chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She received the flu vaccine and came back after she was done shopping (about 45 mins after) and said her arm was sore and she felt it was swollen. I asked to look at it and after seeing the swelling in her upper arm I asked her if she had hives anywhere else and if she had trouble breathing. She denied any other symptoms other than having a sore arm with swelling. I advised her to take some Benadryl when she gets home. I told her if she is uncomfortable or if she feels that it is getting worse she should seek medical attention. I called the patient about 2 hours later to follow up and she said she took the Benadryl and was feeling much better and the swelling went down.
Breast swelling in both breast for the last week and a half now, as well as neck/upper back pain.; Breast swelling in both breast for the last week and a half now, as well as neck/upper back pain.; Breast swelling in both breast for the last week and a half now, as well as neck/upper back pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 at 18:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: LEVETIRACETAM. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 06:15 PM), administration date: 20May2022, when the patient was 23-year-old, for COVID-19 Immunization. The following information was reported: BREAST SWELLING (non-serious), NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 11Jun2022 at 07:15, outcome "not recovered" and all described as "Breast swelling in both breast for the last week and a half now, as well as neck/upper back pain.". Therapeutic measures were not taken as a result of breast swelling, neck pain, back pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not diagnosed with COVID-19 post vaccination. No Known allergies. The patient has not received any vaccines within 4 weeks. Other medications in two weeks was Levetiracetam ER  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 15 minutes of received vaccination: muscle stiffness at injection site, muscle warmth at injection site, redness at injection site, overall fatique, body aches and sore throat. Within 2-4 hours of received vaccination: Severe debilitating muscle stiffness of right arm, unable to raise arm, extreme soreness and hardening of muscle at injection site, persistent redness at the injection site, worsening fatigue, body aches and sore throat and a feeling of sore neck lymph nodes 24-48 hours after received vaccination: Lessening of all symptoms over time with sleep/rest, ibuprofen Overall experience: I was alarmed at how quickly I started feeling ill (within the 15 mins the facility asked me to wait in the lobby after receiving the injection was when symptoms began). By the time I left the facility, all I wanted to do was lie down. My throat hurting was the most alarming initial symptom, feeling sore within 15 min of receiving injection, which I felt was concerning. By the time I got home and lied down, symptoms were worsening and at one point I felt like I was "dying" with soreness, fatigue and arm pain. Overall, it was a terrible experience. I'm lucky I was able to go home and rest it off and sleep through it. I was not able to carry on with normal activities for 2 days. I felt like I had come down with the flu. Being that I was coming off of having an upper resp infection with cough and asthma in weeks prior and was just starting to feel better, the Pneumo vaccine was ill timed in my opinion.
p/ pt recv vax approx 17 days later pt devel an ``attenuated case of varicella'' w/approx 20 lesions. also devel temp 101f & recurrent crops of vesicular rash.
I started getting symptoms of fever, chills, body aches, severe headache, and fatigue. I received a positive COVID-19 home test. Then I went and got a PCR test at a pharmacy which was positive as well. Then my symptoms progress to a cough. I went to the urgent care today to see if I had possible pneumonia. I had a chest x-ray done which has to be read by a radiologist. I did get some prescriptions for a cough suppressant and an inhaler. I still have a bad cough and congestion.
Dose was incorrectly diluted with 2mL of diluent instead of 1.8mL
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a non health care professional. This case involves Adult female patient (age was not reported) who developed a large bruise, while she received vaccine FLUZONE QUADRIVALENT. 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 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date not reported) via intramuscular route in right arm. It was also reported that the pharmacist stated that the vaccine was injected into a vein and the dose is will not be effective. On an unknown date, post vaccination patient developed a non-serious developed a large bruise. It was a case of actual medication error due to incorrect route of product administration. Lab data not reported. Final diagnosis was the vaccine was injected into a vein and the dose is will not be effective and developed a large bruise. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for developed a large bruise. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is 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 has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
interval between first and second doses was greater than 35 days/the patient received the booster dose but did not receive the second dose; patient was given booster dose instead of second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second doses was greater than 35 days/the patient received the booster dose but did not receive the second dose) and INCORRECT DOSE ADMINISTERED (patient was given booster dose instead of second dose) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second doses was greater than 35 days/the patient received the booster dose but did not receive the second dose) and INCORRECT DOSE ADMINISTERED (patient was given booster dose instead of second dose). On 14-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second doses was greater than 35 days/the patient received the booster dose but did not receive the second dose) and INCORRECT DOSE ADMINISTERED (patient was given booster dose instead of second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  As second dose, the patient received a booster dose of Moderna COVID-19 Vaccine (second dose was not a full dose).
Mom reports patient has 3-6 episodes a day since 8/24/2010 of seizure-like activity.  Mom reports episodes occur in which patient blinks eyes on right side and face stiffens up for 15 seconds.  Patient is not as alert and active after episode for a while.  These occur in clusters which may last for a total of 20-30 minutes at a time.  The clusters of seizure-like activity occur mostly in the evenings around 6 PM or late at night per mother.  According to mother, these episodes have also been witnessed at daycare at times.  The episodes have occurred during feedings, play, and while napping per mother.
Redness, itching, swelling at the injection site.  The area is getting worst every day after the injection.  The worst is  on Day 9 (07Jan2021). It is a little better today Day 10 (08Jan2021).
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.  Treatment medications were not provided.
RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion between a temperature of -14 degrees Celsius (C) to -10C (max -9.5C) for 38 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  On 11-AUG-2020, the patient was administered an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 milliliter (ml), lot # T009929, expiration date 16-SEP-2021, strength and route were not provided) for prophylaxis (product storage error).
she spotted (had a spotty menstrual period); This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (she spotted (had a spotty menstrual period)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Postmenopause.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (she spotted (had a spotty menstrual period)) (seriousness criterion medically significant). In May 2021, POSTMENOPAUSAL HAEMORRHAGE (she spotted (had a spotty menstrual period)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The concomitant medications were not reported. The treatment information was not provided. Company Comment: 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 case was linked to MOD-2021-238550 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
9/28/02 rash started. > 30 pox noted on body. No fever, still with rash. Follow up: Dr attributes skin eruption to vaccine.  13 day interval.  Prescribed: Benadryl.
30 days post vax, the pt developed red papular rash in right posterior buttock, thigh and calf. Not vesicular, no fever.
soreness in the back of the head and down the neck; Turning their head is really hard to do; From the middle of the head down their neck it is really sored; soreness in the back of the head and down the neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (soreness in the back of the head and down the neck), HYPOKINESIA (Turning their head is really hard to do), MYALGIA (From the middle of the head down their neck it is really sored) and HEADACHE (soreness in the back of the head and down the neck) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 26A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (soreness in the back of the head and down the neck), HYPOKINESIA (Turning their head is really hard to do), MYALGIA (From the middle of the head down their neck it is really sored) and HEADACHE (soreness in the back of the head and down the neck). At the time of the report, NECK PAIN (soreness in the back of the head and down the neck), HYPOKINESIA (Turning their head is really hard to do), MYALGIA (From the middle of the head down their neck it is really sored) and HEADACHE (soreness in the back of the head and down the neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   No treatment information was provided.   No laboratory data was provided   This case was linked to MOD-2021-255318 (Patient Link).
Patient received pediatric dose instead of Adult Pfizer dose. Mother called and scheduled children for the pediatric clinic. When documenting in MAR noted that patient was 14.
Entire arm extremely painful, unable to lift arm, headaches and discomfort, pain radiating to neck and shoulder and body aches all over. Tried using OTC ibuprofen, ice, heat without relief.
Information has been received from a registered nurse concerning multiple unspecified patients, who, on an unknown date, were vaccinated with doses of PEDVAXHIB (doses and routes not reported, lot # reported as 1886AA, expiry 02-DEC-2013) that were exposed to 31 F for up to 68 hours. No adverse effects were reported. Additional information has been requested.
14 year female in Clinic to receive Covid 19 Vaccine Booster dose.  After received dose in L deltoid stood up to go to observation area and she told her mother she didn't feel very well and fainted.  Mother was behind her and caught her as she fainted and helped her to floor, she did loose consciousness  for  les than 1 minute.  Patient re gain consciousness and  denies any pain or discomfort she was  helped to wheelchair and take to Special Care Room  to access.  Helped to cot and complains of nausea.  14:40 pm , Given water to sip and vitals as follows: Sat 98, BP 101/56, P 86. color pale.  15:00 , states feeling better, color improving, no complaints of pain or discomfort stated and no dizziness stated  Sat 97, BP 102/62, P72.  Taken to  car  per wheelchair with mother waiting .
Asymptomatic, but COVID-19 PCR positive, beginning 07/20/2021. Individual delivered baby on 07/20/2021.
FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES
Initial unsolicited report received from a nurse on 22 January 2016. This case involves female patient (age not reported) who was vaccinated with a dose of Yellow fever (batch number, route and site of administration not reported) and a dose of Hep a (batch number, route and site of administration not reported) on the same day on an unspecified date. The patient's medical history includes annual vaccination with flu vaccine without any adverse event and concomitant medications were not reported. On an unspecified date in 1997, following the vaccination, the patient had experienced Guillain-Barre syndrome. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event Guillain-Barre syndrome. List of documents held by sender: none.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED
sore neck; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On 22Jan2021, an hour after receiving vaccination the patient experienced sore neck, just on the right side. The soreness was still there. The clinical outcome of the event sore neck was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Approximately a half hour (9:10) after leaving the facility, I had severe chills and was shaking due to feeling so cold. I took 1200 milligrams of Tylenol and slept for about 4 hours. Other than slight pain on right arm, I felt fine.
MD recvd a call 11PM on 3OCT94 reporting that pt started crying w/o stopping since 9PM despite be given APAP; no temp or sx; MD suggested to repeat APAP dose; if crying does not resolve p/ 1/2 hr to call back; No call returned;
lower back pain; This is a spontaneous report from a contactable consumer (patient). A female patient (age:72, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unknown route of administration on an unknown date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that caller received the Pfizer covid vaccine last Wednesday and since last Thursday she has been experiencing lower back pain. The outcome of the event was unknown. Patient questioned if her symptoms after receiving the 1st dose of the covid vaccine will be the same after the 2nd dose. Patient would like to know if lower back pain was related to the covid vaccine and if her post vaccine symptoms will run their course. No follow-up attempts were possible; information about lot/batch number cannot been obtained.
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vial did not undergo temperature excursion. Total of 168 doses were given from LOT 048C21A.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
Local induration of injection site 6 cm x 8 cm with redness and warmth.
Initial and follow up information has been received from a certified medical assistant concerning an 87 year old female with no medical history and no drug allergies, who was vaccinated subcutaneously into the left arm with a first dose of PNEUMOVAX (Lot # 659199/1541U). There was no concomitant medication. On 27-JUN-2008 the patient developed redness at the injection site down to here elbow. The injection site was sore and warm to touch. The patient sought unspecified medical attention. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Fever, 24 hours Muscle weakness, 48 hours Headache/migraine, over 1 week (continuing still now)
Heart rate was elevated / north of 150 bpm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced heart rate increased (Verbatim: Heart rate was elevated / north of 150 bpm). The outcome of the heart rate increased was not resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingles vaccine.     It was unknown if the company considered the heart rate increased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient experienced heart rate was elevated for 24 hours. The patient stated just standing and it was north of 150 bpm.  The patient stated no thanks to the 2nd dose. The follow-up could not be possible as no contact details were available.
Patient began to feel nauseas and fainted shortly after. We called 911 while we laid the patient on the floor and monitored her pulse until patient came to.
MRI Brain done on 11/16/21 that showed subacute cerebellar stroke. Patient asymptomatic.  Done for hx of migraine with aura, incidental finding.