chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body ache; Fever (101.9); Chills; Headache; Muscle ache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), MYALGIA (Muscle ache), PYREXIA (Fever (101.9)) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (prior covid-19 infection) in September 2020. Concurrent medical conditions included Lupus erythematosus.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache) and HEADACHE (Headache). On 18-Mar-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever (101.9)) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), MYALGIA (Muscle ache), PYREXIA (Fever (101.9)), CHILLS (Chills) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature increased: 101.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
This spontaneous report was received from a licensed practical nurse, concerning 31 patients of unknown age and gender, who were vaccinated with a dose of M-M-R II (dose, dose number, lot number, expiration date and route were not reported), 6 doses of lot number K002528 (expiration date not provided) and lot numbers reported as 10 doses of K009894, 5 doses of K011313 and 10 doses of J016234, that underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt began to faint while receiving vaccine.  Via w/c to Observation area.  Alert, diaphoretic & taking liquids.  Ice pak to neck & improving rapidly.   Dismissed w/o assistance.
04/21/2022 - morning after 2nd COVID booster: ? couldn't sleep, got up at 5:10am ? was able to walk pups and make coffee ? felt need for BM but stool was hard & stubborn ? aborted attempt, moved around, sipped some coffee, and tried again ? was able to go but a loud SHUSHING began in my ears ? pulse was 51, BP was 108/68 - very low for me as my BP runs around 140/81 ? stood up and vision was blurry, I felt dizzy ? made it to recliner and rested for a few minutes ? pulse and BP still low ? after a few minutes, attempted 2nd bathroom trip ? as I walked, my vision became blurry, and I felt REALLY dizzy ? I felt myself going down, I tried to hold onto the wall to remain standing ? didn't work, I went down, feet slipping out from under me in slow motion ? laid there a minute and then got back up and went to bathroom ? BP and HR were still dancing around 108/70 and 53 respectively, and I spent most of the day on the recliner ? BP and HR for the rest of the morning: o 7:45am - HR is 58, BP is 109/68 o 8:45am BP - 110/65, HR 63 o 9:45am BP - 108/70, HR 67 o 12:18pm BP - 108/67, HR 58 o 1:08pm vitals seem to normalize; BP - 140/85, HR 66 (normal) Considerations: ? I had a stroke from a Patent Foramen Ovalle (PFO) back in 2006.  o I had NO reaction to the initial vaccinations or the booster. o These symptoms were disconcerting. ? I started NOOM in December and have lost 36 pounds so there is less of me than there was back on October 23rd when I got the first booster.
Narrative: Patient is a 65 yo man with history of TBI, T2DM, HTN, HLD, CAD, kidney stone, cognitive-communication deficit and hydrocephalus due to 3rd ventricle, hypothyroidism and HTN, HLD presented for fever and altered mental status. He has cognitive disorder at baseline and unable to reach spouse via phone. Therefore, most of the history is obtained from the medical records and ED notes. He was brought in by wife due to worsening cognition. Per note, he was exposed on Sunday and tested positive for COVID today. He has received covid vaccination. He started fever today and started to become combative and more confused. He also had a headache. He denies dyspnea, nausea/vomiting, diarrhea, cough, weakness or urinary incontinence. Date of onset of symptoms: 9/2/21. Patient with mild hypoxia with recurrent fever to 101.1 in the afternoon on 9/4/21. Patient with mild hypoxia with recurrent fever to 101.1 in the afternoon on 9/4/21. Using 2LNC for sat of 94%. Patient was initiated on Remdesivir and dexamethasone for COVID-19 infection.
The day after the Tetanus/diphtheria vaccine was given to the patient, she noted pain at site (left deltoid) by evening of next day (07/13/2003) she had rash spreading over arms, chest, and abdomen.  No fever or shortness of breath noted.
My wife has a breakthrough case; My wife has a breakthrough case; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My wife has a breakthrough case". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The COVID-19 vaccine administered through vaccine administrator, Health, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Mother called saying client complains of headache posterior, back of neck, fever 100.5 oral, no rash, started am after shot, progressed, no vomiting.
This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 62 year old male patient with hypothyroidism, hypertension, hypercholesterolaemia, glaucoma and no allergies who on 28-APR-2008 was vaccinated SC in the  left arm with a dose of zoster vaccine live (Oka/Merck) (Lot # 659614/0161X). Concomitant therapy included hydrochlorothiazide, unspecified glaucoma drops and levothyroxine Na (SYNTHROID). On 01-MAY-2008 the patient experienced itching, redness, warmth and pain at the injection site. The patient was examined and prescribed cephalexin (KEFLEX), ice, ibuprofen (MOTRIN), and diphenhydramine hydrochloride (BENADRYL). The patient was instructed to call the physician if the symptoms persisted. The patient had not contacted the provider as of 05-MAY-2008. No additional symptoms or treatment were provided. No diagnostic laboratory tests were performed. As of this report, the patient was recovering. No product quality complaints were involved. Additional information has been requested.  Follow up information was received from the physician concerning a 62 years old male patient, with thyroid cancer, hypertension, increased cholesterol, glaucoma and impaired fasting glucose, who on 28-APR-2008 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 659614/0161X). The patient developed a large area of erythema, induration, warmth and pain. The patient was placed on antibiotics because it resembled a severe cellulitis. At the time of the report, the patient recovered from the AEs. No diagnostic tests were performed. There was no illness at the time of vaccination. No further information is available.
pt had vax about 3PM mom came home from work @ 1AM following morning pt lt arm was red swollen, painful, unable to lift arm well; mom stated had elevated temp; did not take it w/thermometer; taken to ER told probably reaction from shot;
In regards to her COVID-19 positivity, she took a home test on 11/07 when she noted a runny nose and sneezing.  She quarantine for 10 days and denies any continued symptoms.  Denies chest pain, shortness of breath, abdominal pain, nausea, vomiting, headache, dizziness, fevers and chills.
Patient was given the second dose too early. Was given at day 13 instead of day 21.
improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-SEP-2021, the patient was vaccinated with an improperly sored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Pt c/o dizziness. Denies LOC, nausea, diaphoresis. Brought to med obs #1 via wheelchair with staff and spouse. Ambulatory from wheelchair to stretcher independently. Gait steady. Pt offered water and crackers. No worsening of symptoms reported by patient. Orthostatic VS obtained. VS are as follows: lying: BP 151/94, HR 97, RR 17, O2 sat 97% on RA. sitting: BP 123/83, HR 61, RR 18, O2 sat 99% on RA standing: BP 121/84, HR 100, RR 18, O2 sat 99% on RA VSS. No s/s of distress noted. Pt escorted to exit with staff and spouse, refused wheelchair.
I'm hoping since I was vaccinated I'll be over them soon/Suspected vaccination failure; Now I have shingles; Pain is driving me crazy; Itching is driving me crazy; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient's mother had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got the shingles vaccine as soon as he/she was eligible because the patient's mother had shingles and the patient didn't want them. At the time of reporting the patient had shingles and hoping he/she would over them soon, since the patient was vaccinated.  Pain and itching was driving patient crazy. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
little arm soreness from the vaccine; accidentally administered an expired vaccine today 7Apr2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (little arm soreness from the vaccine) and EXPIRED PRODUCT ADMINISTERED (accidentally administered an expired vaccine today 7Apr2023) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, the patient experienced PAIN IN EXTREMITY (little arm soreness from the vaccine) and EXPIRED PRODUCT ADMINISTERED (accidentally administered an expired vaccine today 7Apr2023). At the time of the report, PAIN IN EXTREMITY (little arm soreness from the vaccine) had resolved and EXPIRED PRODUCT ADMINISTERED (accidentally administered an expired vaccine today 7Apr2023) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PAIN IN EXTREMITY (little arm soreness from the vaccine) to be related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered an expired vaccine today 7Apr2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    The patient said she was fine. All she had was a little arm soreness from the vaccine. The expiration date was reported as 02-FEB-2023. No treatment information was reported.
Burning sensation in legs, arms and chest and sore throat within four hours of taking vaccine. Severe headaches, ringing in my ears, pain behind skull, tighten of jaw, pain in teeth, heart racing, dizzy, nauseous and light headed within days I would say two or three days. Severe anxiety but not normal like my adrenaline was spiking randomly.
no AE; temperature excursion/products were administered; This spontaneous report was received from a medicall assistant and refers to a 9-week-old female patient. Concurrent conditions icluded growth restrictions (birth weight 2.49 kg) and flattening of the skull from positioning. Historical vaccines included hepatitis B vaccine (manufacturer unknown).   On 17-NOV-2021, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707459, expiration date 27-MAR-2022, 2 milliliter, orally for prophylaxis and improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T042012, expiration date 22-JUL-2023 for prophylaxis. Also on that day, the patient was vaccinated tetanus vaccine toxoid (PEDIARIX) lot # 9X3T5, expiration date 05-MAR-2023 and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) lot # EJ4558, expiration date 01-JUL-2023. There were no adverse reaction.  On 16-NOV-2021, the temperature excursion was 62 degrees Fahrenheit, for a time frame of 12 hours. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2111USA008845:
Varicella vaccine administered 12/7/15 client developed lesions over arms and torso 1/3/16.
Pt given PROQUAD (MMR and varicella) at wrong age. Given at age 6 weeks.
Left arm developed itchiness at site of injection on 4th day after vaccine with swelling and rash. 2/13 - bilateral leg rash, had some swelling to BLE. Pt states used compression stockings, and that it helps with swelling, pt states has bilateral leg swelling at baseline. Pt reports rash is improving, but still present, not spreading. Denies any fevers, red streaks, spreading redness/swelling, CP, SOB, dizziness/weakness, drainage, open areas, or any other associated symptoms. Pt states has been using cool compresses
Red rash at injection site that showed up 8 days after receiving the first dose of the Moderna vaccine. I have taken Benadryl and noticed that the swelling subsided. Rash persists.
This case was reported by a consumer via call center representative and described the occurrence of tenderness in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 26th August 2018, the patient received the 2nd dose of SHINGRIX. On 26th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 28th August 2018, the patient experienced tenderness, influenza-like symptoms and neck pain. On an unknown date, the outcome of the tenderness, influenza-like symptoms, pain in arm and neck pain were unknown. It was unknown if the reporter considered the tenderness, influenza-like symptoms, pain in arm and neck pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. The patient had no issues with the first dose of SHINGRIX. The patient received SHINGRIX in the right arm and 2 days later, experienced tenderness in the artery of the right side of his neck that then traveled to his ear and to his head and flu like symptoms. The patient was seen by his physician, who did an ultrasound of his artery and it was clear. The contact details of the physician was provided.
Two days after vaccination on 3/3,  deep, sharp pain in the upper right portion of the chest and the upper right back, to the point of painful inability to breath beyond shallow breaths.  This pain subsided, but returned shortly after contracting and testing positive for Covid-19 on the 3/12, at which point i decided to go to the hospital emergency room, Well I was tested for and found to have a PE (pulmonary embolism )  in the upper right portion of my right  lung.
nausea within 1/2 hour.  congested and runny nose within 1 hour.  within 24 hours sore throat, cough, vomiting.  Still has runny nose and cough.
Hives, intense itching head to feet, came and went for two days, then solid for 18 hours until sought help at urgent care. Received steroid shot and prednisone, Pepcid, and Zyrtec and Benadryl. Back to normal after 10-12 hours. This was the booster, first two shots were January 18, February 15, hardly any side effects with those.
Patient had full blown chicken pox on 10/10/06 and has been treated with Acyclovir 200/5 ml QID for 7 days.
Numbness in toes; Tingling sensation in toes; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in toes) and PARAESTHESIA (Tingling sensation in toes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: CIPROFLOXACIN (ciprofloxacin 500 mg). Concomitant products included THIOTHIXENE HCL and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in toes) and PARAESTHESIA (Tingling sensation in toes). At the time of the report, HYPOAESTHESIA (Numbness in toes) and PARAESTHESIA (Tingling sensation in toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No symptoms for a week. 8 days after injection, injection site swelled and became red. Hot to the touch. Itched and stung. Continued to swell down arm to elbow (as of 14 days post-injection).
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Nov2022, outcome "not recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I just tested positive for COVID but I have been dealing with COVID for the last 16 days; (11Nov2022) Positive, notes: I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today; (22Nov2022) Negative, notes: I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today; (26Nov2022) Positive, notes: I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Consumer stated, Well I am vaccinated with Pfizer (Clarified as Pfizer covid-19 vaccine) and I just tested positive for COVID but I have been dealing with COVID for the last 16 days. So, I was on paxlovid, I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today. Consumer was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. Consumer was provided with the number of Pfizer Medical Information # (number withheld) and was requested to select option 3, timings. Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. Consumer stated, Well I am vaccinated with Pfizer (Clarified as Pfizer covid-19 vaccine) and I just tested positive for COVID but I have been dealing with COVID for the last 16 days. So, I was on paxlovid, I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CMA administered second dose of Covid 19 vaccine using Pfizer manufacturer Lot 3EW0186.   Patient reported  reaction as "rash and burning up" on vaccine second dose consent form from receiving Moderna vaccine  #1 dose given 12/29/2020.   Patient was monitored and no adverse reaction to second dose was observed. Patient was released with no side effects.
COVID positive Patient presented to ED for increasing SOB At baseline on 4L O2, she increased it to 10L  Treating with dexamethasone, remdesivir, antibiotics, nebulizers
pt recv v ax & that noc or the following day pt again devel raised pimples @ the inj site;rash lasted 304 days;no tx was given;
Injection site with approx 2 cm "blister" filled with serous drainage, surrounded by reddened area, perhaps as large as 10 cm. Reported light-headed and near-syncope. Afebrile. Taken to ARNP in clinic. He did not feel that near-syncope was related to vaccine and referred pt to ER. See in ER by Dr., who also stated that there was probably no relation between local reaction on arm and near-syncope. Patient has apparently been treating wound on left arm at home and recently visited Dr. due to non-healing. He anticipates several weeks of treatment to wound.
Extremely large swollen lymph nodes. Especially in neck and armpit/breast. Pain to kidnies use and liver
I was unable to lift my arm over my head about 1 hour after the vaccine & I was tired for 2 weeks.