chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt deveolped cellulitis at injection site within 48 hrs p/ immun., mass was not drained or cultured, however is was fluctuant, seen in ER treated w/ with Cirpo & warm compresses, returned to ER for pain, asymptomatic on 4th day.
severe pain & warm @ inj site;can hardly move arm-pain wakes pt up @ noc-goes from shoulder & radiates down hand;
Nausea, loss of appetite. Bitter taste in mouth for 4-6 weeks.
sob-12/10/99, chest tightness   12/8 redness around inj site, body aches, weakness, fatigue    12/10 tx-w/benedryl which relieved condition within 30 min.
HEMATOMA; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced hematoma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hematoma. This report was non-serious.
Dose 2 was given too early per vaccine dosing protocol of 6 to 12 months after 1st dose.  First dose given 08/27/2020. Patient experienced no adverse affects but the incorrect spacing of 2nd dose was brought to her attention at the Health Dept.
Swelling of area, itching, fever of 100.1 orally, body aches
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # L008054, expiration date 30-NOV-2016; lot # K011947, expiration date 07-JUN-2016 (strength and dose were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the reporter stated that the physician could not be contacted.
Hives on his body, no reaction at injection site. Presented to school nurse following day & Adm. BENADRYL.
Tingling pins and needles throughout body, especially in hands, arms, feet and legs for over two weeks and not going away.
Stiff neck, severe head ache. Enlarged painful lymph nodes entire neck both sides, mouth sores flu like symptoms, pain joints, muscles in bed about 3 weeks, first time out of house was to friends for Thanksgiving dinner.  Problems continue at some point developing neuropathy in feet, painful joints hands, etc.  Rheumatology ruled out psoriatic arthritis and Sjogrens syndrome.  Rh said "sounds bacterial".  Some days feel okay do things around house or run errand then out of blue next day or several days I'm in bed again it keeps kicking my ass. Illness continues with no diagnosis.
Right upper arm, red, sore, temp increase and swollen. Size at evaluation 3 x 4". Improving in all aspects.
Fever, skin pain nausea. Very low blood pressure. The fever last for 6 hours and the episode of blood pressure was in the next morning.
After my vaccination I started to come down with symptoms that I have had physical therapy for both mid back lower back and neck.  09/27/2022 Cortisone shot in shoulder greatly improved my right shoulder and will being physical therapy for it, however neck is worse. X-ray done before cortisone shot. Physical therapy has greatly improved my symptoms for my hip and back.
Pulse was elevated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Pulse was elevated) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the patient.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced TACHYCARDIA (Pulse was elevated). At the time of the report, TACHYCARDIA (Pulse was elevated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21) for COVID-19 vaccination.     The patient's past medical history included Diarrhea and Full term baby. Family history included Family history of cancer (Family history of breast cancer, paternal aunt and grandmother). Concurrent medical conditions included Hyperlipidemia since 12-Aug-2020, Hypothyroidism, Migraine headache since 13-Mar-2018 and Breast nodule (Benign nodule of breast of right). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN ALMUS), RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ODT), FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), RIBOFLAVIN SODIUM PHOSPHATE (RIBOFLAVIN [RIBOFLAVIN SODIUM PHOSPHATE]), MAGNESIUM, UBIDECARENONE (COQ 10) and VITAMIN D3 for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment details were reported. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Exposure via ingestion: not reported not reported. On an unknown date, Investigation: not reported not reported, not reported not reported, not reported not reported, not reported not reported, not reported not reported, not reported not reported and not reported not reported. On an unknown date, Laboratory test: not reported not reported. On an unknown date, Physical examination: not reported not reported. It was stated that on an unknown date patient delivered child prior to the vaccination and pregnancy outcome reported as live full term birth.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2022: Upon internal review on 24-Feb-2022, significant corrections were performed: patient was not pregnant and event maternal exposure during pregnancy was deleted.
wife is reporting that his right arm felt like it was on fire and like he had hot fingers.  About 30 hours after taking the vax he felt hot at the core and felt like his breath was hot when he was breathing out.  He went to PCP. had blood work with normal results.  He has not developed chest pains and a feeling of heaviness on the left side of this body.  He is feeling weak, tired and BP is elevated. He went to medical facility.  He had a CTA.  He was discharged to go home and FU w/ PCP where the test results were sent.
diarrhea; drowsy; red due to the scratching; rash; itching; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cetirizine hydrochloride (Zyrtec) unknown for pruritus.   On 27th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Zyrtec at an unknown dose once daily. On 1st March 2019, 2 days after receiving Shingrix and not applicable after starting Zyrtec, the patient experienced generalized rash and generalized pruritus. On 2nd March 2019, the patient experienced erythema. On an unknown date, the patient experienced diarrhea and drowsiness. The patient was treated with hydrocortisone and ciprofloxacin hydrochloride (Cipro). On an unknown date, the outcome of the generalized rash and generalized pruritus were recovering/resolving and the outcome of the diarrhea, drowsiness and erythema were unknown.   The reporter considered the generalized rash and generalized pruritus to be related to Shingrix. It was unknown if the reporter considered the diarrhea, drowsiness and erythema to be related to Shingrix. It was unknown if the reporter considered the generalized pruritus to be related to Zyrtec.  Additional details were provided as follows: The patient received 1st dose of Shingrix Two days later she noticed a rash in the evening across her chest and abdomen accompanied by some mild itching. The next morning, the rash was gone but the itching intensified and was spreading to various parts of her body. It started on her right ear lobe that became red due to the scratching. It then moved to her back, shoulders, down the inside of her thighs, genitals, and elbows and eventually went to the bottom of her feet.  She saw the dermatologist on 4th March 2019, and was given hydrocortisone cream. She had to get up several times during the night to apply it to her body. She also had diarrhea for the first time in her life so she saw a gastroenterologist who prescribed Cipro which she took for 3 days. While taking the antibiotics, the itching resolved but started again once she stopped the medication. She started taking Zyrtec once a day and the itching went away. Because it was making her drowsy, she stopped taking Zyrtec and the itching returned. The rash came back across her chest on 21st May 2019, along with the itching which started on her left arm below her elbow She took a half Zyrtec last night which helped. The reporter consented to follow up. The emergency room visit required.
CMA pulled wrong Diluent. She used the sterile water for the MMR /VAR
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was respectively vaccinated three doses of GARDASIL (lot number unspecified) intramuscularly on 15-OCT-2012, 18-DEC-2012 and 22-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Pt experienced syncope within 30 minutes of injection. Pt was held for more minutes until symptoms and vital signs normalized.
No adverse event; Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022).    Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-691560 (Linked Report).; Sender's Comments:  MOD-2022-691560:Original Case : MOD-2022-691256
Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for 3 days Muscle pain for 2 days Joint pain (right knee swollen and painful) for 2 days UTI started 4 days after vaccine
Acute muscle spasm-neck, shoulders, arms, legs, back. Kidney pain, fever 102.4. Chest and rib pain with trouble breathing, chills then sweats, dizzy and weakness, dehydrated-some trouble remembering. Treated-IV drip-toradol robaxin, stadol and (one other).
>> Oct 18, 2021  8:19 AM wrote: Patient called because she started with coughing this weekend. It has gotten worse since it started. Patient has asthma and she is worried she is going to start wheezing. Denies SOB. Patient said she feels very tired and she feels a little warm. No temperature reading to report. Office Visit  10/19/2021 medical facility, MD  Internal Medicine Suspected COVID-19 virus infection  &  Flu-like symptoms  Duration of the symptoms sat afteroon  Cough  yes Fever no Myalgia yes Headache  yes Sinus congestion yes History of allergies yes Dyspnea no Recent travel/immobility/surgery no Sore throat no Smoking no Sputum production yes   Chest pain no   Diarrhea no Nausea/vomiting no Loss of smell or taste, abdominal pain, and rhinorrhea no Exposure to anyone with the same symptoms yes to husband Recent travel no
Throat is extremely sore; Sores on her tongue; Dizziness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Throat is extremely sore), STOMATITIS (Sores on her tongue), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpes simplex (Herpes simplex outbreaks around the mouth.). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes simplex.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Throat is extremely sore), STOMATITIS (Sores on her tongue), DIZZINESS (Dizziness) and FATIGUE (Fatigue). At the time of the report, OROPHARYNGEAL PAIN (Throat is extremely sore), STOMATITIS (Sores on her tongue), DIZZINESS (Dizziness) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No relevant concomitant medications reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
temperature of 101.5; muscle pain; joint pain; nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (temperature of 101.5), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Mar-2021, the patient experienced PYREXIA (temperature of 101.5), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (temperature of 101.5), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea) outcome was unknown.
PATIENT HAD LOWER BACK PAIN 10 MINUTES AFTER IMMUNIZATION...RIGHT LEG WAS WEAK & WAS TEMPORARILY UNABLE TO WALK.
Patient is a 14 year old male with no past medical history who was transferred from an outside hospital ED for new onset chest pain that started 2 days after he received his second dose of the COVID vaccine, with ST elevation EKG changes concerning for pericarditis.  EKG upon admission at another facility also demonstrated diffuse ST elevation.  Echocardiogram was normal.  Troponin values at the outside hospital and at other facility were both normal. During his admission he was started on ibuprofen TID and famotidine BID.  His chest pain resolved and he was discharged home with specific return precaution and follow-up appointments with cardiology in 2 weeks and his PMD in 1 week.
Per employee, "left arm lymphedema, golf ball sized under arm, slightly across top of breast and under lateral breast.  Still experiencing tenderness to where largest lymph node swelled up."
99.2 degree fever; Rash; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (99.2 degree fever), INJECTION SITE RASH (Rash) and FATIGUE (Tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced PYREXIA (99.2 degree fever), INJECTION SITE RASH (Rash) and FATIGUE (Tired).   At the time of the report, PYREXIA (99.2 degree fever), INJECTION SITE RASH (Rash) and FATIGUE (Tired) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Pt had vaccines in office 8/29/17-no reactions or symptoms that day. Pt woke up 8/30/17 complained of not feeling well-got dizzy, nauseated, and lost conscience for about 30 sec. No seizure activity noted.
Within 5 minutes of receiving the vaccine, patient experienced anxiety, shortness of breath, and body aches in her elbows, knees, and ankles.  Vital signs were normal.  No lip/tongue/throat swelling on exam.  She was pale and diaphoretic. Symptoms resolved in 35 minutes with laying supine and applying cold cloth/compress to neck and upper chest.  She developed a headache at 40 minutes, however it was mild and it did not cause her to stay for monitoring any further.
Information has been received from a physician concerning a female consumer who on an unspecified date in February 2007, was vaccinated SC with a dose of Zostavax (Oka/Merck). Subsequently, after a long drive the patient developed fatigue. She was so fatigued that she was in bed for three days. After the return drive she had to stay in bed for a week, due to fatigue. The patient also reported small areas on different parts of her body where red rashes have devleoped, most recently on her wrist. At the time of the report the fatigue had resolved but the rashes persisted. Unspecified medical attention was sought. No further information has been requested. This is a consolidation of two reports concerning the same patient. Follow-up information from the physician indicated that the 65 year old white female retired accountant with osteoporosis who on 15-MAR-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) in the left deltoid. There was no illness at the time of vacination. In September 2007, the patient experienced profound fatigue and was in bed for 3 days. Generalized dysnethesia followed by a rash like "chickenpox" on the arms, legs, forehead and nose were also noted. No labs or diagnostic studies were performed. It was initially reported to the physician via phone that the patient was "still breaking out." In September 2007, VALTREX was requested. Additional information has been requested.
Redness of upper arm.  Swelling and hot to touch.  Tender.  Pain refers to neck and ear.  Itching in upper arm.  Some nausea.
Full Body Aches; Freezing Chills; Headache; Frequent Urination; Constant Yawning; Swollen Lymph Node In Injection Arm; Fatigue; This is a spontaneous report from a contactable Other Health Care Professional, reporting for a 49-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: unknown), via intramuscular, administered in left arm on 26Jan2021 at 16:45 (at the age of 49-year-old) as 2nd dose, single for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1686) intramuscularly in left arm on 05jan2021.The patient medical history includes diabetes mellitus, obesity and smoker and concomitant medications include Metformin, Glipizide, Atorvastatin, Amlodipine, Omeprazole, Vitamin D, Fish Oil, Baby Aspirin. The patient had history of lisinopril allergy. Patient was not tested Covid-19 positive prior vaccination. On 27jan2021, 15hours 30 minutes after the vaccination, the patient experienced Full Body Aches, Freezing Chills, Headache, Frequent Urination, Constant Yawning, Swollen Lymph Node in Injection Arm, Fatigue. The reporter assessed all events as non-serious. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.
Began having abdominal pain and diarrhea after shingles vaccine going on over 8 days now. Diarrhea,chills, abdomenpain.
head ache , dizziness ,  upset stomach , weakness ,  loss of balance ,  soreness in shoulder/joint lasted about 12 hours
Right arm red, swollen, warm to touch. Area 15cm /2. Redness and swelling noticed 7/26/05. Pt. appt with MD on 7/27/05. Started on zyrtec and prednisone po.
This study case was received from the investigator in a trial on 27 January 2014. A 36 year old female subject, developed mild chest pressure, considered mild in severity, 9 days after she received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 08 January 2014 and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported on 08 January 2014). On 17 January 2014, 9 days post vaccination, the subject experienced intermittent episodes times three of chest pressure lasting seconds, since vaccination. On 23 January 2014 the Troponin I result was reported as normal, less than (<) 0.10 ng/mL. On 23 January 2014, electrocardiogram (ECG) was reported as normal. The patient had an abnormal ECG on an unspecified date in 2008. The subject was referred for care. The subject did not seek medical attention and did not require any further evaluation. The patient was well and asymptomatic at the second visit. The chest pressure was considered resolved on 20 January 2014. The patient's outcome was reported as recovered, referred for care. According to reporter, no further information was expected to follow. According to the investigator, the event of chest pressure was considered other important medical events and possibly related to the trial product. Documents held by sender: None.