chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a pharmacist (patient herself) on 29-Aug-2017. This case is linked to case Id 2017SA165455 (Same patient). This case involves a 59-year-old female patient, who was vaccinated with second dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, route not reported) on fall 2016. Patient's medical history and concomitant medication was not reported. Patient's previous medication includes vaccination with first dose of FLUZONE (batch number, expiry date, dose, route not reported) on an unknown date which had been stored incorrectly. On an unknown date of 2016, after the vaccination, patient experienced idiopathic thrombocytopenic purpura (ITP). Lab test was not reported. Patient was treated with corrective treatment (unspecified). On Oct-2016, patient got recovered from the event. Upon internal review the case was considered as serious because of all important medical event: idiopathic thrombocytopenic purpura (ITP). Documents held by sender: none. Sender's Comments: Patient vaccinated with FLUZONE QUADRIVALENT and HEPATITIS B VACCINE. Patient was diagnosed with Immune thrombocytopenia which is unlisted following FLUZONE QUADRIVALENT. Time to onset is compatible with vaccine. Immune thrombocytopenia can cause by autoimmune disease, antibody against platelet, any viral infection which could be triggering factor and sometime it is idiopathic. Patient medical history, medication history and any congenital disorder like antiphospholipid syndrome, von Willebrand factor or any recent viral infection is unknown and, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
77 Y male with COPD, rhabdomyolysis, DM, atrial fibrillation, and COVID PNA. Admitted on 9/24/2021 for worsening oxygen requirements secondary to COVID PNA in the setting of 2x vaccination Pfizer.    PLAN #Neuro: Patient without out acute neurological concerns. Atrial fibrillation active and risk for cardiogenic emboli though no acute concerns. Patient with anxiety and poor sleep since starting higher doses of steroids.  - Sedation: No sedation - Pain: No pain at time of transfer. - Continue PRN, Lidocaine Patch for the right lower rib pain.  - Tylenol 650 PRN.  - Continue: Trazadone 75mg q Nightly    #CV: new onset atrial fibrillation at time of admission hemodynamically stable with paroxsymal runs of rapid ventricular response non sustaining. Considering rate vs rhythm control with preference for rate control given comorbidity. Patient not anticoagulated.  - ASA: 81mg  - Restart: Atorvastatin 20mg    #Atrial fibrillation, new onset stable. Rate control strategy. Patient well controlled over the night. No runs of RVR as in prior nights. No feelings of palpitations, chest pain, SOB, dizziness.  - Continue: Metoprolol 25mg BID   #Pulm: h/o COPD not well documented, here with active COVID PNA with suspected superimposed bacterial PNA on recent CT chest obtained. Patient currently on HFNC at 60L and 9% FiO2 with 20 PPM iNO saturating at 95% and comfortable.   - CONTINUE: 20 ppm iNO  - CONTINUE: HFNC as needed wean as tolerated last settings as above.    # Superimposed PNA: Noted on 9/27 on interval CTA for r/o PE. No PE but notable for concern for super imposed PNA.WBC trend 5-- > 9 ->10.9 -> 13 this morning.  - S/p levofloxacin, monitor for signs of infection fever chills nausea vomiting.    #COVID PNA: POA worsening oxygen requirement. S/p remdesivir (9/28), and mAb (9/27) - CONTINUE: Methylprednisone 30mg q12hr - Con't optimize pulm toilet, IS - PT OT Evaluation and treatment today.
On 1/1/2023 or 1/2/2023, I had just gotten back from a trip to a major amusement park, and I had felt unwell during the drive home. I had dizziness and a little bit of nausea. When I woke up the morning of 1/1/2023 or 1/2/2023, I felt much sicker. I had developed a chill the previous night, which continued into the day and alternated with a fever.  Also, my whole body felt fatigued. The fatigue, chills, and fever continued for about two or three days, during which time I stayed in bed. Once I was over the fever, I began to develop a little bit of a cough. The cough persisted for maybe another week, during which time I began to lose my voice as a result. I also had a little bit of the sniffles, and on about 1/5/2023, I developed conjunctivitis in one eye. By the following day, I had conjunctivitis in both eyes. On 1/6/2023, I saw my PCP, who examined me and prescribed me antibiotic eye drops. After I began using the eye drops, the conjunctivitis began to clear up. I took home antigen tests on 1/2/2023, 1/3/2023, and 1/4/2023 and got negative results on all of them. When I first became ill, I didn't take any medicine for the fever or aches. Instead, I just rode it out. However, when I developed the cough, I took NyQuil, so that my sleep wouldn't be disturbed. By 1/6/2023 and 1/7/2023, the cough had abated and was much milder. Although I tested negative on every home antigen test I took, I think it is worth mentioning that two other people with whom I was in contact also became ill. One of them tested positive for COVID-19, and the other tested negative.
Hx of anxiety. After receiving H1N1 shot and seasonal flu mist. Pt experienced perioper and digital paresthesia, palpitations. These were catecholamine driven/resolving over 20 min of onset.
Information has been received from a registered nurse concerning 4 patients who between 09-MAR-2010 and 18-MAR-2010 received a 0.5 ml IM dose of PNEUMOVAX 23 (lot # 664476/1190Y). Between 09-MAR-2010 and 18-MAR-2010, 24 hours after vaccination with PNEUMOVAX 23, the patients developed cellulitis reaction on their arms. The patients sought unspecified medical attention. At the time of the report, the outcome of the patients was unknown. The nurse contacted during telephone follow-up could not supply the following information: patient names, dates of birth, dates of vaccination, dates of events and recovery status. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664476/1190Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the registered nurse concerning a 32 year old female patient under medication follow-up and no pertinent medical history who on 16-MAR-2010 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 664476/1190Y) into her left arm at 1:00 PM. On 17-MAR-2010 the patient experienced swelling and redness of her left arm. The patient did not go to emergency room or doctor office for medical attention. She was treated with ice and ibuprofen. On 17-MAR-2010, the patient recovered from these events. This is one of several reports received from the same source. No further information is available.
The patient was 15 years of age. The State Health Services was notified, The patient will not receive their second dose  and no other adverse event occurred.
Pt received her first dose of the Pfizer covid-19 vaccine on August 20, 2021 and on August 21, 2021 patient started experiencing numbness in her right arm through right pinky.  As of September 3rd, 2021 she is still experiencing  this numbness.
REDDENED AREA DIRECTY NEXT TO SITE OF VACCINE ADMINISTRATION. DID DEVELOP A "HEAD" THAT RUPTURED  HAD A LITTLE DRAINAGE.
Initial misuse report received on 14 October 2013 from a health care professional. A 6 months old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date.   It was reported that a patient who was 6 months old received 0.5 ml dose instead of age appropriate for 0.25 ml dose. As of 14 October 2013, the patient did not have any adverse events. List of documents held by sender: none.
Patient was admitted to the hospital in February of 2023 with a stroke and had recently tested positive for COVID. Discharged to home with in home therapy
The Manufacturer is Seqirus, Inc. My symptoms: continuous pain at the injection site, shoulder pain from to the injection site. Unable to have normal range of motion without pain as previously had.
Patient presented with a myopericarditis with elevated troponin, normal LV function, normal coronary arteries.
Pain in arm at injection site; swollen/painful lymph node under arms; fatigue; nausea; fever; chills; brain fog; dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 21May2021 at 08:30(at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included fluticasone propionate (FLONASE), minerals nos, vitamins nos (PRENATAL VITAMINS) and magnesium carbonate (MAGNESIUM) taken from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23May2021 the patient experienced pain in arm at injection site, swollen/painful lymph node under arms, fatigue, nausea, fever, chills, brain fog and dizziness. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm at injection site, swollen/painful lymph node under arms, fatigue, nausea, fever, chills, brain fog and dizziness were not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
pt c/o not feeling well, fatigue, shaky, dizzy and weak day after vaccine admin, also experienced hot flashes., around 6;30 am pt experienced increasing head ache followed by seizure activity, pt found postictal, and soon after experience nausea and vomiting
On January 12 eating lunch a sudden feeling of nausea with accompanying vomiting. The Feeling of nausea remained for approx. 4 hours. Some feeling of fatigue remained for the following days. Due to the time span from the vacillation, I questioned my infectious disease, PCP and gerontologist Doctors after the fact about if this could be a side effect from the vaccine, they indicated there was a possibility there was no request for medical aid during the episodes. These same symptoms occurred after the 2nd vaccine. These are the symptoms I reported on the check in.  These symptoms occurred only during this time frame after being vaccinated I have not had a recurrence.
Immunization was given and turned red, within 3 min a mild hive formed. Zyrtec was given along with hydrocortisone cream on the site. Pt had NO respitory symptoms.
GI upset  and vomiting; GI upset  and vomiting; Migraine; Arm pain; Swollen under arm pit; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Nov2021 12:00 (Lot number: PH8030) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "migraines" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE [AMLODIPINE BESILATE]; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; RIZATRIPTAN; NURTEC ODT; VITAMIN D [COLECALCIFEROL]; ANAPROX; VIT C; IBUPROFEN. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_lot_number=EP6955,, prev_dose_administrator_route=Intra, muscular, prev_dose_administration_date=25Mar2021,, prev_dose_administration_time=01:00, PM, prev_dose_dose_number=2, prev_dose_vaccine_location=Left, arm}), administration date: 25Mar2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 ({prev_dose_product=COVID 19, prev_dose_brand=Pfizer, prev_dose_lot_number=EL3247, prev_dose_administrator_route=Intra, muscular, prev_dose_administration_date=05Mar2021,, prev_dose_administration_time=01:00, PM, prev_dose_dose_number=1, prev_dose_vaccine_location=Left, arm}]), administration date: 05Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 12:00, outcome "unknown", described as "Booster dose"; ABDOMINAL DISCOMFORT (non-serious), VOMITING (non-serious) all with onset 14Nov2021 10:30, outcome "not recovered" and all described as "GI upset and vomiting"; MIGRAINE (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Migraine"; PAIN IN EXTREMITY (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Arm pain"; SWELLING (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Swollen under arm pit". Therapeutic measures were not taken as a result of abdominal discomfort, vomiting, migraine, pain in extremity, swelling.  Additional information: The patient received other vaccine 4weeks product "SEQIRUS' (lot number: 308456), administered on left arm as dose 1. The patient had no known allergies. The patient had no COVID prior vaccination. Not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
12:17, RN and another nurse reported that patient complained of nausea. Nurse placed patient in the lying position in the foldable cot and assessed patient's VS: SpO2 97% RA, BP 150/60, T 97.9, HR 68, RR 20. Patient was awake and alert. At 12:26 pm.. Both nurse educator were notified and 911 was called as advised by nurse. Two other nurses continued to assist patient. Nurse allowed patient to sit up and drank water. Patient stated he was feeling better without any other issues. 12:30 pm, nurse rechecked VS: T 98.3, RR 20, BP 140/62, HR 72, O2 Sat 99% RA. Patient remained to be awake and alert. 12:50pm, Fire Dept arrived. Patient signed the document not to receive further treatment and to the hospital. Patient also stated he did not have any friend and family to drive him home. Patient stated he needed to urinate and was escorted to the bathroom without any issues. Patient was able to ambulate with steady gait. Patient then left the facility.
Lump at the site of vaccination; Swelling at the site of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at the site of vaccination) and VACCINATION SITE SWELLING (Swelling at the site of vaccination) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump at the site of vaccination) and VACCINATION SITE SWELLING (Swelling at the site of vaccination). On 06-Mar-2021, VACCINATION SITE MASS (Lump at the site of vaccination) and VACCINATION SITE SWELLING (Swelling at the site of vaccination) had resolved.      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Outcome of the events are updated.
When I pucker my mouth, like when blowing out a candle only one side of my mouth puckers out.  I thought I had a stroke.
pt reported having elevated temp, diff breathing, aching all over-unable to lie down to sleep d/t DIB;localized swelling, redness to lt deltoid where vax given;
She had scattered red hive like rash reported following day. Was evaluated then at Penobscot Job on site. That evening, patient went to ER and given Atarax. Still had itching on 29th and returned to ER for additional treatment. Report fine on 31st.
Body aches, abdominal spasms, heart palpitations (when working out),  decreased endurance (when working out).
Patient experienced syncope and began to fall to floor. Spouse noted that patient had experienced symptoms 6 months previously without exposure to vaccine. Patient was medically evaluated at that time and physician could not determine cause.
Extreme burning pain in right shoulder, not able to sleep because of pain, no relief with over the counter medication, intensifies in evening hours, no relief from Dr prescribed prednisone 20mg of a 5 day course. Heat and or ice minimal relief!
meningitis-h Flu type B 1wk p/2nd Tetramune;
AREA AROUND INJECTION SITE SWOLLEN AND RED.  PATIENT REPORTS SIMILIAR REACTION TO FLU SHOTS IN THE PAST.
Sweating; clogged head; head was heavy and clogged; fever; fatigue; sore injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore injection arm), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), FATIGUE (fatigue) and HEADACHE (head was heavy and clogged) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore injection arm) and FATIGUE (fatigue). On 09-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), HEADACHE (head was heavy and clogged) and PYREXIA (fever). On 07-Apr-2021, PAIN IN EXTREMITY (sore injection arm) and FATIGUE (fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), HEADACHE (head was heavy and clogged) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included paracetamol.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 30 of 190 patients described by the reporter.  No concomitant medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Information has been received from a registered nurse, via a company representative, concerning a 17 year old female patient who was vaccinated with the first, second and third doses of Gardasil vaccine (dates & lot # not reported). Following one of the doses (the nurse was not able to identify which dose), the patient developed a low grade fever and experienced flu symptoms. The nurse confirmed that the patient did not experience adverse events following the other two doses. At the time of this report, the outcome of the events was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007.  Initial and follow up information has been received from a registered nurse, concerning a 15 year old (previously reported as 17 year old) female student who was vaccinated IM in the left arm on 16-MAR-2007 with the first dose (lot # 656051/0244U) with no reaction noted, and on 21-MAY-2007 with the second dose of GARDASIL (lot # invalid).  On 21-MAY-2007, following the second dose, the student developed a low grade fever of 100.7 degrees, had a continuous headache all day, and experienced flu symptom described as "itchy all over".  There were no upper respiratory symptoms.  At the time of this report, the outcome of the events was unknown.  Follow up information from the nurse indicated that on 01-OCT-2007 the student was vaccinated IM in the left arm, with the third dose of GARDASIL (lot # 658563/1063U), with no reaction reported.  Additional information is not expected.
Body aches, fever (101.4) - not unexpected and started morning following the injection. Treated with Tylenol and ibuprofen. Shortness of breath, sharp intermittent chest pain particularly with deep inspiration started 2-3 days following injection. Treated with aspirin and ibuprofen. Occasional (3-6x/year) tinnitus previously lasting seconds increased in frequency and duration starting 10-14 days after injection. No treatment. Chest pain continues but much improved and now infrequent, ~ 1/wk. Not associated with exercise/activity. SOB resolved. Tinnitus slightly improved but continues.
Client complained of swelling and itching on her tongue and around her mouth. That started 10 minutes into post vac. Benadryl 25mg po chewable given ×1. Client continues to be monitored in post vac. Being monitored for 30 minutes. At 1254 client said that symptoms have completely gone away. Informed client of what to expect at home and abnormal reactions and when to seek medical attention.
fever (38.1oC), shivers - starting some 10hrs after injection, and then lasting for approx. 20hrs  "vaccine arm" 6" dia. around injection site starting on 4/2/21
Myalgia, Fever, NauseaVomiting, Chills Narrative:
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 on dtae of administration. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
FOLLOWING PATIENTS FIRST PFIZER COVID -19 INJECTION, PATIENT PASSED OUT, BECAME UNRESPONSIVE AND CYANOTIC IN THE LIPS AND THAN HAD A TONIC CLONIC SEIZURE FOR 45 SECONDS. PATIENT WAS TAKEN TO ER BY EMS WITH HER HUSBAND.