chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in the stomach; Body aches; Nausea; Fatigue; Chills; A report was received from a consumer concerning a 67 year old  female  who was participating in the mRNA-1273 Emergency Use Program and experienced nausea, fatigue, chills, body aches, and pain in the stomach.  The patient's medical history was not provided. Concomitant medications included gabapentin, modafinil, buspirone, tofacitinib citrate, potassium, flecainide, levothyroxine, rosuvastatin, duloxetine, pantoprazole, ondansetron, metoprolol, and vitamin D. The patient also reported using Ticamidint, Busviront and Hydroxychloridium but they cannot be coded.  On 28 Dec 2020, prior to the onset of the events,  the patient received their first of two planned doses of mRNA-1273 (lot 025L20A) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced nausea, fatigue, chills, body aches, and pain in the stomach. She had no fever and no rash. Treatment for the events included Tylenol (acetaminophen) and Thinner (to be confirmed) gum for the nausea.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events of nausea, fatigue, chills, body aches and pain in the stomach were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache, Myalgia, chills Narrative: developled headache, body aches and chills after 2nd vaccine, stated symptoms improved after taking tylenol
Pt recvd 3 doses of Engerix-B & exp pain @ inject site following 3 doses; pt was also a non-responder;
This spontaneous report as received from a currently 63 years old female pharmacist reporting on herself. Medical history included a corneal transplant. The patient's concurrent conditions and drug reactions or allergies were not reported. In December 2013, the patient was vaccinated with ZOSTAVAX, dose, route, anatomical location and lot number were not reported). There were no concomitant medications. On an unknown date, the patient experienced shingles, she had "100 dots" on an unspecified side of her body also, the patient experienced pain which was not bad but the itching on an unspecified side of her body was bad. The patient used an unspecified ointment which did not help with the itchiness and VALTREX and IVY DRY as treatment. No lab diagnostics studies were reported. The patient sought medical attention by visited the pharmacist. At the time of the report, the outcome of shingles, pain and itching ZOSTAVAX was not recovered/not resolved. Additional information has been requested.
Three nights after the shot, experienced prolonged chest pains for hours.  Went to Hospital for testing and observation.
At the site of 2 injections (both done on right leg), a hard, red lump developed under the skin. It was red all round the injection site about the size of a quarter. Redness was starting to spread off of that quarter-sized spot.  Painful to touch. Had a fever of 100.4.
States actually she has felt tired since she had the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 09:40 (Lot number: EW0151) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "States actually she has felt tired since she had the first dose".  No follow-up attempts are possible. No further information is expected.
Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night that was 100.9 . Body aches, cold, headache, dizziness. Saturday ran fever off and on that never got above 100.9. Which broke Sunday am. Sunday just fatigue, sore arm that is warm to the touch, but not red.
High fever, chills, body aches, headache, nausea, fatigue. Took Tylenol for fever. Fever broke 30 hrs after onset.
Information has been received from a health care worker concerning a 67 year old female who on 9/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Concomitant therapy included influenza virus vaccine (unspecified), it was unknown when the flu shot was given. On 9/30/04, the patient developed lymph node swelling and fever. It was noted that one patient had gone to the emergency room. It was also noted that the patient was hospitalized. The outcome was not recovered. The reporter also mentioned 4 other female patients who were also vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N) and developed similar reactions. No product quality complaint was involved. Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested.  Follow up on 10/18/04 states: "Information has been received from a health care worker concerning a 67 year old female who on 09/28/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647359/0740N). Suspect concomitant therapy included influenza virus vaccine (Fluzone), on the same arm, which was administered on the same day.  On 09/29/04, the pt developed lymph node swelling and fever. The pt was seen in the ER. It was also noted that the pt was hospitalized. At the time of the report, the pt had not recovered. The reporter expressed concern with Lot 0740N.  Lymph node swelling and fever were considered to be immediately life-threatening and disabling. Additional information has been requested." Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine leaked out of syringe/needed while patient was being administered dose. Patient was revaccinated with a new dose/syringe.
Brain bleed; Fall; Did not receive second dose, received 1st dose on 18 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Brain bleed) in a 73-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.     Concomitant products included LISINOPRIL, METOPROLOL and AMIODARONE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion medically significant), FALL (Fall) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose, received 1st dose on 18 Mar 2021). At the time of the report, CEREBRAL HAEMORRHAGE (Brain bleed) and FALL (Fall) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose, received 1st dose on 18 Mar 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. The brain bleed was less, only about 2 mm  Company comment: This case concerns a 73-year-old male with a serious unexpected event of cerebral haemorrhage and non-serious events of fall and product dose omission issue. Event onset a few days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old male with a serious unexpected event of cerebral haemorrhage and non-serious events of fall and product dose omission issue. Event onset a few days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
an extra dose (third dose) of menactra was inadvertently administered to a patient,with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case via health professional. Agency number: 01270356  This case involves a 17-year-old male patient who experienced an extra dose (third dose) of Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] was inadvertently administered to a patient with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Oct-2016, patient received 1st dose of suspect Menactra at 1 dosage form at (unknown: formulation, strength, batch number, route, administration site for immunization and second dose on 29-Jul-2021.  On 07-Sep-2022, patient received an extra dose 3rd dose of suspect Menactra at dose 0.5ml once via intramuscular route in the left deltoid (lot: U7211AB, expiry date: 14-MAR-2023) for immunization was inadvertently administered with no reported adverse event (extra dose administered) 5 years 10 months 18 days following first dose and same day following last vaccination.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a 83 year old male consumer, reporting on himself. The patient's medical history included pneumonia in 2015 and bundle branch block left. The consumer stated that on an unspecified date in 2017, he was vaccinated with the first dose of PNEUMOVAX 23 one injection, in the arm, for prophylaxis (strength, frequency, lot # and expiration date were not provided. Then, on an unknown date, (reported as "9 months apart"), at the recommendation of his physician, the patient received the second dose of PNEUMOVAX 23 one injection, for prophylaxis (strength, lot # and expiration date were not provided). Concomitant therapy included unspecified "Flu vaccine". No adverse effects were reported.
migraine; Rash; Spiked Fever of 104; Sicker than sick; Not feeling good; Fever Blister Mouth & Lips; Felt Like Walking Sideways; Weak; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, FEELING ABNORMAL, ORAL HERPES, GAIT DISTURBANCE, and ASTHENIA in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke and Migraine. Concurrent medical conditions included Panic attack.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ILLNESS, FEELING ABNORMAL, ORAL HERPES, GAIT DISTURBANCE, ASTHENIA, RASH, and PYREXIA. On an unknown date, the patient experienced MIGRAINE. On 04-Apr-2021, GAIT DISTURBANCE and PYREXIA had resolved. At the time of the report, ILLNESS, FEELING ABNORMAL, ORAL HERPES, ASTHENIA, MIGRAINE, and RASH outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 104 (High).         The patient takes Trokenki XR for stroke and it did not work because from Friday to Sunday she felt like she was walking sideways. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-067732.   Most recent FOLLOW-UP information incorporated above on 17-May-2021, Reporters contact information updated. On 19-May-2021, Medical history and concomitant medication added.
Hyperglycemia. Patient began experiencing blood glucose > 300mg/dL within 24 hours of receiving th vaccine. He did not develop DKA. His mother is treating him according to his hyperglycemia protocol from his Endocrinologist.
By inadvertent error the vial of pediatric Pfizer BioNTech was diluted with 0.3ml of 0.9% sodium chloride instead of diluting it with 1.3ml. The dose administered to the patient was 0.2ml after dilution.
When closing the safety cap, the syringe is breaking at the neck post vaccination; post vaccination when the issue occurred with the syringe; When closing the safety cap, the syringe is breaking at the neck post vaccination; post vaccination when the issue occurred with the syringe; This is a spontaneous report received from a contactable healthcare professional from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY DEVICE USED (non-serious), DEVICE PHYSICAL PROPERTY ISSUE (non-serious) and all described as "When closing the safety cap, the syringe is breaking at the neck post vaccination; post vaccination when the issue occurred with the syringe".  Additional Information: The healthcare professional was calling to report an issue that was reported to her about the syringe for PREVNAR 20. When closing the safety cap, the syringe is breaking at the neck post vaccination. This is occurring after the product is used. When they are closing the safety cap it is breaking. It happened to at least 10 prefilled syringes. There was no issue with administering the vaccine itself. It was post vaccination when the issue occurred with the syringe.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) has been requested and will be submitted if and when received.
MODERNA COVID 19 VACCINE EUA     High fever, aches , pain, headache in bed had to take off work 3 days.  Full body ichy rash stared  4 nd day, after fever aches went away.  Went to my dr on 1/16 since rash did not go away, kept spreading getting worse all over my body.  Dr diagnoised it as some areas posrisis  other areas as eczema.  I have never had either in my life, and have no allergies to anything.  She told me it may go away, or i may have it for life, the moderna triggued an auto immunne disorder.  she gave me a shot of predinsone,  and scripted cream.  Dr said I should not get the 2nd dose of vaccine, and to come back 3 times a year for the predisone shot to keep it under control
Per pt report received vaccine in March and had leg swelling in June caused from blood clot. He was deployed at the time and was re-deployed due to the clot. Started on blood thinners and clot has since dissolved. No hospitalization occurred.
Patient reported to primary care office on 4/28/21 at 16:50 with chest pain, numbness in left arm(injection site) , jerking/spasms related to pain in chest; pain radiates from left chest to  left scapula, down left arm. Per pt symptoms started after receiving COVID vaccine on 4/19/21 and have only become worse. Pt took tylenol at home with no relief. Pt did not go to the ER anytime after COVID vaccine for evaluation. Pt unsure if got Moderna or Pfizer. Lost his vaccination card. Pt sent to ER- Pt refused EMS stated would drive himself to hospital.
Patient started to feel her "teeth and gums feel numb" at 2:35PM. Patient was given Benadryl at that time.  While being observed after given Benadryl the patient started to feel an "itchy throat" at 2:47PM. Patient was monitored for 10 more minutes. No further symptoms. Patient was allowed to leave the clinic.
DIZZINESS; CANNOT EVEN FINISH A FULL SHIFT AT WORK; NUMBNESS IN ARMS, FEET, AND NECK; TINGLING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced numbness in arms, feet, and neck. On AUG-2021, the patient experienced tingling.  On AUG-2021, the patient experienced cannot even finish a full shift at work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, numbness in arms, feet, and neck, tingling, and cannot even finish a full shift at work. This report was non-serious.
Patient presented with GBS/AIDP (weakness/numbness) to Hospital, transferred from other facility.  Patietn received IVIG at other facility.  01/11/2008 Vaccine info obtained from Tag-2 reort and updated in database. 01/09/2008 MR received for DOS 11/25-12/03/2007 with DX: Guillain-Barre Syndrome.   Pt presented to ER with numbness of all extremities, increasing low back pain with sciatica, generalized weakness, ataxia, balance problems and walking difficulty. By hospital day 2 pt was unable to walk and was choking on fluids. Neuro consult notes dysphagia, upper and lower extremity weakness, absent reflexes of the lower extremities, no sensory level. Pt progressed to respiratory failure requiring intubation.  Txd with IVIG.  Pt transfered to higher level of care.   01/28/2008 MR received for DOS 12/03/2007-01/18/2008 with D/C DX:  Guillain Barre Syndrome.  Respiratory Failure s/p trach.  Renal Failure.  HCAP Pneumonia. Pt transfered from above facility where pt had not shown improvement on IVIG. Txd with Plasmapheresis.  Txd for MRSA and Klebsiella pneumonia. Pt had some autonomic instability 2' GBS. HTN and SVT controlled with meds. Pt developed decubitus ulcer stage II.  Renal failure was 2' to sepsis requiring hemodialysis. Renal function improved. Elevated glucose with infections. Anemia txd with iron.  Neck spasms tx with baclofen, robaxin, and ativan.  Pt failed swallow test.  Speaking through Passy Muir valve only during brief episode where CPAP is tolerated. D/Cd in fair condition to Long Term Care Hospital. 2/11/2008 Final Progress note received for 11/25/07 admission.  Assessment DX:  Guillain-Barre Syndrome, progressive, not responding with IVIG or immunoglobulin.  Myositis with hyper CPK and possible myocarditis.  Hyperbilirubinemia and acute liver abnormality likely from autoimmune.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Jan 4, 2022, at 09:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty) for COVID-19 immunization. The patient had pyrexia/fever, onset Jan 2022, with outcome of not recovered. The lot number for BNT162B2 not provided and will be requested during follow-up.
A consumer report has been received. The report concerns a 3 year old, Female consumer, who had been receiving FLUMIST, (intranasal) started on an unknown date. It was reported that patient received two doses of FLUMIST on the same day. The outcome of the event of patient received two doses of FLUMIST on the same day is unknown. The report was considered to be non-serious.
nausea; like a hundred temperature/high; body aches; headache; fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable 34-year-old female patient reported she received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced like a hundred temperature/high and then nausea but no vomiting on 06Jan2021. And she's currently having body aches, and headache but no vomiting, fatigue since an unknow date in Jan2021. The patient underwent lab tests and procedures which included body temperature: like a hundred temperature/high on 06Jan2021. The patient was better now like a hundred temperature/high was recovering; nausea was not recovered; outcome of other events were unknown.  Information on the Lot/Batch number has been requested.
HYPOTENSION 3/10/2023 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE 4/6/2023 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/21/2023 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/21/2023 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/30/2023 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/25/2023 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Sleep affected- awake 22 hours; Hyperactive anxiety reaction; This is a spontaneous report from a contactable nurse reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685 /expiration date: not provided), via an unspecified route of administration in the left arm, on 28Dec2020 at 07:45 AM (at the age of 45 years old) as a single dose for COVID-19 vaccination. Relevant medical history included penicillin allergy. The patient did not have any chronic diseases or illnesses. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 10:00 AM, the patient experienced hyperactive anxiety reaction- restless, impulsive and hyperactive. The patient could not sit still or control fidgeting and her sleep was affected, as she was awake 22 hours. The patient did not receive treatment for the events. The outcome of the events hyperactive anxiety reaction- restless, impulsive and hyperactive and sleep was affected was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.
Pt received pfizer vaccines on 03/01/2021 and 03/22/2021. Pt presented to the ED on 11/20/21 with complains of headache, diarrhea, and generalized body aches. Pt was found to be COVID positive and required supplemental oxygen while inpatient due to COVID pneumonia. Pt was discharged on 11/26.