chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Whole body started itching; This case was reported by a nurse via sales rep and described the occurrence of generalized pruritus in a elderly female patient who received Herpes zoster (Shingrix) (batch number kb97c, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced generalized pruritus. The patient was treated with hydrocortisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized pruritus was recovered/resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-JUN-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and 2 days after whole body was started itching.  Hydrocortisone and Benadryl didn't relieve.  The itching lasted 2 weeks. The reporter consented to follow-up.
Breathing problems, flushing, anaphylaxis reaction EPI given sub q pt taken to emergency room for further tx.
Patient received a vaccine and was told that he needed to stay in the store for 15 minutes. He went to purchase a water about 5 minutes after vaccine in a different register and was feeling lightheaded. After the transaction he fainted with the back of his head fell on the hard floor. He was being assisted by the store staff as well as a pedestrian who claimed to be a health care professional. He was given an orange juice, one water and a battery powered fan to provide cool air. He also requested to lay down on the floor, and he ended up laying on the floor for about 30 minutes. After that he stood up and regained color on his face. He then walked out of the store. Staff asked him if he wanted the ambulance to be called and he declined.   Pharmacist called patient the next day to check on patient, and was unable to reach the patient.
a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a reaction) 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. On an unknown date, the patient experienced VACCINATION COMPLICATION (a reaction). At the time of the report, VACCINATION COMPLICATION (a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to the company on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a reaction) 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. On an unknown date, the patient experienced VACCINATION COMPLICATION (a reaction). At the time of the report, VACCINATION COMPLICATION (a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
66 yo. male Type 1 diabetic, received Pfizer vaccine, after 15 minutes patient did not leave waiting room as per protocol. After,  about 45 minutes later sitting in the same place, patient discovered to be disoriented. Upon further evaluation patient was discovered to have an insulin pump and he missed his lunch. Upon checking patient's blood sugar it was 37. Patient was treated with 15g glucose and fed his ham sandwich he had on his lap. Patient was fully recovered after approximately 30 minutes. Insulin pump was turn off by the provider, patient understands how to use his pump and what level to turn the pump back on. Patient was stable enough to walk out of the clinic on his own.
MID CLAVICLE - NECK LINE TO THE BACK HAS RED, RAISED BUMPS AND BUBBLES.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient diagnosed with SIRVA after COVID-19 immunization. Managed with NSAIDs and physical therapy.
Patient developed an excruciating headache on 4/12/2021 (unable to walk the pain was so bad). Patient also had cramps / abdominal pain and arm was numb.  On 4/13/2021 the only symptom she had was extreme fatigue.
This is a spontaneous case, initially received from a nurse on 07-Nov-2017, concerning a 48-year-old, adult female patient. The patient did not have any medical history. The patient received unspecified vaccines in past and did not have any allergy. The patient did not receive any concomitant medication. On 27-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose :0.5ml route of administration: intramuscular, anatomical location: right deltoid, batch number: 00644611A and expiry date: 31-Mar-2018). On the same day, 12 hrs after the administration of vaccination, the patient started to have muscle ache, chills and headache. When she woke up she was shaking uncontrollably. The patient did not seek treatment but called her NP niece who said that, she had a reaction to the component and took 2 days off work. She saw her doctor who stated she was well. On 02-Oct-2017, the events (tremor, myalgia, and chills) were resolved, and had slight headache (not recovered). The reporter assessed the case as non-serious. Follow up received on 04-Dec-2017, The stop date for the events (tremor, myalgia, chills) was added. The narrative was amended accordingly. Non-significant case correction received with IRD 07-Nov-2017: The expiry date of the suspect vaccine was changed from Mar-2018 to 31-Mar-2018. The narrative was amended accordingly.
Fever, Chills, Cold sweats, Body aches, Feelings of ear infection coming on, rash on injection site approx 5" in diameter, extreme swelling of injection site like multiple mosquito bites in one area.  extreme exhaustion, symptoms lasted until mid-afternoon, got better for a few hours, then symptoms came back before bed. Symptoms mostly disappeared the next day except for body aches, sensitive inner ears (some difficulty draining the eustachian tube, they randomly pop, and some pressure is released). 3rd day most symptoms gone except still cannot fully release eustachian tubes, still mild swelling in arm light, and started menstrual spotting (day 15 of the cycle, my previous cycle started 4/1 and was regular.). 4th-day post vaccine and I am starting to spot more heavily, I think the cycle is about to start. I wonder if my body was stressed enough I did not ovulate. I experienced a change in discharge on days 2 and 3 but when I took an ovulation test it came up negative on both days,   After the first shot, I felt like I couldn't take a full breath and I felt like something was in my lungs like phlegm or something ( I don't Smoke FYI) but I noticed the symptoms went away after the second dose.
Patient was scheduled to receive 2nd dose of Moderna 6m-5yr Monovalent formulation and inadvertently received bivalent Moderna 6mo-5yr
Patient had severe reaction covering over half of bottom portion of left upper arm, and a small bump/cyst and injection site. Rash started small but continued to spread over 2 days.
Swelling and redness at injection site, fever, severe headache, joint and muscle aches, abdominal pain.  Taking tylenol for aches and fever.
Urticaria 18 hours after immunizations, no local reaction. Urticaria is generalized.
Syncope, dizziness, pallor, hungry, no breakfast. Stable and released with mother after significant improvement.
sore throat, nasal congestion, sl nausea & dec appetite p/3rd dose;
8/24/99:very tired, woke at 10pm with thoracic back pain, dizzy, and felt warm.8/25/99:throat sore, neck glands swollen, temp-100.3 on thermoscan, rectal mode;slept all day.Throat is wnl.
Cold chills, sweats & fever, ear pain, stomach pain (felt like abdominal ripping/tearing), extreme pain in entire body, worst in entire left arm (booster side), slight headache, intractable vomiting, diarrhea, dizziness, difficulty breathing, heavy menstrual bleeding off schedule (one week since last period ended)
doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a vial that had been first pierced 48 hours earlier and stored under refrigeration the whole time; doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a vial that had been first pierced 48 hours earlier and stored under refrigeration the whole time) and EXPIRED PRODUCT ADMINISTERED (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a vial that had been first pierced 48 hours earlier and stored under refrigeration the whole time) and EXPIRED PRODUCT ADMINISTERED (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a). At the time of the report, PRODUCT STORAGE ERROR (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a vial that had been first pierced 48 hours earlier and stored under refrigeration the whole time) and EXPIRED PRODUCT ADMINISTERED (doses of the Moderna Covid-19 Vaccine were given to 3 separate patients on 10Jul2021 from a) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant drugs included no treatment drugs included
1 hr after immunization developed facial swelling and urticaria, progressing to widespread pruritus no dysphagia or respiratory distress - self-medicated with BENADRYL with some relief; seen 3/2/12 and placed on steroids. Follow up scheduled.
her son's rear end and front, back and side of both legs ache; her son's rear end and front, back and side of both legs ache; different than any sore muscle ache form jogging or working on the car; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old male patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "her son's rear end and front, back and side of both legs ache"; MYALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "different than any sore muscle ache form jogging or working on the car". Therapeutic measures were taken as a result of arthralgia, pain in extremity, myalgia.  Additional Information: 20 year-old patient received the first dose of the Pfizer COVID-19 vaccine but wasn't sure of the exact date but was "about 2 weeks ago". 4-5 days ago, his adverse event started. The adverse events did not lead to Emergency room or physician office. No Prior Vaccinations within 4 weeks. No relevant tests done. No Adverse event following prior vaccinations. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Family Medical History Relevant to AE.  The patient's rear end and front, back and side of both legs ache. "The patient took Advil, the pain goes away but 5 hours after taking it, the pain comes back. It felt different from muscle soreness from jogging and that he hasn't had it before. He wanted to know if this had been reported as side effect of the Pfizer COVID-19 vaccine and how long will it last. Also wanted to know if it will get worse if he gets the second dose. Patient wanted to know if her son should get the second dose of the Pfizer COVID-19 vaccine after having experienced the side effect that they reported with the first dose. Spoke from attached document, As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to the healthcare provider of your son about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider knows his health situation and has access to information that can better help inform this decision.   No follow-up attempts are possible; information about lot/batch number cannot be obtained despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pt admitted to hosp with COVID pneumonia; Hx: metastatic small cell lung CA; low O2 sats and ascites; DNR/DNI; started on antibiotics, remdesivir, vitamins; O2 supplementation; tachycardic; unable to take metoprolol by mouth; refusing feeding tube and Dobbhoff tube; IV metroprolol; pt not making good improvements; pt and family wanted to be dc'd to home with hospice; dc'd to home on 8/11/2021;  pt died @ home on 8/12/2021.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 62 years and 5 months.  No concomitant medication information was provided.  On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   Moderna vaccine Ndc code was reported.  No treatment medication information was provided.
Started with fatigue, and then quickly went to headache, muscle pain and spasms, and chills.
@ approx 12 hrs p/immun pt had watery eyes & scratchy throat similar to an allergy attack; sx lasted 6 hrs;
pt started breaking out in a rash;9/25/99 also had some vomiting & diarrhea;was brought to office by grandma 9/28/99 w/fine generalized rash from neck down;started on DPH & motrin;
Headache, erythema, induration, inability to lift left arm where injection was given.
Within two minutes following the immunization, child became dizzy while looking at magazines. He kneeled down and then fell to the floor and had a seizure that lasted approximately 30 seconds. He has never had a seizure prior to this incident. He said the right side of his face and throat were cold and numb. He said he felt like he might vomit. Emergency services were contacted immediately and ambulance arrived to transport to local hospital. He was monitored and tested for causes. He was released within hours.
196 patients received 0.25mL of Moderna COVID-19; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up document received on 27-Dec-2022 with Reporter details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:
1st jab, nothing besides sore arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 (Lot number: EW0173) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Past drug history included: Ampicillin, reaction(s): "Known allergies: Ampicillin". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st jab, nothing besides sore arm.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient had no COVID prior vaccination. Patient was not tested COVID post vaccination. The patient was not provided information regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
Approximately 10 hrs post given vaccine had temp approximately 102 and felt nauseated w/headache. Fever lasted 2 days.
Pt admitted for sepsis d/t unspecified organism presenting as rash. Patient was also COVID positive (d/t previous infection) on admission. Rash began after patient had arthroscopic shoulder decompression on 5/27 that progressed to her entire body leading to sepsis.  After consultation with Infectious Disease, the rash was diagnosed as fungal and patient was discharged on antibiotics after a 2 day hospitalization.  COVID incidental - unrelated to admission.
Approximately 36 hrs after injection, significant swelling of right hand and inability to move the fingers of the right hand occured, these symptoms similar to previous flareup of PMR, but the pain and swelling were amplified over other PMR flareups. On 4/15/22 PCP prescribed abbreviated dose of prednisone to commence on 4/16/22 following lab tests and referred to rheumatologist (earliest aviable appt was on 7/9/22). I did not respond to the abbreviated dose of prednisone, and visited Urgent Care on 4/20/22 and received steriod shot pluse full course of prednisone (30 x 10mg tablets) and did have postive response within 24 hours. At this time, I had not made a connection of the PMR flare to the COVID booster.
Usual: aches, pain at site, headache Unusual:  fever >103, gross hematuria (no history of UTIs or kidney stones)
Low grade fever, muscle aches, fatigue, nausea, headache hours 17 - 29 post vaccine.  Still continuing to have headache, as well as fatigue and shortness of breath with activity.
Pt. Became irritable within 36 hrs. Had diarrhea, slightly elevated temp. of 100.0 and refused to nurse for a normal length of time for approx. 2.5 days after onset of irritability.
got covid and was sick bad; got covid and was sick bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid and was sick bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vax, noticed autistic behaviors, irritable, fever, loss of balance and loss of speech. Most resolved but left with neuro and severe oral apraxia, also excessive drooling.
Intense arm pain, swelling, redness within 1 hour. Weakness, nausea, vomiting, headache within 24 hours
Information has been received from a registered nurse concerning her 5 year old granddaughter with asthma on 16-FEB-2005 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck) (lot number 648555/0274P) and on 11-FEB-2009 was vaccinated subcutaneously with an another 0.5ml dose of VARIVAX (Merck) (661269/0787X). Concomitant therapy included FLOVENT. On 28-SEP-2009 the patient had chickenpox like lesions. There were less than 30 lesions that were mainly on the trunk and one lesion in the lower groin and buttock. Initially, the granddaughter experienced periodical itching and a low grade temperature. The lesions had yet to scab over except the ones the granddaughter had been able to reach to scratch. The lesions on the back had not scabbed over. The patient sought medical attention via office visit. No laboratory diagnostic studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.