chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes (2 inch); Fever; Chills; Body aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 28Aug2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 07Aug2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 29Aug2021 at 10:00, the patient had swollen lymph nodes (2 inch), fever, chills, body aches for 2 days. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with unspecified medications (reported as prescription given). The clinical outcome of the events swollen lymph nodes (2 inch), fever and chills were resolving; while that of body aches was resolved on 31Aug2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Itching swelling to vaccine site. ABX given from ER seen at PCP site.
This spontaneous report as received from Medical Assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date in 2014 the patients were vaccinated with PROQUAD (dose, route of administration and indication were not provided). It was reported that the patients received doses of PROQUAD that underwent supported temperature excursions. Doses were administered between the dates of 26-AUG-2014 through 29-OCT-2014. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Gave a booster to someone who was there to get a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave a booster to someone who was there to get a third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Gave a booster to someone who was there to get a third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Gave a booster to someone who was there to get a third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that an immunocompromised patient was given a wrong dose of 0.25ml.    No concomitant medications were reported.  No treatment information was reported.
On Dec 16th our team mistakenly administered an expired vaccine to this patient. The vaccine expired on 12/14. The patient experienced no complications at the time of vaccination, nor has had any issues since. Patient and health department were notified. Manufacturer contact and advised that patient does not need to repeat vaccination at this time
Patient came in for 1st dose of Pfizer vaccine today. During his post-vaccination observation period, the client became extremely diaphoretic, dizzy and possibly lost consciousness (unwitnessed). Client experienced immediate urinary incontinence. Onsite EMS was called, client had very low blood pressures and pulse measures (below). Ambulance was called and client was transported to the hospital for further assessment and intervention.
ADOLESCENT BOY FEARFUL OF VACCINATIONS. BECAME PALE AND DIAPHORETIC IMMEDIATELY UPON VACCINATION GIVEN. ASSISTED TO FLOOR AS HE BEGAN LOSING CONSCIOUSNESS. AMMONIA INHALENT USED DAMP CLOTHS TO NECK AND FOREHEAD. AFTER 5 MINUTES CONTINUED TO HAVE LOW LOC, DELAYED CAPILLARY REFILL. O2 APPLIED AND 911 INFORMED.
Paresthesia of fingers (when arm raised above head) in arm Hepatitis B was given.
PT received varicella immunization 11-24-09 on 11-26-09 mother noted rash on pt.  On 11-27-09 pt was seen again at clinic and was dx with chicken pox.
soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in my arm) 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 No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness in my arm). At the time of the report, MYALGIA (soreness in my arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Treatment information was not provided. Concomitant information was not provided.
SIGNS AND SYMPTOMS INCLUDE: REDNESS, RASH, ITCHING. TIME COURSE: LASTED 5 DAYS. NO TREATMENT PER PATIENT
Patient reports chest pain, palpitations and dyspnea starting 1 day after vaccination with Pfizer vaccine. Chest pain and palpitations continued requiring ED visit on 10/1 and hospitalization on 10/14 after abnormal stress test. Ultimately underwent coronary catheterization (normal) and was discharged, but continues to have significant dyspnea 3 weeks after vaccination
Heart racing; Super dizzy; Fever; Joints were killing me; Head was pounding; felt like I was being tortured; Super drained; Spontaneous report received on 25SEP2020.  A patient reported that he experienced "heart racing" (PT: Palpitations), "super-dizzy" (PT: Dizziness), "fever" (PT: Pyrexia), "joints were killing me" (PT: Arthralgia), "head was pounding; felt like I was being tortured" (PT: Headache), and "super-drained" (PT: Fatigue), following the administration of BioThrax (anthrax vaccine adsorbed) for post exposure prophylaxis (PEP). On 24SEP2020 at 09:00, the patient received second dose of BioThrax in his left arm. He reported that there was no illness prior to the injection and no issues on day of injection. He woke up at approximately 00:30 and reported that "heart racing, joints were killing me, head was pounding, felt like I was being tortured, super-drained and super dizzy".   It was reported that he woke up around 04:00 and checked his temperature and it was 101 so he took Motrin (ibuprofen) 800mg and his fever was reduced to around 99. He was told to "take lots of fluids, rest and continue Motrin all day and if it did not take his temperature down to call his doctor". He also stated that he took more Motrin around 11:30 or 12:00 on 25SEP2020 and the temperature was staying down. At the time of report, most of his symptoms were resolved but his head was still pounding   A follow up information was received on 29SEP2020, from the consumer. He reported that by Sunday evening (27SEP2020), 95 percent of his symptoms was resolved. He further stated that by Monday morning (28SEP2020), all of the symptoms were resolved, and he was ready to go back to work and currently not experiencing any adverse events. The patient was recovered from the reported events, at the time of report.  Concomitant medication included oral Ciprofloxacin (500mg twice daily) started for PEP on 10SEP2020.  He denied medical history and stated that he had no reaction after the first injection.  Company Comment: A consumer had palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue after receiving BioThrax. In response to the events, consumer took Motrin, lots of fluids, rest and all events recovered with in a few days. Considering the case information, and the potential of BioThrax to cause these events, the causality of palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue is assessed as possible.; Sender's Comments: A consumer had palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue after receiving BioThrax. In response to the events, consumer took Motrin, lots of fluids, rest and all events recovered with in a few days. Considering the case information, and the potential of BioThrax to cause these events, the causality of palpitations, pyrexia, headache, arthralgia, dizziness, and fatigue is assessed as possible.
Arm started to ache; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic reactions to tomatoes, shellfish and some nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 14:00, within an hour or so from the time of injection, the patients arm started to ache and it felt like he had been punched several times by a boxer. Last night when he rolled over in bed it woke him up. Throughout the day it had gotten a little better but was still troubling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event arm started to ache was recovered with sequelae at unknown date at 2021.   No follow-up attempts are needed. No further information is expected.
pt began exp pain in hands & feet approx 2-3 wks p/vax; hand & feet swollen, throbbing/aching pain in joint areas; heat, arthritis, synovitis, tendinitis, pos ANA titer, dizzy, sl cough, arthralgias, ear hurt, neuritis, depression; see WORM
felt effects of  Covid-19 around November 19-20. Probable transmission on evening of November 17.  Nov 19 experienced bouts of sneezing. 2 a.m. Nov. 20 woke with chills, muscle aches, excessive sneezing. Tested negative (RAT) at 9 a.m. but continued to feel ill.  9 a.m. Nov 21 tested positive  (RAT). Same symptoms, more intense. Temp 100.7.  Coughing and heavy chest. Called my doctor to ask about getting Paxlovid.  Began course late that afternoon. Nov 22-24 Fatigued but gradual improvement of original symptoms except for coughing and inability to take full breaths. Fever gone by Nov 23. Nov 25-27 main complaint cough, fatigue, and difficulty with full breaths Nov 28 still positive (RAT) Nov 30 and Dec 2 negative RAT cough persisted until ~Dec 15 Symptom free since then
Got 2 shots, still gets shingles/ Suspected vaccination failure; Still gets shingles; back muscles locked up; Was in bed for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, muscle spasm and bedridden. On an unknown date, the outcome of the vaccination failure, shingles, muscle spasm and bedridden were unknown.   The reporter considered the vaccination failure, shingles, muscle spasm and bedridden to be possibly related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media.  The reporters husband got 2 shots and still gets shingles. After the 2nd shot they drove straight home, got out of the car to go in the house. The patient's muscles in his back locked up. The reporter could not get him in the house, so she called the neighbors to help. The patient was in bed for 3 days. The reporter considered the events might had been to be related to Shingles vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient reported developing a raised bump on her left arm where the varicella vaccine was given. She also mentioned redness and warmth to the touch. She states it was 4 days post receiving the vaccines that she noticed the reaction and lasted approximately 1-2 weeks. She did mention she is still noticing some redness and a bump to the day. She was advised to seek care for the reaction.
Seizure (<5 minutes, generalized, resolved by the time EMS arrived. Transported to hospital for sepsis/seizure evaluation. Tx for 48 hours with Abx and Acyclovir. The hospital record received on 2/24/04 states fever.
Dizziness & NauseaVomiting Narrative:  discharge diagnosis of acute labrinathis requiring walker to ambulate. Having falls
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805503 was crossed linked to the original case 201804863 due to same reporter.
Aunt called on 12/20/2006 to report that his right leg was swollen, warm to touch with moderate pain. She said that it was hard for him to walk for one day and he did't walk on that leg. He was irritable and lethargic with decreased appetite as well. She also said that he had a fever the next day although it was not taken. Was given Motrin but unsure of number of doses. Instructed to apply warm compresses, soak in worm tub, take motrin or tylenol for pain, watch for s/s infection and follow up with primary MD or hospital if not resolved.
joint pain; feels as if she had a cold, feels cold; headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), FEELING COLD (feels as if she had a cold, feels cold), HEADACHE (headache) and MYALGIA (muscle aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01102QA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (joint pain), FEELING COLD (feels as if she had a cold, feels cold), HEADACHE (headache) and MYALGIA (muscle aches). At the time of the report, ARTHRALGIA (joint pain), FEELING COLD (feels as if she had a cold, feels cold), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is on concomitant medication for Diabetes, cholesterol,blood pressure. no treatment medication; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
On 08/15/2021, after I took a shower in the morning, I could not hear anything out of my right ear. I went to the urgent care, they looked at my ears and prescribed ear drops, thinking it was an ear infection. Then I went to my family doctor, he thought it was an imbalance of my eustachian tube. He prescribed steroid. Some hearing returned in my right ear. Meanwhile my left ear hearing has declined. On 10/11/201 I am going to have MRI in my inner ear. I also took a hearing test. I went to the otologist; measured the right ear which is in severe condition and the left ear is declining. I went to an ENT, MRI to be done 10/11/2021. I have had gradual hearing loss in my right ear, but just suddenly my hearing has depleted in my right ear, and my left ear hearing is declining, not as severe as the right ear. From the total deafness from the right ear, I have regained partial hearing, I could hear a little out of the right ear, The condition it's in, I need hearing aids. It is in the severe quality from the measurements they took. I will need hearing aids in both ear.
pt recvd vax 19OCT93 & 2-3 days post vax exp pain @ site of inject; pain worsened when tried to raise lt arm to brush teeth, etc;
Patient started the next day with redness on his left leg at injection site. It was hard, hot to the touch and swollen. This happened over the weekend, so they had called the nurse who was on call. They were advised to draw a line where the redness ended, try cool compress and give Benadryl. It never went outside of the line drew. The redness, hard and hot to the touch lasted a couple of days. The patient never came into the office for evaluation. The parents did take pictures on their cell phone.
Developed hives and itching of left arm at site of injection. Family returned to the office. Patient was stable, no swelling of face or lips, no difficulty breathing, no nausea or vomiting. He received Diphenhydramine in the office and continued Loratadine for 2 days with improvement of symptoms.
Patient had a stroke within 4 weeks of second dose of moderna  Stroke is embolic in nature This report was made at the request of the family  Patient also has untreated Afib and was not on anticoagulation x 2 years which is the most likely cause of the stroke
Tachycardia; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received first dose bnt162b2 (BNT162B2 also reported as COVID-19 Vaccine by Pfizer, lot EL0140, expiry date: 31Mar2021, NDC:59267-1000-2), intramuscularly in the right deltoid on 21Dec2020 09:25 at 0.3 mL singe, for Covid-19 immunisation in a hospital. The patient's medical history was not reported.  Concomitant medication included influenza vaccine inact split 3v (FLUARIX, Lot number: 3E32Z) given last 10Dec2020. The patient experienced tachycardia on 21Dec2020 09:26. The outcome of event was recovered on 21Dec2020.
hard time breathing; This is a spontaneous report from a contactable consumer (patient's daughter-in-law). This consumer reported for two patients. This is the second of two reports. A 92-year-old female patient received single dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 29Dec2020 for immunisation. The patient's medical history and concomitant medications were not reported. The patient took the vaccine the day before reporting (29Dec2020). The patient had a "hard time breathing" at the start but was resolved now (Dec2020). The reporter was asking for recommendations.The event was considered as non-serious by the reporter.  Information about Lot/batch no has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520754 same reporter/drug, different patient/event
hives on her legs; a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning); This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at left arm on 29Dec2020 10:30 at single dose for COVID-19 Immunization. No medical history. No family medical history. There were no concomitant medications. Patient received first dose last Tuesday, 29Dec2020, at the hospital. The next day, she had a slight rash on abdomen (started morning on the next day when she woke up) and it spread to her legs (leg rash started 2 days later in the morning). It was a pretty severe case of hives on her legs now (31Dec2020). Spread to legs and now has hives on legs was reported as worsened. Physician's office visit involved. She had a question. Her doctor prescribed a dosing pack of prednisone to get rid of the hives and her question was, will it affect the effectiveness of the vaccine if she takes it, also, is it ok to get 2nd dose in 2 weeks. She confirmed she had not taken the prednisone yet. There was no prescriber. She received it because she is a healthcare worker. Patient asked if there is any recommendation on getting pre medicated with ex: Benadryl before getting the vaccine. No previous history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect product. No medications prior vaccinations (within 4 weeks). No test done. This is a serious report. The slight rash on abdomen, spread to legs and now has hives on legs was considered medically significant per reporter. The outcome of the events was not recovered.   Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 38-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 13-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Local reaction with abscess 0.75 x 1cm red, edematous area RUE without fever or supportive lymphadenitis present > 3months.