chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels "very achy"; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 12:00 (Lot number: EN6204) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: Nov1948 (unspecified if ongoing); "Scleroderma", start date: Mar2018 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose was on 25 Feb 2021. Lot EN6198, expiration is unknown. Pfizer COVID vaccine. Injected in left arm in the muscle.), administration date: 25Feb2021, when the patient was 76 years old, for covid-19 immunisation; Flu shot (Reaction to flu shot and was achy the next day), reaction(s): "achy". The following information was reported: PAIN (non-serious) with onset 18Mar2021, outcome "not recovered", described as "feels "very achy""; CONDITION AGGRAVATED (non-serious) with onset 18Mar2021, outcome "not recovered", described as "headache".  Additional information: The reporter reported that She has quite a headache and is achy. She would like to know if she can take a Tylenol for the headache. After the lot number, she stated it had the number 6-21 after it and was unable to confirm if that was the expiration date. There was no prescriber. She did not wish to provide an email address. She confirmed that this occurred after the 2nd dose of the Pfizer COVID vaccine. Her first dose was on 25Feb2021, with Lot EN6198, expiration is unknown. It was also the Pfizer COVID vaccine. She received it as prevention because she is Diabetic and has Scleroderma. She was diagnosed as being Diabetic in Nov 1948, when she was pretty little. Scleroderma was diagnosed Mar2018. All her medications have been steady. She did not think they were relevant. No further details provided. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). 1st dose was on 25Feb2021. Lot EN6198, expiration is unknown. Pfizer COVID vaccine. Injected in left arm in the muscle.    No follow-up attempts are possible. No further information is expected.
This was 2nd dose. I was achy and had mild flu-like symptoms for about 2 days. I was extra tired during that time too.   I took some NSAIDS for pain. Otherwise, I just rested and limited my activities. I did not seek treatment as the symptoms did resolve fairly quickly and I assumed it was a sign of my immune system having a good response.
First, I felt extremely fatigued and my arm where I received the shot hurt so badly that I couldn't lift it up to shoulder height. Then I felt muscle aches throughout my whole body. I began to feel sick to my stomach and nauseated. I went to bed early and woke up in the night shivering. I couldn't get warm and my whole body hurt. Headache, sick stomach, and shivering. The next morning I took my temperature and it was 101.8. All day yesterday I had a fever, could barely eat, and felt like I had the flu. The muscle soreness continued - especially in my neck. My ears hurt. My skin hurt-a pins-and-needles sensation. I barely made it through the workday. By last night my temperature was down to 100.3. I took a TYLENOL PM and went to bed early. Today I feel somewhat better, although the soreness in my neck and ears continues, and I still don't have my usual energy. But my temperature is back to normal and I no longer have the chills.
Patient called pharmacy to report feeling ill day after vaccine - about 12 hours post injection. Scratchy throat, lethargy, no fever reported, possible sinus drainage.
Patient left the pharmacy and was at his table eating.  He dropped his bowl and appeared to be shaking and his eyes rolled back.  He was unresponsive so his wife called 911 and an ambulance came and transported him to the Hospital.  Concern at the time was either a seizure or stroke.
Clear nasal congestion. Difficulty breathing through nose. 99.3 temp. Can't sleep well, due to congestion.
NO ADVERSE EVENT NOTED OR REPORTED. Jynneos 0.1ml ID administered with no wheal production; therefore subsequent dose administered (0.1ML, ID) with wheal production.
1. Noticing a sharp headache for about 10 seconds either in the occipital lobe region or temporal lobe region on the right side of my head every now and then. It has happened about 8 times since vaccine administration. The first time being about 25-30 minutes after vaccination. 2. I have also noticed a sharp pain in the back of my right thigh/upper buttock region that feels either like a nerve or muscle pain. It usually is most noticeable when I first stand up from a sitting position or laying position. If I don't put as much pressure on the heel of my right foot, it isn't as bad and ibuprofen has helped the pain subside, but it has been constant. This was first noticed about 4-5 hours after vaccination received.
Headache, runny nose for three days. Paxlovid for 5 days per doctor order.
One week after injection, site had healed well. All of a sudden, the injection site became warm to the touch, swollen, itchy, painful, and hard again. This reaction was worse than the original reaction after injection.
Routine bloodwork on March 10 indicated thrombocytopenia - platelets - 58.
Patient reported back to the pharmacy 1 week after his covid vaccination to inform us that he suffered a stroke shortly after receiving the vaccine. He is currently released but still recovering.
Fever up to 101.2 the day after the vaccine - resolved after several hours. Also nausea & racing heart.
Toxoplasmosis of my left eye resurfaced for the first time sine 1996; Gout in my left big toe; Bladder Infection; Shingles; Repeat rheumatoid arthritis flare; Rheumatoid Arthritis Flare; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) and RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Toxoplasmosis (resurfaced in left eye for the first time since 1996). Concomitant products included ABATACEPT (ORENCIA), Prenisone, AZITHROMYCIN (AZO), ESTROGENS CONJUGATED (PREMARIN), LISINOPRIL, AMITRIPTYLINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) (seriousness criterion medically significant). On 23-May-2021, the patient experienced RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) (seriousness criterion medically significant). On 25-May-2021, the patient experienced HERPES ZOSTER (Shingles). On 09-Jun-2021, the patient experienced CYSTITIS (Bladder Infection). On 15-Jun-2021, the patient experienced GOUT (Gout in my left big toe). On 18-Jun-2021, the patient experienced TOXOPLASMOSIS (Toxoplasmosis of my left eye resurfaced for the first time sine 1996). On 24-May-2021, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) had resolved. On 01-Jun-2021, HERPES ZOSTER (Shingles) had resolved. On 06-Jun-2021, RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) had resolved. On 14-Jun-2021, CYSTITIS (Bladder Infection) had resolved. At the time of the report, GOUT (Gout in my left big toe) and TOXOPLASMOSIS (Toxoplasmosis of my left eye resurfaced for the first time sine 1996) outcome was unknown.            No treatment information provided by the reporter.  Very limited information regarding this events has been provided at this time.   This case was linked to MOD-2021-228447 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.   Further information has been requested.
had one shot and a week later had covid.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had one shot and a week later had covid.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had one shot and a week later had covid.). At the time of the report, COVID-19 (had one shot and a week later had covid.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medications were reported.  Patient was asking should she get the second shot.   Reporter did not allow further contact
Shingles sores  around right ear,  right shoulder and under chin appeared after one day of burning and sensitivity along the right side of entire scalp.
Side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side effects). At the time of the report, ADVERSE REACTION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
1/8 vaccination 1/9 04:30 I woke up, temp was fine. When I went to work, I didn't feel well. When I got there, I looked sick. Couple hours later, I started feeling SOB, weird, 'off'. I took my O2 was 90%, pulse 238. I went home; temp was 101.8, my O2 was 84-86, HR 130 @ resting. Lasted for about a week. O2 did go up to 91.  My PCM gave me a beta blocker, Heart medicine (still taking daily and hoping to get off) I do have continuous swelling on my legs, which comes and goes.
This was a pre-exposure vaccine booster because of low titer. The original series was in 83. Severe headache with nausea within 45 minutes. Fingers and toes became tingly within 5 hours and progressed until both hands and feet felt numb over several days. Hands and feet felt like pins and needles- sensory deficit in feet on neurology exam 14 days post-vaccination. 19 days post vaccination rash on side of face and both arms that was itchy. Day 21 imbalance, tremors, and twitches in fingers, 2nd ER visit for severe headache and new symptom. Legs began to burn and sensation to touch at 29 days post exposure. Muscle weakness concurrent. 5/28/17 legs and feet are burning. Tremor and twitches are still present on 8/14/18.
The day after I had the vaccine my eyes and face were very swollen; The day after I had the vaccine my eyes and face were very swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia in April 2021.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen). At the time of the report, SWELLING FACE (The day after I had the vaccine my eyes and face were very swollen) and EYE SWELLING (The day after I had the vaccine my eyes and face were very swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
At the moment of registration, the mother of patient did not provide an ID of the child and stated he was 11 years old. The patient was anxious as we were administering the vaccine and completing the registration under the database. Once the registration was complete, staff realized that the patient was not the age mentioned by the mother of patient. The patient was, instead, 12 years and 11 days old. Due to miscommunication, the patient was given a Pediatric Pfizer Vaccine of 0.2 mL rather than a 0.3  mL dose as is due for a 12 year old child.
Admit for COVID pneumonia. Treated w/ steroids, lovenox, plavix, Rocephin. Awaiting SNF placement at time of review 7/29.Patient continued to improve during the hospital stay, he is currently on room air but his D-dimer is elevated, so he started on Lovenox b.i.d. and transitioned to Eliquis at the time of discharge. Overall patient is stable from the respiratory point of view, he denies any major shortness of breath or chest pain. Patient will be discharged on supportive care medications including Decadron, Eliquis, antibiotics and continued on the rest of the medications.
Received a flu shot in the am (10/17/01) Within waking night slept. Went home to sleep came back to work at 10 PM that night. Felt itchy all over her body. Noticed redness but no rash or hives. Took Benadryl. It improved. Took Benadryl. It improved. Took 2 more doses of Benadryl over next 24 hours. Redness went away and 24 hours itching stopped.
Weakness, headache, arm ache, back pain, unexpected heavy breakthrough bleeding and cramping LMP was 12/13/2020 not expected to bleed until 01/10/2021
I had a severe cold and nasal drainage for over two weeks. No fever. Weird herpes like blisters on arm and leg. The pain from the second shot in my left arm is still present 10/30/2021. Rash bumps went away. Never visited a doctor because the issues were suspicious but not worth seeing a doctor.
Myalgias, chills, headache, stiff neck, very sore arm at injection site.
Barking cough for 3-4 days. No fever. Sore throat and headache. Prescribed dexamethasone 6 mg PO. Cool mist humidifier, push plenty of fluids.
On Oct. 30, 2018 I broke out with Shingles on the back left shoulder, front left shoulder and left side of the back of the neck.
pt was waiting at the lobby after getting the vaccine  about 15 minutes later pt;'s husband called my attention that she was not feeling well , upon asking the pt she said she  was feeling jittery  and dizzy and she was feeling tightness on her jaw and neck , she declined  us to call 911 for her andjust requested an ice pack and cold water , she placed the ice pack on her neck and felt relieved  , she waited  at least an hour more at the lobby and felt better when she left, I ask my closing pharmacist to  check up on her she was  feeling better that night ,when I came back today I called her again and she said she juts felt her arm was sore and was feeling a lot better no other side effects as of today 6/2/21
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider at a hospital administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2015, the patient was treated by a physician at the hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was stored in refrigerator on 01-Dec-2021 and it did not undergo temperature excursions.  No concomitant medications were reported.  No treatment information was reported.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 69-year-old male patient who received TWINRIX adult. Co-suspect products included TWINRIX adult and TWINRIX adult (batch number AHABB253BC, expiry date 13th July 2014). On an unknown date, the patient received the 1st dose of TWINRIX adult and the 2nd dose of TWINRIX adult. On 23rd July 2013, the patient received the 3rd dose of TWINRIX adult (intramuscular) 1 ml. On an unknown date, several years after receiving TWINRIX adult and TWINRIX adult and 3 years after receiving TWINRIX adult, TWINRIX adult and TWINRIX adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additional details were provided as follows: The first two doses were administered at another facility. The reporter got the information from patient that he had a negative titer after receiving the TWINRIX series. It was not specified if it was for Hepatitis A, Hepatitis B or both. In 2016 (very recently), approximately several years after receiving, approximately several years after receiving first two doses and approximately 2 years after receiving 3rd TWINRIX series the negative titer was found, though the reporter did not know when specifically it was drawn.
Moderna vaccine was administered outside of the clinic - reported by patient   OBSTRUCTIVE SLEEP APNEA 7/22/2021 PULMONARY EMBOLISM, UNSPECIFIED.  PULMONARY EMBOLISM, UNSPECIFIED. 4/10/2021 PULMONARY EMBOLISM, UNSPECIFIED.  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 PULMONARY EMBOLISM, UNSPECIFIED.  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 PULMONARY EMBOLISM, UNSPECIFIED.  HYPOXIA 10/14/2021 PULMONARY EMBOLISM, UNSPECIFIED.  OBSTRUCTIVE SLEEP APNEA 7/22/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  PULMONARY EMBOLISM, UNSPECIFIED. 4/10/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 CHRONIC HYPOXEMIC  RESPIRATORY FAILURE  HYPOXIA 10/14/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  OBSTRUCTIVE SLEEP APNEA 7/22/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  PULMONARY EMBOLISM, UNSPECIFIED. 4/10/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  HYPOXIA 10/14/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  OBSTRUCTIVE SLEEP APNEA 7/22/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  PULMONARY EMBOLISM, UNSPECIFIED. 4/10/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  HYPOXIA 10/14/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE  OBSTRUCTIVE SLEEP APNEA 7/22/2021 CHRONIC HYPERCAPNIA  PULMONARY EMBOLISM, UNSPECIFIED. 4/10/2021 CHRONIC HYPERCAPNIA  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 CHRONIC HYPERCAPNIA  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 10/21/2021 CHRONIC HYPERCAPNIA  HYPOXIA 10/14/2021 CHRONIC HYPERCAPNIA
Redness at injection site, aching all over, confused, sleepy. Started 2-3 days afterward and continued thru 10-12-15.
Given PCV13 on 14 Mar 2017, saw PCM on 20 Mar 2017 (today)- 15x19cm region of erythema of left arm without rubor, non-tender, no lymphadenopathy, appears as site reaction to vaccine and unlikely cellulitis given the size of involvement and absence of pain, lymphadenopathy, and warmth on clinical exam.
This case was reported by a consumer via call center representative and described the occurrence of blood glucose increased in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included type II diabetes mellitus. On 17th August 2018, the patient received SHINGRIX. On 17th August 2018, less than a day after receiving SHINGRIX, the patient experienced blood glucose increased. On an unknown date, the outcome of the blood glucose increased was recovered/resolved. It was unknown if the reporter considered the blood glucose increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Being diabetic, Type II, the patient checked his glucose regularly. At about 11:35 AM, the patient received first of two SHINGRIX doses. After the injection, the patient's glucose was running at least 45 to 55 points higher than normal for the next 36 hours (plus or minus). The pharmacist was contacted by the patient on Saturday AM said that higher glucose was not a listed side effect. The issue had passed so, no harm, no foul. The patient thought that GlaxoSmithKline might wished to know the patient's experience.