chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slow healing/difficulties with sores healing; Sore places on finger and leg; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED HEALING (Slow healing/difficulties with sores healing) and PAIN IN EXTREMITY (Sore places on finger and leg) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced IMPAIRED HEALING (Slow healing/difficulties with sores healing) and PAIN IN EXTREMITY (Sore places on finger and leg). At the time of the report, IMPAIRED HEALING (Slow healing/difficulties with sores healing) and PAIN IN EXTREMITY (Sore places on finger and leg) had not resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
(L) thigh with erythema and purpura skin in large circular area 8cm - no adjacent to but not symptom surrounding needle insertion site from vaccination. No no tracking, no proximal adenopathy (upper spongitis)
Information has been received from a Registered Nurse (R.N.) concerning a female patient with penicillin allergy who on 05-SEP-2007 was vaccinated IM into the right arm with a first dose of Gardasil lot #658558/1061U. The nurse reported that post vaccination patient went to the waiting room and fainted. She got cold compress and they took her blood pressure which was normal. She was monitored in the waiting room for 15 to 20 minutes. The patient recovered. This report is one of the two reports from the same reporter. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a female student with penicillin allergy who on 05-SEP-2007 in the AM was vaccinated IM into the right arm with a first dose of GARDASIL lot #658558/1061U. The nurse reported that post vaccination patient went to the waiting room and fainted. In follow up it was reported that the patient walked out to the waiting room with her father and then experienced syncope episode while sitting in the waiting room after injection. She got cold compress and they took her blood pressure which was normal. She was monitored in the waiting room for 15 to 20 minutes. The patient recovered. This report is one of the two reports from the same reporter. Additional information is not expected.
myocarditis, palpitations, arrhythmia, ventricular tachycardia, periorbital edema, keratoconjunctivitis sicca
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long QT" (unspecified if ongoing). Concomitant medication(s) included: NADOLOL; LOESTRIN; ALLEGRA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201008094 same patient, different AE, different dose of vaccine;
Felt an initial "cool" feeling all over immediately following vaccine injection, this resolved immediately as well.
About 10 minutes after vaccine administration, patient presented w/ c/o feeling of "tightness" in diaphragm and metallic taste in mouth.  Asked if she could take Benadryl, which she did, after which she went home.
Luer lock of needle was not tightened on syringe; when vaccine injected, the needle disconnected from syringe.  Patient received some vaccine; however, unknown amount.
Pt arrived due to shortness of breath. He has a PMH of a previous stroke with aphasia. His wife is at home with COVID. He also has a cough. He was admitted due to dyspnea and COVID positivity.
Swelling, redness, and hardness of the arm 4-5 hours after injection. still reports symptoms 12/24/2016. Pt applied heat. NO help. She will try ice and diphenhydramine when she can.
Local symptoms: Pain-discomfort, swelling. General symptoms: headache, diarrhea, swollen glands Narrative:
Information has been received from a registered nurse concerning one to two female patients between the ages 15 to 18 months out of 20 who were vaccinated with VARIVAX (Merck, lot #659345/1915U). Approximately 13 to 15 days post vaccination, the patients developed red, raised knot at the injection site following vaccination with the same lot numbers. Also refer to WAES #0804USA04795 and 0805USA05445). A lot check has been initiated. Additional information is not expected as the nurse is unable to provide any additional details regarding the three patients. On 05-JUN-2008 lot check results were received. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is expected.
Major sweats; Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Jun2021 11:15 (Lot number: EW0191, Expiration Date: 30Sep2021) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ITP" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Romiplostim for ITP, reaction(s): "No reaction on previous exposure to drug", notes: Verbatim: Romiplastim is 40 microgram. The following information was reported: HYPERHIDROSIS (non-serious) with onset 19Jun2021, outcome "recovered", described as "Major sweats"; CHILLS (non-serious) with onset 19Jun2021, outcome "recovered", described as "Chills"; HEADACHE (non-serious) with onset 19Jun2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache. Additional Information: the PPN patient taken 4 bags a week, that taken of that hold on had to get the exact amount 50 microgram". (Further clarification unknown) If still experiencing these adverse events: patient stated, the headache, yes sorry the Romiplostim is 40 micrograms yes. Outcome of Event patient stated, it was improved but still have the headache and the what so far yeah. Drug was taken for treatment was Aspirin.  Follow-up attempts are completed. No further information is expected   No follow-up attempts are possible. No further information is expected.
Child complained of headache. Was seen by medical health care provider a week later. Is being tested for cause of headache. Parents feel it is from the flu mist.
Swollen eyes, fever 101.0, body aches, burning eyes for only 24 hours after being immunizes.
began to have vertigo symptoms/mild case of vertigo; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9269), via an unspecified route of administration on 05Feb2021 (at the age of 57-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration on 26Feb2021 (at the age of 57-years-old); as a single dose for COVID-19 immunisation. Medical history included prone to vertigo, trigeminal neuralgia, and small fiber neuropathy. The patient was allergic to penicillin. Concomitant medication were not reported. The patient previously received codeine (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 05Feb2021, 40 minutes after the first dose of the vaccine, the patient experienced vertigo symptoms, everything was spinning for about 1.5 days. On 01Mar2021 at 05:00, approximately 2.5 days after the second dose the patient experienced a mild case of vertigo and was able to move around slowly without help. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event vertigo was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient became very lethargic after receiving vaccine, slept for 2 hours and woke up with temp of 102, vomiting. Temp lowered to 100.5 with TYLENOL and increased to 102 after 4 hours. Patient very lethargic, loss of appetite.
Patient reported rash and swelling of right arm with severe pain also fever 101.6. Patient also had seasonal flu vaccine in left arm same day no reaction.
Seizures; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional. This is a report received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history included immunodeficiency, I'm immunocompromised, gastrointestinal disorder from an unknown date and unknown if ongoing. Recently she had undergone several surgeries, radiology, and chemotherapy for a problem in my lower intestine. The patient concomitant medications were not reported. The patient previously took dilantin [phenytoin sodium] for seizure, levetiracetam for seizure. On an unspecified date patient had previous episodes of seizures. She would want to know if the Pfizer-BioNTech COVID-19 Vaccine would "trigger" seizures.  Outcome of event was unknown.  Information on the lot/batch number has been requested.
Client states he woke up the day after receiving vaccine "and had a streaking red infection" near the site of vaccine administration. Client states he did "find myself scratching it several times during the night because it itched and I think I may have broken it open".  Client went to the Emergency Department on 10/22 and was prescribed oral Keflex 500 mg 4 times a day for seven days. He states "it has cleared up nicely".
Received an Expired Dose of Heplisav-B; Initial Report Received on 17-May-2022  A pharmacist reported that 42-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 17-May-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934967, serial # 179060910493, expiration date 11 Apr-2022, NDC # 43528-003-05) intramuscularly in the right deltoid. The patient did not experience any adverse reactions.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Painful headache, dizziness, loss of feeling in right side, numbness in right side, drooping face, blurred vision, shortness of breath
Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 29-MAR-2023, the patient received Havrix. On 29-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used 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 Information: GSK receipt date: 29-Mar-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who received an 0.5ml, standard immunization of invalid ipol today/excursion was 53.6 degrees f. x 38 minutes, while she received vaccine ACT-HIB, PENTACEL, MENACTRA, FLUZONE QUADRIVALENT, ADACEL and IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given. On an unknown date, the patient received a dose of suspect ACT-HIB lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect IPOL lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose  of suspect FLUZONE QUADRIVALENT lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MENACTRA lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect PENTACEL lot number not reported via unknown route in unknown administration site. On 20-Nov-2018, the patient received a 0.5 ml dose 4 of suspect IPOL lot N1F931Mecp date: 05-Jul-2019 via unknown route in the right deltoid. On an unknown date she also received a dose 3, dose 2 and dose 1 of the same vaccine lot N1F931M via unknown route in unknown administration site. The patient an 0.5ml, standard immunization of invalid IPOL today which was excursion was 53.6 degrees f. x 38 minutes (product storage error). There were no side effects and no treatments. This case was an actual medication error due to incorrect product storage (of IPOL vaccine). This case was potential medication error due to incorrect product storage of unopened ACT-HIB, PENTACEL, MENACTRA, FLUZONE QUADRIVALENT, ADACEL. As it was not reported whether the patient received these vaccine or not. Lab data was not reported. 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 Directive and Module VI of the Good Practices. 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. List of documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 17-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 25/0.5, Lot # H010661; Expiration date: 14-FEB-2014 (dose and route was not reported). Pharmacist reported that a patient picked up PNEUMOVAX 23 from the pharmacy and transported it to the physician's office for administration. Pharmacist stated that the PNEUMOVAX 23 was not expired when the patient picked up the vaccine, however, it was expired by the time the physician administered it to the patient. Pharmacist stated that the PNEUMOVAX 23 did not have any known temperature excursions. Additional information is not expected.
No adverse symptoms reported.; patient was vaccinated with expired VARIVAX; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 05-SEP-2019, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: N021318, expiration date: 07-AUG-2019, frequency, route and dose details were unknown) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) did not have any temperature excursions prior to administration. No adverse symptoms reported.
Vaccinated on a Friday. Sunday, a red rash formed on my arm at the injection site. By Monday it had doubled in size (about softball size), was hot to the touch and hard as a rock. Did not fade until the following Friday.
Case number PHEH2015US026843, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 23 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) intramuscularly into left deltoid on 19 Oct 2015. It was reported that FLUVIRIN administered had a temperature excursion of 34 degrees Fahrenheit overnight. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Syncope Hx of syncopal episodes during any procedures, per ED note. Narrative: c/o of feeling flushed and pt. asked to lay down @11 am in the observation area. Staff able to get pt. to cart before she "passed out." She immediately responded but RRT was called to assess the patient. BP low, per RRT (84/54 P 53, 108 /65 P 51) and pt. was taken to the ED at 1112. No SOB, nausea noted. Per ED and final report was that the reaction was not an allergic reaction nor a side effect of the injection.
When getting the injection I could actually feel the liquid from the medication going into my shoulder area and I then felt like the vaccine was given too high on the arm.  My arm was sore that night (like expected) but now 1.5 weeks later, it still hurts when I move my arm certain ways (raising my arm).
Chills immediately - muscle and joint pain temp 102. Went to bed for temp and ache and pain and fever - itching all over body arm (red) and lump and swollen drank a lot of water no food - weak - too ill to realize I should go to hosp was in bed and hurting. Still lymp arm itching - discolored.
21APR94 pt exp a poss sz; mom noted pt twitchy extremities moaning & shaking in car seat; by the time stopped car pt stopped the shaking; seen by MD 25APR94; MD recommended no further pertussis doses; acute pharyngitis dx on 21APR94;
then tested positive; This is a spontaneous report from a contactable consumer or other non HCP via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14Mar2021, the patient tested positive (COVID-19). The patient scheduled to take second dose on 26Mar2021 and wanted to know if patient was okay with taking the second shot of the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Felt weird, pain in my eye starting on 1/8/2021, took a Covid test the next day. Coworker said I didn't look good. I did not have any vision problems just very sore. Called optometrist on Monday 1/11/2021 and went in, left eye pressure was at 42. Doctor could not dilate my eye because the pressure was too high. I was given Combigan and Lumigan drops. I went back in on Wednesday, was able to get dilated, and the doctor saw something, looked like a blood blister in my eye. Doctor then referred me to another doctor. This doctor thought I had shingles in my eye. The second doctor prescribed me Prednisone (qid 80), and Valtrex. On 1/13/2021 second doctor sent me to see another doctor at the eye center (he is a retinal specialist). Retinal specialist dilated me and told me to stop Lumigan drops. 1/19/2021, negative for herpes zoster, stopped Valtrex. 1/20/2021-TB came back positive. 1/26/2021 Dr. dilated me again.  I was seeing uvietis specialist around 2/8/2021.  I had retinal detachment from this.
10/31/05 received shot, 11/5/05 flat in bed too tired and ill feeling to even watch TV.  Within the next week a virus attacked me.  Started with sinus headache, congestion. I did all healthy things that I could do to fight it back.  I was ill for 3 weeks.