chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to ED with Left Shoulder Pain that started prior to going to bed.  Became more severe during the night and when laying down.  She was also having difficulty breathing.  Pain was radiating to chest and neck.  Denies any recent injury.  Rates pain 8/10.    EKG was performed and showed patterns of ST elevation consistent with pericarditis.  Pain continued, troponin was negative, ST elevations continued, so pericarditis was confirmed.
Client reports fever of 102.  States she had severe body ache and weakness to the point that she could not walk.  Client was seen in the ER on 10/20/07.
0950 -After vaccine administered, patient c/o feeling "weird; fuzzy". Denied sob or chest pain. 0955 - c/o nausea, stepped out of car, dry heaving, diaphoretic, pale, BP 210/146, Pulse Ox 95% Pulse 76. 0959 - 911 called, no change in status. 1006 - Fire truck on site, patient assessed. Patients started to feel better. BP 180/90, patient stated he did not want to go to the hospital. 1010 - BP 173/116  Pulse 67  pulse ox 95%  fireman encouraged patient to seek medical attention, patient agreed, ambulance called. 1012 - Ambulance on site, patient walked to the stretcher, stated he feels better and it feels like when he got stung by a bee. 1015 - transferred to hospital via ambulance.
2 patients received vaccine from vial that was not swirled before administering; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-109442 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109442:Patient 1
Pt had Td and ZOSTAVAX on 5/4/09. He started experiencing numbness/tingling (R) feet and hand with weakness one week later which has been progressively worsening to unable to walk.   7/8/09 consult records received DOS 11/3/08 to 6/13/09. Assessment: Idiopathic Neuropathy NOS. Patient presented with increased symptoms of peripheral neuropathy. Increased burning in leg, problems walking. Both feet and hand numbness. No strength in legs. Numbness and tingling both hands. Low back pain and left shouder pain. DTR decreased sym. Sensory decreased with light touch and pinprick but intact with vibration.  10/13/09 ICD-9 Codes received: 357.0 Acute infections Polyneuritis, 719.47 Pain in joint ankle/foot, 274.9 Gout NOS, 272.4 Hyperlipidemia NEC/NOS, V58.63 Long-term (current) use of antiplatelet, V58.64 Long-term use of nonsteroidal anit-infla, V58.66 Long-term (current) use of aspirin, V58.69 Long-term use of other medications, V14.8 Personal HX of allergy to medicinal agen.
Received the flu vac on 11/5/2014 around 11 am. Complained of pain throughout the day and by 8 pm had a dime sized red mark at the site. On 11/06/2014 patient had a quarter sized bright red circle around her vaccination site at 8am It was painful and warm to the touch. It grew in size throughout the day but not substantially. On the morning of 11/07/2014 the bright red area was the size of a softball with a quarter sized circle that was brownish inside of it. There was a deep red line all the way around the big circle, still painful and warm to the touch. Patient was taken to the pediatrician who diagnosed her with cellulitis from the vaccination, she was put on antibiotic. She is still infected and the antibiotics are not finished. Dr follow up is required to make sure the infected area doesn't get a pus-filled pocket.
heart fluttering; chest discomfort; irregular heartbeat; Severe headache; joint pain; nausea; fatigue; pain and redness at injection site lasting two days; pain and redness at injection site lasting two days; This is a spontaneous report from contactable consumer (patient). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via an unspecified route of administration, administered in Arm Left on 05Oct2021 13:00 (Lot Number: FE3592) as dose 3 (booster), single (at age of 78-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included MGUS, Barritts, Ventricular Fibrillation. No known allergies. Concomitant medications included apixaban (ELIQUIS); omeprazole; atorvastatin. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL9262, Location of injection: Arm Left) on 19Feb2021 10:00 AM (at age of 77-years-old) for COVID-19 Immunization; the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL9269, Location of injection: Arm Left) on 09Mar2021 09:30 AM (at age of 77-years-old) for COVID-19 Immunization. On 06Oct2021 03:30, the patient experienced Severe headache, joint pain, nausea, fatigue, pain and redness at injection site lasting two days. On 07Oct2021 (third day), he experienced heart fluttering, chest discomfort, and irregular heartbeat. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Initial pregnancy report received from a healthcare professional on 09 April 2013. A 41-year-old female patient, with no medical history and whose concomitant medications were not reported, had received intramuscular first dose of ADACEL lot number: U4431AA (Anatomical site of vaccination was not reported) on 09 April 2013. The patient was pregnant during vaccination. Date of last menstrual period was reported as 07 August 2012 and the estimated date of delivery was 14 May 2013. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs) was not reported. Treatment for infertility was not reported. As per reporter the patient did not experienced any adverse event. List of documents held by the sender none.
Patient reports symptoms starting about 30 minutes after 2nd dose of vaccine. Started with headache, then progressed to severe chills, and fever. On 4/11 patient had severe weakness and was unable to walk or sit, altered mental status, high fever 104, nausea, diffuse, red bumpy rash on face, neck, torso. Orbital and facial swelling.  Mother took to urgent care and patient was transported to ER and was admitted.
she felt some of those things, specifically her feet; This is a spontaneous report from a contactable consumer. This consumer reported for a female nurse practitioner (patient) that a female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the Nurse Practitioner took the covid vaccine and the nurse practitioner said she felt some of those things, specifically her feet. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Pt recv vax on 1/12/99; on 1/14/99 pt exp rt arm sore/red/warm, fever; tx=cold & warm compress, Tylenol
Irritated, Red, Hard, Swollen Injection Site - for 10+ days (less than 2 weeks); Disrupted Sleep - suddenly staying up for hours longer than before shot and not sleeping as long (each period and total time), irritable from less sleep and significant 'black circles' under eyes - ongoing.
arm slightly swollen; soreness in the injection site; pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm slightly swollen), VACCINATION SITE PAIN (soreness in the injection site), PAIN (pain) and FATIGUE (fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included HIV medication, Blood thinner medication, Chronic pancreatitis medication and Blood pressure medication for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm slightly swollen), VACCINATION SITE PAIN (soreness in the injection site), PAIN (pain) and FATIGUE (fatigue). At the time of the report, PERIPHERAL SWELLING (arm slightly swollen), VACCINATION SITE PAIN (soreness in the injection site), PAIN (pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-308689 (Patient Link).
A lot of pain that first night, could not sleep. The next afternoon I noticed a large fire red, hot to the touch area which covered the entire upper arm from just below where the shot was administered to the elbow joint and surrounded by a thick white welt. The Dr's diagnosis s/s a very very large hive. Treatment: Prednisone- 20mg twice daily for 4 days and Zyrtec.
positive for HPV; This spontaneous report was received from a nurse and referred to a currently 39-year-old female patient. Pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On unknown dates in 2010, the patient received series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) 0.5 ml/series, administered intramuscularly for HPV prevention (strength, lot #, and expiry date were not provided).  On an unknown date (reported as later), the patient tested positive for HPV. The patient sought medical attention and was treated for the event. At the time of reporting, the outcome of the event positive for HPV was not known.  The causal relationship between positive for HPV and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Information has been received from a lawyer regarding a case in litigation concerning a 71 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-JUL-2015, the patient was administered the ZOSTAVAX by a nurse (lot number, dosage and route of administration not provided). On or about 12-SEP-2017, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: shingles. The patient claims damages including: injury to himself , loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Pt recvd 3 doses of Engerix-B & upon completion of series was determined to be a non-responder;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinated with a dose of PEDVAXHIB (lot# was unspecified, 0.5 ml, intramuscular) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Left deltoid pain and in approximately 2 days pain to elbow approximately 2 days pain down to wrist.  On approximately 1/15/08 developed discomfort in antecubital space.  He still has discomfort in left deltoid and left antecubital space lasting approximately 2 minutes at a time several times per day.
affecting multiple areas at the same time Hip wrists shoulders knee; experiencing worse myalgic pain in multiple areas such as Hip, wrist, shoulder, knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (affecting multiple areas at the same time Hip wrists shoulders knee) and MYALGIA (experiencing worse myalgic pain in multiple areas such as Hip, wrist, shoulder, knee) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (affecting multiple areas at the same time Hip wrists shoulders knee) and MYALGIA (experiencing worse myalgic pain in multiple areas such as Hip, wrist, shoulder, knee). At the time of the report, ARTHRALGIA (affecting multiple areas at the same time Hip wrists shoulders knee) and MYALGIA (experiencing worse myalgic pain in multiple areas such as Hip, wrist, shoulder, knee) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: over the highest level High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.  No medical history was provided.   This case was linked to MOD-2021-024393 (Patient Link).
Severe chills, fever, vomiting, headache, loss of all urinary control, exhaustion.  Lasted 3 days.  (Tapered off after about 8 hours).  Called doctor and was told to take Tylenol, which I did.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Additional Details: Patient still has bruising in the arm in which the vaccine was administered.  It does not hurt, but covers a majority of the shoulder.  Counseled to ice and use heat to reduce brusing as well as to apply lidocaine wound gel.  Patient will follow-up with primary care physician.
My throat constricted & made it difficult to breathe.  Obviously, I'm not going in for the 2nd shot in the series.    I don't have the lot no etc.; if needed, please contact pharmacy directly
Expired product administered: On Oct 21st the mobile clinic vaccine team went to provide covid vaccines. The vaccine team gathered their vaccines from the pharmacy fridge kept in the pharmacy under their control. At the clinic the team started to draw and provide vaccines. One of the associates working at the clinic checked the QR code and realized the Janssen vaccine was expired. By the time the vaccine was checked, it was given already
He has seen a  case of stroke for a patient; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown" described as "He has seen a case of stroke for a patient."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Cerebrovascular accident and the suspect drug BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, feeling unwell and fever. On an unknown date, the outcome of the pain, feeling unwell and fever were recovering/resolving. The reporter considered the pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient was a physician. The age at vaccination was not reported. The patient received the vaccine about 2 weeks ago on an unknown arm. Afterwards the patient felt achy and feverish and just did not feel well. The reporter said the patient was getting better.
Patient was feeling lite headed and started throwing up.  The on scene nurse checked the patient vitals and found nothing  negative. The patient was observed for a view minutes and released to go home. The patient was also advised to seek medical assistance if things worsened.
administered their second dose of ROTATEQ "14 weeks after the administration of the first dose"; have "a slight fever"; Information has been received from a the patient's father referring to a 5 months years old female patient. The concomitant medication included 3 other unspecified vaccines. The patient was pre-mature birth and birth at 35 weeks. No drug reactions/allergies was reported.  On around 05-DEC-2018, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1x2ml orally for prevention of rotavirus(frequency, lot # and expiration date were not reported). In March 2019(reported as 14 weeks after the administration of the first dose), the patient were administered second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1x2ml orally (frequency, lot # and expiration date were not reported)(Inappropriate schedule of product administration).  On 09-MAR-2019, the patient had a slight fever. The outcome of event was not recovered. The patient didn't received treatment for event. The newborn infant lab works were normal. The patient didn't sought medical attention. The causality assessment was not provided.The reporter consulted his attorney for possible legal action against the pediatrician due to a dose of medication administered outside of the prescribing Information.; Sender's Comments:  US-009507513-1903USA005115:
experienced one day of not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 39 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FN5318) as dose 1, single and (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "experienced one day of not feeling well".  No follow-up attempts are possible. No further information is expected.
pt states that about a week after taking the covid vax that she became itchy and noticed a big red rash on her neck towards her shoulders and down to the breast.  She took an antihistamine that did not help so she took a Levocetirizine which helped some.  The red rash moved to both arms.  She woke up the next day and the rash was gone.  Once the medicine wore off that night the rash would come back.  She took more Levocetirizine which helps make the rash disappear.  Once the medicine wears off the rash comes back.  She had her virtual doctor appt today 3/2/2021.  Doctor thinks she is having a delayed reaction from the vaccination and to keep taking any medicine that seems to be helping her.
I have long COVID even though I m vaccinated 3 times; I have long COVID even though I m vaccinated 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart condition" (unspecified if ongoing), notes: So I have, and a heart condition. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have long COVID even though I m vaccinated 3 times".  Clinical course: During the call, the patient stated that patient was sick, became disabled. Patient got covid and had long covid even though vaccinated 3 times. Patient was supposed to get vaccinated, get fourth shot yesterday for second booster and patient had a flare up again. So, it gave all kinds of weird symptoms when had long covid. Patient petrified of it that had long covid because just a couple of days ago on the news they were talking about long Covid and they gave another slew of symptoms that are associated with long Covid. If patient needed another thing to make scared to death about dementia. As needed anything else to tell, patient could potentially get dementia. The fear was real and then they said the long Covid was showing dementia, brain (inaudible). Those kinds of things. If patient hadn't been vaccinated 3 times, would have died from it for sure because patient had (inaudible) that are auto-immune related. Patient had a heart condition and so had no immune system virtually. Patient got it in the hospital, still got it (Covid).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200051652 master cases, dose 1;