chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLARE UP WITH CRAMPING; Disorder aggravation; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (FLARE UP WITH CRAMPING) and CONDITION AGGRAVATED (Disorder aggravation) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced MUSCLE SPASMS (FLARE UP WITH CRAMPING) and CONDITION AGGRAVATED (Disorder aggravation). At the time of the report, MUSCLE SPASMS (FLARE UP WITH CRAMPING) and CONDITION AGGRAVATED (Disorder aggravation) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the events of FLARE UP WITH CRAMPING unknown onset and FLARE UP WITH CRAMPING unknown onset was not provided. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Narrative: Dizziness, Myalgia, Pain, Tingling in fingers, Joint pain in shoulder and arm
Sore shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that, the patients only had only side effect of sore shoulder for few days. The follow-up would not possible as no contact details were available. Additional Supportive Information: This case had been linked with US2022AMR146743,reporter by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2022AMR146743:Same reporter
patient began with fever which then resulted to febrile seizures, patient now hospitalized in ICU
I Started to have tachycardia some months ago and I never had it before; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 05May2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Jun2021 at 14:00, the patient started to have tachycardia some months ago and the patient had never had it before. The event resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started to have tachycardia some months ago and the patient had never had it before was not resolved at the time of this report.
Swelling, pain, itching at injection site. Very Red and warm to touch. Ice, BENADRYL, MOTRIN. Ordered to fill Prednisone 20mg tablet if reaction worsened.
Kinrix is to be given in the age range from 4-6 years old.   Kinrix was given to a 17 month old. No reported adverse signs or symptoms. Immunization Registry accepts DTap and IPV as timely doses.  When Kinrix vaccine was given on 10/07/2021 the Dtap  was dose #3. The interval between dose 2 and 3 was 4 weeks.  IPV  was dose number 2. The interval between dose #1 and 2 was 4 weeks
1 week after - the shot site was really swollen .. red.. and hot to the touch .. the area swollen was apex 8? by 4? and a little itchy ... the week right after the shot  I was fine!
Not feeling good; Chills; Fever/it was a low grade fever of about 99.5; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 13Jan2021 19:40 at single dose for COVID-19 immunization. Medical history included blood pressure occasionally and it was high when the patient did not get much sleep. The patient's concomitant medications were not reported. The patient was a healthcare worker and the patient just got his second COVID Vaccine last night. The patient just started not feeling good about an hour and a half and then chills and then the patient checked a low grade fever. He had not had a fever in years. It looked like that it was one of the side effects, the patient was not (incomplete sentence), just trying to follow the process. The patient guessed within last couple hours he started not feeling good, headache, chills and then he just checked it half hour before and it was a low grade fever of about 99.5 (on 13Jan2021). The patient's body height just about 6 feet, just like 5'11", weight about 272 lbs. The outcome of the events was unknown.
On 1/25/2012, as per mother patient developed a black bruise to the left upper arm where vaccines had been administered that covered most of the entire upper arm. On February 1, 2012, he developed a sore throat and fever that lasted a week. On February 7, 2012 at 11 am he reported to hospital. As per mother, patient was non-responsive and was throwing up blood-tinged saliva. He was flown out due to an internal hemorrhage. He was admitted to hospital at around 3 pm. After admission, he remained unresponsive. As per mother, the internal cerebral hemorrhage was too advanced and the patient was not a candidate for surgery so patient eventually became comatose. He passed away on 2/10/2012 at 2 am. Final diagnosis was cerebral hemorrhage and leukemia. As per parent, the client had no previous history of illnesses at the time of vaccination on 1/25/2012.
About 10 days after my moderna  booster I developed hives and severe itching.   I?ve never had an allergy or allergic reaction in my life.  I?ve never had hives.  I?m suffering daily now and my doctor diagnosed me with dermatographic urticaria. We believe this is a delayed allergic reaction.     There is an entire forum on dedicated to this  exact experience. Many are experiencing this exact experience  almost exactly 10 days after their moderna booster.    Luckily we are comparing notes and Zyrtec and Pepcid acid twice per day is helping the majority of sufferers.
RED 9 BY 8 CM REACTION ON RIGHT THIGH THAT SHOWED UP THAT EVENING
The next morning had extreme muscle aches In the back and thighs along with headache, accompanied by fever of 104°.
Patient tested positive for the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for the Moderna vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for the Moderna vaccine). On 07-Jan-2022, SARS-COV-2 TEST POSITIVE (Patient tested positive for the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: negative negative. On an unknown date, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported. It was reported that the patient tested positive for the Moderna vaccine on the 27th (unspecified) and had been tested negative today (07-Jan-2022).  Company comment:  This case concerns a male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19,that occurred after the dose of the mRNA-1273 . The exact time to onset and doses administered was not provided. The rechallenge was not applicable due to nature of the event, as well as unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient with no reported medical history who experienced non-serious unexpected AESI of SARS-CoV-2 test positive,that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not known. The rechallenge was not applicable due to nature of the event, as well as occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Within 24 hours of receiving the vax, the pt had a fever of 102.8 and a macular, erythematous rash on the trunk, face and neck.
pt recvd DTP/MMR/HIB/OPV 6OCT92 & 5 hrs later fell to knees, laid on floor, didn't respond to name or shaking for about 1 minute; no change in color;
Patient stated he didn't feel well 2 days after receiving the vaccine and he went to hospital next day. He was diagnosed for blood clot in lung, treated in the hospital and discharged home.  Patient stated the doctor was not sure what has caused the blood clot in lung.
Moderna COVID-19 Vaccine EUA doe given 19 days after BUD for refrigeration
Very painful right arm that swelled to double normal size, red and hot to touch, fever between 100.5 and 103 degreesF, severe headache, nausea, muscle aches snd fatigue. All symptoms lasted 48 hours except right arm pain, redness and swelling which resolved after 6 days.
Patient given Moderna COVID Vaccine at the age of 17. Patient was screened for contraindications of COVID vaccine via paper form.
Patient reports immediate swelling, hard red golf ball size knot at injection site. Painful lasted app 1 1/2 weeks, she also had dizzy - lightheaded feeling after shot, vomiting reported on 4-12-13.
Patient received in error the Flublok by manufacturer Sanofi Pasteur. Physician spoke with patient mother on date of injection in the evening: at this time mother reported no issues. Physician provided mother with her personal cell to call if any questions or issues arise. Office spoke with mother the next day as a check in. Patient mother at this time reported no adverse effects noted.
Headache, Arthralgia, severe headache; extreme fatigue; upper shoulder pain Narrative:  Tylenol as needed  Other Relevant History:
pt recvd vax 11JAN93 & devel stiffness in the side of the neck on the same side as the inject was given; pt had slipped on some ice that weekend;
Vaccine SHOULD NOT have been administered.  When I took patient I did not know that the Janssen HAS NOT been approved for under 18 year olds.   Nausea, tiredness, weakness, sweating, headache, shakes
sleepy; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) and FATIGUE (Tiredness) in a 43-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (sleepy) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-283057 (Patient Link).
Within a month after my second dose I started feeling heart palpitations. I saw a Cardiologist and was put on a mobile heart monitor for a week and recorded all of my daily activities. I am still experiencing heart palpations however the frequency has decreased. I have an upcoming EKG and Heart Sonogram scheduled for June.
Severe headache, fever, chills, nausea, frequent urination, and could not sleep.
Patient reported to our facility on 4/6/09 that she has been experiencing pain to Right Upper Extremity since Zostavax injection given on 1/30/09. Patient was seen in our office on 7/21/09 and still states pain is constant, worse in certain positions. She has palpable MS tenderness in upper arm deltoid area shoulder FROM. Patient was put on Lidoderm patch to see if it helps with the pain.
His arm was sore by the end of the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 39 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: PAIN IN EXTREMITY (non-serious) with onset 27Apr2021, outcome "recovered" (2021), described as "His arm was sore by the end of the day".  Additional Information: First dose: Sore arm: Patient reported that he received the first dose of the Covid-19 vaccine almost 3 weeks ago to the day around 2:00 PM. He reported that his arm was sore by the end of the day and was sore for a couple of days before returning to normal. Vaccination Facility Type was Hospital. No Vaccine administered at Facility. No Emergency Room or Physician Office visit. No Prior Vaccinations (within 4 weeks), no AE(s) following prior vaccinations and no relevant tests reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SCARRED LEGS; NON STOP RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, batch number: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced scarred legs. On 2021, the subject experienced non stop rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the non stop rash and scarred legs was not reported. This report was non-serious.
3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (2nd dose) and Pfizer (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 incidents in clinic where 3 minors were given Moderna Covid-19 vaccine booster doses (0.25mL).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Information has been received from a medical assistant concerning a 75 year old patient of unknown gender. There was no concurrent condition, medical history or concomitant therapy reported. On 10-JUN-2016 the patient received an expired dose of PNEUMOVAX (lot # K008927 with expire date 17-MAR-2016, one injection, subcutaneous). No adverse effects were reported. Additional information has been requested.
Fever, nausea, fatigue. Persisted for 2 weeks. Heart palpitations
painful to use arm; left leg is not working; severe fatigue; attacked the muscle in upper arm and now locked; attacked left hip joint and pain is so intense; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (painful to use arm), LIMB DISCOMFORT (left leg is not working), FATIGUE (severe fatigue), MYALGIA (attacked the muscle in upper arm and now locked) and ARTHRALGIA (attacked left hip joint and pain is so intense) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (painful to use arm), LIMB DISCOMFORT (left leg is not working), FATIGUE (severe fatigue), MYALGIA (attacked the muscle in upper arm and now locked) and ARTHRALGIA (attacked left hip joint and pain is so intense). On 29-Jan-2021, FATIGUE (severe fatigue) had resolved. On 30-Jan-2021, PAIN IN EXTREMITY (painful to use arm) and MYALGIA (attacked the muscle in upper arm and now locked) had resolved. On 31-Jan-2021, LIMB DISCOMFORT (left leg is not working) and ARTHRALGIA (attacked left hip joint and pain is so intense) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included topical Product, hot/cold compress and injection (steroid or pain killer) administered by orthopedic doctor.  No concomitant medication was provided.    This case was linked to MOD-2021-090574 (Patient Link).
This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. The patient had allergy to intravenous (IV) contrast. The patient's concomitant medication included birth control (unspecified). On unspecified date (reported as over 5 years ago), the patient was vaccinated with 3 doses of GARDASIL, 0.5 milliliter (route, lot # and expiry date were not reported) to prevent human papillomavirus (HPV). On unspecified date approximately in 2018 (reported as a few months ago), the patient was diagnosed with an unspecified type of benign oral squamous cell papilloma (squamous cell carcinoma of the oral cavity) by biopsy. The patient sought medical attention and a surgery was done due to an event. The patient verified that, the papilloma was surgically removed and that her current status was recovering. There was no product quality complaint reported. The reporter's causality assessment was not provided. Upon internal review, squamous cell carcinoma of the oral cavity was determined to be medically significant.
felt pressure under her implants; severe heartburn; pain in her chest; felt the lymph nodes under her left arm and described it as painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMPLANT SITE PAIN (felt pressure under her implants), DYSPEPSIA (severe heartburn), CHEST PAIN (pain in her chest) and LYMPH NODE PAIN (felt the lymph nodes under her left arm and described it as painful) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A2A1A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer, Mastectomy bilateral and Augmentation mammoplasty. Concomitant products included VITAMIN D NOS and ANASTROZOLE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced IMPLANT SITE PAIN (felt pressure under her implants), DYSPEPSIA (severe heartburn), CHEST PAIN (pain in her chest) and LYMPH NODE PAIN (felt the lymph nodes under her left arm and described it as painful). The patient was treated with DOXYCYCLINE at a dose of 10 days course. At the time of the report, IMPLANT SITE PAIN (felt pressure under her implants), DYSPEPSIA (severe heartburn), CHEST PAIN (pain in her chest) and LYMPH NODE PAIN (felt the lymph nodes under her left arm and described it as painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed of face feeling flushed, with face and neck feeling very itchy. Started within a few minutes. Slowly started to get worse over next 5 minutes, but no shortness of breath or other concerning symptoms. Treated with Benadryl 50 mg IM injection into right deltoid.
recurrent urticaria approx. 6 hrs /p inject. and continuing over 6 months.  Pt had similar rxn to penicillin approx 15 yrs earlier.
Patient call to the pharmacy. Inform he felt headache, chest pain. Also he said has low blood pressure and a rise in his pulse.
Didn't feel having coffee today, and patient usually has 1 to 1 and a half cups of coffee a day; Headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Didn't feel having coffee today, and patient usually has 1 to 1 and a half cups of coffee a day), HEADACHE (Headache) and FATIGUE (Fatigue) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Didn't feel having coffee today, and patient usually has 1 to 1 and a half cups of coffee a day), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Didn't feel having coffee today, and patient usually has 1 to 1 and a half cups of coffee a day), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment information was provided
Patient is having stress hives and feeling anxious when driving near pharmacy. Has required additional therapist visits.