chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Blurry vision; Sore-stiff muscles; Headache; Sore-stiff muscles; This is a spontaneous report from a contactable consumer, the patient. An 87-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 16:00 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, impaired kidney function, osteoarthritis, reflux, scoliosis and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN), metoprolol (METOPROLOL), levothyroxine sodium (SYNTHROID) and amlodipine (AMLODIPINE); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 03Feb2021 at 15:00 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. On 09Mar2021 at 04:00, the patient experienced sore arm, blurry vision, sore-stiff muscles, headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, blurry vision, sore-stiff muscles, headache were not resolved at this time of report.  No follow-up attempts are needed. No further information is expected.
Patient phoned the pharmacy at 9am Saturday, 8/15/2020 and spoke to pharmacist who was also the vaccine administrating pharmacist. Patient stated that the front bicep portion of her arm was pink, warm to the touch and slightly swollen. She believed she had cellulitis. She had no fever or chills. Pharmacist explained that the vaccine had been administered into her deltoid vs. the front bicep area where she was explaining the redness to be. She stated that the redness and warmth had begun sometime on Thursday, approximately 48 hours after vaccine administration. During vaccine administration, patient's left deltoid area was cleansed well with an alcohol pad, gloves, a KN-95 face mask and a plastic face shield were worn by pharmacist, the vaccine administrator. Pharmacist attempted to contact her primary care physician but she wasn't available on a Saturday. Patient sought care at medical Center (urgent care). There the provider told her he wasn't sure it was cellulitis but would air on the side of caution and prescribe cefuroxime 500mg, BID x7. Patient came to the pharmacy to pick up the cefuroxime. She had the pink area outlined and it was indeed on her front bicep.
This spontaneous report was received from a healthcare worker via company representative refers to an approximately 65 year old patient of unknown gender. No medical history was reported. On 13-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # J015868, exp. date 25-FEB-2015) (0.5 ml, intramuscular). No concomitant therapy was reported. It was reported that pneumococcal vaccine was administered post expiry. No adverse effects were reported. The outcome of the events was unknown. The events were considered to be not related to PNEUMOVAX 23. No product quality issue was involved. Additional information has been requested.
hives approx 2 hrs p/DTP given; hives few in number would appear & disappear;
10/29/21 1341: Immediate tingling/numbing sensation thru arm to fingertips on the administration of the vaccine. 1345: Chest pain experienced during the observation period. Resolved on its own. 10/30/21 0100: Woke up from sound sleep experiencing chest pain and shortness of breath. Administered self aspirin. Chest pain resolved.  0130-0420: Experienced restless leg syndrome and stomach cramping. Intermittent chest pain throughout the duration of the day.  11/08/21 Stomach cramping intermittently throughout the duration of the day. 11/09/21-11/14/21 Menstrual cycle started 12days early. Heavy bleeding noted.  11/5/21-present Altered memory. Unable to concentrate and focus on daily tasks. Unable to remember calculations that have been used daily for the last 7years.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In December 2016, the patient was inoculated with ZOSTAVAX at a health center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered not resolved. Causality assessment was related. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included, back pain from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (TYLENOL) taken for back pain, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient reported that she received second dose of Pfizer vaccine on Tuesday (unspecified date) and felt very lousy afterward, very bad chills, and a fever of 101.2F. She took an extra strength tylenol and then two subsequent doses of tylenol after that. She also took some tylenol for back pain the morning of the vaccine but several hours before receiving it. The patient underwent lab tests and procedures which included body temperature: 101.2 fahrenheit on an unspecified date. Therapeutic measures were taken as a result of the events. The clinical outcome for the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pt experienced crying immediately post vax described as "worse...compared to (other) vaccines." Manufacturer's comment: The reporter was unable to specify the number of patients involved. Addtl rpts will be generated when identifying info is provided.
25JUN93 red dots on back as w/head rash; raised, isolation, not blisters; runny nose & eyes, skin warm no temp taken; appetite dec, irritable; 28JUN93 no improvement red dots all over body;
AS PT WAS WALKING BACK TO CARE, FELT A SUDDEN WAVE OF NAUSEA, VSS, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.
Itching and rash at injection sits began 7 days after vaccine. The rash is raised in areas, occasionally itchy, warm to hot at times.   I'm at 11 days after the area around the injection site continues to be red with raised areas of  the rash, itchiness and  warm to hog to the touch.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, headache and weakness was not reported. This report was non-serious.
Full vaccination / shingles/ suspected vaccination failure; Shingles; Pain is climbing up spine, cannot get out of bed; cannot get out of bed; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In August 2022, less than 9 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, radiating pain and mobility decreased. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, radiating pain and mobility decreased were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, radiating pain and mobility decreased to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 01-Sep-2022 Reporter's comment: The reporter was the patient.  The patient stated that she completed her full vaccination for Shingrix about 6- 8 months ago and about 10 days ago, she came down with shingles.  This was the second time she had shingles. The first time was in November 2021 before she received Shingrix.  The patient stated that this time the shingles was worse.    The pain was climbing up her spine, she can not get out of bed.  The patient was prescribed acyclovir for treatment. The reporter consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure since details regarding laboratory conformation of shingles was not given at the time of reporting.
NOTIFIED ON 06/10/2022  BY DEPT OF HEALTH THAT I MAY HAVE BEEN EXPOSED BETWEEN 06/3 AND 06/04.  TESTED POSITIVE USING A HOME TEST ON 6/10.  WAS FEELING CONGESTED AND HAD A RUNNY NOSE.  CONTACTED DR. BY PHONE (MY INTERNIST).  HE PRESCRIBED AN ANTI-VIRAL THAT I TOOK TWICE A DAY FOR 5 DAYS.  SYMPTOMS LASTED ONLY TWO DAYS AFTER TAKING ANTIVIRAL.
10/10/00, pt reported to MD that site of Pneumovax injection was red and swollen X 3 days. Advised to apply ice pack and take Tylenol.
floaters in eye; seeing spots of light; vision is a little cloudy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 12Mar2021 (Lot number: EN6206) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High & low blood pressure (fluctuating)", start date: 2015 (ongoing); "sinus issues", start date: 2011 (ongoing), notes: had sinus issues due to sinus polyp surgery; "sinus polyps" (not ongoing); "sinus polyp surgery", start date: 2011, stop date: 2011; "during polyp surgery, physician went up too far and put a hole in the brain", start date: 2011, stop date: 2011, notes: ended up with meningitis and almost died; in a coma; "meningitis" (unspecified if ongoing), notes: has fluid leaking from the brain; "almost died" (not ongoing); "coma" (not ongoing); "Weight loss" (not ongoing), notes: started taking Metoprolol after gaining weight back; "headaches" (ongoing), notes: due to sinus issues; "leg and arms ache" (ongoing), notes: prior to vaccination; "body aches" (ongoing), notes: prior to vaccination. Family history included: "has floaters in vision before" (not ongoing), notes: prior to vaccination; (patient's sister also sees floaters because of diabetes). Concomitant medication(s) included: AMLODIPINE taken for blood pressure fluctuation (ongoing); BENADRYL taken for sinus disorder (ongoing); METOPROLOL; ACETAMINOPHEN taken for headache, pain (ongoing). The following information was reported: VITREOUS FLOATERS (non-serious) with onset Mar2021, outcome "recovering", described as "floaters in eye"; VISUAL IMPAIRMENT (non-serious) with onset Mar2021, outcome "not recovered", described as "seeing spots of light"; VISION BLURRED (non-serious) with onset Mar2021, outcome "not recovered", described as "vision is a little cloudy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Time of vaccination was 9 something in the morning (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that she has oxycodone for ongoing medical history of pain, but needs to be in really severe pain before taking it; still has not taken any. Patient also reported that she has been going online and looking up her symptoms and found something that stated it was possibly a detached retina, but she thought that the floaters and spots of light in her eyes were not due to a detached retina. She was scheduled to get the second dose on 02Apr2021.  No follow-up attempts are possible. No further information is expected.
SICK; PATIENT RECEIVING THE SECOND DOSE OF THE VACCINE MORE THAN 36 DAYS AFTER THE FIRST DOSE; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (SICK) and PRODUCT DOSE OMISSION ISSUE (PATIENT RECEIVING THE SECOND DOSE OF THE VACCINE MORE THAN 36 DAYS AFTER THE FIRST DOSE) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) and DILTIAZEM (CARDIZEM [DILTIAZEM]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (SICK) and PRODUCT DOSE OMISSION ISSUE (PATIENT RECEIVING THE SECOND DOSE OF THE VACCINE MORE THAN 36 DAYS AFTER THE FIRST DOSE). At the time of the report, ILLNESS (SICK) and PRODUCT DOSE OMISSION ISSUE (PATIENT RECEIVING THE SECOND DOSE OF THE VACCINE MORE THAN 36 DAYS AFTER THE FIRST DOSE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     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.   Treatment details was not reported .
Patient was asked to sit down and wait after vaccine since had a reaction on previous year. Within 10  minutes numbness/tingling on arm began--going down arm and from one finger to the other (pinky, then ring, the middle finger. Numbness on same arm as vaccine site.  Patient was still at vaccination site and did not receive any treatment/meds.  Patient told to contact VAERS to report.    Last year, symptoms started within same time and lasted about 1 week.   Numbness just on the vaccine arm. Last year patient went to ER and was prescribed Naproxen.  There was numbness but no tingling and pinky finger was the worse
gave PENTACEL to a child without the powder, the diluent only, liquid component of PENTACEL was administered but not the lyophilized powder,with no reported adverse event; Pentacel once for TB skin test with no reported adverse event; gave PENTACEL to a child without the powder, the diluent only, liquid component of PENTACEL was administered but not the lyophilized powder,with no reported adverse event; Initial information received on 19-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves unknown gender Child Patient of age <1 year who received Pentacel without the powder, the diluent only, liquid component of pentacel was administered but not the lyophilized powder once for TB skin test with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTOTECH for Immunisation   On an unknown date, the patient received a (0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.25 mL) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ737AA) (Expiry date: 18-Sep-2023) (Frequency: once) (Strength: standard) Via unknown route in site UTR for Immunization or TB skin test.  On an unknown date the patient received pentacel without the powder, the diluent only, liquid component of pentacel was administered but not the lyophilized powder once for tb skin test with no reported adverse event (product use in unapproved indication) (product preparation error) (Single component of a two-component product administered) (unknown latency).  It was reported that patient had Emergency Room /Dr. visit and date UTR (Abbreviation unspecified) (estimates around: 4-Jan-2023)  Relevant laboratory test results included: Tuberculin test - On an unknown date:  [Unknown]  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for all the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
From initial information received on 8/2/04 from a physician regarding an adverse event occurring in the USA, it was reported that a male patient (age and date of birth not reported) received a dose of TD ADS ADULT vaccination, lot number U1024AA, inadvertently administered ID instead of TUBERSOL 5 TU on 7/30/04. The next day, on 7/31/04, the patient developed redness and swelling at the injection site. He was treated with a cool compress and improved slightly. The patient has not recovered from these events. From additional information received on 1/4/05 from a physician, it was reported that the patient experienced local irritation after immunization, but recovered from the events. No further information is anticipated. This case is considered closed.
BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) .5 ml, administered on 06-MAR-2021 09:45 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-MAR-2021, treatment medications included: paracetamol. On 06-MAR-2021 16:35, the subject experienced body aches. On 06-MAR-2021 16:35, the subject experienced chills. On 06-MAR-2021 16:35, the subject experienced headache. On 06-MAR-2021 16:35, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from fever, body aches, and chills. This report was non-serious.
6:00PM R arm very sore, soreness progressed to R side of body, began to feel very weak, unable to lift leg to bed, malaise 24-36 hrs, exhaustion, wanting to sleep all the time, extremely weak next day
sore throat, body aches, fatigue, then SOB, wheezing, chills, shaking, loss of taste and smell, weakness, tachycardia, hypertension, and finally hypoxia requiring bipap
Patient described developing a rash after receiving the vaccine.  The rash extended from her upper arm down to her elbow.
back surgery; BODY FELT ACHY; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (back surgery) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis.    Concurrent medical conditions included Hidradenitis suppurativa.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second 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 February 2021, the patient experienced MYALGIA (BODY FELT ACHY). On an unknown date, the patient experienced SPINAL OPERATION (back surgery) (seriousness criterion medically significant). In February 2021, MYALGIA (BODY FELT ACHY) had resolved. At the time of the report, SPINAL OPERATION (back surgery) was resolving.            No concomitant medications were reported. No treatment medications information were provided. On an unknown date, patient had back surgery, a spinal operation NOS.   Somewhere in JAN2021, the patient felt like flu and event resolved.   Reporters causality for event with Humira was not 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 52-year-old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of spinal operation 11 months after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623688 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow up contains significant information.  Seriousness criteria , event Information and narrative  updated.; Sender's Comments: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of spinal operation 11 months after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.