chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (10.22.2021 - present; currently admitted);  COVID-19 positive (10.22.21);  fully vaccinated  HISTORY OF PRESENT ILLNESS: Patient is a 73 y.o. female who has a background of oxygen-dependent chronic obstructive pulmonary disease presents today with worsening cough, wheeze, presyncopal going on for 3 days.  Patient is fully vaccinated for COVID-19 infection in March April.  She uses a walker to walk and lives alone.  Apparently she has been avoiding crowds any close contact however recently been in touch with his grandson and their family.  Patient started to have cough along with some breathing trouble and wheezing going on for 3 days.  She has oxygen-dependent chronic obstructive pulmonary disease and she is a current smoker.  She is on 3 liters/minute oxygen at home and her oxygen needs have not changed.  She is coughing bringing up some whitish sputum.  She denies any fevers at home but she has been having some generalized weakness and chills at home.  All her symptoms are 3 onset. ASSESSMENT / PLAN: 1. COPD Exacerbation: Secondary to covid 19 infection. Methylprednisone given in the ER. She  Tolerated it well. She apparently is allergic to prednisone. Dexamethasone PO started from tomorrow. Home inhalers to continue. Duo nebs prn. Patient on home oxygen 3L/min. Azithromycin is started for 5 days. 2. COVID 19 Infection: No pneumonia. No complications. Symptom onset 3 days ago. No fevers. No worsening hypoxia( on 3L/min oxygen at home and is currently on the same flow rate). Hold off on Remdisevir for now as the patient is not needing any more oxygen that her home needs of 3L/min and no pneumonia on cxr. Patient qualifies for Monoclonal Antibody treatment. I d/w team. She is agreeable and consented and Regeneron is ordered. Dexamethasone is ordered for copd exacebration can continue till discharge. Progress Note from 10.28.21:  ASSESSMENT / PLAN: Acute chronic obstructive pulmonary disease exacerbation Secondary to COVID 19 pneumonia Fully vaccinated Baseline home O2, 3 liters by nasal cannula Azithromycin x5 days Status post Regeneron Albuterol Spiriva Dulera Continue oral prednisone
Linear vertical red lines on cheek. no associated itching, angioedema or anaphylaxis reactions. interval improvement over time. exam notable only for papules vs wheals on R cheek. no neuro deficit, zoster, facial nerve palsy or oral involvement
strong tingling in my tongue/tongue started tingling badly; Lip tingling and burning; lips tingling and burning; This is a spontaneous report from a contactable consumer (patient reported for herself). A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9Z63), via an unspecified route of administration, administered in Arm Right on 08Feb2021 (on Monday, at the age of66-year-old), as single for covid-19 immunisation. Medical history included nerve damage on right side of tongue from wisdom teeth removal and nerve damage on right side of lip from root canal. she had nerve damage near there from 30 years ago from wisdom teeth. The patient had root canal 3 years ago in 2018. There were no concomitant medications. On 08Feb2021, about less than 20 minutes after the vaccine, the patient started having strong tingling in her tongue badly, Lip tingling and burning. The clinical course of the events as follows: patient reported that she received her first vaccine dose on Monday, 08Feb2021, for the first 15 minutes she was fine. As soon as got in the car, her tongue started tingling badly. It was a really strong tingle but did not swell. She reported that she has nerve damage near there from 30 years ago from wisdom teeth pulled. It barely tingles usually. She also reported Lip tingling and burning, but again reported a history of nerve damage from a past root canal. There was something going on with the nerve there. She got the shot on her right arm, and all her nerve damage was on the right side of her tongue and lips too. She stated that these symptoms lasted for about 30 minutes. Her lips started that night and it had not been bad. She was scared it might swell. She had some tingling off and on. Her lips were tingling and burning some. It had gotten better, but she still has it some. She was concerned about the second vaccine. she was two hours from home, so this was scary. She was wondering if this is common. The patient was asking if her symptoms were a common finding after receiving the vaccine and if she should get the second vaccine dose or not. She stated that she might have a strong reaction. There was no Investigation Assessment provided. The patient was resolving from all the events at the time of this report.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Dizziness, fast heart beat, palpitations, redness, pain and soreness at injection site, swelling at site was the depth and width the size of the cap of a one gallon milk jug.
About one week after receiving my first dose, I noticed that my hair was starting to fall out. I do not take any medication as to where this could be a side effect. The only difference in my life was taking this vaccine. I also received my second dose and noticed that my hair is still falling out. I have seen a dermatologist and he recommended that I use Rogaine for men. He noticed that my hair was just dropping off when he examined my hair and my scalp. It takes about four months to see any type of results so I have not seen any results yet. I really don't want to go through this experience again and I do not want to take the booster. I'm worried that I may lose all of my hair at once.
dry mouth/severe dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth/severe dry mouth) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 100006) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRY MOUTH (dry mouth/severe dry mouth). At the time of the report, DRY MOUTH (dry mouth/severe dry mouth) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non-Significant Follow-up added
Cannot walk without falling/very bad vertigo; Dizziness on standing up; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Cannot walk without falling/very bad vertigo) and DIZZINESS POSTURAL (Dizziness on standing up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VERTIGO (Cannot walk without falling/very bad vertigo) and DIZZINESS POSTURAL (Dizziness on standing up). At the time of the report, VERTIGO (Cannot walk without falling/very bad vertigo) and DIZZINESS POSTURAL (Dizziness on standing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Received Flu vaccine on 9/29/10 on the left deltoid and the next day noted reddened area at injection site.
A report has been received from a Pharmacist concerning a 6 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient was administered only a half dose of FLUMIST in one nostril started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Pt states small reddish lump formed @ site of Td inject; 1st noted on 31MAR93; cont to spread down arm to above elbow by 2APR93; warm to touch-pruritic; seen by MD ATB & optical ointment to site prescribed;
Vasovagal syncope after Flumist, approx. 15 minutes after administration.
01/11/22 presents to ED for "dyspnea at rest" "COVID positive since 1/4". PMHx of "CAD and NSTEMI s/p multiple stents, occipital hemorrhagic CVA, HTN, HLD, hypothyroidism, anemia, benign paroxysmal vertigo, depression, and CKD stage IIIb"
itchy hives, welts appearing, and tachycardia when calm and appears when stressed
3 hours after shot arm was sore. By 6 PM flu like symptoms - Aches, chills, nausea.
Patient developed erythema at the injection site, generalized myalgia and arthralgia the day following vaccination.
Information has been received from a nurse concerning a patient who was vaccinated with the first dose of Rotateq. The nurse reported that the patient subsequently developed blood in stool and diarrhea. The patient had a positive hemoccult. At the time of this report, the outcome was unknown. Upon internal review, blood in stool was determined to be an other important medical event. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 17-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. Previously administered products included BEXSERO with an associated reaction of injection site pain (Refer the case for 1st dose_US2018GSK127345). On 10th May 2018, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site swelling, injection site pain and enlargement of lymph nodes. The patient was treated with antibiotics nos. Rechallenge with BEXSERO was positive. On an unknown date, the outcome of the injection site swelling, injection site pain and enlargement of lymph nodes were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain and enlargement of lymph nodes to be related to BEXSERO. Additional details were provided as follows: The patient experienced injection site swelling, injection site pain and 2 left infraclavicular node swollen. This is 1 of 2 cases, reported by the same reporter for the same patient. Lab Comments: On an unknown date, the patient underwent for ultrasound scan and found ultrasound measured 1.2x1.6x0.8 centimeters, 1.1x1.4x0.7.
MY SON SICK & IN THE HOSPITAL; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received nasal Flumist (influenza vaccine (live, attenuated)), on an unknown date.     On an unknown date, the patient experienced sick (preferred term: Malaise) and admitted in the hospital.     The outcome of the my son sick & in the hospital was unknown.    The Reporter assessed the my son sick & in the hospital as serious with the seriousness criteria of hospitalization.
Discomfort on the left armpit; Discomfort on the left lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort on the left armpit) and LYMPH NODE PAIN (Discomfort on the left lymph nodes) 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.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DISCOMFORT (Discomfort on the left armpit) and LYMPH NODE PAIN (Discomfort on the left lymph nodes). At the time of the report, DISCOMFORT (Discomfort on the left armpit) and LYMPH NODE PAIN (Discomfort on the left lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Reporter did not allow further contact
pt recvd vax 25APR95 & had an apnea episode following shot;pt was seen by MD who decided that was a rxn to DTP/HIB;pt has been on apnea monitor for prematurity anyway;MD will give DT
One week after vaccine, he started having episodes of aggitation, weakness, poor appetite.  Had total of 7-9 episodes starting about Feb 20, 2021 until about March 20th.  Went to ER twice, had several office visits.  Brain CT and brain CTA were normal except for vertebral artery stenosis bilaterally.  Neurologist felt that was unrelated to symptoms,  Multiple labs done in ER visits were normal.  I worked him up for carcinoid and pheochromocytoma also.  The pheo labs are still pending.  All else negative.
ITCHING; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 29-JAN-2023) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the subject experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching. This report was non-serious.
Pt recvd 2 doses of Hep B vax on 11SEP89 & 13OCT89 following vax pt devel arthralgia, which persisted 2 yrs & has prevented the pt from working;
Within 24 hours, patient started having jerky movements that resembled siezure activity. This lasted for four months before slowly going away. It then came back whe he received his next DTaP shot at 15 months.
Shaking, 1 week later hands still shaky happened with previous 2 vaccines, extreme fatigue, nauseated. Havnt felt like doing anything since vaccine.
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age. Current conditions and medical history was not reported. On an unknown date, unspecified patients were vaccinated with VARIVAX (Merck), 0.5 milliliter, subcutaneously. Concomitant medications were not reported. Nurse reported that unspecified patients received improperly stored VARIVAX (Merck). VARIVAX (Merck) was exposed to -8.4C for 51 hours and -8.4C for 116.5 hours. No adverse effects were reported. Product quality complaint was not reported. This case is linked to 1410USA013136 (same reporter). Additional information has been requested.
ON 8/19/08 DEVELOPED DISCOMFORT OF RIGHT ARM AND CHEST WALL.  A RED MACULAR-PAPULAR RASH DEVELOPED ON THE MEDIAL RIGHT ARM, ANTERIOR CHEST WALL AND BACK IN A DERMATONE DISTRIBUTION PATTERN.  WAS SEEN IN URGENT CARE ON 8/23/08, ACYCLOVIR STARTED.  FOLLOW UP IN PHYSICIAN'S OFFICE ON 8/26/08, A TOPICAL STERIOD FOR ITCHING AND LORATAB FOR PAIN WAS ADDED.
Information has been received from a physician concerning an approximately 9 month old male who was vaccinated with a first, second, and third dose of Rotateq on 08-JUN-2006, 25-AUG-2006 and 20-OCT-2006, respectively. Concomitant unspecified vaccines were given at the same time. "About a week ago," on approximately 02-FEB-2007 the patient experienced rotavirus and was hospitalized. The time frame of the hospitalization was unspecified. It was reported that the patient's father also came down with rotavirus, but did not have to be hospitalized. No product quality complaint was involved. No other information was provided. The patient's twin sister experienced rotavirus following vaccination with Rotateq (WAES0702USA02548). Additional information has been requested.
Arm pain ¨it is like muscular pain i can not lie down to sleep on that side¨; i can not lie down to sleep on that side; is like muscular pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain ¨it is like muscular pain i can not lie down to sleep on that side¨), INSOMNIA (i can not lie down to sleep on that side) and MYALGIA (is like muscular pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced PAIN IN EXTREMITY (Arm pain ¨it is like muscular pain i can not lie down to sleep on that side¨), INSOMNIA (i can not lie down to sleep on that side) and MYALGIA (is like muscular pain). At the time of the report, PAIN IN EXTREMITY (Arm pain ¨it is like muscular pain i can not lie down to sleep on that side¨), INSOMNIA (i can not lie down to sleep on that side) and MYALGIA (is like muscular pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs are not provided by reporter.   This case was linked to MOD-2021-163442 (Parent-Child Link).   See case MOD-2021-163442 for details regarding the child case.
pt recv vax 20OCT98 & states that the following morning p/vax starting having achy, back pain which has lasted this is the 5th day;
After the first shot I felt foggy and tired for two days starting the day after the injection. After the second does, I  had a terrible headache, chills, fever, nausea, and fatigue/TIRED for 3 full days
2. Men B vaccine:  Today, discussed. After receiving the vaccine left deltoid, the MA took the needle off and set it down and the site swelled up --instantaneously, I walked in to the room right after pt arm had a 5 cm swelling at the injection site mildly firm, as I was massaging the child mentioned she is feeling dizzy, made her lie down and massaged the injection site, POX 98, HR 52, BP 110/70, after 3-4 minutes of lying down the child started feeling better, rested for 15 minutes, CTAB, S1S2, RRR, no hives , swelling in the arm went down to 2cm, pt was sitting up for 5 minutes without any return of symptoms, POX 100, HR 66, BP 104/70, remained symptom free some pain in the injection site started, was given motrin and reassessed, CTAB, S1S2 RRR, no hives, comfortable,  d/c home 45 minutes after the vaccine and pt walked normal and stable at d/c.
Patient has permanent vision loss in both eyes, 2 weeks after vaccine booster, from bilateral optic neuritis.   The patient had normal vision prior to vaccine.  2 weeks after vaccine booster, had subacute onset vision loss.  Patient was seen with normal exam.  Returned several months later with no improvement of vision and with bilateral nerve pallor of optic nerves.  Consistent with optic neuropathy.  Negative MRI brain/orbit.  Most consistent with optic neuritis OU, now with no improvement of profound vision loss OU.  Defect is likely to be permanent.
9/10/21 presenting today for Covid-19. Patient is fully vaccinated. Has a history of multiple sclerosis, sent in by her PCP for further evaluation.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (strength, dose, lot #, expiration date and anatomical location were not reported) intramuscularly for prophylaxis; which experienced a temperature excursion at 1 Celsius degrees for 15 hours. No previous temperature excursions were reported. Data logger was involved. A product quality complaint was not involved, no adverse events were reported and no additional information was provided. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004654:
Patient vaccinated on September 7/ 2020 presents the day after to report redness, swelling, tenderness and erythema from the shoulder at the administration site to the elbow.  Was instructed to put ice on the affected area and if not subsides or get worse to consult her primary care physician.  On September 9/ 2020 patient returned to the pharmacy to pick up electronic prescription for Septra DS #20 take one twice a day for 10 days, after MD visit for the symptoms earlier described.  Patient contacted on September 11, 2020 11 45AM and reported significant improvement on symptoms
Heavy menstrual bleeding with clots; Heavy menstrual bleeding with clots; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 08Apr2021 13:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant and had no other vaccine in 4 weeks. On 08Apr2021 13:30, the patient experienced heavy menstrual bleeding with clots. There was no therapy for the events. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Outcome of events was recovered on an unspecified date.  Information about Lot/Batch number is requested.; Sender's Comments: Based on the available information the reported events were attributed to  an underlying or  an intercurrent medical condition and  it is assessed as unrelated to the  suspect drug bnt162b2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
I?ve been breaking out in severe hives intermittently. Nothing triggers them, they?ll flare up for 20 minutes to an hour at a time. Some are painful, some are itchy, some don?t feel like anything. They are in all shapes and sizes of red welts.
A report has been received from a health professional concerning a 2 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent  started on an unknown date. It was reported that the patient had administered an expired FLUMIST Quadrivalent which started on 06-JAN-2015. The outcome of the event of administration of expired product is unknown. The report was considered to be non-serious.
This spontaneous report was received from a female consumer reporting on her 6 month old baby daughter. The baby's relevant medical history, past drug history, and concomitant medications were unknown. On 24-MAR-2016, the mother received one dose of GARDASIL 9 (lot number, and expiration date were unknown) in her right arm (Dose number, frequency and indication were not provided). It was unknown if this was her first injection. Concomitant medication was not reported. The mother stated that her 6 month old baby daughter may had been exposed to GARDASIL 9 via breast milk because she continued to breastfeed the baby daughter after receiving the GARDASIL 9 injection. (MARRS case no. 1603USA013570). On the same day, the consumer noticed a very mild rash and oral mucosal eruption on her 6-month old daughter's mouth and neck. On 25-MAR-2016, the baby's rash was growing in size but the baby seemed normal otherwise. It was unknown if there were any relevant laboratory data. As of 25-MAR-2016, it was unknown if the baby would continue to be exposed to GARDASIL 9 via breast milk and she continued to have a rash on her mouth and neck. The reporter considered rash and oral mucosal eruption to be potentially medically significant events. This is one of two reports from the same source. Additional information has been requested.