chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for Covid-19 i08/11/2021. I was just having symptoms of Sinus following. I started to have a runny nose and it was constant. I visited my doctor treated me for a Sinus infection because I did not have any other symptoms. Four days later my Oxygen levels were low. I woke up during the night and I had night sweats, but I did not feel feverish. The doctor prescribed Prednisone and Nasal Spray which I used three times daily. I was sick for five days and then I started to feel better. I use a C-PAP and usually I can smell the cleaner after I clean it. I had a brief period where I lost my sense of smell. I was not very hungry during that period. I did another Covid-19 test 08/14/2021 and it was negative. I still get tired in the afternoons since then and I am a little anemic five weeks after the illness.
Pt received ADACEL 4/27/09- And developed cellulitis on site of injection. She was seen at ER.
LOT # FL2757 WAS PULLED FROM FREEZER AND DELIVERED TO CLINIC ON 08/11/22, EXP DATE WAS RECORDED AS 10/25/22, BASED ON PULL DATE. MANUFATURER BUD WAS ESIMATED TO HAVE VACCINE EXP ON 09/30/22. PATIENT WAS GIVEN INJECTION ON 10/14/22, 14 DAYS AFTER MANUFACTURE'S EXP DATE.  WAS NOTIFIED BY THE STATE OF COLORADO THAT VACCINE WAS EXIPRED. PARENT OF PATIENT WAS CONTACTED AND ADIVSIED. SHE REPORTED NO ISSUES WITH THE PATIENT, FURTHER INFORMATION OBTAINED FROM PFIZER THAT THE VACCINE'S BUD WOULD HAVE ACCUALY BEEN 10/19/22, AND IT WAS NOT IN FACT EXPIRED AT THE TIME OF USE. THE STOCK IN QUESTION WAS PULLED FROM OUR SUPPLY AND WAS NOT USED ON ANY OTHER PATIENTS. BEYOND THE ORIGINAL RECOMMENDED USE DATE ON 09/30/22.
heart attack; 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 MYOCARDIAL INFARCTION (heart attack) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) unknown. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant). The reported cause of death was Myocardial infarction. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  No treatment information was provided.  Patient reported a family member died from a heart attack shortly after getting your vaccine.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Myocardial infarction
Tinnitus since the second dose of the vaccine. Worsening over time. Even worse now that I've gotten COVID 19 this week.
Received the Pfizer Covid vaccine second dose after waiting 10 weeks before taking the second dose; Acute fatigue; This is a spontaneous report from a contactable consumer (patient) received from Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced acute fatigue and received the Pfizer Covid vaccine second dose after waiting 10 weeks before taking the second dose on an unspecified date. Patient questioned if they all are lab rats, and Pfizer is of no help. Everything that she was told could be found on the internet. Doctors had no idea what to say. In response, informed client that current information provided is all that is available and referred to MD. Patient received the Pfizer Covid vaccine second dose, after waiting 10 weeks before taking the second dose, at the advise of a physician. Patient stated that 48 hours after taking the second dose of the vaccine, the last 9 days she had been experiencing acute fatigue. Patient stated that she had no significant medical history and was very healthy other than some arthritis. Patient wanted to know how long the acute fatigue would last. Caller not offered transfer to hospital as she was not pleased with response provided, unable to obtain age. In response, caller was told that beyond what was described in the Pfizer-Biontech Covid Vaccine Prescribing Information, Pfizer does not have information on how long what she was experiencing may last and there may be many factors to consider including patient medical history and condition. And advised to consult with her doctor or healthcare provider about what she had experienced or experiencing. And was told that patient's doctor or healthcare provider is in the best position to advise her about the appropriate action to take as they would be most familiar with her medical condition, clinical history, how her treatment had been conducted and any relevant information to her specific case. The events were states as not serious. The clinical outcome of acute fatigue was not recovered.  Information about lot/batch number is requested.
flu; Initial information was received on 12-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via social media.  This case involves a male patient (age unspecified) who had flu (influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (1957-1961), the patient received a dose of suspect INFLUENZA VACCINE (which contained live virus) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (in following year), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (second flu shot) (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (1957-1961), the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event. This was the first time when patient had flu.  On an unknown date (in following year), the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  He never took flu shot again until years later when he learned that they were using dead virus. That was the only time when he had flu twice.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The information on lot number was requested for this case.; Sender's Comments: This case concerns a male patient who had influenza twice after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient previously healthy, developed Graves disease via lab testing 4/16/21, is also undergoing workup for thyroid nodule, also had significantly elevated LFTs but it is unclear of cause for this, they have been down trending.
VOMITING; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a 50 year old female. 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and vomiting was not reported. This report was non-serious.
Two days after vaccination I had extreme costochondritis I called my doctor and he recommended I take Aleve and use heat I took one Tylenol and one Aleve.
Severe headache and body ache and chills on 1/19/12.  I took Tylenol and went to bed at 8pm.  I woke up today 1/20/11 with severe body aches, chills, but no headache.  I feel like I have the flu but I do not have a temperature or respiratory symptoms.  I am aching all over.  Even my eyes hurt and my skin on my head/scalp is painful.
Pentacel with a Pediarix was administered on the same date so patient had a double dose of the DTaP and polio/no AE; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient( unknown demographics) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with a DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID on the same date so he had received double dose of the dtap and polio(batch number, expiry date, route and administration site not reported) on an unknown date for prophylactic vaccination (extra dose administered).   Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to extra dose administered.   At the time of reporting, no adverse event reported.  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.  Information on the batch number was requested.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.
Emp presented to employee health c/o rash and itching of face that started 15 min after administration.
At 2:05, when patient was ready to leave the post-vaccination observation room, she stated that she experienced a brief interval of symptoms, lasting less than 30 seconds; tingling at vaccination site, tingling finger tips both hands, mild dizziness, and brief shortness of breath. Resolved on its own. Took some fruit juice P.O. States she had not eaten since breakfast, 6 hours ago. Felt well and able to leave site independently.
This report from study was reported via Pregnancy Registry (initial receipt 04-Sep-2014) and concerns a neonate patient. Concomitant medications, received via the mother in utero, included prenatal vitamins, iron, estradiol, progesterone vaginal insert, menotropin and urofollitropin. The mother's medical history included IVF (in-vitro fertilisation) treatment, in which embryo transfer took place on day 5. The mother's DOC (date of conception) was 26-May-2013 and EDC (estimated date of confinement) was 16-Feb-2014. On the 12-Nov-2013, the patient received the AFLURIA injection (batch number not reported) via the mother, intra-uterine, 1 shot 1 day. On the 06-Feb-2014, the patient was born at a gestation age of 38.6, birth weight was 3235.0 grams and was diagnosed with Pierre Robin Sequence. The patient was born a twin - the patient's twin was a healthy newborn, without malformation. Outcome was unknown. Linked to case 2014044961.
Mild itching at Flushot site; swelling in lips, went to physician, given steroid and antihistamines. Now symptoms are gone.
I received the Pfizer vaccine on 12/27/2021, two hours after receiving the vaccine, my lip started bleeding and filled my mouth with blood and I had to apply pressure to the opening on my lip for 5 minutes to get it to stop bleeding.  I did not cut my lip, it started bleeding without prior trauma.  Over the next 2-5 days after the vaccine, I kept tasting blood in my mouth and looked at my throat with a flashlight and found an area in the back of my throat, a capillary bleeding.  I drank cold water to have it stop bleeding.  7 days after the vaccine, I got an upper respiratory infection with lots of thick yellow/brown mucus produced over the next 4 days and still ongoing.  On day 7 after the vaccine, I started experiencing muscle twitching throughout my body, a sensation of full body tremors, and electric current feeling in my body all day and night.  When falling asleep and during sleep, the muscle twitching's are quite large and wake me throughout the night and cause my entire lower body to convulse.  I have also broke out in rashes throughout my body since the day of the injection.  I had none of these symptoms prior to the vaccine.
PT received 1st dose of Moderna  COVID 19 vaccine on 04/28/2021. Pt received  to pharmacy for 2nd dose of Moderna COVID19 vaccine on 05/20/2021. This was only a 22 day interval, when manufacturer recommendation is 28 days.
Initial and follow-up information has been received through the Merck pregnancy registry for Gardasil from a Registered Nurse concerning a 15 year old female who on 20-NOV-2007 was vaccinated with the first dose of Gardasil.  Subsequently the patient received the second dose of Gardasil (Lot #658490/0802U) on 24-JAN-2008 and became pregnant.  The patient's estimated LMP is 07-NOV-2007.  Follow-up indicated that the patient had an elective termination six to eight weeks after her last menstrual period.  It was unknown if the products of conception were examined and it was unknown if the fetus was normal.  Upon internal review elective termination was considered to be an other important medical event.  Additional information is not expected.
Day of vaccine arm pain so bad I could not sleep the night of shot. Day 2, sore arm, diarrhea, nausea, severe headache, fatigue all over body aches, chills low grade temp of 99 degrees. Spent a lot of time in bed. Day 3 still have gut issues, some nausea, temp back to normal but still achy, fatigue, headache until late that night. Day 4 (today), very lethargic, still having gut issues and some remaining nausea.  This is the longest lasting and worse side effects I have ever had with a vaccine.
Extreme pain in shoulder. Loss of range of motion and strength. Primary care  doctor believes inflammation of bersa due to shot given too high up on arm near shoulder joint
On 8/21/01, pt's left arm was tender, red and swollen. Inflammatory reaction to DTAP. On 8/24/01, inflammatory process resolved.
Vaccine Saturday morning, arm hurt later that day. Almost exactly 24 hours after vaccine on Sunday: sore throat, aches, fatigue in middle of the day, rested. Monday felt better in the morning, felt a little more tired than usual. Did a weight training work out, that afternoon started feeling funky and tired. Tuesday: felt sick, not as much as on Sunday, laid low.
vax administered 20JUL93; pt had a complex partial sz on 29JUL93; post-ictally had vomiting, h/a & sleepiness; no specific treatment given;
shingles; This is a spontaneous report from a contactable Nurse. This contactable Nurse reported for a 65-year-old male friend (patient) that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced shingles. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fatigue around 2:00 pm. Headache around 5:00 pm. Chills, upset stomach around 7:00 pm.  It is 8:20 pm and side effects are still occurring.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On 10th December 2018, the patient received SHINGRIX (subcutaneous). On 10th December 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In December 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient inadvertently received SHINGRIX subcutaneously, which led to wrong route of vaccine administration. Less than a week after receiving SHINGRIX, the patient experienced redness and swelling at the injection site. The pharmacist did not know when the events started and consented to follow up. This case has been linked with case US2018226103, reported by the same reporter.
aplastic crisis, parvovirus infect;pt c/o neuro signs & sx consisting of pain, fatigue, sleeplessness, weakness, malaise & GI sx;c/o erythema or rash;positive parvo;
Gave an Expired Dose of Heplisav-B; Initial Report Received on 31-Aug-2021   A registered nurse reported that a 52 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    The patient does not have any known allergies. Other relevant medical history was not reported.     Relevant concomitant medications were not reported.   On 31-Aug-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933624, expiration date 10-Aug-2021, and NDC # 43528-003-05; serial # not reported) in the left deltoid by the registered nurse (reporter). The patient did not experience any adverse effects.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pain and swelling at injection site which eventually spread down half the arm and lasting about 2 weeks. No fever reported.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at physician office for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient had a covid shot, passed out after 1 min. i lowered him to the floor. He was acting like he had convulsion, later he is breathing well. so, i gave him a 0.3 ml EpiPen. He woke up after a few mins later and wanted to know what happen. i called emergency, he asked me to call his roommate who brought him there.  He later explains to me he has severe anxiety for needles, and he has passed out before at a blood bank after an injection. Emergency came and check his vitals and everything was ok. Re refuse to go to hospital and he sign a concern with emergency crew declining to go with them. His roommate drove him home after that
Febrile seizure - squadded to ER. Another febrile seizure. CBC, blood cx. attempted. LP. CXR? ? pneumonia. Amox. Then fever again 9/27.
This is a spontaneous report from a contactable consumer. An 84-year-old female patient received PREVNAR 13 via an unspecified route of administration on 16Mar2015 at single dose. The patient medical history and concomitant medications were not reported. Since 16March2015 she have had a hacking cough which sounds like whooping cough. Within two weeks from the shot she had started with the cough and she had experienced all the symptoms of pneumonia and it was horrible, consumer could not eat a meal without coughing and choking. She was prescribed a Nebulizer to use. The patient was in emergency room in April2015 where she had gone through a chest Xray and they said it was bronchial asthma, so they started her on antibiotics but still the symptoms did not go away. At the time of reporting the patient was doing much better and consumer did not have to use Nebulizer as much as now she had a kind of little cough. She was much better but was not 100% better. At the time of reporting the patient stated the all the symptoms of pneumonia were better now and it was over the last year that she had all the problems, X-rays and the hacking cough so she took medications for it and everything. She was recovering from hacking cough which sounds like whooping cough, experienced all the symptoms of pneumonia, bronchial asthma. The outcome of she could not eat a meal without coughing and choking was unknown. The patient stated that she would be 86 years old and before she received PREVNAR 13, she was in excellent health and then everything got changed after she received PREVNAR 13. After a year and half later she had started feeling herself like she was, it took that long to remove out that shot from her body. The patient stated that she know that all the problems were because of PREVNAR 13 that went into her body because she was a healthy woman, she was in her 80s and she would be going to 86 but she was very healthy, she never had a cold, she never had anything so she decided to have the Pneumonia shot (PREVNAR 13) which would be better at her age but she would never consent to have that shot.
RUE, started 10/16/08, AM. 6 x 6 cm, raised, pink. Slight tender, no d/c.