chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MYOCARDITIS; PERICARDITIS; .This spontaneous report received from a consumer via a company representative concerned a 33 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that the patient developed myocarditis, and pericarditis. However, the doctor told that there was no correlation between the vaccine and these conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pericarditis was not reported. The reporter causality of the event myocarditis, and pericarditis was not related to covid-19 vaccine ad26.cov2.s and company causality was not related to covid-19 vaccine ad26.cov2.s. This report was serious (Other Medically Important Condition) This case, from the same reporter is linked to 20211110332.    .; Sender's Comments: V0- 20211109933- covid-19 vaccine ad26.cov2.s Myocarditis, Pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Covid vaccine monitoring documentation. Patient admitted 3/25/21 for cellulitis. SARS-CoV-2 COVID-19 documented positive 03/25/21 21:43, patient documented to be asymptomatic. Patient received both doses of Covid-19 vaccine, of note, documentation stated patient husband not vaccinated. Dose 1, Pfizer 2/26/21 EN6200, Dose 2, Pfizer 3/19/21 EN6204.
1st dose-flu like sx, low T, swollen glands, ear ache, lethargic, pain @ inject site-took Tylenol or Motrin, 2nd dose-trouble /w breathing"like asthma attack" runny nose, facial rash, itchy, abdo pain, diarrhea
4 hours of fever and chills, body aches, weakness, headache; after fever broke I had severe headache, body aches and weakness, which lasted another 24 hours; now left with just weakness.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a one-years old female patient who received fourth dose 0.5 mL vaccine PENTACEL lot C5530AA via unknown route in the thigh on 07-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. It was actual medication error due to inappropriate reconstitution technique. It was reported that the patient received the liquid part and not the powder of PENTACEL. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none. Follow-up information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. The report contains no new information. List of documents held by sender: none.
A few hours after my second dose of the Moderna vaccine, I began having significant chest pains to the point that I initially thought I might be having a heart attack.  I took low dose aspirin just in case.  I realized it was not a heart attack because when I pressed on my chest, it hurt more, which indicated to me it was some sort of inflammation in what I initially believed was my lungs., but later i figured out was my heart.  It was painful and concerning.  The symptoms lasted just a little over an hour after I rested.  It was later that the information came out about myocarditis and pericarditis and I recognized that what I had experienced was one of those conditions.  I just figured out how to report the severe adverse reaction today.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 24-MAR-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported. The total cumulative hours out of range were 360 hours with 34 degrees C and 168 hours with 33 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Headache -fatigue  felt hot and flushed  Body ache Chills  Lasted 24 hours- came on evening after shot
With in a week, my left shoulder hurt so bad I knew something wasn't right. With in two weeks I wanted to go to the Doctor. My left shoulder is crippled. I cannot put my left arm around another persons shoulders without severe pain!
This is a spontaneous report from a contactable nurse. This 8-year-old male patient of unknown ethnicity received PREVNAR 13 (lot number H65736, expiration date 31Jul2015) at 0.5 ml single dose intramuscular in right thigh for asthma on 29Sep2014. Concomitant medications included diphtheria and tetanus toxoids received on 29Sep2014, SINGULAIR, ZYRTEC, FLOVENT and albuterol, no dosage information or indications available for these medications. Medical history included Kawasaki's Disease diagnosed in Jan2014, food allergies (including peanut, egg, and tree nut allergies), and occasional episodes of angioedema. On 29Sep2014, within about 5 minutes of receiving the vaccines, the patient developed itching in his throat and mouth, hives on his neck and back, red flushing of his face and ears, then developed significant shortness of breath. He was transported to the emergency room where he was treated and observed for anaphylaxis. He was treated in the emergency room and was not admitted to the hospital. The patient recovery completely (date not reported). The allergy clinic was notified of the patient referral on 03Oct2014. The nurse would like to know if there is a presence of thimerosal, gelatin, or latex in PREVNAR 13. Follow-up (26Feb2015): Follow-up attempts completed. No further information expected.
Arm was sore and swollen, muscle pain, body aches, headaches, tireness and fever.
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report has been received from a medical assistant, concerning a 4-years-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 31-MAR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneous injection, first dose, administered subcutaneously, for prophylaxis (strength, dose, , vaccination scheme frequency and anatomical location were not provided; lot number U025790 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and upon internal validation established as 19-AUG-2023) (product storage error).   The administered dose of the varicella virus vaccine live (oka/merck) (VARIVAX) was stored in a temperature between -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h) 0 minutes (min) and 0 seconds (sec) and between -10 degrees C up to 8 degrees C for 1 h 30 min 0 sec, on 23-MAR-2022 as recorded by a data logger. There was no previous temperature excursion reported. It was stated that the event was attributable to a device or device component malfunction, however, there was no device involved. No adverse events were reported.  No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA007861: US-009507513-2205USA007749: US-009507513-2205USA007739: US-009507513-2205USA003614: US-009507513-2205USA008830: US-009507513-2205USA008800: US-009507513-2205USA008795: US-009507513-2205USA008064: US-009507513-2205USA008189: US-009507513-2205USA008100: US-009507513-2205USA008069: US-009507513-2205USA008066: US-009507513-2205USA007957: US-009507513-2205USA008028: US-009507513-2205USA008008: US-009507513-2205USA008002: US-009507513-2205USA008000: US-009507513-2205USA007871: US-009507513-2205USA007860: US-009507513-2205USA007852: US-009507513-2205USA007809: US-009507513-2205USA007723: US-009507513-2205USA007704: US-009507513-2205USA007703: US-009507513-2205USA007978: US-009507513-2205USA008006: US-009507513-2205USA007982: US-009507513-2205USA008106: US-009507513-2205USA008105: US-009507513-2205USA007748: US-009507513-2205USA007821:
Injection site is red, hard and itchy - 5 days after injection- still the same  today 7 days after
inc sleepiness x 4 days p/1st vax;hard to wake up but able to awaken to feed & fed well;
The heels on both feet became painful; Pain was so severe I could not walk for several days; This is a spontaneous report from a contactable consumer.  A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247, via an unspecified route of administration on 03Feb2021 07:30 at SINGLE DOSE for covid-19 immunisation; vaccine location: left arm; dose number: 1; facility type vaccine: hospital and pravastatin (PRAVASTATIN), via an unspecified route of administration from an unspecified date to an unspecified date at UNK for an unspecified indication. The patient medical history and concomitant medications were not reported. In 1971 the patient took rabies vaccine inact (duck embryo) and experienced anaphylactic reaction. Approximately one week after the vaccination, on 07Feb2021 07:30,  the patient experienced "heels on both feet became painful. The pain was so severe I could not walk for several days". The pain was present all day, even all night long. The patient was treated with ibuprofen Outcome: recovering. . Information on Batch/lot has been requested.
every night mild heart palpitation when she turn over and shift position/arrythmia very minor; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (every night mild heart palpitation when she turn over and shift position/arrythmia very minor) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, PRAVASTATIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARRHYTHMIA (every night mild heart palpitation when she turn over and shift position/arrythmia very minor). At the time of the report, ARRHYTHMIA (every night mild heart palpitation when she turn over and shift position/arrythmia very minor) outcome was unknown.        The patient presented to a physician for symptoms of heart palpitations she initially experienced every night  when she would turn over and shift position. Eventually, the frequency greatly reduced and she was diagnosed with stress-induced arrhythmia.  No treatment was reported for the event.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: initial additional. On 09-Jul-2021: initial additional.
Shortly after the 6 month vaccines, patient had his first asthma attack. It was diagnosed as croup and we were sent to a pulmonologist. Patient was completely healthy until this set of vaccines. He has had consistent asthma attacks now for the past three years. Upon further research, this is a common theme with this vaccine. This is the reason for just now reporting it.
Weakness, body chills, fever, headache.  Used Tylenol, gatorade, sudafed.  Starting feeling somewhat better on 2/13/2021
Swelling of feet, ankles, face, arthralgias hands, hips, elbows, fingers, feet.  Resolved after 48 hours treated with Motrin.
No adverse effects reported; patient received improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies was not reported. Concomitant medications included properly stored sterile diluent.   On 12-SEP-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, dose number, route of administration and location of administration were not reported) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020 (the reporting nurse was unable to determine which lot was administered to the patient)), for prophylaxis.   The vaccine was exposed to a temperature range of -14 degree Celsius to -10 degree Celsius (-9.74 degree Celsius) for an unknown time frame as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported.
Client came into the chorus room to receive flu vaccine. He walked back into the classroom and sat down, it was reported by another student that he had passed out. It was also reported that he hit and chipped his tooth. Not sure if he feel out of the chair and hit his tooth on the desk, did not witness the event nor did the teacher. The school nurse reported they called the parent and parent was coming to pick up child. She also reported that he had seen cardiologist in the past year for passing out, this was not known prior to vaccination.
Information has been received from a registered nurse concerning a female patient who on 08-DEC-2008 was vaccinated with the first dose of GARDASIL. On 24-MAR-2009 the patient received her second dose of GARDASIL and on 08-OCT-2009, when she was going to receive her third dose the patient developed an upper respiratory infection. So her third dose of GARDASIL was held. At the time of reporting the patient's status was unknown. Additional information has been requested.
Swelling, redness and itching at the injection site following a zoster vaccine that was placed 4/21/15. Skin lesion located in the back of right arm, measure 4 cm around. No tenderness or soreness.
Fatigue; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 24-Mar-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 FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Blood Pressure medications.  No treatment taken.   Reporter did not allow further contact
Exposed to covid positive person entire day/night 12/19. She tested positive on the 20th. My symptoms began the morning of 21st. Sore throat, headache, aches and chills but no fever - temp hovers at 96, tired, sinus & lung congestion, runny nose. Continued w various degree through today. Saturday night 25th & Sunday 26th the worst. Did not feel like a cold or flu, or bronchitis or asthma. Completed course of azithromycin 250mg & methylprednisolone 4mg, Mucinex DM, Ibuprofen rx from Dr. Cough started today.
Patient developed 1.5 cm area of redness and ulceration at left deltoid injection site. 0 pain. Has not received medical tx r/t wound.
Noticed lesion on chest-rash spread down chest and back. Approximately 15 red papules noted. Benadryl by mouth and Calamine lotion.
8x9 cm2 round erythema with 3 cm2 central clearing at injection site which developed 9 days after vaccination.  No lymph nodes.  No fevers.  No fluctuance.
Patient came to the ED with generalized fatigue and shortness of breath.  Patient admitted to the hospital with Covid pneumonia and treated with resesivir.
Patient had an adverse reaction 2 minutes after PNEUMOVAX 23 injection. She became dizzy and said she was having back spasms. Paramedics arrived within 5 minutes and checked her over. Vitals were ok. No sign of allergic reaction within 15 minutes. She was fine to go home.
11:32 Patient complained of lightheadedness, became pale - had her put head down. 11:34 Patient complained of feeling really hot, flushed; followed by complaints of tingling, mild itching sensation. Gave her cup of cool water to sip, cool cloth to wipe face and put to neck. BP 100/60. Patient denies dyspnea or other problems. Had patient lay down until color to face returned and patient stated she felt fine. Released at 12:10.
Fever up to 101.3, symptoms started around 12 to 14 hours after receiving  the vaccine.  Severe chills and body aches and back pain.  Fever lasted for about 36 hours, still have moderate to severe body aches after 36 hours and a low grade temp at 36 hours
Surrounding redness on right leg with swelling and slight warmth. Treated with Benadryl.
4 out of 4 pts in one office & 5 out of 5 pts in another office were found to have neg titers; 2 yrs p/completion of a 3 dose series of Engerix-B vax;
Patient started running a fever of 103 degrees at 9:00pm on 01/08/2020. Patient was treated with Motrin and Tylenol which brought the fever down to 101 degrees. Patient was seen by his Pediatrician on the morning of 01/ 10/2020.  Patient fever was resolved and had a normal temperature with no other negative outcomes. This information was provided by his sister on 01/10/2020.
Allergic reaction, rash on all upper body. Especially on both arms, arm pits and both sides of stomach.
Pain in the arm; Stiff neck; Tingling of his right arm; Headache; Chills; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), MUSCULOSKELETAL STIFFNESS (Stiff neck), PARAESTHESIA (Tingling of his right arm), HEADACHE (Headache) and CHILLS (Chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colonoscopy (received an anesthesia) on 20-Mar-2021. Concomitant products included PROSVENT for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm), MUSCULOSKELETAL STIFFNESS (Stiff neck), PARAESTHESIA (Tingling of his right arm), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body ache). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), MUSCULOSKELETAL STIFFNESS (Stiff neck), PARAESTHESIA (Tingling of his right arm), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided
Nighttime sweating in upper front chest region, feeling hot and cold at approximately 15 minute intervals for prolonged duration of 10-12 hours overnight with associated  difficulty falling or staying asleep.  Daytime low grade fever the following day with chills (102.2), fatigue and lethargy, shortness of breath, malaise, anxiety (generalized, unremitting continued anxiety through a period of 24-36 hours). Nighttime sweating duration = 3 consecutive nights post vaccine Pain at injection site with appearance of swelling onset is 12 hours post vaccine, duration 72 hours Anxiety onset was 20 hours post-vaccine with duration of 24-36 hours, unremitting  Extreme fatigue, lethargy, malaise onset was 16 hours post vaccine, duration 48 hours (4 days) Shortness of breath mild and intermittent in response to ADLs such as showering, post-prandial, during short ambulation within home (walking of 1-2 minutes = SOB) Day 9 post vaccine most symptoms are either very mild or absent
I got my Vaccination on 05/13/2022 and by the middle of June, I started getting worsen allergy symptom's, especially the cough.  It got worse over the fourth of July weekend, it became a full blown cold.  I never lost my taste or smell and I did a COVID-19 Test on July 5, and it was negative. It is now the 16th of August and I still continue with the symptoms of a cold and post nasil drip and a cough and mucus, and it is very annoying that I am still sick when I am never really sick. I believe that I am have an allergic reaction to the Pfizer Vaccine
Had COVID vaccine yesterday.  Felt Fatigued yesterday afternoon.  Felt feverish during the night.  At 7:00am this am Temp 100.3.  Took 2 extra strength Tylenol   At 11:00 temp 98.9    At 2:15  temp 100.8  Took 2 Tylenol extra strength Tylenol.  At 3:00 pm temp 101.8.
9 days after receiving Varivax, broke out in fever and rash all over trunk and abdominal area-little red bumps. Also got MMR #1 at that time.
Started itching, then red and feverish at injection site.  Red spot grew daily. Now is approximately 2 inch diameter.
next day of vaccination had chills fever headache and fatigue, Then blood pressure elevated so high. went to ER had several tests done.  came back from ER, I was asked to  monitor B/P fluctuations. still having headache time to time.
Pt received the 1st dose of Moderna on 4/30/2021,   She started to get a  high fever of 104.2  on 5/1 and claimed to have lost consciousness twice (once on 5/1 and once on 5/2).  She never went to doctor or hospital for this reaction and her family was with her when it happened. She has reported this reaction to the CDC herself and just mentioned this to the pharmacy on 6/18/21.