chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left-sided pulmonary emboli involving the left lower lobe with pulmonary infarction; left-sided pulmonary emboli involving the left lower lobe with pulmonary infarction; This is a literature report for the following literature source(s).  A 24-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY INFARCTION (hospitalization, medically significant, life threatening), PULMONARY EMBOLISM (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "left-sided pulmonary emboli involving the left lower lobe with pulmonary infarction". The patient underwent the following laboratory tests and procedures: Blood fibrinogen: elevated; Coagulation test: Negative; Computerised tomogram thorax: left-sided pulmonary emboli, notes: pulmonary infarction; Haemodynamic test: stable; Haemoglobin: was stable, notes: throughout the hospital course; Labs: were stable; Physical examination: reduced breath sounds, notes: n the left lower lobe. Therapeutic measures were taken as a result of pulmonary infarction, pulmonary embolism: apixaban (ELIQUIS)  Course of the event. A 24 year old male with no significant past medical history presented to the emergency department due to shortness of breath, hemoptysis and chest pain. He denied any family history or personal history of clotting disorders. He received the mRNA COVID-19 Pfizer vaccine 5 days prior to symptom onset. He describes it as constant sharp pain with varying intensity that he rates a 6/10 and can reach a 10/10 pain exacerbated with lying flat and deep breathing. He also states he has been coughing up a teaspoon amount of blood with this chest pain. Physical examination revealed reduced breath sounds in the left lower lobe. Patient was hemodynamically stable. Lab were stable and hemoglobin was stable throughout the hospital course. Fibrinogen was elevated and hypercoagulable work-up was negative. CTA of chest was performed and revealed left-sided pulmonary emboli involving the left lower lobe with pulmonary infarction. Therefore, he was managed by Eliquis. According to the Authors this case is a demonstration of a rare occurrence of isolated PE with no evidence of DVT in such close proximity to receiving the mRNA COVID-19 Pfizer vaccination; Sender's Comments: Based on available information, the causal association between the event Pulmonary infarction, Pulmonary embolism and suspect drug BNT162b2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Experience earaches, jaw aches, and numbness on the right side of her face/unable to close her right eye and was diagnosed with Bell's Palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around 04-MAY-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).   On 04-JUN-2016 (reported as "Approximately one (1) month after"), the pt began to experience earaches, jaw aches, and numbness on the right side of her face. The pt was unable to close her right eye and was diagnosed with Bell's Palsy on or about 30-JUN-2016. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental risks, mental anguish, including diminished enjoyment of life, and also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and suffered incurred other losses and damages. The outcome of Bell's Palsy was not recovered, the pt continued to suffer from right side facial paralysis. The event was considered to be related to the suspect vaccine and to be disabling.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' relevant medical history and concomitant medications were not reported. The patients were administered improperly stored doses of (Oka-Merck) PROQUAD (dose and route were not reported, lot# K007801, expiry on 30-NOV-2015 and lot# K011316, expiry on 14-FEB-2016) on 06-JAN-2015, 12-JAN-2015, 23-JAN-2015, 26-JAN-2015, 28-JAN-2015, 29-JAN-2015, 30-JAN-2015, 03-FEB-2015, 04-FEB-2015, 05-FEB-2015, 06-FEB-2015, 03-MAR-2015, 06-MAR-2015, 11-MAR-2015, 20-MAR-2015, 09-APR-2015, 16-APR-2015, 17-APR-2015 and on 22-APR-2015. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Muscle  aches and left arm pain at injection site started September 5, 2021. I saw my doctor and  he sent for an MRI. Went to immediate care for same arm pain. Off work for 3 days to rest arm. I have to take Tylenol for pain. I still have arm pain at the injection site as of today Jan 11, 2022.
Her son got his 2nd meningococcal vaccine, after that they went home, he ate, acting like normal.  He went to bed, mother heard him making noise and she went to see how he was and found him and he fell into the wall.  He said that he did not feel well, felt like he was going to pass out.  She took him to the sofa, and let him lay down, and he was very hot with fever.  She gave him some water and asked him what happened.  Said that he felt weak, tried to get up from the bed, and that he could not lift his blanket and got up and got water and when he was coming back he lost consciousness and fell on the floor, got up again and fell into the wall is when the mother heard him.  He was also throwing up.  When she checked his temp it would not register, felt it was extremely high.  She then gave him some sprite and he was pale, his hands were cold, sweating.  He started feeling better after the sprite but was very cold.  She gave him some Tylenol and waited and felt that he was better, and she continued to take his temp, which was 103.  She felt that he was getting better, and then in the AM she called the clinic.  She told them what happened again, and they recommended that she take him to the ER.  She explained that she had a high deductible to go to the ER, so asked if he could be seen in the clinic.  They told her to take him to do to the ER so they could do a CT scan.  She did and she found out that he was anemic with a low iron, still had fever so gave him Tylenol.  The CT scan was OK, and was told to FU with PCP.  They wanted to test him for flu, and mother said that he had been OK.  Felt that he may have had a reaction to the vaccine.  He was then rechecked by his PCP, put on iron, and then it was high.  He was then seen by a specialist who said to stop the iron as it was high.  They did more blood work and prescribed iron again.  He wants to do some more blood work to check him out.
Moderna COVID?19 Vaccine EUA  Patient states she was asymptomatic immediately post-vaccination. Symptoms started the next morning when she woke up around 7AM. She noticed she had hives all over her body. She did not notice any other symptoms including difficulty breathing. Hives continued for about 2 weeks on and off. She took benadryl every night before bed to help with symptoms.
full dose (0.5 ml) given for booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (full dose (0.5 ml) given for booster dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J & J vaccine (J & J vaccine). Past adverse reactions to the above products included No adverse event with J & J vaccine.    On 03-Dec-2021 at 11:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose (0.5 ml) given for booster dose). On 03-Dec-2021, ACCIDENTAL OVERDOSE (full dose (0.5 ml) given for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
received a dose from a vial with more than 12 hours of punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured) had resolved.        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.   No concomitant medication details were provided. No treatment information was mentioned.
This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 83-year-old female subject who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). Concurrent medical conditions included diabetes, hypertension and ischemic stroke. Concomitant medications at the time of the event were unknown. On an unspecified date, subject received an unspecified dose of Influenza vaccine (unknown route and injection site). 3 days after vaccination with Influenza vaccine (unspecified), the subject experienced altered mental status, weakness and fever. 5 days after vaccination with Influenza vaccine (unspecified), the subject was hospitalised. On examination, the subject was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL, with lymphocytic pleocytosis (44 cells/microliter). Infectious meningoencephalitis was presumed and broad spectrum antibiotics were started. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, Polymerase Chain Reaction for Herpes Simplex Virus, Varicella Zoster Virus, Human Herpes Virus-6, enterovirus, John Cunningham and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, diagnosis of post-vaccination Acute Disseminated Encephalomyelitis (ADEM) was made based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. Treatment consisted in daily methylprednisolone for 3-5 days followed by prednisone taper was the accepted first line therapy. The patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. Based on the causality assessment criteria, post vaccination ADEM was "very likely".
Swelling on both hands, wrists, leg and under both eyes. Rash (unk location). No resp difficulties, no dysphagia. Rosy checks. No fever. Mild fussiness.
Patient states she has been experiencing mostly vomiting as side effect from vaccine. Pt denies fever or chills. Patient states she is also having a headache which can be due to not having a lot of fluids. Patient works for a healthcare organization. Pt received the vaccine from Pfizer per a doctor. Pt states she has been vomiting 5-6 times over the past 24 hours. Patient has not been able to hold anything down.
Random itching in various distinct places with flare ups of hives that get bad if scratched then last several hours then disappear, unless breaking the skin then they persist looking like bug bites, but they are not. dousing with cold water sometimes breaks the cycle. First the left wrist on top, then right ankle, then belt line or side of abdomen, then right knuckles, then under arm, then left forearm, left leg, right forearm, etc
sharp lower abdominal pain, persistent pain for 2-3 days, went to er and found large complex liquid , diagnosed  as ruptured ovarian cyst
2/1/2021 - low fever, headaches dry throat (needing almost constant iced drinks), dizzy, weak, sleeping a lot, eyes hurt, can't eat, dry cough, arm sore. 2/2/2021 - same as above but lessened. large (3x5) hot, red swollen sore arm
Developed sore throat and general malaise approx 6 hours after injection. No SOB, no rash, no weakness, no treatment given.
Became painful at site and in left elbow/fingers with noticeable swelling and warmth to the left elbow the morning following the vaccine,. Greater pain with extension of joint.
Client complained of dizziness and visual changes @ 10:52 am. Client placed in supine with legs elevated. BP 114/78 Pulse 84. Client recover and placed in chair at 11:10 am. Tolerated. BP 109/87 pulse 97. Client able to ambulate independently out of vaccine clinic at 11:20 am.
Beginning 12-25-04, pt has reported muscle weakness to the point that he could not stand under his own power.  On 12-26-04 wife had to sit pt up in bed because he could not do so under his own power.  Recommended emergency attention.  Status/ treatment unknown. Discharge Summary received on 1/20/2005 states hypokalemic paralysis, tachycardia, and thyrotoxicosis. Medical Records received on 1/20/2005 states pt experienced anxiety, vomiting, nausea, and respiratory failure.
Narrative: 76 YOM on hospice with hx of CHF, tinnitus, ventral hernia, pAF, tobacco use, GERD, polycystic kidney dx, chronic obstructive lung disease, cholecystitis, CKD, BPH passed away at a skilled nursing facility on 6/29/2021. Pt received COVID vaccines on 4/1/2021 and 5/1/2021. Death appears unrelated to vaccines.
Pt presented to clinic with complaint of redness and swelling over weekend, received vaccine (Anthrax) on 27 Feb 04. Presented on 01 Mar 04. No evidence of Allergic reaction. Pt with local irritation/reaction. Not a true adverse event but patient wanted it documented in record.
did not get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second shot) outcome was unknown.            The patient opted not to receive the second dose due to the serious events experienced after first dose of the vaccine.   This case was linked to MOD-2021-102010 (Patient Link).   Reporter did not allow further contact
cold sweats; diarrhea; Chills: described as sweating bullets and felt miserable; Chills: described as sweating bullets and felt miserable; Chills: described as sweating bullets and felt miserable; Body Aches; Arm was sore; soreness; fatigue/Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56-year-old male patient received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number-1), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 15May2021, outcome "unknown", described as "soreness"; FATIGUE (non-serious) with onset 15May2021, outcome "unknown", described as "fatigue/Tiredness"; COLD SWEAT (non-serious) with onset 17May2021, outcome "unknown", described as "cold sweats"; DIARRHOEA (non-serious) with onset 17May2021, outcome "unknown", described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 15May2021, outcome "unknown", described as "Arm was sore"; CHILLS (non-serious), HYPERHIDROSIS (non-serious), FEELING ABNORMAL (non-serious) all with onset 17May2021, outcome "unknown" and all described as "Chills: described as sweating bullets and felt miserable"; PAIN (non-serious) with onset 17May2021, outcome "unknown", described as "Body Aches". Therapeutic measures were taken as a result of pain, fatigue, cold sweat, diarrhoea, pain in extremity, chills, hyperhidrosis, feeling abnormal, pain.  Additional Information: Reporter stated that, he took the second dose of the vaccine on Friday and on Saturday, his arm was sore and he was tired. On Monday cold sweats, body aches & diarrhea and patient woke up sweating bullets, had chills and felt miserable. Patient took cold Medicine, unspecified, and Ibuprofen, and the medications helped with these effect. It has been more than 2 days, and he still has these effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness/warmth/pain later that day with lump and bruising after; prescribed Benadryl & ibuprofen
The evening p/vax were given, pt devel bilateral red, blotchy, swollen legs; cried for 4 1/2 hrs inconsolably, ocassionally high pitched; t104, no sz, convuls or hypotonicity; MOC gave APAP, took pt to ER
moderate swelling for 36 hours, nausea for 12 hours, fatigue for 12 hours-moderate, muscle and body aches for 12 hours -moderate, fever for 12 hours, chills for 12 hours-mild,  headache and diarrhea for 12 hours-moderate
My arm was red and swollen. Extreme pain in my right arm. I found out I had a blood clot; which I received blood thinner. I'm currently feeling better.
Severe lower abdominal and pelvic floor pain, severe diarrhea, generalized aching and fatigue
Headaches, nausea, soreness, aches, tired, weakness. chest hurts.  Continuing as of today 4/13/2021
The first shot left me feeling lethargic, minor body aches, and heavy soreness in the injection site. The second shot caused a fever of 101F, full body aches and chills, a moderate headache, lack of appetite, and heavy soreness in the injection site.
Client states she felt dizzy and sat on the bathroom floor. BP 110/76, P 58, Resp. 18. Alert and oriented and talking to staff. No sign of distress noted. Client offered fluid. Call made to site contact and notified. 14:30 PM site contact called EMS.
We were told they made a mistake when reconstituting the vaccine and gave us doses that were 2-3x what they should?ve been.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.)  for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for tubal ligation, gastric bypass, ESLD, IDA. Admitted in February from 1st to 19th with generalized weakness related to protein calories malnutrition. hgb was 4.3 on presentation. Admitted 4/15 with CC of weakness, failure to thrive, severe protein calories malnutrition. Was also under the care of palliative medicine. Discharged 5/4. Transported to outside entity care center 5/17. deceased 5/18. no cause of death available.
Symptoms began previous Friday with loss of taste. Facial paralysis occurred on 2/20/17.
Heart pain, fluttering, felt like heart was too big for chest. Likely myocarditis or pericarditis
1st dose 27Nov2019, 2nd never received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: The reporter reported that the patient never received second dose. The patient stated that she plans to receive second dose as soon as possible. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did consent to follow up.
extreme diarrhea; feeling sick; vomiting; A spontaneous report was received from a Consumer concerning a 79 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- vomiting, diarrhea, and malaise.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 16/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Jan 2021, Caller states that her husband got the Moderna virus immunization on 16 Jan 2021. Then, he started vomiting and then he had experienced with extreme diarrhea. Upon calling back on 18Jan2021 at 1453 EST: Caller states her husband is still in bed sick on 18 Jan 2021. He started feeling sick at 7 o'clock at night on 16 Jan 2021.  Laboratory details were not  provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   Recovering, ongoing, not resolved or unknown outcomes: At the time of this report, the outcome of the events- diarrhea, vomiting and malaise were not recovered/ not resolved.