chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 44 years old female patient. The patient had no pertinent medical history nor drug reactions or allergies. On 28-MAY-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB, intramuscular, (dose was not reported), lot # K010216, expiration date 17-SEP-2016. The patient was taking no concomitant medication. On 09-JUN-2015, the patient experienced systemic arthralgia in all of her joints that developed into muscle pain following the administration of RECOMBIVAX HB. The reporter stated that the patient sought medical attention by visited an unspecified primary care physician's office on an unspecified date where an unspecified blood test was performed, and treatment was given to the patient in the form of an unspecified dose of nonsteroidal anti-inflammatory drugs (NSAIDS). The reporter also stated that the patient was currently experiencing residual muscle pain that is localized in the patient's calves on 16-JUN-2015. At the time of the report, the outcome of currently experiencing residual muscle pain that is localized in the patient's calves, the patient experienced systemic arthralgia and developed into muscle pain was reported as recovering/resolving. The relatedness between the events and therapy with RECOMBIVAX HB was not reported. Additional information has been requested.
Patient received the vaccine on 8/8/23. Rash/hives developed around 8pm 8/8 on bilateral legs, torso and arm. No viral symptoms. No fever. Rash is itchy. No new foods. No new skin products.
headache, body aches, chills, sniffing, cough and she felt her body was warm; headache, body aches, chills, sniffing, cough and she felt her body was warm; headache, body aches, chills, sniffing, cough and she felt her body was warm; headache, body aches, chills, sniffing, cough and she felt her body was warm; headache, body aches, chills, sniffing, cough and she felt her body was warm; headache, body aches, chills, sniffing, cough and she felt her body was warm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (headache, body aches, chills, sniffing, cough and she felt her body was warm), FEELING HOT (headache, body aches, chills, sniffing, cough and she felt her body was warm), RHINORRHOEA (headache, body aches, chills, sniffing, cough and she felt her body was warm), MYALGIA (headache, body aches, chills, sniffing, cough and she felt her body was warm) and HEADACHE (headache, body aches, chills, sniffing, cough and she felt her body was warm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced COUGH (headache, body aches, chills, sniffing, cough and she felt her body was warm), FEELING HOT (headache, body aches, chills, sniffing, cough and she felt her body was warm), RHINORRHOEA (headache, body aches, chills, sniffing, cough and she felt her body was warm), MYALGIA (headache, body aches, chills, sniffing, cough and she felt her body was warm), HEADACHE (headache, body aches, chills, sniffing, cough and she felt her body was warm) and CHILLS (headache, body aches, chills, sniffing, cough and she felt her body was warm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, COUGH (headache, body aches, chills, sniffing, cough and she felt her body was warm), FEELING HOT (headache, body aches, chills, sniffing, cough and she felt her body was warm), RHINORRHOEA (headache, body aches, chills, sniffing, cough and she felt her body was warm), MYALGIA (headache, body aches, chills, sniffing, cough and she felt her body was warm), HEADACHE (headache, body aches, chills, sniffing, cough and she felt her body was warm) and CHILLS (headache, body aches, chills, sniffing, cough and she felt her body was warm) had not resolved.            Concomitant medications included diabetic medication.
Pain at injection site radiating down arm. Originally attributed pain to gardening but pain persisted and did not go away.  Difficulty finding comfortable position to sleep and pain will cause me to wake up.  PT did not help.
This spontaneous report was received from a physician concerning a patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that another unspecified physician reported to him that an unspecified patient broke out in a rash all over their body about 14 days after receiving ZOSTAVAX. The patient contacted the physician. The outcome of rash all over the body was unknown. The relatedness for rash all over the body was unknown for ZOSTAVAX. Additional information is not expected.
I experienced mild soreness the evening of the shot and the following day, which resolved by 1/14. Mild fatigue was persistent since Tuesday 1/12. I started experiencing mild swelling and tenderness in my L armpit/breast, with mild pain during movement and compression. Yesterday (1/18), the injection site became slightly raised, blotchy, and very itchy. I woke up this morning feeling like I had a cold, with joint soreness and a mild itchy rash around my ankles, in addition to fatigue and warmth/itchiness around the injection site
patient was administered an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 27-Aug-2021 from a Pharmacist via Medical Information (Reference number- 00744399) and transmitted to Sanofi on 27-Aug-2021.  This case involves a 61-year-old male patient who administered an expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Aug-2021, the patient received a dose (once) of suspect HIB (PRP/T) VACCINE [lot UJ355AA, expiry date 24-Jul-21] via an unknown route in unknown administration site for prophylactic vaccination.  It was reported, "A patient has been administered expired ACTHIB today. The caller would like to know how to proceed. The caller would like to know if the patient must be revaccinated".  It was a case of actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
"Covid Arm"    redness increased daily with soreness, itching and hardness.  on day 5 still has redness and hardness, no itching or soreness.
Lump under bend of both arms; Swollen right armpit 1-2; Reaction to the vaccine; Swollen left arm; Second dose given 13 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 13 days after first dose), PERIPHERAL SWELLING (Swollen left arm), LIMB MASS (Lump under bend of both arms), VACCINATION COMPLICATION (Reaction to the vaccine) and PERIPHERAL SWELLING (Swollen right armpit 1-2) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer, Asthma and Lung disorder NOS.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 13 days after first dose). On 29-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swollen left arm) and VACCINATION COMPLICATION (Reaction to the vaccine). On 30-Aug-2021, the patient experienced LIMB MASS (Lump under bend of both arms) and PERIPHERAL SWELLING (Swollen right armpit 1-2). On 05-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 13 days after first dose) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen left arm), LIMB MASS (Lump under bend of both arms), VACCINATION COMPLICATION (Reaction to the vaccine) and PERIPHERAL SWELLING (Swollen right armpit 1-2) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment information was mentioned.  The patient also stated that she also experienced Swollen Left arm bend towards the forearm (about 2.5-3") on 30-AUG-2021.
Normal amount of tenderness at injection site. After about 9-10 hours, I started feeling fatigue and body aches. Several hours later, the body aches turned into a full fever and headache. Fever did not break until 6am the next morning, and body aches and fatigued continued through the full next day.
Developed area of swelling and itching on L upper arm around vaccination site 10 days after injection, also reports feeling of swollen lymph nodes in L axillary area
Headache for 3 days.  The worst part is that I never had chronic headaches...maybe 1 or 2 a year.  Now I wake up with a headache 3 or 4 times a week and cannot drink alcohol, even one wine socially, without suffering a terrible headache.
Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # N013884, expiration date on 05-DEC-2018 (anatomical location and administration route were not reported) (Or) M-M-R II lot # N001532, expiration date on 13-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) which was properly stored. No adverse effects were reported. The vaccines were stored at 47°Fahrenheit to 77°F (61.7°F) for 2 hours 30 minutes; and 32°F to 35°F (33F) for 6 hours 51 minutes. The  previous temperature excursion was reported as  47°F to 77°F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This case was considered Non-valid due to lack of patient identifiers. Follow-up information has been received from the reporting office manager on 07-AUG-2018. This report concerns to a 17 month old patient of an unknown gender. On 04-APR-2018, the patient was vaccinated with improperly stored M-M-R II (Incorrect product storage). This is one of several reports received from same reporter. This case is considered valid due to availability of patient identifiers.; Sender's Comments: US-009507513-1808USA007353: US-009507513-1808USA007354: US-009507513-1808USA007355: US-009507513-1808USA007351: US-009507513-1808USA007352:
Experiencing side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experiencing side effects). At the time of the report, VACCINATION COMPLICATION (Experiencing side effects) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.  Patient was currently experiencing side effect
I have also had kidney issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rapid eye problems." (Unspecified if ongoing), notes: I feel that Covid was the beginning of my rapid eye problems.; "Covid" (unspecified if ongoing), notes: I feel that Covid was the beginning of my rapid eye problems. The patient's concomitant medications were not reported. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "I have also had kidney issues". Additional information: Description of Event Outcome: The patient feel that Covid was the beginning of my rapid eye problems. The patient had an adverse reaction with first vaccine. The patient was advice to take number 2 and a booster. However, the patient had 4 cases of Covid. The patient has also had kidney issues. The patient would like to speak to someone. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient contracted COVID-19 in Jul2021; Patient contracted COVID-19 in Jul2021; This is a spontaneous report from a non-contactable consumer (Patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported ), via an unspecified route of administration on Feb2021 (Age at vaccination: 77 years) as dose number unknown, single for covid-19 immunisation. Patient did not received other vaccines in four weeks. Other medications received in 2 weeks were unknown. Patient did not have COVID prior vaccination. Patient tested COVID post vaccination. The patient medical history and concomitant medications were not reported. The patient contracted covid-19 in Jul2021. Treatment performed was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive in Jul2021 Covid test type post vaccination was Unknown. The outcome of the event was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No fur-ther information is expected.
described GI events and bleeding after receiving the Pfizer COVID19 vaccine primary series; described GI events and bleeding after receiving the Pfizer COVID19 vaccine primary series; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): MOD-2022-613316 (MODERNA). A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Primary immunization complete), for COVID-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant), GASTROINTESTINAL DISORDER (non-serious), outcome "not recovered" and all described as "described GI events and bleeding after receiving the Pfizer COVID19 vaccine primary series". Reporting an AE related to an individual who described GI events and bleeding after receiving the Pfizer COVID 19 vaccine primary series. She expressed that this also continued after switching to Moderna for her booster dose and did not resolve. This individual has provided her name and is willing to further describe this incident if necessary.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
03/12/2022 passed out and hit head; went to see if I had concussion. Blood pressure was elevated, passed out 5 times the last year. Deemed as response to high blood pressure. No definitive answer whether it was related to booster shots.
Cellulitis versus vaccine drug. Pt seen 12/15/05 after receiving inj. 12/12/05 right deltoid.
Sore and inflammed shoulder.  Patient has seen a doctor and received a steroid shot in the shoulder.
Waking up at night around 4 AM; Stinging sensation; Costochondritis between her ribs; Chest discomfort; Feels like a burning sensation; Woke up a few times with her heart going fast; Feeling like it is vibrating; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE INSOMNIA (Waking up at night around 4 AM), CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast) and FEELING ABNORMAL (Feeling like it is vibrating) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F218, 001A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NAPROXEN SODIUM (ALEVE) for an unknown indication.    No medical history information was not provided.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE, TOLTERODINE L-TARTRATE (DETROL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started NAPROXEN SODIUM (ALEVE) (unknown route) at an unspecified dose. On 09-Sep-2021, the patient experienced MIDDLE INSOMNIA (Waking up at night around 4 AM) and PAIN (Stinging sensation). In September 2021, the patient experienced CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast), FEELING ABNORMAL (Feeling like it is vibrating) and COSTOCHONDRITIS (Costochondritis between her ribs). At the time of the report, MIDDLE INSOMNIA (Waking up at night around 4 AM), CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast), FEELING ABNORMAL (Feeling like it is vibrating), PAIN (Stinging sensation) and COSTOCHONDRITIS (Costochondritis between her ribs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Electrocardiogram: perfectly fine with no changes (normal) perfectly fine with no changes.         Patient had been careful with her activities, and had been increasing her anti-inflammatory medications. She mentioned that had been going on for 19 days, and it has not gone away yet.   This case was linked to MOD-2021-329349 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant FU appended, Event was added
Returned at 11:30AM c/ feeling flushed and itching. State "same reaction in 2006. Last 2 years no reaction from flu shot" given at office" BENADRYL 50 mg IM (L) VOQ by nurse. 10-15-09 report from patient - went to ER-. No further Tx need - sent home. Return to work.
1st Modern Booster given too soon - given 2 months after second dose instead of 5 months
I did not have an adverse reaction to the vaccine. I have a family history of heart disease. On 02/02/2023, I went to the emergency room because I had extreme nausea and feeling faint when I stood up. The nausea was a problem for about three weeks for like 8 to 9 hours a day. I was admitted for two days. As of today, I take a bleed thinner and a blood pressure medicine.
coughed up blood; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 85, Unit: unknown) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unknown date in 2021 (lot number was not reported) as dose 1, single for COVID-19 immunization.  The patient's medical history was not reported. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received the first dose of the vaccine on an unknown date in 2021 and had no reaction but coughed up blood twice on an unknown date in 2021. The reporter wanted to know if this was a side effect of the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 21FEB96 & became pregnant (LMP 22FEB96) during 1st trimester, pt had a spontaneous abortion, which was reported to be not assoc w/vax;no further info was provided;
lt arm, deltoid region; signs & sxs of redness, edema warm & firm to touch; mom stated that it had been fine for several days now; allerg react; fever;
admitted to hospital 1/7/2022 due to tachycardia. Tested (+) 1/10/2022. Symptoms started on 1/7/2022 and included cough, chest pain, chills, congestion, fatigue, runny nose, sore throat. Discharged from hospital on 1/12/2022.
This spontaneous report as received from a pharmacist refers to a 36 years old male patient with no pertinent medical history and no drug allergy. The patient was vaccinated with, 0.5 ml VARIVAX (lot#reported as 00181AE, expire date 03-JAN-2014) subcutaneous on 31-JUL-2012. No other suspect therapies were reported. Concomitant medications included iron (unspecified). On 02-AUG-2012 the patient experienced raised, red area that is 2.5 diameter circle and pain at the injection site. The patient had sought medical attention via pharmacy visit. There was no treatment and no laboratory performed gave for this event. The outcome was reported as not recovered. Additional information is not expected.
I noticed immediately that the shot hurt, and that it was almost as if I could feel both the beginning and end of the needle. This was unusual for me, because I don't usually notice pain with vaccines. (It may also be worth nothing that the vaccine was not as centered on the deltoid as usual; it seemed to be injected in a location more anterior than medial.) 36 hours later, while my arm was above my head doing my hair, I suddenly felt a sharp and painful tingling shoot down my arm, with pins-and-needles and numbness. The sensation reached from the top of my arm down the outside around the elbow and heavily culminated in my hand and fingers, especially pinky finger. This sensation somewhat subsided, but lasted for somewhere between 1 and 2 hours.  Since then,  I have experienced pain in my elbow, and sometimes hand/palm and shoulder, and weakness in my hand, fingers, and arm in general. I have described all the different feelings of it as the different stages of having hit your funny bone.