chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After vaccine administration patient felt light headed, nausea, dizzy and shortness of breath. Called code green, paramedics arrived. Patient laid down, vital sign stable. Patient stable.   BP 114/76  100% o2sat  RR 16  HR 76
Pt was given 0.25mL of pediatric FLUZONE. He should have been given 0.5mL of FLUZONE.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On 20-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX (lot # reported as M027117, expiration date 26-JUL-2017, dose and route not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
I had fatigue on day 2 which I anticipated. Day three brought stomach upset with diarrhea and fatigue. Day 4 brought dizziness and inability to carry on normal activiities.
Multiple sclerosis relapse; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Secondary progressive multiple sclerosis.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's past medical history was not reported. No concomitant product was reported. No treatment information was reported. Company Comment This spontaneous case concerns a 47-years-old female patient, with medical history of Secondary progressive multiple sclerosis who experienced the unexpected seriousness criterion medically significant AESI of Multiple sclerosis relapse approximately 3 months after a dose of  mRNA-1273 vaccine.  The medical history of Secondary progressive multiple sclerosis is a contributor for the event. At the time of the report, the events outcome was unknown.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 47-years-old female patient, with medical history of Secondary progressive multiple sclerosis who experienced the unexpected seriousness criterion medically significant AESI of Multiple sclerosis relapse approximately 3 months after a dose of  mRNA-1273 vaccine.  The medical history of Secondary progressive multiple sclerosis is a contributor for the event. At the time of the report, the events outcome was unknown.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Patient was seen in PCP office for a rash on 3/2/2020.  Parent reported the rash onset 2/29/2020. At 3/2/2020 visit, patient was prescribed Bactroban and Bactrim for the treatment of impetigo.  Parent then took patient to dermatologist on 3/9/2020, where dermatologist diagnosed the rash as Henoch Schonlein Purpura.  Parent requested PCP to report this as a possible adverse reaction to MMR  vaccine given on 2/3/2020.
pain at injection site, followed by severe muscle ache and fatigue, followed by upset stomach, followed by fever 101 oral,     Fever broke at about 18 hours, sweats and muscle ache continues into next day.  mild headache
pain at injection site / left arm; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles.   On 19th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th March 2021, 5 hrs after receiving Shingrix, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved.  The patient reported that pain and tiredness lasted for 3 days. It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. This case was self-reported by the patient. The patient received 1st dose of Shingrix and experienced injection site pain and tiredness 5 hours after vaccination. The patient reported that pain and tiredness lasted for 3 days. The reporter consented to follow up. For tolerance of second dose, refer case US2021AMR183233.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183233:Same reporter
The day after receiving TRUMENBA number 1, patient felt nauseous and light-headed by did not lose consciousness. Episode resolved spontaneously.
Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; The vaccine was administered to about 9 to 10 patients before the excursion error was discovered; vaccine expired by 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided to the patient
Extreme shortness of breath. I cannot breathe. There is a lot of phlegm in my lungs and I have a fever
pt recv vax 5MAR96 & 16FEB98 pt exp pruritic lesion over entire body & face which devel over a 6 to 7 days span;also devel fever 101 & sx of illness which included dec activity & dec diet for several days;
received the Moderna COVID-19 Vaccine while pregnant or planning to do so; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (received the Moderna COVID-19 Vaccine while pregnant or planning to do so) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (received the Moderna COVID-19 Vaccine while pregnant or planning to do so). At the time of the report, EXPOSURE DURING PREGNANCY (received the Moderna COVID-19 Vaccine while pregnant or planning to do so) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs.
I was disoriented, didn't know where I was, I had no hand/eye coordination, difficulty with numbers and letters and showed slight cognitative impairment. I called the hospital and was told it would get better in 24 hrs but it didn't so I went to the ED   and was  admitted  from 01/14/2021 through 01/17/2021 with a diagnosis of having a stroke. I am currently going for cognitative therapy.
Few hours after receiving vaccination started with a fever, body aches, fatigue, HA and chills. Resolved two day later.
redness of the injection site for a few days; Swelling of the injection site; developed hives on her legs and under her arms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling of the injection site), URTICARIA (developed hives on her legs and under her arms) and INJECTION SITE ERYTHEMA (redness of the injection site for a few days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis. Concurrent medical conditions included Egg allergy.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced URTICARIA (developed hives on her legs and under her arms). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling of the injection site) and INJECTION SITE ERYTHEMA (redness of the injection site for a few days). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling of the injection site), URTICARIA (developed hives on her legs and under her arms) and INJECTION SITE ERYTHEMA (redness of the injection site for a few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Patient stated that, on 18/19th August  she developed hives on her legs and under arms. When she took Benadryl  it went away and returned when the Benadryl wears off . She states that she had lot of allergies and did not take flu shots as she ended up in the hospital with bad bronchitis.
Patient reports approx. 5-10 min after receiving first dose of COVID vaccine, he became hypotensive (98/60), dizzy, diaphoretic and near syncope.  States he was monitored by EMT for a short time after this happened, did not need to use his EpiPen, but did take Benadryl. Reports that after 5-10 min his symptoms improved/resolved, and he has felt fine since. States he is feeling great today.  He was advised by PCP NOT to get the second dose of the vaccine, and if he would like a second opinion, will need to be referred to an allergist. Patient declined referral, leaning towards not getting the second dose.
Admit 5/25 for AMS and UTI. Rapid COVID+, 2 subsequent COVID PCRs negative but not ruled out as per documentation. Treated with Zinc and Decadron. Remains admitted at time of review 6/7/21, to be transferred to another hospital.
Blurred vision, dizziness, nausea, vomiting tingling sensation in extremities, pallor, syncope, muscle twitches.
extreme hives; tongue related adverse event; itching started on scalp which spread to torso to groin to under the breast to waistline, kind of all over; tightness in chest near esophagus; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest near esophagus), URTICARIA (extreme hives), TONGUE DISCOMFORT (tongue related adverse event) and PRURITUS (itching started on scalp which spread to torso to groin to under the breast to waistline, kind of all over) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 039B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced CHEST DISCOMFORT (tightness in chest near esophagus), TONGUE DISCOMFORT (tongue related adverse event) and PRURITUS (itching started on scalp which spread to torso to groin to under the breast to waistline, kind of all over). On 17-Nov-2021, the patient experienced URTICARIA (extreme hives). The patient was treated with PREDNISOLONE for Adverse event, at a dose of 5 day pack; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of during day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of at night. At the time of the report, CHEST DISCOMFORT (tightness in chest near esophagus), URTICARIA (extreme hives), TONGUE DISCOMFORT (tongue related adverse event) and PRURITUS (itching started on scalp which spread to torso to groin to under the breast to waistline, kind of all over) outcome was unknown.            It was reported while being evaluated by healthcare professional  (HCP),  patient mentioned eating little sushi, scallops, and shrimp for about 4 days. Patient mentioned her tightness in chest was related to  allergic. On 20 Nov 2021, patient visited healthcare professional and HCP said she maybe having a mild allergic reaction.  It was reported that the patient has been eating the same seafood products with no problems anymore. Patient did not had any similar or other events after 1st and 2nd dose of moderna COVID-19 vaccine.  No concomitant medications use were reported. Treatment activities for event was done with Steroid Shot.
Itching, hives, swelling in all 4 extremities 10/10/14 10/11/14 lips swellen, chest pressure. Went to urgent cre on 10/11 - NP wanted to tx her for scabies. Took BENADRYL 50 mg every 6 hrs. 10/10/14-10/13/14.
Increased redness, increased swelling, induration to injection site.  Area tender to touch.  No fever.
pt recv vax & lt upper arm swollen, red & warm to touch;exp some pain @ site last noc then itchy;today area is itchy;pt given DPH;
hot- hurt; by 7PM lt arm raised 3" diameter, swollen, 1/4" raised; 1 1/2 wk reddness still there-swelling; muscle in lt arm sore;
Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; This literature marketed report has been received from authors of a published article, referring to an unknown age patient with ataxia telangiectasia (primary immunodeficiency diseases (PID)). Information about concomitant medication and medical history was not provided.  On an unknown date, at about one year old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed cutaneous granulomatous lesions in different body sites, e.g. face, chest, arms or legs, at various times after vaccination. No pathogenic organisms were identified by the histochemical staining or bacterial, fungal and mycobacterial cultures. Rubella viruses (RV) antigen was detected in the available tissue sections of cutaneous granulomas by fluorescent immunohistochemical staining for measles and rubella antigens. Live vaccines, including rubella vaccine, were contraindicated for individuals with severe antibody deficiency, T-cell deficiencies or innate immune defects because they may cause severe or chronic disease.   The outcome of the events was unknown. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).    A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1912USA000167: US-009507513-1912USA000168: US-009507513-1912USA000169: US-009507513-1912USA000169: US-009507513-1912USA000168:
The patient stated that she received the influenza vaccine and 2 hours later her asthma symptoms kicked in. She had shortness of breath. The injection site was warm to the touch and red. The patient also stated that her arm was very sore. She called her on call doctor today 9/17/16 and received a medrol dose pack.
Blistery rash; Rash looked like shingles; This case was reported by a consumer via call center representative and described the occurrence of blister in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date and no reaction experienced).   On 22nd June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd June 2020, 4 days after receiving Shingrix, the patient experienced blister and vesicular rash. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the blister and vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in right arm. Reportedly four days later the patient developed a blistery rash approximately 1.5 inches long on the bottom of right ankle. The patient went to an urgent care and was told rash looked like shingles. The rash was not painful.  The reporter consent to follow up.
Hand on arm flu shot administered had a tingling feeling to numbness.  Head felt dizzy, feelings of nausea, and light headed.  Pulse that evening and blood pressure went to inaudible.
He requested the vaccine not be administered in the deltoid or thigh, so it was administered in the left gluteal muscle. No symptoms were reported after the vaccine.
four earlier Pfizer COVID vaccines, I had fevers the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP6955) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: she just takes an unspecified thyroid medication. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 19Mar2021, outcome "unknown", described as "four earlier Pfizer COVID vaccines, I had fevers the next day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no investigations and relevant tests. Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. Caller stated that she just taken an unspecified thyroid medication and did not think it was relevant. The patient had no additional vaccines administered on same date of the Pfizer Suspect. It was reported that the patient recently received our bivalent booster shot and experienced no side effects.  The odd thing was, for all four earlier Pfizer COVID vaccines, patient had fevers the next day.  They ranged from 100 to 101 degrees. Caller was asking about why she had no side effects with this most current vaccine.  Caller has agreed to report on her side effects she had after the first 4 doses of the COVID Vaccines. Caller stated that her fevers actually ranged from 100-101.5 degrees. The event did not requited a visit to Emergency Room or Physician Office.  Follow-up attempts are completed. No further information is expected.
Within 10 days of receiving the first dose I developed itchy hives on my head. Six months after the first dose the hives/rash spread to my body. The itchy rash is now all over my body. I have tried Light box therapy, Prednisone (Two 12 day tapers), multiple solutions and creams, as well as a daily regimen of  2 Claritin am  2 Zyrtec pm  10 mg. Montelukast pm  10 mg. Doxepin pm
Swelling at site of injection, large as peach, red, warm to touch, hard bump. Seen by doctor on 4/2/15 given cephalexin.
Red around the injection site. It was raised, hot, arm was sore, and itching.
About 5-10 minutes after receiving vaccination, patient passed out. He has done this in the past when receiving vaccines or shots.
Pt presented to ED with symptoms of serum sickness 2 days after receiving PNEUMOVAX 23 in a local physician's office (eg. had malaise, chills, blanching, joint pain, low grade fever).
pt previously admitted to Medical Center on 8/23/21 with sepsis and respiratory failure; pneumonia; was given ABX, steroids and nebulizer tx; COVID test at that time was negative ; echocardiogram showed EF of 63%; esophagitis with esophageal ulcers; PE right main artery; 9/3/21 was transferred to Regional Medical Center for IVC filter; on O2 supplement; IVC filter placed; on 9/6/21 pt tested positive for COVID; pt's condition worsened and he was placed on comfort measures; he passed away in the hospital
Body rash in left arm - small hives and severe itchiness. Then same rash and hives in right arm shortly thereafter. Rash appeared on the back the evening of the injection around 9:30pm and has continued for 12 hours with severe itchiness.
Per the patient's wife, he had a severe headache that began the evening of the vaccination and lasted overnight.
Light headed and dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed and dizziness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included VERAPAMIL and ATENOLOL for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Light headed and dizziness). At the time of the report, DIZZINESS (Light headed and dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.