chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220116192 (Janssen).  A female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Lot number: THB020) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (DOSE 1, SINGLE, batch number: 1808900, 1808980, Suspension for injection), administration date: 09Apr2021, for Prophylactic vaccination. The following information was reported: HEADACHE (non-serious) with onset 07Jan2022, outcome "unknown", described as "experienced headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No adverse events were reported following administration of covid-19 vaccine (dose number in series 1). On 07Jan2022, the patient experienced headaches (dose number in series 2). On 08Jan2022, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Negative. On 10Jan2022, Laboratory data included: COVID-19 rapid POC (Point of care) test (NR: not provided) Negative. Event abate after stopping drug was Not applicable. Causality as per reporter and as per Mfr. was Possible.   No follow-up attempts are possible. No further information is expected.
OUT OF SPECIFICATION PRODUCT USE; INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced out of specification product use, and incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect storage of drug was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000241162
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 13:00 (Lot number: FF2587) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraine headaches" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination :Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, Lot number: FC3184, Administration time: 01:00 PM, Vaccine Location: Left arm), administration date: 02Sep2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 26Sep2021, outcome "recovering", described as "aches"; CHILLS (non-serious) with onset 26Sep2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 26Sep2021, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 26Sep2021, outcome "recovered" (27Sep2021), described as "severe headache"; URTICARIA (non-serious) with onset 26Sep2021, outcome "recovering", described as "hives in the pelvic region". Relevant laboratory tests and procedures are available in the appropriate section. These events were not serious. (medically significant, Life threatening , hospitalisation, disabling, resulting in death or congenital anomaly). Therapeutic measures were not taken as a result of pain, chills, pyrexia, headache, urticaria. Additional information: Facility type vaccine: Pharmacy or Drug Store. The patient did not had other vaccine in four weeks nor other medications in two weeks. The day following the second dose, the patient had had aches, chills followed by fever, and a severe headache for 24 hours along with hives in the pelvic region. The patient had no known allergies. Device Date : 27Sep2021. Follow-up attempts completed. No further information expected.
(L) deltoid erythema, warmth, swelling x 3 days proximal/upper 1/3 of UE Motrin for tx
pt recvd vax;mom stated vax caused local rxn of rt thigh,lasted for 2 mo;rxn began immed p/ inject;MD told mom that pt had a subcutaneous necrosis;large golf ball size,red,inflammation rt thigh;
Rash Hard red bump Narrative:  Came to Occupational Health to have it looked at
I'm fighting that in my eye now. I had the vaccine/ Suspected vaccination failure; I'm fighting that in my eye now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient was fighting that (shingles) in his/her eye now.  The patient had the vaccine. It was almost cleared up with lots of treatments. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
fever; nausea; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), NAUSEA (nausea) and MYALGIA (body ache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (fever), NAUSEA (nausea) and MYALGIA (body ache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), NAUSEA (nausea) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.
About 8 hours after injection I started feeling inescapably freezing no matter what I do.. it also came on with severe nausea, and a pounding headache like I?ve never experienced. My eyes feel incredibly sore and swollen these symptoms have persisted for 4 days only getting worse in severity. On the 4th morning I discovered my left leg was covered in peculiar non itchy pussing sores. I have tried to treat the symptoms with Tylenol then I switched to ibuprofen because Tylenol didn?t help.. then the ibuprofen wasn?t helping so I tried excedrin.. I took a dose of Benadryl for the sores. nothing has really helped. I can only describe my last 4 days as an agony far worse than the last time I got the flu
a reaction after my second dose; Tinnitus; clogged ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus), EAR DISCOMFORT (clogged ears) and VACCINATION COMPLICATION (a reaction after my second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L24A and 029L26A) for COVID-19 vaccination.     The patient's past medical history included Acupuncture since 22-Jun-2021. Concurrent medical conditions included Osteoporosis (post-menopause) and Sulfonamide allergy. Concomitant products included DENOSUMAB (PROLIA) from 02-Feb-2019 to an unknown date for Osteoporosis, COLECALCIFEROL, FISH OIL (OMEGA 3D), COLECALCIFEROL (VIT D [COLECALCIFEROL]), PROBIOTIC 4 and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced TINNITUS (Tinnitus) and EAR DISCOMFORT (clogged ears). On an unknown date, the patient experienced VACCINATION COMPLICATION (a reaction after my second dose). The patient was treated with PREDNISONE for Ear feels clogged, at a dose of UNK dosage form; GINKGO BILOBA (GINGO BILOBA) for Ear feels clogged, at a dose of UNK dosage form and Manual therapy (Accupuncture started on 22-JUN-2021) for Tinnitus. At the time of the report, TINNITUS (Tinnitus) and EAR DISCOMFORT (clogged ears) had not resolved and VACCINATION COMPLICATION (a reaction after my second dose) outcome was unknown.            The doctor prescribed flavonoids to the patient for 1 month for ringing in ears .   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Patient demographics,Dose 1 details, past medical history, concomitant medications, treatment medications were reported On 28-Jul-2021: Non-significant follow-up
He went out recently to a football game  where most people were not wearing a mask, started to have sore throat, cough  and headache going on for about 2-3 days and on 9/17/21  he had dyspnea on exertion  and therefore came to emergency room.  In the beginning he was saturating  well.  He did test positive for COVID-19 and the plan was for the ER to send  him home after they give him Regeneron.  However, when the patient tried to go  to the restroom his saturations dropped to 88% on room air.  His 1st ABG done  in the ER showed a pO2 of 84.7%.  I am not sure whether it was on room air or  on oxygen, but the 2nd one repeated on room air showed a pO2 of only 58.8,  and then the hospitalist service was called for admission.  I have started the  patient on Decadron and remdesivir since his onset of symptoms is just 2-3  days.  His CT of the chest was done in the ER which is showing bibasilar  pneumonia/consolidation, so the patient was started on Rocephin and Zithromax  which I am going to continue.  Blood cultures have already been sent.  Sputum  cultures have also been ordered.  Patient will be admitted as an inpatient  with a diagnosis of acute hypoxemic respiratory failure secondary to COVID-19  pneumonia.  Pulmonary consult will be obtained in the morning as well.  Please  note, the patient is already on anticoagulation with Coumadin with INR of  1.8.  He takes it for history of PEs and DVTs.  Patient denies any chest pain  except occasionally when he tries to take a deep breath.  He is unable to  produce any sputum when he coughs.  Says he has chronic right lower extremity  swelling, which he attributes after surgery on that leg and the fact that he  has had DVT in the right lower extremity as well. Was admitted on 9/17/21. Dexamethasone, remdesivir, vitamin C, vitamin D, ceftriaxone, and azithromycin started.Was placed on 3 L of oxygen via nasal cannula and was saturating well.  He denies any significant complaints of breathing.  Remained afebrile.  Was also treated with remdesivir and Decadron.  He continued to remain stable.  He did complete 5 day course of remdesivir.  Oxygen walk was performed on 09/21/2021.  Required no oxygen at rest, 3 L with exertion. Discharged on 9/22/21
Fatigue shortly after Nausea and Headache lasting 24 hours, so far.
Tremors in R hand started 12-24 hours after injections. Dizziness - resolved.5/18/09 records received-office visit 12/28/08 C/O swollen glands, lethargic, strep 1 month prior. 12/31/08-C/O fever times 3 days, started 5 weeks ago with sore throat, headache, malaise, headache, tired. 2/19/09-lump onleft side of hip. HX of strep 3 times since 11/08-shoddy nodes at neck. Impresion lymphadenopathy. 3/4/09-rash all over, swollen lymph nodes, had mono, strep. C/O headache, body aches, red face. 5/4/09-C/O shakiness right hand, tremors. Referred to neurologist.
Patient admitted to medical center with weakness and at risk for alcohol withdrawal.  Has significant liver failure with hyperbilirubinemia, elevated ammonia and elevated INR. Discharges 3 days later, no resolved hospital problems. This visit was within 6 weeks of receiving the COVID vaccine.
Pt has a history of HTN and HLD.  She has had 10 days of body aches, weakness, fatigue, and now shortness of breath.  Admitted with acute respiratory failure with hypoxia and acute COVID-19.
PATIENT STATES PAIN IN RIGHT ARM (DELTOID AREA) THAT HAS CONTINUED SINCE RECIEVING THE VACCINATION.  PATIENT STATES THAT HE HAS LIMITED RANGE OF MOTION TO ARM.  HE STATES THAT HE HAS BEEN TRYING  PHYSICAL THERAPY AT HOME, BUT HAS NOT SEEN A DOCTOR.  HE HAS NOT TRIED ANY MEDICATIONS TO RELIEVE SYMPTOMS.  PHN ENCOURAGED PATIENT TO TRY AN ANTI-INFLAMMATORY AND IF PAIN PERSISTS TO SEE A HEALTHCARE PROVIDER.
I began to feel dizzy and light-headed about an hour after the shot. I also began to feel a stiffness all through my left shoulder and up the left side of my neck (the shot was given in my left arm). I sat in a quiet room for about 30 minutes and then took a shower to alleviate the stiffness. Within an hour, all symptons were gone, besides a soreness just at the injection site.
Patient got full injection but once needle was removed 2 drops of liquid ran down arm and patient called on 1/31/21 worried she did not get enough of the Moderna Vaccine. Question should she be re vaccinated.
Pt experienced fainting within 5 minutes after the injection, but awake and alert after 5 minutes.  Pt was doing fine 1 hour after fainting.
This spontaneous report was received from a Licensed Practical Nurse referring to unspecified multiple patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On 21-MAR-2016 and 11-MAY-2016, the patients were vaccinated with an improperly stored dose of M-M-R II (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. The Licensed Practical Nurse stated, that the first and second vaccine administered had a lot # K011317 with an expiration date of 13-AUG-2016. The first vaccine had an exposure at the time of 20.8 C for 18 minutes, while the second vaccine was exposed to a temperature excursion of 23.4 C for 3842 minutes (64.03 hours) with cumulative exposure. Moreover, data logger and no previous exposures were reported. Furthermore, no adverse effect was stated and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 16 weeks female patient who within the last several months was orally vaccinated with the second dose of ROTATEQ (Lot # and expiration not reported). It was reported that on an unspecified date, 24 hours after receiving the second dose of ROTATEQ the patient experienced severe diarrhea. The patient sought unspecified medical attention. It was reported that the patient would not receive the third dose ROTATEQ. At the time of reporting the outcome of the patient was unknown. This is one of several reports from the same source. Follow up information has been received from a health care professional who reported that the patient was a 9 weeks old female (previously reported as 16 weeks old) who on 22-JUN-2011 was vaccinated with the first dose of ROTATEQ orally (Lot number 669827/0257AA) and on 24-AUG-2011 was vaccinated with the second dose of ROTATEQ orally (Lot number 669476/1529Z). It was reported that the patient after both doses, first and second, of ROTATEQ developed severe vomiting and severe diarrhea. Signs and symptoms developed about 24 hours after vaccine, on "approximately 23-JUN-2011". At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. No further information is available.
Home AG-Positive; Home AG-Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Jan2021 (Lot number: EL3247) as dose 2, single and administration date 05Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Home AG-Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative, notes: covid test type post vaccination=Other; (06Jan2022) positive, notes: covid test type post vaccination=Other. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: the patient never got booster but was exposed to someone on 25Dec2021 who was positive COVID and then she developed cough on 30Dec2021, tested neg Ag Home test and then continued to cough and tested on 06Jan2022 mild HA and cough.The patient was not diagnosed with COVID-19 prior to vaccination.   No follow-up attempts are possible. No further information is expected.
Rash for 48 hours with increased each day over chest, back, face and scalp advancing to extremities.
receive Fluzone High Dose in error with no reported  adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 3 adult patients of an unknown age (under age of 65)  who received fluzone high dose in error with no reported  adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, 3 patients received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , (lot: UT7729BA ; expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the 3 residents under the age of 65 received fluzone high dose in error with no reported  adverse event (wrong product administered) (latency: unknown).  Action taken : not applicable.  Outcome: unknown   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.
nausea; severe headache; lethargy; body ached; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 09:15 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shellfish" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing); "iodine" (unspecified if ongoing). Concomitant medication(s) included: NEXPLANON taken for contraception. Past drug history included: Macrobid, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, Single, Time: 10:30 AM, Anatomical location : Arm left), administration date: 02Mar2021, when the patient was 26 years old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "nausea"; HEADACHE (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "severe headache"; LETHARGY (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "lethargy"; PAIN (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "body ached". Therapeutic measures were not taken as a result of nausea, headache, lethargy, pain.  Additional information: Within 3 hours of receiving the second dosage of the Pfizer BioNTech vaccine, the patient experienced nausea, severe headache, lethargy, and body ached. These symptoms persisted for ~30 hours post vaccination. The most recent COVID-19 vaccine was administered at workplace clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received for Nexplanon for Birth Control within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Ethnicity information is available. Race information is available. The patient had allergies to medications, food, or other products which included Macrobid and Pepto Bismuth.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.