chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like I had a cold; Felt like I had a fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt like I had a cold) and PYREXIA (Felt like I had a fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), BUSPIRONE HYDROCHLORIDE (BUSPAR) and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced NASOPHARYNGITIS (Felt like I had a cold) and PYREXIA (Felt like I had a fever). At the time of the report, NASOPHARYNGITIS (Felt like I had a cold) and PYREXIA (Felt like I had a fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was reported as some unknown medication for cold.   This case was linked to MOD-2021-240827 (Patient Link).
Approximately 1 week after vaccine, patient began shaking /trembling per caregiver and son.  Less shaking 2 days before she died. Following vaccination, appetite decreased and then appetite disappeared 2 days before she passed. History of infection in her foot per caregiver.  noted to have a blister on her right toe that became purple/ dark color.  MD was notified and was started on an antibiotic.  Patient was on palliative care due to advanced age and bedridden status.  MD -  No autopsy was done.
inj into lt anterolateral thigh; no immed rxn; that evening pt seemed warm, a bluish, brownish indurated area 4 1/2cm x 1 1/2cm appeared laterally & inferiorly to the point of inj of hep B
Persistent Right deltoid pain that has existed since the administration of the vaccine. Radiates to lateral elbow, top of forearm moving to ulnar area of wrist intermittently, sometimes without agitating factors (exercise, movement, etc)
Initial report received on 12 October 2009 from an investigator in the above mentioned trial. A 80 year old male subject developed transient ischemic attack on 7 October 2009 i.e. 14 days after receiving an intramuscular injection of FLUZONE SV 2009-2010 in left arm on 23 September 2009 (batch number- UD12321). The subject had medical history of hypertension diagnosed in 2005, hypercholesterolemia diagnosed in 2005. Glaucoma diagnosed in 2008, bladder cancer diagnosed in 2005 and benign prostatic hyperplasia diagnosed in 2008 and also had a transient ischemic attack 6 months ago in the past. The subject was on following concomitant medications: PLAVIX, ASPIRIN, SIMVASTATIN, METOPROLOL, TRAVATAN and DOXAZOSIN. On 07 October 2009, the subject developed muscle weakness, headache, dizziness and disorientation, leading to hospitalization on 07 October 2009. He was admitted to the regional hospital and was under observation for 25 hours and was diagnosed of having transient ischemic attack and kidney infection. FLUCONAZOLE 100mg 1 tablet for 3 days was started as corrective treatment. No laboratory data was provided. The symptoms of headache, dizziness and disorientation resolved on 8 October 2009 and the subject was discharged on the same day. The event of Transient ischemic attack resolved 2 days later on 10 October 2009. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. List of the documents held by sender: None.
Patient received shingles vaccine on 4/23/23 then the following morning he had stomach pain which is a common side effect of shingrix and believed that was all that is. By that afternoon patient stated pain was too severe and went into the emergency department. Received multiple injections of narcotics throughout their stay. Was put on oral norco every 4 hours and IV Fentanyl for the pain. Patient received a CT scan of pancreas/gallbladder/liver (upper right abdominal quadrant). Swelling and inflammation were found. Patient had lipid and lipase panel run and lipase levels were 13,000 at the highest point. Was on clear liquids and IV from Tuesday through Thursday. Friday was able to switch over to non-clear and later was discharged.
itchy rash with bumps; rash; bumps; This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number P9733, expiry date 12th March 2022) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix. In September 2020, 24 hrs after receiving Shingrix, the patient experienced itchy rash, rash and papular rash. On an unknown date, the outcome of the itchy rash and rash were not recovered/not resolved and the outcome of the papular rash was unknown.   It was unknown if the reporter considered the itchy rash, rash and papular rash to be related to Shingrix.  Additional details were reported as follows: The patient received the dose of Shingrix in her left deltoid and 24 hours later experienced an itchy rash with bumps from her left deltoid until her elbow.  The symptoms were still going on two months later. Consented to follow up.
Information has been received from a registered nurse (R.N.) concerning a 16 year old female student with dyslexia, alexia and depression who on 09-JUN-2008 was vaccinated subcutaneously in the left arm with a second dose of VARIVAX (Oka/Merck) (Lot #659357/1567U).  There was no illness at the time of vaccination.  Concomitant therapy included fluoxetine.  On 10-JUN-2008, at 8:00 p.m., the patient developed left upper arm erythema, induration, warmth and edema.  The outcome of the patient was unknown.  Unspecified medical attention was sought.  The reporter considered left upper arm erythema, induration, warmth and edema to be other important medical events.  This is one of several reports from the same source.  Additional information is not expected.
hematoma after 2nd dose; hematuria after 2nd dose; 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 HAEMATOMA (hematoma after 2nd dose) and HAEMATURIA (hematuria after 2nd dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOMA (hematoma after 2nd dose) and HAEMATURIA (hematuria after 2nd dose). At the time of the report, HAEMATOMA (hematoma after 2nd dose) and HAEMATURIA (hematuria after 2nd dose) outcome was unknown. Not Provided          No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Nonsignificant Follow-up appended
1PM - fatigue, muscle pain, and bone pain 10/11/2011 - Fever 100.7 on Tylenol 10/11 - Chest pain - left side in AM and Right side in PM.  Symptoms gone by Wednesday 10/ 12/2011
pt presented to hospital, positive for COVID; COVID pneumonia and Acute renal failure; pt's condition worsened; pt refused Dobbhoff tube placement; pt desired comfort care; pt passed away in the hospital
numbness in right forearm; headache; This is a spontaneous report from a non-contactable healthcare professional. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness in right forearm and headache. It was reported that during the 15-minute waiting period after the injection, the patient began to experience numbness in right forearm and headache. He denied difficulty breathing, difficulty swallowing, itching and lightheadedness. Treatment included was Tylenol 1000 mg and water. The follow up response to treatment was good and symptoms were completely resolved. The patient reported that he would take Ibuprofen in the evening if he experiences some numbness in the right forearm or fingers. He denied symptoms of headache and numbness; resolved prior to discharge. The reporter walked with the patient to exit the facility. The patient was discharged, stable to go home and for follow up with PCP. The outcome of the events was recovered.  No follow-up attempts are possible. No further information expected.
Severe Palpitations, Rapid Heart rate at rest, walking and standing, Severe Shortness of breath, Pain on left lower abdomen after eating
Headache; muscle pain; fever; exhaustion; injection site swollen, red and itchy; injection site swollen, red and itchy; injection site swollen, red and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 11Mar2021 08:15 AM (at the age of 48 years old) as single dose for covid-19 immunization. Medical history included asthma, high blood pressure, lymphedema, postoperative hypothyroidism, mixed hyperlipidemia, anxiety, depression, covid-19 (prior vaccination), allergy to amoxicillin/clavulanic acid (AUGMENTIN). The patient's concomitant medications in two weeks reported as yes. The patient had no other vaccine in four weeks. The patient experienced headache, muscle pain, fever, exhaustion, injection site swollen, red and itchy on 11Mar2021 at 11:00 AM. The patient did not have COVID tested post vaccination. No treatment for events. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 14Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Oct2023 to 08Oct2023 (Lot number GJ3916).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300329586 same patient, different drug and different event;
Patient developed rash about 6 hours after receiving vaccine and it continued to worsen through the night.
Headache all 6 days.  Body temp shifts between 105.3 and 92.  Sweat all night for 4 nights in a row now.  Heart burns and while this I had blurry vision while pumping.  Lower back pain.  Right arm numbs.  Energy shifts between 80% and goes down to 10%. Can?t lift my body.  Chills everyday. I shiver quite often.  Just like the covid, symptoms come and go.  Now neck pain. Muscles feel contracted.  Lymph node under opposite arm of injection  No vomiting.  No diarrea.  Dizziness when heart was burning.  Numb fingers sometimes, like a thunder strike on the fingers.  Too many days in a row now.
her husband was freezing last night; her husband threw-up 1 or 2 times; her husband has muscle aches allover; her husband has body aches allover; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 15Feb2021 (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced her husband was freezing last night, her husband threw-up 1 or 2 times, her husband has muscle aches allover and her husband has body aches allover. Reported that she and her husband got their second COVID-19 Vaccines shots yesterday. She said she was fine, but her husband was freezing last night, and threw-up 1 or 2 times. She said her husband has muscle and body aches allover, so she gave him 2 Tylenol PM this morning. The reporter asked if her husband is going to be all right. It was advised that Pfizer does not give medical advice, and if she thinks her husband needs medical attention to call his doctor, or if emergent to go to an emergency room. The reporter stated she thinks she read to give Tylenol if a person hurts after getting the COVID-19 Vaccine. She said her husband is achy allover, so she thinks the Tylenol PM will help, and her husband will sleep for a while. The reporter stated that she used to work at a nursing home. No further details provided. The reporter was unwilling to complete the report. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
very few side effects; Pain - Near Injection Site; Swelling; Redness - Near Injection Site; Warm to Touch Sensation - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION COMPLICATION (very few side effects), VACCINATION SITE PAIN (Pain - Near Injection Site), INJECTION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 0062MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), INJECTION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). On an unknown date, the patient experienced VACCINATION COMPLICATION (very few side effects). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 30-Jan-2021, VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), INJECTION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) had resolved. At the time of the report, VACCINATION COMPLICATION (very few side effects) had resolved.            No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: The significant follow up information received on 19-MAY-2021. Patient demographic details were added. Medical history information is added. Second dose details were added.
PNEUMOVAX 23 given (L) deltoid (23 PCV) -> developed no redness (L) site but developed heavily indurated cellulitis circumferentially above elbow.
COAGULOPATHY, UNSPECIFIED TYPE 11/17/2022 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT  COAGULOPATHY, UNSPECIFIED TYPE 11/17/2022 ANEMIA
12/27/10 at 4:00PM - at work. Eye burning, red, swollen difficulty swallowing - pain abdomen top of hips after sneezing. Tried eye drops - no relief - to ER at Hospital Emergency Room treated - BENADRYL IM. Symptoms resolved after 3 hours. BENADRYL PO 3 hrs after IM.
fever 103.5 returned to MD next AM-103 double ear infect;pt throwing up phlegm racking cough;placed on ATB;nebulizer treatments;seen twice by MD in next couple days;was told may be bacterial & required blood tests;
swelling; redness injection; nausea; not feeling well; tiredness; difficulty of breathing; heart fast; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient experienced these side effects after getting the first dose: swelling, redness injection, nausea, not feeling well, tiredness, difficulty of breathing and heart fast. The outcome of the events was unknown.
This spontaneous report was received from a pharmacist technician and refers to 2 unspecified patients of unknown patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, improperly stored doses of ZOSTAVAX (lot # L031272, expiration date: 19-NOV-2016, dose, route of administration and injection site were not reported) were administered to two unspecified patients. Administered doses of ZOSTAVAX underwent temperature excursions at 36 Fahrenheit degrees for 12 hours. The previous temperature excursions were at 26 Fahrenheit degrees for 21 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Two weeks after my vaccine I went in for routine bloodwork and my iron level and saturation were high, which I've never experienced before. I had joint pain and pain in my upper abdomen, as well as numbness in my left arm at night. Certain foods or positions of my head would also cause a horrible pain/itching in my gums on the left side (which I've never experienced before). My iron went up even higher in mid-November and is finally in a normal range again (as of 2/14/22). I've had intermittent numbness on the inside of my left foot and all of my symptoms have been occurring on the same side that I received my vaccine.  I have had an MRI to rule out a pinched nerve and I have another MRI scheduled to check my brain and spinal column on February 25th.
chills; blood glucose was up the next morning; sore arm; tiredness; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 66 year-old female patient received  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 12:00 (Lot number: ER8730) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 27Sep2006 (ongoing); "Retired" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Pneumonia vaccine (Injection, left arm), administration date: 09Mar2021, for immunisation, reaction(s): "sore arm", "Fatigue"; Flu vaccine (received the flu last fall, in Sep2020 or Oct2020), administration date: 2020, for Immunisation, reaction(s): "tiredness", "sore arm". The following information was reported: FATIGUE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "tiredness"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 20:00, outcome "recovered", described as "sore arm"; BLOOD GLUCOSE INCREASED (non-serious) with onset 25Mar2021, outcome "recovering", described as "blood glucose was up the next morning"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient had chills but stated that the patient is always chilly off and on. Patient's arm is good today. Blood glucose is a little higher the last few days. Patient has health issues and thought to get the Covid-19 vaccine. Patient has not started any new medications. Patient's blood sugar went from 113 before eating to 249 after eating a bread pizza. Patient experienced the same thing with the flu vaccine and pneumonia vaccine, tiredness and sore arm. Patient had to wait 2 weeks after the pneumonia vaccine to get her Covid-19 vaccine. Patient inquired if a call and filing of a safety report is needed after they received their second dose of the Covid-19 vaccine in 3 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the non-serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021351658 same reporter different patient;US-PFIZER INC-2021351658 same reporter different patient
Patient c/o of feeling lightheaded and dizzy approximately 20 minutes after vaccination.   Vital signs: 1006: BP 170/102, P-91, R-16, Pox: 96% 1018: BP 168/97, P-80, R-16, Pox: 96% 1022: BP 179/96, P-86, R-16, Pox: 97% Patient transported to Emergency Room via EMS at approximately 1035 for evaluation due to hx of HTN and CVA