chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WEAKNESS OF THE RIGHT SIDE OF THE BODY; NUMBNESS ON RIGHT SIDE OF THE BODY; PAIN ON THE RIGHT SIDE OF THE BODY; STIFFNESS OF BODY; FEELING OF HEAVINESS IN BODY; HEADACHE; MUSCLE PAIN THAT EXTENDS TO THE BONES; This spontaneous report received from a consumer concerned a 59 year old not Hispanic or Latino, Asian female. The patient's weight was 130 pounds, and height was 162 centimeters. The patient's past medical history included pain on the right side of the body but not similar to what she was experiencing now, and concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies and patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805029, expiry: unknown) frequency 1 total, dose was not reported, administered on 13-MAR-2021 at deltoid in left arm for prophylactic vaccination. No concomitant medications were reported. The reporter stated that on the 15-MAY-2021, his mother started to develop side effects of the vaccine such as headache, pain and numbness on her right side of the body which started from her head to her feet and weakness of the right side of the body. According to the reporter the pain scale varied from 6-10/10, she described the pain like a feeling of heaviness, stiffness and muscle pain that extends to her bones. The patient consulted her health care professional and Chiropractor 2 days before the date of report and they did not prescribe anything but recommended to do MRI which she will do moving forward. Patient was taking over the counter pain medication and had massage on the painful area but it only helped for a short period of time and according to her son it was really affecting her activity of daily living (subsumed under event weakness of the right side of the body) as the symptoms were getting worse. On an unspecified date in MAY-2021, Laboratory data included: Pain scale (NR: not provided) the pain scale varies from 6-10/10. On 01-MAY-2021, Laboratory data included: Colonoscopy (NR: not provided) Unknown.  The action taken with covid-19 vaccine was not applicable. The patient had not recovered from numbness on right side of the body, pain on the right side of the body, weakness of the right side of the body, headache, feeling of heaviness in body, stiffness of body, and muscle pain that extends to the bones. This report was serious (Other Medically Important Condition). covid-19 vaccine weakness of the right side of the body. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Starting 07/13/2022, I just felt bad and like I was "hit by a truck". My whole body hurt and I had nasal congestion and muscle aches. I tested positive on 07/15/2022 via a test at urgent care. They prescribed me two medicines: Molnupiravir and Bromfed. The symptoms lasted a few days. The muscle aches went away pretty quick. I still have a little nasal congestion but its much better.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. On an unknown date, 2 months after receiving the first dose (date unspecified) of VAQTA (dose, route of administration, lot/batch number, expiration date and indication were not reported), the patient was vaccinated with the second dose of VAQTA (dose, route of administration, lot/batch number, expiration date and indication were not reported). No adverse effects reported. Additional information is not expected as no consent for contact was given.
Fevers ranging 102 - 104.8° lasting 30 hours 3 days  Night sweats 3 days Body aches 3 days Severe fatigue 4 days Mouth sores 4 days Cold sores in nose 4 days Headache 4 days  Swollen lymph nodes in left arm put severe 3 days
Intradermal vaccination given in let arm and did not wheal. Repeat intradermal vaccine given subcutaneous in left arm successfully.
Within 12 hours after the shot, I awoke during the night feeling very strange, went to get some juice and i do not remember what happened. I woke up on the kitchen floor. Feeling very weak moved to the couch. When i woke in the morning i had alight rash to my arms and legs. After 48 hours of getting the shot, I had a read rash over my entire body, very weak with a terrible headache. I had the rash for 3 days, was weak with the headache for 5 days. Within a couple of weeks I developed pressure in my ears and dizziness. I sought out an ENT and underwent some testing that all come back WNL. Over the last two months my dizziness has become debilitating. I returned to my ENT for further test, MRI, lab work and vestibular testing have all been normal. I have taken oral steroid with no relief.
SEVERE GASTROINTESTINAL SYMPTOMS; PAIN; DIARRHEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included ustekinumab for drug used for unknown indication. On an unspecified date, the subject experienced severe gastrointestinal symptoms, fever, pain, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe gastrointestinal symptoms, fever, pain and diarrhea was not reported. This report was non-serious.
1 1/2 x 3 1/2 induration, 4 x 3 cm redness. 2 red streaks toward axillia. 10 cm and 4 cm. Gen'l swelling upper arm. Benadryl, ice to area
Immediately following immunization, the pt didn't feel well and his body stiffened up. He was placed on the exam table where he relaxed but was unresponsive for approximately 1 minute. His mouth was open, some tremors but no clonic movements. Also states that the pt had incontinent of urine, circumoral pallor, and complained of nausea. After 20 mins, he sat up for four minutes then became nauseated and slumped over against mom.
This is a spontaneous report from a non-contactable consumer. This patient of unspecified age, ethnicity, and gender received PREVNAR single dose on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced came down with bad viral infection in chest and bad rash all over upper body that itches like crazy on an unspecified date with outcome of unknown. The patient "was due for pneumococcal booster, but got PREVNAR instead". No additional information was reported. Follow-up (30Jan2015): Follow-up attempts completed. No further information expected.
Initial Report Received on 21-Mar-2019 and 22-Mar-2019. A nurse reported that a newborn male patient (age and race not provided) was administered with 2 doses of HEPLISAV-B for hepatitis B immunization. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient received 2 injections of HEPLISAV-B (lot #, expiration date, and NDC # unknown) when he was born. On 21-Mar-2019, a nurse reported that a newborn patient received 2 doses of HEPLISAV-B when he was born. No further information was provided. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment:  The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B USPI.
Chills; Fatigue; Muscle twitching; Tingling (feet) persisting for 2 weeks; Cold/ ice feeling in bloodstream; Nausea; dose number= 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Jan2022 (Lot number: unknown) at the age of 45 Year(s) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: unspecified), administration date: 13Apr2021, when the patient was 44 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: unspecified), administration date: 04May2021, when the patient was 44 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022, outcome "unknown", described as "dose number= 3"; CHILLS (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Chills"; FATIGUE (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Fatigue"; MUSCLE TWITCHING (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Muscle twitching"; PARAESTHESIA (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Tingling (feet) persisting for 2 weeks"; FEELING COLD (non-serious) with onset 07Jan2022, outcome "unknown", described as "Cold/ ice feeling in bloodstream"; NAUSEA (non-serious) with onset 07Jan2022, outcome "unknown", described as "Nausea". The events "Chills", "Fatigue", "Muscle twitching", "Tingling (feet) persisting for 2 weeks", "Cold/ ice feeling in bloodstream" and "Nausea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, fatigue, muscle twitching, paraesthesia, feeling cold and nausea.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a consumer (patient's mother) refers to a 4 month old patient of unknown gender. On 20-FEB-2015 the patient was vaccinated with (Oka/Merck) VARIVAX for prophylaxis at the age of 4 months. No adverse effect was reported. No product quality complaint (PQC) was reported for varicella virus vaccine live. Additional information has been requested.
Swollen lymph node under left arm.; Fever; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 26Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included tetanus vaccine (TETANUS) started from 21Apr2021 for an unknown indication and isotretinoin (ACCUTANE) from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received any other vaccines within four weeks prior to the vaccination. On 01May2021 the patient experienced swollen lymph node under left arm. After lymph node swelling went down delayed reaction with headache, fever, body aches, 6 days after vaccination. The clinical outcomes of headache, fever, body aches were not recovered while that of swollen lymph node was recovered on an unknown date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain in arm; Bone pain/bone pain in arm; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain/bone pain in arm) and VACCINATION SITE PAIN (Injection site pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain/bone pain in arm) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain/bone pain in arm) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
Headache, muscle pain, joint pain, chills, nausea, stomach cramps. For 28 hours Treatment: rest, fluids, ibuprofen
Swollen and tender lymph nodes i left armpit for 7 days. This was a different pain from the injection site soreness I had too for a few days. From the lymph swelling my arm hurt for a full week.
Rash on forearms, face, legs. Returned to clinic day after injection. Decadron 8mg IM and Benadryl OTC.
7:30 pm c/o shortness of breath with temp of 100.5, at 7:45 continued to c/o shortness of breathe with temp of 102.5, at 8:30pm Antacid 2 tabs and Tylenol 650mg was given, at 8:36pm Provider orderes received to send out to Hospital emergency. at 9:10pm EMS arrived to unit, and at 9:23 patietn had left the unit.  At 12:30 am patietn returned to facility Temp 99.2, denies complaints with no new orders received from the hospital.
Pt recvd vax JUL92 & 2 to 3 wks later pt exp coughing, congestion, low grade fever, lightheadedness & joint pains; No further details were provided;
First seizure 10 days after first gardasil vaccine.  Two months later, second seizure episode 16 days after second gardasil.  08/22/2008 MR received from Neuro consult dated 12/22/06 (as well as some past hx.) Assessment: 1st Seizure.  Most likely a complex partial seizure with secondary generalization. Pt was trying to speak but unable to do so, then had a 30-40 sec grand mal seizure which may have begun in the legs. Neuro exam WNL. 9/11/2008 2 ER recs received dated 12/21/2006 and 6/16/2007 with DX: 1st seizure and seizure.  Pt 1st presented 12/21/06 following 30-40 sec seizure.  Seen 6/17/07 after 2 episodes of lip quivering and feeling of throat closing which was a similar aura with last grand mal seizure. C/o headache after.
Around 4pm left arm was swelling (entire) and pain. my left eye closed completely,tears and right eye barely closed. I was very sleepy was driving home.The next day I exp fatigue,diarrhea, chills and headache(right side) for the remainder of the week. I took Tylenol for headache the pain wasn't going away.I went to ER did a test for Paralysis discharged with drops for eyes. I followed up with Ophthalmology clinic they put a light to my eyes due to both being completely closed and did some test. I was told to stop using the drops from the ER because it was toxic for my eyes.Upon my discharge given instructions to due warm compress on my eyes for swelling and blurred vision. As of today I'm still ex blurred vision (both eyes) to see, hard for me to see computer,cell phone, letters.
Patient had nausea for 2 days after receiving 2nd dose; Patient had chills for 2 days after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Patient had nausea for 2 days after receiving 2nd dose) and CHILLS (Patient had chills for 2 days after receiving 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Patient had nausea for 2 days after receiving 2nd dose) and CHILLS (Patient had chills for 2 days after receiving 2nd dose). At the time of the report, NAUSEA (Patient had nausea for 2 days after receiving 2nd dose) and CHILLS (Patient had chills for 2 days after receiving 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-063834 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Updated reporter information.; Sender's Comments:  MOD-2021-063834:Daughter
Inflammation on her right side; Redness on her right side and leg; Hives; Chills; Temperature of just over 100 degrees F; Mild reaction at the time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild reaction at the time), INFLAMMATION (Inflammation on her right side), ERYTHEMA (Redness on her right side and leg), URTICARIA (Hives) and CHILLS (Chills) in a female 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION COMPLICATION (Mild reaction at the time). On 07-Mar-2021, the patient experienced INFLAMMATION (Inflammation on her right side), ERYTHEMA (Redness on her right side and leg), URTICARIA (Hives), CHILLS (Chills) and PYREXIA (Temperature of just over 100 degrees F). On 19-Feb-2021, VACCINATION COMPLICATION (Mild reaction at the time) had resolved. At the time of the report, INFLAMMATION (Inflammation on her right side), ERYTHEMA (Redness on her right side and leg), URTICARIA (Hives), CHILLS (Chills) and PYREXIA (Temperature of just over 100 degrees F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: high (High) Temperature of just over 100 degrees F.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Patient received injection on 4/22/08 and returned to the clinic on 4/24/08 with a 2 inch circular inflammed area on the left deltoid at  injection site. Patient had no respiratory problems to report and wasn't running a fever. Advised to apply cold compress and administer Tylenol as directed for patient weight to ease any discomfort.
Pt seen in clinic 2 days after injection with warm, erythematous patch around injection site, 5" in diameter. No systemic signs or evidence of excoriation.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine with an associated reaction of injection site pain (received 2 years ago without incident). On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, headache and fatigue. In August 2018, the patient experienced difficulty sleeping, fever and chills. On an unknown date, the outcome of the injection site pain and fatigue were recovering/resolving and the outcome of the difficulty sleeping, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, difficulty sleeping, headache, fever, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. This case was not reported to anyone previously. The patient received the ZOSTAVAX vaccine 2 years ago without incident; accept for soreness at the injection site. In the early afternoon, the patient received SHINGRIX in the left deltoid. The patient began to have pain at the injection site in the early evening and became extremely fatigued after dinner. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, fatigue and developed a headache prior to going to bed. In August 2018, 12 hours after vaccination, the patient experienced fever and chills in the middle of the night and had difficulty sleeping. The fever and chills and difficulty sleeping have resolved, but the patient continued to feel tired and had soreness at the injection site.
Redness, rash getting bigger, itchy. applied hydrocortisone/eucerin cream combo (5/16/21) helped with itch
Monomorphic Ventricular tachycardia Reduced LV systolic dysfunction Myocarditis
The pt experienced lethargy, somnolence post vax. Vomiting, increased heart rate, and fever of 104 were also experienced.
This spontaneous report as received from a registered nurse refers to a 10 months old patient. The patient was vaccinated with a dose of VAQTA (Lot # not reported) on an unspecified date, "a few months ago". No adverse event was reported. Additional information has been requested.
This case was reported by a health professional and described a 45 year old female pt who did not respond to Engerix-B immunization series. On unspecified dates in 2000, a hepatitis B surface antibody titer was "negative".
"Covid Arm" after booster dose only.  Red, itchy hard swelling about 2 inches below the injection site about 2x1 inches wide.  Took benadryl and advil for 2 days.  Mostly gone 6 days later.
ears to throat felt very numb; ears felt very muffled; could not swallow for several minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 27Mar2021 at 10:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included gerd, shellfish allergy and allergic to NSAIDS. Concomitant medications included unspecified medication used within two weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 10:45, the patient experienced ears to throat felt very numb, ears felt very muffled (for 2 weeks and still feel this way) and could not swallow for several minutes (suddenly was able to swallow). No therapeutic measures were taken as a result of the events. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events very numb, ears felt very muffled and could not swallow for several minutes was recovered/resolved with sequelae at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained.