chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 10 Dec 2014. This case is a part of 3 cluster cases and is linked to case no 2014SA172329 and 2014SA172330 (same reporter). A cluster of 2 patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number UI245AB and expiry date 30 Jun 2014) in the deltoid between (11/25/14-12/10/14). On an unknown date after vaccination, the patients experienced redness and pain below the injection site. Laboratory investigations and corrective treatments were not reported. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. At the time of this report the patient outcome was unknown. Documents held by sender: none. Follow-up information received from a nurse on 07 April 2015. The patient had received a dose of FLUZONE QIV on 27 November 2014 in the morning. On 27 November 2014, on the same day after vaccination patient had experienced swollen armpits, nausea, vomiting, diarrhea and temperature (102). Other relevant diagnostic test/laboratory data, other medications, illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions reported as no. On an unknown date, the patient recovered from all the events. Documents held by sender: none.
Eye floaters on the right eye; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Eye floaters on the right eye) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced VITREOUS FLOATERS (Eye floaters on the right eye). At the time of the report, VITREOUS FLOATERS (Eye floaters on the right eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included high blood pressure medication.  No treatment medication was reported.
Flushing/sweating, dizziness, nausea, vision problems. BPs 122/64 (pulse 61), 88/47 (pulse 65), 106/62. O2 sat 100%.
Inflamed arm; Itching; Vomiting; This case was reported by a nurse via sales rep and described the occurrence of inflammation localized in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GH33, expiry date 13th October 2023) for prophylaxis.   On 27th January 2023, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inflammation localized, pruritus and vomiting. On an unknown date, the outcome of the inflammation localized, pruritus and vomiting were unknown.   It was unknown if the reporter considered the inflammation localized, pruritus and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Feb-2023 The representative called in to report that nurse from a clinic services had an adverse reaction to a dose of Shingrix.  The representative stated that the nurse who was the patient experienced an inflamed arm, itching, and vomiting after getting the vaccination. The representative did not inquire about consent to follow up for the safety team.
When she recieved the flu shot she did did not have any pain. That night she said her arm was achy but not out of the ordinary. Over the next 2 weeks she had increasing pain so went to see an orthopedic physician. He felt she may have damage to the tendon. An x-ray was done but they could not see anything. She worried there was something wrong with the needle as it retracted into the syringe as it was suppose to do. She has been in pain and has difficulty doing tasks such as dressing herself. The physician ordered physical therapy. She has been been through 4-5 sessions. The therapist stated that he/she could isolate which tendon was affected due to her limitations. The therapy does not seem to be helping. She is still in pain. The physician may be giving her a cortisone shot at the next office visit.
Patient experienced sore arm and fever on the day of her injection. Starting  5/1/21 (8 days after vaccine), patient developed a rash of itchy and sometimes stinging or burning, fluid filled red bumps and blisters.  The rash began on her stomach, then spread to arms, back,  and legs.  It was worst at injection site. She went to  clinic  on 5/2/21 and was treated by NP, who gave her prednisone 10mg for 3 days, loratadine, and recommended three days of rest. The rash has mostly resolved now but she still has fading marks all over her body and some scabbing where itching was worst.
Left shoulder is still stiff; left shoulder is still swollen; left shoulder was inflamed; stabbing pain; severe pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Left shoulder is still stiff), JOINT SWELLING (left shoulder is still swollen), PAIN (severe pain), PAIN IN EXTREMITY (stabbing pain) and INFLAMMATION (left shoulder was inflamed) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, DICLOFENAC POTASSIUM (VOLTAREN ACTI), DONEPEZIL HYDROCHLORIDE (ARICEPT), ROSUVASTATIN CALCIUM (CRESTOR), VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR), VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and DOXYLAMINE SUCCINATE (UNISOM 2) for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-May-2021, the patient experienced PAIN (severe pain). On 08-May-2021, the patient experienced PAIN IN EXTREMITY (stabbing pain). On 09-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Left shoulder is still stiff), JOINT SWELLING (left shoulder is still swollen) and INFLAMMATION (left shoulder was inflamed). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 650 mg every 6 hours and METHOCARBAMOL for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Left shoulder is still stiff), JOINT SWELLING (left shoulder is still swollen), PAIN (severe pain), PAIN IN EXTREMITY (stabbing pain) and INFLAMMATION (left shoulder was inflamed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-116660 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116660:Reporter's case
Complained of progressive swelling at both injection sites approximately 1.5 cm, red, warm, firm, slightly tender. Treated with ice packs and acetaminophen. Had full ROM of extremity.
swelling from groin to knee lasting 2 hrs as described by mom; pt in pain @ the time; p/sx resolved was absolutely fine; sx lasted a total of 2 hrs on 16OCT;
Thyroid problems and hair loss after receiving the booster vaccination; Thyroid problems and hair loss after receiving the booster vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), THYROID DISORDER (non-serious), outcome "unknown" and all described as "Thyroid problems and hair loss after receiving the booster vaccination".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Approximately 10 days after the second shot, I began having widespread muscle twitches all day. These range from my head, eyes, calfs, arms, and any muscle in my body.
I take my blood pressure measurement daily and the two days following the vaccine, my diastolic blood pressure reading jumped and sustained 10mm both days.  Also, my resting HR is typically 55-65BPM and it sustained for these two days at 75-85BPM.  It did not even drop below 70BPM when I was sleeping and I usually trend 45-55BPM during sleep.  I felt very easily tired when doing tasks and out of breath more easily as well.  On Wednesday, I developed severe abdominal pain after a 15 minute light effort walk so I put in a request to my provider who wanted to see me for evaluation since I recently had an IUD inserted.  She found my Diastolic BP to be elevated at 90mm and my HR was in the upper 70s but nothing else was found wrong.  I am back to normal today.
felt very sick; She had a bad sinus infection; She had a bad sinus infection; This is a spontaneous report from a Pfizer- sponsored program COVAX US Support. A contactable consumer reported for herself that, a 73-year-old female received first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration, administered in Arm Left on 12Aug2021 (Batch/Lot Number: FC3100) as dose 1, single for (at age of 72-years old) covid-19 immunization. Medical history included Borderline Diabetic from an unknown date and unknown if ongoing, Acid Reflux from an unknown date and unknown if ongoing which had it a couple of years, arthralgia from an unknown date and unknown if ongoing and not thinking about a knee replacement. She can endure the pain. She does water aerobics, asthma from an unknown date and unknown if ongoing, sinusitis from an unknown date and unknown if ongoing. She had a sinus earlier that year in March, a really bad sinus infection, bronchitis from an unknown date and unknown if ongoing. She had surgery on the right one in 2010 and then she wore the left one out. She had COVID test and was negative for COVID but had infected sinuses. She was not putting that on the COVID shot because it could be something in her house making her sneeze and her eyes waters. She has allergies. She always gets a cold after the flu shot. She hasn't had the flu shot this year. She was waiting to take the vaccination before the flu shot. If not, she will get the flu shot. No Vaccines Administered on Same Date of the Pfizer Suspect. Concomitant medication included metformin taken for borderline diabetic from 2010 and ongoing. She did not take insulin but takes the pills. The pills were Metformin. The patient experienced felt very sick, had a sinus infection, and Condition aggravated on unknown date in 2021. It was reported that, she received first dose of Pfizer Covid19 Vaccine on 12Aug2021. She got very sick afterwards. She was not able to get second dose because she was 47 days over the recommended time. Reporter added that she was not able to get her 2nd dose on time because of adverse events experienced. She got sick. She had a bad sinus infection. She was not sure if that came from the shot or what. She was not sure if the shot did it. She has a sinus infection regularly. About a week or so later was when she got very sick. She has recovered. She feels great. She went to Urgent Care. No emergency visits. She didn't have x-ray to check for pneumonia. The patient underwent lab tests and procedures which included SARS-CoV-2 RT-PCR test: negative on unknown date. The patient recovered from the events on unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Patient felt funny reaction after the vaccine . Onsite EMS was called vitals were taken BP 132/74  99% O2 room air HR 64. General Malaise unknown cause . Patient refused evaluation/care. Left aginst medical advice.
skin is on fire after second dose; swelling in her soft palate after second dose; angioedema after 2nd dose; Ribs were swollen after 2nd dose; tongue was swollen//2nd dose; Covered in hives after 2nd dose; small reaction// 1st dose; A spontaneous report was received from a healthcare facility staff member concerning a 36-year female patient who developed urticaria, angioedema, swollen ribs, swollen tongue, hives that were welts, skin burning and soft palate swelling.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 14-JAN-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After the patient's first injection on 14-Jan-2021 the patient developed a small reaction within 45 minutes.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) on 11-FEB-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   After the receiving their second injection on 11-FEB-2021 the patient went to the ER on 12Feb2021. The patient developed angioedema and an epinephrine pen was used.  The patient also had swollen ribs, a swollen tongue and hives and was given a steroid shot. The patient then returned to the ER on 14Feb2021 for angioedema. The patient was given intravenous Diphenhydramine, intravenous dexamethasone and intravenous Famotidine. The patient developed hives that became welts, that were bright red in color and burned. The patient described that their skin felt like it was on fire, and there was swelling in their soft palate.    The outcome of the events were unknown/not reported.; Reporter's Comments: This case concerns a 36 year old, female patient, who experienced a serious unexpected event of Angioedema, and a few non-serious events, after receiving second dose mRNA-1273 (Lot# 006M20A).  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
CHILLIS, HEADACHE, PAIN AT SITE AND BODY, FEELING LIKE HAVING FLU LIKE SYMPTOMS
In May, 2000, the pt received his 3rd dose of Lymerix and 24 hours, post vax, the vaccinee developed an upper body rash. The rash lasted 5 days. No treatment was given. The most recent information received on 6/20/00, reports the outcome of the event as resolved without sequelae.
Sore, tender and ache (L) arm until present. Went to MD x 2 weeks later and was prescribed Rx.
Flu like symptoms; Headaches; Nauseous; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 13Feb2021 at 10:00 (age at vaccination 46-year-old) as single dose for Covid-19 immunization. The patient medical history included migraines, vertigo, high blood pressure, gastrointestinal and covid-19, prior to vaccination, patient was the diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included ascorbic acid (VIT C) and zinc. The patient previously received tetanus shot, toradol and had experienced allergy. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 14Feb2021 at 05:00, the patient experienced flu like symptoms, headaches and nauseous. Patient received treatment with advil and acetaminophen for pain. Since the vaccination, patient was not tested for COVID-19. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning a 11 month old white male with bilateral otitis media who on 27-Mar-2006 was vaccinated in the left thigh with a first dose of measles virus vaccine live  (+) mumps virus vaccine live (+0 rubella virus vaccine live (+) varicella virus vaccine live (lot#651815/0950R).  On 24-Apr-2006 the patient developed a rash on his stomach, back and chest.  Medical attention was not sought.  On an unspecified date the patient recovered from the rash.  There was no product quality complaint involved.  Additional information is not expected.
I was partially blind in both eyes; extreme headache; fever; pain; malaise; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 19-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, at age 19 years, on 12Apr2021 14:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included seasonal asthma from an unknown date and unknown if ongoing and taking birth control medications in 2 weeks. Patient had no known allergies. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient had not had other vaccine in 4 weeks. Patient received vaccine on 12Apr2021 14:00. Six hours later (12Apr2021 20:00), she experienced extreme headache, fever, pain, malaise that lasted through Monday night, Tuesday, and early Wednesday morning (14Apr2021). Fever broke early Wednesday morning and when she woke up later in the morning, She was partially blind in both eyes. All other symptoms were gone. COVID was not tested post vaccination. Treatment was received for the events by ER, personal physician, opthamologist. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient had not recovered from partially blind; while recovered for all other events on 14Apr2021.  Information on the lot/batch number has been requested.
The day following vaccination, 12/31/2020 at 1230, the patient had an acute onset of shortness of breath, tachypnea (rate 34)wheezing, tachycardia (rate 130s and irregular), oxygen desaturation (89 to 91% on room air), and clear rhinorrhea, non-productive cough. Earlier in the day he complained of not feeling well, but non-specific.  He was assessed and given an albuterol nebulizer treatment. In the coming hour, his wheezing resolved, work of breathing improved, heart rate and respirations decreased. He was ambulating around without signs of activity intolerance. It was felt that he was stable and back to baseline, so he was monitored by the nursing staff. A chest x-ray was ordered but not completed.  On 1/1/2021 at approximately 0925, a nursing assistant described loss of consciousness for 20-25 seconds. It appeared that he was not breathing, slumped over in the chair at the breakfast table eating cream of wheat, eyes rolled back in his head. He regained consciousness, breathing normally after coughing. He did not appear to be choking. His heart rate was recorded as irregular, rate 32 by the nursing staff. He was transported to the Emergency Department at Hospital for evaluation. No concerning findings.
STARTED WITH A RASH AROUND THE INJECTION SITE THAT KEPT GROWING. AFTER CONTACTING HIS PRIMARY DOCTOR - HE WAS /DIAGNOSED WITH CELLULITIS. HE SPENT 10 HOURS IN THE EMERGENCY ROOM AND RECEIVED ANTIBIOTICS AT THE HOSPITAL AND WAS DISCHARGED WITH CLINDAMYCIN 150MG (3 CAPS (450MG) THREE TIMES A DAY IN CONJUNCTION WITH A Z-PAK. THEY MARKED THE RASH (WHICH WAS AS BIG AS HIS UPPER ARM) AND INSTRUCTED THE PATIENT TO RETURN IF IT GROWS.
Tinnitus (Constant day and night)  Doctor trying LIPO FLAVONOID for two months starting 08-05-2021  I had seen primary doctor on 05-18-2021 for ringing in the ears.  She referred me to ENT doctor.  First appt available with ENT was 08-05-2021.
characteristic of heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (characteristic of heart inflammation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 CARDITIS (characteristic of heart inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (characteristic of heart inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. treatment information was provided. 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.  Company comment: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the expected serious (medically significant) AESI of Carditis, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on risk factors, detailed clinical course, investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the expected serious (medically significant) AESI of Carditis, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on risk factors, detailed clinical course, investigations, treatment and outcome of the event was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
PT presents with n/v/d and "Acid reflux" x 1 day with onset of rash to R hip and L ribs. reports itching to site of rash. received JJ vaccine x 2 days ago. denies taking any medication today.
Presented to emergency department 9/7/2021 after presenting to an outpatient clinic to receive REGEN-COV infusion where she was found to be hypoxic and was sent to the emergency department for further evaluation. She did not receive the REGEN-COV infusion due to her meeting criteria for severe Covid.   Date of COVID onset 9/3.  -9/7: On 2 L supplemental oxygen via nasal cannula. Started on remdesivir, dexamethasone, azithromycin, ceftriaxone, zinc, vitamin C, and vitamin D. Unable to tolerate prone positioning.  -9/8: On 3 L supplemental oxygen via nasal cannula.  -9/9: Oxygen at 2.5L.   -9/10: Oxygen at 2L -9/11; Continue to require O2 intermittently. She is asymptomatic and cannot recognize if her saturation is low.   -9/12: O2 saturation 89-90% on room air.
This spontaneous prospective pregnancy report as received from a nurse midwife refers to an approximately 21 years old female patient with drug reactions/allergies to penicillin. The patient's medical history included had chickenpox before. On 30-MAY-2014, the patient was (9 to 10 weeks pregnant, in her first trimester) vaccinated with a dose of VARIVAX (Merck) injection, dose (unknown), subcutaneously, for given by mistake. Concomitant therapies included Prenatal Vitamin and albuterol sulfate. The patient became pregnant with LMP of March 2014 and EDD of December 2014. The nurse midwife stated the patient was seen in the office on 29-MAY-2014, at which time the patient had a positive pregnancy test performed. Treatment given for adverse event was reported as no. The pregnancy outcome was outcome pending. No Product Quality Complaint (PQC) was involved. The outcome of events was unknown. No further information was provided. Additional information has been requested.
Patient contacted primary care provider on 11/17/15 and stated that he had a local reaction of redness after receiving his Flu shot on 11/10/15. Patient also stated he has had redness before from bandaids.
pt recv vax 6JUN96 & pt noted stinging upon administration of ID inj of hep b vax;10JUN96 5x6mm induration was noted;