chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Area of the injection hot; Area around her collarbone was tender; Area around her collarbone was swollen; Area around her left breast was tender; Area around her left breast was swollen; Golf ball sized swelling on her left armpit; Tender, sharp pain on her left armpit; Area of the injection red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender) and BREAST SWELLING (Area around her left breast was swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 026L20T(?) and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender), BREAST SWELLING (Area around her left breast was swollen), LYMPHADENOPATHY (Golf ball sized swelling on her left armpit), AXILLARY PAIN (Tender, sharp pain on her left armpit) and VACCINATION SITE ERYTHEMA (Area of the injection red). At the time of the report, VACCINATION SITE WARMTH (Area of the injection hot), TENDERNESS (Area around her collarbone was tender), SWELLING (Area around her collarbone was swollen), BREAST TENDERNESS (Area around her left breast was tender), BREAST SWELLING (Area around her left breast was swollen), LYMPHADENOPATHY (Golf ball sized swelling on her left armpit), AXILLARY PAIN (Tender, sharp pain on her left armpit) and VACCINATION SITE ERYTHEMA (Area of the injection red) was resolving.            No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report was received from a reporter via agency (Control # 60341), concerning a female patient of an unknown age. Co-suspect and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number and route were not reported) lot # K008410, expiration date 26-FEB-2016. The reporter stated that on an unknown date patient received her injection and she also had a severe reaction. At the time of the report the outcome was unknown. This is one (1) of three (3) reports from the same source. Additional information has been requested.
I had soreness and swelling at injection site. I had mild fever that lasted 24 hours. 3 days of fatigue. I took TYLENOL for fever and it helped.
Injection site rash; Injection site Itchy; Bad body aches; Fever; Nausea; Bad headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Injection site Itchy), MYALGIA (Bad body aches), PYREXIA (Fever), VACCINATION SITE RASH (Injection site rash) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Apr-2021. Concurrent medical conditions included Hypertension since May 1994, Thyroid disorder since July 1994, Drug allergy (Sulpha drugs) and Penicillin allergy. Concomitant products included LISINOPRIL for Hypertension, LEVOTHYROXINE for Thyroid disorder, BIOTIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Bad body aches), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Bad headache) and FATIGUE (Fatigue). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site Itchy) and VACCINATION SITE RASH (Injection site rash). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Nausea, at an unspecified dose and frequency and PROCHLORPERAZINE MALEATE (COMPAZINE [PROCHLORPERAZINE MALEATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Injection site Itchy), MYALGIA (Bad body aches), PYREXIA (Fever), VACCINATION SITE RASH (Injection site rash), NAUSEA (Nausea) and HEADACHE (Bad headache) had resolved and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 102 (High) Fever that rose  to 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: follow-up received on 20 April 2021.reporter contact details was updated, medical history details was updated, concomitant medications details was updated, event outcome details was updated, treatment details was updated
This spontaneous report as received from a physician Assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that on 19-AUG-2014, 01-OCT-2014, 03-NOV-2014, 14-NOV-2014, 29-DEC-2014, 14-JAN-2015 and 10-MAR-2015, the patients received doses that were improperly stored VAQTA (strength, lot number, expiration date, dose # and route of administration were not reported). There was not concomitant medication reported. No adverse experiences were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Light headed, fatigued, fever of 101, muscle aches. Lasted about 12 hours before fever broke. Took tylenol.
At site of vaccine (Varicella) developed erythema & induration. Erythema border outlined, grew 5 x 4 cm -> 13 x 10 cm in 24 hrs. No drainage. Prescribed Amoxicillin x 10 days.
Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated with tingling down arms and legs. Blood pressures in the 150/90s, HR 86, 98% O2 saturation, and alert/oriented. Patient was placed in a supine position and monitored. EMS was called as symptoms persisted and increased.
This spontaneous report as received from a nurse refers to a 2 patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX, 0.5ml, subcutaneous (lot number and expiration date not reported). No adverse effects reported. Additional information has been requested.
ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) ACUTE HYPOXEMIC RESPIRATORY FAILURE
muscle aches; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle aches on 26Dec2020. Outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number could not be obtained. No further information is expected.
Headache; Bone pain; Generalized muscle pain; Had swelling in the injection side underneath the breast and to the arm; Had swelling in the injection side underneath the breast and to the arm; Had swelling in the injection side underneath the breast and to the arm; Has not been able to sleep due to the pain; Has not been able to sleep due to the pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; BONE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Bone pain"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "Generalized muscle pain"; VACCINATION SITE SWELLING (non-serious), BREAST SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Had swelling in the injection side underneath the breast and to the arm"; INSOMNIA (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Has not been able to sleep due to the pain". Therapeutic measures were taken as a result of headache, bone pain, myalgia, vaccination site swelling, breast swelling, peripheral swelling, insomnia, pain.  No follow-up attempts are possible. No further information is expected.
pt recv vax & devel a fever of 99.9, nausea, muscle weakness & an inj site rxn @ the site of pnu-immun 23 characterized by redness, swelling, warmth, & pain;f/u 14JAN97 indicated pt also exp body aches & chills;tx w/advil & APAP & warm comp
pt reported to clinc; hospitalization for a papillary fibroelastoma tumor on mitral valve which caused an occlusion of the main artery to the optic nerve of the lt eye; presented to ER 16NOV92;
This spontaneous case reported by a consumer, describes the occurrence of rash (got an arm rash with both doses) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced rash (got an arm rash with both doses). At the time of the report, rash (got an arm rash with both doses) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication list and treatment information not provided.
Blurry vision with wavy lines for about 10 minutes. Followed by a strong frontal headache about a half hour later which didn?t respond to Motrin. Headache lasted approximately five hours
Pt. c/o numbness and tingling of the left hand and fingers.  Pt. Seen and assessed by paramedics and vital signs are, BP 128/60, HR 68.  Pt. observed for 30 min. and cleared to go home after verbalizing she felt a decrease in sensation.  Pt. told to call MD if sensation worsens.
11072007 @1:10pm father called and c/o redness, erythema and edema at RD injection site of DTaP given on 11-06-2007.  I explained to father like I explained to mother at the time of the injection that this localized reaction was a normal side effect of the vaccine administration of the DTaP vaccine.  father just wanted to make sure his son was going to be okay and reassurance were repeated to the father, like the mother at the time of the administation:  Ice/cold pack for 20m intervals with 10 min breaks, ibuprofen 100mg PO Q6hrs.  Explained that this was a normal but unfortunate reaction and that there was no detrimental affects to the son.
About 20 minutes of the injection, I got a headache. Within 3 hours my had a slight fever of 99.9 and I had chills for the next few days. I had vertigo and was very dizzy.
1 day following PENTACEL administration, child had 60 sec. ALTE (apnea, color change, loss of tone, central cyanosis). Fully self-recovered within 5 minutes. No fever. Exam normal.
Initially, some soreness in the arm for about 24 hours.  Then, eleven days after the injection, upper arm swollen, red, itchy and hot to the touch. Worse on the twelfth day following injection
Left side of the face is swollen, especially lift side of the lip. It has been swollen day.
Dizziness/lightheadedness; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other and describes the occurrence of DIZZINESS (Dizziness/lightheadedness) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Jan-2021, the patient experienced DIZZINESS (Dizziness/lightheadedness) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, DIZZINESS (Dizziness/lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment information were not reported.  Company comment: This is a case of product exposure during pregnancy with the associated AE, dizziness, for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. However, based on the current available information and temporal association between the use of the product and the start date of the event, dizziness, a causal relationship cannot be excluded.  The reporter stated that they no longer have access to this patient's chart.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No newinformation; Sender's Comments: This is a case of product exposure during pregnancy with the associated AE, dizziness, for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. However, based on the current available information and temporal association between the use of the product and the start date of the event, dizziness, a causal relationship cannot be excluded.
Pt recvd vax 10NOV92 & immed following vax exp burning & felt the vax going in; 17NOV92 pt exp pain in the arm which radiated into the shoulder; No further details were provided;
Administered adjuvant without the active component; Administered adjuvant without the active component; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient was administered the Shingrix adjuvant without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Shingrix vaccine batch number, expiration date were unknown. The reporter consented to follow up. This case has been linked with US2022051806 and US2022051804, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022051806:Same reporter. US-GLAXOSMITHKLINE-US2022051804:Same reporter.
Woke up 8:30 am the day after her 4th vaccine, with severe vertigo reporting the room was spinning and upon trying to sit up she fell over. Attempted to sit up again but again fell over. Called her husband  to assist. She again tried to sit up but fell over. She did not lose consciousness at any time just loss of balance/equilibrium. Her husband called 911 and she was transported to the hospital and is currently inpatient. She also reports her B/P has intermittently been elevated while she has been hospitalized.
I've been having swelling and bruising on various parts of my left arm, left leg since the vaccine shot.    This was my first shot, second one was on June 19, 2021 and my left arm still hurts and the bruising continues.   I was seen at , the doctor who say me said "your reaction and bruising is a mystery"
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On 19-JUL-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient suffered from a severe right facial nerve axonopathy and was diagnosed with Bell's palsy. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, Bell's palsy was considered to be medically significant. Additional information has been requested.
24 hours later vomiting for 12 hours; dehydrated for 2 days after; unable to tolerate food for several days 2 weeks later labs due to continued unwell status including excessive aches, fatigue, and intestinal distress  Acute Lyme results; treatment with doxycycline; continued symptoms including POTS, chest pains/pinching Gastrointestinal evaluation; Internal and Critical Care evaluation, Cardiac evaluation, Immunology follow up
Shaking, tremor, fever after 3 hours of flu shot. Went to emergency room, IV treatment of antibiotics & discharged with levofloxacin prescription.
Developed herpes zoster on 10/9/14 given valcyclovir on 10/15/14. Post herpetic neuralgiia requiring steroids, amitriptylene and LYRICA. Pain now subsiding.
Patchy rash that began localized over liver and lymph nodes, worsened with each subsequent dose of pneumococcal vaccine. Began to have mottling of legs and cold blue hands and feet. Baby came home and slept for 20 hours almost every day that week, just would lay on the floor and cry.
3JUL93 mom noticed pt had fever-? high; mom gave APAP x 1 dose; fever cont mom bathed pt who seemed to have a sz during bath; mom took pt to ER & was told pt had mild ear infect;
Patient received 0.5ml of FLUZONE vaccine instead of 0.25ml on 10/22/2018.
numbness, tingling and stiffness to whole right upper extremity from shoulder to fingertips
Several 3 hr episodes of screaming, x 3 days, with inconsolability & poor feeling starting the day of shot.
Sustained fever up to 104 F (48 hours), extreme chills and body shakes, muscle aches, body aches, headache, nausea, fatigue.
Cough, soar throat, flared up sinuses, fatigue  Currently 36 weeks pregnant. Due January 27, 2022
LEFT ARM HARD,SWOLLEN AND WARM  BENADRYN LIQUID AND NIZORAL CREAM
PATIENT REPORTED FEELING NAUSEATED, CLAMMY, AND HAD DIARRHEA WITHIN IN 30 MINUTES OF THE SHOT. WAS TOLD TO GO TO URGENT CARE BUT SHE REPORTED FEELING BETTER WITHIN THE NEXT 30 MINUTES.
102.7- 103 degree fever lasting 36 hours (even with use of acetaminophen and ibuprofen), after that temperature went down to 100.3 degrees. Baby refused solid food and was not able to nurse; 48 hours after vaccinations baby exhibited profuse, projectile vomiting requiring administration of electrolyte solution via dropper. 72 hours after vaccinations all symptoms subsided.
At 11:30pm on 04/07/2021, I (the patient) began to experience chills and nausea. At 1:00 am On 04/08/2021 I experienced a fever and began vomiting every hour until 8:30 am the same day. Once the vomiting stopped at that time I continued to experience a fever, chills, and joint and muscle pain until around 5:00 pm when I took two Tylenols. The Tylenol brought the 101.9 temperature to 100.0 and reduced the joint and muscle pain.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 11:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:55 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 84.96   Concomitant products were not provided.  On 31-Mar-2021, Excursion temperature at 09 AM was 32, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
This spontaneous prospective pregnancy report as received from a Registered Nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 18 years old female patient without Drug Reactions/Allergies The patient's medical history included birth control until 20-SEP-2012, patient had just gotten off unspecified antibiotics. The patient was on unspecified antibiotics once in September 2012 and then in October 2012. The patient's history of previous pregnancies and live births was not know. The patient was vaccinated with the first dose of VARIVAX (Merck) (0.5 ml, subcutaneous, lot # was unknown) on 26-APR-1999. No other co-suspects were reported. There was none concomitant medications. The patient became pregnant with an LMP of 30-SEP-2012 and an EDD of 07-JUL-2013. The patient received the second dose of VARIVAX (Merck) (0.5 ml, subcutaneous, lot # was H006529, expiration date was 09-MAR-2014) on 31-OCT-2012 and was pregnant. No treatment was given for adverse event. The outcome of event was unknown. The patient's urine pregnancy test was positive. The patient sought medical attention via visiting to the nurse. Additional information has been requested.