chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea began two days after first shot (4/23/21) and has continued for 6 weeks (today is 6/11/21).  I did not report it as it was one of the side effects listed to be expected.  But the diarrhea continued to be chronic and I was advised by my Primary Doctor's phlebotomist to report the incident after a routine lab bloodraw.
Headache  Narrative: Employee reported headache x 2 days following both 1st and 2nd in series vaccination. Resulted in unable to work 12/20/2021.
No adverse reaction to the first dose. With the second dose - large area of redness around the injection site. Large knot in my left armpit that is very painful to the touch.
I had a very mild soreness on my right jaw at about 10 mins about my shot.
Had vaccine August 12. On 13th developed breast tenderness, cough, congestion, fatigue, shortness of breath, aching, chest pain "elephant sitting on my chest" used to describe. Seen in the office. lungs clear. oxygen saturation 100%. appearance was quite ill. Vitals were stable though. Advised go to ER for evaluation. Did not want to go. Obtained EKG which was normal. ordered labs: CBC, CMP, ESR, CRP, D-dimer, Troponin.
Experienced an extremely irregular menstrual cycle following the first vaccine dose and continuing beyond the second dose, including increased feelings of depression and anxiety, and excessive cramping and bleeding. Also a noticable shift in the cycle days has occurred since receiving the first dose. In particular, my ovulation days occurred immediately following the end of menstruation (days 6-10) rather than on days 14-18 (which is normal for me). These irregular symptoms is why I am submitting this form as they may be related to the vaccine. Continuing to monitor via menstrual tracking app that I've used for years.
Had a very small amount of poison oak on left wrist at time of shot. Few days after shot the poison oak morphed into a very disturbing looking dark crater with white haze over it and had become most likely cellulitis that required antibiotics
Around 24 hours after vaccine, a rash started on stomach and thighs. Next morning, rash was bright red, hot to touch, and spread to under arms, arms, and chest. Went to an urgent care facility, was giving a steroid shot of methylprednisolone sodium succ. Prescribed a 6 day dose of Prednisone starting the following day,   Rash did not show improvement for 24 hours after methylprednisolone injection, but started recede after. Still on going.
My left arm was red, hot, raised and itchy.  It is 3 days, and it is better, but still a little red, hot and itchy.
pt felt dizzy the morning he went to the ED, instead of going to hemodialysis; found to be hypotensive with hypoxia - O2 saturation 85% on RA; pt is positive for COVID; productive cough with congestion; COVID pneumonia; given ABX, Decadron, Albuterol, O2 supplementation; septic; pt's condition worsened; DNR/DNI; transitioned to comfort care; passed away in the hospital;
I developed a hissing and ringing in both ears and was diagnosed with tinnitus; I developed a hissing and ringing in both ears; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2021 13:00 (Lot number: el3249) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 301ssba, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 11Jan2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 12Apr2021, outcome "not recovered", described as "I developed a hissing and ringing in both ears and was diagnosed with tinnitus"; TINNITUS (non-serious) with onset 12Apr2021, outcome "not recovered", described as "I developed a hissing and ringing in both ears". The events "i developed a hissing and ringing in both ears and was diagnosed with tinnitus" and "i developed a hissing and ringing in both ears" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, tinnitus.  Additional information: Medical qualification reporter: Other Health Professional. If other vaccine in four weeks: No. Other medications in two weeks: Yes. If COVID prior vaccination: No. Known allergies: Yes. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
Patient has no symptoms related to the injection, the adverse event its a error on administration. Patient comes to the clinic for his 3rd dose (1rst booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine, the administered vaccine doesn't present any previous temperature excursion or any related problems.
The injection site is very hot to the touch. It seems hard/swollen - about 4 inches in diameter. Very sore. Face and ears and arm are all hot to the touch. VERY itchy, but a painful itch- in various parts of my body. Almost like shingles. Arm; upper left chest; under arm/side of body; left side of neck; both firearms; near hips; back of knees. Just very random, but painful itching. Low grade fever of 99.8 (just checked it at 6:00).
PNEUMOVAX severe redness other side of arm from injection site, myalgias diffuse, exhaustion 5/9/18. SHINGRIX 2nd dose tactile fever and chills lasting over 24 hours 4/13/18.
Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial did not went under any temperature excursion.   Treatment information was not provided by the reporter.
Itching, red, hard at injection site. Patient also complained of headache and nausea.
Development of MIS-C with COVID like symptoms developing on 11/27/21 and MIS-C symptoms (multi system involvement ) beginning on 12/2/21). Respiratory, Gastrointestinal, dermatologic, and neurologic symptoms reported, starting with fever vomiting, diarrhea, rash, and neck stiffness.
Swollen glands in cheeks, neck and throat. Every joint in my body aches. Very painful to move. Extreme tiredness and lethargic. Fever (not over 102). Irritability level high.
experienced an improvement in her arthritis pain in her shoulder; This is a spontaneous report from a contactable consumer via a Pfizer Sales Representative. A female patient (reporter's mother-in-law) of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at a single dose for COVID-19 immunization. Medical history included arthritis pain in her shoulder. Concomitant medications were not reported. The reporter's mother-in-law received the first dose of the Pfizer Covid vaccine and experienced an improvement in her arthritis pain in her shoulder. The outcome of the event was unknown.  No follow-up attempts are needed, no further information is expected. Information about lot/batch number cannot be obtained.
Sore arm; Within 3 minutes an unusual taste in her mouth; Sensation of adrenaline rush for about 40 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), TASTE DISORDER (Within 3 minutes an unusual taste in her mouth) and EPINEPHRINE INCREASED (Sensation of adrenaline rush for about 40 minutes) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), TASTE DISORDER (Within 3 minutes an unusual taste in her mouth) and EPINEPHRINE INCREASED (Sensation of adrenaline rush for about 40 minutes). At the time of the report, PAIN IN EXTREMITY (Sore arm), TASTE DISORDER (Within 3 minutes an unusual taste in her mouth) and EPINEPHRINE INCREASED (Sensation of adrenaline rush for about 40 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache, Myalgia, Arthralgia,  stiffness and unable to sleep Narrative:   Other Relevant History:
Information has been received from a health professional concerning a 14 year old female who was vaccinated intramuscularly with her first dose of Gardasil vaccine. Subsequently, the patient experienced flu-like symptoms, fever, vomiting, nausea and body aches for 10 days. The nurse practitioner reported that the patient also experienced flu like symptoms, fever, vomiting, nausea and body aches for about 4-5 days after receiving the second dose of Gardasil vaccine intramuscularly. The patient sought unspecified medical treatment. Additional information has been requested.
4-5 days of a tingling sensation, chest tightness (mild, intermittent) post vaccination.   Generalized macular rash on chest/back. Denies any shortness of breath or swelling.  Vitals stable and within normal limits.
Afibrile with flu office visit - fever, erythema, edema, localized tenderness and induration.  Given Celestone 6 mg IM on 8/22/08.  Still symptomatic thoughts afebrile on 8/25.  Given Medrol dose pak.
Patient received a higher concentration of the Covid vaccine than intended.  Parent of patient reported a sore arm and some trouble sleeping on the arm.  Patient was well enough to go to school.
This is a spontaneous report from a contactable consumer or other non-HCP. A 59-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection batch/lot# EW0150), via an unspecified route of administration, administered in left arm, on Apr 12, 2021, 13:45, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medication(s) included tamoxifen. The patient previously took prednisone and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID-19. Reportedly, patient tested negative for COVID-19 3 days before receiving the vaccine and then tested positive for COVID-19 2 days after receiving the vaccine on Apr 14, 2021, with outcome of recovering. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative on Apr 9, 2021; and SARS-CoV-2 test: positive on Apr 14, 2021. No follow-up attempts possible. No further information expected.
pt recvd vax; w/ 20 min of vax pt devel hives around neck, shortness of breath & heaviness in her chest ;
a sore throat; runny nose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (a sore throat) and RHINORRHOEA (runny nose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (a sore throat) and RHINORRHOEA (runny nose). At the time of the report, OROPHARYNGEAL PAIN (a sore throat) and RHINORRHOEA (runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Fever 100.8 Chills Head Ache. Tylenol 325mg 2T PO q4-6hrs for fever. Rest.
Cellulitis Rt knee, warm to touch. Treatment with Keflex 125mg/5ml & Motrin Susp. 100mg/5ml on 2/1/06.
The first episode - 03:00 am - waking up and the room started going around. Nothing else was going on. I have an apple watch and all the numbers were fine. I felt a little off balance after waking the next morning. I called an Urgent Care that was going to come out 02:15-04:15 - but at 03:45, I was reading a book on the iPad and all of a sudden the whole room was spinning, I started vomiting, I couldn't get out of the chair due to my balance. We called 9/1/1 and all vitals were fine. They took me in though to Hospital - I couldn't walk so that is why I had them take me in. The doctor at ER said there was a bunch of wax in my ear and he thought it was causing the problem. They put some drops in the ear. And after about 10 minutes, my hearing went out and then they took a metal thing and dug the wax out - there was a lot of wax. I was still having some walking problems when they discharged me. Said it was normal, and I threw up once more time when I got home. Next morning, I didn't feel the greatest but by noon time I started feeling normal again. I have never had an issue too much ear wax ever before. I will see an ENT doctor soon (on the 22nd of this month) to see what is going on. I know within the last year, a doctor has looked in my ear and has not said anything. In the ambulance, they gave me something in IV to stop the vomiting.  They gave me a pill while in ER but I'm not sure what it was - maybe to stop the vertigo. I brought some ear drops home to use for four days, twice a day - Najar - something to dissolve ear wax. It wasn't a prescription. I can walk my couple of mile walk without getting vertigo. I have had a couple of times when I am lying down and the room starts spinning a little so I'll talk to the ENT doctor about that. I did go to my Primary Care doctor for follow up and she had looked in my ears and said everything was fine - Tuesday, the 12th.
This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing), notes: other medical history: GERD. Concomitant medication(s) included: CLARITIN [LORATADINE], start date: 22Aug2022, stop date: 02Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after testing negative for three days in a row; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient received Paxlovid as a treatment of COVID-19 from 23Aug2022 to 28Aug2022. It was reported that on 02Sep2022 worsening symptoms 4 days after finishing Paxlovid and after testing negative for three days in a row. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case narrative, a causal association between reported events vaccination failure, Covid 19 and suspect BNT162B2 cannot be excluded.
Tachycardia and shaky 5-10 min post vaccine. Approximately 30 min post vaccine same S/S plus flushed,  feeling feverish and Headache.  2 hrs post in addition to all the above body aches, fever 102.0, abdominal pain, diarrhea. Today still feeling  the same including injection site pain, swelling and erythema.
Fever; chills; total body joint pain; This is a spontaneous report from a contactable Nurse, the patient. A 59-years-old non-pregnant female patient received the first dose of bnt162b2 (BNT162B2, Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 26Feb2021 10:00 (at the age of 59-years-old) as a single dose for covid-19 immunization. Medical history included ESRD hypothyroidism, hyperparathyroidism. The patient previously took and had allergies with latex, gaseoflatex plus, stadol, trimethoprim, noroxin and progesterones. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021 07:15, the patient experienced fever, chills, total body joint pain and treated with Tylenol, pain medication. Outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included varicella zoster virus vaccine, live, oka strain (Zostavax) for shingles.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Zostavax at an unknown dose and frequency. On an unknown date, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: On an unspecified date, in August or September 2018, the patient had Shingrix vaccine and 3 weeks later had another, very mild, shingles outbreak. The emergency room visit was required. It was unknown if the reporter considered the shingles to be related to Zostavax as well. The reporter consented to health care professionals for follow-up.
When injecting the vaccine into the right deltoid, the vaccine ran down the patient's right arm.  It wasn't possible to know the amount of vaccine that was received vs the amount of vaccine that was wasted.  The patient was advised to receive another dose.  She preferred not to receive the second dose in her left arm because per her self report she got "COVID arm" in her left arm after her first dose, so she received the second dose in the right arm an inch from the original site.
This spontaneous case reported by a patient's family member or friend, describes the occurrence of decreased mobility (doesn't feel like getting up to move about), pyrexia (temperature of 101.5ºF) and fatigue in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 8, 2022, patient experienced decreased mobility (doesn't feel like getting up to move about), pyrexia (he has a temperature of 101.5ºF) and fatigue. At the time of the report, decreased mobility (doesn't feel like getting up to move about), pyrexia (temperature of 101.5ºF) and fatigue outcome: unknown. Diagnostic results: Jun 8, 2022, body temperature: 101.5 (high) 101.5ºF. The action taken with mRNA-1273 (Moderna COVID-19 vaccine); intramuscular: unknown. No concomitant medication or treatment information reported.
Reaction began with a headache, hives surrounding the injection site,  and arm soreness 1 week after receiving the vaccine. Within 12 hours of the initial symptoms additional symptoms of muscle soreness, fatigue, low appetite, and low-grade fever developed. All of these symptoms lasted for 5 days.
Cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case  received from a consumer/non-hcp via public post.  This case involves patient of unknown demographics who experienced cardiac arrest while 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 at (unknown: formulation, strength, dosage, route, frequency, lot number, administration site) for prophylactic vaccination. Information on the batch number was requested.  On an unknown onset and unspecified latency, the patient developed a serious cardiac arrest following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (Cardiac arrest).  At time of reporting, the outcome was Unknown for the event cardiac arrest.; Sender's Comments: Sanofi Company Comment dated 27-Jan-2022: This case involves patient who experienced cardiac arrest while receiving vaccine Influenza Vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.