chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 73 year old patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 26-APR-2018, the patient was vaccinated with a dose of  PNEUMOVAX 23 for prophylaxis, intramuscularly, 0.5ml, lot # R000692, and expiration date 09-SEP-2019. The patient had previously been vaccinated on 2017 with PNEUMOVAX 23 for prophylaxis; dose, route of administration, strength, frequency, lot# and expiration date unknown. On 27-APR-2018, the patient reported a cellulitis like reaction. The outcome of injection site cellulitis was unknown. Causal relationship between PNEUMOVAX 23 and the event injection site cellulitis was unknown.
A non-serious spontaneous report or INFLUENZA LIKE ILLNESS, FEVER, CONJUNCTIVITIS, DRY COUGH and MUSCLE ACHE has been received from a  physician concerning a male child subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither past medical history nor concomitant medications have been reported. The patient received FluMist vaccine intranasally on an unknown date. Three to four days later, the patient developed an influenza-like illness with fever "up to 105", conjunctivitis, dry cough and muscle aches. The reported events lasted for about five days.
Head fuzzy, head pressure, head aches - started day of shot and still happening 12 days later Ears ringing - started 2 days after shot and still happening 12 days later Pain, then numbness/weakness/tingling in right side (face, arm, hand, leg, foot) - started day of shot and still happening 12 days later Sensitivity to noise - started 3 days after shot and still happening 12 days later
Approx 48 hrs after receiving vaccine, slight rash appeared in 4 areas of the Left side(same side as vaccine) as follows- Left forearm, Left mid thigh. left top of foot and left upper breast/chest area. In all but chest area, the appearance was a single pustule that was light pink/red and itchy and then opened and drained.  The chest area was the same in appearance but had 4 pusules. Immediate area around sites remained normal in color.
Patient sat for a few minutes.  Felt fine.  Stood in line for a couple minutes and stated he felt dizzy and fainted where impact of floor caused gashes above eye and he bite through his lip.
Chills; Fever throughout the first night/Fever reaching 102.7; Vomited; Muscle aches; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 19Mar2021 at 16:15 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included congenital ventricular septal defect. The patient had no allergies to medications, food or other products. Concomitant medication included chlorthalidone (MANUFACTURER UNKNOWN) and potassium citrate (MANUFACTURER UNKNOWN); all for an unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 26Feb2021 at 16:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 00:00, the patient experienced chills and fever throughout the first night. She also vomited and had muscle aches and fever persisted until evening on 20Mar2021 (30 hours after vaccine). Fever was reaching up to 102.7 (units unspecified). The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fever, vomiting and muscle ache were recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient initially experience dizziness, increased heart rate, and rapid breathing, then patient temporarily loss consciousness for less than 30 seconds.  One dose of Epipen was immediately given.  After giving patient the epipen, she remain lying down on the floor for a few minutes until she is capable of sitting up on a chair.  She was fine after a few minutes, but the patient stayed at the pharmacy for at least another 20 minutes for monitoring.  She left after she felt no other symptoms.
Lethargic; Headache; fatigue; Coughing; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), COUGH (Coughing), HEADACHE (Headache), FATIGUE (fatigue) and MYALGIA (sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced MYALGIA (sore arm). On 25-Aug-2021, the patient experienced COUGH (Coughing). On 26-Aug-2021, the patient experienced LETHARGY (Lethargic), HEADACHE (Headache) and FATIGUE (fatigue). In August 2021, MYALGIA (sore arm) had resolved. At the time of the report, LETHARGY (Lethargic), COUGH (Coughing), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
My blood glucose is gone through the roof; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (I also had your first and your second one they are back in February and March, My blood glucose is gone through the roof.), administration date: Feb2021, for Covid-19 immunization, reaction(s): "blood glucose is gone through the roof"; Bnt162b2 (I also had your first and your second one they are back in February and March, My blood glucose is gone through the roof.), administration date: Mar2021, for Covid-19 immunization, reaction(s): "blood glucose is gone through the roof". The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "not recovered", described as "My blood glucose is gone through the roof". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (02Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Flu-like symptoms; Stuffed nose; Sore throat; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), NASAL CONGESTION (Stuffed nose), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), NASAL CONGESTION (Stuffed nose), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), NASAL CONGESTION (Stuffed nose), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment drug information was not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-127329 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127329:fiancé case (female)
AE: light headed, dizzy, pale, fainted  Tx: n/a, just food and drink Outcome: juice, crackers helped resolve AE.                                 pt was discharged home.
Patient's father made appointment online to get first Pfizer Covid-19 Vaccination. He put his daughter's birth date as 08/28/2007 which made her 15 years old. But patient is actually 11 years 7 months old.  We injected Pfizer for 12 years and up for the patient.   We found out later from the copy of passport that we made. We contacted the father and let him know that he put the wrong DOB on the consent form and the vaccination that the patient received was wrong. Patient is doing fine.  We advised the father put the right DOB on the form online so that the system will lead him to the store that has children's vaccines in stock for the second dose.
Local reaction, patient stated it was like 1 large welt-2-3 cm area around injection site. Site was painful and burned and took a few days to go away.
Patient had vaccine dose #2 on 01APR21 @ 1630.  Injection site (right deltoid) red, hot, swollen and itchy.  Patient has taken Benadryl every 6 hours at home since 01APR21.  Temp 98.2, HR 89, B/P 150/110.  Patient had the same symptoms with the first dose.
injuries resulting from Zostavax use: Shingles; Shingles; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 71 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2017, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a healthcare provider. On an unknown date, the patient was treated for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles.  The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages.  The outcome of the events was unknown. Causality assessments were related.
A week after I received my first vaccine shot. On  Feb 1st, I developed a fever of 102, cough, diarrhea and chills, this was reported to my Primary doctor and was told to give it 48 hours and call back if it persisted. By Feb 4th Fever has subsided but cough and diarrhea remain.
10 yo girl presented for first covid without PMD or allergies  who 2 mins after reported have cloudy vision then fell forward from chair hitting the right side of face .exam remarkable for mild orthostasis of blood pressure supine 140/100 sitting 120/80 standing 100/60 appearance anxious well developed well nourished girl with swelling over right superior orbit but alert and responsive approximately 30 seconds of syncope. head with 1.5x1 cm hematoma over the superior orbit without laceration or ecchymosis eyes visual acuity 20/16 right eye and 20/20 left eye PERRL unable to do fundi due to lack of opthalmoscope  no clear drainage for nare mouth with chipped incisor neck full range of motion chest clr p and a cor rrr neuro o&a x3 after syncope cranial nerve 2,3,4,&6 as well as other cranial nerves grossly intact motor grip good cerebellar grossly intact no romberg dtr wnl. impression +post vaccination vasovagal syncope c/b right orbital hematoma and chipped right incisor thus advised ED visit for orbital imaging and evaluation whether hematoma might require I&D but if taken home apply ice pack and use tylenol rather than NSAIDs and observe for altered mental status ie somnolence or progressive headache with nausea or blurry vision or bulging of the eye or double vision
Given ADACEL (TDAP) on 8/18/10 in left deltoid. ON 8/22/10 soreness, tenderness in deltoid. On 8/23/10 swelling. Not ill at this time. Worked out at gym; lifting weights on 8/22/10. Temp 98.1.
Liver failure; This spontaneous case was reported by a nurse and describes the occurrence of HEPATIC FAILURE (Liver failure) in a 62-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC FAILURE (Liver failure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to HEPATIC FAILURE. At the time of the report, HEPATIC FAILURE (Liver failure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date, a week post vaccination, the patient had liver failure and she ended up to stay in the hospital for a week.  No treatment information was provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-142944 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-142944:
Received a partial dose; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received a partial dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, during vaccine administration, the patient received a partial dose. The nurse reported the syringe was not fully attached to the hub and there was leakage. The patient received a partial dose, but how much she received was unknown. No treatment information provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, received a partial dose, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered.
Moderna COVID-19 Vaccine EUA Itching, swelling, soreness and stiffness at injection site within 6 hours of injection on February 20, 2021.  Those symptoms lasted for 3 days and then went away.  However, in the afternoon of February 27, 2021, an incredibly intense itching began at the injection site, followed by hives/welts all around the site.  The hives ended up turning into an area about 2 quarters in diameter of a red, swollen area on the injection site, and the skin was very hard swollen.  It feels like a rock is under my skin.  I've used Cortisone Cream on it to stop the itch and it's helped, but it's still very itchy.
Pt. c/o wheezing & swelling of face within one hour of receiving vaccination.  C/o nasal congestion and rhinorrhea, pt. has remote h/o asthma- and was out in field with hay- not sure if Rx was caused by vaccination or environmental allergies.  Temp outside was very warm & pt. was in car while dad came back into office to get shot record.  Pt. was given Breathing treatment of A/b/PULMICORT in office.  Dad called next day.  Pt. doing fine.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Arm swelling; Unable to stand without falling; Unable to stand without falling; Very dizzy; Severe fatigue; Migraine/sledgehammer feeling in my head and temp; Migraine/sledgehammer feeling in my head and temp; Chills; High fever; Vomited; Chest palpitations; A 43-years-old non pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history was none. Patient had no known allergies. The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 as single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Apr2021, 7 hours after the vaccination, patient experienced arm swelling, unable to stand without falling, very dizzy, severe fatigue, migraine/sledgehammer feeling in my head and temp, chills, high fever, vomited 4 times and chest palpitations. Patent reported that she started recommended medication and will seek medical care. The outcome of all the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 04-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Pt recv'd vax on 12/3/99.On 12/4/99, mom noticed swelling & redness at injection site on rt leg, irritability, & pain.  ER visit on same day measured 6 cm induration. As of 12/9/99, child was acting normal but site was still swollen.
Pt. received H1N1 vaccine at 14 wks. Fetal heart tones present 5 days later at MD appt. At next appt (12/23/09), fetal heart tones absent (18 wks). US confirmed fetal demise. Delivered 12/26/09.
This case meets criteria for vaccine breakthrough review. Patient brought in unresponsive to ED, no known COVID SxS at the time.
This case was reported by a physician and described the occurrence of hepatitis B surface antigen positive in a 48-year-old male subject who was vaccinated with ENGERIX B. Concurrent medical conditions included reflux symptoms (nos). On 28 November 2007 the subject received 1st dose of ENGERIX B (unknown, right arm). Two days after vaccination with ENGERIX B, the subject donated blood and a positive surface antigen test was reported. The subject was seen by his physician and six weeks later the surface antigen test was negative. The subject received a second dose of ENGERIX B at an unspecified time and experienced inappropriate schedule of vaccine administered. Following the second dose of ENGERIX- B, the surface antigen test was also negative. At the time of reporting the hepatitis B surface antigen positive was resolved. The physician considered the hepatitis B surface antigen positive was probably related to vaccination with ENGERIX B.
Headache, backache, chills, fever and general achiness.  Took Tylenol.   Symptoms began to subside after 16 hours.
Headache; A spontaneous report was received from consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the consumer called asking if she could take aspirin for her headache.   Treatment for the event included aspirin.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, headache, was unknown.; Reporter's Comments: This case concerns a female patient on unknown age who experienced an expected non-serious event of Headache. The event occurred on the same day after receiving first dose of mRNA-1273, (lot # unknown). Treatment for the event included aspirin. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
pt recvd vax; 20oct94 seen in ER for chest pain; started 7AM after eating; walked 10 blocks to hosp; admit 22oct94 expired;