chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as recovered from a healthcare worker (also reported as Certified Medical Assistant (CMA)) refers to unspecified patients (less than 5) of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On an unknown date, the unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, dose, route and frequency were unknown). The reporter was at the early stage of identifying how many patients were involved, so she was unable to provide further details at this time. No adverse symptoms reported. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
My arm felt a little bumpy and then I noticed an oval or circle shape on my arm. It is red and itchy.
Immune thrombocytopenic purpura w/ subsequent anemia. IVIG infusions/therapy to prevent ITP.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-358220 (Patient Link).
Pain, edema, warm to touch, cold compress, Ibuprofen, BENADRYL prn itching.
Patient received J&J vaccine instead of 2nd Moderna shot; patient had normal signs/symptoms of getting COVID vaccine - achy, sore arm - but nothing out of the ordinary. This was considered one-and-done and patient will not receive second Moderna vaccine.
SORE ARM; LOW GRADE FEVER; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a 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 not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 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 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced low grade fever. On 10-APR-2021, the subject experienced massive headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, low grade fever and massive headache was not reported. This report was non-serious.
eye with the new cornea turned bright red; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6205) via unspecified route of administration in the left arm on 15Mar2021 at 12:30 PM (age at vaccination 47-years-old), as a single dose for COVID-19 immunisation. Medical history included keratoconus, cornea transplant, epilepsy, depression. Past drug included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot no: EN6209) via unspecified route of administration in the left arm on 22Jan2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Concomitant medication included levetiracetam (KEPPRA), venlafaxine (EFFEXOR), ibuprofen (UNKNOWN MANFACTURER), for unknown indications from unknown date. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that recently had a cornea transplant. My eye with the new cornea turned bright red after the vaccinations and also sore arm. On 15Mar2021 16:00 the patient experienced bright red eye, sore arm. Therapeutic measures included as Steroid eyedrops for the events bright red eye. The clinical outcome of the events bright red eye and sore arm was recovering.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient name added in general tab, 47 years added as age/units for Historical Vaccine since DOB and 1ST DOSE date provided, Start Date/Time and Stop Date/Time of 2nd dose updated to 15Mar2021 12:30, Vaccine Facility Information added, Keppra, Effexor, ibuprofen added as Concomitant drug, Onset Date/Time of events updated to 15MAR2021 16:00.
This spontaneous report as received from a registered nurse. The nurse reported on unknown date, multiple unspecified patients were administered RECOMBIVAX HB that were stored improperly. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
unusual reaction to the first dose; odd sensation in the upper arm muscle / occasional numbness / most pronounced when my arm was on the steering wheel or / relatively stationary position; This case was reported by a consumer and described the occurrence of numbness of upper extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy.   On 10th September 2020, the patient received Shingrix. In September 2020, less than a month after receiving Shingrix, the patient experienced numbness of upper extremities. On an unknown date, the patient experienced adverse reaction. On an unknown date, the outcome of the numbness of upper extremities was not recovered/not resolved and the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the numbness of upper extremities and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient was still experiencing an odd sensation in the upper arm muscle. The occurrence of this occasional numbness had diminished, sometime since September 2020 but till the time of reporting, it was still reoccurred daily. At first it was most pronounced when her arm was on the steering wheel or in a relatively stationary position for extended lengths of time. The patient reported that, the Shingrix website had no information that she could find on long term side effects. The patient's concerns were that taking a 2nd dose might exaggerate this condition. The patient would like to know how effective in preventing shingles in one dose of Shingrix. She asked if she choose to take a second dose can could she have the injection in her other arm.  The patient also reported that, she had an unusual reaction to the first dose. She was asking how effective one dose of Shingrix was.
At 9:15 pm. he took three steps and he started shaking. Got home and went to sleep,  woke up every couple hours with a stabbing chest pain, chills and sweating.  About 10:30 a.m. the next day, he took 800mg of Ibuprofen and slept for a while and feels better.
Red circle around injection site.  Hot to touch and knotted.  About 3.5 inches in diameter.
Patient reports she slept so heavily for 4 days  after 1st shot-hard to even get out of bed, and noted bilateral new on set tinnitus the day after the shot-symptoms not dissipating since (has been a month) and didn't get worse with 2nd shot, which she did get at 3 weeks per routine.  headaches during this time too
Moderna COVID-19 vaccine EUA  Raised,  red, itchy rash at vaccine injection site. Lasting more than 24 hours; subsiding after use of  OTC anti-histamine
Moderate to severe diarrhea since 2-3 days after first shot; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer ER8731) via an unspecified route of administration in the left arm on 29Mar2021 at 08:30 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Pfizer ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient has known allergies to mercury derivatives. The patient received other medications (unspecified) within two weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, 2-3 days after first shot the patient experienced moderate to severe diarrhea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diarrhea and included treatment with KAOPECTATE which slowed it down, and IMODIUM controlled it for 1-2 days and then it returned. The clinical outcome of the event moderate to severe diarrhea was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient came in on 3/4/18 stating that she thinks she may have had a reaction to SHINGRIX vaccine. She stated that she had a rash on her arm where the vaccine was given but don't know if it's related to vaccine and it went away quickly after taking BENADRYL.
Initial misuse report received from a healthcare professional on 11 April 2013. A patient (No information was provided regarding the patient) had received a dose of Acthib that had been reconstituted with another diluent and not with the supplied diluent. It was reported that it may have been a Merck diluent. No adverse event was reported. List of documents held by sender: none.
hands and feet turned dark red; incredibly bizarre sense ofsmell I can smellThings others cant very very acute; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208)via unspecified route of administration (at the age of 46-year-old) on 18Mar2021 at 11:00 as a single dose for COVID-19 immunisation. The patient medical history was reported but not specified. Patient had Allergies to medications, food, or other products which are not specified. Concomitant medications included  natural thyroid extract( ARMOUR THYROID) Fexofenadine hydrochloride (ALLEGRA), Dextromethorphan hydrobromide, Diphenhydramine hydrochloride, Pseudoephedrine (BENADRYL CHILDREN), ibuprofen (IBUPROG) all for unknown indication and date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021 the patient had an incredibly bizarre sense of smell she can smell things others cannot very very acute. On18Mar2021 When she got the shot her hands and feet turned dark red and she had to be monitored for an hour. No treatment was taken for adverse events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of incredibly bizarre sense of smell and hands and feet turned dark red was not resolved.   No follow-up attempts possible. No further information expected.
5/21 started feeling poorly, fatigue, shortness of breath, evening headaches 5/24 Fatigue, shortness of breath,  unable to complete any task, low grade fever 99.8, unable to eat or drink well 5/25 severe heartburn, shortness of breath continued, extreme fatigue 5/28 went to ER with continued extreme shortness of breath and fatigue.  CT scan revealed multiple clots in lungs and was admitted for needing  oxygen and to start anticoagulation.
Noted 9:30PM on 8/13/04 began experiencing Left hip pain and took Advil 200mg. By 11PM began experiencing Left upper chest/neck pain radiating down left arm specifically c/o joint pain which shortly after began on right side upper body then began experiencing intense itching to both legs. Pain to joints and itching persisted until 1:30AM when he fell asleep. When he woke up at 5:30AM continued to experience sore joints but not at the same intensity which persists to date. Also on occasion experiences severe left hip pain since 8/13/04. Has not Rx symptoms with OTC medications 2 hr,  fear of further problems.
Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Four patients received incorrect dose. They received 0.25 ml when they should have received 0.5 ml.).    It was unknown if patient received any other vaccine 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  They were wondering if Moderna has any information on handling these 4 patients. Date of administration was unknown, but this was last week. The pharmacist reports that the 4 patients did not experience any adverse reaction. One of the patients did come back and get the other half of the dose. She was not sure the location of vaccination, but she assumes it was at her workplace. The pharmacist did not know the patients' COVID19 vaccination history. All 4 of the patients were adults over 18 years old.  Treatment information was not provided.  This case contains information about patient 1st  out of 4 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-727655, US-MODERNATX, INC.-MOD-2023-727656, US-MODERNATX, INC.-MOD-2023-727657 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727655:Patient 2 out of 4 patients US-MODERNATX, INC.-MOD-2023-727656:Patient 3 out of 4 patients US-MODERNATX, INC.-MOD-2023-727657:Patient 4 out of 4 patients
Full body left side pain from 5:30pm 1/11/2022-current as of 1/16/22.  Sore tender breast as of 1/12/2022- current as of 1/16/2022. Spotting/ light bleeding and cramping since 1/12/2022 (unrelated to period, not pregnant)  Headache and neck pain since 1/11/2022
low energy; tired, exhausted; average increase in blood pressure and heart rate by 10-15%; swelling in lymph nodes; Increased blood pressure of 215/135; chest pain; He experienced tightness of the throat; tightness of the chest; Heart beat of 118 per minute; irregular heart beat; irregular blood pressure; pain in lymph node in left arm pit; blood pressure rising and dropping; stabbing feeling around lymph node in left arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired, exhausted), BLOOD PRESSURE INCREASED (Increased blood pressure of 215/135), CHEST PAIN (chest pain), THROAT TIGHTNESS (He experienced tightness of the throat) and ASTHENIA (low energy) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Increased blood pressure of 215/135), CHEST PAIN (chest pain), THROAT TIGHTNESS (He experienced tightness of the throat), CHEST DISCOMFORT (tightness of the chest), TACHYCARDIA (Heart beat of 118 per minute), HEART RATE IRREGULAR (irregular heart beat), BLOOD PRESSURE ABNORMAL (irregular blood pressure), LYMPH NODE PAIN (pain in lymph node in left arm pit), BLOOD PRESSURE FLUCTUATION (blood pressure rising and dropping) and LYMPH NODE PAIN (stabbing feeling around lymph node in left arm). On 03-Apr-2021, the patient experienced FATIGUE (tired, exhausted), ASTHENIA (low energy), BLOOD PRESSURE INCREASED (average increase in blood pressure and heart rate by 10-15%) and LYMPHADENOPATHY (swelling in lymph nodes). At the time of the report, FATIGUE (tired, exhausted), BLOOD PRESSURE INCREASED (Increased blood pressure of 215/135), CHEST PAIN (chest pain), THROAT TIGHTNESS (He experienced tightness of the throat), ASTHENIA (low energy), CHEST DISCOMFORT (tightness of the chest), TACHYCARDIA (Heart beat of 118 per minute), HEART RATE IRREGULAR (irregular heart beat), BLOOD PRESSURE ABNORMAL (irregular blood pressure), LYMPH NODE PAIN (pain in lymph node in left arm pit), BLOOD PRESSURE FLUCTUATION (blood pressure rising and dropping), LYMPH NODE PAIN (stabbing feeling around lymph node in left arm), BLOOD PRESSURE INCREASED (average increase in blood pressure and heart rate by 10-15%) and LYMPHADENOPATHY (swelling in lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by patient.  Treatment of these events included Pepcid.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Events added
1st dose 11/10/2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked, how to proceed with schedule from now on. Lot number and expiration date were asked but healthcare professional did not have that information. Healthcare professional did not mention about administering any 2nd dose of Shingrix. The reporter consented to follow up.
Initial report was received on 02 March 2011 from a health care professional. A 19 year-old female with a medical history of mental retardation, (illegible) seizure, trisomy abnormality and chronic respiratory failure, had received on 01 March 2011 an intramuscular left thigh injection of ADACEL, lot number U3051AA (sanofi pasteur Ltd. lot number C3312). On 02 March 2011, the patient's parent reported a temperature of 103 in the patient that had persisted since the evening of 01 March 2011. The patient had no illness at the time of vaccination. Concomitant medications included Dilantin, Rantidine, Ducolax, Lactulose and Albuterol. The patient had a previous dose of ADACEL in 2008. No further information was available at the time of the report. The patient's outcome was unknown. Follow-up information was received 07 March 2011 from a health care professional. From new information received, it was determined this case now meets seriousness criteria and this case has been upgraded from nonserious to serious. The patient's mother informed the reporter that the patient had a fever of 102 (previously reported as 103) and heart rate of 120 on 01 March 2011. During the late evening hours on 03 March 2011, the patient experienced a seizure lasting three minutes and was taken to the emergency room. She was observed overnight and diagnosed with pulmonary infiltrate. The patient also had an irregular rash on her chest and she had been spitting up foamy G-tube feeding through her mouth. On 05 March 2011, she experienced another three minute seizure and then another short seizure on 07 March 2011. Outcome was not reported and no additional information was provided at the time of the report. Documents held by sender: none.
Patient claims that 10 - 12 red round spots with white centers appeared on his legs, one on his hip and one on his chest. He believes this is due to the vaccine. Patient was told to visit the Dr office and report back the finding. He has yet to call us and did not answer his phone when pharmacist tried to follow up.