chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of phantom pain in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included amputee. Concurrent medical conditions included phantom pain. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced phantom pain and condition aggravated. On an unknown date, the outcome of the phantom pain and condition aggravated were unknown. It was unknown if the reporter considered the phantom pain and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: This case was reported via text message to the agency. The age at vaccination was not reported. The physician had an amputee patient with a pre-existent condition of phantom pain.  The phantom pain became severe on the day of the vaccination. The pain was so severe that he had to be put on medication (not specified). No additional details were provided. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK186891.
Runny nose; right eye lid is swollen; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated her son received his first Pfizer vaccine last Monday (12Apr2021). And he woke up yesterday (19Apr2021) and his right eye lid is swollen and today (20Apr2021) they are swollen much more and he also have a running nose. The reporter was not worry about runny nose because it was usual for him, the reporter had seen it was a side effect reporter can't find anything about the eye lid being swollen because dramatically there was no information about the vaccine but it was 7 days after he got the vaccine and he never had this problem before. So reporter was just wondering if that is listed somewhere side effects or the side effects are very rare or what was that. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
excessive pain and swelling at injection site after injection of PCV20; excessive pain and swelling at injection site after injection of PCV20; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (MANUFACTURER: PFIZER), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "recovering" and all described as "excessive pain and swelling at injection site after injection of PCV20".  Additional information: the excessive pain and swelling at injection site, after injection of PCV20, started to resolve four to five days later.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
The patient is taking AVASTIN and stated their chemo numbers went up after taking the flu shot and getting the flu, numbers changed from CA61 to CA125.
Suspected vaccination failure; Got the shot and yep got shingles for the first time; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient never had shingles before the vaccination. The patient received the shot and got shingles about 6 months later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and lab test confirmation was unknown at the time of reporting.
10/25/21-Patient listed as deceased as of this date, no records of where or why
While in the recovery area, Patient was found on the floor by recovery RN. EMS immediately activated. Patient was turned onto her left side. BP 90/50, P98 and SpO2 98% room air. Fan held to face and cool compresses applied to face. Patient regained consciousness after approx 2 mins. BP 80/58, P105, SpO2 100% room air. Care transferred to EMS.
sore arm; pulled muscle; A Spontaneous report was received from consumer concerning a female patient of 68 age who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced Pain in extremity, Muscle strain.  The patient has no medical history and no relevant concomitant medications.   On 16-Feb-2021, prior to the onset of the events the patient received their first of dose of two planned doses of mRNA-1273 (lot/batch: 006M20A) Intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.   The events Vaccination site rash, Pain in extremity, Muscle strain were unknown. The outcome of the events is unknown.   Action taken with mRNA-1273 in response to the events was not reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015353:
requested medical records, but never received them; pt had a positive COVID test on 9/2/21; per death certificate, pt died in the nursing home with causes of death being COVID and Dementia
patient complaining of nausea and rapid heart rate after receiving vaccine. denies h/o DM or taking any medications.    initial VS at 1400 sitting:  BP: 150/84 HR: 137 SpO2: 100% temp: 98.3 deg F  repeat VS after 10 min supine at 1445: BP: 118/68 HR: 103  repeat  VS sitting at 1450: BP: 139/87 HR: 107  repeat  VS sitting at 1455: BP: 146/83 HR: 105  client states she "feels much better" and denies nausea and dizziness escorted to car by PHN; driven home by husband encouraged follow up with PCP; patient verbalized understanding.
I started with a low grade fever and a cough. The cough got worse and was worse at night. I took some over the counter symptomatic relief. I called my doctor. He prescribed Paxlovid. We picked it up the next day. The cough hung on at least two more nights. I generally felt better after taking the Paxlovid. After the fourth or fifth day, I felt like I was pretty much over it.
Body ache, swollen fingers and wrists, puffy eyes, sore throat, low grade fever.
From initial info received on 8/13/04 from another mfr., a physician reported of an adverse event occurring in the USA. A 49 year old female pt received a TD ADS ADULT vaccination, lot U1019AA, route and site of administration not reported, on an unspecified date. On 4/16/04, the pt developed swelling down the arm, extreme induration and extreme warmth at the injection site. She was treated with prednisone, Allegra, ranitidine and ibuprofen. The pt improved after drug therapy and recovered from these events. From additional info received on 10/21/04 from the reporting physician, the pt's date of birth was provided. The pt was 48 years old at the time of the adverse events. The TD ADS ADULT vaccine was administered IM, in the left deltoid, on 4/14/04 at 11:00 AM. Two days later, on 4/16/04, the pt experienced the adverse events. No other info was provided. No further info is anticipated, this case is considered closed.
This spontaneous report as received from a nurse refers to a 7 months 22 old days male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several report received from the same reporter. Additional information is not expected, no contact details were provided.
Complaints of blurry vision, R knee pain, fatigue. Started after 1st HPV vaccine 3-10-09. HPV# 2 5/12/09. HPV#3 9-15-09. Not seen by MD until 9/24/09. VA 20/20 ou, R knee exam normal, hemogram --> no anemia.
Patient states that it started with her arm being red and painful then developed a rash on her face and her throat felt like it was "tightening" and having difficulty breathing. Declined an ER visit or visit to clinic. Seen by the school nurse who cleared her to go home. She did not use her EPIPEN, or any other antihistamines.
vasculitic neuropathy / vasculitic neuropathy is a rare subtype of immune-mediated neuropathy; weakness / acute onset lower extremity weakness; distal symmetric axonopathy due to vasculitic neuropathy; This literature marketed report has been received from the authors of a published literature article and refers to a 60-year-old, female (reported as a woman) patient. She was healthy, non-diabetic. Her medical history, concomitant medications, previous drugs or allergies were not provided.  Several autoimmune disorders have been linked to vaccination. One that stood out was Guillain-Barre syndrome (GBS) following "influenza vaccine" (unspecified). Molecular mimicry was a proposed mechanism. As opposed to GBS, the vasculitic neuropathy was a rare subtype of immune-mediated neuropathy. It might or might not have been associated with systemic vasculitis. The most common phenotype was multifocal neuropathy known as mononeuritis multiplex. To the best of knowledge, distal symmetric axonopathy due to vasculitic neuropathy has not been described following pneumococcal vaccination.  On an unknown date, previously healthy, non-diabetic woman developed purpuric rash 3 days after she received a Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (dose, strength, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The rash was biopsied showing vasculopathy. For persistent eosinophilia, that was noted after vaccination, she underwent bone marrow biopsy without any evidence of malignancy. On an unspecified date, she developed acute onset lower extremity weakness worse in distal muscles. She became non-ambulatory prompting her admission to neurology service. Cerebrospinal fluid was normal, spine magnetic resonance imaging scans (MRI) were negative. Nerve Conduction Studies (NCSs) and Electromyography (EMG) revealed acute axonal neuropathy (also reported as distal symmetric axonal neuropathy). She was treated with intravenous (IV) immunoglobulin G (Ig) for possible axonal GBS without any improvement. On an unknown date, a radial sensory nerve biopsy was undertaken showing perivascular lymphocytes in the epineurial connective tissue. Rheumatology was consulted and confirmed the diagnosis of eosinophilic granulomatosis with polyangiitis. The patient was treated with high dose corticosteroids (unspecified), cyclophosphamide followed by azathioprine. The outcome of the events was not reported (unknown).  Vasculitic neuropathy was a rare entity. When it occurred, the typical presentation was multifocal neuropathy. This case described the unique case of vasculitic neuropathy, that developed in the setting of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) vaccination and presented as a distal symmetric axonal neuropathy causing weakness. The causality between the suspect vaccine and the events was assessed by the authors to be related.  Upon internal review, the event immune-mediated neuropathy was determined to be medically significant.
Pt had what looked like cellulitis; fever; chills; malaise; area above needle mark got very hot and hard; blistering.  The swelling spread and pt was treated with Dicloxacillin.
Patient was outside of the approved age range to receive the Quadracel vaccine. She did not have any adverse outcomes/signs/symptoms.
This spontaneous prospective pregnancy report has been received from a physician referring to a female patient of unknown age. On 29-DEC-2015, a dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017) was inadvertently administered to a pregnant patient (dose and route unknown). The last menstrual period (LMP) was on 19-MAY-2015 per the 32 weeks gestation at the reporting time and estimated delivery date (EDD) was on 23-FEB-2016. The pregnancy outcome was unknown. No adverse effects had been reported. Additional information has been requested.
1 day after TDAP injection, pt had fever 101 degrees. C/o nausea and vertigo. General malaise. Worth noting; pt states same type of symptoms occurred 1 wk ago.
shingles; discomfort; pain; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles, discomfort and pain. On an unknown date, the outcome of the shingles, discomfort and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, discomfort and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's friend. The age at vaccination was not reported.  The patient had both shots and a week again came down with shingles on her neck, shoulder and down her arm. The patient was in a lot of discomfort and pain.
Severe headaches, belly pain, bilateral feet-legs tingling numbness, legs aching while walking, weakness in upper and lower extremities - happened 2 wks after vaccinations - patient was hospitalized.  8/24/09 Hospital records received - 2 admissions. DOS 6/10/09 to 6/14/09 Assessment: Guillain-Bare Syndrome. Allergic rhinitis. Transfered from another hospital ED. Presented with leg pain and weakness, headache, cough, and intermittant abdominal pain for 2 weeks. Vomiting. Difficulty walking, legs buckled. Decreased patellar DTRs bilaterally, unsteady gait. Anterior thigh pain, 'stinging' sensations in feet. IVIG administered.  DOS 6/16/09 to 6/23/09. Assessment: Guillain-Bare Syndrome. Allergic rhinitis. Patient returned with recurrent headache and abdominal pain. Dysautonomia associated with GBS. Decreased appetite. Fecal impaction. Large amount of loose stool with resolution of abdominal pain.  ICD-9 Codes: 357.0 Acute infective polyneuritis, V17.49 Family history of cardiovascular diseases, 455.6 Unspecified hemorrhoids without complication, 789.00 Abdominal pain unspecified site, 477.9 Allergic rhinitis cause unspecified, 518.89 Other diseases of lung, 792.0 Nonspecific abnormal findings in cerebrospinal fluid, 790.99 Nonspecific findings on examination of blood, 787.91 Diarrhea, 346.20 Varients of migraine.
This case was reported by a consumer via interactive digital media and described the occurrence of hives in a female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to Meningococcal B vaccine. Additional details were reported as follows: The age at vaccination was reported. The reporter's daughter had one on the 29th and experienced hives for over 14 days.
It began with violent throwing up, fatigue, inability to eat and dehydration. It turned into a brain swell and a subsequent craniotomy.
neuropathy in each arm and both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in each arm and both hands".  Clinical course: After receiving a Pfizer vaccine in each arm I now have neuropathy in each arm and both hands. I don't have diabetes or any other issues I think I need to be compensated for this horrible heath issue.   The information on the batch/lot number for BNT162B2 NOS has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300093283 same patient, same vaccine, different doses, same events;
Patient passed out. Because of falling and hitting her head a number of medical issues arose but the issues were due to the fall not the vaccine.
her arm swelled up; This is a spontaneous report based on the information received by Pfizer from Merck National Service Center (Mfr. Control No.#: 01514538). A contactable consumer (patient's daughter) reported for a female patient that:  To Whom It May Concern:  The Merck National Service Center has received information regarding an adverse experience report for the product listed below. Since this product is manufactured by your company, I am forwarding all available data we have received for this report of an adverse experience to you for your processing and follow-up investigation.  Description: The daughter of the patient stated "My mother received Prevnar 13 in 2010, I think, and her arm swelled up." Many fields marked refused to answer as the caller disconnected the line and an outbound call to them was unsuccessful. Full patient and health care provider demographics refused. No AE/PQC.  Physician Information: First Name: Refused to answer Last Name: Refused to answer Type: Physician Country:   Product: Product: Prevnar Product Circular #: # Lot Number: Refused to answer Expiration Date: Refused to answer Dose/Frequency: Refused to answer  No follow-up attempts are possible. No further information is expected.
PT DEVELOPED SOFT TISSUE SWELLING IN UNDERARMAND NECK AREA.   DENIED PAIN, SWELLING, IRRITATIN OR REDNESS AT INJECTION SITE.  MD RECOMMENDED PT NOT GET FLU VACCINES IN THE FUTURE AND PT IS TAKING IBUPROFEN FOR PAIN ASSOCIATED WITH SWELLING.
My partner and I got the vaccine around 1 pm, we decided to go home immediately after in cause any of us developed side effects. During the first couple of hours, I felt a little nauseated, but that went away. Everything seemed ok until at around 9pm I started to develop pain on my left arm. I took Advil and relaxed, at around midnight, I was in excruciating pain, I lost complete movement of my arm. I wasn't able to sleep that night. The next day I tried 800mg of Aleve which helped very little. I couldn't move or do anything I normally do. That night I also developed fever and I sweat a lot soaking the sheets and the mattress. The extreme pain continued for the next 3 days, until on the forth day, it went away. Today marks 8 days since my injection, and I woke up last night with the same pain. I took Advil and it alleviated somewhat. I could describe the pain as an inflammatory pain that pulses in the bone and nerves. If I tried to forcefully move my arm, it felt like my arm was being ripped from my body. I was in tears for days.
Several hours after injection, the patient began shaking with chills, burning eyes and a fever of 101. This continued most of the night and subsided by 9 AM on 4.1.21.  Since then he has continued with regular activities with minor discomfort.
I got the first dose of the Pfizer vaccine on Saturday 8/7/2021. A few hours later I developed symptoms like a cold (extremely runny nose, scratchy throat, headache) but no fever. Those symptoms lasted through Monday 8/9/2021. Sunday night (8/8/2021) I developed pressure in my chest  which continued through 8/11/2021. I wouldn't say it was shortness of breath exactly as I was not gasping to breathe, but I was having to work harder to breathe.
pt recv vax;pt was well until 12:30pm,cried & fussed from 12:30 - 2:15pm;sz;listed < 1min;
This case was reported by a consumer via call center representative and described the occurrence of memory impairment in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (at 45 years old). Concurrent medical conditions included blood cholesterol increased. Concomitant products included SHINGRIX, simvastatin, citalopram and fexofenadine hydrochloride (Allegra). On 2nd November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 7 days after receiving SHINGRIX, the patient experienced memory impairment, confusion and light-headed feeling. On an unknown date, the outcome of the memory impairment, confusion and light-headed feeling were not recovered/not resolved. It was unknown if the reporter considered the memory impairment, confusion and light-headed feeling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 17th October 2018, the patient reported getting dose 1st of SHINGRIX at the doctor's office. There were no events associated with this injection. The concomitant products included unspecified vitamins. The reporter gave consent to follow up.
64 Male retired, with obesity, HTN, HLD, DM, OSA on CPAP, HFpEF, depression, Covid vaccinated with J&J in March 2021, developed cough on 10/30, tested COVID positive 11/3/21, had increased SOB at home with O2 sat 90%   COVID Pneumonia/acute respiratory failure - treated with decadron and remdesivir with good response. Supplemental O2 was successfully weaned to room air.    HTN/HFpEF -  BP stable, no overt HF on exam. Continued on amlodipine, atenolol, losartan, and asa   DM - managed with a regimen of NPH, pradnial and sliding scale insulin. Will need to continue titration at home as last dose of decadron was given on day of discharge.   OSA -  continue home CPAP   Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  covid pneumonia
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAY-2016 the patient was vaccinated with M-M-R II (dose and route not reported, lot # K021950, expiration date 10-NOV-2016, therapy type rHA (recombinant human albumin)). Concomitant therapy was not reported. The vaccine was exposed to temperature excursion of 27.9 degrees Fahrenheit (F) for 20 hours 53 minutes and 41.7 F for 12 minutes. Data logger was involved. It was reported that there was no previous temperature excursion. No adverse effects were reported. This is one of two reports from same reporter. Additional information has been requested.
Day 1-2 warm, arm pain Day 4-8 headache with pressure causing dizziness and some mild tingling in face, extreme fatigue, lack of appetite