chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients were administered pediatric monovalent vaccines instead of bivalent boosters).    Concomitant products were not reported.  This case contains information for the 10th of 16 patients described by the reporter.   Treatment medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Information has been received from a physician's assistant (PA) concerning a 45-year-old male who on 12-APR-2006 was vaccinated intramuscularly with a 0.5 ml dose of Varivax (lot# 651280/0408R). There was no concomitant medication. On 22-APR-2006 the patient developed a macular papular rash, headache and achiness. It was also reported that the patient had 4-5 red papular lesions generally located on his body. Unspecified medical attention was sought. At the time of this report, it was noted that the patient's rash persisted. No product quality complaint was involved. Additional information has been requested.
Influenza vaccine given around 8 AM. Within 30 to 40 minutes started itching all over & felt like throat was swelling. Seen at clinic, SOLU-MEDROL & BENADRYL given which relieved symptoms.
Information was received from a pharmacist regarding two patients of unknown age and gender s part of market research. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date the patients were vaccinated with one dose of ZOSTAVAX. On an unknown date, they complained of injection site reactions - redness and irritation. The patients recovered with sequelae from the events on unspecified dates The action taken was reported as none. The causal relationship between the event injection site reactions - redness and irritation and ZOSTAVAX was not reported. Additional information is not expected, as the consent was not given for further correspondence. This is one of several reports received from the same reporter.
diffuses hives; recommended oral benadryl & she was instructed to go to the ED should she develop difficulty breathing
3x6 cm raised, hives-like rash on her (R) upper deltoid region where she had her shot 2 days ago. No symptoms of anaphylaxis or other complications.
Allergic reaction to the covid vaccine...arm was swollen; Allergic reaction to the covid vaccine...arm was swollen; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporter similar events for 2 patients (Wife and himself). This is 1st of 2 reports. This male consumer (Patient) reported that:  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date, the patient experienced allergic reaction to the covid vaccine, arm was swollen. Patient was asked for the confirmation of appointment for a second dose due tomorrow, asking if the facility would cancel due to the bad weather. The clinical outcome of events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207649 Same reporter/drug/AE, different patient
Patient complained of a headache for 2 days. Also complained of left arm being red, itchy and swollen about the size of her palm / hand. Advised patient to take Tylenol as directed for the headache, and Benadryl as directed for the itching. Advised patient to use cool compresses to arm and may try Hydrocortisone creams as directed.
30 mins after IM injection: Left arm tingling 45 mins after IM injection: Left arm, Left shoulder, Left upper back tingling, Headache, chills, fatigue
Information has been received from a nurse practitioner concerning a male who was vaccinated with a first dose of VARIVAX (Merck). The nurse reported that the patient developed a fever and a red swollen arm that lasted for 7 days on the injection site arm following the first vaccination. The nurse practitioner did not have any further information at the time. No other information was reported. Unspecified medical attention was sought, patient returned to the office for second vaccination. There was no product quality complaint. Additional information has been requested.
Patient stated that after the vacination, he experienced tireness, body aches and pain, lost of appetite and agitation.  As of 3-19-2015, patient still experiences these symptoms.
12 hours after administration of vaccine -  he reported progressive headache then left trigimenal nerve palsy.  Hospitalized 11/2 for work up of alternative causes, improved with steroids.  Possible new lyme infection (serology positive, CSF Lyme positive) discovered as part of work up.  He had developed COVID 7/2020 and recovered.
Patient was given the monovalent Pfizer COVID vaccine for a booster dose when the day prior it had been unauthorized for use as a booster due to the new approval of the bivalent Pfizer COVID vaccine. No adverse effects.
did get vaccine nov 1 st 2021  vaccine moderna , then second vaccine nov 30th   , then december 2nd developed eye weakness    co bilateral lower extremity numbness only in feet -started 1st of october then developed flushing in face and the progressed to numbness on top of head and eyes and into mouth   co face and head numbness and face muscles feel weak seeing dr    then after second vaccine moderna, 2 days after developed facial weakness and inability to open eye-suspected bells palsy vs guillane barre  , scheduled for spinal tap next week and testing for tick borne illness and myasthenia gravis   denies generalized muscle weakness in other parts of body   was started on mestinon for MG
runny nose; fever; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 25-year-old patient received BNT162b2 (BNT162B2), on 25May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "runny nose".  Additional information: Phlebotomist, described experiencing fever and a runny nose following both 1st and 2nd doses of the Pfizer COVID-19 vaccine on 25May2021 and 16Jun2021, respectively. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Eyes swollen, mostly right eye, but also left eye. Taking Benadryl every 4 hours plus other allergy medicines and asthma medicines to combat allergic reaction. As of 3/8/2021 the left eye is still almost swollen shut - going to doctor office for further treatment options
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine that underwent a temperature excursion in the Freezer), POOR QUALITY PRODUCT ADMINISTERED (patients received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medications were not reported.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer. No adverse event reported.  Treatment medications were not reported.
Local red cutaneous reaction without infection. Imyculin-maximum dimension approx. 8cm -9cm.
After I got the vaccine, i didnt get any immediate reaction. Started to ache on the 9th, next day. Then I got a little nausea at one point on the 10th. Yesterday in the morning, I had diarrea after I ate.  After lunch, 2:30 pm , I started getting stomach cramps, which progressed from 3:00 into the evening to be pretty much unbearable to about 8:00pm. Then I broke out into a sweat, I got very hot and needed to be wipe down with a cold towels. I took my temp, but it registered as low (may not be right ). I had to lay in a fetal position to go to sleep. Awoke at 3: 30 with same symptoms. woke back up at 4 with mild cramping, and it felt like food poisoning.  I am still having mild cramping and nausea.
36  hours post injection, swelling in lymph node under right jaw began. Swelling for more than 12 hours, ibuprofen taken. Swelling so severe affected ear, sinus and jaw on right side and swallowing became difficult. Oral prednisone taken, swelling greatly reduced in the next 8-10 hours. Day 4 post injection mild swelling residing, right side of face tingling sensation to the point of vomiting. Diarrhea, cramping, vomiting, loss of fine gross motor movements in fingers and hands, tics throughout the body. Saw primary care and received a short acting steroid injection and taking gabopentin. 6 hours after injection and medication with no change noted.
This spontaneous report as received from a medical assisstant refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 15-MAR-2017, 16-MAR-2017, 20-MAR-2017, 20-MAR-2017, 23-MAR-2017, 23-MAR-2017, and on 30-MAR-2017, the patients were vaccinated with improperly stored doses of VAQTA (lot # M033611, expiration date: 02-MAR-2018; lot# M038572, expiration date: 11-MAR-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 52 hours. Digital data logger was not involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA007820:
Information has been received from a pathologist concerning a 13 month old Hispanic male with interstitial lung disease (diagnosed 11/02) who on 7/31/03 was vaccinated in the left lower extremity with a 0.5 ml dose of varicella virus vaccine live (lot # 644799/0191N). At the end of August 2003, the patient developed a vesicular rash and was hospitalized. The admission diagnosis and present diagnosis were unknown. The pathologist obtained fluid from a vesicular lesion which was direct fluorescent-antibody positive. The reporter noted that he would like to send the vesicular fluid swabs and a small scab for varicella zoster virus identification. The pathologist indicated that he was not sure why the patient was hospitalized but suspected it was due to his medical history. The reporter was attempting to obtain clinical information from an infectious disease doctor. Additional information was received from the pathologist which indicated that on 8/23/03 a two to three millimeter scab was obtained from the right lateral thigh and submitted for varicella zoster virus identification. The patient's rash was described as having pustules, vesicles, and scabs. The distribution of lesions included five on the upper back, two on the left arm, one on the left hand, one on the right hand, and one on the right thigh for a total of 10 lesions. It was noted that the patient did not have a recent exposure to chickenpox or shingles. At the time of the report, the patient remained hospitalized and stable. Additional information has been requested. Follow up on 11/25/2003: "Additional information was obtained from the University which indicated that an adequate lesion specimen consisting of a vesicle swab and a scab was received for a polymerase chain reaction analysis.  The results revealed that varicella zoster virus DNA was amplified and contained the OKA/MERCK vaccine strain virus.  B-globin DNA was also amplified.  It was noted that the patient had developed varicella zoster.  Additional information has been requested.  This report no longer meets the criteria for expedited submission because the adverse experience has been changed to an expected event."
Patient was accidently administered 3ml of vaccine; patient did not report any adverse signs or symptoms during the observation period of 60 minutes; patient was sent for evaluation to Hospital, and returned to work the same day where he worked the remainder of his shift without complaint of symptoms and no adverse signs were observed.  At some point a few days later patient c/o chest discomfort and sought medical attention; currently patient is off work
hydrated; soreness in the arm at the injection site (only when to the touch); little chills; little headache; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (hydrated), VACCINATION SITE PAIN (soreness in the arm at the injection site (only when to the touch)), CHILLS (little chills) and HEADACHE (little headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O08B21-2A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Patient has very exceptional immune system, 5 years ago went to chemo and had no problem.). Concurrent medical conditions included Osteoarthritis. Concomitant products included VITAMIN D NOS for Osteoarthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-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 experienced DEHYDRATION (hydrated), VACCINATION SITE PAIN (soreness in the arm at the injection site (only when to the touch)), CHILLS (little chills) and HEADACHE (little headache). At the time of the report, DEHYDRATION (hydrated), VACCINATION SITE PAIN (soreness in the arm at the injection site (only when to the touch)), CHILLS (little chills) and HEADACHE (little headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M009378 with an expiration date 24-APR-2018 (dose, route of administration and anatomical location were not reported). Administered doses of GARDASIL 9 experienced temperature excursion of 35 degrees Fahrenheit for 9 days. There was no previous temperature excursion. Digital data logger was not involved. No adverse effect was reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
mom noticed on the morning p/inject pts rt arm was swollen & red ( & warm also) approx from deltoid muscle to just above elbow; pt did not c/o of pain-did not have fever; pt taken to MD; area of inject gradually went back to nl w/in 5 days;
Shaking; terribly cold; very bad Chills; I have extreme fatigue which I still kind of have right now; have been sleeping like all day and night like all week, I didn't go down from bed, I am just really tired; I have my cheeks were very pink, pink like rash on the cheeks it's down half way down my arm; so I have a knot in my arm; Cramp; 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 70 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: EV8723) as dose 2, single and administration date 18Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Respiratory failure" (unspecified if ongoing), notes: Verbatim: Respiratory failure, Yes I am on oxygen 24 hours a day from last 3 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EN6205, expiration: Jun21, after the 1st vaccination I had less fatigue), administration date: 25Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "after the 1st vaccination I had less fatigue". The following information was reported: TREMOR (non-serious) with onset 2021, outcome "unknown", described as "Shaking"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "terribly cold"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "very bad Chills"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "I have extreme fatigue which I still kind of have right now"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "have been sleeping like all day and night like all week, I didn't go down from bed, I am just really tired"; RASH (non-serious) with onset 2021, outcome "unknown", described as "I have my cheeks were very pink, pink like rash on the cheeks it's down half way down my arm"; MASS (non-serious) with onset 2021, outcome "unknown", described as "so I have a knot in my arm"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Cramp". Therapeutic measures were not taken as a result of tremor, nasopharyngitis, chills, fatigue, somnolence, rash, mass.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling in the tip of my tongue as well as in all fingertips.  Took two Benadryl within a half-hour of the injection.  The tingling disappeared in the fingertips, but my tongue, although no longer tingling, still feels sore and irritated almost two weeks after the injection. As far as I can tell, no swelling involved.   Also still experiencing tiredness.
Lower extremity swelling (waist to toes) of both legs. Low grade fever and fussiness to do cool compresses and to administer Tylenol every 4-6 hrs. Family to call if child worsens.
Patient contacted me on 04/09/21 and said she has never had a nose bleed in her life.  She received the Moderna vaccine at 1:00 pm on 04/08/21 and had a nose bleed at 10:00 pm.  She was able to get it stopped and  then had another nose bleed on the morning  of 04/09/21.  She was able to also stop the second nose bleed.  I ask her if she had a rash and she answered no.
No adverse event; The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     There was no parental vaccine exposure.  The patient's past medical history included COVID-19 (Patient had a Covid-19 infection and Patient lost her taste for 2 weeks.) in January 2021.    On 12-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received a Moderna Covid-19 vaccine bivalent booster dose for her one and only Covid-19 vaccine).    No concomitant medication was provided.  Treatment medication was not provided by the reporter.
Patient was inadvertently given a second Moderna Bivalent Booster.  She had one in October, then repeated on 1/4/23
Swollen tonsills  Fever of 102 Runny nose Cough Loss of voice
First adverse events began 10 hours after injection.  Starting with chills - 2 hrs, fever (peaked at approx. 101.3) - 19 hrs, multiple aching joints - 19 hrs, body aches - 19 hrs, headache - 2 hrs, congestion - 2 hrs.  Treated with 2 consecutive doses of 500mg acetaminophen, drink sips of cool water, cold washcloth on forehead, sleep.