chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomach distress; pain in her stomach; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of gastric disorder in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced gastric disorder, stomach pain and upset stomach. On an unknown date, the outcome of the gastric disorder, stomach pain and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the gastric disorder, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband. The patient received Shingrix and she experienced stomach distress, pain in her stomach and upset stomach.  The patient said that she was a tiny person and might be the Shingrix dose was too strong for her.  The reporter consented to follow up. The caller put the patient directly on the phone. For the tolerances of 2nd dose, refer case US2019116952.
No Adverse reactions occurred.  Learned that moderna had been approved , believed  it to of been from the CDC. It was however the Advisory Committee.
Breakthrough Case admission after  4th vaccine 1/27/21 Moderna Lot# 029L20A 3/11/21 Moderna Lot# 02B21a 10/27/21 Moderna Lot# 039D21A 4/5/22 Moderna Lot# 001M21A
Pain in my left arm; It is like a welt; Very large red rash on my muscle on my left arm; About 5 in. x 4 in. across my bicep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my left arm), URTICARIA (It is like a welt), RASH (Very large red rash on my muscle on my left arm) and RASH (About 5 in. x 4 in. across my bicep) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (In the left arm.). Concurrent medical conditions included Heart disease, unspecified (taking heart medication.) and Arthritis (In Left shoulder.).    On 22-Feb-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 PAIN IN EXTREMITY (Pain in my left arm), URTICARIA (It is like a welt), RASH (Very large red rash on my muscle on my left arm) and RASH (About 5 in. x 4 in. across my bicep). At the time of the report, PAIN IN EXTREMITY (Pain in my left arm), URTICARIA (It is like a welt), RASH (Very large red rash on my muscle on my left arm) and RASH (About 5 in. x 4 in. across my bicep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Information has been received from a consumer concerning a her 4 year old son with "neurological delay" who couple years ago was vaccinated with a dose MMR II (lot # not reported). Recently he had test for titer and the only one that was no longer active in the system was mumps virus. The patient did not sought medical attention. At the time on the report on 23-JUN-2009 the patient had not recovered. No further information is available.
Healthy, no symptoms prior to vaccination. Vaccinated at temporary clinic approx. 3PM.  Symptoms appeared within 24 hours.  Coughing, phlegm, headache, chills and fever.  Persist until this report (12-26-04).  Suspect that flu vaccine was rushed to meet emergency, and contained live virus.  Christmas ruined. Would like to know if others vaccinated in this mass operation were also affected.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 21-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 degrees Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Rash, hives on arms, chest, legs, back. Warmth at injections site  Solumedrol 125 IM given in office Oral prednisone
Site: Pain at Injection Site-Severe, Systemic: Pain at deltoid spread to forearm-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Severe chills and extreme body aches 8 hours, low grade fever next day, continued muscle aches & headache 24 hours
Moderna COVID-19 Vaccine EUA fatigue,headache,chills,fever, aches tenderness at injection sight, pain
Information has been received from a 64 year old female with chronic obstruction pulmonary disease, emphysema, arthritis, diabetes and cardiac failure congestive who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included " too many" medications (therapy unspecified).  Subsequently the patient experienced injection site reaction.  The patient's outcome was not reported.  The patient also reported her experiences while on therapy with ezetimibe.  Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient who was intended to receive ZOSTAVAX was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously due to human error on an unknown date in February 2013. No concomitant medications were reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Started being symptomatic with Covid on 11Jul; Started being symptomatic with Covid on 11Jul; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing), notes: Other medical history: diabetes type 2. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "unknown" and all described as "Started being symptomatic with Covid on 11Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took other medication in 2weeks. Treatment received with Paxlovid from 12Jul2022 to 16Jul2022. Started being symptomatic with Covid on 11Jul. 12Jul woke up with fever of 101, deep painful cough, hoarse voice and congestion. Called to get Paxlovid and took 2 does that day. Improved substantially by Saturday, day 5. Day 10 after taking Paxlovid have redeveloped deep cough, congestion and fatigue and low grade fever. Also took toujeo insulen, start date was 04Jul2022, stop date was 24Jul2022. Patient also took Moderna covid-19 vaccine, start date was 08Sep2021, stop date was 08Sep2021 (Dose 3), Moderna covid-19 vaccine, start date: 11May2022, stop date: 11May2022 (Dose 2) and Moderna covid-19 vaccine, start date: 08Sep2021, stop date: 08Sep2021, for Covid-19 immunization on Arm left. Batch number was unknown for all doses (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Myalgias, arthralgias, fatigue, sore arm, in arm given.
very painful  swollen  lymph  node under arm pit,  sometime with sharp stabbing  pains that radiates  through  chest
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 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, 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 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non-significant follow-up
Information has been received from a physician concerning an approximately 52 year old female patient with asthma who during the past few months (2008) was vaccinated with PNEUMOVAX 23 (lot #660685/0619x) 0.5 mL IM. The physician reported that the arm in which the injection was given because swollen, red and painful from elbow to shoulder. The patient was seen in the office. The patient was treated with BENADRYL and ibuprofen. No further information was available. This is one of several reports received from the same source. Additional information has been requested.
01/05/23 presents to ED for "shortness of breath". PMHx of "chronic hypoxic respiratory failure due to COPD"  "atrial fibrillation on sotalol, HTN" "anxiety/depression, morbid obesity with OSA, CKD stage II, hyperlipidemia, gastric banding, history of DVT, and chronic HFpEF"
Moderna Covid Vaccine given 21 days after first dose, 3 days too soon.  Provider, manager, and patient to be made aware Will follow up with another dose on or after 8/20/21 as this dose was ineffective
On 8/31/10 pt. noticed 3 spots on her left arm that were red and warm to touch and stated it feels like it "burns" "under the skin a little bit".
Two days after the vaccination you experienced body pain all over. No fever, very cold/chills  in the middle of her back. Severe neck and back pain, not able to walk without pain, unable to get our of bed, was in so much pain. Pain moves around her body, not in the same place every day. Hands still swollen, unable to make a fist. Legs and feet hurting. Still unable to open a door.
Fever about 100; Diarrhea, vomiting x 3 days;
This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On 02-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000495, 0.65 ml, subcutaneous in the left arm. On 03-JUL-2013, the patient presented to the doctor office with confirmed poison ivy. The patient was seen by physician for medical attention. Prednisone was recommended for treatment. The outcome of poison ivy was reported as not recovered. The causal relationship was not reported. Additional information is not expected.
Information has been received from a consumer concerning her 15 year old son with no drug reactions/allergies and a history of migraine who on approximately 15-MAY-2012 was vaccinated with his first dose of GARDASIL (Lot# and route not reported). There was no concomitant medication. Consumer reported that approximately 10 days following the vaccination her son experienced migraine with a partial onset seizure. Consumer reported that while her son had a history of migraines, he had never experienced a partial onset seizure before. The patient did not seek medical attention. Subsequently, the patient recovered from migraine and partial onset seizure on an unknown date. Additional information has been requested.
Developed swelling, redness, warmth and itching at AVA injection site within 48 hours of receiving the vaccine.  Edema at injection site >120mm not beyond elbow - start: 08/2007, erythema start: 08/2007, pruritis start: 08/2007.
This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 51-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that, the patient was administered the vaccine with a 0.5 inches needle (explicitly considered as wrong injection technique), hence possible received only a partial dose (explicitly considered as incomplete dose administered). It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Expired vaccine dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 044A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had received expired dose of vaccine from the vial which was opened about 28 hours prior to the administration, it was unknown if the patient had experienced any events.  Number of doses/vials: 1 dose, vial was initially stored in the refrigerator on 01-Dec-2021. Vial was first punctured on 01-Dec-2021 at 11:20 am CST, post punctured, vial was stored back in the refrigerator, the vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Only exposed when shots were given.  No concomitant medications were reported. No treatment medications were reported.
Erythematous rash over the left anterior upper arm. Blanches. No significant urticarial. not tender.
FEVER, LIGHT SENSITIVITY, CRAMPING IN LOWER BACK & STOMACHE FOR ABOUT TWO WEEKS.
Fever of 101.7, muscle aches, headache, scratchy and sore throat, very tired.  I'm 31 weeks pregnant, pregnancy has been normal, estimated date of delivery is May 6th 2021.
Trouble taking a deep breath when going to bed at 10:00 pm, had trouble all night. Awoke at 3:15am to use bathroom reports feeling the following s/s: out of breath, dry mouth not relieved by water, dizzy when walking to and from bathroom, entire body aches.  Got out of bed 2.5 hrs later than typical secondary to fatigued and achiness "like somebody hit me!"  Left arm sore all night and currently.  Head (mild), dizziness and nausea and felt like passing out occurred when finally able to get OOB and continues at time of call.  (10;15am).  Now is nervous for her wellbeing.  Tried to drink OJ and extra water to help but no relief.  RN instructed resident to contact MD re possible need for inhaler refill.  Resident reports not wanting to go to ER. RN recommends Urgent Care.  Case confirms she is not alone, her adult son is with her and can be heard in background. RN instructed resident to go to ER if SOB occurs or difficulty taking deep breaths increases.  Resident with good verbal recall of all instructions provided.  She is A/A/0x3 and with no audible distress during call; no SOB noted in speech at time of call.
Pt given DTaP IPV on left arm with raised patch since time of vaccine which increased in size arm swollen with tenderness over deltoid area. Pt mom advise to put Neosporin, Benadryl PRN prescription given for Keflex 250mg 5ml 3/4 tsp TID x 7 days if swelling and tenderness persist.
I have had on going foggy brain, very forgetful, extreme fatigue, issues with my vision, coughing, headaches, pain in my bones everyday and all over my body.  I have had chest pains and palpitations and I was walking sideways like I was drunk. I have seen several Specialist for my ongoing health issues.   My work productivity has decreased. I felt that I had COVID-19 in 2020 but never tested positive. I tested positive for COVID-19 in October 2021. I was prescribed antibiotic and coughing medicine . I had a headache for 17 months every single day.
Had the injection on Friday morning. I had no problems Friday or Saturday. Woke up Sunday morning and was lightheaded and disoriented when standing up to get out of bed. Was not really dizzy and was not nauseated. Laying down or sitting down reclined I felt OK, but was distressed if I sat upright and particularly if I stood up. I was like this all day Sunday and all day Monday. Today, on Tuesday the symptoms have decreased but I still feel a little disoriented with a mild headache. During this whole time I was able to eat and drink pretty normally, but in small quantities. Hopefully will feel better on Wednesday.
Pt came in 6 days later and reported that her shoulder had turned red, swollen, hot to the touch, hurt to move. She said she had received many flu shots and never had any reactions. She had not reported any allergies at time of vaccine but today reported a latex allergy. Gloves, band-aids, and vaccines listed as latex free. Today (day 6), her arm had no redness, swelling or any sign of injection. She did not report any pain today.
Mother of pt report that several days after her shot - she developed pain in her knee generally in Rt knee pain. Also developed ? arthralgia origin undetermined. Has improved. Some occasional pain in joints.
She sometimes started to cry / Crying has gotten worse; Feeling abnormal; Pain; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (She sometimes started to cry / Crying has gotten worse), PAIN (Pain) and FEELING ABNORMAL (Feeling abnormal) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.  No Medical History information was reported.  On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced CRYING (She sometimes started to cry / Crying has gotten worse). On an unknown date, the patient experienced PAIN (Pain) and FEELING ABNORMAL (Feeling abnormal). The patient was treated with FLUOXETINE HYDROCHLORIDE at a dose of 10 milligram. At the time of the report, CRYING (She sometimes started to cry / Crying has gotten worse), PAIN (Pain) and FEELING ABNORMAL (Feeling abnormal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Additional treatment details included vurveroe XTL 5 mg. The patient tried it but not taking presently.   This case was linked to MOD-2021-057945 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: New event pain and feeling abnormal were added.
Right after my vaccination, I developed a small rash on my arm. In February, I was exposed to Strep. I had a sore red throat. I went to a walk-in clinic to test for Strep. They cultured my throat after doing a rapid test for Strep. The test was never received by the lab. I returned to the walk-in clinic to repeat the culture. The results indicated the sample was insufficient. The walk-in clinic prescribed penicillin which I took for 10 days.  I followed up with my regular doctor who repeated the culture. The culture proved negative for any concerning bacteria including Strep. My doctor thought it was viral. Now, I'm fine.
Itchiness in  scalp, face and both arms that feels like bugs crawling  on my skin, since 1/3. Nausea and diarrhea on 1/4 in the morning, and still have the itching.
Information has been received from a pharmacist a patient who on 18-MAY-2012 was vaccinated with a dose of MMR (Lot# 667319/0408Z, dose and route not reported), that had an expiration date of 18-MAR-2012. No symptoms reported. It was unspecified whether the patient sought attention or not. Follow up information was received from the pharmacist reported that the 26 years old female patient who at 14:14 on 18-MAY-2012 was vaccinated on the right arm with the first dose of MMR (Lot# 667319/0408Z). There was no illness at time of vaccination. The concomitant therapies included MIRENA. On 06-JUL-2012 the patient's rubella antibodies test revealed 108 IU/mL which indicate immune. No adverse events reported. No further follow up was planned. Additional information is not expected.
Next day had general body aches, soreness in arm, raised red hot area size of egg around injection site.
Blur spot in the middle of my vision in my right eye. I am prone to CSR (central serious retinopathy), and have had it in the past in my other eye, but it resolved in about 3 to 4 months. This is now in my right eye and has not resolved. It has now been about 10 months. There is no pain, and no additional symptoms. The blur spot in the center of my vision is increased with lack of sleep.
POSSIBLE VACCINE ADMINISTRATION ERROR:  Parent thinks that vaccine administrator, put the vaccine in the wrong muscle. Parent states that the shot was given in the middle of child's arm instead in Deltoid muscles. Child then passed out and vommitted about 2-5 minutes after receiving vaccine. Parent asked vaccine administrator if the vaccine was put into the wrong muscle. Vaccine administrator stated that vaccine should have been injected higher.
Constant migraines became regular with no trigger after spending the first weekend, bedridden due to flu like symptoms from vaccination
7/28/10 DTP before MMR, PREVNAR & Varicella. Red arm edema x 1-2 wks.