unknown", described as "I now have ''Occipital'' Neuralgia because of your stupid vaccine"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "It feels horrible that I am going through". The event "i now have ''occipital'' neuralgia because of your stupid vaccine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: I had a lot of lab work done; computerised tomogram: unknown results, notes: I have had 4 CT Scans; magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of occipital neuralgia. Consumer stated, "I have had so many medicines pumped into me when I was in the hospital. I had 9 different meds (Further clarifications unknown). Now I am on Gabapentin, Baclofen and Imitrex at home".   Follow-up attempts are completed. No further information is expected.
Symptoms after 1st shot 12/23/2020- Severe chills, severe fatigue, headache - resolved after 24 hours.  Symptoms after 2nd shot01/19/2021 - slight fatigue recovered after 24 hours.  4 days after 2nd shot - Developed cold sore on lower lip area. To my recollection, I have never had a cold sore before which is a bit concerning. I understand that I may contracted HSV-1 and not have know it as child. I am curious if somehow the COVID vaccine somehow compromised immune system to a degree that the HSV-1 is now active? May very well not classify as an "adverse event," but since I haven't heard of any such issues I thought I should report.
21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 17-FEB-2022 10:00 am The vial did not undergo any temperature excursion. No concomitant medication were provided No treatment details were provided  Upon follow up reporter stated analysis of the vials associated with storage excursion is completed.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up information was received on 11/Apr/2022: reporters comment added.
just following vaccination pt developed a swelling under the skin, not itchy or painful and no other symptoms.   applied ice for 15 minutes and started to subside
Febrile seizure reported by Medical Center ER 18 hours after DTAP/PREVNAR/FLUZONE given
Fever, body aches, headache. Started at 12:30 p.m. on 5/12/21 and lasted 6 hours
t101 28AUG95-10 days p/vax; 11th day p/vax rash appeared-(dx viral exanthem) dx measles post vax
Started out with mild muscle pain with certain movement. Effects ability to drive and work. Saw Dr on 3/16/2021 Steroid cream, tylenol, and Xrays done. Informed that they might need to do an MRI. At this time she does not feel like it is getting any better. Sometimes hurts more than other times depending on activity, feels heavy and week. Can feel it poping and grinding with movement.
DIFFICULTY BREATHING; DIFFICULTY IN SPEAKING; FEELS  AWFUL; FEELING HOT; FEELING COLD; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered 1 total on 06-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced difficulty breathing. On 06-APR-2021, the subject experienced difficulty in speaking. On 06-APR-2021, the subject experienced feels awful. On 06-APR-2021, the subject experienced feeling hot. On 06-APR-2021, the subject experienced feeling cold. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feeling cold, muscle aches, feels awful, difficulty breathing, feeling hot and difficulty in speaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non-serious.
Info has been received from a health professional concerning an approximately 5 year old pt, "who was entering kindergarten", who on 5/18/05 was vaccinated with a dose of varicella virus vaccine live. In approximately May 2005, the pt experienced breakthrough chickenpox described as mild with less than 50 lesions. It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. The pt's sibling experienced breakthrough chickenpox following vaccination with varicella virus vaccine live. Additional info has been requested.
A non-serious spontaneous report of accidental exposure, cough, chills, headache, fatigue, and nausea has been received from a consumer concerning herself, a 33-year-old female, involving H1N1. The patient's past medical history and concomitant medications were not reported. The patient was exposed to H1N1 on 22-Oct-2009. The patient did not receive the vaccine. On 22-Oct-2009, the patient's daughter was administered H1N1. The patient was holding her, and as the syringe was pulled from her daughter's nose, her daughter took a deep breath and blew it into the patient's face. The next day, 23-Oct-2009, the patient experienced a cough. That evening, the patient was "very ill" with chills, headache, fatigue, and nausea. The event of headache was resolved on 10/24/2009. The outcome for the other events was not reported. The patient indicated she did not receive the vaccine "but thinks the virus was transmitted from her daughter's vaccination".
sharp stabbing pain on the left side of my chest with deep breaths; This spontaneous case was reported by a consumer and describes the occurrence of PAINFUL RESPIRATION (sharp stabbing pain on the left side of my chest with deep breaths) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were 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 PAINFUL RESPIRATION (sharp stabbing pain on the left side of my chest with deep breaths). At the time of the report, PAINFUL RESPIRATION (sharp stabbing pain on the left side of my chest with deep breaths) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not reported. No lab data has been provided by the reporter.
This spontaneous report was received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. The medical history, concurrent condition and concomitant medications were not reported. On 26-MAY-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # K005078, 01-APR-2016 intramuscular. No adverse effect was reported. Additional information has been requested.
about 1 hour after shot i started getting bad stomach pain in the upper stomach  and all over stomach and intestine cramps and 3 days later i still have them. also still have lots of nausea. body aches all over. swelling ankles more on right side, headache, fell sick all over.  no treatment just staying in bed.
This case was reported by a pharmacist via call center representative and described the occurrence of welts in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated multiple patients have reported large round welts after receiving SHINGRIX vaccine. The reporter did not have vaccine or patients information during the call and requested to be contacted at a later time when she was able to provide all the details about the patient, patient's experience and vaccine details.
Temperature per patient 99.2 - patient took Tylenol. Weakness - no treatment done.
pt reported feeling light headed and nausea bp: 81/41 upon initiation, p: 57, o2 100% took zofran 4mg
Package insert states .85 diluent in vial and to draw up .6 to reconstitute. All the diluent was drawn up for reconstitution. Manufacture notified of administration error and recommended to repeat dose.  From 2017 to present there have been 9946 doses administered in the local health units. At the present time Department of Health is working on notifying all children under the age of 5 years that received a dose with the full amount of diluent for revaccination.   The error was identified by the Immunization Nurse as she was updating policy. No adverse events have been identified.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included a severe reaction to IVP dye once and had difficulty breathing. She also had contact dermatitis and her dermatologist said she may be "allergic to something in the air". The patient's concomitant medications were not reported. The patient previously took TYLENOL. The patient stated that shortly after the vaccine, on an unspecified date, she had a rash, swelling, and pain at the site of injection. She added that 2-3 days later, "broke out in hives" on her hip, leg, toes, arms, wrist and shoulder. She had also taken TYLENOL so she was not sure if it could have been caused by that, although she has taken TYLENOL in the past with no issues. The outcome of the events was unknown. Information on the batch number has been requested.
Breakthrough COVID / History of COVID in August 2021 72-year-old female with PMH of diabetes, HTN, hypothyroidism and COVID-19. recently admitted to the hospital on Septr 30, 2021 due to constipation and  found to have  cholecystitis vs common bile duct obstruction, severe gallbladder dyskinesia and renal dysfunction. She was evaluated by general surgery and gastroenterologist. Gen Surg recommended elective cholecystectomy. she returned to the hospital due to generalized weakness, cold extremities and inability to urinate. VS includes tachycardia 120s, tachypnea RR 37, hypertension, fever 102.  Her WBC was 7.54, hemoglobin 10.7, 24% bands, platelet 111,000, creatinine 1.8, increased from 1.3 2 months ago, alk-phos 1
SWOLLEN, RED, HOT SPOT.  TREATMENT, ICE, AND ADVIL
Systemic: Body Aches Generalized-Mild, Systemic: Headache-Medium, Systemic: Hypotension-Medium
W/in 24 hrs p/receiving immun mom tc PHN reporting child refusing to eat-sore mouth; On  HV swollen red gums noted; Also low grade fever;
About eight days after shot, myself and friend got shot one day apart but both  of us developed an intense itching and redness and rash about three inches  around.  Still present  as of nine days total but not as itchy.
Client  presented to  vaccination site. Client received Pfizer Booster Lot#FF8841. Client was sitting in observation area and kept putting her head down into her hands. RN asked her if she was feeling ok. Client stated she was fine. When client?s son came in.  RN asked son, if mother was feeling ok. Son, asked her mother, and stated her mother was feeling dizzy. RN asked client if she had food and water and client stated she had. Client was offered water and client had a few sips. Vitals were taken 1343 BP 156/79 HR 90 02 99%. Client kept touching her chest and said she felt mild palpitations and stated she had trouble breathing. Client denied chest pain. Client was AA0X3. Son, stated mother has a history of high blood pressure and asthma. Client stated she takes all her meds for conditions. EMS were called to scene at 1349 by RN. RN asked Client how she was feeling and responded, she was better and she just wanted to ?go home and rest?. Vitals at 1347 BP 145/78 HR 81 02 99%. EMS arrived at 1349. At 1352 Client declined any services and stated she didn?t want to go to the hospital. EMS left scene at 1353.When EMS left scene Client insisted on going home and declined to stay any longer. She stated she was feeling ?better?.. Client was able to stand up with and transfer to wheelchair with no trouble. Son, was recommended by  RN to seek emergency care if symptoms worsened. Son, verbalized understanding.  Client left vaccination site via wheelchair with son.
I woke up before normal time to go to the bathroom at about 5:00AM. Part of the way through urination, I started experiencing dizziness, which didn't feel abnormal for having got out of bed/upright quickly. By the end of urination, the dizziness had come to an uncomfortable level, and faintness began to set in. I leaned on the sink to hold my body up, before trying to return to bed. I blacked out (probably very briefly) and resumed consciousness when my face hit the bathroom  door as I fell. I was almost immediately fully aware of my surroundings and what had happened after I resumed consciousness. Although I felt no further symptoms, I remained on the floor on my back for 3-5 mins before getting up and back to bed. Other than soreness at the injection site, which is gone this morning (May 15), no additional symptoms returned.
Pt recvd 3 doses of Hep B vax & 1st & 2nd dose 9MAY90 & 7JUN90 & 3rd dose Engerix-B 8NOV90 & it was determined that pt was a non-responder; 4th dose of Engerix-B was administered 13JUN91;
I got extremely sick; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient with unknown demography who got extremely sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication 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 expiration date were not reported) via unknown route at an unknown administration site.  On an unknown date, the patient got (severe) extremely sick (illness), unknown latency following the administration of INFLUENZA VACCINE.   Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome was unknown at the time of reporting.  There will be no information on the batch number for this case.
Two patients / completed / series / younger than / preferred age; Series was repeated / received / four doses; Two patients / completed / series / younger than / preferred age; Series was repeated / received / four doses; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration 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, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and 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 the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 3rd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 4th dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, extra dose administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, extra dose administered, inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The physician stated that, the patients who completed the series at a different practice were younger than the centers for disease control and prevention preferred age range of 16-18, which led to inappropriate age at vaccine administered. And the series was repeated to ensure maximum protection during peak risk ages, which led to extra dose administered. The patients received a total of four doses. The reporter consented to follow up. The physician did not have additional patient details at the time of reporting, but she does provide permission for safety to follow up via email if additional details were needed. This is 2 of the 2 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021171388:Same reporter. Pt 1 of 2.
Hives; A spontaneous report was received from a nurse concerning a 40 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed hives.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 ([LOT # 026L208) on 23 Dec 2020.  On 23 Dec 2020, unknown amount of time from the time of vaccination prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT # 026L208) intramuscularly (injection site not provided) prophylaxis of COVID-19 infection.   The nurse reported after receiving the mRNA-1273 vaccine the patient developed hives which started at the injection site.   Treatment for the event included diphenhydramine 25 mg orally. The nurse reported the hives disappeared after taking the diphenhydramine. The nurse reported at 23 hours post vaccination, the hives reappeared all over the patient's body.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event was unknown.; Reporter's Comments: This case concerns 40-year-old female patient, who experienced a non-serious unexpected event of urticaria, which started at injection site.  The event occurred at the same day of the first dose of mRNA-1273 vaccine. Treatment included diphenhydramine orally and the event resolved, however reappeared again The event was assessed as related to mRNA-1273 vaccine due to temporal association.
nonstop crying 15FEB94 @ 1500; 16FEB94 @ 1300 APAP given;
syncopal episode, elevated HR, tingling in fingers, daughter states he's "afraid of needles," EMS evaluated, patient refused transport.
Pt devel GBS p/receiving flu vax; pt was hospitalized on 16NOV91 & recvd plasma replacement therapy;