chrisvoncsefalvay/vaers-outcomes huggingface dataset:
deep pain in her chest which is worse with deep breaths; cough; fever; chills; joint pain; muscle pain; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (deep pain in her chest which is worse with deep breaths), COUGH (cough), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache). On 12-Jan-2021, the patient experienced CHEST PAIN (deep pain in her chest which is worse with deep breaths) and COUGH (cough). On 13-Jan-2021, CHEST PAIN (deep pain in her chest which is worse with deep breaths) had resolved. At the time of the report, COUGH (cough), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided; Reporter'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.
1/31/22 patient presented to ER by EMS following MVA. Patient was traveling at highway speeds and collided with a truck. Subsequently he tested positive for Covid19.
Patient is a 81 y.o. male patient of (name withheld), MD with a history of myasthenia gravis admitted for COVID-19 infection and urinary tract infection.  ID consult appreciated patient completed remdesivir.  Remains afebrile during the hospitalization patient was found to have acute on chronic renal failure which was treated with IV hydration Lasix being discontinued.  Blood pressure was running high all throughout initially patient was reluctant to get any new blood pressure medication finally agreed to go home with Norvasc.  We will follow-up as outpatient.   Discharge Diagnoses: Urinary tract infection Assessment & Plan Urine growing Proteus pansensitive.  Being discharged on cephalexin 500 3 times daily for a week   * COVID-19 virus infection Assessment & Plan Patient was hypoxemic on admission.  CT chest negative for pulm pulmonary embolism or any infiltrate.   Has completed remdesivir now asymptomatic  Elevated troponin Assessment & Plan Patient's troponin slightly elevated probably secondary to type II MI/demand ischemia.   Patient's nuclear stress test done February 2022 negative for inducible ischemia however did show drop in ejection fraction from 66 from a previous echocardiogram to 34.  We will do a repeat 2D echo.   Hypernatremia Assessment & Plan Resolved   Acute renal failure with acute tubular necrosis superimposed on stage 3a chronic kidney disease (HCC) Assessment & Plan Acute component resolved with IV hydration.  Plan to hold Lasix reevaluate as outpatient   Myasthenia (HCC) Assessment & Plan Continue home medication   Essential hypertension Assessment & Plan Not under control amlodipine added discussed about benefit risk side effect including leg edema.   Acquired hypothyroidism Assessment & Plan Continue home medication of Synthroid
mild case of diarrhea; pain at injection site; stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (mild case of diarrhea) and INJECTION SITE PAIN (pain at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for an unknown indication.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On an unknown date, the patient experienced DIARRHOEA (mild case of diarrhea) and INJECTION SITE PAIN (pain at injection site). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency and CHARCOAL ACTIVATED for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (mild case of diarrhea) and INJECTION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Birth control medication was reported as concomitant.
Patient exhibits cough, severe HTN, fatigue, and development of Bell's palsy. Treatment: Patient started Ivermectin
sick with the other doses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with the other doses) in an elderly 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 ILLNESS (sick with the other doses). At the time of the report, ILLNESS (sick with the other doses) outcome was unknown. No concomitant medications were reported by the reporter. Patient reports that she did not have side effect like second booster dose with the other doses, she was just very sick. No treatment medications were reported by the reporter. This case was linked to MOD-2022-568195 (Patient Link).
Like the second shot, the 3rd shot made me bed-sick for 3 days with fever, body aches, fatigue, sick to stomach.  However, this time I also broke out with Shingles, even though I had the first Shingles shot in my 50's and Shringrex in late 60's.  Clearly, this 3rd shot weakened my immune system to the maz.
Redness on her arm; Diarrhea; just does not feel great; Fever of100; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on her arm), DIARRHOEA (Diarrhea), MALAISE (just does not feel great) and PYREXIA (Fever of100) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ERYTHEMA (Redness on her arm), DIARRHOEA (Diarrhea), MALAISE (just does not feel great) and PYREXIA (Fever of100). At the time of the report, ERYTHEMA (Redness on her arm), DIARRHOEA (Diarrhea), MALAISE (just does not feel great) and PYREXIA (Fever of100) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on June 8th. Pt reports all AE's resolved.  Denied further follow up.
Patient:  Oct 14, 2021: 59 year old female patient received her second COVID 19 vaccine. Patient stated before the vaccine was administered that she had an allergic asthmatic reaction six hours post vaccination.  Patient spoke to provider and was given medical consent to receive second dose and to bring personal albuterol and epinephrine with her. Patient also stated that she took Benadryl prior to vaccine appointment.  After the vaccine was administered the vaccinator asked the patient how he was feeling and the patient stated he was "fine".  Patient was given discharge instructions and told to sit for thirty minutes in the observation area. It was there that the patient began to at first cough and then began wheezing and gasping for air. Patients vitals were taken and Epi Pen was administered immediately. Rapid response team from the ER was called and provider monitored patient until ER unit responded. Patient did not have albuterol on her person.  Vital signs were as follows HR 129, Spo2 97, A/O x3 BP was unsuccessful. Patient was transferred to the Emergency Room based off hospital protocol.
High dose (20 mcg) of pediatric pfizer vaccine was given due to a failure to dilute the vial with 1.3 ml of Sodium Chloride prior to drawing up the dose out of the vial. Patient's mom was notified and reported no adverse events from the vaccination at this time. Patient should be monitored over next few days for any adverse reactions and it's recommended that they still receive a second dose 21 days later as long as local and systemic side effects are clinically concerning from the high 1st dose given. From a quality improvement perspective, moving forward only the pharmacist will be allowed to dilute pediatric pfizer prior to administration (not an intern or a certified tech immunizer).
Severe skin reaction/hives/itching/burning on legs, chest, underarm, back, arms neck, scalp & now begging for on face. Started Saturday April 10th, now 1 week later, Saturday April 17th, it is still spreading.
Rash, swelling and itching at injection site- still present on 3/5/21
Vaccines at 4pm. At 8pm while burping, pt vomited chunks, went pale and limp. Was pale and limp for 45 minutes, then fine. Eating well and active.
12/28/2022 I started having a runny nose and tickly cough. I took an at home COVID test and it was positive. About three or four days later, I started feeling a little bit of aches and pains and my cough became more severe, especially at night. I had low grade fever that resolved increasing my aspirin intake. I started getting better at that point. About two weeks later, I got very sick with regard to my cough amplifying, shaking chills, high fever and felt terrible. I saw a physician. I had bloodwork done, blood cultures and liver function studies which went up and were abnormal. My WBC was up a little bit. There was nothing I could take. Within about four to five days, it began to resolve. I am now back to normal, liver function has resolved and is good.
Information has been received from a mother concerning her 27 year old daughter who on 20-JUN-2007 was vaccinated in the left arm with a dose of Gardasil (Lot #654885/1424F).  Concomitant vaccination included MENACTRA.  Other concomitant therapy included tuberculin purified protein derivative.  On 20-JUN-2007 the patient stated within five minutes after receiving the vaccines that "she started to feel weak within ringing in the ears".  Her face was pale with no color and she was unable to walk.  The nurse and the mother escorted her to the treatment room where she laid for approximately five minutes.  She used cold compresses.  On 20-JUN-2007 the patient fully recovered and went home.  Additional information has been requested.
25 JUL 2022: congestion, cough; 26 JUL 2022: high fever, congestion, mucousy cough, gagging/vomittingMotrin, Tylenol; 27 JUL 2022: high fever, congestion, mucousy cough, Motrin, Tylenol; 28 JUL 2022: high fever, congestion, mucousy cough, Motrin, Tylenol, vomitting; 29 JUL 2022: fatigue, no appetite or thirst, mucousy cough, Motrin, Tylenol, vomitting; 30 JUL 2022: fatigue, no appetite or thirst, mucousy cough, Motrin, Tylenol, vomitting; 31 JUL 2022: fatigue, no appetite or thirst, mucousy cough, Motrin, Tylenol, vomitting; 31 JUL 2022: fatigue, no appetite or thirst, mucousy cough, Motrin, Tylenol, confirmed double ear infection, Amoxicillin; 01 AUG 2022: fatigue, no appetite or thirst, mucousy cough, Motrin, Tylenol, Amoxicillin;
Patient reports feeling achy and tired,; Patient reports feeling achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: Patient reports feeling achy and tired,) and pain (Verbatim: Patient reports feeling achy). The outcome of the tiredness and pain were not resolved.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.     It was unknown if the company considered the tiredness and pain to be related to Shingrix.   Additional Information: GSK Receipt date: 01-NOV-2023 The patient seif-reported this case. Patient reported that he got the vaccine at a local pharmacy. Patient reported feeling achy and tired and that symptoms had not resolved.  Patient had called to get medical advice and inquired if he could take Tylenol for the symptoms and the patient disconnected abruptly and no additional information was provided.
Information was received from a pharmacist regarding a 62 year old female patient with a history of unspecified lung disease. On 28-SEP-2013, the patient was vaccinated with PNEUMOVAX 23 in the arm (dosage and route of administration not provided), lot # H009826, expiration date 11-FEB-2014. FLUVIRIN was given concomitantly in a separate arm. The patient began to experience redness, pain and warmth at the PNEUMOVAX 23 injection site and also headache, body stiffness, and sweating "about 4 to 6 hours" after the administrations. The patient called her physician on an unspecified date due to her symptoms and was treated with ibuprofen (manufacturer unknown) and was advised to rest. The patient was prescribed an unspecified antibiotic for an unspecified reason on 30-SEP-2013. The pharmacist did not know if this was related to her symptoms. The patient recovered about 2 weeks later. Additional information has been requested.
tired; could've slept longer after the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cyst" (unspecified if ongoing), notes: he got a very small dose Cortisone shot behind his ear. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; HYPERSOMNIA (non-serious), outcome "unknown", described as "could've slept longer after the shot".  Additional information: Caller mentioned he received the 1st dose of the Pfizer vaccine yesterday. He was held up by the nurse in the facility for 15-20 minutes because he mentioned to them that he got a very small dose Cortisone shot behind his ear from his dermatologist for a cyst 13 days ago. After debating, he finally got the shot. He mentioned that a day after his 2nd dose, he will go to his dentist for a bridge replacement and will be injected with Novocaine. He mentioned that originally, he will get a shot for his knee but is thinking of delaying for his shot. He would want to know if he can take the the Novocaine and proceed with the bridge replacement or how long should he wait before getting it.   No follow-up attempts are possible. No further information is expected.
91yr old female arrived to ED with complaints of chest pain. She was at her home with her daughter in law. She noticed she has been more short of breath, and had some chest pain this morning after taking out the recyclable container and stripping the bedsheets off the bed. Daughter in law brought her into the clinic for further eval. Then patient was brought to ED due to abnormal EKG and changes. Patient is pain free upon arrival .   worsened today.  She has new onset A. fib and daughter in law thinks that may have started 2 weeks ago.   She has bilateral large PEs.  She is thankfully saturating well on room air.  She is not in respiratory distress.  91yr female who presents for admission to swing bed from hospital.  She was seen in the ED 12/2/2021 with complaint of chest pain and fatigue with activity .  She was transferred to hospital with diagnosis of acute pulmonary embolism,  elevated troponin level,  and new onset atrial fibrillation.  Past medical history is significant for HTN, HLD, T2D, depression, hypothyroidism, OSA , CKD. For her pulmonary embolism and atrial fibrillation, she was started on Eliquis.  Her atrial fibrillation was rate controlled with a CHA2DS2-VASc score of 7.  She presents to Hospital for strengthening and physical therapy.   Acute pulmonary embolus, started on Eliquis New onset Atrial fibrillation, rate controlled Generalized weakness.
Covid arm.  On March 16 I noticed a lump at the injection site and mild itching.  The next day I noticed a big, red circle around the injection site.  It was slightly raised.   There was a burning/itching feel to it.
Rapid Heart Rate, elevated BP  initial 181/110 hr 123,  195/111 hr 125, later she became SOB.  911 was initiated
Within 24 hours after second dose of Pfizer, unable to urinate for 15 hours with flu like symptoms and low grade fever. Body ache, joint pain, and low back pain. Joint stiffness of the injected extremity (left shoulder). Have not seen a healthcare provider. Seem to improved a little on day #3. Continue bedrest and hydration.
No additional AE reported.; HCP reported PNEUMOVAX 23 (PFS) was administered after a temperature excursion to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 14-JUN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) once (strength, dose and route of administration were not provided), lot #U003306, expiration date: 15-OCT-2022, administered for prophylaxis, after a temperature excursion (Product storage error) occurred on 12-APR-2022 in 62 degrees Fahrenheit for 5 hours 12 minutes. No previous temperature excursion. No additional adverse event (AE) reported.   This is one of four reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA010861: US-009507513-2209USA000715: US-009507513-2209USA000730:
This spontaneous report as received from a nurse refers to an unspecified amount of patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally lot # L037921, expiration date 31-MAY-2017 (dose was not reported). No adverse event were reported. The vaccine was exposed to temperature of 57 Fahrenheit (F) for one hour. There was no previous excursion. This is one of two reports from the same reporter. Additional information has been requested.
Patient started coughing about 2 hours after his vaccinations. He was fussy that evening and through the night. The following day mom noticed he was 'more lethargic' and 'had less of an appetite'. approximately 24 hours after his immunizations he started with profuse continuous vomiting, she called her pediatricians office for guidance and conservative measures were tried. The following day 9/22 he seemed better in the morning and again had an episode of vomiting, repeatedly and then collapsed. 911 was called, CPR was initiated, EMS intubated the child on arrival. He was ultimately found to have aspiration pneumonia, was intubated for about 9 - 10 days and was evaluated with found intracranial abnormalities both acute and subacute possibly due to the resuscitation attempts or delayed appropriate intubation or underlying pathophysiology not yet clarified.
Within a few hours of receiving flu vaccine, developed achiness, fever 102-103, no energy for 2 days.
Localized erythema, edema with pruritis. No airway compromise. Resolved with ice application. No pain. ROM is full. LUE 5/5 strength bilaterally.
Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing; the vaccine may have been refrozen; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 prophylaxis.     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 EXPIRED PRODUCT ADMINISTERED (Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired original booster Moderna COVID-19 beyond 30 days after thawing) and PRODUCT STORAGE ERROR (the vaccine may have been refrozen).    This case included information of patient 3rd out of 4 specified patients. None of the patient were pregnant.  Concomitant products were not reported.  The vial was initially stored in the refrigerator on 29-Mar-2022, and the vial was administered to patients on 13-Apr-2022, 15-Apr-2022, 22-Apr-2022. The vial did not undergo temperature excursion. The patient received expired original booster Moderna COVID-19 beyond 30 days after thawing and the vaccine may have been refrozen. Patient had no adverse event.  Treatment medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2023-694650 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-694650:Master case
redness on chest; This case was reported by a physician via call center representative and described the occurrence of localized erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown.   The reporter considered the localized erythema to be unrelated to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but age group was captured as per product indication. The patient received 1st dose of Shingrix and experienced redness on her chest. The reporter did not consent to follow up. The physician was not convinced that this was related to Shingrix as the patient has a history of eczema and did not wish to report this as an adverse event. The reporter submitted limited information as did not wish to report the event and disconnected the call. This case was linked with US2019AMR232984, reported for same patient by same reporter.