chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose of the Moderna vaccine to a 17 year old; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (dose of the Moderna vaccine to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (dose of the Moderna vaccine to a 17 year old). On 07-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (dose of the Moderna vaccine to a 17 year old) had resolved. Not Provided      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.   No concomitant medications were  reported   No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Updated the patient demographics. On 26-May-2021: Follow-up received. Patient' s gender changed. Second dose details were added.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# J014152, expiration date 07-NOV-2015, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
injection site swelling; injection site knot; injection site tenderness; injection site black; injection site has a scab; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling), INJECTION SITE INDURATION (injection site knot), INJECTION SITE PAIN (injection site tenderness), INJECTION SITE DISCOLOURATION (injection site black) and INJECTION SITE SCAB (injection site has a scab) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical information provided).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (injection site swelling), INJECTION SITE INDURATION (injection site knot), INJECTION SITE PAIN (injection site tenderness), INJECTION SITE DISCOLOURATION (injection site black) and INJECTION SITE SCAB (injection site has a scab). At the time of the report, INJECTION SITE SWELLING (injection site swelling), INJECTION SITE INDURATION (injection site knot), INJECTION SITE PAIN (injection site tenderness), INJECTION SITE DISCOLOURATION (injection site black) and INJECTION SITE SCAB (injection site has a scab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication nor treatment provided
Patient received Moderna vaccination at approximately 10:30 and reported to observation. Patient reported multiple sensitivities and allergic reactions at screening and was recommended for 30 minute observation. 10:55 patient reported feeling nauseous and requested water. Provided water and recommended patient remove large coat. 11:05 patient reported having an itchy feeling in her throat. No shortness of breath, wheezing, respiratory distress. BP 148/104, 62. patient instructed on Benadryl actions, side effects. Administered 50mg Benadryl IM to right deltoid. After 15 minutes patient reports itchy feeling resolved and she feels better. Recommended patient call for ride given sedating effects of Benadryl. BP 128/80 68. Patient states she feels better, declined need for ride home and left observation.
1325 -- injection given 1327 -- pt states dizziness, vision blurry, thought he would pass out, sweating 1330 -- pt given water and crackers 1333 -- pt states he felt like he would pass out, extracted from vaccination area to observation 1335 -- BP 124/75  HR 60  SaO2 95% 1340 -- pt states he is feeling better 1345 -- pt standing at the side of the stretcher 1345 -- BP 116/70 HR 57 1348 -- pt walking around observation area without concern, VSS, pt states he feels fine 1353 -- pt requesting to be discharged; discharged to self, escorted to west entrance
sore arm; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided          No Concomitant medication were reported.
Induration, left thigh, 5cm. + hives on face, arms, both legs. Vaccine given 6/2/04, onset of symptoms 6/5/04, visit 6/8/04
LEFT ARM BELOW INJECTION SITE WITH REDNESS, SWELLING AND TENDERNESS TO ARM. PT DID F/U ON 10/12/2018. FOR INJEC. GIVEN ON 10/10/18. MD EVALUATED AND STARTED ON SHORT COURSE OF ANTIBIOTICS , KEFELEX 500MG TID FOR 5 DAYS, AND STERIOD DOSE PACK. ICE TO AREA AND TO F/U ON TUES FOR AN OFFICE VISIT
Child was given Pneumovax 23 as one was showing due for Pneumoccocal. Our understanding was that this 23 could be given. But per our Standing  Orders it should have been the 13 or 15 version due to the child not having any special conditions for him to receive this type. Child received 4 vaccines that day. Tolerated well. No adverse side effects reported.
2 days later, with bulging fontanelle and CT scan with prominence of anterior CSF Spans over both frontal and temporal lobes - No hydrocephalic. This followed 1day of upper respiratory symptoms.
The main complaint is injection site soreness that has not gone away and affects normal range of motion of my left arm particularly when raising my arm above my head or pressing down on my left arm, although the tenderness and often pain has been continuous since receiving the second shot.  Secondary to that is a day of mental confusion one week out from the injection after each shot.
dizziness, nausea, vomiting, extremity sore arm, spots on eyelids;
Nausea, pain in upper arms and shoulders, body aches, fever, chills, sweats.
Pt reported chest pain at midnight on Friday, 11/5; presented to ER on Saturday, 11/6 after intermittent chest pain. Saturday?s chest pain was non-relenting; pt admitted to hospital. He received a NSAID on 11/6 in the am and 11/7 at approx 1am,  with an asa in between. Pt received  nitroglycerin between 1am-2am on 11/7, as well as oxygen  due to non-reduction of chest pain with nsaid administration. Pt remained hospitalized until 11/9, and followed proper with his cardiologist, on 11/17. The pt was discharged without meds.
one patient received expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one patient received expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (one patient received expired doses). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (one patient received expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter has updated that expired vaccine administration was done in single patient, which was previously stated as administration in two person. Concomitants were not provided. Treatment was not given.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow up received on 18-oct-2021 contains non significant information.
After 10 days, noticed a large reddened area; painful; tenderness; heat; itchy; off-centered from injection hole in deltoid muscle; and swollen lymph nodes; with difficulty swallowing. This lasted for 2 days. Now on 14 days post first injection, site is still slightly red. No treatment was necessary
1st shot in june 2019; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting,the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if need to start over.
fever; Malaise; chills; muscle and joint aches; muscle and joint aches; extreme fatigue; nausea; headache; both arms started itching on lower arm, not at site/the face and scalp started itching; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiration date unknown), dose number 1, intramuscularly on 16Dec2020 10:00 at a single dose for COVID-19 immunisation. Medical history included Hashimotos Thyroiditis, MDD (major depressive disorder), and acne. Concomitant medications included zinc, ergocalciferol (VIT D), venlafaxine, levothyroxine sodium (SYNTHROID), and spironolactone. The patient had vaccine at 10 AM. At 11 AM, both arms started itching on lower arm, not at site; injection arm was worse than non injection arm. At 11:45, the face and scalp started itching. By noon, all symptoms had resolved. The patient did not medicate. Two days post vaccine, on 18Dec2020, the patient had all symptoms on warning sheet: fever, malaise, chills, muscle and joint aches, extreme fatigue, nausea and headache. The outcome of the event was recovered for itching and not recovered for the other events.
I woke up the next morning with an extreme headache that would not resolve for the entire day despite taking migraine medication. I felt achy and tired as well. The next day 5/29 I had extreme nausea, muscle pain, chills, shortness of breath/tiredness and a flare up of psoriatic arthritis and psoriasis activity as well as diarrhea. Today 6/1 I have a flare in PSA symptoms and diarrhea still.
Severe headache 24', aches and tiredness. Symptoms  1/2 as bad next 24 '.
pt recvd vax & devel lt thigh w/anterior lesion of umbilicated papule w/surrounding area of 1cm diameter that is skin colored; itchy mass of total diameter of 2 cm; palpable 2-3mm spherical mass-moveable just under skin; lasted 1 wk;
Against my wishes, my son was sneakily given the Hep B vaccine. On the early morning of June 19, 2017, my son was taken to do a routine hearing screening. Over an hour later he was brought to me, lungs retracting and running a high fever. They prepped him, did a spinal tap, did multiple blood draws and tried to cath him, and got an IV started in his head which later had to be moved to his foot. He was then transported to the ICU. There he stayed for FOUR days until his bloodwork and spinal tap came back completely NORMAL. During his time in the NICU, he was administerd 72 hours of antibiotics through his IV.
Diverticulitis; cannot lift anything up or drive; painful arm between the elbow and shoulder; muscle spasms; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms) and ABDOMINAL PAIN UPPER (stomach pain). On an unknown date, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) had resolved, MUSCLE SPASMS (muscle spasms), ABDOMINAL PAIN UPPER (stomach pain) and MUSCULAR WEAKNESS (cannot lift anything up or drive) outcome was unknown and MYALGIA (painful arm between the elbow and shoulder) had not resolved.            No concomitant medication were provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Action taken with mRNA-1273 Moderna vaccine was Not applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up was accepted on 27-May-2021 On 26-May-2021: Non significant follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is an initial spontaneous report from a contactable registered medical assistant via a Pfizer sales representative. A 4.5-year-female patient received a dose of PREVNAR 13 in her left thigh on 22Oct2010 as a catch up supplemental vaccine. No other vaccines were given. The patient's relevant medical history, past drug history, and concomitant medications are unknown. Within a day or two after the vaccine was given, the injection site was red and it was warm to touch. On 24Oct2010 the patient was taken to the emergency room and was diagnosed as having allergies to vaccine. There was no relevant lab test done or treatment given. The patient had recovered from the events within 24 hours.
Information has been received from an 81 year old female consumer with a prolapse heart valve and a history of hysterectomy (45 years ago) who on 18-DEC-2006 at 14:30 was vaccinated SC in the "fat part" of the left deltoid with a first dose of ZOSTAVAX vaccine (Merck).  Concomitant therapy included MSD, DIOVAN HCT, TOPROL XL, ECOTRIN, CENTRUM SILVER, CALTRATE 600 PLUS VITAMIN D, beta carotene and cyanocobalamin.  On 19-DEC-2006 the patient developed a rash which "has gotten worse". The rash started in the forearms and spread to the top of her hands and "now" the rash is in the ankle and going up the leg into the torso. She mentioned that at the site of injection there was a 0.5 inch x 2 inch "strip like area" that was discolored, sore and red. The consumer went to see a dermatologist on 27-DEC-2006 and was prescribed triamcinolone topical lotion. She used the lotion until it was gone and saw the dermatologist again on 08-JAN-2007.  The lotion was not working and the dermatologist told the patient that the rash would have to run its course through the body. The patient will go back to the dermatologist in three to four weeks if needed.  At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 02/13/2007. Additional information from the registered nurse who reported that on 26-DEC-2006 the patient called the physician's office to report her rash. She was seen on 27-DEC-2006 and had a 1 cm X 2 cm lesion at the site of injection which the physician did not feel was problematic. On the ventral aspect of each forearm the patient had erythema multiforme which looked like small little red dots the size of "push pin heads" from the elbow to the wrist. The physician thought that this reaction was a problem so she referred the patient to the dermatologist. On 28-DEC-2007 she was seen by the dermatologist and the derm consult was drug reaction and the patient was treated with triamcinolone. The nurse reported that the patietn had a significant reaction, however it wasn't something of imminent doom". The patient's experience was not life threatening, the patient never went to ER, was not hospitalized and is not disabled. She felt that it was 7 on a scale of 1-10. The patient was seen at the dermatologist again 10 days later on 08-JAN-2007 and had since recovered. No further information is expected.
Initial report received from a health care provider on 21 November 2007. A 3-year-old female patient with medical history of cataracts, had received an intramuscular left deltoid injection of Menactra, lot number U2419AA and an intramuscular left deltoid injection of Adacel, lot number C2775AA on 29 October 2007 and four days later complained of headaches leading to hospitalization on 14 November 2007. The patient was admitted to the hospital for two to three days (discharge date not provided), and was diagnosed with Pseudotumor "cereberi". Corrective treatments were not reported. Diagnostic testing included an MRI and CT of the head and a spinal tap (results not provided). The patient had not received any vaccines during the four weeks prior to receipt of Menactra and Adacel. The patient had not been ill and had not been taking any concomitant medications at the time of vaccination. According to the reporter, the patient had recovered completely from the event. No further information was provided. 1/22/08-records received for DOS 11/15-11/17/07 DC DX: Pseudotumor cerebri. Presented with 2 week history of headache which has not gone away with 1-2 seconds blurring or blackouts of vision. Papilledema on exam. and 11/21-11/22/07-DC DX: Headache improved status post lumbar puncture. Pseudotumor cerebri. HX of recently diagnosed pseudotumor with chronic recurrent headaches.
Received ZOSTAVAX at his local pharmacy on January 20th. Developed outbreak of shingles right chest wall 2 days later. Seen in office 1/31/11. Treated with oral pain medications, topical LIDODERM, and oral gabapentin.
mom reports 18JUN98 that p/vax 27APR98 pt cried inconsolable, had glazed eyes & red swollen leg;taken to ER;mom states ER MD stated was d/t colic;PCP according to mom thinks it was d/t pertussis & pt should recv DTAP;
hives on chest ER dr prescribed Benadryl, Prednisone, and Famotidine
pt recvd vax;approx 2min,sz;Amb called,but over by the time they arrived;on 16jan90 was hosp & put on dilantin;she cont to have gen sz to date;
Severe nausea; severe headache; fever; couldn't get out of bed; Weak Lasted 72 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 17:15 (Lot number: FK9729) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2, single, product=COVID 19, brand=Pfizer, lot number=EW0179, administration date=28Jun2021, administration time=10:00 AM, vaccine location=Left arm), administration date: 28Jun2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (dose 1, single, product=COVID 19, brand=Pfizer, lot number=EW1077, administration date=07Jun2021, administration time=10:00 AM, vaccine location=Left arm), administration date: 07Jun2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 29Jan2022 12:00, outcome "recovering", described as "Severe nausea"; HEADACHE (non-serious) with onset 29Jan2022 12:00, outcome "recovering", described as "severe headache"; PYREXIA (non-serious) with onset 29Jan2022 12:00, outcome "recovering", described as "fever"; BEDRIDDEN (non-serious) with onset 29Jan2022 12:00, outcome "recovering", described as "couldn't get out of bed"; ASTHENIA (non-serious) with onset 29Jan2022 12:00, outcome "recovered" (01Feb2022 12:00), described as "Weak Lasted 72 hours". Therapeutic measures were not taken as a result of nausea, headache, pyrexia, bedridden, asthenia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks. The patient had no known allergies. Facility type vaccine: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Noticed 13 days later flat, warm to touch, itchy rash about 5 inches diameter near injection site.
Pt developed intermittent bloody, mucousy stools 1 week after receiving vaccinations.
Patient started with diarrhea and skin breakdown around buttock area.  Patient is still having these issues.  Mupirocin ointment prescribed for skin breakdown and rash.
Patient "getting her periods every 8 days" after the COVID-19 vaccination. Patient with 'bloating' PMS periods and then 'resurgence of eating disorder' thoughts. Prior periods "kind of irregular." Family History: Mom with "microscopic colitis" after COVID-19 vaccination.
Soreness in muscles of entire upper right arm, red blotches over affected area, painful when touched, headache, feeling ache and dry throat.
Large Pulmonary Embolism beginning in left leg, traveling to Lungs form Leg and pressing against heart. Could not breath, severe pain in chest, profuse sweating, almost passed out. Hospitalized in ICU 3 days, 36 hours in general ward. Given oxygen and IV of Heparin.
DX: Urticaria- extremities, trunk  Symptoms of severe itching, body rash began 4 days post vaccination, persistent hives for approximately 2 weeks, break through hives still present currently on upper extremities   Treated with oral antihistamines, topical steroids