chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the Moderna Covid-19 Vaccine at 9:40 am, the patient reported to observation. Patient reported to the nurse that she " felt weird " with a warm flushing/tingling feeling in arms and chest. No redness or flushing noted . Patient stated that she had been anxious over the vaccination. Vitals : 9:57 133/95, HR 96, 02 98, 10:02 am 145/95 , HR 95, 02 97 , 10:07 am 144/84, HR 82, 02 98, 10:12 am 147/89, HR 76, 02 97, 10:17 am 144/88, HR 77, 02 97. By 10:12 am pt reported feeling better. Released to go home at 10:20 am with instructions to contact MD or ER if symtpoms return . Patient stated that she had taken her blood pressure medication in the AM.
08/17/2021 - The day of the vaccine I contributed having a hard time swallowing to mucous from previously having pneumonia. The next morning, 08/18/2021 when my throat was swollen, and it was hard to swallow. It was hard to swallow food or water or saliva. My head was swollen, and my ears were clogged. I had itchy hands, but I did not have a rash and me throat was itchy and swollen, and that concerned me to go to the emergency room. On 08/18/2021, I went to Hospital, they treated me with an EpiPen and an IV for Benadryl and Prednisone and prescribed me Prednisone to bring home. I was monitored for 4 hours. It's unknow it I have recovered from the AEs because my throat still swells now and then. I was prescribed an EpiPen.
patient said her doctor told her to come in and get a tetanus shot.  claim processed through the insurance.  After discussing shingrix with patient discovered she had an adacel dose in 7/2022
admitted for syncope. She was found to have covid and was treated for 5 days with remdesivir.  She was on heparin drip for intermediate VQ scan.  She had several episodes of bradycardia in the hospital. She had a subsequent short cardiac arrest that she was quickly resuscitated from and  Started on a dopamine drip.  She was taken for PPM and tolerated well. The last 2 days dopamine was titrated off however her blood pressure began to drop.  This morning she began to feel very ill and developed abdominal pain.  Workup was in process and she developed profound respiratory distress, bipap was placed and she subsequently vomited.  She was intubated and suctioned and cardiac arrested.  Cardiac resuscitation were attempted however despite all treatments, we were unable to obtain cardiac rythm.     TOD was 1157 Cause of death was not clear, suspect circulatory shock
Engerix B pediatric given to adult patient; Engerix B pediatric given to adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number SFB9RH, expiry date 21st January 2023) for prophylaxis.   On 28th January 2022, the patient received the 3rd dose of Engerix B pediatric. On 28th January 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The patient received Engerix B pediatric in left deltoid. The patient received a pediatric dose of the Engerix-B inadvertently, which led to underdose and adult use of a child product. The reporter consented to follow up.
Starting about 30 min after receiving the vaccine, I was driving back home and started having vertigo. I was trying to breath so I wouldn't have a panic attack. I made it to a fast food restaurant and sat in the parking lot and ordered a drink to try to see if the vertigo episode would pass because sometimes they pass on their own. I sat for about 30 min. Then, I drove straight home. Within a few hours of getting home, I started feeling very badly. My head hurt and I was nauseous, and I started eating ginger chews. When I became nauseous, with my pre-existing ulcers in my esophagus, I decided to take DRAMAMINE so that I would not go into full blown vomiting fits. I laid down and I was shivering badly. The shivering went on all night long. I started running a fever at some point. By the next day, the fever was about 102 and my head hurt really bad. I felt inflamed and a lot of pressure in my head. Also, I was more fatigued than usual. Also, I was having shooting stabbing pain all over my body that lasted for days. The fatigue was very bad and I didn't eat much. Also, I had a little bit of diarrhea. The fever started going down but lasted a couple of days. The chills lasted about a day, worse during the night but by the next night they were calming down. The head pain would go down my neck and my neck was hurting more/differently than usual (as if I was having more inflammation). I have had headaches that have fluctuated in intensity since then. They feel like pressure behind the sinuses and eyes, and overall inflammation in my head and in my neck. Sometimes I take decongestants even if I'm not congested to see if that helps take the pressure off my ears to prevent vertigo. It got really bad last week which is why I reached out to my doctor. I have had fatigue and I have been feeling more depression since getting the vaccine. Also, I had a swollen lymph node on the right side of my neck since receiving the vaccine, but it's gotten better. I am unable to take anti-inflammatories due to my ulcers. A few days ago, after the headaches got worse, I developed a cough and wheezing. I have been taking cough syrup and a decongestant to see if it would stop. I haven't felt right since the last shot. Also, I am more light sensitive than usual when my head hurts more. I feel worn out and winded.
Patient given third dose of Pfizer COVID vaccine. Unable to contact patient. Condition and side effects unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 91-year-old female patient who received SHINGRIX (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. Concomitant products included SHINGRIX. On 14th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information was reported as follows: On 18th July 2018, the patient received 1st dose of SHINGRIX. The patient received her second dose of SHINGRIX earlier than the recommended interval, which led to shortening of the vaccination schedule. No other side effects were reported.
First rotavirus/rv5 vaccine was ordered after 17 weeks of age and given. No adverse reaction noted to patient.
Fever, malaise, diffuse myalgia/arthralgia, injection site erythema and calor, ipsilateral axillary adenopathy.
itching at the injection site; blistering at the injection site; Initial information was received on 28-Jul-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a 45-year-old female patient who experienced itching at the injection site and blistering at the injection site, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On 27-Jul-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported via intramuscular route at an unknown administration site.  On an unknown date, the patient developed a non-serious itching at the injection site (injection site pruritus) and blistering at the injection site (injection site vesicles) (latency unknown) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.  Final diagnosis was injection site vesicles and injection site pruritus.  It was not reported if the patient received a corrective treatment.  The patient was reported as recovering from both events at the time of reporting.  There will be no information available on the batch number for this case.
This case was reported by a nurse to a sales representative and described the occurrence of pruritic hives in a 61 year old female patient who received hepatitis a inactivated and hepatitis b recombinant vaccine (Twinrix). On 07 April 2004, the patient received the first dose of Twinrix in the left arm. On 07 April 2004, the patient also received injections of Typhoid vaccine and poliomyelitis vaccine. At an unspecified time following administration of Twinrix, on 07 April 2004, the patient developed a "dime size hive area." The site of the hives were not specified. The hives resolved on 10 April 2004, the patient received the second dose of Twinrix. This represented a schedule of seven days between the first and second doses of Twinrix rather than the recommended schedule of one month between the  first two doses. At an unspecified time following the administration of the second dose of Twinrix, on 14 April 2004, the patient experienced "a six inch area of hives that did mildly itch." The site of the hives was not specified. The patient was seen at a physician's office and was treated with diphenhydramine. The events were unresolved. The immunization series with Twinrix was discontinued. The nurse considered the events to probably be related to vaccination with Twinrix.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        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.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-270272 (Patient Link).
heart started racing for a period of 4 hours; felt a little dizzy; fatigued the whole month; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart started racing for a period of 4 hours), DIZZINESS (felt a little dizzy) and FATIGUE (fatigued the whole month) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart started racing for a period of 4 hours), DIZZINESS (felt a little dizzy) and FATIGUE (fatigued the whole month). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart started racing for a period of 4 hours), DIZZINESS (felt a little dizzy) and FATIGUE (fatigued the whole month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
The pain has prevented me from performing my daily routine/ I have to have assistance with minor and major activities, such as getting dressed, holding objects; Soreness and pain has continued since the vaccination was given/ can't lay on my arm; Difficult to move; lack of sleep; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 02Feb2021 at 09:00 (Batch/Lot Number: EN6202) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included morniflumate (FLOMAX [MORNIFLUMATE]), vitamin d nos (VITAMIN D NOS) and tocopheryl acetate, ubidecarenone (COQ10 [TOCOPHERYL ACETATE;UBIDECARENONE]) all taken for unspecified indications, start and stop dates were not reported. The patient experienced the pain has prevented me from performing my daily routine/ I have to have assistance with minor and major activities, such as getting dressed, soreness and pain has continued since the vaccination was given/ can't lay on my arm, difficult to move and lack of sleep all on 27Feb2021 at 09:00. Reporter stated that Soreness and pain has continued since the vaccination was given. Difficult to move and constantly hurts. The pain has prevented me from performing my daily routine. I have to have assistance with minor and major activities, such as getting dressed, holding objects, lack of sleep, difficulty to rest, can't lay on my arm. Using pain medications to try and relieve the pain. Therapeutic measures were taken as a result of soreness and pain has continued since the vaccination was given/ can't lay on my arm. Outcome of the events was not recovered.
Mom states pt woke up on 3/9 complaining of pain in left leg. Mom noted swelling, redness and warmth to touch on left anterior thigh. Mom called office and spoke with RN. RN advised to mark reddened area, apply cool compress and give Motrin. Mom had given Motrin and taken pt to daycare. Advised if worsening symptoms, have pt seen.  Mom presented to office with pt the afternoon of 3/9. Pt complained of pain in left leg. Left thigh was notably larger in girth than the right thigh. There was dispersed light redness noted on anterior  of left thigh with warmth to the touch.  No fever noted. Pt was assessed by Dr. Pt was seen walking around office without issue.  Called mom om 3/10/2021. Mom says the thigh continues to be a little swollen, but less than the day before. No other symptoms. Pt is walking and playing.
Bronchitis; Ear infection; Diagnosed with the flu; Vaccine was administered to a 2-year-old patient; Flucelvax Quadrivalent administered in the leg; This is a spontaneous case, reported by other non-health professional to Agency [reference number: SEQ19-06849] and initially received on 20-Nov-2019 with additional information received on 22-Nov-2019 (being processed together), concerning a 2-year-old, male patient.  The patient had no relevant medical history. The patient's concomitant medications included Zithromax (azithromycin) for an unknown indication.   On 14-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: leg, batch number: 259811 and expiration date: not reported] (explicitly coded as Inappropriate age at vaccine administration' and Vaccine administered at inappropriate site') for influenza prophylaxis.  On an unreported date, an unknown amount of time after vaccination, the patient experienced ear infection and bronchitis, and was treated with unspecified antibiotics.  On 15-Nov-2019, the patient had first symptoms of flu, and on 19-Nov-2019, he was diagnosed with flu. The patient was treated with Tamiflu (oseltamivir phosphate).  At the time of initial reporting, the patient had not recovered from the event of flu, while the outcome of the events ear infection and bronchitis was not reported.  The event of 'flu' was assessed as serious (medically significant).   The reporter did not provide causality assessment.  Company Comment: The patient experienced influenza, bronchitis and ear infection after suspect product, Flucelvax QIV administration at inappropriate site and to patient of inappropriate age. Chronology is possible. It was only stated that flu was diagnosed, and no laboratory test was reported to confirm this diagnosis. Reportedly, the patient had no relevant medical history. Causality was confounded with concomitant medication, Zithromax (azithromycin). Product administered to patient of inappropriate age and product administered at inappropriate site are assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and all the other events is assessed as possibly related.; Sender's Comments: The patient experienced influenza, bronchitis and ear infection after suspect product, Flucelvax QIV administration at inappropriate site and to patient of inappropriate age. Chronology is possible. It was only stated that flu was diagnosed, and no laboratory test was reported to confirm this diagnosis. Reportedly, the patient had no relevant medical history. Causality was confounded with concomitant medication, Zithromax (azithromycin). Product administered to patient of inappropriate age and product administered at inappropriate site are assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and all the other events is assessed as possibly related.
Received first dose of Covid19 vaccine on 10/24. Had a fever of 104 later that night. On 10/25 I woke up with shortness of breath, dizziness, and dull chest pain on the left side.  Dull chest pain on the left side has not subsided.
Screaming for 3-4 hours, unconsolably. Patient then had an episode of her eyes rolling back and jerking movements of the extremities for approximately 30 seconds, possibly seizure activity.
Tuesday: Extreme redness at injection site covering an approximate 9 inch by 12 inch area of upper arm. Injection site turned hot to touch and hard. Pain under arm. Joint pain beginning 8 hours after vaccine and increasing throughout the night. Wednesday: Nausea, headache, dizziness upon waking. Debilitating pain in every joint including fingers, toes, knuckles. Drowsy. Slight cough. Strong chills until approximately 2am Thursday: Tired, slightly dizzy, mild joint pain, increased redness, heat, pain and 'hardness' at the injection site. Mild cough.  Light chills at 9pm.  Friday: Redness has increased at injection site, that area is extremely tender to the touch, body aches and chills and cough gone. Slight headache and dizziness. I have had adverse reactions to all of my Covid vaccines. This was my 2nd booster.
Woke up this morning to symptoms of sore muscles, body aches, headache, and fever of 99.8 degrees. Took one Acetaminophen around 7:20am which lessened the symptoms until around 10:00am. Ate lunch around noon which made me nauseated. Felt very tired around 12:45pm so I took a nap. Woke up around 2:00pm with same symptoms only worse. The fever had gone up to 101.5 degrees. I took one Acetaminophen and the fever is currently at 100.4 degrees. Still experiencing headache, muscle and body aches, and slight nausea.
Bell's Palsy: Numbness, loss of movement to muscles in right cheek, and orbital
Crohn's disease aggravated; Chills; Unevaluable event; Flu-like symptoms; Fever; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 21K-163-4170952-00 (RA).  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Aug2021 (Lot number: UNKNOWN) at the age of 33 years as dose 2, single and intramuscular, administration date 09Jul2021 (Lot number: UNKNOWN) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1151978) at unk, citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset 15Sep2021, outcome "not recovered", described as "Crohn's disease aggravated"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; UNEVALUABLE EVENT (non-serious) with onset 2021, outcome "unknown", described as "Unevaluable event"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Flu-like symptoms"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever". The action taken for adalimumab was dosage not changed.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Pfizer vaccine caused chills, fever, and flu like feeling onset in 2021, Pfizer vaccine caused chills, fever, and flu like feeling onset in 2021 and Pfizer vaccine caused chills, fever, and flu like feeling onset in 2021 with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of food vergency was not provided. The reporter's causality for the event(s) of Crohn's disease flare up with Humira (Adalimumab) was a reasonable possibility. Causality of events with Pfizer BioNTech covid-19 vaccine was reported as not related.  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 available information aggravation of crohn's disease, chills, influenza like illness and pyrexia cannot be totally excluded for BNT162B2 and unevaluable event unrelated to suspect drug BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Convulsions in newborn on 2012-11-26, clinicial comment: +CMV culture.
Initial diagnosis of supraventricular tachycardia, narrow complex tachycardia, atypical chest pain on 12/7/2021. Was admitted 12/7/2021 and discharged on 12/11/2021. 12/28/2021 notes received from cardiologist with diagnosis of cardiomyopathy.
Sudden onset SVT tachycardia with rate of 160-174 . No prior history of cardiac disease
20 minutes after vaccine pt developed severe abdominal pain, leg pain - cough and fever to 101 degrees seen in ED, followed here this am.
4 days after shot massive headache on top of head and front front of head. Lasted two weeks  Buzzing noise in both ears that is still present 24/7