chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leg cramps in my calve; Inflammation; Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh; She reported the side effect; Leg pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She reported the side effect), PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Leg cramps in my calve), INFLAMMATION (Inflammation) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts, Allergy to antibiotic, Penicillin allergy and Drug allergy. Concomitant products included FENOFIBRATE from an unknown date to 11-May-2021 for Hypertriglyceridemia, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION COMPLICATION (She reported the side effect), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh). On an unknown date, the patient experienced MUSCLE SPASMS (Leg cramps in my calve) and INFLAMMATION (Inflammation). At the time of the report, VACCINATION COMPLICATION (She reported the side effect) outcome was unknown and PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Leg cramps in my calve), INFLAMMATION (Inflammation) and ARTHRALGIA (Leg pain behind her knee and thigh after her first dose/Pain behind knee that radients to my thigh) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2021, Ultrasound scan: no blood clots (Inconclusive) No blood clots. On 05-Sep-2021, Ultrasound scan: no blood clots (Inconclusive) Blood clots- none were found.     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.   Patient experienced leg cramps in calve, pain behind knee, radiates to thigh and inflammation.  Treatment for inflammation will start from next day included steroid pack and natural massage.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16 Jun 2021 included details on: patient demographics(height, weight and ethnicity), relevant medical history, details on concomitant medication, and event outcome.
swelling at injection site; pain at injection site; fatigue; Nauseous; dizzy; mental fog; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (mental fog), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (pain at injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-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 06-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (mental fog) and NAUSEA (Nauseous). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (pain at injection site) and FATIGUE (fatigue). At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (mental fog), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and NAUSEA (Nauseous) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Reporter Contact information updated
Fever, chills, congestion, pneumonia, dehydration, stomach pain, death. #21-n (Hospitalization 11 days, remdesivir, oxygen, steroids, Patient died from COVID pneumonia on 1/6/22
This spontaneous report as received from a certified medical assistant refers to a unkonwn number of patients of unknown demographics. On 27-JAN-2015 the patients were inadvertently administered VARIVAX (Merck) (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. Follow up information has been received from the reporting medical assistant, during a phone call on 23-MAR-2015. The medical assistant reproted that VARIVAX (Merck) lot# involved was K010337, expiration date was not provided. This is one of several cases received from the same reporter. Additional information has been requested.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 2/3/2022 HYPERCALCEMIA
Patient had significant facial swelling several hours later after her initial COVID dose on 2/11/21
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 at 13:00 as dose number unknown, single (Lot number: EL3248) at the age of 76 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vancomycin, reaction(s): "Known allergies: yes, vancomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient was treated with Anti-viral (COVID 19 Treatment, Brand: Pfizer, Lot number: FM9992) drugs from 08Jun2022 to 08Jun2022,, with indication was Treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
fever for a day on the second day (around 14-16 hours after the 2nd dose), weak energy, pain issue when opening mouth or eat (like the  temporomandibular joint disorder, and whenever I opened my mouth for about an inch, I would feel the pain, not to mention eating, has to eat soft food and chew slowly) for a month by now, and will go to see doctor for the reason next week.
pt recvd vax 2PM 11JAN96;mom stated inj site very swollen that noc & pt w/pain & fever;temp @ time of exam 100.9R
I got what appeared to be my first ever herpetic outbreak in my genitals. I?ve never in my life had herpes. I got the Moderna vaccine on 4/30 and the rash appeared on my labor on 5/2, so 2 days later. I had no reason to believe it was an STD because I?ve been monogamous for 20 years and never had it before so I went to the ER. The rash started out as little blood blisters that grew in size, scabbed over, fell off, became ulcerated, then eventually healed. It was a little itchy at first when the scabs were forming. The ulcers were extremely painful. It all lasted about a week.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 17; Unit: Unknown) and ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included bee stings. There were no concomitant medications. The patient previously took flu vaccine for immunization and experienced skin reactions. On an unspecified date, 3 hours post injection, patient experienced pain at site, fatigue and fever. On the second day, patient experienced fatigue, pain and swollen red with the size of baseball at injection site, fever and body aches. The patient took ibuprofen (ADVIL) for pain and fever. The outcome of the events was unknown.
Pediarix instead of Dtap (Infanrix); With Pediarix, now has 4 doses of hep b; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 26th October 2025) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered 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: 2-Feb-2203 Reporter's comment: Nurse assistant reported by getting Pediarix, the patient now had received 4 doses of Hepatitis B, 4th dose of Dtap and reporter was unaware of where patient was in series for IPV. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Pediarix (extra dose for Hepatitis B), Hiberix (Hib) and Prevenar instead of Infanrix, Hiberix and Prevenar, which led to wrong vaccine administered and extra dose administered.
This case was reported by a physician and described the occurrence of injection site pain in unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, general malaise and fatigue. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, general malaise and fatigue were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, general malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient experienced adverse events. This case was linked with case US2018GSK085312 reported by the same reporter.
Patient arrives to our pharmacy Sunday 02/02/2014 around 9:10AM informing us that she is still experiencing soreness on her upper left arm from a flu shot on 10/30/2013 around 7:30PM, particularly at the injection site. She was administered Fluzone Intradermal (NDC: 49281-0707-55, LOT #: UT4726AA, Exp: 04/23/2014) by RPh. When asked why it took her over 3 months to notify us about this adverse reaction, patient stated she thought it would eventually go away. When asked if she sought out medical attention with her primary physician, patient stated that she hadn't yet but had "set an appointment this Tuesday or Wednesday." When asked, patient denied doing any strenuous activity or heavy lifting between then and present time. Her primary physician was contacted by RPh on 02/03/14 with no response, so a message was left.
Hot flashes; Cold flush; Face is swollen; Heart raced a little; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), FEELING COLD (Cold flush), SWELLING FACE (Face is swollen) and PALPITATIONS (Heart raced a little) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetes mellitus.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HOT FLUSH (Hot flashes), FEELING COLD (Cold flush), SWELLING FACE (Face is swollen) and PALPITATIONS (Heart raced a little). At the time of the report, HOT FLUSH (Hot flashes), FEELING COLD (Cold flush), SWELLING FACE (Face is swollen) and PALPITATIONS (Heart raced a little) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine received 15:00 while at work at Medical Center; Around 19:00 started having intermittent "hot flash" feeling and general fatigued feeling. Got home from work (RN in ED) at 19:40.  Took a shower and felt nauseous when I sat down to eat dinner. Declined to eat dinner and opted to lie down in bed instead, at 20:50.  Awoke at 22:00 to urinate. Felt dizzy standing up, with cold-sweats and body aches. Checked temperature, 97.9 F. Went to the bathroom, drank some water, took 400mg ibuprofen and 325mg tylenol, and went back to bed. Awoke back up at 01:30am with abdominal cramping and nausea. 2 episodes of dry heaving, but no vomit. Awoke back up at 06:55am, GI symptoms resolved but bodyaches persist, as well as overwhelming fatigue. Checked temp at 07:25, 98.3 F. Employer notified.
enlarged and painful right axillary lymph node, enlarged and painful bilateral inguinal lymph nodes, painful  mesenteric lymph nodes right abdomen. symptoms started three days after Covid vaccine , worsened over next several days . symptoms didn't start resolving until several days later
Patient c/o high fever and chills.  Inflammation/redness at site of injection from top of arm to elbow.
Coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COUGH (non-serious), outcome "unknown", described as "Coughing".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 hours after I was vaccinated I woke up with a severe headache and also felt very hot/feverish. When I got up at 3:30 am to get some water/Advil I also felt light stomach pain  and dizziness.  It took me about an hour to go back to sleep. Currently the time is 11:00 AM on 07APR2021 and I am experiencing a light headache, but am no longer experiencing dizziness or stomach pain. Arm is still sore from the site of injection.
Case number PHEH2014US003802, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 23 OCT 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
A nurse reported the occurrence of an anxiety attack in a 29-year-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent conditions, and concurrent medications were not provided. On 05/28/2002, the pt received an injection of Engerix-B (lot ENG5186C6) into an unspecified arm. The pt stated that her arm began to tingle "immediately". The reporting nurse attributed this to an anxiety attack, because the vaccine injection was "very dramatic for [the pt]." The pt was treated with diphenhydramine (Benadryl). The reporting nurse contacted the pt that evening, and was told that the arm tingling had resolved. The reporting nurse considered the anxiety attack to be unrelated to Engerix-B administration. However, the Engerix-B immunization series was discontinued.
About 10-11 hours after receiving the vaccine began to have severe body aches and 102 fever.   Fever subsided but extreme fatigue and body aches for two full days following the vaccine.  Two days after the vaccine I began to have sharp intermittent pains in my head and lost my balance and had trouble walking for about two hours.  I took Advil for the fever and the pains in head and this seemed to help with both.  Three days after the vaccine I am feeling less fatigue and body aches have improved.
Breakthrough Case of COVID, throat is a little swollen, a headache, very tired, and running nose, the fever was low grade just about a 99.
Painful body and muscle aches, fever chills, headache. Swelling of right hand, followed by dark bruising of right hand/wrist.
Mild tongue and throat swelling which subsided by day 2. Mild skin rash on both forearms.
Approximately 5 minutes after receiving the injection, patient began coughing and had a noticeable change in her voice. She complained of chest tightness that later moved into her throat. Patient has a history of asthma.  She was provided an initial dose of nebulized beta agonist therapy and was referred to a local emergency department for further evaluation.  She was evaluated, treated and discharged home from the emergency department.  She returned to work the following day pending further followup evaluation per her personal physician.
During event, client approached me and asked for another COVID-19 card as she had lost her card. Upon checking her record, I noticed patient was given J&J vaccine on 05/07/2021 and then given 1st shot of Moderna on 06/28/2021. Patient was well and not exhibiting any health problems and had no medical complaints. Sending report for documenting incident.
It was three weeks after the first dosage, I developed arthritis in my knees, elbows, and ankles (very swollen and painful...found it very hard to walk). The PA stated that I was positive A&A (Anti-nuclear embody where the body attacks itself). She leaned towards an Autoimmune disease and she placed me on steroids. I had to take them for three weeks.
Head ache Arm ache Slight fever  Joint pain Slight stomach ache  Fatigue  Lack of appetite  Cough Shallow breathing
Information has been received from a nurse concerning her daughter, who on an unspecified date was vaccinated with a dose of GARDASIL, 0.5 mL, I.M., and developed blood clots. The patient sought medical attention. Additional information has been requested.  6/18/09 Medical records received 7/30/07 to 12/23/08. Assessment: Tinea corporus, bilateral macromastia, superficial phlebitis R and L lower extremity - thrombus, subluxation of left patella Patient presents with injured foot. Heavy painful menses. Lower back, shoulder, and neck pain. Obese. Itchy rash on arm, erythematous plaque. laceration of finger. Bilateral large pendulus breasts. Nonproductive cough. Bilateral breast reduction surgery. Delayed healing of surgical site. Bilateral leg pain. Bruise on leg. Scraped knee. Fell and injured knee. Reduction of patellar dislocation. MEDS:   PMH.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced first dose unspecified 1 year ago, to received the second dose 12/04/2012. No treatment information was reported. The outcome of first dose unspecified 1 year ago, to received the second dose 12/04/2012 is unknown. The relatedness for first dose unspecified 1 year ago, to received the second dose 12/04/2012 is unknown for GARDASIL. Patient is in the office today, 12/04/2012, to receive the second dose of GARDASIL. No AE reported. Additional information has been requested.
Patient reported swelling and pain at injection site, followed by redness in the eye that evening that improved slowly over the next few days. Patient reported no changes in vision.
HAD NOT SEPARATED THE VACCINE DOSE FROM MEALS BY MORE THAN AN HOUR; This spontaneous case report was received from a physician (PVX2019-436) on 15-Feb-2019. The report describes a 53-year-old adult female consumer who "had not separated the vaccine dose from meals by more than an hour". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif on 08-Feb-2019 and the last dose on 14-Feb-219. The physician stated that the consumer ate food within an hour of taking Vivotif.  The action taken with Vivotif with respect to the event "had not separated the vaccine dose from meals by more than an hour" was not applicable.  The clinical outcome of the event "had not separated the vaccine dose from meals by more than an hour" was unknown.  Company's Comment: The causality of the event "had not separated the vaccine dose from meals by more than an hour" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "had not separated the vaccine dose from meals by more than an hour" was considered as not applicable.
Information has been received from a physician who reported that on unspecified date one of two boys may have received GARDASIL (Lot # unknown) instead of polio virus vaccine inactivated (unspecified) (manufactured unknown). One boy was 12 year old and the other was 5 year old. The physician was not sure if either boy received GARDASIL. No adverse event was reported. No further information is available.
Start having severe nasal congestion on the left side from day 5th (5/12).  Certirizine HCI, XClear Nasal spray, NeilMed Sinus rinse dose not help. Now it's day 14th. The nasal congestion still persist. The last time I have similar condition was Dec. 2019.
Intense cold sensation, cold all over the body; Was not able to move; Shivering and Teeth trembling (like a start of hypothermia); This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Intense cold sensation, cold all over the body), HYPOKINESIA (Was not able to move) and CHILLS (Shivering and Teeth trembling (like a start of hypothermia)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Intense cold sensation, cold all over the body), HYPOKINESIA (Was not able to move) and CHILLS (Shivering and Teeth trembling (like a start of hypothermia)). At the time of the report, FEELING COLD (Intense cold sensation, cold all over the body), HYPOKINESIA (Was not able to move) and CHILLS (Shivering and Teeth trembling (like a start of hypothermia)) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment medications were provided.  Patient had shivering and teeth trembling (like a start of hypothermia) and this went on for a few hours the patient was not able to move.
Patient was taken by ambulance to hospital with severe dizziness and nausea. Patient was found to be dehydrated at hospital.
Patient was seen by me on October 23, 2020. Her left arm had significant swelling from deltoid muscle down past elbow, along with mild erythema. Patient was experiencing itching and pain.  The swelling and erythema had been noticed by mom the day prior but had worsened by the time she came to see me.