chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WEAKNESS (NO STRENGTH); SEVERE SHAKY CHILLS; SEVERE HEADACHE; TIREDNESS; BODY ACHES; LOSS OF APPETITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient had no abuse or illicit usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043821A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced severe shaky chills. On 12-APR-2021, the subject experienced weakness (no strength). Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, severe shaky chills, severe headache, tiredness, and weakness (no strength) on 13-APR-2021. This report was non-serious.
Fatigue, fever (101.9 and 102 on days 9 and 10) begining 7th day after given MMR vaccine. Localized reaction on 4th day after given MMR vaccine. Arm redness, soreness under arm and around shoulder.
2" x 3" reddened area, warm to touch, on left upper deltoid.
Severe Flare-up of joint pain in ankles, knees, shoulders, elbows, wrist, &  hands. Treating with prednisone 5mg tablet daily and at night before bed, also Equate 8 hr  arthritus pain relief, 650mg, 1 tablet up to twice a day.
PATIENT REPORTED A RASH ON ARM BELOW THE INJECTION SITE; STATED RASH WAS HOT TO TOUCH.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient Fainted. Responded to slight shake and was able to communicate with pharmacist. Patient reported he had previously fainted from immunization as child, but did not feel necessary to report on information sheet. The outside temperature was very warm and he had been working outside and had not eaten. When paramedics arrived and took blood pressure, 100/?, slightly low but patient was feeling better and less light headed. Patient was able to stand without fainting and leave.
weakness, severe joint pain & swelling, body aches, body rash, bedridden for 2 days;
This is in follow-up to report(s) previously submitted on 2/14/2007; 4/6/2007. Information has been received from a physician concerning an 18 year old female with no past medical history who on 29-DEC-2006 at 10:00 AM was vaccinated with a first dose of GARDASIL (yeast) (lot # 654885/1424F), intramuscularly in the left arm. Concomitant therapy included CRYSELLE and "Flintstones multivitamins." There was no illness at the time of vaccination. On 29-DEC-2006 at 5:00 PM the patient initially developed hives around injection site, but then developed approximately 10 hives over entire body." It was also reported that the patient developed malaise and fever, also had a sore arm such that she felt she couldn't move it for 24 hours. It was also reported that there were no other symptoms reported. There were no relevant diagnostic tests or laboratory date. The patient recovered on 30-DEC-2006. In follow up it was reported that the patient had been given a 2nd dose of GARDASIL with ZYRTEC and BENADRYL administration and had no reaction. Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2007. It was reported that "used 1% hydrocortisone cream but no oral meds, resolved by next day".
Lung right upper lobe   ( Malignant )cells present )  Lymph node (Left level 4 )level 7
Sore arm; Low grade fever (101); Swollen lymps (throat); Swollen lymps (throat); Lethargy; This is a spontaneous report from a contactable consumer (patient). A 31-years-old (non-pregnant) female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EL8982), dose 1 intramuscular in arm left on 28Jan2021 at 15:45 (at the age of 31-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history included anxiety. The patient did not had allergies to medications, food, or other products. Concomitant medication(s) included escitalopram 15 mg and pyridoxine hydrochloride (VIT B6) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 at 16:00, the patient experienced sore arm, low grade fever (101), swollen lymph (throat) and lethargy. The patient underwent lab test and procedures which included body temperature 101. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Pt recvd vax 1130AM 27APR92-pt reported awakening @ 3AM 28APR92 w/"hard chills & fever" (temp not measured); pt felt severe aching in joints & bones & was unable to go to work; felt sleepy most of day; stomach queezy; little soreness @ site
Chills and extreme tiredness- no medical treatments were given. I slept and put on extra blankets. The symptoms were present when I woke up the next morning around 7am and gone when I woke up the morning after around 9am.
felt like he got hit by a truck; Sore arm; was very tired requiring he nap; achy; This case was reported by a other health professional via sales rep and described the occurrence of feeling abnormal in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix .5 ml. On 16th November 2019, 1 days after receiving Shingrix, the patient experienced feeling abnormal, pain in arm, tiredness and pain. On an unknown date, the outcome of the feeling abnormal, pain in arm, tiredness and pain were unknown.   It was unknown if the reporter considered the feeling abnormal, pain in arm, tiredness and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, however the patient could be 88 or 89 years old. The patient received a dose of Shingrix in left arm. The patient felt like he got hit by a truck and his symptoms included sore arm, was very tired and required nap. The patient was achy. The reporter did not give consent to follow up.
On going symptoms : chills body ache head ache nauseous it?s been just under a year since i recovered from covid 19
This spontaneous report as received from a pharmacist refers to a 67 years old male patient. The patient's medical history included kidney removed, three weeks ago in approximately 07-JUN-2013. There were no drug reactions or allergies reported. On 26-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose unspecified) (lot # J001009, exp. date 24-APR-2014) subcutaneous in the right arm. Concomitant therapies included VIAGRA. Pharmacist reported that after ZOSTAVAX administration, on 27-JUN-2013, patient experienced redness, itching, and swelling at the injection site. On 28-JUN-2013, the patient went to the pharmacy to seek advice from pharmacist. Pharmacist recommended the patient take BENADRYL. The outcome of redness, swelling, and itching at the injection site was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Additional information has been requested.
Vomiting (3 episodes), Fever ( up to 102F) that lasted for 2 days, chills, aches, generalized weakness
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was coronary artery disease. She had a CABG x 2.
I could feel the fluid going into my arm. Not much pain in the arm after the shot. That evening around 8:30 I started to get sharp burning pain in my back right side around my rib cage and under my right breast also pain in my right jaw area. Took 1000mg TYLENOL went away eventually, slept well. Next day around 3:30 the pain came back in the same areas took 1000mg TYLENOL pain eased up again.
Case number PHEH2014US019850 is an initial spontaneous report from the health care professional received on 30 Sep 2014. This report refers to a 54-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1410701) at a dose of 0.5 ml intramuscularly on 29 Sep 2014. On the same date, after vaccination she experienced swelling and tenderness at injection site. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
2 days after receiving vaccination, patient developed abdominal cramping and watery diarrhea, as well as a persistent frontal/temporal headache bilaterally
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (inhaled). On 25th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on Left deltoid. The patient received SHINGRIX and experienced soreness in his left arm. The patient had denied permission to contact their physician. This case was linked with case US2018176527, reported by same reporter.
LEGS SWELLING/ SWELLING IN CALF MUSCLE; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, atrial fibrillation (afib), non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced legs swelling/ swelling in calf muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from legs swelling/ swelling in calf muscle. This report was non-serious.
On Sunday, Feb. 14, I awoke to find my left arm paralyzed. I was unable to move  my fingers or thumb. Could not hold anything. Towards the end of the day, I got feeling back in my thumb, first and middle fingers. the outside of my hand, the ring finger and little finger were still numb and I had no control over them. Could not keep them straight. Since Monday was a holiday, the clinic was closed so I sent an email to Dr. explaining the situation. He told me to report to the CDC and that he would refer me to a neurologist. My two fingers and the outside of my hand are still numb. I have seen Dr. and have been referred to a hand therapist.
This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. The patients concurrent conditions, medical history and concomitant medication were not reported. On 15-JUN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 as prophylaxis, lot number reported as L033707 and expiration date 18-MAY-2017 (dose, frequency, route and anatomical location were not reported). No adverse events were reported. There was no product quality complaint (PQC) involved.
Mild weakness on day 2.  Marked swelling and pain of axillary lymph nodes. Lasted 48 hours
Initial report received from a non-healthcare professional on 05 November 2012. A 68-year-old female patient, whose allergies included Amoxicillin, Erythromycin and Bactrium and concomitant medications and illness at the time of vaccination were not reported, had received an intramuscular dose of ADACEL vaccine in left deltoid (batch number: C4313AA) on 26 October 2012. The reporter stated that, after vaccination the patient returned to the office on 01 November 2012 with rash, redness, swelling at vaccination site and sore arm. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Follow-up information received from a health care professional on 18 March 2013. Based upon the new information provided, this case has been upgraded to serious due to diagnosis of cellulitis. The patient also received a dose of Influenza vaccine, Novartis, lot number 1204101, (route not reported) in the deltoid (side not reported) on 05 October 2012 (within four weeks date of ADACEL Vaccine). The patient had allergies reported as Amoxicillin causes rash, Erythromycin causes stomach ache, and BACTRIM (previously reported as Bactrium) (reaction not reported). Concomitant medications included Aspir-Low, CRESTOR, Calcium, and CENTRUM SILVER ULTRA WOMEN'S vitamin. The patient was a non-smoker and denied alcohol use. The patient had an office visit on 01 November 2012 and she presented with rash on her left arm. According to medical record, the patient had received a dTap vaccine two days ago (date of ADACEL vaccine was reported as 26 October 2012), (which makes latency six days), but the redness and swelling was getting worse and arm was reported as swollen and itchy. The patient had no fever or systemic symptoms (sx) and denied pain. She did report some itchiness. The patient's height was reported as 59.75 inches (150 centimeters) and weight was reported as 155 pounds (lbs), (70 kilograms). The patient's vital signs were reported as: temperature 98.9 (37.1 degrees Celsius); blood pressure 130/80 and pulse 72. Review of symptoms was negative. Physical exam was normal, except for skin: 6 X 6 centimeter (cm), erythematous and warm macular lesion over left upper arm and elbow area, reported as exam consistent with a cellulitis. There was no open wound. The patient was diagnosed with cellulitis and abscess. Treatment included KEFLEX 500 milligram (mg) one tablet (tab) three times a day (tid) for seven days and ice. The patient was instructed to return to office (RTO), if not improving or systemic sx. The patient's outcome remained recovered on an unspecified date. List of documents held by sender: Medical Record.
Redness and swelling at the injection site, and warm to the touch, but reaction is localized and swelling is improving.
Lip swelling; Adverse drug reaction; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lip swelling) and ADVERSE DRUG REACTION (Adverse drug reaction) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Angioedema. Concomitant products included HYDROXYCHLOROQUINE from 01-May-2016 to an unknown date for an unknown indication.   On 01-May-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced LIP SWELLING (Lip swelling) and ADVERSE DRUG REACTION (Adverse drug reaction). On 21-May-2021, LIP SWELLING (Lip swelling) and ADVERSE DRUG REACTION (Adverse drug reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received concomitant drug Hydrochloroquine from  01-May-2016 (400mg, 200 mg, 2 in 1D). The patient received Humira from 01-May-2002 to 21-May-2021. The patient received 2nd dose of Moderna on 21 May 2021  (intramuscular) and 3rd dose on 21 Jan 2022 (intramuscular). It was reported that the patient experienced adverse reaction to Humira and lips swelled. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event adverse reaction to Humira and lips swelled with Humira was a reasonable possibility.  No information on treatment medications was reported.
3 days after receiving vaccine, started to have episodes of vertigo that last as long as 2 hours. 6 days after vaccination, he continues to have episodes of vertigo limiting his ability to return to work.
RIGHT SIDE OF BODY HURTS, DIZZY, NAUSEA, FEELS WEAK, BODY ACHES, FATIGUE, HEADACHE
Pt developed severe cellulitis requiring 2 ER visits, antibiotics & pain medications.
Pt came in for a total of four vaccines: Boostrix, Prevnar 13, Flu HD, and Shingrix.  I started with Boostrix and Prevnar 13 in the left arm. Boostrix was first, in upper portion of deltoid. Prevnar 2nd, 2 inches below Boostrix. After the pt received the Prevnar 13 vaccine, the wife noticed the pt had a blank stare. When she asked how he was feeling, he could only mumble. At that point I told her to call 911 and I grabbed for the EpiPen. In the meantime the wife went to lay him down and he fell over. Before I administered the EpiPen the pt came too and was confused and unaware of what occurred moments before. The wife noticed he had peed himself. Paramedics showed up to the scene and took over. The pt was come to become more aware and said he was just feeling lightheaded. The pt did say that he had begun to fell lightheaded after the fist vaccine, boostrix. The paramedics took him to the hospital for further care
BURNING HEADACHE; BLURRY VISION; DIZZINESS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, expiry: UNKNOWN) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced dizziness. On 20-JUN-2021, the subject experienced blurry vision. On 02-JUL-2021, the subject experienced burning headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning headache, blurry vision, and dizziness. This report was non-serious.
Patient has experienced transient hive-like welts that resolve without treatment. They do not itch most of the time. They appear suddenly. They first appeared on 11/14 and still experiencing as of 11/17 when patient contacted pharmacy. She was instructed to take Benadryl and monitor for worsening of symptoms.
pt stated that about 5 hours after getting the vax she got a sharp pressure pain in her chest and upper back area and her heart rate went up.  Pt said it took about 4 1/2 hours for this pain to subside.  She contacted her doctors nurse on 3/5/2021 and the PCP will get back with her next week.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date:08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; No adverse event; Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022 at 11:49 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 11:49 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    Concomitant medication information was not provided.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  No adverse reactions had been reported for the patient as per the reporter's knowledge.  No treatment information was provided.
Information has been received from a physician via a company representative concerning a 17 year old who on an unspecified date was vaccinated with Gardasil IM.  On approx 07-FEB-2008, "about 3 weeks ago" the patient developed neurological symptoms and was hospitalized for one week.  The neurologist at the hospital diagnosed her with Miller Fisher variance of Guillain-Barre syndrome.  At the time of reporting the patient "improved but she's undergoing therapy" and has not recovered.  No further information was provided.  The reporter felt that Miller Fisher variance of Guillain-Barre syndrome was disabling and required hospitalization.  Additional information has been requested. 4/8/08-records received for DOS 2/6-2/12/08- DC DX: Guillain-Barre variant.  Developed cough and diarrhea week prior to admission. Also had vomiting and fevers. On morning of admission developed tingling in hands and feet and dysarthric speech, blurry vision and difficulty with walking. Treated with IVIG with improvement of ataxia and dysarthria.  CDC's CISA staff has reviewed this case and concluded that this case is not GBS.