chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unknown cause of death; Breakthrough COVID-19; This case was reported in a article and describes the occurrence of DEATH (Unknown cause of death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  REFERENCE: Increased mortality among persons with symptomatic coronavirus disease 2019 (COVID-19) during the period of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.617.2 (Delta Variant).    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 DEATH (Unknown cause of death) (seriousness criterion death) and BREAKTHROUGH COVID-19 (Breakthrough COVID-19). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, BREAKTHROUGH COVID-19 (Breakthrough COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEATH (Unknown cause of death) and BREAKTHROUGH COVID-19 (Breakthrough COVID-19) to be related.    Concomitant and treatment medications were not provided. Reported that delta period was associated with 2.43 fold higher odds of death.  Company comment: This study case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected fatal event of Death (reported as Unknown cause of death), unknown days after receiving an unspecified dose of mRNA-1273 vaccine. It was reported that the patient had a breakthrough COVID-19 infection on an unknown date. The cause of death was not known. No information on risk factors, detailed clinical course, autopsy findings and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked. Sender's Comments: This case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected fatal event of Death (reported as Unknown cause of death), unknown days after receiving an unspecified dose of mRNA-1273 vaccine. It was reported that the patient had a breakthrough COVID-19 infection on an unknown date. The cause of death was not known. No information on risk factors, detailed clinical course, autopsy findings and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-657781:This case refers cluster of 999 pts (breakthrough infections); Reported Cause(s) of Death: Unknown cause of death
Itching on back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching on back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PRURITUS (Itching on back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of UNK dosage form. At the time of the report, PRURITUS (Itching on back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax 2JUN95 arm very sore painful for 2 days then cleared up; 8JUN95 arm became swollen, red & very itchy, tender over most of upper arm but not into joint area; still visible on afternoon 9JUN95
Post vax, the pt developed redness and swelling at injection site. The child cried most of the day after injection. He had a fever of 102.9; by that evening-after multiple doses of Tylenol; he was weak and not as responsive as his norm. Pt recovered from acute reaction but has seizure disorder and autism.
After immunization administered, blood streamed out of injection site.  Applied cotton ball with pressure to stop bleeding, then applied bandaid.  After a few minutes Forrest complained of numbness and weakness in his arm.   Patient had PCP's nurse check his arm and stated, that the shot may have been administered a little low.  Encouraged to keep ice on the injection site and tylenol or ibuprofen for pain.
pain in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Blood disorder.  relevant concomitant products usage were not reported by the reporter.  No treatment information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (pain in the muscle). On 05-Mar-2021, MYALGIA (pain in the muscle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recvd vax 25MAR93 & 5 hrs p/vax devel a patchy red raised rash on neck & head; treated w/DPH;
Patient reports small rash that is boot shaped around injection site which is sore and itchy. Reported that when she ate imitation crab and tomato soup the site swelled and reddened more. She felt "wiped out" and called in sick to work. She did take Benadryl to help with itching which may contribute to her drowsiness. Reported feeling better today (10/07/2014) but still has a rash.
From what I am being told and Google, my lymph nodes in the armpit are swollen.  Quite scary to not know and not be able to reach anyone about it.  Aches and pains are a discomfort to say the least, but add a tennis ball size swollen mass under your arm pit and you get concerned.  You should have a 24/7 hotline or something or add this to your possible side effects at least.
Missed second dose of vaccine; Felt like I had flu; Really sick for 7 straight days; Chills; Fever; Vomiting; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine), INFLUENZA (Felt like I had flu), ILLNESS (Really sick for 7 straight days), CHILLS (Chills) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine), INFLUENZA (Felt like I had flu), ILLNESS (Really sick for 7 straight days), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine) had resolved and INFLUENZA (Felt like I had flu), ILLNESS (Really sick for 7 straight days), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-May-2021,contains significant information. Added Patient Demographics, Suspect drug details (Onset Date, Route), New Adverse Events are added. On 26-Jul-2021: Significant FU received - Information on dose 2 is updated
small painful skin eruptions on my lower right back, back of left leg and left rib cage.; increased dehydration; lips splitting; debilitating fatigue for over 6 days and counting; This is a spontaneous report from a contactable consumer (patient) from RA. This 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0151) via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. Medical history included chronic fatigue syndrome (CFS) from 2011 and unknown if ongoing, myalgic encephalomyelitis (ME) from 2011 and unknown if ongoing, and shingles from an unknown date and unknown if ongoing. The patient reported her CFS/ME was in remission since 2013 but seemed to have reactivated; she also suffered shingles many times. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included citalopram from an unknown date for an unknown indication. The patient previously received penicillin from an unknown date for an unknown indication; and the first dose of BNT162B2 (lot number EN6208) on 17Mar2021 at 11:30 for COVID-19 immunisation. The patient reported after her second shot, she got small painful skin eruptions on her lower right back, back of her left leg and left rib cage. She also reported increased dehydration and lip splitting. She stated that two weeks after the second shot, she experienced debilitating fatigue for over six days and counting. She stated she suffered CFS/ME for a year and a half in 2011; further reporting this felt like a reactivation of that virus in the herpes family. The clinical outcomes of small painful skin eruptions on her lower right back, back of left leg and left rib cage, increased dehydration, and lip splitting were unknown and the outcome of debilitating fatigue for over 6 days and counting was not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist concerning a patient who was vaccinated with PNEUMOVAX.  A nurse told the pharmacist that the patient had to go to an emergency room because the axillary lymph nodes were swollen.  At the time of this report, the outcome was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
NAUSEA, VOMITING, ABDOMINAL PAIN, FEVER(101F), RASH, ADENOPATHY, WEIGHT LOSS(5#), headache for 5 days
Patient was administered vaccine at approx. 9:00 AM within 3 minutes patient fainted. Patient was placed on the floor and within seconds gained consciousness. Emergency services were called to evaluate patient. They cleared patient and she left office with her mother.
schedule of vaccine; This spontaneous report was received from a medical assistant  and refers to a 15 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 25-SEP-2019, the patient was vaccinated with thefirst dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of 0.5 milliliter for prophylaxis. On 25-NOV-2019, the patient was vaccinated with thefirst dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of 0.5 milliliter for prophylaxis. Caller was requesting to know if patient will require a dose 3 related to the interval at which the previous doses were given.   2
purpuric hives approx 12-24 hr p/vax;also edema of hands & feet;Ibuprofen & DPH then atarax used;
Rash; redness; itching. Cortisone cream and Benadryl.  3 - 5 days.
Very similar symptoms to Renault?s syndrome. Pain and tingling in feet after exposure to cold water or ambient cold. It causes numbness and tingling in the extremities.
Patient called pharmacy saying arm was bruised, swollen, red  and was hot to the touch .
On routine blood test 11/4/10 she had a platelet count of 64. She followed up with another platelet count in which they had dropped. She is now under care of hematologist with a diagnosis of ITP. She is being treated with prednisone and follows up in 3 weeks.
This spontaneous report as received from a certified medical assistant (CMA), refers to a patient of unknown age and gender. On 22-AUG-2013 the patient was vaccinated with the third dose of GARDASIL (lot # H012973, exp date 05-MAR-2015) (0.5 ml, intramuscular) that was unsupported due to lack of in house stability data. Concomitant therapy was not reported. The reporter noted that his was the third and final dose in the vaccine series for the patient. This medical assistant was uncertain of the date for the start of the GARDASIL series. No adverse effect reported. Additional information has been requested.
pt brought to ED with c/o bright red blood from rectum after a BM in the morning; packed RBCs transfused; pt found to be positive for COVID; treatment for COVID given (specific tx not listed in medical records); pt showed improvement with COVID tx; O2 supplementation; pt developed ischemic bowel; pt decided on comfort measures; he passed away in the hospital
Blood pressure increased in the afternoon after the shot. Sever nausea and vomiting on Day two started at 1000 on January 5th. intense Headache lasted through January 7th requiring ice packs to my head and jaw. Unable to keep anything down, except slow sips of clear liquids. Vomiting lasted only 24 hours.
mom phoned & stated pt had h/a @ 8AM; This became severe by 4PM; pt also vomited once & had sore throat; pt felt better on 1JUN95 w/only a sl h/a; advised to see MD if sx persisted or worsened;
Patient had no reported side effects; was accidently administered to a patient intramuscularly instead of subcutaneously today.; vaccine administered to a 28-years-old patient; This spontaneous report was received from certified medical assistant and refers to a 28-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 05-AUG-2022, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant human albumin (rHA), 0.5 ml, lot # U006487, expiration date: 26-FEB-2023, administered intramuscularly for prophylaxis (strength, and route of administration were not provided) (incorrect route of product administration, product administered to patient of inappropriate age). Patient had no reported side effects (no adverse event).
Looks like it is spreading; hard; itchy where the shot was given; it is very red; Swollen; very painful; A spontaneous report was received from a nurse concerning a 47 years old female patient who received Moderna (mRNA-1273) vaccine and  arm became  red, swollen, itchy, painful, hard and looked like spreading.  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included lorazepam.  On 1 Feb 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in her right arm for prophylaxis of Covid-19 infection . On 8 Feb 2021, one week after receiving the vaccine, the vaccination site was red, swollen, itchy, and painful. The area was still  very hard, swollen, and very red. It looked like it was spreading. No lab data was provided.Treatment information included Allegra   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events red, swollen, itchy, painful, hard and looked like spreading were not recovered.
No adverse effects reported; received improperly stored ROTATEQ between 03-OCT-2019 and 28-OCT-2019; This spontaneous report as received from a Vaccine Coordinator refers to a 12 week old female patient.  The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.   On 28-OCT-2019 , the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (strength, frequency not provided) (lot #S000961 had been verified to be valid lot number; expiration date 19-OCT-2020) (product storage error). The  temperature  excursion was above 9 degrees Celsius (C) (0.6 C, multiple) for a time frame of 5 hours. There were no previous temperature excursion. It was reported that the call was due to data logger. No adverse effects were reported.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA016835:
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (19400, PFU, lot#, dose, route and frequency were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 1OCT98 & pt states arm began to hurt w/in a short time of adm then began to be red, swollen on large area of lt arm-had inc temp to 102 x 2 days;used ice packs & saw pt 5OCT98;advised not to take another Td d/t local rxn;
graves disease ...hyperthyroidism..rapid weight loss ..sweating profisely..rapid heart beat ...went to er and admitted to hospital with afib
Pt woke with tingling in the heel surface of his feet (bilateral).  No difficulty with ambulation or LE weakness.  On 3/9 pt noted additional tingling in his right calf.  Pt presented to ER; referred to hospital.  On 3/10/09 right calf and right foot tingling resolved.  On 3/11 when presented to hospital all sx had resolved. Symptoms:  Paresthesia
Patient received 3rd HPV vaccine and flu shot in right upper arm on 10/19/07. At time vaccine (HPV first) was given she experienced extreme pain described as a line down her arm into her thumb.   Patient asked employee to wait until the pain subsided some before giving the flu shot.  Flu shot was then given in same arm a couple of minutes later.  Over the course of the next few weeks, the pain somewhat subsided in the whole arm and was more above the elbow to the injection site.  The pain has been so extreme that it has woken the patient from sleep on 3 occasions. Returned to Dr on November 7, 2007 for an evaluation.  Dr. ordered shoulder xrays, physical therepy, 600 MG ibuprofin 3X a day until further notice and would consult with another doctor and be in touch about recommendations for further assessment. NOTE:parent observation of injection was that the  injection was given in a manner of puncture/poke like compared to more of a pushing the injection into the arm.  There was no 'squeezing' of the muscle/arm prior to injection. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a physician concerning a 17 year old female who on 20-NOV-2007 was vaccinated IM into his left deltoid with a first dose of GARDASIL (lot#655327/1287U). Within 15 minutes, the patient fainted and stopped breathing for a moment. It was reported that the patient sat for 15 minutes and when she walked into the waiting room she passed out for about a minute. The patient was conscious but not talking and clammy. After 10 minutes (approximately) of being monitored the patient became talkative and laughd about what happened with her mother. An ambulance was called but the patient was not admitted to the hospital. Unspecified medical attention was sought. On 20-NOV-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Right thigh - red area 5-6 cm diam. w/2 puncture points, received KINRIX & VARIVAX on 6/7/11, area is red, warm to touch & painful. Tx: warm compress & TYLENOL, F/u PRN.
Fever lasting 2 days,  large area red and swollen.  Very hot to touch and hard for the past 3 days.
Few minutes after vaccination, patient was observed by RN turning very, very pale; patient denied feeling faint or dizzy or nauseated, did not become cold or clammy; patient was made to keep head down between legs, vital signs taken at five minute intervals for approximately 20 minutes; when patient pinked up and blood pressure returned to normal, was discharged from clinic to the care of father.
Pt had syncopal episode while sitting chair.  Pt fell backwards, possibly hitting head on floor.  Pt was transported to UC for eval.
Loss of smell day after 2nd shot, maybe 70%-85% degraded from exceptionally acute sense of smell to nearly nil. [Also fever chills congestion loss of balance walking first night tho fine initial 12 hrs following 2nd M shot, no lymph gland swelling detected, yellow phlegm next morning, persistent hollow sore feeling head, kidney pain like severe dehydration first night. Previously in Feb 2020 sudden onset unfamiliar acute respiratory issues matching covid, passed in a day.] F 57 C A / H healthy but obese since gaining 60 lbs 11/19-3/20. Loss of smell following 2nd Emergency Auth Moderna shot seemed not yet visible online, but, rather, med researchers saying unlikely, journalists reporting it can't happen. But it did, to me. Another plausible explanation would be catching covid a few days ago priir to 2nd shot but I almost never leave the house and side effect onset and now taper seems to coincide w 2nd injection. After 1st injection, I felt like a super hero. After second starting 12 hrs later as tho knocked down. Loss of smell persisting as fever and chills and loss of balance ebb.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 74 years old female patient who experienced ache, diarrhea, sickness and feeling lousy, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Chemotherapy in 2012 and 2013. The patient's past medical treatment(s), vaccination(s) and family history were not provided. In 2015, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported). On an unknown date, the patient developed a non-serious achy, diarrhea, very sick and feeling lousy (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was illness, sickness, diarrhea and ache. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was reported as Unknown for all the events. List of document held by sender: None.
Two hives on my right side and itchy. Tired, sluggish and felt like I was getting a cold.
Itchy/tingling sensation of tongue. Swelling of face, lips and neck. Hives. Tingling and numbness throughout the arm of injection.