chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in the upper right arm; Right foot and leg started swelling; She couldn't walk, had to stay out of that foot; Redness in the leg; Fever (max. of 101°F); Extremely tired (the first two days she slept all day) and could not walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in the upper right arm), PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot), ERYTHEMA (Redness in the leg), FATIGUE (Extremely tired (the first two days she slept all day) and could not walk) and PYREXIA (Fever (max. of 101°F)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Blood pressure high. Concomitant products included IRON for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (Extremely tired (the first two days she slept all day) and could not walk). On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the upper right arm), PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot), ERYTHEMA (Redness in the leg) and PYREXIA (Fever (max. of 101°F)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 10-Feb-2021, PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot) and ERYTHEMA (Redness in the leg) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness in the upper right arm), FATIGUE (Extremely tired (the first two days she slept all day) and could not walk) and PYREXIA (Fever (max. of 101°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 101 (High) 101 degree F.     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.
Received Moderna vaccine on 1/5.  Had a single episode of vomiting approximately 1 hour after vaccine.  Hx of Asthma, started to develop SOB approximately 2 days later.  She reached out to PCP and used inhaler with little relief.  SOB worsened and she was admitted to the hospital on 1/8/21.  Eval was negative for COVID (3 tests completed), flu and pneumonia.  She has elevated WBCs and was given steroids and supplemental oxygen.  She is improving but remains inpatient.
Redness, warmth to injection site - 4/28/09 @ 8 AM followed with itching, increased heat/swelling on same morning. By 9 PM on 4/28/09, she had a large knot @ injection site with oral Temp of 99.6 - 100.8 4/29/09 - Temp 99.2 - 99.4 all day - redness/heat/swelling continued to spread. 4/30/09 - T- 98 deg - edema present, itching (+), less redness.
CHILLS; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25/MAY/2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The patient vaccinated at right arm. No concomitant medications were reported. On 12-MAR-2021, the subject experienced injection site pain. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98.6 F, 100.1 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 14-MAR-2021, and had not recovered from fever, and chills. This report was non-serious.
patient received unspecified dose in PROQUAD immlllliz.ation series that was improperly stored; No symptoms or additional adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot # S031704, expiration date 06-APR-2021 (strength, route of administration and dose were not reported) reconstituted in properly stored sterile diluent, for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 67 Fahrenheit (F) degrees for 17 hours. There was no previous temperature excursion. The call was due to digital data logger. No symptoms or additional adverse effects reported.
blisters; Rash all over; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blister and generalized rash. On an unknown date, the outcome of the blister and generalized rash were unknown.   It was unknown if the reporter considered the blister and generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got blisters and rash all over after vaccine. The follow-up would not possible as no contact details were available.
Cellulitis type site reaction.  4 inch diameter round,  Itching, swelling, redness, hot, inflammation. Reaction occured approx 2 weeks post vaccination.  Applied heat.  Took OTC Benadryl, which was effective in stopping the itching.  Seems to be better today.  Recommended seeing her doctor if it is not getting better.
Patient stated that 3-5 days following vaccination, she began having a tingling/numb sensation inside arm that has persisted. It is not generally painful and it is in the upper arm (between shoulder and elbow area).  She hasn't received treatment but does plan to make an appointment to discuss with healthcare provider.
(1) Severe heart palpitations 24 hours following vaccination. (2) Severe all-over body rush with red, itchy, raised bumps.
booster dose; Needle pain; Sick; Coughing; Have a pressure in my lungs; didn't sleep overnight; I have a fever of 100; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; PAIN (non-serious), outcome "unknown", described as "Needle pain"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; COUGH (non-serious), outcome "unknown", described as "Coughing"; LUNG DISORDER (non-serious), outcome "unknown", described as "Have a pressure in my lungs"; SLEEP DISORDER (non-serious), outcome "unknown", described as "didn't sleep overnight"; PYREXIA (non-serious), outcome "not recovered", described as "I have a fever of 100"; FATIGUE (non-serious), outcome "recovered", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- When requested to take the number for Pfizer medical information, consumer denied taking the number and hung up abruptly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional adverse events.; patient was administered an improperly stored VARIVAX; This spontaneous report as received from an insurance manager in charge of vaccine storage and refers to a patient of unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 16-JUL-2020, the patient received a dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # reported as S009753 (upon internal validation was determined to be non-valid for this vaccine), expiration date reported as 27-SEP-2020, for prophylaxis (strength, number of dose, dose, route of administration and frequency were not reported). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent a temperature excursion on 09-JUL-2020 in the range 15 degrees of Fahrenheit (F) to 46 F (32.9 F) for 2 hours and 11 minutes. There was a previous temperature excursion on 03-JUL-2020 in the range 15 F to 46 F (22.3 F) for 3 hours and 24 minutes Digital data logger was not involved. No additional adverse events reported. No product quality complain (PQC) involved.
swollen up between the neck and chin; on the site of the shot it was swollen up a little bit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen up between the neck and chin) and VACCINATION SITE SWELLING (on the site of the shot it was swollen up a little bit) in a 76-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (on the site of the shot it was swollen up a little bit). On 24-Jan-2021, the patient experienced SWELLING (swollen up between the neck and chin). At the time of the report, SWELLING (swollen up between the neck and chin) and VACCINATION SITE SWELLING (on the site of the shot it was swollen up a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant medications were reported.   No treatment medications were reported.
This spontaneous report was received from a registered nurse and refers to a 12 year old male adolescent patient. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. In August 2016, the patient was vaccinated with GARDASIL injection, (dose, frequency not reported) for prophylaxis when the patient was 12 years old. The patient did not receive any additional doses of GARDASIL injection. The patient did not return to the office until 07-JUL-2017 (when he was 13 years old) and on that date, the patient was given a dose of GARDASIL 9 injection, (dose, frequency were not reported) for prophylaxis. Outcome of events was unknown. No symptoms were reported. There was no product quality compliant involved. No further information was provided.
Moderna Covid-19 monovalent were administered BUD; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    Concomitant medications details were not reported by the reporter.  This case was considered for 1st adult patient out of 15 recipients who received moderna vaccine after by used date.  Treatment details were not reported by the reporter.
My tongue and mouth have metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8782) via an unspecified route of administration in the right arm on 09Feb2021 at 16:30 (at the age of 64-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 03Mar2021 at 09:45 (at the age of 64-year-old), both as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for unknown indication from unknown date and unknown if ongoing. The patient previously received ciprofloxacin (CIPRO) for unknown indication from unknown date and experienced drug allergy (years ago). On 16Feb2021 at 12:00, the patient experienced metallic taste in tongue and mouth. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event tongue and mouth have metallic taste was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt developed hives Vitals:128/76, 86, 20, Temp 97.9 No medications administered Pt stable and released from the vaccination site.   Recommended pt f/u w/ healthcare provider, f/u instructions provided.
Blood clot in right calf; This is a spontaneous report received from contactable consumer for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 11Apr2021 17:15 (Batch/Lot Number: EW0151) as 2nd dose, single for covid-19 immunisation. No pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history allergy to penicillin.  The patient's concomitant medications were not reported.  Historical Vaccine included the first dose of BNT162B2 on 21Mar2021 05:15 PM in Left Arm (Batch/lot number: Ep6955) as 1st dose, single for COVID-19 Immunization. The patient experienced blood clot in right calf on 15Apr2021 03:00 AM. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of blood clot in right calf included Blood thinners. No Hospitalization Prolonged. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.
adverse event; fatigue; loss of appetite; loss of taste; migraines; shortness of breath; chest pain; fever; muscle pain; joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (adverse event) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event).        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.   No adverse event name is provided by the reporter.No treatment information was provided by the reporter. Primary reporter refused to be contacted.
2-3 weeks after the vaccination had ringing in head, headache for two weeks, fatigue, did feel like self as in energy level and anxiety. Called GP and saw ENT office ear noise and thought hearing test. Results were okay.
Within 1 week post vaccine began having bright red blood mixed in with stool worsening. Dr unsure if related to vaccine and prescribed mild laxative. Problem continued and worsened after receiving booster vaccine 5/14/21. Sometimes small amount mixed in with stool other times enough blood to make water and toilet paper bright red.
Very sore arm accompanied with weakness and what feels like a strain, massive headache, chills, malaise, bad fatigue, sore quad muscles (weird)
Approx 2 wks extreme pain at injection site & around. Over several days pain traveled down to mid arm.. making - movement & use difficult!
Patient was entered into the electronic medical record as a female.  The nurse gave the patient an HPV as indicated for female patients.  Upon returning to the clinic in one month for additional vaccines it was discovered the patient was actually a male.  No adverse symptoms were reported.
On 2/10/00, mom reports dizziness & body aches 2 hrs post/vax & temp of 99.6. Referred to DR. MD office reports that pt's mom reported above sx's as well as servere abd pain. No treatment. All v/s nml. All symptoms resolved.
This spontaneous report as received from a pharmacist refers to male patient of unknown age. The pharmacist reported that due to a product defect the patient only received 0.5 ml of ZOSTAVAX (lot#, route of administration not reported) which had excessive foaming. PQC was filed for the excessive foaming. No adverse effect was reported. A follow up call was received from a nurse practitioner later on the same day. The nurse practitioner confirmed that the patient received 0.5 ml of ZOSTAVAX due to the excessive foaming of the product, and that there were no adverse effects for this patient. Follow up PQC information was filed. This is one of two reports for this reporter. See MARRS# 1501USA0005853. Additional information has been requested.
ACUTE ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/28/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pain at the injection site that radiated down the arm and up the neck. Body aches inside and out. Restlessness. All for about 24 hours
Initially this case was reported with two unidentified patient in case ID 2012-09898. The reporter for this case is the same as for case number 2012-08999. Summary narrative: Initial report was received from a healthcare professional on 18 October 2012 and follow up information received on 19 October 2012 and 06 November 2012. A 57-year old male patient received an Intradermal injection of FLUZONE intradermal, sanofi pasteur Inc., lot number UT4470AA (site and side not reported) on 18 October 2012, one day after post vaccination the patient experienced a painful vomiting and he was away from work for three days, He did not seek medical care. The patient's medical conditions and illness at time of vaccination was reported as unknown. The patient's outcome was reported as recovered on unspecified date. Documents held by sender: None.
Trembling, shaking, dizziness, excess lung phlegm, fever off and on, no energy, no strength
On 3-24-2021 I began having itching and redness to the left arm site injection area.  Area of redness and itching continued to grow, involving the complete upper arm moving to just past the elbow to the top of the fore arm area and become more itchy.  I also experienced eye itching and some swallowing issues.  It kept feeling like a lump in the throat around my thyroid area.  The eye itching and throat discomfort was not anything I had ever experienced before.  I was also having minor tingling to my lower legs. I did take 25mgs of diphenhydramine HCL when symptoms would progress with some relief, although not complete relief.  Then on 3-28-2021, I experience swelling of my ankles and feet.  I did elevate my legs over night which seemed to alleviate the symptom.  As of this morning, my feet are not swollen but the tingling is still occurring.  I do exercise regularly and have never had this issue before.   The symptoms of the arm are beginning to subside but the tingling in the legs are continuing. I will be continuing to exercise and monitor the situation as to improvement
Had severe chest pains for 3 weeks.  Woke up multiple times with thoughts that I was having a heart attack.  Sat on the the edge of bed with chest pain for hours multiple nights.
Client requested a Janssen vaccine. Later it was found in the immunization registry that he had received a Moderna on 4-1-21. No adverse symptoms.  Nursing is reaching out to him for follow up.
Mother phone call at 4:35pm on 11/02/04.  States baby lethargic and difficult to arouse.  Temperature 102. Encouraged ER visit.  Physician notified who called family and stressed ER visit. Lab work done. Spinal done.  Per mother (phone call AM), mother states nothing abnormal found. Repeat lab CBC 11/03/04.
Pt reported sob, tight chest, difficult breathing before leaving store. I was called to service desk where I advised customer service to call 911. I administered epi pen 0.3mg to pt's right thigh after getting her in a chair (approx 1:57pm). Pt felt breathing was easier after approx 1 min post epi. EMSA administered O2 approx 10 min did not transport. Pt stayed here approx 20 min longer and drove to Dr office. Dr called and said she appeared ok and released her to go home.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. Physician reported that since 21-JUL-2014, an unspecified number of patients had been administered (Oka/Merck) VARIVAX (dose, lot#, expiration date not reported), subcutaneous) that had been improperly stored. This was supported. No adverse effects was reported. Additional information has been requested.
Irregular menstrual cycles post vaccination.  End of April 2021 cycle last 2 weeks and very heavy, May missed cycle, June late cycle lasting longer than usual, July missed cycle, August very heavy cycle lasting 3-4 dyas, end of September spotting x 2 days  then cycle started again 3 days later in early October.