chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Complete left sided deafness; This is a spontaneous report from a contactable physician. A 69-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular, on 29Jan2021, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension and diverticulitis. Patient had no known allergies. Concomitant medications included several prescription medications. Patient did not receive other vaccine in four weeks. The patient experienced complete left sided deafness (disability, medically significant) on 29Jan2021 with outcome of not recovered. Therapeutic measures were taken as a result of the event and included treatment with steroids. The event required physician office visit. The reporting physician could not say that the vaccine definitely caused the event. But as the event happened shortly after the vaccine, the physician felt that it was reportable. The patient was not tested for COVID-19 after vaccination.  The information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event deafness unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Client received first dose COVID vaccine @ 1:52 pm.  Client complained of dizziness and headache @2:15pm.  Client helped to zero-gravity chair, given some water to drink.  Client denied shortness of breath.  Client denied any allergies, not taking medications, her son reports she's had high blood pressure before.  Blood pressure @ 2:25pm is 170/115, heart rate 86, respirations 16, O2 sat 98 %.  Blood pressure 162/98, pulse 78, respirations 16 @ 2:33pm.  Client reports head ache and dizziness present but lessened @ 2:40pm, blood pressure 155/98, pulse 81, respirations 18.  Client states she wants to go home @ 2:47pm, instructed to follow up with primary care and when to call 911.  Client left observation area with son, able to walk with steady gait.
Patient c/o onset of upper left arm redness, itching and heat on 8/16/16 that spread slowly from injection site to elbow and shoulder. Initially treated symptoms with BENADRYL but no significant relief. Pt sought further evaluation from PHP on 8/20/2016. Patient given Rx Prednisone 10mg daily PO and Cephalexin 500 mg PO. Patient presented to our HD on 8/22/16 with only slight appearance of redness to reported area. Swelling was absent.
Patient's arm turned black and blue from shoulder to elbow and was sore. The black and blue is still there but not as bad and still a bit tender even a month later.  Did not seek treatment or medical help.
Case number PHHY2011CA84230 is an initial literature report received on 16 Sep 2011. Authors described about novel influenza (H1N1) infection in pediatric renal transplant recipients who were vaccinated with influenza H1N1 vaccine. This report refers to a pediatric patient (age less than 18 years) of unknown gender. The patient's medical history included renal transplant. The patient received induction therapy consisting of five doses of daclizumab (1mg/kg) at two weeks intervals starting the day of transplant. Concomitant medications also included prednisone 0.22 mg/kg/day, tacrolimus 0.32 mg/kg/day and mycophenolate mofetil 862.1 mg/BSA/day. The patient was vaccinated with influenza H1N1 vaccine (manufacturer and batch number: unknown) on an unspecified date. Ten days after vaccination, the patient developed H1N1 influenza infection which got confirmed. The patient received either oseltamivir or antibiotic medications and supportive treatment for the same. The length of H1N1 course was in range between 3 to 14 days. Authors stated that the clinical course of influenza (H1N1) infection in pediatric renal transplant recipients was generally mild and posed neither significant morbidity nor mortality when supportive treatment and oseltamivir were administered. Authors also mentioned that it is unlikely that H1N1 vaccine administration played a significant protective role as longest interval between vaccine administration and presentation with illness observed was only 10 days.
COVID arm. Redness and raised skin surrounding inject site. Area was not itchy or pain, no medication was take for symptoms. Redness and raised skin lasted approximately 48 hours.
Shortness of breath  Suspected COVID-19 virus infection  Contact with and (suspected) exposure to covid-19 MDM 72-year-old female with a history of pulmonary fibrosis presents with 3 to 4 days of a productive cough.  I found her alert, oriented, nontoxic, well-appearing in no apparent distress.  Her vital signs are stable.  She is not hypoxic, tachycardic or hypotensive.  She was noted to have bilateral crackles which she reports is baseline.  Chest x-ray was obtained and she has no new findings.  I discussed these findings with the patient and recommended supportive treatment, however discussed having a low threshold to return or follow-up with primary care should her symptoms worsen.  She expresses understanding and agrees with this plan.
Erythema multiforme - appeared 3 days post smallpox vax on forearm of vax'd arm. Prescribed steroid creme.
Itchy palms Swelling of Tongue Itchy arms and legs Swollen / puffy eyes Hives just below lower lip Itchy buttocks Took Benadyl Feel asleep Woke up fine, just puffy eyes.                                                              All within one hour from start to falling asleep.
Case number PHEH2013US006547 is an initial spontaneous report received from a pharmacist on 20 Mar 2013: This report refers to a 44-year-old male patient. he was vaccinated with an expired dose of MENVEO (batch number: A10051 and expiry date: Jan 2013) intramuscularly on 19 mar 2013. No revaccination had occurred. No adverse event was reported following this administration error.
Patient received Monavalent Moderna 0.5ml blue cap purple label.  Patient was intended to receive Bivalant Moderna 0.5ml blue cap gray label.
Initial response was local pain in injection area, some fatigue and soreness.  About a week later,  the area around injection area became red and raised. This  seemed consistent with what has been referred to as covid arm. This subsided about five days later. The pain though in the left shoulder continued. Three weeks in, the pain was present in both left and right shoulders at the ball. And by four weeks after Vaccine dose, the pain in his shoulders had gotten extreme and was also present in the knee joins.  An appointment with a primary care physician she?d no light and Monday Nov. 8th , with the pain excruciating, he went to the emergency room., where he was diagnosed with reactive arthritis from the vaccine. No other causative factors were present.
My left foot starts swelling; I am going to throw up holding the phone; I am getting sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 (Lot number: FC3183) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis; "Anaemia" (unspecified if ongoing), notes: Verbatim: Anemia; "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure. Concomitant medication(s) included: CARVEDILOL; FUROSEMIDE. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: FD8448), administration date: 30Aug2021, for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "My left foot starts swelling"; VOMITING (non-serious), outcome "unknown", described as "I am going to throw up holding the phone"; ILLNESS (non-serious), outcome "unknown", described as "I am getting sick".  Additional information: Consumer stated, "Well, she called her pharmacist because she got her second COVID shot (BioNTech COVID-19 Vaccine) two weeks ago today and about six days ago her left foot starts swelling and she said that some people's wrist and ankles are swollen (Further clarification was unknown, hence split case was not made) to give you all a call because she didn't know how long it lasted. She didn't know how long it lasted or if she should go to the doctor but it's pretty swollen, have you heard of this?" What was the expiration date getting a do with? she does not see the expiration date on the card it was got the two dates. She got it on August 30th (30Aug2021) and September 20th (20Sep2021)." She does not see expiration date, she sees it says next to the date it has RA1987 she don't know what that means and then it has a number of the dose Pfizer FD8448, was that what you are looking for that? That was for 8/20 and then 9/20 was FC3183.  Follow-up attempts are completed. No further information is expected.
About 3 hours after getting vaccine, patient started having swelling in corner of left eye.  She went to ER & it was noted that left side of face was drooping some, and tongue was pulling to left side as well.  She chose not to be admitted to ER, and instead went home & took some Benadryl.  Woke up with similar problem next morning, continues to get a little better each day, even today 8/30/2021. Not completely recovered, but doing better
Patient developed fever of 101 on the evening of vaccine administration. Fever abated by morning and was followed by a red, macular lesions on the legs that had a vasculitic appearance on exam. These became confluent on the legs and lower abdomen by morning and then generalized to the trunk, arms and face. No purpura. No petechiae. No edema. No observed hematuria. Baby remained active and in good spirits.
high pitched scream off & on for about 6 hrs (11AM-5PM) on 21JUN93;
Patient states that she has severe pain in her arm and cannot lift her arm. Patient contacted the nurse for the health department. Nurse contacted me and informed me of the problem that the patient was experiencing.
See attached clinic note. Cried inconsolably, body stiffened, eyes rolled back: had 6 of these episodes - Did go to ER - Was cleared.
No taste morning after shot (5am) body pains and headache gradually worsened until 2pm when ibuprofen was taken, all symptoms subsided by 5pm
Patient was administered influenza vaccine and immediately complained of pain at injection site. After approximately 30 minutes, patient complained of arm feeling warm and turning red. Noted change and immediately gave Benadryl 25mg orally. Monitored for any respiratory issues.
- Sore arm at site of injection 12 hours after shot. - Diarrhea,  general malaise, and fever 16 hours after shot- improved later in day.
Fever/chills, body aches, H/A relieved with Motrin.  Symptoms returned when Motrin wore off.  Lasted 3 days.
Patient said that redness started at the injection site and spread to the lower arm. Patient had mild fever and was diagnosed with cellulitis.
dime sized raised scar mark at injection site of left arm; red scar mark at injection site of left arm; Flu like symptoms; fever; chills; soreness at injection site of left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site of left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), CHILLS (chills) and SCAR (dime sized raised scar mark at injection site of left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site of left arm). On 02-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced SCAR (dime sized raised scar mark at injection site of left arm) and INJECTION SITE SCAR (red scar mark at injection site of left arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Antidepressant therapy, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at injection site of left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), CHILLS (chills), SCAR (dime sized raised scar mark at injection site of left arm) and INJECTION SITE SCAR (red scar mark at injection site of left arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment with Advil medication was provided for first dose events.   This case was linked to US-MODERNATX, INC.-MOD-2021-092455 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092455:2nd Dose events
This spontaneous case, initially received from a pharmacist on 04-Sep-2018, concerns a 24-year-old, adult, male patient. The patient's concomitant medications included fluticasone and azelastine for unknown indications. It was reported that, the FLUCELVAX QIV vaccine underwent temperature excursion (52 Fahrenheit) for 2 hours. On 04-Sep-2018, the patient was administered FLUCELVAX QIV [dose: 1 DF (reported as full dose), batch number: 252381, expiry date: 31-May-2019, route of administration and anatomical location: not reported] that underwent temperature excursion. The Seqirus confirmed that, batch number (252381) was a valid FLUCELVAX NH1819 QIV PFS LL 10X1 batch number. No adverse event was reported. The reporter assessed the case as non-serious. Update received on 07-Sep-2018: Non-significant case correction (IRD: 04-Sep-2018): The Seqirus confirmed that, batch number (252381) was a valid FLUCELVAX NH1819 QIV PFS LL 10X1 batch number. Hence, batch number (252381) of the suspect product was added in the product tab and the narrative was amended accordingly.
On 4/7/09 had a rash on neck and chest. Lips were swollen. Itching at rash sites. Also complained of itching throat. Went to ER administered Benedryl at ER and instructed to continue as needed. Given prescription for Prednisone instructed only to take if symptoms worsened. States Benedryl was helpful. States went to ER due to time of day (8pm) Would have gone to clinic if opened.
After receiving varicella vaccine on 4/3/11 pt states a "red knot, hard, hot and felt like a plate was under the skin." Lasted two weeks and was about 2 inch diameter. No systemic fever; only spot was warm to touch on right upper arm. Took two weeks to go away per pt.
Neck pain; Shoulder pain; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), COVID-19 (COVID-19), ARTHRALGIA (Shoulder pain) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease and Ulcerative colitis.   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19). On 12-Oct-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain). In January 2022, PYREXIA (Fever) had resolved. At the time of the report, NECK PAIN (Neck pain), COVID-19 (COVID-19) and ARTHRALGIA (Shoulder pain) was resolving.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-628692 (Patient Link).   Reporter did not allow further contact
This spontaneous report as received from an office manager, referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot # K011562 and expiration date 08-APR-2017) (lot # L040460 and expiration date 27-MAY-2017) dose, anatomical location and administration route were not reported. The reporter stated that she was not aware of any adverse effects and no product quality complaint was involved. Temperature: 19.9 Fahrenheit degrees. 4 cycles below 24F. Time Frame: unspecified at the time of his reporting. Temperature excursion (cumulative time): 255 hours. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Information was received from a pharmacy manager referring to a number of unspecified patents of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K008868, expiration date: 19-DEC-2015, first dose reported on '23-OCT-2015' and last dose on 06-MAY-2015; lot # K020750, expiration date: 30-APR-2016, first dose on 05-JUN-2015 and last dose on 03-SEP-2015; lot # L005923, expiration date: 17-AUG-2016, first dose on 15-JUL-2015 and last dose on 02-SEP-2015; strength, dose and route unknown). The PROQUAD was stored in a clinic freezer which had operated for 13 months with excursions above 5 degree Fahrenheit for 10-20 minutes three times a day. These temperature variations continued until the problem was discovered on 04-SEP-2015. At that time all PROQUAD was sequestered and new vaccines ordered. This is one of several reports received from the same reporter. Additional information has been requested.
8 days after Flu shot-Vertigo, tinnitus, labyrinitis. 11 days-complete hearing loss of left ear. 40% of right ear to date severe vertigo, tinnitus, labyrinitis prescribed antivert 25 mg  6/3/08 Reviewed PCP medical records of 11/30/2007-4/1/2008 which included ENT & neuro consults.   FINAL DX: sudden severe-to-profound sensory hearing loss. Records reveal this was first flu vaccine patient had ever received.  Experienced dizziness, lightheadedness, fatigue, tinnitus, vertigo, nausea, fever, chills, ears blocked, hearing loss, loss of balance, difficulty walking.  Unable to work.  Dx w/viral labyrinthitis or vestibular neuronitis.  Sent to ER for eval.  Tx w/steroids w/o improvement.  Continued severe hearing losson left, partial hearing loss on right; hyperacusis.  Developed anxiety & depression r/t health & inability to work..  ENT eval x 2, Neuro eval & ID eval.  Left pupil unequal & dx w/iritis. 1/21/2010 Severe hearing loss. 100% left ear, 52% right ear severe vertigo, Tinnitis, scalp lesions, left side Facial Nerve Pain, joint pain.  Since this event, it has left me permanently disabled, mainly due to tinnitus, vertigo and extreme pressure changes. The vestibular nerve in the left; is permanently damaged causing extreme tinnitus. Also, skin lesions "keratosis" on scalp which required surgery to remove, only to have 8 more pop-up. This event was diagnosed as direct effects on my immune system.
Headache; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, headache was unknown.
Bubbly chunks causing me to choke often on my own mucous; Irritating persistent cough, Cough emitting little bubbly chunks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Bubbly chunks causing me to choke often on my own mucous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history 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 CHOKING (Bubbly chunks causing me to choke often on my own mucous) (seriousness criterion medically significant) and PRODUCTIVE COUGH (Irritating persistent cough, Cough emitting little bubbly chunks). At the time of the report, CHOKING (Bubbly chunks causing me to choke often on my own mucous) and PRODUCTIVE COUGH (Irritating persistent cough, Cough emitting little bubbly chunks) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medication was reported.  Ever since patient got first injection patient had an irritating persistent cough emitting little bubbly chunks causing the patient to choke often on own mucous.   Treatment medication was not provided by the reporter.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
A red area about 5-6 inches long and 2.5-3 inches wide appeared on left arm about 4-5 inches below injection site. It took about 4 days to get to the point where it almost cleared up completely. She also had fever and felt fatigued and nauseated.
Pt states that immediately after H1N1 vaccine developed severe headache, became dizzy and felt "out of body" sensation. HA and dizziness persisted 12/10 and 12/11 when she was so dizzy she fell and hit her head (left eye). She also stated that her left foot had had increased swelling and tingling (had had surgery for ganglion cyst 2 weeks earlier) sx resolved on own. Dizziness gone in 3-4 days.