chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax;1 hr later,became quite irritable & 3-4 hr p/ vax T of 104;screamed all day & noc; leg at inject site became red, hard & hot; MD called;tx apap w/ codeine & ped motrin;
Information has been received through the pregnancy registry from a physician concerning a 32 year old Asian female who on 11/20/00 was vaccinated with varicella virus vaccine live. Concomitant therapy included measles - mumps - rubella vaccine. She was pregnant at the time of vaccination. LMP was 10/23/2000. Expected date of delivery is 07/30/2001. On 12/23/2000 at 8 weeks from LMP the patient had an elective termination.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 14-MAR-2016, the patient was inadvertently vaccinated with improperly stored GARDASIL 9 injection, lot # L020015 with expiry date 16-AUG-2017 or lot # reported as L006546 with expiry date 27-NOV-2017 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for further contact.
type 2 diabetes; This spontaneous case was reported by a nurse and describes the occurrence of TYPE 2 DIABETES MELLITUS (type 2 diabetes) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Niacin Allergy) and Drug allergy (Oxybutin Allergy).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced TYPE 2 DIABETES MELLITUS (type 2 diabetes) (seriousness criterion medically significant). At the time of the report, TYPE 2 DIABETES MELLITUS (type 2 diabetes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2022, SARS-CoV-2 test: 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.   Company comment: This is a spontaneous case concerning a  90-year-old female patient with no relevant reported medical history, who experienced the serious (medically significant) unexpected event type 2 diabetes mellitus, 3 months after the second dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to MOD-2022-665372, MOD-2022-674132 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a  90-year-old female patient with no relevant reported medical history, who experienced the serious (medically significant) unexpected event type 2 diabetes mellitus, 3 months after the second dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
After 15 minutes I started feel numbness in my left hand; tingling in my left hand; it passed almost 2 months after the first dosis and I still feel some pain and numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 12:45 (at the age of 41-year-old) as dose 1, single; and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 08:45 (at the age of 41-year-old) as a dose 2, single both for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to any medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 13:15, the patient started feeling numbness in left hand and tingling in left hand and it passed almost two months after the first dose and the patient still feels some pain and numbness. Therapeutic measures were taken as a result of the events numbness in left hand and tingling in left hand and still feel some pain and numbness which included treatment with ibuprofen for pain and some cream (unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness in left hand and tingling in left hand and still feel some pain and numbness was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added.
Initial pain and swelling at injection site. Delayed reaction starting approx. day 7. Rash, itchiness, swelling, redness over large area. Treated with Benadryl  and Hydrocortisone. Reaction continued for additional  7-10 days.  Patchiness and sensation at injection site 4 weeks later.
This spontaneous report as received from a physician via company representative refers to a 61 year old male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (strength, dose, lot number and expiration date not provided). On an unknown date the patient experienced bilateral diffuse and rash across his upper chest and arms after receiving ZOSTAVAX. The patient sought medical attention - saw the doctor. The outcome of bilateral diffuse and rash across his upper chest and arms was reported as not recovered/not resolved. The relatedness between therapy with ZOSTAVAX and bilateral diffuse and rash across his upper chest and arms was not reported.
Information regarding Prevnar was received from a consumer regarding a 6 month old male patient who developed pneumococcal meningitis. At 6 months of age, the patient received the third dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A mother reported that her son died of pneumococcal meningitis from a serotype included in the vaccine. His last vaccination was administered 2 weeks prior to his death. No additional information was available at  the time of this report. Additional CoStarts added from Medical Record rec'd 07/25/05 -- lymphopenia, edema brain, edema larynx, atelectasis, hem lung. Discharge Summary received stated patient experienced pallor, fever, cough, congestion, decreased appetite, emesis, anemia, thrombocytopenia, bacterial infection and hypoxia.
The patient received the Pneumovax vaccine on Sept 26, 2008.  Approximately 1 day later, the patient developed a "red, circular, edematous area on the left upper extremity that was tender to the touch," as reported by the nurse taking care of the patient. This area was where the vaccine was administered. All other infectious causes of cellulitis were ruled out; therefore the infection was attributed to Pneumovax. Cephalexin 250 mg po q6h was initiated.
PAIN SWELLING AND REDNESS AT SITE OF INJECTION HOT TO THE TOUCH
Information has been received from the patient's mother concerning her 17 year old son. The patient's pertinent medical history, drug reactions and allergies were not informed. The patient's concurrent conditions included warts and anxiety. Concomitant therapies were not reported. In October of 2016, reported as "two months ago", the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date and therapy route were not provided), for prophylaxis. The reporter stated that her son had an impressive crop of warts on his hands. The patient had tried various unspecified therapies, none of which worked. On an unknown date 2016 (reported as 5 weeks after injection), reported as "5 weeks after injection", the patient's hand had cleared except for one wart on his palm. The reporter was excited, thankful and amazed and she was hopeful that it would secure an indication to use GARDASIL for warts. The reported stated that GARDASIL saved her money and most importantly took her sons warts and anxiety over them. No product quality complaint (PQC) was involved. Additional information has been requested.
A-fib; AKI (acute kidney injury); AMS (altered mental status); Dehydration; Hyperkalemia; Urinary tract infection without hematuria, site unspecified
Low grade fever and chills that began on Wednesday. Arm started swelling with redness and warmth. Notified health department 1/15/2021 Moderna COVID- 19 Vaccine EUA
This case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced cough. On an unknown date, the outcome of the cough was unknown. It was unknown if the reporter considered the cough to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. Almost 5 weeks ago from the date of reporting, the patient received flu shot. And experienced terrible, horrible hacking and coughing. The patient was not interested in any more vaccines for anything.
pt recvd vax;rt arm shoulder pain,started that eve;difficult to raise arm;cont to be painful;wakes her up at noc;to MD 5dec;given shot of cortisone in rt shoulder;given scripts for motrin,apap;to rest shoulder x 1 wk;MD felt not rxn to vax
tested positive with few symptoms; tested positive with few symptoms/I had a mouth taste away; This is a spontaneous report from the Pfizer-sponsored program, via a contactable consumer (who reported for herself). A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number ER8730) on 27Mar2021, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. The On 11Apr2021, the patient experienced she got the 1st dose of the vaccine, but she stated that after 2 weeks she got tested positive with few symptoms, I had a mouth taste away. Right now she wants to ask when she will be getting the 2nd dose of the vaccine, upon probing she mentioned that on the 01May she will be getting it. The clinical outcome of the events was unknown.   Information on lot/ batch number has been requested.
Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, affected work.
chills Narrative: Pt took second dose of moderna covid vaccine on 19feb, he reported headache, fatigue and chills on 20feb. His symtoms have improved on 21Feb. no sob, no cp, no fever.
This spontaneous report was received from a medical assistant referring to a 14 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot reported as: N026814; Expiry date: 15-JUL-2020 and lot reported as: N021572; Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
had flu vaccine 1-4-21, reddened area this AM size of quarter now at is size of baseball, no fever, hurts to to touch, able to move arm, 3 in x 3 in, feels warm to touch and firm, no swelling in arm pit  On PE erythematous circular rash left upper ext, able to move arm w/o difficulty, per mom no node palpated under axilla, mom\ able to touch w/o significant tenderness  Treatment:  Finish Cephalexin as directed, area appears to be a localized reaction to flu vaccine, not appearing to be cellulitic, especially since on abx already for Folliculitis, advised cool compresses, benadryl prn
1 hr. after GARDASIL shot was given - patient became dizzy, nausea & weak. 2 hrs. later - headache w/ extreme exhaustion - fell asleep & woke up 1 hr. later, not remembering anything after shot was given! She experienced headache, nausea & tingling & numbness of the fingers/hands 2 days later. She will not be getting the 2nd or 3rd vaccine of GARDASIL!!! (Fri) 10-28-11 - patient had a sudden dizzy spell in school, lost feeling in finger & hands, headache.
COVID-19; Swelling of hands and fingers, as well as middle of arch of left foot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PERIPHERAL SWELLING (Swelling of hands and fingers, as well as middle of arch of left foot) in a 33-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Kidney stones and Sleep apnea. Previously administered products included for Product used for unknown indication: Azythromyacin. Past adverse reactions to the above products included Allergy with Azythromyacin. Concurrent medical conditions included Gout, Allergy to nuts (Name of drug reported as unknown) and Dairy intolerance (Name of drug reported as unknown). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 24-Apr-2022 to an unknown date for an unknown indication.   On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022 at 1:15 PM, the patient experienced PERIPHERAL SWELLING (Swelling of hands and fingers, as well as middle of arch of left foot). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and PERIPHERAL SWELLING (Swelling of hands and fingers, as well as middle of arch of left foot) was resolving.            No treatment medications were reported.  company comment: This spontaneous case concerns a 33-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 . The event Covid-19 occurred unspecified days after second dose of mRNA-1273 vaccine. Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID-19(18-may-2022 to 20-may-2022) 3 days, pheripheral swelling is noted one day after RITONAVIR (Paxlovid) treatment. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 33-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 . The event Covid-19 occurred unspecified days after second dose of mRNA-1273 vaccine. Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID-19(18-may-2022 to 20-may-2022) 3 days, pheripheral swelling is noted one day after RITONAVIR (Paxlovid) treatment. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
1/31/21: initially itchy within a few hours of vaccination 2/1/21: next day there was a raised rash on her Lt arm (3x2 inch patch) 2/11/21: rash still present no increase in size or severity
mom called today to report 2-3 wks p/receiving vax had flu-like sx plus very swollen glands in neck; Pt was out of school 3 days; t101; believes it lasted about 5 days; did not take pt to see MD:
Right deltoid inflamed and reddened 24 hrs-48hrs after Pneumococcal vaccine, temp 100.
Intially pain at site, muscle aches, fatigue, headache, chills; but a week later a rash that is spreading outward from the injection site.
Information has been received from a nurse practitioner, concerning a 16 year old female patient with no known allergies and a history of an abnormal Papanicolaou (Pap) smear and a cervical biopsy, who on 17-SEP-2007 was vaccinated IM, with a dose, 0.5 ml, of Gardasil (lot #658558/1061U).  There was no concomitant medication.  On 19-SEP-2007, 48 hours after vaccination, the patient developed hives.  The patient's mother contacted the physician, but no treatment was required and the hives subsequently resolved (duration not specified).  Additional information has been requested.
claim #2155603, 2155604, 2155606, 2155607, 2155609, 2155610, 2155612, 2155613, 2155614, 2155615 Moderna dose given on 10-25-21  had expired on 10/22/21.
I had feelings of rapid heart rate and flutters and heart palpitations soon after getting my shot of Moderna. Rattling in my chest. .
Fever, NauseaVomiting, arm pain (not specified), chills, body aches (not specified), fatigue Narrative:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 10:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:20 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 38.53.  Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021. The vaccines moved to clinic on 13-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
Bell's Palsy; After the second dose, his arm was sore at the site; Face felt more droopy; Face felt more weak; Wrinkles on the right side of his forehead; His speech got messed up and slurry; The right side of his face was going numb; Severe headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's Palsy) and FACIAL PARALYSIS (Face felt more droopy) in a 37-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.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Severe headache). On 29-Jun-2021, the patient experienced HYPOAESTHESIA (The right side of his face was going numb). On 01-Jul-2021, the patient experienced FACIAL PARALYSIS (Face felt more droopy) (seriousness criterion medically significant). 01-Jul-2021, the patient experienced FACIAL PARESIS (Face felt more weak), SKIN WRINKLING (Wrinkles on the right side of his forehead) and DYSARTHRIA (His speech got messed up and slurry). On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant) and VACCINATION SITE PAIN (After the second dose, his arm was sore at the site). The patient was treated with NORTRIPTYLINE for Headache, at a dose of 30 milligram once a day; PREDNISONE at a dose of 50 milligram once a day and VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1000 milligram three times a day. At the time of the report, BELL'S PALSY (Bell's Palsy), FACIAL PARALYSIS (Face felt more droopy), HYPOAESTHESIA (The right side of his face was going numb), SKIN WRINKLING (Wrinkles on the right side of his forehead), DYSARTHRIA (His speech got messed up and slurry) and HEADACHE (Severe headache) outcome was unknown, FACIAL PARESIS (Face felt more weak) had not resolved and VACCINATION SITE PAIN (After the second dose, his arm was sore at the site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. Patient underwent tests such as the EKG, chest X-RAY and  results were not reported and also received a neurology consultation. Patient was discharged from the hospital at 2:15AM in the morning.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.   This case was linked to MOD-2021-249536 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.