chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis Secondary to COVID-19 mRNA Vaccine; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Secondary to COVID-19 mRNA Vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event "Myocarditis" and the 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Extreme headache, nausea, fatigue. Could barely get out of bed for 33mhours. Could not eat for 33 hours.  Felt much better after waking up at about 7am two days after receiving vaccine.
Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Nov-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Nov-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 04-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Information has been received from a physician concerning 1 female patient who on an unspecified date was vaccinated with Gardasil (lot#'s unknown) 0.5 mL injection and fainted.  Medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  No additional information was provided.  No further information is available.  This report is one of two reports from the same source.
I developed rigors with high fever 39.4 C.  I was coughing, non-productive cough, pain at the base of my lungs from coughing, running nose, muscle pain, GI problems- vomited once and stool foul smelling, loose.  I developed hematuria- visit to Patient first, placed on an antibiotic.  Continued with high fever and shivers- went to Emergency Department, admitted.  Started on cefuroxime- fever and symptoms subsided.  Discharged home.  One week at home- getting stronger by day.  Back to work January 11, 2021
Patient reports experiencing chills starting 12 hours later and continuing all night, back pain, body aches and fainted next day at 3pm after experiencing dizziness. Said she was unconscious for about 15 seconds. Feeling better now at time of reporting 4/10/21. Patient did not seek medical treatment for the incident.
pt recvd vax;noted to be floppy, unresponsive, unable to walk; no diff breathing, color change or sz activity;pt observed for 2 hrs; pt would wake & alert & was interactive; slowly improved; able to walk but still somewhat sleepy;T 98.3;
Numbess around lips and cheeks. BP:140/80 Pulse: 88/min Benadryl 50mg given.
Fever 102.6 shaking chills malaise myalgia nausea diarrhea headache
On Day 5 (2/14/21), I experienced mild itchiness in the area of the injection.  I applied a generic antihistamine cream to the spot.  Gained some relief from the irritation.    On Day 6 (2/15/21),  I still had mild itchiness and noticed swelling and hardness in the area of the vaccine injection.  There had not been any changes in diet or use of medication. This irritation did not impede my ability to engage in daily activities.  On Day 7 (2/16/21)  The area of the injection was now swollen and itches.  The area was hard.  Why am I having a reaction 7 days after the initial injection.  That night, I took 600 mg of generic ibuprofen. On Day 8, today, the swelling has subsided.  The hardness has eased.  Itchiness is not apparent.
I have Polycythemia Vera. After receiving the first dose, my blood counts (hemaglobin, hematocrit, platelets) all went down. After the second shot, they went down again. My oncologist referred me a medical center after doing a bone marrow biopsy and CT scan which showed an enlarged spleen. My blood counts last week are finally starting to rebound. The doctor at the medical center  feels the vaccines lowered my counts which resulted in four months of being extremely tired and fighting an enlarged spleen. I feel a study should be done for people with polycythemia on hydroxyurea so no one else has to go through this.
Onset of pain and swelling on right arm which grew large, hot and very indurated over entire upper arm lateral, anterior and posterior per patient. Lasted 1 week. She was unable to sleep with arm at side due to swelling. Did not seek medical care.
2 days post vax, the pt had 2 quick jerks involving head and trunk to side. She was talking in one episode and she stopped in mid sentence. She had several others.
This case was reported by a health care professional and described the occurrence of swelling of legs in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included INFANRIX; GlaxoSmithKline; intramuscular; unknown given on an unspecified date. On 26 April 2008, the subject received 5th dose of INFANRIX (.5 ml, intramuscular, left thigh). On 28 April 2008, two days after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter strongly felt there was a quality issue with INFANRIX. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 09 May 2008 via a healthcare professional, who reported that the subject's mother stated that the child's leg was very swollen, not just "knotty". The reporting healthcare professional considered the events to be clinically significant requiring intervention.
pt recvd vax;abdo cramping,n 4 days p/ 1st dose,w/ possibly low grade fever;several hrs p/ 2nd dose on 17aug93 felt :unwell" w/ low grade fever 99-101 & flu like sxs;tx w/ ASA & better now;in for 3rd dose,but dose will not be given;
Low grade fever (100.1) Chills Nausea Arm soreness Lymph node inflammation under arm
Information has been received from a 72 year old male physician who on 16-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number: 669404/1359Z; Expiration date: 15-JAN-2012). Concomitant therapy included LIPITOR, hydrochlorothiazide (Manufacturer unknown) and NORVASC. On 23-APR-2011 the patient developed a case of Bell's palsy. The patient sought unspecified medical attention and was given prednisone and VALTREX for treatment. "Within the last week or so", approximately on 24-APR-2011, the patient recovered. Additional information has been requested.
Information has been received from a medical assistant concerning a 69 year old female patient who on 01-OCT-2008 was vaccinated with the first dose of PNEUMOVAX (Lot# 660717/0224X). On 02-OCT-2008 the patient had a swollen arm that was warm to touch. The patient contacted her primary care physician and was sent to wound care. The patient was given antibiotics and as of 24-NOV-2008, was improving. Follow up information received from a physician reported that the patient with sulfonamide allergy received the dose of PNEUMOVAX on the left deltoid. Concomitant therapy included influenza virus vaccine (unspecified) on the left deltoid. There was no acute illness at the time of the vaccination. The reaction site had to be treated in the wound care center for an incision and drain (I &D) and debridement of the site. The patient recovered on 04-DEC-2008. Additional information is not expected.
Patient received first dose of Moderna Vaccine on 3/8/2021 Lot 036A21A, second vaccine received on 4/5/2021 was Pfizer Dose. Patient reports no side effects, no issues with receiving two different vaccines. Patient was advised that she was fully vaccinated and no further immunizations were required.
A 47 year old female experienced hair loss coincident with RabAvert therapy. The pt received her 1st dose of post-exposure RabAvert on 6/1/01. She noticed hair loss at the beginning of August. The pt reported that the hair loss was severe and bald spots on her scalp were noticeable. In the beginning, the bald spots were the size of a dime, however as of 9/18/01, one bald spot was the size of a half-dollar and the 2nd one was the size of a quarter. The pt's physician treated her condition with an injection of corticosteroid into the scalp area (8-10 injections per spot).
75min p/vax pt became limp & shaking;mom carried child back to office;pt awaked slowly & able to ID mom;sent to ED for eval;pt neuro work-up negative;dx vasovagal response;
Ache Fever Shortness of breath Hives From initial information received on 11/21/2003 from a health care professional, regarding an adverse event occurring in U.S.A., it was reported that a 45 year old female patient received FLUZONE SV '2003-'2004 USP, lot number U1139AA, administered intramuscularly in the left deltoid on 10/14/2003. The next day, on 10/15/2003, the patient developed a fever of 102 degrees Fahrenheit, shortness of breath and body aches. The patient took Advil and was fine. On 10/18/2003, the patient developed hives, but was already on Claritin. The patient informed the office on 10/27/2003 that the hives resolved on an unspecified date. The patient has recovered from these events.
Agitation; Unable to focus; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021 at 11:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included A-fib (atrial fibrillation). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received ibuprofen (MOTRIN), for unknown indication on an unknown date and experienced drug allergy. On 06Feb2021, the patient experienced agitation, unable to focus and anxiety. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events agitation, unable to focus and anxiety was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Really bad headache (described that it was so bad that for 3 days she can barely lift her head); Sweating; Shaking; Difficulty in getting up and walking; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient really bad headache (described that it was so bad that for 3 days she can barely lift her head), sweating, shaking, and difficulty in getting up and walking (she described that she had to be very careful when walking because she feels like falling). The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
According to the witness (driver of the vehicle): The patient received the vaccine and within five seconds was slumped over in the seat, passed out. The driver notified staff and they were instructed to exit the vaccination lane, prior to proceeding to post administration area. Staff requested on scene BLS unit for evaluation. The patient became alert and oriented and allowed BLS to perform an assessment. BLS reported all vitals good. Patient stated that his has never happened before and didn't remember anything beyond receiving the vaccine until he woke up. Patient refused BLS transport. Driver stated they were self transporting to the ER for further evaluation.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Prolonged adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Prolonged adverse reaction). At the time of the report, VACCINATION COMPLICATION (Prolonged adverse reaction) outcome was unknown. There is no relevant treatment and concomitant medications provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient name and contact information.
Tingling hands, arms, lips, face in waves.  Hot and clammy back and forth for two days. Rash started 2-3 days after vaccine and still has it. Also, 10/18/2012 sharp stabbing pain, different parts of body, comes and goes, still having (11/1/2012).  Mentioned to Dr. and was ignored.
PT RECIEVED 8 VACCINES IN TOTAL. PT STATED HE EXPIERENCE H/A AND DIZZINESS AFTER VACCINE ADMINISTRATION. PT WAS GIVEN CRACKERS, APPLIED COLD PACK. PATIENT WAS PLACED IN A SUPRINE POSITION AND WAS OBSERVED FOR 30 MINS. PATIENT FELT GOOD BEFORE DISCHARGE.
Patient came to the pharmacy stating that his arm is still sore from his flu shot that he got on 10/11/19. He said that the soreness is consistent and doesn't get any better or any worse. He tried to take Ibuprofen for 2 days and he states that it doesn't help.
I began to feel faint; blood pressure remained high (145/90); rapid increase in heart rate; shortness of Breath; Dose 1 16Apr2021/ Dose 2 11Aug2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 12:45 (Batch/Lot Number: FA7485) (at the age of 42-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included covid-19 from an unknown date, Prior to vaccination, the patient was diagnosed with COVID-19. There were no known allergies.  There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the patient received first dose of BNT162B2 administered in Arm Left on 16Apr2021 10:00 AM (lot number: EW016) (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  About 8 minutes after first dose (16Apr2021), the patient began to feel faint, rapid increase in heart rate and shortness of breath.  Major symptoms subsided after a couple of minutes. On 11Aug2021 12:45 PM, Immediately after receiving 2nd dose (after consulting with primary physician), the patient began to feel faint (pharmacist rush to ensure he was okay and asked if she should call an ambulance), rapid increase in heart rate (pulse 120-130) and shortness of breath.  Major symptoms subsided after about 15 minutes, however pulse remained about 100 bpm for over an hour and blood pressure remained high (145/90) for 6-7 hours. Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for the events. The outcome of the events was resolving.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101039594 same patient, different vaccine dose and events
Pt admitted 7/12 for induction of labor and delivered healthy infant. Discharged on 7/14. Received Pfizer COVID vaccine on 7/14 per patient. Initial vaccination was with Janssen; first booster was Moderna, and second booster was Pfizer on 7/14.  On 7/16 developed fever, trouble breathing while lying down and R sided chest heaviness/pressure. Found to be hypoxic and hypertensive upon arrival in ED.  At first, felt to be pre-eclampsia with fluid overload +/- postpartum cardiomyopathy. Cardiology consulted. Echocardiogram showed mildly reduced EF consistent with myocarditis, slight troponin rise. Cardiologist's note states "I suspect this is related to the COVID-9 vaccination." She was started on low-dose ACE inhibitor. Pt discahrged to home on 7/18/22 on enalapril 5 mg PO daily.
Pain in my joints, pain in hands; A little fatigue; Muscle pain; Pain in upper part of the hands; Walking like a really old man; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in my joints, pain in hands), FATIGUE (A little fatigue), MYALGIA (Muscle pain), PAIN IN EXTREMITY (Pain in upper part of the hands) and GAIT DISTURBANCE (Walking like a really old man) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure. Concomitant products included NIFEDIPINE (NIFEDIPINE L) for Hypertension.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in my joints, pain in hands), FATIGUE (A little fatigue), MYALGIA (Muscle pain), PAIN IN EXTREMITY (Pain in upper part of the hands) and GAIT DISTURBANCE (Walking like a really old man). At the time of the report, ARTHRALGIA (Pain in my joints, pain in hands), FATIGUE (A little fatigue), MYALGIA (Muscle pain), PAIN IN EXTREMITY (Pain in upper part of the hands) and GAIT DISTURBANCE (Walking like a really old man) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Immediate development of 2 cm raised red nodule lateral to injection site (likely in muscle body) on R thigh.
Day of vaccine arm started hurting and difficult to lift. Next day, arm hurting but add in high fever over 102
TESTED POSITIVE FOR COVID; CHILLS; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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 was not reported, administered on 26-MAR-2021 14:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced chills, and fever. On 22-JUL-2022, the patient experienced tested positive for covid. Laboratory data included: COVID-19 virus test Positive. On 28-JUL-2022, Laboratory data included: COVID-19 virus test Positive. On 29-JUL-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tested positive for covid, and the outcome of fever and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20220820796.
Came to ER on 10/19 after 10/11 COVID Diagnosis. Visit was for worsening congestion. Upon talking with patient it became apparent that pt was very confused and not oriented. Was admitted to hospital and remains hospitalized.
Pt received the FLUZONE HD Monday 10/13/14 morning. Monday evening she developed a rash about 3 inches below the injection site. The rash was raised, red, and itchy. It was still there and about 4 inches in diameter when she came into the pharmacy 10/16/14.
Client states that 1 hour after immunization she started shaking. States "I wasn't myself". BS 62 at that time. Called OB-GYN, referred to ER. Client states "hands and my feet were blotchy and red, my cheeks were abnormally red". Client states she experienced shortness of breath. Given prescriptions for albuterol inhaler, PEPCID. No other treatments. D/C after 3 hours. Recovered quickly. States she "felt odd from the reaction" for remainder of day, but was able to perform ADL's. No lasting effects.11/17/2009 MD and ED records for 10/16/2009, pregnant patient with c/o's muscle aches, fatigue, dizziness, nasal congestion and dyspnea. BS checked and was 79, given OJ and crackers, BS normal. Patient refused any other tx. Given Rx for Pepcid and Albuterol inhaler.
0950 influenza vaccine administered, not first time, left to office. 1000 began to feel light headed sat down, hard to swallow "feeling difficult to breath", waited until 1010, came to me had him sit VS 1012 -70 - 24 135/92 no SOB, diaphoretic, good air movement bilaterally cold wash cloth applied, asked to relax 1019 - 90 - 18 - 128/82, 1025 70 -16- 122/70 relaxing good air movement stated feeling better throat "opened" no difficult breathing, no diaphoresis. 1033 - 80 -20 118/82. 1047 spoke with nurse left at 1040 and took 25mg BENADRYL. 1115 back without any complaints 70 -32 - 122/72 asked to call MD tomorrow and at next medical event to discuss MD plans for future immunization.
Vaccine administered on 1/23/09 - On 1/23/09 leg was hot, red, swollen, from hip to knee, painful to touch, fever and hives on neck-chest - Pt instructed to take BENADRYL, Ibuprophen, cool compress and rest
I have been having muscle twitching all over my body since being vaccinated. I've also had increasing back and hand pain
The next day after vax, pt felt achy and had a temp of 103.  It was a mild reaction to the shot and it lasted about 2 days.