chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prolonged redness on the arm; A spontaneous report was received from a consumer concerning a 82-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site erythema (prolonged redness on the arm).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced red at the site of injection and stated that after 3 days od vaccination redness is still there.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, prolonged redness on the arm was unknown.
The upper arm where the shot was administered had gotten red, swollen, hard, and hot to the touch. The lump on her arm was about 5 inches in diameter. The doctor prescribed antibiotic (Augmentin) on 10/2.
Patient stated that adverse reaction to the pneumonia, extremely painful for over 5 days, could barely move the arm, did attempt to move the arm more after the shot.
pt recv vax 10NOV97 3PM & inj site became red, hard to touch & very sore by 7PM;pt phoned office on 11NOV97 & was instructed to use APAP or advil for pain & to apply ice to inj site;
Extreme perspiration, thought I was fainting. Managed to get to the bed, called my son. Slept on/off 24 hrs. Dizziness for 3 days.
vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a infant patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced vomiting and diarrhea. On an unknown date, the outcome of the vomiting and diarrhea were recovered/resolved.   The reporter considered the vomiting and diarrhea to be possibly related to Influenza vaccine Quadrivalent 2017-2018 season.  Additional information received were as follows: The age at vaccination was not reported. 2 years before the reporting date, the patient received flu vaccine. The patient did not know the name of the flu vaccine. The patient had vomiting and diarrhea following the vaccination. They cause was believed to be a reaction to formaldehyde. Did not consent to follow-up. The patient hung up before additional information could be obtained. This case has been linked to US2019189804, reported by the same reporter.
Redness, swelling at injection site, hives all over body - local reaction. No issue.
Experienced allergy symptoms on his arm and legs using Moderna; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Experienced allergy symptoms on his arm and legs using Moderna) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Experienced allergy symptoms on his arm and legs using Moderna). At the time of the report, HYPERSENSITIVITY (Experienced allergy symptoms on his arm and legs using Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.   This case was linked to MOD-2022-449024, MOD-2022-449535 (Patient Link).
HCP called to state that a patient was given a dose of VARIVAX with a temperature excursion that had a unsupported outcome.; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-MAR-2023, the patient was vaccinated with varicella virus vaccine live (OKA/MERCK) (VARIVAX) valid lot #U019906, expiration date: 24-JUN-2023, administered for prophylaxis (dose, frequency, anatomical location, strength, and route of administration were not provided). It was reported that the dose experienced a temperature excursion (Product storage error).
Swelling of right hand and joint pain in right hand.  Symptoms persisted into the next day but lessened after 1 tablet Aleve 220 mg
DIARRHEA; BACK ACHE; JOINT ACHE IN NECK/KNEE/FINGER/WRIST; GENERALLY WEAK; PAIN IN SHOT ARM; MUSCLE ACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions include severe asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced back ache. On 07-APR-2021, the subject experienced joint ache in neck/knee/finger/wrist. On 07-APR-2021, the subject experienced generally weak. On 07-APR-2021, the subject experienced pain in shot arm. On 07-APR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shot arm, back ache, and nausea, and the outcome of muscle ache, joint ache in neck/knee/finger/wrist, tiredness, diarrhea and generally weak was not reported. This report was non-serious.
NAUSEA; DIARRHEA; SLIGHT FEVER; TOOK UNREFRIGERATED VIVOTIF; This spontaneous case (PVX2019-1486) was received from a caregiver on 10-Jun-2019. It describes a female consumer who had nausea, diarrhea, and slight fever, after the administration of Vivotif for an unknown indication. She also "took unrefrigerated doses of Vivotif".  Case report: The consumer completed all the doses of Vivotif which were placed unrefrigerated for three weeks. She had nausea, diarrhea, and slight fever, just after she started taking it. She took the last dose on 08-Jun-2019.  The consumer had no medical history and did not take any unhygienic food or water.  She did not receive any concomitant and treatment medicines.  Action taken with Vivotif with respect to the events nausea, diarrhea, and slight fever was dosage maintained while with respect to the event "took unrefrigerated doses of Vivotif" was not applicable.  The consumer had recovered from the events nausea, diarrhea, and slight fever on 09-Jun-2019, while the clinical outcome of the event "took unrefrigerated doses of Vivotif" was unknown.  Company's Comment: In this case, it was reported that the consumer had nausea, diarrhea, and slight fever after intake of Vivotif. She also "took unrefrigerated doses of Vivotif".There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and slight fever are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "took unrefrigerated doses of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had nausea, diarrhea, and slight fever after intake of Vivotif. She also "took unrefrigerated doses of Vivotif".There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and slight fever are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "took unrefrigerated doses of Vivotif" was considered as not applicable.
Bad Headache the evening after vaccine.  Next day Chills, Body Aches (Extreme) Arm very soar where vaccine was administered.
COVID-19; Broken ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Broken ankle) and COVID-19 (COVID-19) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced ANKLE FRACTURE (Broken ankle). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, ANKLE FRACTURE (Broken ankle) and COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: This is a spontaneous case concerning a 57-year-old female patient with Rheumatoid arthritis, who experienced the non-serious unexpected event of COVID-19 (AESI), on an unknown date  after receiving an unspecified dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided. Ankle fracture was also reported as an event. Adalimumab was reported as a co-suspect product.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  No concomitant product was reported. The patient missed two to three doses of Humira because she had COVID-19 virus. On 27-Sep-2021, she had ankle surgery as she broke it. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events with Humira was reported as reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: Company comment: This is a spontaneous case concerning a 57-year-old female patient with Rheumatoid arthritis, who experienced the non-serious unexpected event of COVID-19 (AESI), on an unknown date  after receiving an unspecified dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided. Ankle fracture was also reported as an event. Adalimumab was reported as a co-suspect product.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fatigue; Severe armpit; Edema; Muscle Aches; Chills; Diarrhea; Nausea; Right Arm pain; This is a spontaneous report from a contactable nurse. This 26-year-old female nurse (patient) reported that she (Weight :200 lb, Height :5' 8 in) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), dose 2 via an intramuscular route of administration on 21Jan2021 at 15:45 in right arm (at the age of 26 years-old) as DOSE 2, SINGLE for covid-19 immunisation. Vaccine facility type was reported as hospital. Vaccine was not administered at the facility. Patient's medical history included Covid-19 contracted. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, Lot number; EJ1685 via an intramuscular route of administration on 30Dec2020 at 15:45 at right arm (at the age of 26 years-old) for covid-19 immunisation. Adverse event after the first dose was Fatigue, muscle aches, R arm pain, nausea, diarrhea, fever, chills, cough. There were no relevant tests performed. None culture tests were performed. Predisposing factors included Covid-19 contracted in Aug2020. Antipyretic use included XS Tylenol with Ibuprofen orally on 23Jan2021 after vaccination with onset of symptoms. Patient was not admitted in the hospital. On 22Jan2021 at 15:00, patients experienced fatigue, severe armpit, edema, muscle aches, chills, diarhea, nausea, right arm pain. Causal relationship was provided as yes, serious or life threatening events : no. Patient was not deceased. No treatment was required for the events. No AEs required a visit to emergency room or physician's office. The outcome of events was recovered on 24Jan2021.
Patient received first dose of Pfizer covid vaccine. About 1 minute after receiving the vaccine, while Rph was counseling the patient, eyes suddenly rolled back, her body stiffened and patient became unresponsive. She began to slip off of the chair. Rph yelled 911 and patient spoke to them and stated okay and didn't want ambulance sent. She stated this happens when draws blood. Patient had friend with her and left about 20minutes afterwards.
After receiving vaccine, patient stated that she had chills, shakes, and muscle stiffness. Patient stated that she also had some anxiety, and insomnia.
Arm sore; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of   in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Aspirin
Fever, chills, severe body aches, all over joint pain, severe headache, light sensitivity, sore throat, swollen glands, fatigue, inability to sleep, abdominal pain, generalized weakness, loss of appetite. Symptoms not relievable with ibuprofen while bed-ridden for 24hrs. All symptoms lasting a full 24hrs. Joint pain and body weakness persisting well into the 36 to 48 hr range.
I discussed options with her and her husband 8/12. RTAC for CRRT offered, not likely to change outcome, she and her husband were very clear that they desire transition to comfort care. This occurred and she died shortly thereafter.
Information has been received from a physician concerning a 12 year old white female patient who in June 2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). In June 2008, the patient shortly (within days) began to have decrease energy and had several episodes of cataplexy. Her energy continued to decline. Sleeping longer and longer, her blood work was normal (including Lyme) and finally the patient was sent to a neurologist who specializes in sleep disorders, he immediately suspected narcolepsy and it was confirmed on a sleep study-polysomnogram. Additional information has been requested.
01/24 found tender, swollen lymph nodes around neck and ears which remained until 02/04/2002 when rash appeared on face, neck and back. Went to private doctor and received prednisone 10 mg 48.
Patient developed an unexplained on 07-20-09, followed by a generalized seizure and respiratory failure & RUL collapse.  Baby was mechanically ventilated & hospitalized at the hospital.  Baby recovered within 24 hrs.  All cultures were negative.  8/27/09 Hospital records received DOS 7/20/09 to 7/22/09. Assessment: Respiratory Distress following febrile seizure. On the day prior to admission, child had chin trauma. Morning of admission child woke up with a coughing episode, increased work of breathing, and an episode of vomiting. Found unresponsive and limp, eye rolled back in head. Sick contact - grandfather with pneumonia. Gasping respirations. Patient was intubated at another facility and transferred. Stridor. PICU. Palpable liver edge. Erythematous diaper rash.
Patient came in 2 days later complaining of fever, sore throat. Throat was biggest complaint just very sore. Onset > 24h after vaccine.
All of a sudden could not remember who I was, or what I was doing, as if I had total amnesia. I kept looking around wondering what was going on, I had NO idea. it was really scary.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the arm left on 18May2021 at 10:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Relevant medical history included unspecified condition and penicillin allergy. The patient received other medicines (unspecified) within two weeks 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 at 12:00, when the patient was at work and all of a sudden could not remember who he was, or what he was doing, as if had total amnesia, this went on for about an hour, kept looking around wondering what was going on, the patient had NO idea. It was really scary. The patient would realize then what he was doing, and it would happen again, it was like would wake up, and not know where patient was, but was awake the whole time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event all of a sudden could not remember was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Patient returned to clinic within 24 hours of vaccination for macular rash on trunk. Macules approx 1-2 cm, annular. Pt did test (+) for strep and was diagnosed with gutate psoriasis vs vaccine rxn. This is in follow-up to report(s) previously submitted on 5/14/2007.  Initial and follow up information has been received from a physician concerning a 15 year old female with acne, who on 09-APR-2007 at 1:00 pm was vaccinated with a first dose of GARDASIL (lot #654895/1424F) into the right arm IM.  Concomitant therapy included VAQTA (lot # 656497/1213F) into the left arm IM, VARIVAX (lot # "0150F) into the left arm SC, and MENACTRA (lot # 42158CA) into the right arm IM.  Within 24 hours, the patient  experienced a diffuse maculopapular rash.  On 10-APR-2007, the patient returned to the office and a strep test was positive for strep throat.  The patient subsequently recovered from the strep throat and the maculopapular rash.  Additional information has been requested.
C/o fever of 101 next day. Treatment include Tylenol. Symptoms resolved. Patients feels much better has been return back to work.
p/vax pt devel hives & it was reported that pt mom used epi pen & hives resolved;pt redeveloped hives;reporter believes pt tx in ER & released;mom reported hives persisted;pt exp wheezing;dec 02 sat;tx zyrtec;other med important event;
Started not feeling well on Wednesday,  April 21st. Have gotten worse and have had a fever (100) for the last 2 days. Body aches, head ache, congestion,  burning eyes.
my husband woke up on Thursday, October 7 with an extremely swollen left calf.  It remained this way until Saturday, October9, 2021 at which time we went to the ER where he was diagnosed with a very large blood clot in his left calf and two clot in each of his lungs.  Subsequently he was admitted to a hospital, was put on a Heparin drip.  He remained hospitalized and was discharged on Monday, October 11, 2021.  He is on a course of Eliquis 20 mg per day and blood pressure medication.
Initial unsolicited report received from a non-health care professional on 13 April 2016. This case is linked to case 2016SA074914 and 2016SA074938. This case involves a 72-year-old male patient who was vaccinated with a dose of ADACEL (batch number U5278AA, expiry date 25 February 2018, site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date (in December), following the vaccination patient arm was so sore he couldn't lift it and it was swollen and red. Patient came back in March still complaining of pain where shot was given. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. It was reported that, events was related to quality of injection. List of documents held by sender: none.
Leg swollen, red and irritated. Tx: Benadryl 1 tsp q 6 hours. Derma Smooth oil BID to area.
Patient scheduled for second dose of Pfizer primary series, vaccinator at health dept. gave a bivalent booster dose.
Patient was given (Pediarix) when only Dtap was needed. provider called patients mother back and explained there is no adverse reactions but extra protection.
Side effects were not serious, but I elected to report them anyway. On Jan 2nd I received my 2nd dose of Shingrix (1st dose was mid-December). That evening I experienced chills and fever, then headaches. Symptoms lasted about 24 hours. Feel fine now.
Patient developed worsening edema and shortness of breath.  Became fatigued and went to Emergency Department.  He was admitted for 3 days with CHF atrial fib.
8 days after injection in left arm, injection site got red, sore and itchy along with gland swollen behind left ear. Still red and slightly itchy on 10th day. Immediately after injection, had headache for less than 30 mins and then arm was sore from shoulder to elbow but went away after 2 days.
8/10/2022- Presents to ED, c/o covid + at home, headache, vomiting . Covid- test. HR-109 and RR-24. Afebrile. Spo2 99% on 6L, place on  Bipap. Creatnine 1.6. EGFR-40 CXR: pulmonary infiltrates.  Admit acute resp failure s/t CHF exacerbation . 8/12/2022-Increased SOB, eKg no change. Monitor. Albuteral inhaler.  8/13/2022- Alternated between 6l nc and Bipap 60%. Trop critical 1.860. Heparin Drip. PM- trop now 6.180. non-ST segment elevation MI  ICU.Nitro.  Covid + test. EGFR-21. 8/14/2022-Venous dopplers negative. Continue Heparin drip. Start Decadron and Doxy. Held remdesivir d/t renal function.  8/16/2022- Creatnine now 3.0 BUN-110 Continue to hold ARBs/ACEi. Unable to do cardiac cath d/t renal fucntion. ALT-396
Vaginal bleeding not related to menstrual cycle. Approximately 8 oz. of blood within a hour on Wednesday night. Red spots on whites of eyes occurring the day after vaccine and currently ongoing. Nausea with stomach(not menstrual) cramps started Thursday morning leading to vomiting Friday night. Nausea has been continuous.
Ringings in the ears from end of March till now. Ringings are intermittent, 2 days on and one day off. They are not totally disappearing.
POSSIBLE THAT PEOPLE GOT THE VACCINE WHEN STORED UNDER LACK OF TEMPERATURE MONITORING FOR 10 MONTHS; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced possible that people got the vaccine when stored under lack of temperature monitoring for 10 months, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible that people got the vaccine when stored under lack of temperature monitoring for 10 months and out of specification product use was not reported. This report was non-serious.