chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Angioedema; Nonurticarial rash; This is a literature report for the following literature source(s): "Graded Administration of Second Dose of Moderna and Pfizer-BioNTech COVID-19 mRNA Vaccines in Patients with Hypersensitivity to First Dose", Open Forum Infectious Diseases., 2021; Vol:8 (12), DOI:10.1093/ofid/ofab507.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic rhinitis" (unspecified if ongoing); "Food allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant) with onset 2021, outcome "unknown", described as "Angioedema"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Nonurticarial rash". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: (2021) 16.85, notes: Log2 dilution; skin test: (2021) positive, notes: Intradermal; (2021) positive, notes: Intradermal; (2021) positive, notes: Intradermal. Therapeutic measures were taken as a result of angioedema, rash. Additional information: Reaction to Second Dose Via Graded Administration (Step Number) was none. Treatment With Graded Administration (Step Number) was none. Treatment after first dose included Diphenhydramine. Vaccine was administered between Jan2021 and May2021.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200151789 Same article/drug, different patient
According to patient he was hospitalized for Polymyalgia Rheumatica which he determined was caused by the SHINGRIX injection; however, he also received a Hep A vaccine. The physician treating him suggested he speak with his pharmacist and report it as an adverse reaction. I have no direct knowledge to determine claims made by patient. Patient is now taking steroids for his condition.
had flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu like symptoms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-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 INFLUENZA LIKE ILLNESS (had flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (had flu like symptoms) 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.   This case was linked to MOD-2021-342263 (Patient Link).
I felt extremely tired and woke up with a headache two days after the shot. My arm is also still very sore.
administered the Pfizer covid-19 bivalent, orange cap vaccine that was 10 days past expiration of 10 weeks upon refrigeration; administered the Pfizer covid-19 bivalent, orange cap vaccine that was 10 days past expiration of 10 weeks upon refrigeration; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 6-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 as dose number unknown (orange cap; booster), 0.2 ml single (Lot number: GK1657) at the age of 6 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (medically significant), PRODUCT ADMINISTRATION ERROR (medically significant) all with onset 10Feb2023 and all described as "administered the Pfizer covid-19 bivalent, orange cap vaccine that was 10 days past expiration of 10 weeks upon refrigeration". Therapeutic measures were not taken as a result of poor quality product administered, product administration error. Clinical course: Warm transfer: # Pfizer Medical Information, # has a registered nurse who called about the Pfizer Covid Bivalent orange cap vaccine that was inadvertently administered ten days past the expiration of 10 weeks upon refrigeration. Information confirmed as provided. Clarified that they were two siblings aged 7 and 8 years old. Later clarified that this patient was 6 years old at the time of the adverse event. Clarified as a doctor of osteopathy. Treatment: None.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Poor quality product administered", "Product administration error" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-PV202300075173 Same product/event, different patient;
Woke u 24MAY91 w/few spots, by afternoon had whelps all over temp approx 99-100; Given DPH then given Hydroxyzine by MD; Rash began to disappear then returned;
Temp 103.5 at 6am-motrin given, Temp 103.8 at 7am, tylenol given; crying more this AM-irritable, examined @ clinic- no source for increase temp found, 1/17/03 temp normal, now has runny nose/cough.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events reported through the medical clinic associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
received an expired dose; 61 years old received menveo; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 3rd December 2021, the patient received Menveo. On 3rd December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Menveo, which led to expired vaccine used and inappropriate age at vaccine administration.  The reporter consented to follow up. This case was 1 of 6 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261527:Same reporter US-GLAXOSMITHKLINE-US2021261531:Same reporter
2:45 pm - 10 minutes after receiving vaccine pt reports throat tightness and sensation of lump in throat,  and rash to face and chest  2:50 Pm pt evaluated by EMS  and transported to Hospital pt reports is 10 weeks pregnant
Patient was received incorrect Moderna 6M-5Y formulation.  Patient was scheduled for Moderna Bivalent Booster and received a monovalent formulation for their age group.  Patient had previously completed primary series and did not require a 3rd dose of the monovalent formulation.
woke up 4/5/2021 with diarrhea and pain. took covid test 4/6/2021 (negative). went to urgent care 4/7/2021 with severe pain in lower right abdomen (thought was appendicitis). Dr. said he didn?t think it was. 4/9/2021-saw another doctor who said it was a virus. On 4/14/2021 finally got in to Doctor, who took blood test and sent me to hospital, where it was confirmed that my appendix had ruptured and I was almost septic, hospitalized 6 days, no surgery, drained abscess. Remainder of appendix surgically removed August 2021.
Possibly did not get full second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Possibly did not get full second dose) 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 ACCIDENTAL UNDERDOSE (Possibly did not get full second dose). At the time of the report, ACCIDENTAL UNDERDOSE (Possibly did not get full second dose) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No Relevant concomitant medications was reported.  Treatment information was not provided.
Sore arm; low grade fever/highest 100.7; tired; This is a spontaneous report from a contactable 64-year-old female nurse reporting for herself   A 64 Years old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included migraines, osteoarthritis and gastritis, kidney stones, mild hypertension, Hashimoto's disease. Concomitant medications included thyroid, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), nitrofurantoin (MACROBID), galcanezumab gnlm (EMGALITY), pantoprazole sodium sesquihydrate (PROTONIX). On 04Feb2021 at 13:00 the patient experienced sore arm x 24 hours, low grade fever for 8 days , highest 100.7, didn't feel bad just tired. At the time of the reporting the patient was recovering from reported events.   No follow-up attempts are possible. Information on batch cannot be obtained. No further information is expected.
Information has been received from a nurse concerning a 53-year-old female patient who on 27-OCT-2008 was administered a dose of PNEUMOVAX (lot # 659149/1383U, route and injection site not reported).  Subsequently, the patient experienced cellulitis at the injection site.  She contacted the physician for medical attention and was treated with antibiotics and pain medication (unspecified).  At the time of reporting, the patient was recovering from the event.  Additional information has been requested.
Moderna bi-valent was given  but patient had only received #1 moderna  in series of two.
This spontaneous report as received from a healthcare worker refers to a 42 year old male patient. Pertinent medical history, drug reactions or allergies were unspecified. On 16-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 "1 shot", lot # K004542, expiration date 19-AUG-2015, (dose, dose number, route, anatomical location were unspecified). The patient also received a Flu vaccine (unspecified) on 16-OCT-2014. Concomitant therapies included PERAZONE. On 17-OCT-2014 the patient experienced cellulitis. The patient sought medical attention (unspecified). The patient received an unspecified antibiotic for the treatment of the cellulitis. The outcome of cellulitis was reported as recovering. The relatedness between cellulitis and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter.
Patient complained that she had pain in her arm  started to move to her legs and all other joints. she went to the urgent care on 02/28/2020 with negative test for flu.  Her symptoms did not get better and she went to ER on 03/02/2020 and was discharged 03/07/2020.  she  said she had to be hospitalized for 6 days after.
Information has been received from a medical assistant concerning a female patient who on an unknown date was vaccinated with a 0.5 ml third dose of GARDASIL. Subsequently the patient had abnormal PAP (Papanicolaou test) and tested positive for HPV (human papillomavirus). The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. The medical assistant contacted during telephone follow-up stated that she did not remember the patient's name or any other patient identifier. Additional information is not expected.
Patient got a painful red rash in a band around the left arm. The rash was sensitive to touch pressure. No itching. Patient got chills in her back approximately 6 hours after the onset of the rash in the arm. The rash continued until Tuesday when pt's healthcare provider recommended acetaminophen and antihistamines. After taking the recommended medications, patient began to feel better. Pt was also administered FLUZONE HD in the same arm.
Nerve Pain went away for 24 hours; lethargic; weak; achy; A spontaneous report was received from a consumer concerning a 67-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nerve pain went away for 24 hours/neuralgia, lethargic/lethargy, weak/asthenia, achy/pain.  The patient's medical history, as provided by the reporter, previously administered products included Covid-19 VACCINE (Covid -19 vaccine 1st dose) on unknown date. Concurrent medical conditions included Multiple sclerosis (relapsing remitting multiple sclerosis). Concomitant products included GABAPENTIN for Nerve pain.  On 26 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 023M20A) via unknown route on the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced neuralgia (nerve pain went away for 24 hours), lethargy (lethargic), asthenia (weak) and pain (achy). At the time of the report, neuralgia (nerve pain went away for 24 hours) had resolved and lethargy (lethargic), asthenia (weak) and pain (achy) outcome was unknown.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, at the time of the report, neuralgia (nerve pain went away for 24 hours) had resolved and lethargy (lethargic), asthenia (weak) and pain (achy) outcome was unknown.
Fatigue/Tiredness beginning at 7:00pm. Chills and body temperature began to rise at 8:30pm. I took ibuprofen to help decrease my body temperature. At 7:45am on 02/04/2021, I had a fever of 101 degrees. I also has chills and a headache at this time. I took ibuprofen and my body temperature went down. The headache lasted until 7:00pm on 02/04/2021.
This is a spontaneous report from a contactable pharmacist (patient's mother). A female patient of unspecified age received the 3rd dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took 2 doses of TRUMENBA for immunisation. The patient passed out about 6 months before report, after the third dose of TRUMENBA, with outcome of unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 20-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot# L016284, expiration date: 07-AUG-2016), which was improperly stored for 8 days (incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Hospitalized 9/28/22-10/2/22 confusion, fatigue, malaise, tachycardia, HTN, alcohol withdrawal, encephalopathy, dehydration, cough, thrombocytopenia, hyponatremia,
approximately 2 days post vaccine, recipient developed tingling in left armpit radiating to left breast nipple.  Vaccine recipient now (11/2/04) describes "electrical current-like, tickle sensation" in same area as noted above and across upper back.
she got COVID; she got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 81 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "have blood pressure medications" (unspecified if ongoing), notes: have blood pressure medications. The patient took concomitant medications. Vaccination history included: Covid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "unknown" and all described as "she got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2022) Positive.  Clinical course details: Patient was not hospitalized with Covid, through home testing she determined there was Covid. She was very sick but was not hospitalized.
On 6-12-12 mom reported 100 degrees F temp, soreness in Rt thigh, swelling and erythema. Bump approximately 2.5 inches x 1.5 inches on 6-13-12. Mom reported continued swelling, redness in Rt thigh increased to 4 inches x 5 inches. Pt still c/o soreness. Temp 99.9. Pt otherwise normal, appetite, activity, etc.
Vaccines given at 1430. Pt ate at 1600 after waking from nap. At 1900 pt with intense screaming. Pt picked up and quit breathing face turned purple and pt looked terrified, tongue moving inward. Skin felt clammy and was gasping for air. Eyes closed and pt looked limp. Taken to ED and spontaneous breathing returned. Admit for observation x1 day. Dx with GERD and started on PREVACID. EEG pending.
Patient received second Pfizer vaccine on 2/8/2021. Became symptomatic with COVID like S/S on 4/30/2021. Was admitted to Hospital on 5/4/2021  and tested positive for COVID 19 upon admission. Patient was intubated on 5/12/21 and expired while still admitted to the hospital on 5/17/21.
flu; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a =sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) 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: INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "flu"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness on back of arm at injection site. Hot to touch - per patient via telephone conversation. Her physician concurred with recommendation to use hydrocortisone Cr and BENADRYL.
p/vax pt arm became very sore, hot to touch, swollen, limited ROM of arm;came for eval 8/5/99 site swollen, tender, warm to touch;to use warm moist heat,extra strength APAP, DPH call if sx persist beyond 7 days from now;
13 year old identical twin boy who started having chest pain approximately 24 hours after 2nd dose of vaccine. Chest pain was persistent and he then developed shortness of breath so was brought to ED. Found to have troponin very elevated and EKG with some ST segment elevation and was admitted for acute myocarditis.
pt recv vax 21MAY96 & 28MAY96 pt devel a mark on scalp & red dots on chest;29MAY96 pt exp low grade fever;
pt recv vax in the fatty portion of upper arm not in deltoid muscle;2 days later pt devel redness, swelling, tenderness, & a hematoma @ inj site;
Fever to 101F, Axillary lymphadenopathy, left arm uticaria
Quarter size rash on Rt arm. Parents called Doctor-BENADRYL given 1 time-rash disappeared.
Chills, body aches, temp 101.7 started on 01/28/21, one day after receiving second Covid -19 vaccine. Took Motrin for the symptoms.
The patient received catch up vaccines from two different MAs. Due to lack of communication I administered a second  dose Tdap vaccine. A MA informed me that this patient's tdap vaccine was not ordered on our system, so  I went back to our system to double check and it was not sowing as ordered.  We were about to closed the clinic so I went ahead and administered the vaccine before they left. Later the MA that administered the vaccines told that she did administered the all vaccines including Tdap.
Guest complained of feeling dizzy, lightheaded, and blurred vision about 10 minutes after receiving the vaccine. Patient was given juice and water by clinical staff. EMS was called to see patient. Medics  checked the patient. Vital signs were taken; patient observed by EMS. About 6 minutes after EMS arrived, they cleared the patient to be "safe" to go home with his friend who was driving. At this time, patient  reported that he felt good and back to "normal". Denied dizziness or blurred vision.