chrisvoncsefalvay/vaers-outcomes huggingface dataset:
General malaise; Bit of a runny nose; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), RHINORRHOEA (Bit of a runny nose) and PYREXIA (Mild fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Condition were reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MALAISE (General malaise), RHINORRHOEA (Bit of a runny nose) and PYREXIA (Mild fever). At the time of the report, MALAISE (General malaise), RHINORRHOEA (Bit of a runny nose) and PYREXIA (Mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No conmeds reported.  No treatment reported.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event,  a causal relationship with the event cannot be excluded.  Fever is consistent with the known safety profile of the vaccine.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient reported being dizzy after vaccination for both first and second dose.
COVID vaccine given 3 days post expiration date. No adverse event occured. PCP, dept of health notified and family notified. Awaiting advice from dept of health on validity of dose and subsequent dosing.
Hives that come and go all over body. Started in the evening just a few hours after Flumist. Itching that comes and goes with hives. Doctor prescribed Zantac, steroid, and told to give Benadryl or Zyrtec. Hives are still occurring as of 10/23/1014.
Waves of nausea every few hours for about 24h after injection. Also tenderness upon touching injection site for same amount of time.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 2:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:35 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 47.53 for dose administered on 13-FEB-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion 13-FEB-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-FEB-2021 and beyond use date for the vial was reported 10-MAR-2021. Product moved to clinic on 13-JAN-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Booster vaccine was given 10 days after the beyond use date of 11/20/2021 Patient notified, no adverse reactions and patient has chosen not to revaccinate
This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. In approximately February 2016 (reported as "one or two months ago"), the patient was vaccinated with a dose of PNEUMOVAX23) (route, concentration, dose, dose number, anatomical place of vaccination, lot# and expiration date were not provided), for prevention of pneumonia. Information regarding concomitant therapies were not reported. Then, in approximately 2016, the patient experienced dermal itching (pruritus). Therefore, the patient was treated by their physician with an unknown therapy. Nevertheless, no product quality complaint was involved. At the time of reporting, the outcome of pruritus was unknown. Also, the reporter did not provide a causality assessment between PNEUMOVAX23 and the event. Additional information has been requested.
ankle swelling; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (ankle swelling) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (ankle swelling). At the time of the report, JOINT SWELLING (ankle swelling) outcome was unknown.            No concomitant medications were reported. No treatment information was provided by the reporter.    Reporter did not allow further contact
H1N1 Mist given to pt. Her brother reacted dramatically when he received his H1N1 Mist and Hgb. Pt fainted and recovered rapidly. Gave her Coca Cola. Mom phoned at approx. 5 PM and said pt said her brain was going round and round. Had been playing all afternoon. Mom phoned in 12-09 and said pt seemed fine and was not dizzy.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 27-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Mild headache, warm temp, and tiredness 24 hours after the initial shot.  Took Tylenol and it helped with the symptoms  2/11: Right lymph nodes feels swollen when swallowing and left underarm pit felt sore when raising the left arm but that went away.the next day.  2/12: One week after the first shot,  left arm started to develop a round hard bump, warm to touch, and red at the area. It now doubled in size the next day and very hard bump when touch.
Hives, rash, hot to touch and itchy. The hives appear randomly and Benedryl has not been helping.
Patient tested positive for COVID following completion of the 2 dose series.; Patient tested positive for COVID following completion of the 2 dose series.; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration on 19Feb2021 as dose 1, single for COVID-19 immunization administered at Workplace clinic. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID following completion of the 2 dose series. The patient had vaccination failure. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on an unspecified date. The outcome of the events was unknown.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe local rxn characterized by induration, hot to touch, painful 1/2 of buttock; 5th DTP;
I was unable to move out of bed for 4 days. Hallucinating. My bones felt like they were breaking.  Severe migraine and I get migraine all the time. These were unbearable.  My vision was completely blurry.   It's been almost 4 weeks and my vision is still blurry. I'm going to eye Doctor next week.
Son states: 11/15/21: Both father and mother received Moderna booster.  They both started having stomach issues and diarrhea some time later. The wife's symptoms resolved in about 3 days.  The husband's symptoms continued.  11/22 or 11/23/21  His father was complaining of intense stomach pain and his abdomen was distended, so his wife took him to the ER.  He was admitted to Medical Center and stayed for 5 days  They performed exploratory surgery on his father and it was decided they would remove his colon because his small intestine was swollen and twisted on itself.  He had the surgery and a colostomy.    11/26/21: The surgery did not resolve his symptoms and his GI system continued to swell until he aspirated on his stomach contents.  11/27/21:  Date of death.
See copies of pt's record 7/31/09. 8/20/09 Spoke by phone to mother of patient says that patient received #1 HPV on 9-19-08. On Oct/2008 patient was hospitalized for 2 mos with S/S like the S/S she had on 7/31/09 but much worse. According to mom, patient was seen at ER on 7/31/09 but not admitted. According to mom, they were told that the episode of what happened to pt. were not for sure if it was related to HPV vaccine. 17 y/o presents with c/o headache which started on Monday and increased in severity to a 7 out of 10 on pain scale. Pt. reports no blurry vision with headache. Pt. reports the headache is on the (L) side of her head and is dull in description. Pt had one episode of N/V yesterday. Pt. reports headache is about 1 out of ten now. Pt. reports neck stiffness since Monday and has increased. Pt. reports tenderness to touch of her upper neck and pain when putting chin to chest. Pt. has had similar episode in Oct. 2008 and was hospitalized for about 1 1/2-2 months with IV antibiotics (ROCEPHIN) & Acyclovir for what appeared to be HSV-1 encephalitis. Pt had CT scans & MRIs which showed some edema & focal enlargement of the right media temporal lobe. Herpes encephalitis was a consideration. Pt. also had started taking ORTHO-TRICYCLEN & GARDASIL 2 wks prior to incident. Pt also reports taking both drugs again for about 2 wks. Pt has recently returned from band camp.
Developed fever and fatigue the evening the shot was given.  Also c/o mild intermittent headache.  Fever was up to 102 and lasted for 5 days.  Self medicated with advil prn.  Patient seen today, (6/21/05) doing better with no fever so far.  No further treatment given.
Diagnosed Tachycardia at Hospital, fever, extreme fatigue., shortness of breath.
Sunday 4/24/05 in am had little raised bumps on hands to elbows bilateral. Sunburn rash from elbow to hands swelled up and blue line appeared at wrist the circulation was cutting off at the fingers, fever 100.5 diarrhea 4/27/05.
05/09/21 - start of Uterine Hemorrhaging after six months of no menstrual cycle; bleeding lasted 10 days followed by 2 days of spotting.  Severe lower back pain and extreme fatigue included in symptoms. 05/20/21 - start of chest pains, upper back pain, and difficulty breathing 05/24/21 - visit to doctor, concern of possible extreme anemia from hemorrhaging, lab work done 05/25/21 - doctor visit to address lab results, chest pain, back pain, difficulty breathing, light headedness, and sweatiness condition at extreme level.  EKG in doctor office shows problem.  Doctor staff takes me to ER.  EKG in ER points to heart attack (also labs, xray, and other tests).  ER sends me by air lift to a hospital with a cath lab. 05/25/21 continued....cath lab does angiogram, blood tests, etc... Cardiologist cannot find cause of heart arrhythmia, no blockage found, "wandering" EKG settles back to normal.  Cardiologist verbally mentions Paricarditis as a possible diagnosis but does not include that in his written report/medical record.  Discharged. Since 5/25/21 doctor's have continued with diagnostic tests to explain "heart" event.  As of 07/07/21 no definitive diagnosis, continuing tests.
Pt recvd vax & the day of the 3rd dose exp h/a, eye droop, vision affected (nystagmus);
I was very tired and then started coughing really badly on Saturday. I had a sinus infection, but it was gone at that point and then my daughter insisted I test for COVID-19 when I started coughing. I had a slight fever and was coughing and was so tired. I ended up being bedridden for over a month. My doctor did give me a medication and cough syrup to help with the symptoms I was having. I did have my flu vaccine on the same date as my COVID-19 shot but I do not have the information for that shot.
Swelling, redness, and itching at injection site; Swelling, redness, and itching at injection site; Swelling, redness, and itching at injection site; Swelling of lymph nodes under left arm; Off label use; A third (booster) dose of BNT162b2 was administered subsequent to the Initial 2 dose regimen of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 05Oct2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lithium (MANUFACTURER UNKNOWN), quetiapine fumarate (SEROQUEL) and multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Oct2021, the patient experienced swelling, redness and itching at injection site and swelling of lymph nodes under left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling, redness and itching at injection site and swelling of lymph nodes under left arm was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
/5/2022   Chief Complaint:  Chills, mental status changes and near syncope   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 79y.o. male with past medical history of dementia, diabetes, and hypertension who presents to the ED via EMS for concern of coronavirus.  Per EMS run sheet, squad found patient over toilet coughing, with 2 other family members with him who recently tested positive for Covid.  Patient had not tested for Covid yet.  Patient is a poor historian and states that his symptoms have been chills, as well as loss of consciousness-approximately "half a dozen times".  He is unable to characterize the events leading up to his loss of consciousness or what he was doing at the time of these events.  He denies any fevers, cough, sore throat, chest pain, shortness of breath, wheezing, palpitations, abdominal pain, nausea, vomiting, constipation, weakness in arms or legs.  He endorses 1 month history of diarrhea.
per pt received first dose of pfizer on 12/12 and had severe menstrual bleeding for 2 weeks and fatigued symptoms
had the shot and has Shingles right now.\ suspected vaccination failure; has Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's cousin. The age at vaccination was not reported. The reporter stated the patient had Shingles shot and had Shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Moderna COVID Vaccine EUA  Pt received Dose 1 of Moderna vaccine 3/18/21. Developed symptoms 3/25/21. Presented to ED 3/28/21.  3/28/21: 65-year-old female with past medical history of hypertension, hyperlipidemia, and type 2 diabetes mellitus presented to ER with complaints of shortness of breath. Per patient she received her 1st COVID-19 vaccination last Thursday. Since Monday the patient has felt "unwell." Three days ago she started having shortness of breath which has progressively worsened, especially with exertion. She has developed increased fatigue, cough, nausea and decreased appetite. Denies chest pain. No vomiting or diarrhea. On arrival to ED patient she had a low-grade fever and was hypoxic at 87% on room air. Supplemental oxygen with 2 L NC with improvement in oxygenation saturation to 94%. Laboratory findings were significant for hypokalemia 3.0, transaminitis ALT 55, AST 44. COVID positive. Chest x-ray revealed bilateral airspace disease with obscured pulmonary vasculature. Favored to represent pneumonia over heart failure.  EKG normal sinus rhythm, rate 74, QTC 472. Patient was given IV fluid resuscitation with NS 3 L bolus. Potassium 60 mEq p.o. given.  IV Rocephin was initiated and DuoNeb treatment given in ER.  4/2/21: Pt received remdesivir, convalescent plasma, ceftriaxone, doxycycline, dexamethasone, vitamin C, zinc sulfate. Patient discharged on doxycycline course, PO zinc and vitamin C, supplemental oxygen. Instructed to follow up with PCP in 3-5 days.
Mother reports that approximately six hours post immunization, patient became limp & grey. Paramedics were called, patient taken to Hospital, received oxygen en route. Discharged from ER, no intervention.
First dose on 2/6/21 - Intense pain on injection site of left arm on first two days. Abated after 5-6 days. No other symptoms detected. Second dose on 3/6/21 - Pain on injection site of right arm. Abated after 5-6 days.  Additional symptoms includes:  - Axillary swelling and tenderness of lymph node on vaccine arm. Almost gone 3/16/21 (10 days).  - Very mild fever and fatigue on first day. Did not take temperature. -  Itchy skin hives and rashes on arms (more on vaccine arm), chest, back, waist, and thighs started about fifth or sixth day after vaccination.  Itchy hives and rashes are slowly abating as of today (5th day).  Am trying not to scratch them. Not taking medication for it.
Local reaction injection site measuring 5x5 in diameter, red, swollen. Pt personal MD did evaluate.
pt recvd vax 1MAR94 & on 2MAR @ 1AM had fever of 102, nausea & vomiting; later that day, fever to 103.4 & sl warm, tender inj site; seen by MD; given APAP; 3MAR 8AM pt afeb; pt recovered;
This spontaneous report as received from a nurse practitioner via pharmacist refers to a 58 year old female patient. The patient's relevant medical history included being healthy. She had no relevant concomitant medications or past drug history. On 25-APR-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (reported lot# J013556), dose: 0.1 mg, intradermally instead of MANTOUX TB SKIN TEST made by Sanofi Pasteur. On 25-APR-2015, the nurse practitioner checked the patient's arm 10 minutes after she received the PNEUMOVAX 23 and she did not see any symptoms. It was unknown if any relevant lab work had been done. As of 25-APR-2015, it was unknown if the patient will receive PNEUMOVAX 23. The nurse was unable to find where the PNEUMOVAX 23 was administered. The outcome of patient's event was not reported. Additional information has been requested.
Started with fever, headache, body aches, chills, exhaustion, malaise (week long). Then severe yeast infection (following 5-10 days). Extreme malaise continued. Put on Bactrim and anti yeast pill. End of week 2, 10 lymphnodes around base of head and behind ears were large and painful. These lasted 5-7 days. Shortness of breath. Pt. missed 3 weeks of school.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # M025193, expiration date: 21-MAR-2019, (dose number, route and anatomical location of administration were unknown). The temperature excursion reported was: 51.3 F for 40 minutes. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt developed a small, round, red, irritated spot on his left arm which he states is exactly at the injection site. The patient states that it is not itchy but is sometimes painful. He states that it developed within day of his injection and has persisted despite OTC antibiotic treatment. He is now going to see a dermatologist to get it evaluated.
One of my nurses drew up the syringe with the vaccine that she mixed.  After the administration, was noted that she did not add the appropriate amount of diluent.  I did not catch the error until after the shot was given.