chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant while vaccination; Nauseous; Body aches; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant while vaccination), FATIGUE (Tired), NAUSEA (Nauseous) and MYALGIA (Body aches) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN and Prenatal for an unknown indication.    On 26-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Dec-2020 and the estimated date of delivery was 08-Sep-2021. On 24-May-2021, the patient experienced FATIGUE (Tired). On 24-Jun-2021, the patient experienced NAUSEA (Nauseous) and MYALGIA (Body aches). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant while vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant while vaccination), FATIGUE (Tired), NAUSEA (Nauseous) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
High pitched scream, inconsolable for 3 days after vaccine administration per mother's report.
Shingles rash over the skin . painful blistering rash occurring of the right dermatome over the back associated with itching and pain occurring one month after the vaccine. the rash was topically treated with OTC lysine. then occurred once again the following month for 3-4 days
Two-day fever that reached 102 the first day after the vaccine; headache; strong body aches.
This spontaneous report was received from a 65 year old female patient (physician) via a company representative. The patient's pertinent medical history, drug reactions/allergies were not provided. The patient's vaccination history included PNEUMOVAX 23 (self-administered at the age of "44 or 46") and PREVNAR 13 at the age of 64. On approximately 27-NOV-2015, reported as "6 weeks ago", the patient was vaccinated with a dose of PNEUMOVAX 23, subcutaneous, (dose, lot number, expiration date and anatomical location were not reported). There were no concomitant medications reported. On 27-NOV-2015, immediately after vaccination, the patient felt lethargic and her arm hurt "kind of a flu shot". The outcome of lethargy and pain in extremity was reported as recovered/resolved on approximately 29-NOV-2015 reported as "three days after receiving shot". The reporter did not assess the relatedness of lethargy and pain in extremity with PNEUMOVAX 23. Additional information is not expected because the reporter did not want to be contact.
employee reports receipt of COVID-19 vaccine dose #2 on Thursday 1/21/21.  C/o left thigh problem. Reports the following day post vaccination (Friday) had injection site pain, eyes were burning at work and general malaise.  Reports she took tylenol and went home early due to symptoms. Reports fever up to 106.6 F Friday night which resolved the following morning. Now concerned about left thigh problem.  States she woke up Saturday morning and when got out of bed left thigh was "off".  States feeling like she is not able to walk normal since then, feels like she's "limping".  Denies any falls.   Patient also concerned about late menses. States she was scheduled to get it on 1/20/21 and wonders if this is vaccine related.
A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 31-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Body aches, sore joints, sore back of neck and headache.  Back hurt and fever
Patient develops rash through out body. No swollen gland. Adverse event appears to be topical rash only.
Pt. c/o of dizziness, nausea, diaphoresis, pressure on throat, feeling that tongue is getting swollen.  Paramedic and Dr on scene.  Assessed pt. and vital signs obtained.  BP 136/92, HR 90, O2 Sat 97% on RA, RR 18.  Recheched BP  116/80, HR  73, O2 sat 98% on RA.  Pt. was advised to go to ED if symptoms worsen.  Pt. stated improvement of symptoms after about 15 mins.  No angioedema noted.  Pt is able to speak in full sentences without any distress noted.  Observed for 30 mins.  Pt. is allergic to ibuprofen and has hx of asthma.  Lungs clear to auscultation per paramedic on scene.
Injection site inflamed starting today 4-25.wqs inflamed for a few days after injection on 4-13 but was fine until now.
Patient had pallor and dizziness. He then experienced a syncopal event with subsequent seizure. The seizure was accompanied by loss of bladder control. Patient rapidly regained consciousness and had minimal post ictal state. He has no history of previous seizure though his mother had a seizure disorder. Patient was sent to the emergency department where he was given IV fluids, and bloodwork was noted to be normal. Was discharged in 1 to 2 hours to home. He states he is doing well this morning.
Information has been received from a physician concerning a 5 year old male with no pertinent medical history and no known drug allergies who on 19-AUG-2006 was vaccinated IM with 0.5 mL dose of Vaqta (lot# 652509/0036F). There was no concomitant medication. On 19-AUG-2006 the patient developed fever of 104 degrees F. On 20-AUG-2006 the patient also had one episode of vomiting. He felt dizzy, but on 21-AUG-2006 he felt much better and walked around. Additional information is not expected.
Janssen COVID-19 Vaccine EUA:  Patient received Janssen Vaccine on 4/11/2021. On 10/1/2021, patient presented to Medical Center with a chief complaint of cerebrovascular accident. Symptom onset was overnight and patient woke with complaints of left sided weakness. He was seen by teleneurology and CTA showed occlusion at the right ICA origin. CT perfusion scan revealed at risk tissue that was felt to be amenable to reperfusion, so pt was transferred to Hospital emergently for cerebral thrombectomy. He was intubated for procedure. Of note he is Covid positive. Patient was extubated after procedure on 10/1. Patient was reintubated on 10/7. He developed acute hemodynamic instability and worsening hypoxemia on 10/11/2021. Etiology was unclear: acute sepsis vs cardiac event vs venous thromboembolic disease. WBC acutely elevated. CXR stable. LE dopplers (-). Troponin 0.14-- >0.15. Hb stable. He progressed to PEA arrest and did not have ROSC despite ACLS.  Patient passed away on 10/11/2021.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 9:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 25.42   Concomitant products were not provided.  On 24-May-2021, Excursion time was 08 AM and 09 AM, temperature was 35, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-MaY-2021, vial was moved to clinic on 24-May-2021. 3 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Rotarix was ordered. It was most likely improperly reconstituted as 4 vials of vaccine remained in an open box with- out any syringes of liquid. Therefore the infant did not receive the vaccine component The parent was contacted and is bringing the infant back in for readministration of the vaccine.
I had the pneumonia vaccine 2 days ago and now my arm is red and swollen and painful and I am running temp at home 101 last eve, cough non prod cough. Treatment: Prednisone.
The day after I was running a fever and was very tired. Days later my stomach was hurting, I was vomiting, and passed out. I was in the hospital for over night
This 82  year old  male hospice patient received the Covid shot on  3/6/21    and went to the ED on  4/6/21     and was admitted  on  4/6/21  with respiratory distress, acute hypoxemic respiratory failure, anasarca, atrial flutter, hypothyroid and died on  4/15/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
got COVID 19; Initial information was received on 12-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case is linked with 2020SA358011 (Same reporter). This case involved an unknown age male patient who got COVID-19 (corona virus disease), after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient got COVID-19, unknown latency following the administration of INFLUENZA VACCINE.  Laboratory test included COVID-19 test.  Final diagnosis was COVID-19.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
3 hours post-vac: hives on scalp and rt side of forehead. Itchy scalp.  4 hr post-vac: itchy on stomach.
Information has been received from a physician concerning a 13 month old male with numerous "chronic neurologic and pulmonary conditions" and multiple congenital anomalies who on 01/03/2002 was vaccinated with a dose of varicella virus vaccine live. The reporter stated that, to his knowledge, the pt was not immunosupressed. It was noted that the child is currently hospitalized and on a ventilator and that the reporter was not sure if the child was hospitalized at the time of vaccination or afterward. It was also reported that the pt was hospitalized due to his pre-existing chronic medical condition and it was, in no way, related to vaccination with varicella virus vaccine live. On 01/28/2002 the pt began to develop a rash. He had approximately 12 lesions described as very large juicy vesicles. It was also described as "typical varicella." It was noted that there were 150 vesicular lesions on his trunk, face and extremities that occurred 27 days post vacicnation. His max temp was 101 deg. It was noted that the child had no chickenpox until now and that he had no known exposure to varicella. However, three weeks ago, there was a pt in the hospital who had a case of chickenpox. To the reporter's knowledge there was no contact between that case and this pt. The physician collected a swab specimen from a vesicular lesion on 01/10/2002 the physician and it was sent for PCR analysis. It was reported that the pt recovered. Another pt (WAES0201USA03220) experienced herpes zoster following vaccination with varicella virus vaccine live. Follow-up info indicated that preliminary results showed the specimen was VZV + and that the specimen would be typed in the next week or so. Additional follow-up reported that the swab from the vesicular lesion was VZV+ and that the PCR analysis identified the presence of Oka/Vaccine strain. The pt is at home and has recovered. It was reported that, to the doctor's knowledge, the pt was not on steroids for his other underlying conditions and he was "surprised that the child's rash looked like classic chickenpox." He reported that the child was treated with acyclovir and recovered. It was also reported that the child did expose several other children in the hospital, but no other cases have been reported. One of the children exposed got prophylactic IVIG. Upon internal review varicella was considered an other important medical event. Additional info has been requested.
About a week after getting the SHINGRIX vaccine, Patient reported that she was diagnosed with shingles.
Information has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 20-SEP-2017, the patient was vaccinated with an expired dose of PROQUAD lot # M007960 and expiration date of 15-AUG-2017, (route of administration and anatomical location were not reported), reconstituted with sterile diluent (MERCK) (lot # unknown) for prophylaxis. No adverse effects were reported.
Chronic muscle pain in my legs and numbness  in my top lip and gums, high fever and chills./ Moderna
Pt admitted with metastatic breast cancer with liver metastasis and died on 12/21/21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose number unknown, single (Lot number: EW0180) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Aspirine, reaction(s): "Known allergies: Aspirine"; Iodine, reaction(s): "Known allergies: Iodine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: It was reported that no other vaccines were given within 4 weeks. Anti-viral details: product=COVID 19, treatment, brand=Paxlovid, treatment start date: 27Jun2022, treatment stop date=01Jul2022, indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
uticaria and pruritis with papules present, started day 8 after injection, and continues currently although uticaria are beginning to fade.
atonic epiode-limp, slumped forward, eyes open but pt unresponsive but pink ? amt of time; no rx; family notified PMD next day
Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 15-SEP-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  1 day after dose 2 moderna, developed T103 for 7 hours. then developed a headache x 2 days
Pt recvd 3 doses of Engerix-B 18MAY90; 27JUN90, & 13DEC90 & it was determined that pt failed to seroconvert;
redness/swelling/heat in the arm.patient reported to dr and was given augmentin 875/125 mg for potential infection
pt c/o redness in extremities & body-swelling in hands-tightness of throat making swallowing difficult; welts on back-turned to rash;
C/O STUFFINESS IN EARS, 97.6, 122/88, 69.
Fever; Weakness; This is a spontaneous report from a contactable physician (Patient). A 24-year-old male patient received first dose of BNT162B2 (PRIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration, administered in Arm Left on 24Feb2021 09:00 (at the age of 24-year-old) as single dose for covid-19 immunisation. Medical history included covid-19. There were no concomitant medications. Patient did not receive any other vaccine within four weeks of COVID vaccine and he did not receive any other medication within two weeks. Patient was not tested for COVID-19 since vaccination. On 25Feb2021 at 10:15 AM, the patient experienced fever and weakness. Therapeutic measures were taken as a result of fever and weakness. The outcome of events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Severe menstrual cramps on and off (mostly on) for 3 weeks, started about 5 days after receiving vaccine.  Cramps continued with no bleeding except for the occasional very light spotting.  Difficulties sitting, moving around.
She tested positive for COVID-19 on 12/8/22. She had Influenza A, COVID-19, and Strep all at the same time, so it is hard for me to determine which symptoms were COVID-19. She had fever of 103, congestion, a light cough. Her symptoms lasted for about 3 days. On 12/23/22, we had to take her to the ER because she was having chest pains. She was prescribed Xofluza and Amoxicillin, but nothing or COVID-19. She is doing better, but she was just diagnosed with another strain of Influenza A.
2nd booster dose of Moderna given today at the clinic.  A nurse gave .5ml Moderna instead of 0.25ml dose.  Client is feeling well with no adverse reaction as of 11:45am today.  Client has been notified of this error and is calm and understanding.  She is happy to be notified and not concerned of receiving a higher dose than what is recommended at this time.  Client does not notice any adverse side effects at this time.
Symptoms -fever, started in evening 99.7F and steadily climbed to 101.1F (last check) over 2 hour period -chills  -body aches  Treatment -rest -herbal tea
all of a sudden my heart started to beat really fast; anxiety; This is a spontaneous report from a contactable consumer(patient) reported for herself. An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and expiration date was not reported), via an unspecified route of administration, on 22Jan2021 as UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On 29Jan2021 the patient had experienced that the heart started to beat fast and took an anxiety pill because patient do have anxiety at times. The patient underwent lab tests and procedures which included heart rate: really fast. 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.
Modern a COVID-19 Vaccine EUA Injection site was sore the day after the vaccine for about 12 hours. Approximately 1 week after the vaccine the injection site is very red in area about the size of a baseball, some itchiness and hot to the touch.
Congestive Heart Failure and AFib, this still continues, she now has a pacemaker for the AFib and is taking an unreal amount of medication to try and control the heart failure. We currently have her on Hospice care, Level 1.
Awoke on Saturday 11/6/21 with slight fever (99.8) and noted lump on left clavicle/neck area. Lump very sensitive to touch approx the size of a small plum. No known injury to site. Throughout 11/6, I remained extremely fatigued with slight headache and and increased pain at site of lump. Sunday 11/7, lump noted to be slightly larger and more painful and grew slightly in size. Marked fatigue. Today 11/8, lump remains the size of plum, is painful to any touch, extreme fatigue persists and temperature of 99.3
Information has been received from a consumer concerning her 4 year old daughter who on 26-JAN-2010 was vaccinated with a dose of MMR II (Lot # not provided) and a dose of VARIVAX. For 2 days following vaccination, the patient had pain, redness, swelling, and bruising of the injection site in her left arm. On 09-FEB-2010, she experienced fevers of 103-104 F that lasted for 2 days. On 12-FEB-2010, she developed a papular urticarial rash on her back and scalp. It was unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Additional information had been requested.
The patient's wife called on 11/2 stating that patient was experiencing leg numbness and tingling ever since receiving the vaccines. His wife stated that it only occurred after receiving the vaccines, and that nothing else in his regimen was different other than getting the vaccines. We advised that patient should be seen by a doctor, as this could be a very rare but serious side effect from the vaccines.
Onset 12/02/2008 HA; dizziness; stomach & current (12/3/08) fever- 100.0-100.5
Gall bladder inflammation the evening after vaccine.  I am prone to gall bladder inflammation because of gall stones, but I had not had a major incident in a while.  This was the worst incident in over a year.  Also, I had another case of inflammation with the second vaccination dose that was even worse than this one.  I will report it separately.