chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of on 9/2/2021, hasn't received second; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd September 2021).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 04-May-2022 Reporter's comment: Medical Doctor called on behalf of self to inquire about, how to proceed with the 2nd dose of Shingrix. The reporter stated that it had been 9 months since had not receive the 2nd dose. The reporter unable to provide vaccine details. Did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
4 day p/ vax had bloody stools & episodic screaming which seemed to resolve; 7/7/99-in car seat-episode where pt let out painful cry & appeared to have difficulty swallowing; hosp 7/16/99; episodes of abd pain decreased,  ? vaccine rxn
27JUL94 pt c/o h/a p/supper-sleepy; In AM still had severe h/a; t103 for 48 hrs-vomited 2x-spoke w/MD; APAP supp ordered;
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: PT  SAYS HAS RASH OVER WHOLE BODY, SHE SHOWED HIVES , RASH ON HER ARM
Soreness in arm, throbbing, shooting pain, tingling in fingers, numbness. Persistent congestion, headaches, and cough. All symptoms still occurring to date.
Delayed reaction to the shot  redness and itch at site of injection. Appeared about a week later.
pt was given expired vaccine. vaccine expired on 7/7/22. this was pt first in series.  no adverse event occured. Pt was revaccinated 8/5/22.
Bell's palsy: Treatment Prednisone 50 mg once a day for 6 days
Pt recv vax on 5/4/99; on 5/5/99 pt exp swollen/ warm vax site, stiff arm w/ inability to move easily -rt arm; tx=antibiotic
1/4 vaccination Within 24 hours, right away the area of injection site was swollen, hard, grew to the size of my hand. The following day, I started getting hives, SOB, and my sinus swelled up, face and extremities. I took Benadryl and went to Urgent Care. Urgent Care put me on medication;  vertigo, allergic reaction and sinus infection.   Start taking Famotidine, Hydroxyzine-pamoate, prednisone.  Followed up with PCM; benadryl Sinuses are still swollen, facial parts still swollen.  Going to follow up with PCM I take a nebulizer. That medicine, the albuterol, inhaler Prevail.
Site: Bruising at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium
Moderna Dose 1 3/5/21 (029A21A) Moderna Dose 2 4/16/21 (027B21A) COVID Positive 5/20/21  5/20/21: Presented to ED. The patient presents with fever. 61 year old male presents to the emergency department for a fever with an onset of 1 day. Patient was diagnosed with pancreatic cancer in April 2021. Patient states he has had 2 rounds of chemotherapy but states he could not have his 3 round last week because his white count was too low. Patient is also complaining of dull chest pain that is exacerbated with deep breathing, cough, and a headache but denies vomiting, diarrhea, neck pain, dysuria, hematuria, and nausea. Patient was diagnosed with blood clots on 05/09/2021 but states that he is not having similar symptoms to when he was diagnosed with blood clots. Patient is taking Xarelto. He has never had COVID but is vaccinated. Patient sees Dr. (Name) at the UI Oncology clinic.  5/25/21: 61-year-old male on chemotherapy for pancreatic cancer, also recently diagnosed pulmonary embolism on rivaroxaban, presents with 1 day of fever.  Initially, did not have any cough or shortness of breath, was admitted to the hospital, where a chest x-ray, urinalysis and examination failed to reveal an exact source of the fever.  His absolute neutrophil count was less than 500, so he was admitted for neutropenic fever. Cultures were obtained. IV antibiotics started.  COVID-19 was tested and, surprisingly, came back positive.  The patient has actually had both of his COVID-19 vaccines and basically, does not have pneumonia, shortness of breath, or hypoxemia.  We did not use any medications for COVID while in the hospital, watching for any signs of respiratory compromise, but none developed.  Blood cultures were negative.  He was switched from ceftazidime to doxycycline at time of discharge.  Will follow up with Dr. (Name) for his next cycle of chemotherapy.  Because of his COVID-19 positivity, we will not schedule any immediate followup appointments, although the patient will call if he has persistent fever, dyspnea, or signs of hypoxemia.  For the past 2 days, the T- max has been 99.9, and most the time 98.6.  He was seen the day of discharge, doing quite well.  Blood pressure 153/80, pulse 90, regular, oximetry 95% on room air.  Glucose was 210. Discharged on Rivaroxaban 15 mg b.i.d., doxycycline 100 mg b.i.d., Robitussin AC as needed for cough, Lantus 28 units at bedtime, atorvastatin 80 mg daily, aspirin 81 mg daily.  The patient did get 1 dose of Neupogen 480 mcg subcu while in the hospital.
Fever 101 at 4am this morning, 101.8 later. Has  headache, neck with stiffness, body aches with fatigue.
Patient reports flu like symptoms then was tested positive for covid 19 on 04/28/21
Periorbital angiedema; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Sep2021 12:15 (Lot number: EW0178) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. No covid prior vaccination. No covid tested post vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number=EL1284, Intramuscular, dose number=2, vaccine location=Left arm), administration date: 14Jan2021, when the patient was 42 years old, for Covid-19 Immunization; Bnt162b2 (lot number=EL0140, Intramuscular, dose number=1, vaccine location=Left arm), administration date: 23Dec2020, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: ANGIOEDEMA (medically significant) with onset 27Sep2021 13:00, outcome "recovered", described as "Periorbital angiedema". The event "periorbital angiedema" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of angioedema including Benadryl.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event Angioedema and the suspect drug BNT162B2 cannot be excluded.
Headache; sore arm; Tired, minor; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on an unspecified date (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache, tired, minor, and sore arm. The clinical outcomes of the events headache, tired, minor, and sore arm were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presented to emergency department on 11/22/2021 following testing positive for COVID-19 at skilled nursing facility. Patient was admitted until placement could be found at a new facility due to COVID status. Patient was discharged on 12/2/2021 to a different skilled nursing facility.
The vaccinating pharmacist inadvertently mixed the Pfizer Covid-19 Pediatric vaccine with sterile water for injection instead of 0.9% sodium chloride. The patient was then administered the vaccine. The patient's parents report the patient had a sore arm and it was more painful than the primary series.
Generalized tonic-clonic sz p/temp of 104F; 13AUG90 developed a nonspecific febrile illness w/temp 102F then temp rose to 104F;
Same arm as injection - breaking out with rash, red rust and itching back of neck with rash and itching scalp ithing - this all happened on Friday Oct 15th.
Local reaction - arm soreness; area of induration starting the size of a mosquito bite (day 0) spreading to size of softball (post-vaccine day 4); warm, erythematous; no effect on range of motion or function of arm; no systemic reaction
it has been 6 or 7 weeks since received first dose (>35 days); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since received first dose (>35 days)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since received first dose (>35 days)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since received first dose (>35 days)) had resolved.        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.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow-up information included no new information On 02-Aug-2021: Follow-up information included no new information
Developed a large DVT in my left knee; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 11:30 (Batch/Lot number: unknown) at the age of 64 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021 11:30, outcome "unknown", described as "Booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 25Dec2021 07:00, outcome "recovering", described as "Developed a large DVT in my left knee". The event "developed a large dvt in my left knee" was evaluated at the physician office visit. Therapeutic measures were taken as a result of deep vein thrombosis and included treatment with Prescription blood thinner. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. Known allergies were reported as No. Hospitalization Prolonged was reported as No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Joint aches and low grade fever, started 12 hours after dose, lasted approximately 24 hours  Rash at injection site, started 48 hours after dose
A 13 year old girl received her Fluzone quad vaccine. She was very nervous and was crying. Afterwards she was told to sit down and wait 10 to 15 minutes. She did and I offered her and her father water and a sucker. He took the water. I left to help someone with an OTC and upon return she was slumped over leaning on her father. He said she has passed out before but this was not noted on her consent form. We called a code white and offered water and a sucker again. She took the sucker after she aroused a little. I said the sugar will help. She managed to drink a little water as well. Her father and sister were present to help comfort her. They waited until she was awake and aware and store employee was able to document the incident. She walked out with her father.
grand mal seizure, quit breathing turned blue, seized for about 3 minutes then stopped took to dr office per his request, started seizing again, they gave him a shot of volume and called 911
Pt called me 10/8/18 to notify me just in case there were others with similar S/S after receiving the influenza vaccine. She C/O N/V that evening, followed by feeling tired and "just not feeling well" the next day. She made a full recovery of S/S.
Patient got COVID vaccines on 3/22/21(Janssen) and 11/19/21(Moderna).  Patient hospitalized with shortness of breath and COVID symptoms on 12/31/21.
patient only reported sore arm with no additional side effects; Accidental 3rd dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidental 3rd dose of Moderna vaccine) and MYALGIA (patient only reported sore arm with no additional side effects) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 24-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (Accidental 3rd dose of Moderna vaccine). On 25-May-2021, the patient experienced MYALGIA (patient only reported sore arm with no additional side effects). On 24-May-2021, EXTRA DOSE ADMINISTERED (Accidental 3rd dose of Moderna vaccine) had resolved. At the time of the report, MYALGIA (patient only reported sore arm with no additional side effects) had resolved.        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.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant Follow up Appended - New reporter and event added
Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by the reporter.   This case was linked to MOD-2021-148611 (Patient Link).
Pt experienced systemic reactions of headache, general malaise, fever, nausea, vomiting and myalgia. Follow-up information received on 2/23/98, reported that the headaches, nausea and upset stomach lasted about 48 hours and the pt recovered from this experience.
felt like someone was crushing her hand,; could not walk; feet were burning; legs give out every now; tremors are worse; It is terrible/It is awful/Felt everything was accelerated; bad shoulder which felt like was on fire; 103 degrees fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now) and TREMOR (tremors are worse) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19, Tremor and Peripheral neuropathy. Concomitant products included PREGABALIN (LYRICA), DULOXETINE HYDROCHLORIDE (CYMBALTA), OXCARBAZEPINE and VALPROATE SEMISODIUM (DIVALPROEX) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now), TREMOR (tremors are worse), FEELING ABNORMAL (It is terrible/It is awful/Felt everything was accelerated), ARTHRALGIA (bad shoulder which felt like was on fire) and PYREXIA (103 degrees fever). At the time of the report, PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now), TREMOR (tremors are worse), FEELING ABNORMAL (It is terrible/It is awful/Felt everything was accelerated), ARTHRALGIA (bad shoulder which felt like was on fire) and PYREXIA (103 degrees fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment listed.
Lasting shoulder pain bilateral and reduced range of motion in the bilateral arms, worse in left arm (adhesive capsulitis).
improperly stored vaccine was administered to an unspecified patient; The birth dose seemed not effective and the series to be restarted; This non-valid, spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 12-FEB-2022, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine, thimerosal-free (recombinant)(RECOMBIVAX HB) lot # T028933, expiration date 03-NOV-2022 (dose and route of administration were not reported) for prophylaxis (incorrect product storage). There was no adverse event or product quality complaint reported. Administered dose of vaccine experienced the temperature excursion of 17.6 degrees Fahrenheit (F) for 7 hours. It was also reported that the vaccine was not monitored for 7 hours and it is actually unknown what the temperature of the vaccine reached during that time. There were no previous excursions reported.  Lot Number T028933 has been verified to be valid lot number for Recombivax HB formulation vial.  This is a non-valid report due to lack of patient's identifiers.  Follow-up information was received from Licensed Practical Nurse on 28-MAR-2022. The patients identifiers were provided. The patient had no other vaccines withing 4 weeks prior, no illness at time of the vaccination and no preexisting physician-diagnosed allergies, birth defects or medical conditions.  The dose of hepatitis b vaccine, thimerosal-free (recombinant)(RECOMBIVAX HB) was administrated to the patient intramuscularly in the left thigh by trained healthcare professional in accordance with the instruction leaflet and it was the first one she received.  On 11-FEB-2022, the primary data logger was replaced and normalizing, vaccine were kept in a backup refrigerator.  On 12-FEB-2022, the data logger at the back up refrigerator indicated an excursion of 17.6 degrees Fahrenheit (F). It appeared that the data logger was malfunctioning for 1 hour. Actual conditions and observation showed that none of the fluid in the fridge or vaccines were frozen. Due to malfunctioning data logger, the vaccine was not monitored before administration. Immediately after noticing, vaccines were put aside to avoid usage (the vaccines would not to be used due to no data supporting the excursion). Medical director of the clinic, pediatrician and public health department were notified about the incident.  Per agreement with medical director and pediatrician the birth dose hepatitis b vaccine, thimerosal-free (recombinant)(RECOMBIVAX HB) seemed not effective  (Vaccination failure) and the series to be restarted. The patient vital signs and assessment did not show any adverse reaction to the vaccine. The patient's parents were aware of care plan.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 031L20A and advised vaccine maintained  activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to advise of adverse event.  This was adminstrative error without adverse event.
Her arm now hurts; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Her arm now hurts) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis. Previously patient received four dosages of COVID-19 vaccination.     On 12-Jan-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PAIN IN EXTREMITY (Her arm now hurts). At the time of the report, PAIN IN EXTREMITY (Her arm now hurts) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient received additional booster dosage.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 55 year old female patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.