chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BIG KNOT LIKE BUG BITE OR A BEE STING ON ARM AROUND THE INJECTION SITE; HOT SKIN AROUND THE INJECTION SITE; SLIGHTLY ITCHY AROUND THE INJECTION SITE; HARD SKIN ON ARM/TOUGH SKIN ON ARM; SORE ARM AROUND THE INJECTION SITE; SWELLING AROUND THE INJECTION SITE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clots. The patient was previously treated with warfarin for blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced big knot like bug bite or a bee sting on arm around the injection site. On 09-APR-2021, the subject experienced hot skin around the injection site. On 09-APR-2021, the subject experienced slightly itchy around the injection site. On 09-APR-2021, the subject experienced hard skin on arm/tough skin on arm. On 09-APR-2021, the subject experienced sore arm around the injection site. On 09-APR-2021, the subject experienced swelling around the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm around the injection site on APR-2021, was recovering from big knot like bug bite or a bee sting on arm around the injection site, swelling around the injection site, hot skin around the injection site, and slightly itchy around the injection site, and the outcome of hard skin on arm/tough skin on arm was not reported. This report was non-serious.
AIHA; Hemolysis; Elevated potassium levels; Damaged red blood cells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 15:00 (Lot number: ER8731) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Eng203, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant) with onset 07Dec2021, outcome "unknown", described as "AIHA"; HAEMOLYSIS (medically significant) with onset 07Dec2021, outcome "unknown", described as "Hemolysis"; BLOOD POTASSIUM INCREASED (non-serious) with onset 07Dec2021, outcome "unknown", described as "Elevated potassium levels"; RED BLOOD CELL ABNORMALITY (non-serious) with onset 07Dec2021, outcome "unknown", described as "Damaged red blood cells". The patient underwent the following laboratory tests and procedures: blood potassium: (07Dec2021) elevated; red blood cell count: (07Dec2021) damaged; Spit in cup: (17Aug2020) negative, notes: Other. Therapeutic measures were not taken as a result of autoimmune haemolytic anaemia, haemolysis, blood potassium increased, red blood cell abnormality. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Engerix-B 20 mcg administered instead of 10mcg dose; Engerix-B 20 mcg administered to 15y/o; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 15-year-old male patient who received HBV (Engerix B adult) (batch number 29RN7, expiry date 25th February 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2022, the patient received Engerix B adult 20 ug and Engerix B Pre-Filled Syringe Device. On 12th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information:  GSK Receipt Date: 28-OCT-2022 Reporters comment: The reporter stated that on 12th October 2022, an Engerix B 20 mcg vaccine was administered to a 15 years old patient.  The reporter reported that the Engerix B 20 mcg dose was administered instead of a 10 mcg dose.  No additional information was reported.  The reporter consented to follow up with HCP. Additional supportive information: The patient received 20 mcg vaccine instead of 10 mcg, which led to overdose and adult product administered to child.
4in diameter swelling and red, hard and hot to the touch, headache, painful. So far it's been just over 2 days.
Information has been received from a health professional concerning her 13 year old female cousin with pertinent medical history and drug reactions/allergies not specified who in approximately February 2007, was vaccinated with Gardasil (Lot # not reported) 0.5 ml. Concomitant therapy was unspecified. In approximately February 2007, the patient experienced "internal bleeding throughout her body" after being vaccinated with Gardasil. The bleeding presented initially as bruising and most recently as rectal bleeding. Medical attention was sought. On an unspecified date, the patient was hospitalized. At the time of reporting, the patient had not recovered. The patient's internal bleeding, bruising, and rectal bleeding were reported as immediately life threatening and disabling events No further information was available at the tiem of reporting. Additional information has been requested.
Patient was given the flu shot for the second time. The facility had a prior clinic with us in October for flu. They filled out a consent form and gave it to the staff and told them the patient needs a flu shot.  They did not tell the employee  who administered the vaccine that patient had already received this in October already.  After the employee had given the vaccine the staff told her the patient had already received this vaccine. Staff was told to watch for any symptoms or additional side effects.
This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 78-year-old male patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 1st November 2018, 62 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced product supply issue. On 24th November 2018, the outcome of the ophthalmic herpes zoster was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to SHINGRIX. Additional details were provided as follows: About two months after receiving SHINGRIX, the patient experienced herpes zoster in his left eye. The emergency room visit was required. The patient visited his doctor and was treated with drops, medication and it was resolved. The patient stated that he was unable to get the 2nd dose but had been notified by his pharmacy that they had got it. The reporter did not consent to follow up.
Headache, muscle ache, joint ache, fever (100 degrees), nausea, increased heart rate, extreme fatigue and sleepiness (it was hard to stay awake).   I took Tylenol for the headache and the symptoms resolved  by 5pm that day except the fatigue and sleepiness. They ended by the morning of the following day.
muscle soreness; stiffness at the injection site; tender arm; have trouble with certain movements. such as reaching; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site muscle pain, stiffness, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the injection site muscle pain, stiffness, pain in arm and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site muscle pain, stiffness, pain in arm and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, still had muscle soreness and stiffness at the injection site after vaccination with dose of Shingrix. The patient reported that, after vaccination, the patient's upper arm was very tender and had trouble with certain movements, such as reaching.
hearing totally gone/complete hearing loss in left ear; tinnitus in ears and feeling of pressure; tinnitus in ears and feeling of pressure; Didn't make a real issue out of it and thought it was just congestion; This is a spontaneous report from a contactable consumer.  A 78-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 in left arm at 11:15 at single dose for COVID-19 immunisation at the age of 78-year-old. Lot number was E18982. Medical history and concomitant medications were unknown. Historical vaccination included flu in Jan2021 for immunization. On 08Feb2021, the patient woke up with complete hearing loss in left ear, hearing totally gone, tinnitus in ears and feeling of pressure. In Feb2021, the patient did not make a real issue out of it and thought it was just congestion. On 08Fb2021, the patient saw ENT. On 08Feb2021, the patient performed a hearing test: complete hearing loss. On unknown date, blood work was performed, and the results were unknown. The patient did not recover from woke up with complete hearing loss in left ear/ hearing totally gone, tinnitus in ears and feeling of pressure, the outcome of nasal congestion was unknown.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted approximately 5 minutes after vaccination and was unresponsive for approximately 10-15 seconds. EMTs were called and continued care. Patient was alert and oriented when taken by EMTs.
Patient is almost 60 days out and still has not received the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is almost 60 days out and still has not received the second dose) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is almost 60 days out and still has not received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is almost 60 days out and still has not received the second dose) had resolved.        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.   This report refers to a case of Product dose omission issue, for mRNA-1273, lot #: 004M20A, with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue, for mRNA-1273, lot #: 004M20A, with no associated AEs.
24 hrs. Barely see issue with vision and head ache sever. 102. fever at head ache and 01:00am started 2 200mg of Epinephrine following the onset, two hours later drenched in sweat no more fever 03:00PM  and went back to bed at 04:00am and slept until noon then went into work. The infection in eye was a week after the vaccination and the primary care Dr. referred to the eye specialist for the surgery , Feb. 2021,  into see the eye specialist , would need surgery. 09/2021 second opinion trusted source would need to do surgery to correct his vision 11/2021  surgery on first eye and three week later second eye surgery. Results  small tumor or blood clots blocking the nerve eye. The infection in eye was a week after the vaccination and the primary care Dr. referred to the eye specialist for the surgery. infections and all same time and was given antibiotic cream after visiting his doctor the gave eye drops with antibiotics in it. Fever for three days and knees ache and cold hold his weight.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 11Oct2023 to 15Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360517 same patient, different drug/event;
On 6-24-21, the patient came  in to inform us that he could not get his 2nd dose of moderna on the advice of his doctor.  He said about 45 minutes after he received the vaccination, he started experiencing chest pains. He went to the  emergency room. He said they did 2 E.K.G's, 2 chest X-rays, and blood work.  He said they could not find the cause. He said the day after the vaccination he started experiencing shortness of breath and 1 week after the vaccination he started having swelling of the extremities.  He said his doctor doesn't know if the vaccination is the cause but warned him not to get the 2nd dose. He says to this day he still experiences a dull ache in his chest, shortness of breath and swelling of the extremities.  He said he is seeking treatment from a cardiologist. He said he is concerned about myocarditis.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 04/05/2021, 04/26/2021, and 12/02/2021. They presented to hospital on 06/24/2022 with a strangulated ventral hernia and a small bowel obstruction. They were admitted same day. They experienced further complications of an anastomotic leak. They were transferred to a different hospital on 07/12/2022 for nursing care after their health continued to deteriorate. They transitioned to comfort care only. They tested positive for COVID-19 on 07/14/2022 and died on 07/15/2022. It is not well understood if the individual experienced COVID-19 symptoms since this was a medically complex situation and the individual had several underlying medical conditions.
1 week following Pfizer vaccine booster administration, developed acalculous cholecystitis.
After initial vaccination, I experienced common muscle soreness that disappeared after 2-3 days. One week after vaccination, muscles soreness came back and the injection site is red and swollen.
Strong headache within an hour lasting 5 days, itching burning rash 10/29/10, lethargy, pain in spine to lower extremities, dry cough, chest aching, extreme tiredness.
Information has been received from a RN concerning a 5  year old white male with no known allergies who on 11/03/98 was vaccinated at another facility with a first 0.5mL dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. On 07/05/03 the pt started breaking out with small red spots on his trunk. Within 24 hours, as the day and weekend progressed, the rash spread and the spots got a little bigger and vesicular looking. On 07/07/03 the pt was seen in the office by a physician and diagnosed with varicella. The pt was treated symptomatically. No prescription drug was required. Subsequently, the pt recovered. Additional information has been requested.
Information has been received from a physician concerning a 12 year old female who on 22-MAR-2007 was vaccinated with Gardasil (lot# 657005/0314U). On 23-MAR-2007 the patient experienced diffuse erythematous rash upper and lower extremities. The patient sought medical attention on 26-MAR-2007 and was prescribed ZYRTEC. Subsequently, the patient recovered from diffuse erythematous rash upper and lower extremities. Additional information has been requested. Initial and follow up information has been received from a physician and a physician's assistant, concerning a 12 year old white female student with seasonal allergies, and no illnesses at the time of vaccination, who on 22-MAR-2007, at 9:00am, was vaccinated in the left gluteus maximus, with the first dose of GARDASIL (lot# 657005/0314U). On 23-MAR-2007, at 1:00pm, the patient experienced a morbilliform rash, also described as a diffuse erythematous rash, on the upper and lower extremities. The PA confirmed that the rash worsened when exposed to sunlight, but involved no itching. The patient sought medical attention on 26-MAR-2007 and was prescribed ZYRTEC. No laboratory diagnostic studies were performed. On 28-MAR-2007, the patient recovered from the morbilliform rash. On 21-MAY-2007, at 4:30pm, the patient was vaccinated in the right gluteus maximus, with the second dose of GARDASIL (lot# 657005/0314U). No further information is expected.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided. It was stated that the date of refrigeration was 07 May 2021.
Extreme fatigue, headache, body aches the day after the injection. First dose caused same reaction. Was fine after that one day.
Sore arm for 3 days. On the 4th day, I experienced numbness in hands and feet. Bottoms of feet were burning. Numbness went into my thighs. Dizziness and faintness. Lasted all day and numbness in hands stayed until the following day which accompanied a headache that lasted all that next day.
Severe pain at injection site that still persists, (after more than 3 weeks) and actually feels like its gotten worse.
No adverse event; Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Non significant Follow up received; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Initial report received from a consumer, who is also the patient's mother, on 14 June 2014. It was retrieved during routine monitoring of the Sanofi Pasteur Facebook page. A three-month-old male, with no reported medical history, was "vaccinated for meningitis" on an unspecified date. Less than one week later, he contracted meningococcal disease. He was hospitalized for nine days. Per the reporter, "though he suffered side effects for years, he is now a healthy, thriving 15 year old". No additional information was reported, and follow-up was not available. Documents held by sender: None.
Sore arm first day of injection at injection site (day 0-1 Tuesday), day 1 (wednesday) hard lump under skin at site of injection (deltoid region), day 2 (thursday) lump under skin has resolved but now there is a slight redness on the skin in bicep area/side of arm below the deltoid  that is warm to the touch.
Moderna COVID-19 Vaccine EUA redness, warmth and itching of skin around injection site, no fever.  Symptoms began last evening , one week after injection and are continuing. Notified employee health and PCP. will continue to self monitor and notify others if symptoms worsen.
Pt with multiple allergies and history of anaphylaxis/angioedema requiring intubation x5 per report. Received first dose of Moderna Vaccine and developed swelling of lips, hives, and acute shortness of breath.  VS at 10:04: 116/93, HR 94, SpO2 on RA 83% exam w stridor, swollen mucous membranes, tongue and periorbital swelling.  EMS Called, 0.3 mg of epinephrine x 2 (at 10:05 and 10:09) Administered with significant improvement in stridor, SOB, and improvement in lip/tongue swelling. Transported to ER for further care/evaluation.