chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt complains of a sore left shoulder.  Received injection (FLUVIRIN) 9/1/09 still having problems as of 9/17/09.  Pt called 9/8 saying she had a problem with her arm.  I told her to see her doctor.  Prescriber prescribed VOLTRAN gel and told the patient had she not come in the soreness could have traveled to her bone.  Prescriber said the pt received the injection into a tendon (according to the patient).  Prescriber APNP saw the patient on 9/17/09 and talked to her at 3:50 pm  9/17.  She said there is no sign of infection, that the tendon was not infected that it appears to be IM myofascitis: The patient has been guarding the arm and prescriber is sending her to therapy (PT).  She observed the point of injection and that the injection site was correct.  She expects the situation to resolve in a couple of weeks.  The inflammation has spread a little but not to the tendon or bone as the patient described.
I started feeling achey close to midnight, so roughly 12 hours after the shot. I had chills throughout the night. In the morning I had a migraine, chills, aches, and a 102 degree fever. This lasted most of the day until around 6pm. I'd taken tylenol in the morning and ibuprofen around 3pm. By 7-8 I felt much better. I started feeling chills again around midnight, but after sleeping, I feel basically 100%.
Information has been received from a nurse practitioner concerning a 25 year old female with congenital adrenal hyperplasia- late onset 17 years no treatment or follow up since diagnosis, and penicillin allergy, who on 31-MAR-2010 was vaccinated with a first dose of GARDASIL (IM, lot # 665768/1377Y). Concomitant therapy included methotrexate and hormonal contraceptives (unspecified). No other vaccines were administered. On 04-MAR-2010, magnetic resonance imaging (MRI) of the thoracic spine, cervical spine and brain indicated the following: MRI of the thoracic spine showed multiple areas of abnormal signals predominantly in the inferior half of the thoracic spinal cord, compatible with areas of demyelination; MRI of the cervical spine showed multiple cord lesions, most important at C1-C2, compatible with demyelinating plaques and multiple sclerosis and severe left neural foraminal narrowing at C3-C4 related to disc osteophyte complex; MRI of the brain without contrast showed prominent periventricular white matter disease consistent with multiple sclerosis. Contrast enhancement to assess for acute plaque was recommended. Last week, on approximately 24-MAY-2010 the patient was diagnosed with Multiple sclerosis. The patient's multiple sclerosis persisted. The nurse practitioner did not believe there was a causal relationship. Their office had no other details since they are not the primary physician. The nurse practitioner contacted during the telephone follow-up could not supply the actual date of the event. Upon internal review, multiple sclerosis was considered to be an other important medical event. Additional information has been requested.
like hay fever; pressure behind the eyes; congestion feeling across the bridge of the nose; pressure in the teeth; nose was itching; runny nose; headache; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (like hay fever), OCULAR DISCOMFORT (pressure behind the eyes), NASAL CONGESTION (congestion feeling across the bridge of the nose), DENTAL DISCOMFORT (pressure in the teeth) and NASAL PRURITUS (nose was itching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Urinary tract infection.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEASONAL ALLERGY (like hay fever), OCULAR DISCOMFORT (pressure behind the eyes), NASAL CONGESTION (congestion feeling across the bridge of the nose), DENTAL DISCOMFORT (pressure in the teeth), NASAL PRURITUS (nose was itching), RHINORRHOEA (runny nose) and HEADACHE (headache). The patient was treated with CEFALEXIN (CEPHALEXINE) on 10-Aug-2021 for Urinary tract infection, at a dose of UNK, 7 days; VITAMINS NOS ongoing since an unknown date at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SEASONAL ALLERGY (like hay fever), OCULAR DISCOMFORT (pressure behind the eyes), NASAL CONGESTION (congestion feeling across the bridge of the nose), DENTAL DISCOMFORT (pressure in the teeth), NASAL PRURITUS (nose was itching), RHINORRHOEA (runny nose) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications also included Allergy release medicine.
Left arm with 1 day no redness, swelling and tenderness. Moderate amount of local inflammation at site of injection.
This spontaneous report as received from a pharmacist refers to an unspecified patient. On an unknown date (believed to be recently) the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified). On an unknown date (believed to be recently) the patient developed an injection site reaction following vaccination with ZOSTAVAX. The event outcome was unknown. Additional information has been requested.
Pt received moderna immunization yesterday (10:29 am), and called today (at about noon) to report side effects.  He  states he was fine yesterday, but this morning has noticed body aches (not unusual with an immunization) and also labored breathing, vision changes, and a rapid heartrate (which could be related to allergy).  He states this has been going on intermittently this morning, and I recommended either getting in to his doctor, or discussing with a nurse.  I did let him know that Benadryl may help as well.  I called to notify his doctor.
This is a spontaneous report from a contactable consumer who reported for herself. A 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) in early Jun2017 at single dose in arm for immunization. The patient medical history was not reported. Concomitant medication included baby aspirin. On an unspecified date in early Jun2017 (shortly after vaccination) the patient experienced muscle pain, fatigue, weakness, chills and cold and she couldn't sleep. Blood work was done on an unspecified date and no results available. Patient received ADVIL to treat muscle pain; no treatments were given for the other events. Patient not recovered from the events at the time of the report. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Day after vaccine given pt. developed headache, stiff neck, body aches and generalized fatigue. Throbbing head pain at temples heavy eyelids. After 15 days with consistent headaches pt was evaluated by neuro and neuro ophthalmology and dx with pseudo tumor cerebri. Idiopathic intracranial pressure and bilateral papilledema. 8/25 started DIANEX.
Employee came to a mass vaccination event. She had come to the event previously on 10/29/22 and received her COVID-19 Pfizer Bivalent booster. She returned on 11/4/22 to receive her influenza vaccine and the vaccinator charted that she gave her the COVID-19 Pfizer bivalent booster once again. Given that it is a mass vaccination situation, we are unable to verify if the employee received the COVID-19 booster again or the influenza vaccine and the vaccinator charted wrong. We are going to assume the COVID-19 bivalent booster was given a second time given the charting. No adverse events noted, no side effects noted. Employee discussed with provider. Influenza vaccine still recommended. Internal investigation ongoing for further safety measures to be put into place to prevent human error. Vaccinator educated.
4 hrs p/vax pt had an apnea episode turned blue brought to ER where was in good state of health;
11-17 pt called c/o pain in arm of shot - (Flu) - throbbing pain, can not lift arm w/o pain. Waken pt up at night. Pain on day 1 of shot & continues today. Been taking Ibuprofen at onset but pain continues advised pt to see PCP re: further Tx. Site not red or warm.
Received pneumococcal 23 vaccine in lt deltoid 10/7/13 next day lt arm swollen and painful, hardened approx 2 cm diameter at injection site pain radiated into shoulder and neck, relieved with cold compresses - subsided 8 days after vaccination, also experienced itching at site on neck and across chest. No hx of neomycin allergies.
Narrative: COVID infection following COVID vaccine series 04/13, Pfizer, dose #1 05/04, Pfizer, dose #2 98/13 COVID swab, result: detected 08/14 pt cc: cough, fatigue, exposure: unknown
Initial report received from a RN on 10Oct05. A 17 year old male pt developed a fever of 101F, increase heart rate, difficulty breathing, dizziness, difficulty swallowing and disorientation, 25 hrs after receiving the IM injection in the right deltoid of Menactra, lot number U1656AC on 22Jul05. The pt was not on any medications and had no illnesses at the time of vaccination. The pt was taken to the ER on 23Jul05. Treatment received was not reported. The pt recovered.
Excruciating pain from neck to wrist. Loss of use of arm. Went to ER and was given 800mg ibuprofen which did not help.  It took over a week for most of the pain to subside and to regain full use of my arm. There is still some pain in the shoulder area of my arm.
Developed a non-itchy or painful rash on left arm and left side of chest, fatigue, fever of 101.5, bilateral neck lymph node swelling x 2-3 days post vaccination.
At end of visit, after Covid vaccine given, chart was reviewed and provider, CPNP realized that while this visit was scheduled as a 5 year PE,  patient is not yet 5 (will turn 5 in 5 days). Discussed with PCP. Mom made aware of error. While clinically, no adverse outcomes are expected, mom aware that this initial dose likely will not count toward patient being "fully vaccinated." We counseled on returning for Covid #2 in 3 weeks and advised that he will likely need a booster dose later if wants to travel internationally or be considered "fully vaccinated." Mom understanding of error and agreeable to plan/recommendations. Incident report and VAERS report filed.
9MAR93 high temp 103 R for 5 days until 13MAR93; rash started 11MAR93 neck behind ears, under belly button then the rash borke out all over body from head to toe 12MAR93 @ 10AM; throwed up green & slimmy stuff & seen by MD still had rash
Woke up on Tuesday Morning after shot on 11.21.20. Woke up on 11.24.20, was nauseous. Husband took temp and it was 100.6 temp. Was having violent chills. Husband called the ambulance and went to ER. ER stated that pneumonia was present. Was admitted to hospital. Tests for flu and Covid test was done and negative results.
The uvula was inflamed; Had inflamed tonsils; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration in Arm Right on 11Mar2021 12:00 (Age at the time of vaccination: 61-years-old) (Batch/Lot number was not reported) as single for covid-19 immunization. The patient's medical history included anxiety and known allergies: sensitivities; both unknown if ongoing and ongoing childhood tonsillitis. The patient's concomitant medications were not reported. Historical vaccine included patient received first dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as single for covid-19 immunization. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19 was mentioned as no. On 15Jun2021 09:00 AM, the uvula was inflamed, felt it trying to swallow when she woke up a few months after the second injection. Soon after the second injection in 2021, she had inflamed tonsils. Both went away later that day. The patient did not received any treatment. The outcome both the events was recovered on unspecified date in Jun2021.  Information on the lot/batch number has been requested.
I had the initial Johnson & Johnson one dose vaccine on 3/12/21. My booster vaccine was Moderna given on 11/15/21 and I awoke on 12/15 21 with very blurred vision in my right eye. I subsequently saw a Retinal surgeon who evaluated my eye and diagnosed Central Retinal Vein Occlusion and said there is no treatment for this to cure. He did inject an anti-Vascular Endothelial Growth Factor drug to decrease the chance of vascular growth and worsening of my condition and possible pain in the future.
This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age and ethnicity started to receive PREVNAR 13 via an unspecified route of administration at single dose on 07Apr2017 for immunization as a booster shot. The patient medical history and concomitant medications were not reported. On an unspecified date in 2017 the patient experienced severe headache and pain at injection site for 3 days, mental confusion, disorientation, myalgia, generalized weakness for approximately 10 days. The outcome of the events was  unknown. There was no quality issue associated with this event, no complaint.
sort of a rash on my toes its like that COVID, it almost like kill veins; sort of a rash on my toes its like that COVID, it almost like kill veins; It' painful; This is a spontaneous report from a non-contactable other healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included vasculitis from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported. The patient experienced sort of a rash on the toes its like that covid, it almost like kill veins its painful on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
administered vaccine to a 17 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to a 17 year old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Nurse reported that they inadvertently administered 1st dose of the Moderna Covid-19 vaccine to a 17 year old.
Brain fog; Blue color of arm at injection site; Black color of arm at injection site; Swelling of arm at injection site; Nauseated; Fever; Chills; Headache; Diarrhea; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Arm pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PROPRANOLOL, ENALAPRIL and AMLODIPINE for an unknown indication.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm pain), NAUSEA (Nauseated), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 24-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site) and VACCINATION SITE SWELLING (Swelling of arm at injection site). On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog). The patient was treated with PARACETAMOL (TYLENOL) for Symptom recurrence, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain fog), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and INJECTION SITE DISCOLOURATION (Blue color of arm at injection site), INJECTION SITE DISCOLOURATION (Black color of arm at injection site), VACCINATION SITE SWELLING (Swelling of arm at injection site), NAUSEA (Nauseated) and HEADACHE (Headache) had not resolved.
Broken out with rash/hives all over my body.  Waxes and wanes, but I still have them.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a elderly female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was recovered/resolved. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to ask whether Guillain Barre had been seen in any patients who received SHINGRIX. During the call the pharmacist stated that the patient received a flu vaccine 4 years before the time of reporting and developed Guillain Barre. The pharmacist did not know the name of actual Flu vaccine, and patient did not remember as per the pharmacist since it had been 4 years. Very limited information was provided.
Fever 101.9, severe headache, chills, sweats, bone & muscle pain
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 9 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
first dose of Twinrix in August 2022 but hasn't yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received in August 2022, route - Intramuscular).   On an unknown date, the patient received did not receive the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was 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: 07-Nov-2022 Reporter's comment: The reporter was the patient. She received her first dose of Twinrix in August 2022 but had not yet received the second dose.  The patient did not realized that the second dose was due after 1 month.  Nothing else was reported. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Initial report received from a consumer, who is also the patient's parent, on 22 February 2012. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of sanofi pasteur. A male patient had received an injection of hib vaccine, poliomyelitis vaccine inactivated and DTAP (manufacturers, lot numbers, dates, routes and sites of administration not reported). The patient was behind in speech (approximately 6-12 months behind) when he turned two years of age. The patient was evaluated in February of 2011 and diagnosed with autism. At the time of the report, the patient was showing improvement, and his condition was very mild now. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.