chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a 3rd Booster dose of Moderna on 11/16/21. The medical assistant accidentally gave this patient a full dose (o.5mL) of Moderna, instead of the necessary half a dose (0.25mL) that is needed for "booster" doses. The medical assistant was under the impression that Healthcare professionals should receive a full dose instead of a half (as this patient is a nurse). So the patient has now received 3 full doses of Moderna and she is not immunocompromised, but does work in Healthcare. Patient was monitored for 15 minutes post injection and no adverse effects observed or reported at all. Patient was contacted via phone approximately 1 hour after injection when the MA realized that they made the mistake. The patient verbalized understanding and still has no adverse effects at this time. NP at the vaccination clinic was notified.
AUTOIMMUNE SMALL FIBER POLYNEUROPATHY AFTER COVID-19 VACCINATION; POTS; This is a literature report for the following literature source(s).  A previously healthy 27-year-old woman who presented with several months of progressive weakness, neuropathy, and tachycardia that began shortly after her second dose of the Pfizer COVID-19 vaccine. Initially, she noticed fatigue followed by occipital neuralgia and paresthesia. Weeks later, she was febrile with extremity tremors and neuralgia. She went to the ED where she was lymphopenic, group A strep positive (GAS+), and had unremarkable imaging; she was given antibiotics and gabapentin. Her fever resolved, but her pain/tremor continued. Occipital nerve blocks provided temporary relief; acyclovir and duloxetine had no effect. On two subsequent ED visits, she was again GAS+ and was given additional antibiotics. Later, she developed non-pruritic rash, dermatographia, and blepharitis; skin biopsy showed non-vasculitic progressive pigmented purpura. An extensive rheumatologic, post-infectious, and paraneoplastic workup was unrevealing. Notably, she had high anti-COVID-19 spike antibody on qualitative assay. During workup, her symptoms rapidly worsened, leading to admission. On exam, she had intact sensation, profound gait imbalance, and HR to 150s with standing. LP was negative; EMG ruled out large fiber polyneuropathy (LFPN). She was diagnosed with autoimmune small fiber polyneuropathy (SFPN) and POTS. She improved rapidly with IVIG and steroids. Given her negative workup, the COVID-19 vaccine was identified as the likely trigger.; Sender's Comments: Based on the known safety profile and information in the case report a casual association between reported event Autoimmune Polyneuropathy and the suspect drug cannot be excluded. 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, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202200048823 Same article, different patient, drug and events;US-PFIZER INC-202201087490 Same article and patient, different drug and event;
Pt experienced lymph node swelling in arm that injection was given; This is a spontaneous report from a non-contactable pharmacist. A 31-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on arm on 08Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included allergies to sulfa. Concomitant medication included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYTREC), and birth control. The patient experienced lymph node swelling in arm that injection was given on 09Jan2021 with outcome of recovered. The patient received the 2nd dose of the vaccine with no issue.  No follow-up attempts are possible. No further information is expected.
First dose of Havrix on july 5th, 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received Havrix on 5th July 2019, batch number E9G4E, expiry date 29th November 2021).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive 2nd dose of Havrix till the time of reporting, which lead to incomplete course of vaccination. The batch number for 1st dose was reported as E9C74E which was corrected to E9G4E as per sales data sheet. The reporter did not consented to follow up. This case has been linked to US2021097941, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097941:Same reporter.
pt recv vax 19DEC96 & devel multiple urticarial rash 13JAN97;abd pain;
Pt received vaccine, child was given Tylenol by mom. Pt slept approximately 3 hours. Awoke and began crying uncontrolled. Right leg was very red and warm and edematous. Pt was brought back to our office. Cool compress applied, Benadryl given. Child cried approximately 3 hours. Child stopped crying 3 hours later. Redness subsided.
severe sharp pains in my ankle that got worse and my ankle and leg were sensitized; severe sharp pains in my ankle that got worse and my ankle and leg were sensitized; foot swelled up; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number not reported, patient was not pregnant and 53-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 03Mar2021 as single dose for covid-19 immunisation. The patient's medical history included High blood pressure, low blood sugar, anxiety, Ulnar nerve damage, start and stop date was not reported, Patient had known allergies with Sulphate and Dicloxacillin and baclofen. Patient had no covid prior vaccination and not tested covid post vaccination. Patient had no other vaccine in four weeks. Patient received unspecified other medications in two weeks. Reported that patient was 9 weeks into my recovery from a bimalleolar fracture. I was cleared to walk and had been doing well with minimal pain and no swelling putting 50 percent weight on my foot. Within 24 hours of getting my vaccine, my foot swelled up, I began having severe sharp pains in my ankle that got worse and my ankle and leg were sensitized. I called my doctor 5 days later and was referred to physical therapy. The only difference during this time was the vaccine. On 04Mar2021, the patient experienced severe sharp pains in my ankle that got worse and my ankle and leg were sensitized, foot swelled up. Patient received treatment with Physical therapy and Voltaren cream. The outcome of reported events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
08/11/2021  19:08 The patient presents with 77 year old male with a PMHx of HTN, MI, distant lung cancer, CAD, and high cholesterol presents with shortness of breath x 2 days. Pt got COVID a week ago and states he was feeling better but reports he started to have shortness of breath 2 days ago. He denies taking any medication for COVID. He denies fever, n/v, diarrhea or any other symptoms. Pt reports he had a headache, chills, myalgia but denies those symptoms now. Pt states he is here to get BAM done. Pt reports he got his COVID vaccine earlier this year but is unsure which one. No chest pain, abdominal pain, urinary symptoms.  No leg swelling.  No other complaints.  The onset was 1  weeks ago.
28-year-old female, medical assistant employee presents to urgent care 45 minutes after receiving her second dose of covered vaccine, presents to urgent care complaining of a 4 of 10 throbbing headache and left ear/lateral neck pain. She has not taken anything for pain, having come straight from work/vaccination clinic. She tolerated her first dose of vaccine well.
45 year old /has a medical order to receive Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist reported that the 45 year old patient had a medical order to receive Shingrix and the vaccine had not been administered, which led to drug prescribing error. The reporter consented to follow up.
Patient c/o pain to left leg all day 7/2/20. Mom examined at 7pm on 7/2/20 and took him to the ER. Positive for fever of 99, left thigh swelling, redness left anterior thigh, rash left anterior thigh. Given oral dexamethasone and diphenhydramine at ER.
Narrative:  #Rash: Present on bilateral legs. Pruritic. Started after 2nd Moderna vaccination. Resolving. Did start with something of a herald patch. Ddx includes erythema multiforme, fungal, infestations, contact dermatitis. Of these, erythema multiforme seems most likely, although interesting that it was limited to his bilateral legs. -Althoug unclear that rash was precipitated by the vaccine, the timing makes this possible. Will make those monitoring for vaccine SE's aware.- Given it's resolving, will hold off on treatment other than topical OTC hydrocortisone at this time.
tingling in both arms and all the way down to their fingers; numbness in both arms and all the way down to their fingers; skin felt hypersensitive/ hurt to wash their hands; Fever; Chills; Body aches; Fatigue; Nausea; under the weather; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather), PARAESTHESIA (tingling in both arms and all the way down to their fingers), HYPOAESTHESIA (numbness in both arms and all the way down to their fingers), SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient confirmed they had COVID last year) in 2020.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced MALAISE (under the weather). On 05-Aug-2021, the patient experienced PARAESTHESIA (tingling in both arms and all the way down to their fingers), HYPOAESTHESIA (numbness in both arms and all the way down to their fingers), SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 05-Aug-2021, SENSITIVE SKIN (skin felt hypersensitive/ hurt to wash their hands), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, MALAISE (under the weather), PARAESTHESIA (tingling in both arms and all the way down to their fingers) and HYPOAESTHESIA (numbness in both arms and all the way down to their fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product information was not provided.
Right ear has red blood slowly seeping.  Awake at 1am when it first drained.  Felt like swimmers ear.
Itchy hands, feet, hairline, midsection causing contact rash. Persistent after a month. Significant enough to cause disruption to daily activities, awaken at night.
This spontaneous report as received from a physician assistant via a company representative refers to a female patient "in her 20's". No medical history provided. On an unknown date the patient was vaccinated with PNEUMOVAX23. No concomitant medications were reported. Then, she was inadvertently administered a second dose of PNEUMOVAX23 on an unspecified date 1 year later. No adverse events were reported. No outcome was reported. PNEUMOVAX23 was administered by another unspecified practice. Additional information is not expected.
Fever, chills, muscle ache, headache, weakness. No special treatment; just rest, aspirin, drinking fluids. Lasted about 24 hours; felt fine the next day. Note: no reaction to first COVID vaccine injection 3 weeks earlier.
Headache, Fuzzy Brain,  Felt Cold, Lethargic and Tired
Patient received vaccine on tuesday 5/4. Patient developed a rash surrounding both ankles. Patient and wife dismissed this as possible side effect of vaccine. The  patient had difficulty breathing and dismissed it as a panic attack on 5/10. Symptoms continued for several days, went to walk-in clinic on Wednesday 5/12 for tests and inconclusive.  Thursday 5/13 the patient continued to experience these symptoms and elevated pain, tightness and cramping in legs and went to the ER where he was diagnosed with bilateral pulmonary emboli. Patient was admitted for 2 days and treated for clots. Upon discharge the patient was instructed to discontiue meloxicam, carbidopa/levodopa and started on eliquis for 6 months. After 6 months the patient will follow-up with a hemotologist.
After receiving the vaccine, I was instructed to wait i for 15 minutes to ensure there were no reactions. I sat down in the provided chair, put my headphones in my ears, and started my timer on my watch for 15 minutes. after about 5 minutes I began to feel like my injection arm was a little weak, as if perhaps my arm was stiffening from the injection sore. I remember feeling slightly warm and started to read over the COVID-19 Vaccine symptoms sheet and then I blacked out (Fainted). The nurse in the hallway woke me up and was asking me if i was alright and then rushed me in the back room where they tested me and ensured I was ok. I had not eaten anything the morning of the vaccination shot and barely anything the night before. I have been experiencing higher levels of anxiety recently due to pressures of day to day life; school, work, etc. The nurses are thinking it is likely I had more of a reaction to the anxiety and low food or blood sugar (I am not diabetic), than a reaction to the vaccine itself. They did refer to my experience as sounding like Vasovagal syncope. I have never had this experience with any flu vaccine or shots before; I do not have a fear of needles or shots.
12/22/22 presents to ED for "SOB". PMHx of "CHF, CAD, COPD, CKD, GERD, lung CA s/p radiation".
pt had red swollen eyes, itching rash, inc nasal mucus, some difficulty breathing;
2 days of fever and muscle aches with fatigue. 11 days of bicep pain radiating down to elbow and into armpit of left arm.  Unable to use arm except for limited activity.
Gastrointestinal issues including upset stomach, abdominal pain and diarrhea w some loose stools.. Also had irritability, chills.   Lasted 48 hrs... was sever for the first 24 hrs.
Hives (giant) on left arm and forearm with intense pruritus and moderate edema of entire upper extremity.
Swollen lymph nodes in the neck ongoing still since 3/29 after 12pm through today.
Information has been received from a consumer concerning a male consumer who on an unspecified date was vaccinated IM with zoster vaccine live (Oka/Merck). Subsequently, the patient experienced injection site pain. At the time of the report the patient's status was unknown. Additional information has been requested. This is one of several reports from the same source.
Bladder/urinary tract infection; symptoms started on 8/6/21 (fever, lower abdomen pain, fatigue); consulted physician's assistant via online appointment (with pharmacy) on 8/8/21, who recommended I see my primary care doctor or urgent care, since she could not diagnose/provide treatment without seeing me in person and conducting a lab test. I went to Urgent Care on 8/9/21 and was diagnosed with a UTI. Follow-up lab results confirmed an infection. I was prescribed a 5 day course of antibiotics (Bactrim) which I completed and the infection was resolved. I also took an at-home rapid COVID test on 8/10/21 and result was negative.
About an hour after I received the vaccine my entire head was in pain including upper jaw and back of neck.  My face was flushed and my throat began to tighten a little  The headache and flush lasted about an hour.  (I had taken Tylenol right after getting the vaccine.)  The throat symptoms lasted longer ,lessening slightly after about an hour and a half.  Never had trouble breathing, talking, eating or drinking.  But the feeling has lasted into the late evening to a very mild degree; as if something is caught at the back of the throat, or the back of the tongue feels a little fuzzy.
I had fever and also I had a seizure, I went to the doctor because I felt sick on 10/04/2021 I was told that I positive for Coronavirus. I had a fever for 101 for a few days and I was told it was normal. Ever since I had the vaccination I notice hair loss and I've gained weight.
This spontaneous report was received from a physician refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL dose 1 (dosing regimen unspecified). On an unknown date the patient was vaccinated with second dose of GARDASIL one week too early (dosing regimen unspecified) (inappropriate schedule of vaccine administered). No adverse symptoms reported. No further information provided. Additional information has been requested.
DEVELOPED 2 SMALL HIVES AT PROQUAD INJECTION SITE. ICE PACK APPLIED. MOTHER SPOKE WITH PCP AND CHOSE NOT TO TAKE CHILD TO OFFICE OR ER.
Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023; No adverse event; expired vaccine being accidently administered/administered 1 day past the post thaw expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine being accidently administered/administered 1 day past the post thaw expiry date), PRODUCT STORAGE ERROR (Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine being accidently administered/administered 1 day past the post thaw expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine being accidently administered/administered 1 day past the post thaw expiry date), PRODUCT STORAGE ERROR (Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine being accidently administered/administered 1 day past the post thaw expiry date) and PRODUCT STORAGE ERROR (Thawed on 13-Jan-2023 and first punctured and administered on 13-Feb-2023).    No concomitant product was reported. It was reported that affected vaccine was Spikevax Moderna 6mo-5yr royal blue cap purple label with lot number 047D22A and expiry date 08-Mar-2023 on vial. 1 vial was affected. This lot number did not undergo any previous temperature excursion. The unopened vial was initially stored in the refrigerator post thawing on 13-Jan-2023. It was first punctured on 13-Feb-2023. Vaccine was drawn up into the syringe, wherein 3 were doses withdrawn and administered on 13-Feb-2023 wherein from 1-3pm, 3 were doses administered. The vial/syringe was stored at room temperature once punctured. It was not returned into fridge. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius) was 2 hours. No treatment information was reported.  This case contains information for the 1st of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712032, US-MODERNATX, INC.-MOD-2023-712033 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712032:Patient 2 out of 3 Patients (child) US-MODERNATX, INC.-MOD-2023-712033:Patient 3 out of 3 Patients (child)
Initial report received from a consumer on 07 Dec 2009: This patient was received FLUVIRIN (batch no: 97840P1) on 17 Sep 2009. The patient had an allergic reaction after receiving flu shot on 17 Sep 2009. The outcome of the event was reported as recovered on 17 Sep 2009.
12/15/2021: Admitted into hospital with some SOB and other complications 12/16/2021-12/19/2021: COVID 19 infection with hypoxia. Supplemental oxygen of 2L. Started Dexa and Remdesivir 12/20/2021: Pt discharged. Remdesivir completed today. Start taking Dexamethasone 6mg tablet (start: 12/21) 1 tab PO daily for 5 days. Wean O2 as tolerated.
first dose on 17 july, second dose not yet taken; my skin was itching; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (my skin was itching), HEADACHE (headache) and PRODUCT DOSE OMISSION ISSUE (first dose on 17 july, second dose not yet taken) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Jul-2021, the patient experienced PRURITUS (my skin was itching) and HEADACHE (headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose on 17 july, second dose not yet taken). On 19-Jul-2021, PRURITUS (my skin was itching) and HEADACHE (headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose on 17 july, second dose not yet taken) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: positve (Positive) POSITVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant medication was not provided.