chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed shingles approximately one week after receiving  dose 1 of the Pfizer-Biontech vaccine. I reported my symptoms at the hospital in which I am employed, and was diagnosed with Shingles. I had a red rash on my right side only running horizontally sternum to spine. i was prescribed antivirals and topical Lidocaine patches. The rash progressed to a two inch wide strip of blisters running along my right side. The blisters closed within two weeks. I am still experiencing  neuralgia, although to a much lesser degree as time goes by.
Arm soreness at site of injection., sore throat, tactile fever (did not measure temp), mild malaise. Not severe enough to impact daily activity meaningfully.
Patient in observation, reported feeling left arm numbness, tingling. Patient state feeling left hand and forearm red and splotchy, no hives. Vital at 1430- BP 122/80, HR 122 (patient is anxious), RR 24, O2 100. Patient denies any SOB, swelling of face or tongue, no trouble swallowing, chest pain or hives. Patient calling provider, as patient is waiting for provider to reach back vital were assessed again at 1442, BP 118/74, 02 100, HR 95, RR 20.  Provider called back,  nurse reports provider would like for the patient to stay at site for additional site hour and monitor.  Provider any severe symptoms to see ED. Provider okay to for patient to take Benadryl. Patient refused Benadryl at this time wants to take it at home do to concern of drowsiness. Patient denies any new symptoms. V/S check at 1512- 114/80, 02 99%, HR 93, RR 20, Temp 98.5. No changes.  V/S check- 1548 BP 112/78, 02 99%, HR 91, RR 16, patient no worsening or new symptoms. After hour, patient reports feeling fine and safe to drive home.  Called patient in the evening, patient reports feeling fine and took some Benadryl.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 28-SEP-2016, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-DEC-2016, the patient was treated by a physician/MD at medical office for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Developed shingles (Zoster) 3 days after receiving ZOSTAVAX.
This spontaneous report as received from a pharmacist refers to a patient, over the age of 65 years. The patient's concurrent conditions, medical history and concomitant medications were not reported. The pharmacist reported that on an unspecified date the patient (over the age of 65 years old), received a first dose of an PNEUMOVAX 23 (reported as unspecified PNEUMOVAX 23 could not be ruled out) (strength, lot#, dose and route not reported). The pharmacist reported that on an unspecified subsequent date, the patient was given a possible 2nd dose of PNEUMOVAX 23 (strength, lot#, dose and route not reported). No adverse effects reported. Product quality complaint (PQC) was not involved. No additional information available. Additional information has been requested.
2ND DOSE WAS ADMINISTERED , ONE OF OUR FILL-IN PHARMACISTS; PERHAPS WASN'T CHECKED?; PFIZER WHEN IT SHOULD HAVE BEEN MODERNA; CORPORATE CLINICAL STAFF WERE INFORMED & CONSULTED; MODERNA 2ND DOSE DOES NOT NEED TO BE REPEATED; PT WAS INFORMED AND IS COMFORTABLE WITH THE 2 BRANDS.
Facial tingling/numbness to face contralateral to injection site starting 30 minutes  (time 1600) after injection and spreading to entire face.  Symptoms resolved 4 hours later.  Intermittent palpitations starting during this time  which have not resolved to this day.  Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected  supraclavicular lymph node swelling on injection side.  Consistent fever of 102 degree  fahrenheit starting 12 hours (time 0330) post injection and lasting  for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose  (0630). Also have continued to have dull headaches since vaccine dose.
Outbreak of shingles on the trunk of left side of body. Completely wrapped around the mid-section.
Extreme weakness, difficult to get up from couch, difficulty getting up to use bathroom, unable to change clothes on own, very weak. Parents were unable to get through to doctor's office that administered vaccine.
Shortness of breath, hives, tachycardic approximately 20 minutes after receiving vaccine. Treatment: BENADRYL, PEPCID IV.
Approximately 11 hours after shots both feet swelled and turned purple with red blotches. Fussy. No fever or crying. Called family MD who ordered Benadryl. Back to normal after about 8 hours. Fever reducer also given.
Nearly fainted while doing normal activity; Extreme dizziness; Leg muscle weakness; Weight on chest; Difficulty catching breath-lasting; This is a spontaneous report from a contactable consumer.   A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0155), dose 1 via an unspecified route of administration, administered into the  right arm on 10Apr2021, at 16:30 as single dose for covid-19 immunization. Medical history included no significant findings. Concomitant medication included botulinum toxin type a (BOTOX) taken for an unspecified indication, start and stop date were not reported. No known drug allergies were noted.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 13Apr2021, at 19:30, the patient nearly fainted while doing normal activity, extreme dizziness, leg muscle weakness, weight on chest, difficulty catching breath-lasting were all noted. The events resulted in doctor or other healthcare professional office/clinic visit.   Details were as follows:  the patient nearly fainted while doing normal activity, had extreme dizziness, leg muscle weakness, weight on chest, difficulty catching breath-lasting more than seven days. Unspecified therapeutic measures were taken as a result of the events;  treatment was also noted as still pending labs, to identify problem.  There was no COVID-19 diagnosis prior to vaccination. Patient has not been tested for COVID-19 since vaccination. The outcome of events, nearly fainted while doing normal activity, extreme dizziness, leg muscle weakness, weight on chest, difficulty catching breath-lasting  was recovered with sequelae; the patient recovered with lasting effects.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event "Nearly fainted while doing normal activity" and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. 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.
Feels fever/chills, rigorous appearance, 99.8 degrees symptoms started 20 minutes earlier, vaccines administered 1 hour earlier treated with rest and TYLENOL.
I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circle. I also started to get a headache. I took 3- 200mg ibprofen. About 10 minutes later, the vision problem went away.
Patient received her flu shot administered very high up on the shoulder that resulted in arm numbness that lasted for hours, chest pain that radiated from the shoulder across the chest, shortness of breath.  This prompted the provider to take ibuprofen and head to the ER.  While being seen in the ER her arm numbness and other symptoms slowly resolved on its own.
Covid19 Adverse Event.  1st vaccine received on 08/08/2021.  30 y/o with PMHx Lupus, Lupus Nephritis with ESRD on Hemodialysis, HTN, GERD, Pancreatitis, Marijuana use presents to ED with c/o generalized weakness, fatigue, headaches and muscle/body aches since received Covid19 booster vaccine on 02/05/2022.  Pt immunocompromised due to monthly Brilinta infusions, steroids and Cellcept.  As a result of Covid19 vaccine booster side effects, pt missed two hemodialysis sessions resulting in elevated BP requiring ICU stay for Cardene gtt.
About 15 minutes I started to get hives, skin reaction and felt chest pressure, I let Dr. know I wasn't feeling well, administered Epinephrine with own EpiPen,  noticeable hives and redness across neck and upper chest.  Transported to the ED.   2nd dose of Epinephrine at 1:20pm for throat swelling and bronchospasm.
Case number PHEH2016US026307, is an initial spontaneous report received from a nurse on 07 Oct 2016. This report refers to a 96 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with single dose of FLUCELVAX (batch number: 185327) at a dose of 0.5 ml, intramuscularly on 06 Oct 2016. It was reported that, FLUCELVAX was exposed to 65 Fahrenheit for 32 hours and administered to one patient. No adverse event was reported following this medication error. Follow up report received from a healthcare professional on 14 Oct 2016: Updated reporters (nurse) complete address.
Chills, body aches, head ache pain.  pt went to md office and got a steroid shot
I had a fever I couldn't sleep and ringing in the ear and then I went to the ENT. They said it's just normal and then I tried a couple of medicines and it still didn't work and I couldn't sleep. I had the ringing in the ear and I did the hearing test and they said I don't need to worry about it and then in August I went to do an MRI and found a brain tumor. I just had the surgery to remove to the tumor.
Diarrhea for 3 weeks now; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included known allergies to sulfur. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced diarrhea for 3 weeks now. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of diarrhea. The patient has not recovered from diarrhea.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient c/o of gross swelling & redness of upper (L) arm. Stated it felt warm, temperature was checked & normal. Patient stated she was extremely lightheaded. Experienced same reaction last year by primary doctor thought it was from tetanus as she received at the same time at f/u.
This spontaneous report as received from a physician via a field representative refers to a 80 year old patient of unknown gender. In August 2011, three years ago, the patient was vaccinated with ZOSTAVAX lot# and strength unknown, one injection, subcutaneous for prevention of shingles. On unspecified date in August 2013, one year ago, the patient experienced shingles and was experiencing chronic pain from nerve damage and complications with Postherpetic Neuralgia (PHN). The outcome of shingles, complications with (phn) postherpetic neuralgia and nerve damage was unknown. The patient sought medical attention ("out patient setting") and received unknown treatment for the events. The outcome of chronic pain from nerve damage and complications with (phn) postherpetic neuralgia was not recovered as she was still experiencing at the time of the report. Additional information is not expected since we cannot contact physician.
Initial unsolicited report received from a nurse on 10 Nov 2016. This case involves a male patient (age-unspecified) who was vaccinated with an injection of FLUZONE QUADRIVALENT  (Batch number-UI684AA; expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed change in mental status and confusion which lasted approximately 4 hours and patient had to be driven home from work. Laboratory investigations and corrective treatments were not reported. The patient recovered from all the events. List of documents held by sender: none
Pt is enrolled on protocol 0065 at the hospital. He signed consent 9/4/02 and has only received the pneumococcal conjugate vaccine on 9/9/02. He came into hospital with c/o right arm pain. After careful assessment, a pathologist fracture of the right humerus was diagnosed. In addition, the pt has a left inguinal hernia which pre-dated his enrollment on study. The pt was admitted for a surgical consult for both complaints. Neither event will alter the treatment schedule for the study. Date of Visit: 9/9/02 I had seen the pt on 9/9/02 because of a complaint of right arm pain. For details of his disease, refer to the prior dictation of 9/5/02by MD. Briefly, complained of more or less of a sudden onset of right arm pain that has gradually increased in intensity. Today, he has limited range of motion related to that pain. The pt is able to pinpoint the pain to the midshaft fo the humerus. I have reviewed the skeletal survey that was done last week for involvement on the protocol, and it is clear that the pt has multiple lytic lesions affecting the midshaft of the humerus, which I believe is the reason for his pain. Of note, is the pt also noted that there is increased left inguinal swelling which has gone down the scrotum, and according to him, was turning blue in the last couple of days. On examination of that area, it is clear that the pt does have a large inguinal hernia extending into the scrotum. I was unable to detect any masses. This hernia was reducible on deep palpation and I really did not have any evidence of strangulation at this point. The testis was palpable below the inguinal hernia and was a normal size, and I could not palpate any hard masses. There is no lymphadenopahty in that area. However, because of the size of this lesion, I believe the the pt should have a Surgical consult for possible reduction to prevent any further complications, considering his age and the chemotherapy he is anticipated to undertake in the future. I will convey this info to MD. I do not believe that it should interfere with any of the protocol sequencing, however, we might want to postpone the Cytoxan mobilization until the reduction is obtained. I will leave the decision up to MD. This document has been read and signed. Please contact the medical records dept for any questions regarding this document. Final report: indication-multiple myeloma in hepatitis B pt, previous lesion right humerus, now painful, suspicious for fracture. Right humerus: two views are compared to the prior bone scan 9/4/02. Diffuse moth-eaten lucency extending through the mid humeral diaphysis with scalloping of the endostoal cortex is unchanged from previous without evidence of acute fracture. Area of abnormality extends over 9.5cm in vertical extent. This was seen on the prior bone scan. Focal luancies within the proximal humeral diaphysis are ntoed which were seen on prior study consistent with foci of multiple myeloma as well.
5/6/2021-symptomatic with Covid symptoms of fever, cough. 5/10/2021-admitted to Hospital for Covid 19 issues.
DRUG INDUCED POLYNEUROPATHY 9/30/2022  &  3/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Sore shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulders) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulders). At the time of the report, ARTHRALGIA (Sore shoulders) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were provided.   This case was linked to MOD21-070927, MOD-2021-069954, MOD-2021-069633, MOD-2021-069962 (Patient Link).
Per hospital event report "Mixed Pfizer with Sterile Water Diluent instead of the NS as was supposed to. Noted this error when removing syringes from bag provided and the NS diluent was in the bottom of the bag for use." This was noticed prior to administering to patients.
local and widespread rash immediately after vaccine. development of inflammatory arthritis affecting multiple joints along with dyspnea and productive cough 2 weeks after vaccine.
Vaccination was uneventful. Day after felt slight nausea and little dizzy/off with increasing pain in left axilla - mild swelling and tender lymphnodes on palpation. Recent mammogram was normal. No other lesions on arm or chest to explain unilateral lymphandenopathy.
brusing; hot sweats; dizziness; eye sight weak; muscles hurt; nausea; headache; fatigue; vomiting; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8733) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL), mefenamic acid (ADVIL) and ibuprofen sodium (MANUFACTURER UNKNOWN); all for unknown indication taken on unknown date and unknown if still ongoing. The patient did not have allergies to medications, food, or other products. On 10Apr2021 at 12:00, the patient experienced sore arm, brusing, vomiting, hot sweats, nausea, dizziness, headache, fatigue, muscles hurt and eye sight weak. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, bruising, vomiting, hot sweats, nausea, dizziness, headache, fatigue, muscles hurt and eye sight weak was resolved on an unknown date in May2021. Later patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0172) via an unspecified route of administration in the left arm on 05May2021 at 21:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
When logging 5/11 Moderna dose into , patient was logged for a Janssen vaccine on 4/09/2021. Patient stated at time of appointment that this was his first dose of COVID vaccine.
Fever, headache, dehydration, acute worsening of renal failure, required aggressive rehydration. 12/2/09 Hospital records and DC summary received for dates 11/9/09 to 11/18/09. DX:pyelonephritis, acute renal failure. Presenting SX: fever, cough x2 days, emesis, HA. Pt received H1N1 vax x5 days ago. Assessment: cough, wheeze, HA, fever, elevated creatinine, nasal congestion, vomiting
patient had fever on 1/14/22. Developed chest pain with every beat and change in position on 1/15/2022..
This spontaneous report as received from a physician via a company representative and refers to a female patient of unknown age. In 2014 (exact date unspecified, reported as this summer) the patient was vaccinated with GARDASIL in the arm (dose, units, route of administration, lot number were not reported). In 2014 (exact date unspecified) the patient experienced numbness in an unspecified arm. There was treatment given for the adverse event ADVIL. The patient did not seek medical attention. The outcome of numbness in an unspecified arm was not reported. The relatedness between event and GARDASIL was not reported. Additional information has been requested.
Flu like symptoms Chills Low body temperature  Vomiting  Aches Extreme fatigue  Headache  (No treatment)
Soreness at injection site One week later, my doctor discovered a subchronic hematoma in my uterus after I had spotting at home
No Adverse reaction received booster at 16 year old and 11months ( Pfizer)
This is a spontaneous report from a contactable consumer (reporting for cousin of mother). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient passed out either the next day or shortly after receiving dose of BNT162B2 on an unspecified date, a medically significant event.  The outcome of the event, passed out was unknown.   Information on the lot/batch number has been requested.
6/17/02 mother calls stating child given varicella 6/6/02 child now has red spot on legs, did not have last week. Advised child to be brought to office. Child not brought in. 6/19/02 mother calls pt child still with spot of redness, insists report be filed. Speaking with MD and advised mom use Benadryl it if spot still present in AM child to be seen.