chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHAKING UNCONTROLLABLY; FULL BODY ACHES EVERY WHERE, FEET, KNEES, SHOULDERS; SWOLLEN EYES; CHILLS; TERRIBLE HEADACHE; FEVER; This spontaneous report received from a consumer via a company representative concerned a patient 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-APR-2021, the subject experienced shaking uncontrollably. On 12-APR-2021, the subject experienced full body aches every where, feet, knees, shoulders. On 12-APR-2021, the subject experienced swollen eyes. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced terrible headache. On 12-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from terrible headache, chills, shaking uncontrollably, fever, full body aches every where, feet, knees, shoulders, and swollen eyes. This report was non-serious.
Patient stated the day after her vaccination, she experienced a burning sensation in her body on the side she received the vaccination. She stated she had extreme arm pain where she could not lift her arm. She stated she experienced extreme swelling from elbow to shoulder on the arm she was vaccinated in. Her swelling subsided some but was still present today.
Over a week after injection, the site is still red, warm and itchy. At injection, it was very painful. I expected the warmth and itchiness to go away, but it hasn't.
I was giddy and giggling; Thought process was delayed / slight delay in standard processing; racing thoughts; Reaction was similar to being drunk or high; Reaction was similar to being drunk or high; At first, I was giddy and giggling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17May2021 14:45 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "I was giddy and giggling"; BRADYPHRENIA (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "Thought process was delayed / slight delay in standard processing"; TACHYPHRENIA (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "racing thoughts"; EUPHORIC MOOD (non-serious), FEELING DRUNK (non-serious) all with onset 17May2021 15:15, outcome "recovered" (2021) and all described as "Reaction was similar to being drunk or high"; INAPPROPRIATE AFFECT (non-serious) with onset 17May2021 15:15, outcome "recovered" (2021), described as "At first, I was giddy and giggling". Therapeutic measures were not taken as a result of dizziness, bradyphrenia, tachyphrenia, euphoric mood, feeling drunk, inappropriate affect.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reaction the patient experienced was similar to being drunk or high. At first, the patient was giddy and giggling. Thought process was delayed. By end of evening, was having racing thoughts. Next day, still slight delay in standard processing. Just wanted to report, so others with similar experience aren't surprised.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 30 hours later (next day), noted his Apple watch showed HR to be around 120's, he was essentially asymptomatic. Waited for 1 hr, spoke with colleague, where a decision was made to bring him to ED for monitoring. Had overnight stay in ED with spontaneous resolution of his tachycardia, elevated BP and had in hospital work up and discharged at 0920 hrs on 01/22/21.
Had PPD (R) forearm and Tdap (R) deltoid with (R) deltoid hematoma, fever / pruritus. (L)UE lymphadenopathy, increased erythema / swelling / fever/ pruritus / pain / sore throat, facial flushing, arthralgia.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/20/2021 and 02/10/2021. They presented to Emergency Department on 10/07/2021 with a primary complaint of chest pain. They were evaluated and discharged back to the nursing home at which they were a resident without being admitted to hospital. They tested positive twice on 10/11/2021 via antigen test at the nursing home at which they were a resident. They were hospitalized briefly on 10/14/2021 (admitted and discharge dates are the same day). The individual died on 10/16/2021.
achy; little diarrhea; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unknown age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 19Jan2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient got the first dose on 19Jan2021  (last Tuesday) and now (22Jan2021) experienced little diarrhea and achy.  Outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Unexplained syncopal episode with acute respiratory arrest. Was taken to ER by EMS, placed on ventilator and in ICU.
Basically I went into Afib, it happened Friday a few hours after I got the vaccine. Then it happened again at 5:15am this morning, and I am still in afib right now, I just checked and my heart rate is at 117. When I checked it Friday, it was about 120. Normally my medication controls that, but it's not doing it now. It just seems odd that I had the vaccine on Friday and now I am getting afib.
arm numbness, lightheadedness, vomiting. Evaluated by EMS-Cleared
Became ill, dysfunctional, unable to successfully perform duties. Dx-w/brain disorder (bi-poplar), but he believes it was caused by anthrax shot.60 day follow-up the pt also experienced CFS, skin disorder, digestive problems, joint pain and severe muscle spasm.
This spontaneous case was reported by a patient and describes the occurrence of the second episode of DIZZINESS, the second episode of INFLAMMATION, the second episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, and the second episode of MYALGIA (January 2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection in January 2021.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On 04-Mar-2021, the patient experienced CHILLS, the first episode of DIZZINESS, the first episode of INFLAMMATION, the first episode of BLOOD PRESSURE INCREASED, HEART RATE ABNORMAL, and the first episode of MYALGIA. On 06-Apr-2021, the patient experienced the second episode of DIZZINESS, the second episode of INFLAMMATION, the second episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, the second episode of MYALGIA, HEADACHE, VAGINAL HAEMORRHAGE, EPISTAXIS, and DYSKINESIA. At the time of the report, last episode of DIZZINESS, the last episode of INFLAMMATION, the last episode of BLOOD PRESSURE INCREASED, HEART RATE INCREASED, the last episode of MYALGIA, HEADACHE, VAGINAL HAEMORRHAGE, EPISTAXIS, DYSKINESIA, CHILLS, and HEART RATE ABNORMAL outcome was unknown. Not Provided.          The patient received the 1st dose of the vaccine on 04-Mar-2021 in her right arm and she had dizziness, her whole body, hand, and feet inflammation, chills, elevated blood pressure, elevated heartrate to 110, general head and body pain like when she had Covid in January 2021. The patient received the 2nd dose of the vaccine on 06-Apr-2021 in her left arm. That same night she started to have dizziness, her whole body, hand, and feet inflammation, elevated blood pressure, elevated heartrate to 110, general head and body pain like when she had Covid in January 2021. On Wed 07-Apr-2021 she had vaginal and nose bleeding and also involuntary movements on her left thumb.   This case was linked to US-MODERNATX, INC.-MOD-2021-071186. Sender's Comments:  US-MODERNATX, INC-MOD-2021-071186. Case for first dose.
Racing and pounding heart; Feeling out of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 14:30 (Lot number: FK5618) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D [COLECALCIFEROL]; MOTRIN [IBUPROFEN]. Past drug history included: Flu vaccine, reaction(s): "Had allergy", notes: Had allergy to flu vaccine previously. The following information was reported: PALPITATIONS (non-serious) with onset 17Nov2021 19:45, outcome "unknown", described as "Racing and pounding heart"; DYSPNOEA (non-serious) with onset 17Nov2021 19:45, outcome "unknown", described as "Feeling out of breath". It was unknown if therapeutic measures were taken as a result of palpitations, dyspnoea. No follow-up attempts are possible. No further information is expected.  Follow-up (22Dec2021): Follow-up attempts completed. No further information expected.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Patient is fully vaccinated. Hospitalized 12/26/2021 and COVID +. Admission dx: hypoxia and COVID 19. 65y.o. male with a past medical history of Hepatitis C, liver transplant, DM, HTN presenting for hypoglycemia. Patient states that he his friends noticed that he was pale, and were worried about him, and called EMS. He reportedly had a glucose in the 50s on EMS arrival, He  states that he has been eating and drinking well.  Patient notes that he has been experiencing dyspnea at rest over the past week. In the ED,vitals were significant SpO2 of 80% on room air. He was placed on 15L non-rebreather with improvement in saturations.AKI (1.81). DVT Prophylaxis: Lovenox Imaging:  Diffuse patchy airspace/interstitial opacities. Acute Hypoxic Respiratory Failure secondary to COVID Pneumonia.  Treatment: oxygen, lovenox, decadron, remdesivir. Discharged.
A 42-year-old male patient, with no illness at the time of vaccination, had received a first dose, right deltoid, intramuscular injection of MENACTRA, lot U2558AA, on 08 February 2008. Twelve hours post-vaccination, the patient developed a fever of 100.0 degrees Fahrenheit. Two days following vaccination, the patient noticed edema and tenderness of the right axilla. The patient was treated with MOTRIN. The event did not require medical examination. At the time of this report, the patient had recovered. Follow-up information received on 12 February 2008 from a health care professional. Per the reporter, there was no additional information concerning the tetanus vaccine that was administered ten years prior by the patient's family physician. Additional information was not provided.
Pt recieved the vaccine and minutes later developed itching in her throat and ears. Pt recieved benadryl en route. At the hospital pt was also given Prednisone 40mg. Patient significantly improved and was discharged home.
on the back part on my back/shoulder pain/My pain was pertaining to my back and spine; tingling; This is a spontaneous report received from a contactable consumer or other non hcp. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on unspecified date on her left side, "started having problems like on the back part on my back/shoulder pain there and thought maybe it will go away but it ended up going across my top of my back and tingling." It was reported that pain was pertaining to my back and spine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 10 hours after getting the 2nd dose, I started getting chills that lasted about an hour or two. I went to bed early and woke up soon after feeling feverish and achy all over.  I could not sleep well, and when I got out of bed in the morning I had a throbbing headache. For most of the next day I just wanted to lay around and didn't feel well. It took about 34 hours after getting the injection until I started feeling back to normal. My right arm was very sore for about two days. On the first night I could barely lift my arm. I also developed a slight red rash at the injection site and the area was noticeably more swollen. The rash and swelling went down by the third day after injection.
On the day of the injection, within a few hours I had some mild symptoms like light-headedness (head rush when I stood up), and slight fatigue. It was the next day, more than 24 hours after the injection that symptoms became more intense. At that point I developed a bad headache with moderate nausea, as well as significant fatigue, and a little bit of runny nose. Now it is over 40 hours since the injection and my headache is not as bad, but I still do have a headache and mild fatigue.
arm tender, hard knot, warm, rash 8 days after dose. Used ice and ibuprofen
Rec immun 28FEB91 @ 230PM; 28FEB during night ?time p/midnight began hard screaming cry lasting 2-2 1/2 hrs, temp 100-101F(ax) vomited 4-5 times; To ER 9AM 1MAR91 no tx temp down to 99F rectally;
2/6/22 10:50 received vaccine     5pm started with severe tight thoracic spasms 2/7/22  am   fever 101-103 (took advil/abuprofin for relief) 2/8/22 am  headache           pm vivid nightmares 2/9/22  pm visual disturbances , 3D Color images, hallucinations, lasted around an hour
Sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L208 and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve disease (medical history: microvalave disorder). Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient was using blood pressure pills and cholesterol pills as a concomitant medication for an unknown indications.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-016692, MOD-2021-016692 (Patient Link).
Mom reported a few days of upper respiratory symptoms, and per mom states he was pretty sick. He also received his Tdap at the same time.
Detailed Email from patient: 12/22/20 @ 4:30 PM: tingling sensation around jaw area, working up to cheeks and around side of eyes, lasting a few hrs., but lessening in intensity at bedtime at 9:30 PM; same funny feeling on upper cheeks & sides of eyes, lasting all day. Felt swollen but didn't appear swollen; 11:30 PM: awakened by chest discomfort, possibly anxiety. Had diarrhea, shaky/weak muscles and sweaty chills. 12/23/20 @ 12:45 AM, 1:45 AM: diarrhea, shaky/weak muscles & chills continued until 4 AM.  6:00 AM: Nausea lasted until 1 PM; Lips slightly swollen, lasting 2 hrs but no breathing issues;  5:30 PM: GI issues resolving but fatigued;  8 PM: GI issues return with heartburn, muscle aches and nausea. CONT
For the past two weeks, left side has been hurting (off and on). There's a pain in my neck and shoulder. Recently, it has become difficult to lift my left arm past a certain point (mid-body). Sometimes, left arm feels hot. It feels like someone is sticking something in my back near shoulder area and along neck.
NOT REALLY AN ADVERSE EVENT. THE PATIENT HAS A TRIP  PLANNED AND WITH RECENT CHANGES TO COVID-19 GUIDANCE, SHE WANTED TO BE "FULLY VACCINATED" FOR HER VACATION. THE PATIENT SCHEDULED AN APPOINTMENT FOR MAY 18TH, 2021 FOR A JOHNSON &JOHNSON VACCINE SO SHE WOULD MEET THE REQUIREMENTS OF BENIG "FULLY VACCINATED" FOR HER TRIP. THE PATIENT STATED THAT SHE HAD NOT RECEIVED A COVID-19 VACCINE IN THE PAST, SHE ALSO DID NOT DISCLOSE HER MODERNA VACCINE WHEN QUESTIONS ABOUT VACCINES RECEIVED IN LAST FOUR WEEKS, SO THE J&J VACCINE WAS ADMINISTERED. THE ORIGINAL MODERNA VACCINE (ADMINISTERED ON APRIL 29) WAS NOTICED WHEN THE BILLING CLAIM WAS REJECTED FOR THE JOHNSON&JOHNSON VACCINE.   WHEN THE PATIENT WAS QUESTIONED ABOUT GETTING THE J&J VACCINE AFTER RECEIVED A DOSE OF THE MODERNA VACCINE, SHE STATED THAT SHE WANTED TO BE CONSIDERED FULLY VACCINATED AT THE BEGINNING OF HER TRIP AND SHE HAD DONE A LOT OF RESEARCH AND IS NOT CONCERNED ABOUT REACTIONS/ADVERSE EVENTS AS A RESULT OF RECEIVING THE J&J VACCINE AFTER RECEIVING THE FIRST DOSE OF THE MODERNA VACCINE.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient who on 23-DEC-2009 was vaccinated with the first dose of GARDASIL (lot# 0669Y). It was reported that the patient might have been pregnant when she was given the first dose of GARDASIL. No other doses had been given to the patient. The nurse stated the patient had no adverse reactions but did go to the Emergency Room for vomiting in February 2010. The patient was not admitted to hospital. At the time of the report, the patient's status was unknown. The patient's last menstrual period was 13-DEC-2009. The estimated delivery date was 19-SEP-2010. Additional information has been requested. The patient went to Emergency Room at medical center.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent condition or medical history were reported. On an unknown date, unspecified number of patients were vaccinated with a dose of VAQTA (lot number, Expiry date, dose and route were not reported) that underwent temperature excursion. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent for follow up.
Numbness in left arm. Person left under his own will after 10 minutes of further observation
Patient received 2nd dose of Pfizer vaccine only 2 weeks after 1st dose
43 yo female with 1 day h/o nausea, diarrhea X 2, melena
I had lost control of my bladder not completely but enough/incontinence; After the day and half the covid symptoms came back; This is a spontaneous report from a contactable consumer (the patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) via an unspecified route of administration on 23Feb2021 at age of 77-year-old at single dose for COVID-19 immunisation. Medical history included COVID-19 from 17Dec2020. The patient had no concomitant medications (reported as "no other products"). The patient had COVID, 17Dec2020 her system started and then about 90 days later she had the Pfizer vaccine and then had Pfizer vaccine again and it was been a while since it is been over two weeks what she had COVID. She had lost control of her bladder, not completely but enough so that she had to change her pajamas bottoms quite often. When she had first Pfizer shot about day and half she had the same problem. The patient's doctor often said that incontinence was not symptom of COVID but it might was. it was just after the shot. The patient had COVID symptoms started in 17Dec2020 and lasted for about 2 or 3 weeks. She had experience of COVID. Her experience of COVID was incontinence not all the time but particularly night and when she have first Pfizer shot about 3 months later after the day and half the COVID symptoms came back including the incontinence. No treatment received for the events. No investigation assessment. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient was given three shots all in one day Fluvirin, Pneumovax and Shingles, on the site of injection of Pneumovax shot, she had a lump size 6 inches long and 4 inches wide which is red, swollen, hot and very painful.  She took Benadryl and the pharmacist advised her to take Ibuprofen and put Ice on the lesion.
soreness in the thumb joint; patient received 1 ml instead of 0.5 ml of the vaccine; A spontaneous report was received from a pharmacist concerning a 24-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental overdose  patient received 1 milliliter instead of 0.5 milliliter of the vaccine and arthralgia  soreness in the thumb joint.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the right arm intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient received 1 milliliter of the Moderna COVID-19 vaccine instead of the recommended 0.5 milliliters.  On 15 Jan 2021, the patient reported he had soreness in the right thumb.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, accidental overdose  patient received 1 milliliter instead of 0.5 milliliter of the vaccine, was considered resolved on 12 Jan 2021.  The outcome of the event, arthralgia  soreness in the thumb joint, was considered unknown.; Reporter's Comments: This case concerns a 24 year old male patient who experienced a  unexpected events of Accidental overdose and Arthralgia. The latter event occurred 3 days after first dose of the study medication administration.   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.
This was the booster: Thursday evening nausea started just as feeling a bit bad. Then 5am Friday morning I vomited from 5am to around 2pm with severe headaches. Some relief during evening. Didn't sleep well. Woke up Saturday morning vomiting again till afternoon. Headache persisted. After much Tylenol and cold rags it lifted about 3pm. Haven't had that violent of vomiting before.