chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced significant pain in my arm - injection site. Mostly muscular pain. It only lasted about 12-24 hours. But it was very difficult to use my arm. I was having what felt like chest pain. It felt like pressure in the center of my chest. I ended up going to ER that evening per recommendation from doctor. They did blood tests and EKGs and x-rays. Vaccine caused inflammation and it caused the diaphragm think I was having a heart attack. I had pretty severe fatigue for about four or five days. I could only do bear minimum of what I needed to do for about a week. I have been seen by a doctor for a number of different things - health events since then.  ER - visit again - I have since gone twice again. I hit my head again - when I hit my head and I felt a pain in my neck. I have chronic neck pain - went to ER for neuro checks since I have brain tumors - CT scan of head and neck and didn't see anything that was of concern for ER. Pain management for neck pain - I'm seeing a specialist for that pain management. I was having severe pelvic pain and my doctor recommended that I go to get blood work done - pelvic and vaginal area ultrasound.  The ultrasound  found one fibroid in uterus that doesn't appear to be causing any pain. The ultrasound also found a Cyst on an ovary that it looks to have burst and that was causing the severe pain. They said that the cyst would dissipate. The pain is gone now and essentially they said it (the cyst) would dissipate.
Left upper arm swelling down to elbow. Afebrile child c/o limited ROM appears to play well in office, slight redness.
Has 14cm x 16cm erythema, has warm to touch area of induration.
Fully vaccinated.  Vaccine Breakthrough.   Planned admit for a C-section, tested COVID + asymptomatic.
Case was hospitalized for Covid pneumonia 8 months after completion of the primary Covid vaccine series.  * Pneumonia due to COVID-19 virus Assessment & Plan Presented with 7 to 10 days of generalized weakness and cough. He is vaccinated however he is immunosuppressed with rituximab and methotrexate. CXR with infiltrate c/w covid. He was borderline hypoxic on arrival. ID recommended erring on the side of being more aggressive with covid treatment since his immunosuppression increases risk of severe disease so dexamethasone and remdesivir were started. He improved quickly so these were discontinued at discharge. His rheumatologist recommended he wait until his CD19 count recovered following his last rituximab dose in March 2021 to get a covid booster. Repeat B cell panel scheduled on an outpatient basis Date of symptom onset: circa 10/4 Date of positive test: 10/11 Duration isolation needed: 20 days Date isolation can be discontinued: 10/24
Information has been received from the patient's father referring to an 8 month old male patient. Information regarding medical history, concurrent condition or concomitant medication was not provided. On 02-MAY-2017 the patient was vaccinated with an expired dose of ROTATEQ (lot # M042822, expiration date 01-SEP-2016, dose and route unspecified) for prophylaxis. No adverse effects reported.
pt recv vax 16JUN98 & same day exp T100.9 & could not lift head or arms;pt still could not lift head @ 48hr;pt was not shocky or obtunded;pt was seen by 2 MD;
Tired no energy (approx 5 mos) (2007 and 2008) This began about 3 days after each vaccine.
Very swollen and reddened area from area of vaccination. I advised to seek medical treatment-was given SOLU-MEDROL- IV, BENADRYL IV and PEPCID IV.
She received the GARDASIL shot - in a series of 3 shots in 2007. She was 17 yrs. GARDASIL is to prevent cervical dysplasia. 3 yrs. after she started to have abnormal Paps. So they went from yearly to every 6 months. She had 4 altogether. On the last one her abnormal cells went from low grade to mild. She was set up for a colposcopy. The procedure was performed on 2-6-2012. Patient had no health insurance when GARDASIL was administered and I had to pay $500.00 out of my pocket. I don't understand why push the shots when you end up with cervical dysplasia anyway. It was a waste of money for me. The biopsy cost me $114.00 and who knows how much more. I am against giving shots (GARDASIL) for it does not prevent what is supposed to.
The reason I am reporting this as an adverse event, is not because the symptoms were out of the ordinary, rather the symptoms lasted TWO FULL WEEKS.  0 Friday, March 5, 2021, I worked Pfizer, 1st shot @ 8:30am, no symptoms at all 1 Friday, March 26, 2021, did not work, Pfizer, 2nd shot @ 9am, Began feeling flush on my face, no other symptoms, felt fine, functioned normally 2 Saturday, March 27, 2021, weekend, home, Tiredness, fatigue, was still able to do a little around the house 3 Sunday, March 28, 2021, weekend, home, Tiredness, fatigue, was still able to do a little around the house 4 Monday, March 29, 2021, did not work, home, Significant Fatigue, mild headache, very unwell, in bed 5 Tuesday, March 30, 2021, did not work, home, Significant Fatigue, mild headache, very unwell, in bed 6 Wednesday, March 31, 2021, 1.5 hrs sick leave, worked 6.5 hours, Significant Fatigue, went to work but had to come home and take a nap 7 Thursday, April 1, 2021, 4 hrs sick leave, worked 4 hours, could not make it through the whole day.  Came home exhausted, extreme fatigue, unwell 8 Friday, April 2, 2021, 1 hour of leave, worked 7 hours, couldn't last 8 hours.  Came home and went to bed. 9 Saturday, April 3, 2021, weekend, home, did a little housework, but so fatigued.  Had to take rest breaks a lot 10 Sunday, April 4, 2021, weekend, home, did a little housework, but so fatigued.  Had to take rest breaks a lot 11 Monday, April 5, 2021, home, Significant Fatigue, unwell, on the couch most of the day. 12 Tuesday, April 6, 2021, home, Starting to feel a better.  Fatigue is not as bad. Still need to rest though 13 Wednesday, April 7, 2021, home, Starting to feel a better.  Fatigue is not as bad. Still need to rest though 14 Thursday, April 8, 2021, home, dramatic improvement.  Although still a little tired, I feel pretty much back to my old self.
LEFT FACIAL DROOPING, WEAKNESS LEFT EYELIDS, TEARING OF LEFT EYE, NUMBNESS LEFT SIDE OF FACE
Patient experienced headache, body aches, fever and photophobia. Symptoms relieved with Ibuprofen and symptoms would recur.
pt recv vax 12NOV98 & 20NOV98 Am arm where vax given was hard itching;states could feel swell knot also;9cm x 10cm red area w/o tenderness on palpation;area warm to touch;area is itchy;
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient received a dose of live ZOSTAVAX on 22-OCT-2012 (lot number H013017 exp 09-OCT-2013) and a second dose on 03-JAN-2013 (lot number H018798 exp 15-JAN-2014). Concomitant medications included: influenza virus vaccine (unspecified) 4 weeks prior to receiving the 2nd dose of live ZOSTAVAX and an unspecified heart medicin. The first dose of live ZOSTAVAX was given on prescription, but the 2nd dose was asked by the patient at pharmacy. On 15-JAN-2013 the patient experienced nose won't stop running, and fever. No treatment was given. The outcome of nose won't stop running and fever was reported as recovering. The relatedness for nose won't stop running and fever was not reported for live ZOSTAVAX. Additional information has been requested.
Headache, Myalgia, weakness (general)  Narrative: Per nursing report: " c/o of body aches, weakness and headaches"
Shoulder pain and immobility - Dx frozen shoulder and small tear in rotator cuff.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 612L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. No known allergies. ). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Dec-2020 and the estimated date of delivery was 01-Oct-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       At the time of this report prenatal care was not yet established.
Got vaccine, went home, around 4 PM started with redness, warm to the touch. Area of redness measures 7" x 7". Came into the office today, redness and temp are better. Told to take Ibuprofen 7.5 ML @ 100 MG/5ML PO.
Swollen lymph nodes in left armpit and collar bone approximately 48 hours post vaccine.
Headache, rise in Blood Pressure, Rash and Itching all over body, Backstabbing pain, tightness, and pain in the chest.  Was placed on Benadryl  two every four hours, Tylenol, and additional blood pressure meds
Left arm pain at injection site started 3/17/21. The pain got worse 3/18/21, having trouble lifting arm sideways.  Improved 3/19/21, resolved by 3/20/21. Starting 3/24/21, developed a few hives at left arm injection site, no treatment given. Better on 3/25/21 but not yet completely resolved.
Patient received vaccine at 3:42 pm.  At 3:50pm, patient was unconscious but breathing in his chair in the post-vaccine waiting area.  911 was called.  Patient was placed on the floor in the recovery position, he regained consciousness after about 1 minute.  He stated that he has passed out previously after giving blood as he has a fear of needles.  EMS took his BP several times (last reading at 4:13 pm was 96/63) after arriving at 3:57pm.  At 4:13 pm he signed a waiver that he did not want to go to the ER.
Seizure activity, shaking arms repeatedly for approximately 1 minute 30 seconds. Second seizure next day at 4 pm. shaking head and arms for approximately 1 minute 30 seconds.
Pt. Had a Vesovegal episode at 14:55 and lasted until14:06 , pt felt dizziness and diaphoresis , vital sign was 122/81 76 20 97% on room air. Pt was laid down by this nurse and elevated legs sip of water given. Pt recovered without difficulties, verbalized she is not feeling dizzy and no sweating, ER precaution was given, pt acknowledged understanding. Observed pt for another 15 minutes and was let go.
A 25-year-old female patient, who had an active infection from an IUD that was being treated with CIPRO, had received an intramuscular left deltoid injection of ADACEL, lot number U2937BA (foreign lot number C3160) on 19 August 2009. The patient had received a tetanus vaccination 10 years ago. One day post-vaccination, the patient reported pain at the injection site and feeling a little warm. The patient had not taken her temperature. She was instructed to be seen for evaluation; however she did not do so. No treatment was prescribed, and no diagnostic tests or laboratory data were performed. At the time of this report it was unknown if the patient had recovered. The reporter for this case is the same as for cases 2009-03623 and 2009-03624. Documents held by sender: None.
pt recvd vax;devel a dec platelet count,dec white blood cell count,petechiae & bleeding gums;
fever (101 degrees), chills, body aches, headache, nausea for about 48 hours. Those symptoms resolved for about two days, then I started getting severe headaches, stomach aches, loose bowel movements, and insomnia. Also a feeling of electric jolts throughout my body. These started around October 5th and have continued to present. I initially contacted my primary care Dr. on Monday, Oct. 24th via video call. He suggested they would resolve in 1-2 months. I contacted him again via video call on Monday, Oct. 31 for advice on managing the ongoing insomnia.
couldn't stand up and had to lay down.; she was very dizzy; couldn't drive her car; Pains in all of her joints; Felt as if she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (couldn't stand up and had to lay down.), DIZZINESS (she was very dizzy), IMPAIRED DRIVING ABILITY (couldn't drive her car), ARTHRALGIA (Pains in all of her joints) and PYREXIA (Felt as if she had a fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F214, 013M20A and 032L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Right arm). Past adverse reactions to the above products included No adverse event with Flu shot.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced DYSSTASIA (couldn't stand up and had to lay down.), DIZZINESS (she was very dizzy), IMPAIRED DRIVING ABILITY (couldn't drive her car), ARTHRALGIA (Pains in all of her joints) and PYREXIA (Felt as if she had a fever). At the time of the report, DYSSTASIA (couldn't stand up and had to lay down.), DIZZINESS (she was very dizzy), IMPAIRED DRIVING ABILITY (couldn't drive her car), ARTHRALGIA (Pains in all of her joints) and PYREXIA (Felt as if she had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
redness, swelling, itchiness around the injection site, symptoms began 1 day after vaccination. Patient states that it has been improving and is only mildly itchy currently
This spontaneous report was received from a Doctor of Pharmacy concerning two patients who on 06-JUN-2012 were vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 670542/0619AA, expiration date on 26-JUL-2012) that had been stored at an average temperature of 6 degrees Fahrenheit since an unspecified date in April 2102.. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
1st shot Sep2021, 2nd 31oct2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2021).   On 30th October 2022, the patient received the 2nd dose of Shingrix. On 30th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got busy and did not receive second dose of Shingrix till today and received on 30th October 2022 (on the day of reporting). The patient assumed he/she would still benefit from it despite being six months later than recommended on second dose. Additional Supportive Information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up would not possible as no contact details were available.
01/28/12 hospitalization with pyloric stenosis. 1/29/12 laparoscopic pyloromyotomy. 07/05/12 hospitalization with "recurrent intussusception". 7/06/12 exploratory laparotomy, appendectomy.
He has a lingering cough; Chills; Sneezing; Fatigue; fever; This is a spontaneous report received from a contactable nurse. A 67-year-old male patient (Husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 15Jan2021 at single dose for Covid-19 immunization. Medical history included patient considers it to be an actual heart attack. The doctor put a stent in but they think the pain was coming from muscle spasm because the widow maker was blocked. That was in the fall of 2014. He has cholesterol medication. He has medication for high blood pressure and it is controlled with medication. Concomitant medication was not reported. They were vaccinated on 15Jan2021 with first dose. The Wednesday after which was about 5 days after the vaccine her husband got chills, sneezing and fatigue. He didn't call the doctor and didn't get tested. About a week later her son had nasal congestion and cough. This is the third day for that. Called her son's doctor since this is the second person in the house to have symptoms. He had COVID test and it came back positive. Maybe he will develop a fever down the line. She is at a quandary. She has to quarantine in case it is. A week in between her husband and son and it is hard to believe. It should have been her to get it worse since she sleeps with her husband. She and her husband have not been tested for COVID. Only her son was COVID tested. Her husband's chills, fever, and fatigue started on 20Jan2021. They have stayed home. Occasionally he will still sneeze. Then caller clarified that the night before 20Jan2021 her husband had chills and was tired. He went back to sleep and that was unusual. He had enough fatigue he had to rest more. He went to bed early. Outcome of events was unknown.  No follow-up attempts are possible. No further information was provided.
Rapid heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (booster), single (Lot number: FJ5682) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; TAMSULOSIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 10Apr2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 01May2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Rapid heart beat". The event "rapid heart beat" required physician office visit. Therapeutic measures were not taken as a result of heart rate increased.  Additional information: Facility type was vaccine pharmacy or drug store. The patient did not received other vaccine in four weeks. The patient had COVID prior vaccination and COVID tested post vaccination was reported as no. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient also received Dose 4 vaccine on 09Jan2023 at 07:00 PM, lot number was GJ6796 and vaccine location was left arm.
Patient developed apparent anaphylaxis.  Presented with facial swelling, sensation of tongue swelling/throat closure, audible wheezing, poor air movement.
PAIN, NUMBNESS AND TINGLING IN LEFT ARM SINCE FLU SHOT GIVEN IN AUGUST.
fully vaccinated with PCR test positive CV19 on 8/31/21. Client was primary contact to CV19 positive case and sought testing on 8/30/21. Client is asymptomatic.; fully vaccinated with PCR test positive CV19 on 8/31/21. Client was primary contact to CV19 positive case and sought testing on 8/30/21. Client is asymptomatic.; This is a spontaneous report from a contactable other health professional. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247) dose 2 via intramuscular administered in the arm right on 23Feb2021 (at the age of 58 years old) as dose 2, single and dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247) via intramuscular, administered in the arm right on 03Feb2021 (at the age of 58 years old) as dose 1, single both for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was a clinic. The patient medical history and concomitant medication was not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications received within 2 weeks of vaccination was reported as unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. On 28Aug2021, the patient experienced asymptomatic Covid-19. The patient was fully vaccinated with PCR test positive CV19 on 31Aug2021. Patient was primary contact to cv19 positive case and sought testing on 30Aug2021. Patient was asymptomatic. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR test resulted positive on 30Aug2021 Nasal Swab. Treatment received was reported as unknown. The event resulted in Doctor or other healthcare professional office/clinic visit. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization / Disabling /Incapacitating / Congenital anomaly/birth defect). The clinical outcome of the event was recovering. Based on the reported information, a causal relationship between the events and suspected drug cannot be excluded.
medication error with Pentacel described as the DTap-IPV portion was given and the Hib powder portion not given with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist and transmitted to Sanofi on 21-Jan-2021.  The case involved an unknown age patient who received Pentacel which was described as the DTap-IPV portion was given and the HIB powder portion was not given (Product preparation issue).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or was to be held liable for the occurrence of this medication error.  There would be no information available on the batch number for this case.
Last 5/16/23 around 1:30PM mom called our office and informed us that patient had reddish mucus in the stool after their appointment with us. 2 hours later, mom informed us and described it as "strawberry jelly mucus". No fever, no vomiting, abdomen was soft, patient a little bit fussy. Talked the situation to the provider.  He spoke to parents about the concerns and plan. The provider ordered stat ultrasound abdomen and stat occult blood screen. But the patient ended up being seen in the ER d/t almost past office hours of the clinic and occult blood sample was not accepted at the lab because it has to be in a stool container and that sample may be contaminated with urine. Patient was transferred to facility