chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information provided.; accidentally been given PEDVAXHIB vaccine that was diluted; accidentally been given PEDVAXHIB vaccine that was diluted; This spontaneous report was received from a registered nurse and refers to a 15 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 14-SEP-2022, the patient was vaccinated with the diluted booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, lot # W002453 was confirmed to be valid, expiration date 24-JUN-2024, for prophylaxis (route of administration and anatomical site were not provided). It was reported that the person administering the product was diluting the vaccine with 0.5 ml of normal saline and then drawing up 0.5 ml, and administering it to patients (product preparation error, incorrect dose administered). No additional adverse event information was provided (no adverse event).; Sender's Comments:  US-009507513-2209USA007893: US-009507513-2209USA007866: US-009507513-2209USA008290: US-009507513-2209USA007924: US-009507513-2209USA008058: US-009507513-2209USA008125: US-009507513-2209USA008275: US-009507513-2209USA008249: US-009507513-2209USA008273: US-009507513-2209USA008037:
Moderna COVID-19 Vaccine EUA. Nause, dizziness/weakness and palpitations about 5 minutes after received the second dose.
Weigt increased; Dizziness; Tired; Chills; Having to frequently urinate at night it is like clockwork every 2 hours; Increased craving for sugar; sick; slightly sore arms; Urinating more than usual; I didn't sleep well last night; Lot of gas when i bend over; This spontaneous case was reported by a non-health professional and describes the occurrence of NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours), FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms) and POLLAKIURIA (Urinating more than usual) in a 77-year-old female 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 RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera.    Concurrent medical conditions included Polycythemia vera. Concomitant products included VITAMINS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   In February 2021, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours), FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms), POLLAKIURIA (Urinating more than usual), SLEEP DISORDER (I didn't sleep well last night), FLATULENCE (Lot of gas when i bend over), FATIGUE (Tired) and CHILLS (Chills). On an unknown date, the patient experienced WEIGHT INCREASED (Weigt increased) and DIZZINESS (Dizziness). At the time of the report, NOCTURIA (Having to frequently urinate at night it is like clockwork every 2 hours) had not resolved and FOOD CRAVING (Increased craving for sugar), ILLNESS (sick), PAIN IN EXTREMITY (slightly sore arms), POLLAKIURIA (Urinating more than usual), SLEEP DISORDER (I didn't sleep well last night), FLATULENCE (Lot of gas when i bend over), WEIGHT INCREASED (Weigt increased), DIZZINESS (Dizziness), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 5 lbs (High) Month before last patient gained weight 5 lbs and 4 lbs (High) Weight gained 4 lbs .Patient went from 125 lbs to 135 lbs.         No Treatment details were reported. Patient received third, 100 percentage Modena dose.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose number unknown (booster), single (Lot number: GH9702) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Nov2021 as dose number unknown, single (Lot number: FF2590), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Apr2021 as dose number unknown, single (Lot number: 008C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive rapid test after days of no symptoms and testing negative; Negative, notes: positive rapid test after days of no symptoms and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Experienced rebound of COVID-19 symptoms along with positive rapid test after days of no symptoms and testing negative. Proprietary medicinal product name: Paxlovid (Indication for use in the case: Treatment of COVID-19, Date of start of drug: 09Jan2023, Date of last administration: 13Jan2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300031642 same patient, different vaccine dose and event;
Patient states swelling, itching, pain, rash, and redness was experienced in site of administration immediately after administration of HPV#1 vaccine. This happened on 08-27-2015, but patient did not return for treatment until 8-31-2015. Patient described prednisolone 15mg/5mL, and cetirizine 1mg/1mL.
Complained of swelling and knot at shot site on right arm tmes 4 days.  Good ROM.  No MD visit.
Felt drowsy; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt drowsy) and LETHARGY (Lethargic) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Felt drowsy) and LETHARGY (Lethargic). At the time of the report, SOMNOLENCE (Felt drowsy) and LETHARGY (Lethargic) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was not provided
This spontaneous report was received from a licensed practical nurse and refers to a 4 month infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 19-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004944: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1608USA012794: US-009507513-1705USA004968: US-009507513-1705USA004972: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004953: US-009507513-1705USA004951: US-009507513-1705USA004950: US-009507513-1705USA004974: US-009507513-1705USA004942: US-009507513-1705USA004945: US-009507513-1705USA004946: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1705USA004887: US-009507513-1705USA004888: US-009507513-1705USA004889: US-009507513-1705USA004890: US-009507513-1705USA004891: US-009507513-1705USA004892: US-009507513-1705USA004893: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899:
Patient states about 15 minutes after getting her immunization she had redness at the injection site.  Throughout the day her upper left arm started swelling and feels hot. Patient states that her arm is still swollen. I explained to patient that reactions like that can happen and told patient to see the doctor if it worsens.
pt recv vax 22OCT98 & parents returned w/child on 29OCT98 w/ulcers in the back of throat & lips;
Patient noticed Tuesday evening on 5/10/16 reddened area under left axilla and noted pain when tried to sleep on it. Woke up the next morning and had total of 3 red areas of 2 inches in all areas and noted erythematous induration around areas noted petechiae. Saw MD on 5/12/16 and given prednisone.
legs cramp; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (legs cramp) and VOMITING (Vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced MUSCLE SPASMS (legs cramp) and VOMITING (Vomiting). On 19-Apr-2021, MUSCLE SPASMS (legs cramp) had resolved. At the time of the report, VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow received and contains No new information On 02-Aug-2021: TCR received. Contact address updated. Data correction; outcome of Vomiting changed to Not recovered.; 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.
Large, red area on arm;  Warm to touch.  Swollen (1.5X10 cms).  Placed on MEDROL DOS-PAK.  Dx: Localized allergic reaction.
Admitted to Hospital on 09/11/2022-09/19/2022 readmitted on 09/24/2022 to the ICU at Hospital for acute respiratory distress (ARDS) due to Covid-19, placed on Bi-Pap therapy. Expired on 09/29/2022.
Severe bloody nose for hours; fever of 103.7 for 9 days leading to two day hospitalization; Providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage; Providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage; administration_date=07/May/2021, administration_time=01:00 PM, dose_number=2; administration_date=23/Apr/2021, dose_number=1; This is a spontaneous report from a contactable consumer. A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07May2021 01:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 23Apr2021 in right arm for COVID-19 immunization. On 07May2021, the patient experienced severe bloody nose for hours, fever of 103.7 for 9 days leading to two day hospitalization, providers believe vaccine caused dormant mononucleosis to surface which caused extreme liver damage. The events were assessed as serious (hospitalization, and disability). The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021, sars-cov-2 test: negative   on 15May2021   , sars-cov-2 test: negative   on 16May2021. Therapeutic measures were taken as a result of the events: medication, ultrasounds, blood work, IV, antibioti. The outcome of the events was recovered with sequel.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax; was pale, diaphoretic, unconscious for approx 1 1/2 mins; 90/60, P 52; semi conscious approx 6 mins; ears ringing; feels tired;
This spontaneous report was received from a healthcare worker concerning a male patient of unknown age. On 30-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) instead of ZOSTAVAX (medication error, no product confusion discovered). No concomitant therapy was reported. No adverse event was reported. Additional information is not expected.
Vaccine on Nov 21, 2021 and began reaction on Dec 2.  Symptoms- hives on much of my body particularly upper leg and groin plus hands, torso . Used Benadryl  Dec 4 the skin turned blackish purple under the hives- most on his thighs and groin area with continue hives all over my face- Used Benadryl and topical Calamine  Dec 6 Got prescription for prednisone and antihistamine as I was extremely itchy, and uncomfortable.  I felt as if the vaccine was spring through my system. It was scary. Dec 6-13. Prednisone helped settled the hives but the rash continued as severely. Dec 13-  Started a new prescription antihistamine called Blextin which I am still using.  However the rash continues randomly.moving from one spot to another throughout the day.   Feet bothering him . Dec 26- rash continuing on his face a great deal : moving around through out the day from forehead to cheeks, to eyes etc etc.  It continues on the arms, stomach and hands particularly along the life lines on his hands and up arms and elbow.  Feet continue to be bothersome.  NOW my kidneys are sore and I am worried about it damaging my organs.   Jan 1- kidneys continue to be sore and well as the rash not subsiding
Guillain Barre syndrome.  12/15/09 Discharge summary, hospital records received. Service dates 11/6/09 to 11/24/09. Discharge Diagnosis: Guillain-Barre Syndrome with associated debility. Secondary Diagnosis: Hypertension, alcohol abuse, impaired glucose tolerance, hyperlipidemia, degenerative joint disease of the lumbar spine. Patient presented with progressive weakness and numbness in extremities. Started in feet and lower legs, progressed to involve hands. IVIG administration. Alcohol withdrawal with tremor, tachyardia, increased blood sugar. Mild upper respiratory infection. Superficial venous thrombosis upper forearm. Right knee injury.  12/15/09 Rehabilitation Hospital discharge report. Service dates not included. Additional information abstracted: Impairments in mobility and activities of daily living. Knee pain. Strength of lower limbs improved.
strong chills overnight (approx5-6 hours after injection), could not sleep through it, whole body aches, headache, took Motrin and felt a little better (by 2pm the following day) but not 100%. Notably better by second day but still a tad sore.
soreness when touched; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness when touched) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0BM201A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness when touched). At the time of the report, INJECTION SITE PAIN (soreness when touched) had not resolved.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided. The patient reported soreness when touched (around the injection site) symptom started when given the shot, and symptoms is still going on.
mom states found pt cold, clammy & unresponsive Thursday morning in bed; was taken to MD who told parents the pt was having a rxn to pertussis vax;
pt recvd vax; high fever of 105; lethargic,taken to hosp on 10aug94;dx w/ viral meningitis at hosp;
Pt stated at least 3 times, both in verbal in written form that they had received no previous COVID-19 vaccine, and requested a Novavax vaccine. After vaccination, it was found that the pt had been misrepresenting their vaccination history and had previously completed a first series of COVID-19 vaccinations. Pt was informed of this error and that she wouldn't be eligible for a second dose of Novavax. The pt was monitored for 15 minutes, no signs or reports of distress were noted, the pt exited ambulating independently.
Pfizer 1st dose 4/10/21 (lot # ER8732) ? on LD?.Patient had PMHX of chronic pancreatitis and multiple visits to ED with concerning history of malingering and narcotic seeking behavior.  Patient had hx of depression, GERD and alcohol abuse.  Patient coming with chief complaint of abdominal pain. It was not sure if this related to COVID vaccine, but we report for record keeping
Chemical pregnancy experienced 3 weeks after 2nd shot in Moderna vaccination cycle.  No reason to believe it was a related event, but reporting it nonetheless in case a trend emerges.  Some flu-like symptoms (body aches, headache, fatigue) were experienced 24-48 hours after the shot but no fever.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree F to 24.7 degree F. All doses were injected IM in deltoid muscle.  Administration date: 23 Nov 2021 and 27 Nov2021.  The reporter stated that While the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt, they have not had any adverse events. Moderna has stated vaccine could continued to be used until expiration.   No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up document received on 10-Feb-2022 contains significant information, Confirmed that Not experienced any Adverse events.
I had severe stiffness on the left side of my neck and it caused migraine headaches, which included tooth pain. This lasted about 3 weeks. The tension always started in the middle afternoon. By evening, it had progressed to include tooth pain and pain on the whole left side of my head.
After 5 minutes of receiving IMZ, pt felt hot, light headed, dizzy, and sweaty, skin palor and clammy.  After 10 to 15 minutes supine, pt felt better and was 100% normal after 30 minutes.
Received a booster dose that was outside of the 12 hour window; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was outside of the 12 hour window) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was outside of the 12 hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose that was outside of the 12 hour window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Really bad sinus infection; Hurting all over his body in lungs and sides; Hurting all over his body in lungs and sides; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Really bad sinus infection), PULMONARY PAIN (Hurting all over his body in lungs and sides) and MYALGIA (Hurting all over his body in lungs and sides) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Congenital cystic kidney disease. Concomitant products included OMEPRAZOLE, AMLODIPINE, VALSARTAN, TRAZODONE and PRAZOSIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced SINUSITIS (Really bad sinus infection), PULMONARY PAIN (Hurting all over his body in lungs and sides) and MYALGIA (Hurting all over his body in lungs and sides). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (THERAFLU [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, SINUSITIS (Really bad sinus infection), PULMONARY PAIN (Hurting all over his body in lungs and sides) and MYALGIA (Hurting all over his body in lungs and sides) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Blisters inside mouth, on tongue (canker sores) as of 3/22/21