chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Peeing more often than normal; Like flu symptoms; Reaction to the vaccine; To the point he almost peed in his pants twice today; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Peeing more often than normal), INFLUENZA LIKE ILLNESS (Like flu symptoms), VACCINATION COMPLICATION (Reaction to the vaccine) and BLADDER DISCOMFORT (To the point he almost peed in his pants twice today) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced POLLAKIURIA (Peeing more often than normal), INFLUENZA LIKE ILLNESS (Like flu symptoms), VACCINATION COMPLICATION (Reaction to the vaccine) and BLADDER DISCOMFORT (To the point he almost peed in his pants twice today). At the time of the report, POLLAKIURIA (Peeing more often than normal), INFLUENZA LIKE ILLNESS (Like flu symptoms), VACCINATION COMPLICATION (Reaction to the vaccine) and BLADDER DISCOMFORT (To the point he almost peed in his pants twice today) outcome was unknown.            No Concomitant and  treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Non-significant FU - Email address provided.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported event and excluding any other etiology, a causal relationship with the event cannot be excluded.
This case was reported by a physician via call center representative and described the occurrence of rash in a 64-year-old female patient who received SHINGRIX. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th April 2018, less than a day after receiving SHINGRIX, the patient experienced rash, fever and erythema. On an unknown date, the outcome of the rash, fever and erythema were unknown. It was unknown if the reporter considered the rash, fever and erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient received SHINGRIX on right deltoid and developed events within 24 hours of the dose. The health care professional stated that the patient required a physician visit because she went in to see the physician on 16th April 2018 due to these adverse events. The health care professional was not sure how the patient was doing and they would be calling the patient later on the day of reporting. The reporter did not collect vaccine lot number and expiry date.
Pt had fever 101 F and excessive crying. Taken to VHCC ER on 7/26/01
Pathological fracture of right hip due to neoplastic disease with routine healing, subsequent encounter. Hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from an unspecified reporter via a company representative concerning a 35 year old patient of unknown gender. On an unknown date, a 35 year old patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Narrative:  54 yo M with h/o HepC, hyperlipidemia, hyperparathyroidism, tobacco use, and opioid use disorder died on 5/26/2021 at an out pt, unknown location. Pt had received covid vaccinations on 04/05/2021 and 05/05/2021. Death unrelated to vaccinations.
Case number PHEH2013US018639, is an initial spontaneous report received from a physician on 03 Sep 2013, with the follow-up received on 15 Oct 2013. This case refers to an 18-years-old patient of unspecified gender. The patient received MENVEO (batch number: A11072) accidentally mixed with sterile water instead of Men CYW-135 liquid conjugate, intramuscularly in the left deltoid on 02 Aug 2013 at 12:09 PM. The patient also received hepatitis A (other manufacturer, batch number: JR737) at dose of 0.5 ml intramuscularly on 02 Aug 2013. On the same day after vaccination, the patient experienced vasovagal syncope and recovered on the same day. The patient received complete dose of MENVEO on 11 Oct 2013 without any adverse event. The event was reported as non-serious. Follow-up received on 15 Oct 2013: Updated patient demographics (initials, date of birth, height and weight), vaccine batch number, vaccination date and route of vaccination, co-suspect vaccines, adverse event and outcome, information on complete dose.
Received shots 8-16-10. On 8-17-10 began with headache, hot flashes, chills, sore throat, weakness, trouble breathing. Mother took to E.R. 8-17-10 in pm.
This spontaneous report as received from a physician via company representative refers to a 14 year old female patient. On 28-AUG-2014 the patient was vaccinated with GARDASIL (dose, lot no. not reported) intramuscular. On 28-AUG-2014, therapy the patient experienced nausea right after GARDASIL injection. Nausea lasted for 30 minutes. The outcome of nausea was reported as recovered on 28-AUG-2014. There was no intervention to prevent serious criteria. The patient did not receive any treatment for the event. Product quality complaint was not involved. The causality of nausea with GARDASIL was unknown. Additional information is not expected because physician cannot be contacted.
Information has been received from a physician concerning a 67 year old male with colitis ulcerative, gout and metabolic syndrome whose wife was vaccinated with ZOSTAVAX (Merck).  The physician believed that ZOSTAVAX had been transmitted from a vaccinee to a susceptible contact causing shingles.  The patient's concomitant therapy included balsalazide disodium (manufacture unknown), OMEPRAZOLE (manufacture unknown), and  PAROXETINE (manufacture unknown).  The patient's wife was vaccinated with ZOSTAVAX (Merck) (LOT# not reported) on 19-JAN-2009.  The patient started to feel "funny" approximately one week ago, then rash appeared 3 days ago.  The rash appeared near his right forehead and eye.  The wife had no symptoms.  The patient was not recovered from the adverse events.  It was reported that the patient sought medical attention:  saw the physician.  Additional information has been requested. 06/24/09 This is in follow-up to report(s) previosly submitted on 3/27/2009. Follow-up information was received from the physician which reported that the male patient also had GERD, allergic rhinitis and spondylolisthesis. The information about vaccination was unknown because the vaccine was given by the wife's physician to the patient's wife on 19-JAN-2009. The patient developed atypical zoster like rash and outbreak of shingles on the face on 31-JAN-2009. The patient was seen in the eye clinic on 21-FEB-2009. The patient's experiences had been treated (treatment not specified). The outcome of shingles was unknown. The relevant diagnostic test and laboratory was reported as NA. Additional information has been requested.
Deceased received second Moderna dose on 3/11/2021 at unknown location and unknown time. Complained of 'side effects' which are unclear at this time. Had a sudden witnessed cardiac event on 3/14/2021 and was rushed to a local emergency department. Diagnosed with ST elevation MI and could not be fully resuscitated.
Pt felt dizzy about 2-3 minutes after BOOSTRIX was given(MENACTRA given about 2 min earlier). Pt tried to lie down on exam bed but felt from bed - did not recall falling from bed. Awake after few seconds.
A non-serious spontaneous report of administered FLUMIST to pregnant patient was received from a consumer concerning a 15-year-old female. The patient's medical and obstetrical history were not provided. The patient received FLUMIST on 06-Oct-2009 and later reported that she was seven weeks pregnant. Laboratory test, date of LMP and estimated date of delivery were not reported. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experienced any adverse events during the pregnancy.
About 2 weeks after my shot, I started to experience muscle twitches in various/random parts of my body, but the majority were in my arms and legs.  They do seem to be persistently happening behind and above my right knee with regularity.  It is particularly noticeable in the mornings right before and after I am awake.  During the day, I either don't notice the twitching, or it is not as prevalent.
Pt reported localized itchiness at injection site. No redness or swelling noted. Pt given 10ml Benadryl PO. Pt educated not to drive. Pt stayed for 30minutes. No other reactions noted.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm) 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 MYALGIA (Sore Arm). At the time of the report, MYALGIA (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-237486 (Patient Link).
w/in a few min of vax pt exp gen itching, felt hot all over, devel lumps @ site of vax;w/in 2-3hr devel swelling & pain @ vax site which extended from neck to fingers;seen by MD rx DPH & claritin;swelling improved but painful area ecchymosi
sore arm; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for an unknown indication.    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 and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of Every four hour. At the time of the report, PAIN IN EXTREMITY (sore arm), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            Patient received antidepressant and sleeping pill.  It was reported that patient received Johnson and Johnson vaccine and then the second dose of Moderna. Caller did not have their vaccination card at the time of call. patient said they had a sore arm with the first two.   This case was linked to MOD-2022-667601 (Patient Link).
This is a spontaneous report from a contactable consumer, patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6198) via an unspecified route of administration on 02Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient experienced itchy arm, itchy and watery eye on an unknown date in Mar2021.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for itchy arm and watery eye. The clinical outcome of itchy and watery eye was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Red skin on the arm that took the vaccine. Feel Itchy on the same arm. My pollen alergy symptom gets worse - noses are completely blocked and hard to breathe.
Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid). At the time of the report, COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment drug details was reported.
Ppatient presents to immunizations clinic on 2 November 2011.  She reports that she has had pain above the injection site of left arm since the day of injection.  She notes that it is worse over the past few days and now she has pain in her whole arm.  She also notes swelling above her injection site on that side.  No redness or induration.  No fevers.  No systemic symptoms suggestive of anaphylactic event.  According to shot record, pt was given MMR and Tdap in that arm. Pt was referred to flight medicine for acute evaluation and treatment.
This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was excursion from freezer) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient experienced product temperature excursion issue (there was excursion from freezer). On Oct 25, 2021, product temperature excursion issue (there was excursion from freezer) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Used excursion tool but their is no option for the excursion they experienced. Tool only gives option for excursion one hours and not less than.
Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-366918, MOD-2021-366925 (Patient Link).
Swelling on right arm near the shot but below it, hot to touch, painful, very itchy.  Tightness in chest for one day after shot; a little difficulty breathing
Within 5 mins. of receiving Tdap and MENACTRA, pt began scratching (R) arm - lower arm MENACTRA was given IM deltoid are (R) arm. Pt had dizziness as well.
Less than 12 hours after administration, complained of tactile fevers, nausea, vomitting, dizziness.
I had swelling of my arm with redness for a couple of days. The headache came a day or two after, a wicked migraine. I wasn't able to focus and had to close my eyes and lay down. At first, the headaches were on and off for several days, then they were constant for 2-3 weeks. I was told to take Tylenol and rest.
flu symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (flu symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu symptoms). At the time of the report, INFLUENZA (flu symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2022-561891, MOD-2022-561887 (Patient Link).
Intermittent episodes of discrete palpitations - heart beating strongly and has continued to occur, started day of vaccine. Also with vague sense of upper mid-chest tightness.    Had brief symptoms after 1st dose.  They have persisted after 2nd dose
Initial and follow-up information has been received from a physician concerning an "otherwise healthy" 13 year old female who was vaccinated with her first and second doses of Gardasil. Subsequently the patient experienced what was thought to be transverse myelitis and was hospitalized. She experienced paralysis from the chest down, lesions of the optic nerve, and was diagnosed with "Neuromyelitis Optica (NMO)". The patient was treated with high dose corticosteroids (unspecified) and did not respond. A course of Cytoxan was planned. Duration of hospitalization was not reported. At the time of the report the patient had not recovered. Additional information has been requested.  5/13/08 Reviewed hospital medical records of 8/1-8/24/2007 & 9/25-9/26/2007. FINAL DX: neuromyelitis optica. Records reveal patient experienced sudden onset of bilateral LEs weakness & numbness proceeded by several hours of leg pains, LBP & urinary retention.  Parent w/gastroenteritis several weeks prior.  Patient had malaise at that time but never actually ill.  Admit exam revealed areflexia bilateral LEs, loss of sensation below T12 bilaterally as well as flaccid paraplegia & urinary retention.  Admitted to PICU.  Tx w/IV steroids w/no improvement.  Tx w/plasmapheresis, I/O cath, bowel regime. Neuro, rheum, psych consults done.  Developed decreased sensation up to T8, restarted IV steroids & MRIs repeated.  Tspine MRI revealed traumatic progression of disease up to T4-5.  No improvement w/additional steroids or plasmapheresis.  Tx w/IVIG x 7 days w/no improvement but no worsening.  Transferred to inpatient rehab to be readmitted for rituximab in the next month.  Medical records of 9/25-9/26/07 for rituximab infusion.  Exam revealed loss of motor control of bilateral LEs.  Was to return 10/2 for second treatment & PICC placement.  Patient continued to be home schooled due to her condition.
Severe erythematous rapidly progressive rash spreading distally down right arm past elbow. Self-resolved after 3 days.
Patient reported feeling shaky and dizzy Patient seen by medical team and refused medical transport and signed AMA form Patient stated symptoms improved Patient driven home by family
Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:
1635 patient reported feeling faint and "felt dizzy after vaccine" and "body tingly". Patient was escorted to separate observation area where their pressure was 140/74 and patient was alert and oriented. At 1638 - skin color returned to color. 1640 119/81, HR 60, 100% on Room Air. 1645 135/85, HR 84, RR 18, 99% on RA. 1653 patient sat up "feeling warm sensation" in right shoulder up to neck. 1700 128/75, HR 67, 100% on room air and not in acute distress. At 1708, patient was asymptomatic. Pt left via ambulation with family member and was escorted out of the facility. She was encouraged to rest, take fluids, and call their PCP.
Shaking chills and a fever of 101 on the vaccine. Fever of 103 degrees on the next day. Some Lymph node pain. Muscle aches and fatigue not much memory of that day.
Feeling unwell, T 103, marked erythema to (L) arm vaccination site, no ulcer, no drainage, mild erythema to (R) arm vaccination site.
Chills; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 15:15 (Lot number: EW0217) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Cholesterol" (unspecified if ongoing); "blood clots in legs" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol (ongoing); ELIQUIS taken for thrombosis (ongoing). Vaccination history included: Bnt162b2 (Dose:1, Lot:  EL3247, administered in left upper arm), administration date: 05Mar2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Lot: EP6955, administered in left upper arm), administration date: 24Mar2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "Headache"; Flu vaccine (Date: 05Oct2021, it was two weeks before the Pfizer Covid Booster. ), administration date: 05Oct2021. The following information was reported: PYREXIA (non-serious) with onset 21Oct2021 10:00, outcome "recovered" (22Oct2021), described as "Fever"; CHILLS (non-serious) with onset 21Oct2021 11:00, outcome "recovered" (22Oct2021), described as "Chills".  Additional information: He got the booster dose on Wednesday 20Oct2021 and everything was fine. Then on 21Oct2021 he started to have fever and chills.  He stated the fever is all the way gone. He is starting to get better. He went to bed on 21Oct2021 and when woke up 22Oct2021 he felt better. He was unable to confirm if he has recovered completely or with lasting effects from the fever. He stated he is 80% recovered as it has not been exactly 48 hours yet. He confirmed the chills are gone. They went away the morning of 22Oct2021. He confirmed the outcome as recovered completely. The fever and chills began around 10:00 /11:00 AM Awareness date of fever and chills after the Pfizer Covid Booster- confirmed as 21Oct2021.   No follow-up attempts are possible. No further information is expected.
45 min post vaccine: hives x3 on neck interior, 1 1/2 hours post vaccine: resolution of above after elimination of Diphenhydramine 12.5/5ml 10ml PO 15 min after onset of sxs.
sudden loss of taste, sinus pressure and drainage,  Zyrtec and Flonase, Sudafed