chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Patient received improperly stored dose of vaccine; This spontaneous report was received from a registered practical nurse and refers to a 12 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 23-SEP-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1637641, expiration date 16-FEB-2022 (dose, frequency, vaccination site and route were not provided), for prophylaxis. No adverse effects reported.  Temperature LOWEST Temperature BELOW 36°F (29F) Time frame 3 days Previous temperature excursion? No
Information has been received from a nurse concerning a 13 year old female who on approximately 11-MAR-2008 was vaccinated IM with a 0.5 ml dose of GARDASIL in the right arm. Concomitant therapy included a dose diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid in the left arm (manufacturer unknown), a dose of hepatitis A virus vaccine (unspecified) in the left arm (manufacturer unknown) and a dose of vaccination (unspecified) in the right arm. The patient experienced an immediate onset of blisters and swelling at the injection site on the left arm. The patient was prescribed BENADRYL. Medical attention was sought via exam in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Chills, Muscle and Joint aches/pains,  headaches, neck pain,  vaccine site..pain,swelling,red,warm  x 2 days
Pt vaccinated with MMR developed URI symptoms beginning 18OCT90 with headache. 29OCT90 dx rt parotitis.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Severe, Systemic: testicle swelling/lymphnodes groing swelling-Severe, Systemic: Headache-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Weakness-Severe, Additional Details: fever for 2 weeks, blister, rash all over body. drained and body felt beat up, fever of 102.4 for 2 weeks
The patient administered booster dose of the Moderna vaccination after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 020B21A, 001C21A and 077C21B) for COVID-19 vaccination.     The patient had never been diagnosed or tested positive for COVID-19. No acute illness reported at the time of vaccination or up to one month before it. Patients chronic and long-standing conditions were reported as unknown. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was reported as unknown.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered booster dose of the Moderna vaccination after the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had no adverse reaction  after receiving the vaccine and after 15 minutes of standard post-vaccination observation.  The vial was initially stored in refrigerator on 18-Apr-2022. The vial did not undergo any temperature excursion. Number was doses/vials was 2. The frequency was reported as times per.  No treatment medications were reported.   This case was linked to MOD-2022-548520 (Patient Link).
Information has been received from  a physician concerning a patient who on June 03 2004 and Jul 20 2004 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine, during a six week period. On June 03 2004, in the period immediately following vaccination, the patient developed a right sided headache and a fever. The symptoms resolved after a (short while), however, it was noted that since the immediate period the patient has reported to the physician that they suffer from an occasional headache. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in 2014 (reported as "vaccinations occurred between 13-OCT-2014 and 17-NOV-2014"), an unspecified number of patients received GARDASIL (doses, routes of administration, lot # and expiration dates were not reported) stored at 33F for 3 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Lump under arm put; Body aches; Sore at injection site; Fever; Dose received: 3; This is a spontaneous report from a contactable reporter (Nurse). The reporter is the patient.   A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 03Dec2021 at 18:00 (Lot number: unknown) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), administration date: 22Dec2020, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 at 18:00, outcome "unknown", described as "Dose received: 3"; AXILLARY MASS (non-serious) with onset 04Dec2021 at 07:00, outcome "recovering", described as "Lump under arm put"; PAIN (non-serious) with onset 04Dec2021 at 07:00, outcome "recovering", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021 at 07:00, outcome "recovering", described as "Sore at injection site"; PYREXIA (non-serious) with onset 04Dec2021 at 07:00, outcome "recovering", described as "Fever". Therapeutic measures were not taken as a result of axillary mass, pain, vaccination site pain and pyrexia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle cramps  / couldn't use rest room/ shaking. Started next morning, 2days later admitted  to hospital. Doctor said reaction to influence injection. 2years 6months. Many other Doctors also involved.
Patient stated "Late yesterday my nose stated to bleed and then I became very dizzy. Started vomiting and had serious diarrhea."
Tiredness; This case was reported by a consumer via other manufacturer and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix and COVID VACCINE. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR003782  Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comments: The patient was reporter himself. The patient received Shingrix and Covid vaccine at the same time. The reporter stated that for the first dose, he did not experience any side effects other than tiredness. No additional adverse event information provided. It was unknown if the reporter considered the tiredness to be related to Covid vaccine.  Additional Supportive Information: For tolerance of 2nd dose refer case US2023AMR003782.; Sender's Comments:  US-GSK-US2023AMR003782:Same reporter
PT received the J and J covid vaccine on 11/19 without any incident during administration or observation period.  Patient called later that afternoon stating both arms were numb. Patient was advised to call her pcp for additional direction. PCP sent pt to ER for further medical evaluation- according to pt, blood work, MRI and CT scan were negative. Pharmacist f/u with patient on 11/24 who reported numbness in legs/feet but symptoms in arms and hands had resolved. Patient reported that ER doctor excepted symptoms to resolve with time.
Had fainted for few seconds. Started to have seizures.  Gave Epipen autoinjector. Called 911. EMS arrived.
Patient woke up feeling pain in her left arm, the day after vaccine administration. Pt experienced chills, arm was red, red and swollen in the large area around injection site. For 7 days pt didn't seek medical attention but since it didn't get any better she visited doctor. Diagnosed with cellulites and prescribed antibiotics on 04/15/2022. Fully recovered now.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L049316 with expiration date of 03-DEC-2017; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA013210: US-009507513-1703USA014483: US-009507513-1703USA014484: US-009507513-1703USA014485.
30 to 60 minutes after the vaccine I started to feel extremely tired, woke up in the middle of the night with low grade fever of 100 and chills (sweating).Also had pain in my left arm from my elbow up into my neck. Up and down all night. 6:30AM felt nauseous and dizzy. Could not drive to work. So tired I slept most of the day. 3/17/21 Left work at lunch for home. Continued pain in arm & neck, very tired, pressure (achy) in chest .
Patient given 4th dose/2nd booster dose even though not immunocompromised and not of age to be eligible. Patient observed after for 15 min. No sign of adverse reaction. Patient's parent informed and told to watch for any unusual side effects and seek medical care if needed. Patient's parent verbalized understanding.
has red blotches all over, and  it was increasing in numbers.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (has red blotches all over, and  it was increasing in numbers.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (when young).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RASH MACULAR (has red blotches all over, and  it was increasing in numbers.). At the time of the report, RASH MACULAR (has red blotches all over, and  it was increasing in numbers.) had not resolved.            No Concomitant medication details were provided. No Treatment medication details were provided.
Lightheadedness, dizziness, tingling in toes and fingers, and headache.
Began with dizziness and sleepiness which continued for approx 2 days. Followed by moderately severe headache and body aches.  Most symptoms were relieved by around noon on the 3rd day.
This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician reported pain, redness and swelling in 2 or 3 patients that had received SHINGRIX vaccine.
Weakness, sweating, body ache, rash at injection site BP 170/107. BP Decreased to 111/72 Pulse 128. Pulse decreased to 74 Patient declined ER and went home  Seen by RN
Pt passed out momentarily after vaccination. He recovered quickly without intervention. BP 136/64, HR 60, SP02 99%. His significant other drove him home. He recovered completely at time of departure.
Developed fever and redness in left thigh on 10/1/17. Pt was evaluated on 10/4/17, afebrile and monitoring redness, no treatment recommended.
Continuous vomiting since receiving the vaccine.  Patient is febrile at 101.4 F.   Patient has epithelial ovarian cancer FIGO stage IV B.  She was treated one week prior with injections of pembrolizumab and bevacizumab.  Patient becomes septic, found to have NSTEMI.  Antibiotics started.  Dobhoff placed.  Patient discharged to hospice.
This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There was no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
respiratory issue; my lungs crackle; inhale and wheeze/lungs wheeze and crackle; like having bronchitis; terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back; more and more mucus keeps coming on; lots of phlegm kept coming back; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis) and COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis), COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back), SECRETION DISCHARGE (more and more mucus keeps coming on) and PRODUCTIVE COUGH (lots of phlegm kept coming back). At the time of the report, RESPIRATORY DISORDER (respiratory issue), RALES (my lungs crackle), WHEEZING (inhale and wheeze/lungs wheeze and crackle), BRONCHITIS (like having bronchitis), COUGH (terrible cough/horsy cough/cough and more and more mucus keeps coming on/lots of phlegm kept coming back), SECRETION DISCHARGE (more and more mucus keeps coming on) and PRODUCTIVE COUGH (lots of phlegm kept coming back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, X-ray: normal (normal) Normal.         No concomitant medication was provided.  Doctor gave antibiotics which seemed to subside the problem but after that it went back. So patient got a second set of antibiotics for 10 more days. Patient said that he has been having this issue for around 2 months
Pt. began to feel "funny" Chest felt "cold" Ears felt "cold" Back of throat "cold" EMT assessed as well as RN BP 180/80 she was given water and her husband drove her to their local hospital to be checked out at 1:15
patient was flushed and saying her stomach was upset. I instructed her to sit down and have a drink of water to cool off and possible ease her stomach. Her husband stated that she can get very nervous when it comes to vaccines and this has happened before. She then left the store to get some fresh air. Before I could find her and check on her again my front end cashier informed me that she got sick outside and her and her husband left.
adverse effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse effect). At the time of the report, ADVERSE REACTION (adverse effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Nausea; Dry heaves; Headache; Extreme body aches; Fatigue; Chills; Fever started; Slight vertigo began; Still felt unwell until Tuesday when I felt like myself again; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injec-tion, Batch/Lot Number: EW0168), dose 2 via an unspecified route of administration, administered in Arm Left on 28May2021 14:45 (at the age of 51-year-old) as dose 2, single for COVID-19 immunization. Medical history included PKD, Anxiety, HBP from an unknown date and unknown if ongo-ing. Concomitant medication(s) included metoprolol succinate; citalopram; losartan and Vit. taken for an unspecified indication, start and stop date were not reported (other medications the patient received within 2 weeks of vaccination). The patient was not pregnant at the time of vaccination. The patient was previously received first dose of BNT162B2 (Lot number: EW0179), administered in Left arm on 07May2021 03:30 PM (at the age of 51-year-old) for COVID-19 Immunization. Facility where the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. 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. Patient had no known allergies. Reported, approximately 12 hours after injec-tion (3am on Saturday, 29May2021) chills and fever started, 4 hours later (7am) nausea and dry heaves started with headache and extreme body aches, and fatigue. By noon after the nausea and dry heaves stopped and slight vertigo began (29May2021). (1000mg of Tylenol was started and taken every 6 hours following until Tuesday morning at 7am.) Fever decreased to upper 99's -101, and chills were on and off and didn't completely go away until Monday morning (31May2021) when I woke up at approx. 7 am. Body aches and headache also continued until Monday morning. Still felt unwell until Tuesday when I felt like myself again on an unspecified date in 2021. Patient received 1000 mg of Tylenol was taken every 6 hours as treatment for all events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included Fever: 99's-101 on 2021 (decreased to upper 99's-101). Therapeutic measures were taken as a result of chills, fever started, nausea, dry heaves, headache, extreme body aches, fatigue, slight vertigo began, still felt unwell until Tuesday when I felt like myself again. The outcome of events was recovered on an unspecified date in 2021, event nausea and dry heaves was recovered on 29May2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a 27 year old female patient. The patient's medical history, drug reaction, allergies or concomitant therapies were no provided. On 20-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dosage, frequency, lot# and expiration date were no provided). The pharmacist stated that on 24-JAN-2018, the patient received the second dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dosage, frequency, lot# and expiration date were no provided) and may have turned 27 years of age during that time.
Asthma issues the same night; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma issues the same night) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ASTHMA (Asthma issues the same night). On 30-Jan-2021, ASTHMA (Asthma issues the same night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided