chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid test result Positive; covid test result Positive; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL3247) at the age of 33 years as dose 2, single and administration date 27Jan2021 (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 31Dec2021, outcome "recovered" (2021) and all described as "covid test result Positive"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovered" (2021), described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue.  Clinical course- It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient had been tested for COVID-19. She was give the PCR results once she gets them.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out.
LEFT ARM SWELLING, NO LYMPHADENOPATHY OR SIGNS OF CELLULITIS.  TREATED WITH ORAL ANTIINFLAMATORIES.
This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 08-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (lot # 669308/0636AA, expiry date 11-AUG-2013), dose and route were not reported. On 25-JUL-2016, the patient was vaccinated with the second dose in series with GARDASIL 9 (lot# L019297), intramuscularly. The nurse reported that the patient was in the office "2 days ago" to receive the 3rd dose of GARDASIL 9 in the series and did not receive it due to "surgery for teeth removal scheduled the next day" on an unspecified date. The nurse reported that the "the teeth removal is due to an unknown cause and was unsure of diagnosis". The relatedness between "the teeth removal is due to an unknown cause and was unsure of diagnosis" with vaccination was not reported. Additional information has been requested.
PATIENT RECEIVEA A BIVALENT VACCINE BUT ALREADY HAD ONE ON 12/3/2022. NO ADVERSE EFFECT.
No treatment sought for reaction observed, which is reddened, slightly raised skin the size of a quarter at the vaccination site.
compalints of AMS, frontal headache. daughter states she has been sleeping more and less active. INR >13.89 on admit. DX Itracerebral hemorrhage. COVID + - other than cough, no other symptoms. incidental finding per physician.  pt placed on decadron. no remdisivir given. HTN - nicardipine gtt based in ICH/subdural hematoma. downward mass effect from hematoma  in repeat CT.  Coumadin toxicity/INR reversed. ICH stabilized in size (likely secondary to coumadin toxicity).
Muscle pain, pain at injection site, arm soreness, headache, sore throat, no appetite, fatigue.
Metallic taste; Aches; Fever of 100.9F to 99.6F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), PAIN (Aches), PYREXIA (Fever of 100.9F to 99.6F), CHILLS (Chills) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 003B21A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ROSUVASTATIN CALCIUM (CRESTOR), BUSPIRONE HYDROCHLORIDE (BUSPAR), MULTIVITAMINS [VITAMINS NOS], VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste), PAIN (Aches), PYREXIA (Fever of 100.9F to 99.6F), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Metallic taste), PAIN (Aches), PYREXIA (Fever of 100.9F to 99.6F), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            The patient received both their first dose and second dose of Moderna Covid-19 vaccine on 03-Mar-2021 and 31-Mar-2021 respectively. The patient post receiving their second dose of vaccine reported of experiencing metallic taste in mouth within 15 minutes of waiting period which resolved in seconds.   Reportedly, the patient experienced fever of 100.9F to 99.6F, chills, aches, and headache.  Action taken with mRNA-1273 in response to the event was not applicable.
daily nausea; Lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd December 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced nausea and appetite absent. On an unknown date, the outcome of the nausea and appetite absent were not recovered/not resolved.   It was unknown if the reporter considered the nausea and appetite absent to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient's mother. The patient received the first dose of Bexsero and since that day after receiving the vaccine, she experienced daily nausea and lack of appetite which had not resolved. The reporter stated the patient was still experiencing nausea at the time of reporting. The reporter wanted to know if this was a long term side effect from the vaccine. The patient stated she had only received first dose and had not gotten dose 2 because of the symptoms. The reporter stated that the patients next dose was scheduled for June and asked if this was correct, as she saw on the Bexsero website that the dose schedule was 1 month apart. The reporter consented to follow up.
05/19/2022  (Thursday) approximately 2:00 PM administered Moderna vaccine #1 (0.5cc, Lot# 004M21A) to Right Deltoid of patient.  No adverse effects observed at time of injection or for 15 minutes afterward.  5/20/2022 (Friday) Approximately 2:25 PM I was informed by ID nurse that had experienced multiple grand mal seizures very recently.  I was informed that patient was en route to hospital.     5/20/2022 (Friday) Approximately 3:30 PM Spoke with patient , brother and POA for resident.  Mr. informed me that as acting POA for his brother, he had not given consent for any covid vaccinations.  I informed Mr. that I was instructed to provide Moderna Covid Vaccine injections to both Mr. as well as his roommate in Room 413.   I exchanged contact information for follow up from himself and hospital if needed.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 30-NOV-2016, the patient was vaccinated with a dose of VAQTA, intramuscularly, injection (dose, lot# and expiration date were not provided), instead of RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Another person who had a heart attack post vaccination; This is a spontaneous report from a contactable consumer or other non hcp.  This consumer reported for a patient (reporter's neighbour). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. on an unspecified date, the patient experienced "another person who had a heart attack post vaccination" on an unspecified date. The reporter if led was an ingredient used in the Pfizer COVID-19 vaccine. She received some information through an e-mail. It said to stay away from vaccinated people because the virus starts shedding. She reported that the patient had a heart attack post vaccination. This was serious it needed to address by  doctors. The reporter mentioned that as per the e-mail 45000 people died from the vaccines. Some of the doctors are saying breastfeeding mothers are poisoning their child.  This information was available on the website and written by the best doctors. The email they received contains Pfizer's number. The reporter asked if Pfizer-BioNTech COVID-19 vaccine shed the virus. She asked if breastfeeding mothers stay near vaccinated people and if that can harm the child. Reporter told children particles are used in the vaccine. Reporter also asked if any deaths reported with the Pfizer COVID-19 vaccine and if the vaccine was safe.  Outcome of the event was unknown.   The lot number was not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 672675/0068AE, EXP 03-APR-2013) subcutaneous 0.5 ml on 19-SEP-2012 because only 0.5 ml could be withdrawn from a vial of ZOSTAVAX following reconstitution with the entire contents of the Diluent vial (lot number H013939). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. PQC is involved. This is one of several reports from the same source. Additional information is not expected.
Frequent urge to urinate; slight pain at lower abdomen; slight pain at bladder area; This is a spontaneous report received from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8727), via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves disease (hyperthyroidism), moderately cholesterol and sulpha allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), estradiol (DIVIGEL), atorvastatin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6203), via an unspecified route of administration in the left arm on 25Feb2021 at 14:00 as a single dose (at the age of 58-years-old) for COVID-19 immunisation. On 20Mar2021 at 12:00, the patient experienced frequent urge to urinate with slight pain at lower abdomen/ bladder area. The patient did not receive any treatment for these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events frequent urge to urinate with slight pain at lower abdomen/ bladder area was not recovered.   No follow-up attempts are needed. No further information is expected.
A report received from a health care professional on 11/08/2002, concerning a 38 year old male vaccinee who inadvertently received 0.5 ml Fluvirin with a TB syringe and may have received the vaccine subcutaneously on 11/11/2002. On 11/11/2002, the vaccinee was administered Fluvirin with a TB syringe. The reporter speculated that the vaccinee may have received the Fluvirin via the subcutaneous route. The vaccinee did not experience any adverse events. There was insufficient information to determine the reporter's causality assessment.
headache, nausea, fatigue, pain around injection site, joint pain left arm, wrist, shoulder and elbow
I had a sore throat, cough, headache, low grade fever, I went to bed that night feeling really bad thinking that if I felt the same in the morning, I would test for COVID-19. Once I tested with a home COVID-19 test, it came back positive, I called my doctor, she prescribed the Paxlovid. I feel better but I have a dry lingering post COVID-19 cough that is a real nuisance.
We have someone who missed the 2nd dose; We have someone who missed the 2nd dose; They are calling to reschedule; Case reference number US-BN-2021-002144 is a spontaneous case report initially received from a health care professional via regulatory authority (reference number: USBAV21-0392) on 03-Aug-2021 and concerns an adult female patient of unspecified age.   The patient's medical history and concomitant medication details were not provided.  On 26-Jul-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus; batch number was not provided), at unknown dose, reported as standard dose, administered intramuscularly, for pre-exposure prophylaxis.   The reporter stated that the patient missed the second dose and called to reschedule (explicitly coded as Missed dose' and Inappropriate schedule of vaccine administered').  The reporter assessed the events as not related.   The reporter did not give consent for follow up.  No further information was provided.; Reporter's Comments: Product dose omission issue and inappropriate schedule of product administration are listed for RabAvert per convention. Reportedly, the patient missed the second dose and that there was a reschedule request, which is consider as product dose omission issue and inappropriate schedule of product administration. No information regarding concomitant and co-suspect medication and medical history were provided. No adverse event was reported. Reported events are not related to suspect vaccine, but to human action. The case is considered as non-serious.; Sender's Comments: Product dose omission issue and inappropriate schedule of product administration are listed for RabAvert per convention. Reportedly, the patient missed the second dose and that there was a reschedule request, which is consider as product dose omission issue and inappropriate schedule of product administration. No information regarding concomitant and co-suspect medication and medical history were provided. No adverse event was reported. Reported events are not related to suspect vaccine, but to human action. The case is considered as non-serious.
unable to raise arm all the way; tenderness under arm pit; This is a spontaneous report from a contactable consumer (patient [first responder/fire fighter]). A 44-year-old male patient started received single dose of BNT162B2 (batch/lot number and exp date not reported), via an unspecified route of administration on19Dec2020 09:00 to 19Dec2020 09:00 for immunization. Medical history included allergy. He tested positive for antibodies in the middle to end of Nov2020 prior to Thanksgiving. His daughter has IGT and his mother had Lupus. He was tested so he could be around them. At some point he had the virus and didn't know. The patient had no other history. Concomitant medication included fluticasone propionate and montelukast (generic of SINGULAIR); both given from 2010 and ongoing for allergy. The patient received the Covid-19 vaccine on a Saturday around 9 am. On 20Dec2020 (Sunday) he started having tenderness under his arm pit. He had an appointment to see his doctor the day of reporting at 4pm. He was also unable to raise his arm all the way up on 21Dec2020. No investigation assessment was performed. The outcome of tenderness under armpit was not recovered: he still had tenderness (ongoing) at the time of reporting; and recovering for unable to raise his arm all the way up wherein at the time of reporting he could raise it some.    Information about lot/batch number has been requested.
not feeling well; she could not sleep; had no energy; no appetite; had a little bit of a headache; upset stomach; tiredness; chills; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. An 84-year-old female patient received BNT162B2 (COMINARTY), via an unspecified route of administration in Aug2021 (reported as almost 3 weeks ago) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient is scheduled for her second dose on 23Sep2021. She reported this past Saturday (18Sep2021) and Sunday (19Sep2021), she was not feeling well and yesterday (20Sep2021) she was fine. And today (21Sep2021) or last night could not sleep and felt the same signs again this morning and last night. In addition she reported she she had no fever and takes her temperature every morning, had no energy, no appetite, had a little bit of a headache, upset stomach. Stated she experienced tiredness, chills, nausea, and diarrhea. She was asking if those are side effects from the vaccine that could occur this late. She heard that it is worse on the second, so is scared. The outcome of the event not feeling well was resolved on 20Sep2021, while the outcome of the other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
febrile sz occurred <12hr p/vax;no other inj that day (according to routine);no obvious focus infect;
No additional AE reported; Nurse reporting that one patient was administered VARIVAX after experiencing a temperature excursion (Temperature: 6.6F); This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection after experiencing a temperature excursion (temperature: 6.6F; time frame: 0 hours 5 minutes and 0 seconds) for prophylaxis (lot # U019908 is valid upon internal validation, expiration date: 24-JUN-2023; strength, dose, and route of administration were not provided) (product storage error). No additional adverse event was reported (no adverse event).
23 month old with no previous conditions except speech delay perfectly well when got vaccine and 45 minuted later developed first generalized seizure.  No FH of same.  Was still in midst of seizure when presented to ED and witnessed by ED personnel.  NO fever noted.
Vaccinated 3:45 pm 9/19/14. Noticed pain and swelling and redness within 2 hrs. Joint pain, fever, swells that evening. Took ALEVE. Seen on 9/22/14 reports decreased sensation (R) arm throughout, full strength, 3 cm induration and erythema at site. Tx CLARITIN, f/u 3 days.
pt recv vax 5JUL96 & states had soreness @ site for a couple of days;23JUL96 stated started having aching & pain in that arm on 15JUL96;states pain is from the inj area up to the shoulder;pain not relieved by APAP;also exp h/a
Diarrhea; Off label use; Product use for unapproved combination; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "High A1C" (unspecified if ongoing), notes: High A1C; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; PROPRANOLOL; METFORMIN; ESCITALOPRAM. Past drug history included: Darvocet, reaction(s): "Known allergies: Darvocet", notes: Known allergies: Darvocet; Lipitor, reaction(s): "Known allergies: Lipitor", notes: Known allergies: Lipitor. Vaccination history included: moderna (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 12Jul2022, when the patient was 57-year-old, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 027H21b, Location of injection: Arm Right), administration date: 26Nov2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 18Oct2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 18Oct2022, outcome "unknown", described as "Product use for unapproved combination"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 18Oct2022, outcome "unknown"; DIARRHOEA (non-serious) with onset 20Oct2022, outcome "recovered" (Oct2022), described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not the diagnosed with COVID-19, Since the vaccination, the patient had not tested for COVID-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.