chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menquadfi administered to patient after temperature excursion at 31.5° Fahrenheit for 2 hours 45 minutes with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA240011, 2023SA238269, 2023SA240457, 2023SA240518, 2023SA240546, 2023SA239548, 2023SA239679 and 2023SA239960.  This case involves a 16 years old female patient to whom MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] administered after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (Frequency = once), (Strength = standard) (lot number and expiry date not reported) via intramuscular route in unknown administration site for immunization. Information on the batch number was requested.  On an unknown date the patient was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes with no reported adverse event (poor quality product administered) (unknown latency).  It was reported that "Products involved? ADACEL, DAPTACEL, IPOL, MENQUADFI, PENTACEL, QUADRACEL, TENIVAC, VAXELIS Product activated/prepared? NO Ask how the situation occurred? POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR.Did it occur due to a human error? NO. Does extended stability data cover the excursion: NO. Was the product used by/ administered to the patient: YES. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023. MENQUADFI administered."   Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received first dose Pfizer at 4:30 pm.  Around 6:30 pm she began to experience shortness of breath, weakness, "shaking" in legs, lightheadedness, dizziness, nausea and hives.  She presented to the emergency room and her blood pressure was elevated.  She was given Zofran and Benadryl in the ER.  After administration of the medications, her shortness of breath and hives began to improve.  She remained in the ER for 3 hours for observation then was discharged.  No epinephrine was administered during her visit.
next day I experienced chills; low-grade fever; arm pain; bump at the injection site; extremely fatigued; I broke out into hives; took a Benadryl to stop the itching; This is a spontaneous report from a contactable consumer (patient). A 23-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0175, Expiration date: Unknown), dose 2 via an unspecified route of administration, administered in left arm on 27Apr2021 14:45 (at the age of 23-years-old) as dose 2, single for covid-19 immunisation in doctor's office/urgent care. It was reported that, other vaccine was administered 27Apr2021 but it was not clear. No other vaccine administered in four weeks. The patient did not have Covid prior vaccination. The patient was not tested for Covid post vaccination. No known allergies were reported. Medical history included obesity. Concomitant medication(s) included ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for an unspecified indication, start and stop date were not reported; vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ep7533, Expiration date: Unknown), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 11:15 (at the age of 23-years-old) as dose 2, single for covid-19 immunisation in doctor's office/urgent care. On 27Apr2021 at 22:30, the patient experienced she broke out into hives, took a benadryl to stop the itching. On 28Apr2021, the patient experienced she experienced chills, low-grade fever, arm pain, bump at the injection site and extremely fatigued. The patient underwent lab tests and procedures which included body temperature: low-grade on 28Apr2021. Therapeutic measures were taken as a result of itching with Benadryl. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Acute neuropathy pain in their left foot particularly in the lateral aspect; Made walking difficult and running (which they do frequently) impossibl; Two weeks of significant discomfort; A spontaneous report  was received from a Physician concerning a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced acute neuropathy pain in their left foot particularly in the lateral aspect/neuropathy peripheral, made walking difficult/gait disturbance and two weeks of significant discomfort/discomfort.  The patient's medical history included kidney removed because of cancer. Concomitant medications reported included vitamin d3, calcium carbonate, cyanocobalamin, calcium levomefolate and curcumin.  On 9 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 024M20A) in the left arm for prophylaxis of COVID-19 infection.   On 21 Feb 2021, the patient experienced medically significant event acute neuropathy pain in their left foot particularly in the lateral aspect, made walking difficult and two weeks of significant discomfort.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, acute neuropathy pain in their left foot particularly in the lateral aspect was considered resolving (gotten gradually better). The outcome of events, made walking difficult and two weeks of significant discomfort was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Woke up with a large round red circle that looks like a rash.  It's mildly itchy, but it is slightly sore.  I received the first dose of Moderna 10 days ago.  I looked it up online and they're calling it "covid arm"
Soreness in arm of injection /Today she stated she has occasional on and off soreness in arm of the injection; Fatigue; Chills; Brain fog; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (Brain fog), PAIN IN EXTREMITY (Soreness in arm of injection /Today she stated she has occasional on and off soreness in arm of the injection), FATIGUE (Fatigue) and CHILLS (Chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), PAIN IN EXTREMITY (Soreness in arm of injection /Today she stated she has occasional on and off soreness in arm of the injection), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), FATIGUE (Fatigue) and CHILLS (Chills) had resolved and PAIN IN EXTREMITY (Soreness in arm of injection /Today she stated she has occasional on and off soreness in arm of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Above mentioned events were experienced after patient received second dose of vaccine on unspecified date. No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-017694 (Patient Link).
Patient had redness, itching  and swelling of the left arm that appeared to be warm to the touch in patients medial distal upper arm.  Patient was advised to use an over the counter antihistamine Benadryl and over the counter hydrocortisone cream for the itching  and ice for the swelling.  Patient was advised to follow up with provider in 24-48 hours or sooner if redness and swelling exceeded the marked parameters.
This was a medication error.  The patient needed a 2nd dose of Moderna.  The nurse administered a booster dose of Moderna (1/2 dose or 0.25 mL) rather than the full dose (0.5 mL).  The mistake was noted and the nurse gave the patient an additional 1/2 dose of Moderna.  No known adverse outcome, other than patient had to get 2 shots to get the full dose.
1 of 2 children who exp an inject site react; pt exp swelling of entire leg (down to the ankle); questionable allergic react; afebrile; pt recovered w/in 48 hrs;
Initial misuse report received from a healthcare professional on 12 February 2014. A 21-year-old patient had received PENTACEL instead of ADACEL on unspecified date. On same day ADACEL was also administered. Wrong vaccine was administered to the patient and it was overdose. No adverse event was reported. List of documents held by sender: None.
I had normal soreness in my arm after the shot, but that soreness turned into muscular pain about a week later and continues to this day (~3 months post vaccine). I currently have tenderness at the injection site, and about an inch below it towards my elbow,  and I can't lift up my arm all the way without pain in the deltoid.  The muscle fibers are tense. I've seen a physical therapist about it, who tries to massage it and ease tension to that muscle but nothing has helped.  She says she has 2 other patients she sees with the same complaint
Immediately after getting the shot I broke out in cold sweats, body went limp, arms and hands were tingling very badly and I lost my hearing to fast ?whooshes? couldn?t really speak or move for at least 15-20 minutes. Then got up and couldn?t stand up felt almost drunk. I had another spell exactly the same about 4 hours later
Immediately following vaccine- Arm soreness, headache, fatigue and slight fever 4 days later- Skin rash on face and neck
I suddenly experienced sudden hearing loss in my left ear. Thinking it may be ear wax or fluid contributing to this issue, I went to an urgent care and they cleaned both ears. They found no fluid or infection, but I still could not hear in my left ear. I made an appointment with an ENT. He also did not see any physical issues and ordered an MRI.
passed out; This will drive me nuts all day; I don't feel comfortable walking in my own house; I got up this morning with the feeling of vertigo; getting little worse, worse than they were; This is a spontaneous report from a contactable Consumer. A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number of Covid-19 Vaccine: 592671000-1, Expiry Date of Covid-19 Vaccine: 31May2021, Lot: EL9267), via an unspecified route of administration on 21Feb2021 13:24 at single dose for covid-19 immunisation. The patient medical history were none. Concomitant drug received. Patient stated, "Yes, I am on Inhalation Pump so, I take it went for one when I need it, I just had that was just little while ago, it wasn't (Incomplete sentence). The patient stated, "I got my second shot (Covid-19 Vaccine by Pfizer) Sunday about 1:30(13:24 PM) it says on the piece of paper, and I was fine all day Sunday, Monday(22Feb2021), I got up this morning with the feeling of vertigo, which I have had in the years of the past okay, all day, got out of shower from the bathroom out here and get some coffee, and I sat down I went to get up and the vertigo hit and I almost fall over, now I went into the shower and I dropped the wash cloth on the floor, so I went down to pick it up and again  almost passed out, almost immediately, and I sat and I get in the kitchen for some toast and I said well let me see what happens here and sat down eating some toast and when I got up to put dirty dishes in the sink, I almost again passed out, now I just got up to get the check I have to write to the gentleman right here who is working for me and just before that I got the same thing now I don't like it, how are these supposed to last, is what I want to know because I can't, this will drive me nuts all day, I can't go anywhere, I can't drive anywhere, yeah I don't feel comfortable walking in my own house. Right now, I have to say I am feeling them getting little worse, worse than they were." No treatment. Outcome was not recovered.
Hot flashes; Sweating daily; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 07:30 (Lot number: ER8732) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Menopausal", start date: 2016 (unspecified if ongoing), notes: Pt has been menopausal since 2016 without symptoms. Concomitant medication(s) included: COZAAR; CHLORTHALIDONE; CALCIUM D; MULTIVIT. Vaccination history included: Bnt162b2 (1st Dose:, lot number=EN6204,, administration time=07:30 AM, vaccine location=Left arm), administration date: 20Mar2021, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: HOT FLUSH (non-serious) with onset Jul2021, outcome "not recovered", described as "Hot flashes"; HYPERHIDROSIS (non-serious) with onset Jul2021, outcome "not recovered", described as "Sweating daily". Therapeutic measures were not taken as a result of hot flush, hyperhidrosis.  Additional information: Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Approx 3 months after inj 2 experiencing hot flashes and sweating daily. Ae results in None of the above. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Known allergies was None.  No follow-up attempts are possible. No further information is expected.
Itchy rash; Patient reports, rash appears to be in a resolving stage, with indurated sites replacing the rash; Elevated WBC; This case was reported by a physician via call center representative and described the occurrence of white blood cell increased in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash. Concomitant products included clobetasol propionate (Clobetasol).   On 16th March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st April 2020, 16 days after receiving Shingrix, the patient experienced white blood cell increased. On an unknown date, the patient experienced itchy rash and induration. The patient was treated with topical steroid nos (Steroid Cream). Shingrix was discontinued. On an unknown date, the outcome of the white blood cell increased and induration were unknown and the outcome of the itchy rash was recovering/resolving.   It was unknown if the reporter considered the white blood cell increased, itchy rash and induration to be related to Shingrix.  Additional details were reported as follows: The patient reported rash and elevated white blood cell, 2 weeks following his first dose of Shingrix vaccine. The patient visted dermatologist and shows negative potassium hydroxide test for fungi. The patient was prescribed steroid cream that relieved the itching. Patient reported that rash appears to be in a resolving stage, with indurated sites replacing the rash. The patient told that he will not receive the second shot in the series. As per evnt onset date TTO for event white blood cell increased  should be 16 days however it was reported as 2 weeks that is 14 days.
experienced extremely dry mouth; severe mouth ulcers; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (experienced extremely dry mouth) and MOUTH ULCERATION (severe mouth ulcers) 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) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (experienced extremely dry mouth) and MOUTH ULCERATION (severe mouth ulcers). At the time of the report, DRY MOUTH (experienced extremely dry mouth) and MOUTH ULCERATION (severe mouth ulcers) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Three weeks ago patient received the Moderna bivalent booster and almost immediately experienced extremely dry mouth and severe mouth ulcers which lasted almost 3 weeks. It was recommended that patient received next booster in three months. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Dec-2022: Live significant follow up appended.
Day 11 after Varivax severe pain at injection site. Day 12 fever, headache, erythematous eruption began. Office notes included.
the caller has pulmonary fibrosis; the caller has not received the prescribed second administration of Pneumovax; This spontaneous report was received from a a male patient of unknown age referring to himself. His historical vaccine included "the 13" (the patient believed this was pneumococcal vaccine conj 13V (PREVNAR 13), but it was unable to verify), the patient stated he was vaccinated prior to 2014, but a physician noted a fictitious date of 01-JAN-2017 for this administration. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided.   On an unspecified date in December 2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On an unknown date, the patient experienced pulmonary fibrosis. The patient's physician was now recommending a second administration of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) because of the pulmonary fibrosis. The caller stated insurance had denied covering a second administration of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and would not give him  a reason for denial. Therefore, the patient had not received the prescribed second administration of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). On an unknown date in 2021, the patient experienced the incomplete course of vaccination (onset based on information that vaccination was recommended "now"). The outcome of pulmonary fibrosis and incomplete course of vaccination was unknown.    The causality assessment between the event of pulmonary fibrosis and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.   Upon internal review the event of pulmonary fibrosis was considered to be medically significant.
extreme shortness of breath/ongoing minor shortness of breath; This is a spontaneous report from a contactable consumer (patient himself).  A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E19267), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 as DOSE 1, SINGLE (age at vaccination was 71 years old) for covid-19 immunisation. Medical history included hypertension, depression and arthritis, all from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril, bupropion, glucosamine and multi-vit. The patient reported absolutely nothing until four days after, on 21Feb2021 04:00, he had maybe eight hours of extreme shortness of breath, followed by ongoing minor shortness of breath for another day or two. It was reported that the patient did not have Covid prior to vaccination and Covid was not tested post vaccination. The patient did not receive any other vaccination 4 weeks prior of BNT162B2. It was unknown if any treatment was provided. At the time of this report, the outcome of the event was recovering.  Follow-up attempts completed. No further information expected. .
Skin allergy; Lot of allergic reaction on both hands/across my body; Sneezing; is really discomfort able right now; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164), via an unspecified route of administration on 10May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient stated was having allergy like skin allergy it had been like 3 to 4 days (May2021) after getting second shot of vaccine and early morning patient was having like sneezing (May2021) continually when patient got up and right then patient was having lot of allergic reaction on both hands, it was getting spread across the body. Patient further stated that patients condition was really discomfort (May2021) able right then. The clinical outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number L014876 with an expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 216 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.