chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received from a health care professional on 11 June 2008. A 17-year-old female patient with a past history of Bell's palsy and asthma, received an intramuscular injection of MENACTRA, lot number U2330AA, in the left deltoid, and an intramuscular injection GARDASIL (manufacturer Merck), lot number 1060U, in the right deltoid on 22 August 2007. 224 days later, on 02 April 2008, the patient presented to the physician's office with painful dysesthesias in her feet and legs. She also complained of numbness and tingling in her feet, which was reported to have been "going on for awhile". The numbness and tingling had progressed to her fingers and forearm. She was treated with gabapentin with no success. Subsequently, she was seen by a neurologist and was diagnosed with Guillain-Barre syndrome. Laboratory work was completed on an unspecified date and showed a sed rate of 30 and Rheumatoid factor greater than 15. At the time of this report, the patient had not recovered from the events. 11/4/08-records received-office visit 4/9/08-C/O numbness in both feet for 2-3 weeks progressively worse. Present in bottoms of feet only with pins and needles sensation and sharp stabbing pain. Able to walk and run without any problems.  Assessment:sensory polyneuropathy subacute onset-probably Guillain-Barre syndrome. Office visit 4/11/08-more pain in feet and numbness is a little bit worse, denies weakness. Presented 4/15/08 with C/O either a viral syndrome or streptococcal pharyngitis, diarrhea, nausea and purulent pharyngitis. Impression: subacute sensory polyneuropathy of undetermined etiology, possibly Guillain-Barre variant.Office visit 5/20/08-largely asymptomatic since 4/21/08-working diagnosis is sensory variant of Guillain-Barre syndrome resolving.
Hard time thinking; Hard time standing; Throwing up; Low grade fever; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Hard time thinking), DYSSTASIA (Hard time standing), VOMITING (Throwing up), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (soreness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DROSPIRENONE;ETHINYLESTRADIOL for Birth control, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced THINKING ABNORMAL (Hard time thinking), DYSSTASIA (Hard time standing), VOMITING (Throwing up), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. At the time of the report, THINKING ABNORMAL (Hard time thinking), DYSSTASIA (Hard time standing), VOMITING (Throwing up), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (soreness at injection site) had resolved.            Concomitant medication taken by the patient included Anti-inflammatory topical gel, supplements.
some arm pain but lasted several hours and mild; This is a spontaneous report from a contactable Physician (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, lot number: EJ1685) at left arm, via an unspecified route of administration on 19Dec2020 12:00 at single dose for covid-19 immunisation. The patient did not have other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient had no known allergies, no other medical history. Concomitant medication included sertraline, ascorbic acid (VIT C), ergocalciferol (VIT D), zinc, cetirizine hydrochloride (ZYRTEC) and vitamin. After her first dose, the patient just had some arm pain but lasted several hours and mild on an unspecified date. The patient did not test COVID post vaccination. The outcome of event was recovered.
RED, ITCHY, BLOTCHY RASH SPREAD FROM CHEST TO FACE. DENIES ANY SOB.
Patient administered FLUMIST vaccine and one week post vaccine, patient developed flulike syndrome, followed by fatigue and shortness of breath that worsened over 6 weeks before being referred to local cardiologist presenting with severe cardiomyopathy and associated congestive heart failure. 12/22/06 Received medical records from hospital which reveal patient admitted 11/10/06-11/14/06 after having flu like s/s of fever, malaise & body aches for approx 1 week after received the FluMist vax, followed by SOB & fatigue that continued to worsen over approx 6 wk period before presented to cardiologist office profoundly symptomatic.  Exam revealed JVD & est CVP of 10-12; summation gallop; small amount of ascites; trace bipedal edema Final DX: Congestive heart failure, compensated; cardiomyopathy, severe & presumably post-viral.
Case number PHEH2016US027648 is an initial incomplete spontaneous report received from a nurse on 21 Oct 2016. This report refers to multiple patients whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patients received FLUCELVAX Quadrivalent vaccine (batch number: 185887, expiry date: unknown) prefilled solution (PFS) at a dose of 0.5 ml intramuscularly on 21 Oct 2016. It was reported that the vaccine had temperature excursions. The first excursion was at 34.3 Fahrenheit for unknown time and the vaccine was not frozen. The second excursion was at 46.4 Fahrenheit for unknown time. The patient's received the vaccine after the temperature excursion. No adverse events were reported following the maladministration. the reporter provided consent for follow up contact.
Pt came into pharmacy and said he needed a covid shot. RPh and pt spoke about each one and together they decided on Janssen. No problems with administration and no side effects afterwards. Once we logged dose into the system, we saw pt had moderna 1st dose 1/15/21, 2nd dose 2/12/21 and a 3rd dose 3/5/21. Pt had no knowledge of these shots, no white card and these were not given at our pharmacy. Notified pt and daughter of extra dose. Pt has memory problems per daughter, but is still allowed to drive and appears to be cognitively intact when we spoke to him. No adrs reported. Pt more then adequately vaccinated.
PATIENT HAD SEVERE PAIN AND NO RANGE OF MOTION FROM 1ST DOSE OF SHINGRIX GIVEN 9/07/2018, ADDED ABOVE DETAILS. SHE HAD TO GET A CORTICOSTEROID SHOT FROM HER DR'S OFFICE. SHE FORGET TO MENTION THIS YESTERDAY WHEN SHE CAME IN FOR HER 2ND SHOT, 1/8/19. SHE SAID YESTERDAY HER ARM STARED TO GET PAINFUL AND PUFFY. THE PAIN IS ALL DOWN HER ARM AND IN HER ARMPIT. SHE HAS BEEN PUTTING ICE ON IT AND WILL TAKE SOME IBUPROFEN. SHE HAS MORE RANGE OF MOVEMENT THAN LAST TIME, BUT IT IS VERY PAINFUL.
Pt stated having no pain at time of injection or immediately following.  She developed radiating arm soreness in November that first radiated down the arm and now up to the arm.  Has been to the doctor and they are unsure of cause. There is no lump, swelling, or redness and MD has attributed it to the shingles vaccine for now
Information has been received from a physician concerning a 16 year old female with attention deficit disorder who on 14-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 659182/1757U). Concomitant therapy included ADDERALL TABLETS and ZOLOFT. On approximately 15-MAY-2008, "within 24 hours", the patient had severe gastroenteritis (vomiting, diarrhea). It was unknown if the patient had fever. On an unspecified date the patient was recovered. The patient's mother called the office to seek unspecified medical attention. Additional information has been requested.
Patient called on 12/10/19 to report persistent pain at the site of injection.  She stated she felt pain upon vaccine administration.
Patient was given H1N1 vaccine at approximately 0930 in right deltoid. The area did bleed a little and immediately started swelling at injection site. Subject became unresponsive.
Approximately 3 days after her booster shot, she experienced chest pain (left part) around 6pm and when she woke up the next day it has gotten worse. It was very difficult for her to move and it got so bad around 2pm and we decided to take her to the Emergency Room and the medical staff said they couldn't find anything unusual and we mentioned that she has recently gotten her booster shot then the doctor said it could possibly be a reaction and the doctor had mentioned that he read somewhere that there are cases of women experiencing breast pain and would last about 12 -14 days and would just disappear. With my mother's case it the pain did last for 12 days there was no medication for treatment and she did not take the pain medication prescribed by the doctor.
One week after 2nd Moderna, started coughing periodically in day and night chest conjestion started to build at night. After three days of cough periodic and each night became more conjested with problem being to not inhale deeply, and lower right side adobonem pain. Sought medical appointment March 20 but did not get appointment until March 9 with medical facility due to increasing pain and not sleeping from conjestion.  March 10 doctor visit ordered blood and urine tests and CT scan. Early Mar11 test B type natriuretic protein was high (CHF), Doctor ordered chest xray, ekg and echogram. CT scan found clot in right lower lung. Told to go to ER Mar 10 evening, ER ordered Ultrasound images of the legs.BILATERAL LOWER EXTRE BILATERAL LOWER EXTREMITY DEEP VEINS: Nonocclusive thrombus in the distal right femoral vein and popliteal vein extending into the tibioperoneal trunk. Thrombus is hypoechoic and expansile consistent with acute thrombus.Left lower extremity veins are patent and compressible. Left common femoral vein demonstrates normal waveform without loss of respiratory phasicity.Positive for right lower extremity DVT of the distal femoral vein, popliteal vein, and tibioperoneal trunk. CT;LUNG BASES: Small right pleural effusion with overlying compressive atelectasis and consolidation. There are addition, there are apparent filling defects within the subsegmental pulmonary arterial branches suggestive of emboli. Many /multiple blood tests March 9, 10 ,11 , 12 and 16 available to examine details..one perhaps low Platelets count 151 K/uL (range) 140 - 400 K/uL. I can give permission for these tests results to study to correlate lung and leg clots . This is unique because hospital data available to diagnose in detail my reaction after 2nd Moderna shot. Please look into it with experts..Did Moderna cause my clots I never had before?
Missed his due date for second dose of vaccine; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and PRODUCT DOSE OMISSION ISSUE (Missed his due date for second dose of vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain (The patient's pre-existing medical condition includes back problem.) and Neck pain (The patient's pre-existing medical condition includes neck problem.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his due date for second dose of vaccine). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed his due date for second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Non-Significant Follow up includes complete mailing address.
died in 30 to 35 minutes after; booster; This is a spontaneous report from two contactable pharmacists. Three serious adverse events occurred after administration of Pfizer booster doses just in the past 5 days from one pharmacy location and all have been from the same Lot# FD0810 of Pfizer product. This is one of three cases. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, COVID 19 Vaccine, mRNA, purple cap), dose 3 via an unspecified route of administration on an unspecified date (Lot Number: FD0810; Expiration Date: 30Nov2021) as dose 3 (booster), single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historic vaccine was 1st and 2nd dose of bnt162b2 (lot unknown) received for COVID-19 immunization. The patient died in 30 to 35 minutes after on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal.; Sender's Comments: The information provided is limited and does not allow a meaningful medical assessment of the case. However, based on the available information in the case, a possible contributory role of the suspect product BNT162B2 to the development of reported fatal events of Unknown cause of death and Booster cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202101489288 same reporter/drug/AE, different patient.;US-PFIZER INC-202101489289 same reporter/drug/AE, different patient.; Reported Cause(s) of Death: died in 30 to 35 minutes after; booster
Swelling and Pain at sight of shot. 2 days later patient was in school and her arm started to shake uncontrollably, she tried raising her other hand to get teachers attention and could not, then tried to speak at was unable to.  At that time she dropped to the floor.  The instructor said she seized for about 5 minutes. The School Called 911 then they brought her to Hospital.  09/11/2007 Reviewed hospital medical records which reveal patient experienced right sided seizure which became generalized tonic clonic seizure w/LOC while at school working on computer. Admitted 8/31/07-9/1/07.  Neuro consult obtained FAMILY HX: paternal aunt, great aunts/uncles w/seizure disorder. FINAL DX: New onset seizures.
bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding; Burned, bubbled almost effervescent/Painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful). On 27-Nov-2021, VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 41,500 level of 41,500.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that patient took other medications. However, non of them were blood thinners that would had caused the bleeding and patient is due to get a MRI on 14 Jun2022.  No treatment medications were provided.   This case was linked to MOD-2022-587336 (Patient Link).
They asked if I had allergies before vaccine and what I was allergic to and then I got the injection and since I have allergies and have had reactions in past I had to stay for 30 mins and within 10 minutes I started getting big whelps from head to toe and started having trouble breathing. After I left I went home and had to take an EpiPen and for several days I still had whelps and hives. This lasted 4-5 days.. When I followed up with my Doctor they said to not take another shot and that I shouldn't have taken it in the first place since I've had a reaction to a vaccine before. I had a migraine and nausea for several days as well for 4-5 days after the vaccine.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Narrative :  Symptoms: Headache, Fever & Temp of 102.5 w/ chills  Treatment:
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns an 86-year-old, elderly female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805005) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Very high fever the following morning (10/20) and evening - 103.9F - being the highest
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Total number of doses were 168 doses and the vial did not undergo any temperature excursions. Dates f administration of vaccine on 10-Nov-2021 and 11-Nov-2021. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow up contains non significant information: reporter address updated
Fever (102.5-103); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (102.5-103)) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever (102.5-103)). At the time of the report, PYREXIA (Fever (102.5-103)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 102.5-103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
I started getting brain fog and exhaustion 3-4 hours after receiving the 2nd dose. My energy level was at 10% after receiving the shot. I did not feel better after day 4 or 5. I did not see any improvement. I called into a tele-health visit because I was having problems with exhaustion. On day 6 I went to Urgent Care, even though I should not have driven myself there. The doctor told me that she has seen a range of adverse events. I asked for a week off of work because of the exhaustion. My brain fog started lifting 7 days after receiving dose 2 of Pfizer. I was at about 50% energy on day 8-9. I did not feel at 100% energy until day 14. I constantly felt overwhelmed. I feel like this was a very scary time that I experienced.
Cellulitis to 20cm X 14cm on upper arm. Fever 102F with slight chills. Resolved on 5th day.
01/14/04: Client received Td and IPV vaccine.  01/15/04 @ 06:00: experienced body ache, joint pain, headache, low grade fever, rash development.  01/15/04: Seen ER MD, Benadryl, Cortisone injections given.
Redness + swelling, heat @ site of injection erythema 130mm X 70 mm - slightly indurated.
Flu like symptoms (achy, tired, slight/ brief nausea, general malaise)
MALAISE, HEADACHE, JOINT AND MUSCLE ACHE,  PVC FLARE-UP