chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine ran down individual's arm; syringe which malfunctioned; A spontaneous report was received from a pharmacist concerning a 68, year old, male patient who experienced an incomplete dose administration of Moderna's COVID-19 vaccine, when the syringe malfunctioned and the vaccine ran down the patients arm.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly, the injection side/site not given for prophylaxis of COVID-19 infection.    The reporter, a pharmacist, called from a clinic. On 05 Feb 2021, one of the immunizers attempted to give a second dose using the agency supplied syringe which, malfunctioned and the vaccine ran down the patient's arm.  Treatment information was not provided/unknown.     Action taken with mRNA-1273 in response to the event(s) was not provided.  The events incomplete dose administration of vaccine and syringe issue were considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered, and syringe issue for mRNA-1273, lot # 029L20A with no associated AEs.
Case number PHEH2013US023646 is an initial spontaneous report received from a pharmacist on 28 OCT 2013. This report refers to a 17-year-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. The pharmacist reported that this patient under 18 years of age received FLUCELVAX 2013/2014 (batch number not reported) on 26 OCT 2013. No adverse event was reported following the maladministration.
patient vomited and could not hear as well from one ear. patient was sitting at the time of event, it began immediately after injection. ice pack was provided to comfort patient, patient sat until symptoms resolved, given water to rinse mouth out after vomiting. patient was speaking the entire time, mother was present. mother mentioned that her other child had a similar reaction this past week as well. patient felt back to normal with 15 minutes.
Six days prior to Vac. had physical and BP was 127/72 Blood pressure went up to 192/103 pulse 60 at dentist appt. Checked several times in the evening and pressure remained  very high over 180 and 100
The vial was first punctured on 04-Apr-2022, was stored in refrigerator post puncture and expired vaccine administered on 05-Apr-2022, past 12 hours puncture time.; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022, was stored in refrigerator post puncture and expired vaccine administered on 05-Apr-2022, past 12 hours puncture time.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022, was stored in refrigerator post puncture and expired vaccine administered on 05-Apr-2022, past 12 hours puncture time.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022, was stored in refrigerator post puncture and expired vaccine administered on 05-Apr-2022, past 12 hours puncture time.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the second booster dose of Moderna Covid-19 vaccine on 05-Apr-2022 (lot number : 045L21A, expiry date : 05-Jul-2022).  No concomitant drug was reported.  It was reported that the vial was initially stored in the refrigerator on 04-Apr-2022. The vial was first punctured on 04-Apr-2022 at 1:55 PM and administration of vaccine on 05-Apr-2022 at 9:00 AM . The vial was stored in refrigerator post puncture. Total amount of time the vial was exposed to room temperature range was reported as unknown, the vial was not exposed to room temperature for more than 24 hours. The vial did not undergo any temperature excursions.  No treatment information was reported.
Sore arm immediately after vaccine.   Left hand was also sore to the touch for the rest of the day. Fatigue started several hours after and lasted for about 40 hours. Nausea started several hours after and the following day diarrhea started and lasted for the day. The evening of the vaccine I started having small bumps appear inside on my lower lip.
her legs dont work at all; Guillain-Barré syndrome (GBS); serious nervous system disorder; is paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included The patient was completely healthy women in her 50s.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barré syndrome (GBS)) (serious criteria GSK medically significant), nervous system disorder (Verbatim: serious nervous system disorder) (serious criteria other: serious per reporter) and paralysis (Verbatim: is paralyzed) (serious criteria GSK medically significant). On an unknown date, the patient experienced mobility decreased (Verbatim: her legs dont work at all). The outcome of the guillain barre syndrome, nervous system disorder and paralysis were not recovered/not resolved and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the guillain barre syndrome, nervous system disorder, paralysis and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome, nervous system disorder, paralysis and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient's friend via interactive digital media. The patient got her shingles shot and now (at the time of reporting) had guillain-barre syndrome, a serious nervous system disorder and was paralyzed. The patient's legs did not work at all. The follow-up could not be possible as no contact details were available. The case was linked case US2023AMR050646, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR050646:same reporter - reporter´s case
Immediately felt woozy/queasy which lasted for about 2 hours. Jan. 28 began having minor diarrhea and itchy rash at shot site Jan. 29 continued with diarrhea and itchy rash at shot site Jan 30- heavy diarrhea with rash on arm as well as ribcage Jan 31 lighter diarrhea with rashes persisting
fever of 101; arm hurt/ arm was very sore; bad headache; This is a spontaneous report from a contactable consumer or other non hcp reporting for a patient (son). A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on 22Mar2021 as dose 2 , single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: not reported; expiration date: not reported) administered via unknown route on an unknown date in 2021 as dose 1, single for covid-19 immunization and experienced arm hurt a little bit. On 22Mar2021, the patient experienced arm hurt/ arm was very sore and on 23Mar2021 the patient had fever of 101 and bad headache on an unknown date in Mar2021. Reporter stated that patient had first shot a couple of weeks ago. He was ok, but his arm hurt a little bit and he was fine. Yesterday, his arm hurt about an hour later and was still hurting him. Had a fever of 101 early this morning. Fever went down a little bit. Reporter wanted someone to call her back and let her know what kind of aspirin she should get or should she get Tylenol, Ibuprofen, or Advil. Patient's head hurts now. Reporter further stated it looked like the fever went down and broke. Just has a bad headache and his arm was very sore. The patient underwent lab tests and procedures which included body temperature: 101 on 23Mar2021. The outcome of hurt/ arm was very sore was unknown, the outcome of fever of 101 was recovering and headache was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
A very loud ringing in both of my ears, Tinitis. This loud ringing lasted for about 1 week. Now, 11/25/2009, I still have ringing in my right ear. The ENT doctor said that he had never heard of this type of side effect from the vaccine. I just thought that I would send the info to you just for your records.
Dose was given to patient under the age of 18.  Parents gave us the wrong date of birth.
Patient fainted for <10 seconds after vaccination. patient was in chair. After patient woke up she was given water. observed by pharmacist for 30 minutes. felt okay. denied medical attention.
NOV 13 1430 mild nausea and HA. 1800: chills  2015: shivering, peripheral vasoconstriction, HA, nausea - temp 100.8 p.o. - 2 ibuprofen + 1 Zofran. 2045 chills stopped, veins in hand now visible, temp still 100.8 with HA and nausea. 2115: feeling nice and warm, HA, nausea - temp 101.4!!  NOV 14  0350: woke with worsening HA, gut ache, temp 100.0 p.o.  0400: 1000mg acetaminophen. 0500: HA resolving temp 99.6.  0745: HA resolved, still have gut ache, mild fatigue - temp 97.8 p.o. (my normal)
Soreness, redness, swelling at injection site. Dizziness, fatigue, headache. I slept, took Advil.
Note Text: Resident oxygen was going down to 74% during change of shift 3-11, oxygen initiated 3liters via nasal canula per standing order want up to 84-86% NP notified, ordered Prednisone 20mg stat, Rocephin 1gram IM stat administered, Per NP statement if pt's condition worsening sent him to ER, continue monitoring pt and his oxygen going to 82% increasing distress. Notified Nurses supervisor, 911 was called pt left building at 1819 to Hospital alert oriented. Vs bp. 165/60, temp. 98.3,m pulse 109, res 22, 02. 82%. Resident father notified.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0170), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "bilateral mastectomy", start date: 2008 (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "slightly elevated cholesterol" (unspecified if ongoing), notes: genetic (medicated with rosuvastatin, this was paused during Paxlovid treatment + 2 Days). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with Paxlovid from 04Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300119803 same reporter/patient; different dose/events;
Pt. states she developed redness and swelling to injection site and muscle aches also c/o itching to injection site.
Severe Headaches , Fatigue, Muscle pain , Joint Pain  Two days after there was tightness to my chest, I had to use my inhaler ... Headache lasted for a few days, I had diarrhea..  White blood count was off Vitamin D was low
Slight fever of 100.2, nausea (I did vomit), major body aches, migraine, uncontrollable shaking, soreness at the injection site and lack of sleep (due to the pain in my arm and body aching) all from 1/4 to 1/5 early morning. During the daytime hours of the 1/5, took Tylenol (1,000mg) every 5 hours (or so). Also had nausea (as well as had difficulty wanting to eat because I was nauseous), slight fever of 100, headache (no longer a migraine) and major body aches. Stayed home from work and relaxed on my couch (mostly). Today/currently, on 1/6 at 12:50pm, only symptoms I still have is soreness at injection site (not as sever-more of a discomfort) and slight body ache (not as sever). Last does of Tylenol was taken at 01:30am on 1/6.
my son received the Tdap (the list had too many to choose from, I am unsure of actual one used)  on 6/9/21 around 10:00am approx in one of his arms. I believe right arm.  I would say around dinner time he was complaining of being cold. (5:00pm) My son is hardly ever cold so this was a red flag to me. He didn't want to eat dinner and he started to get a low grade fever. He was sent to bed and woke up middle of the night throwing up and fever of 101 degrees. He was then given Tylenol and went back to bed. Morning came and he threw up again and fever was up to 103 degrees. Still had chills and felt very hot. Tylenol was given and a warm/cool-ish bath was given. I called the ped's office to speak to nurse. Told her his symptoms and she advised if his fever didn't go down with alternating Tylenol and ibuprofen then I should call back and we would discuss the next steps. It started to go down very slowly over a long period of time but went down. This lasted a little over 24+ hours. No longer than 48 hours though.   I just had to take his sister in on 7/6/21 for the remainder of hers and brought this up again to them and was told that they never had seen a reaction to this vaccine like this and that he probably caught a flu or cold bug. I don't believe that. He has been healthy and was only Ill after receiving this vaccine. This is why I am sharing this here and now . thank you for taking the time to read the reaction my son had to this.
Delayed reaction Round, red itchy rash that continues to get bigger each day.  Today is size of my fist, is raised, tender and warm to the touch.
Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient).   A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely 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.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Additional Details: approx 90 min after receiving vaccine patient reported with very slight chest tightness that resolved shortly after. He then began experiencing chest tightness, but no difficulty breathing. Approx 2hrs and 15min after the dose his symptoms are now considered a normal (just slightly sooner than expected).
Hospitalization: 10/4/2022 - 10/9/2022  Presentation to the ED: CHEST PAIN RADIATING TO HIS BACK.  COVID + date: 10/4/22. Treatment: PAXLOVID. Discharge to: HOME.
she had a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (she had a headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 062C20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE (NORVASC) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (she had a headache). At the time of the report, HEADACHE (she had a headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications provided.   This case was linked to MOD-2021-406529 (Patient Link).
Information has been received from a consumer, a male physician who in approximately 9/99 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. Subsequently, "a couple of days after the vaccination," the pt experienced paresthesia down his forearm. One to two days later, the pt experienced achiness in his arm that extended beyond the injection site. The pt is currently experiencing severe pain down the forearm, going into his wrist that has interfered with his ability to sleep. Additionally, the pt is experiencing slight erythema, the area feels warm to the touch and he has an increase in sensitivity at the injection site. The pain is unresponsive to NSAIDS. The physician noted "feel that nurse hit a nerve whien administering the vaccine. Follow-up information received from the pt indicated that "initially thought that this pain was from the placement of the needle during injection, however, he was dx'd by a neurologist with brachial plexus neuropathy and was told that this is from the Pneumovax vaccine and not secondary to the mechanics of the injection." The pt describes the pain as severe and deep seated. The pt is presently being treated with amitriptyline and a steroid dose pack. The pt was instructed not to take any pain killers for the pain. Additional information has been requested.
Weakness and pain in the arm injected, swelling, redness and heat around the injection site that spread around the upper arm and down to the elbow over 2 days. Fatigue and pain.
Unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  the treatment information was Unknown.
fluctuation in blood pressure it was 165/86 bpm; headache; sore arm,; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm,), BLOOD PRESSURE FLUCTUATION (fluctuation in blood pressure it was 165/86 bpm) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm,) and HEADACHE (headache). On 06-Feb-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (fluctuation in blood pressure it was 165/86 bpm). At the time of the report, PAIN IN EXTREMITY (sore arm,), BLOOD PRESSURE FLUCTUATION (fluctuation in blood pressure it was 165/86 bpm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications  are provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Followup information received on 22-APR-2021 added patient doesn't want to do any follow-up as she doesn't have any reactions to the vaccine.
1st shot with red upper arm 2 weeks post vaccine and LN in clavicular area swelled, nerve pain in upper thighs and moved to legs and then abdomen and then red arm came back, after the second shot had fever aches and covid arm again and headache x 2 days after #2. .
This is a spontaneous report from a contactable nurse, via a Pfizer sales representative. A 20-year-old patient of an unspecified ethnicity and gender received TRUMENBA first dose at single dose, and first dose of  influenza vaccine both via an unspecified route of administration on an unspecified date for immunization. Medical history included diabetes mellitus.  The patient's concomitant medications were not reported.  The patient felt sick after receiving the two vaccinations and later developed ketones on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Received Moderna vaccine #1 dose on 12/29/2021 and developed  no s/sx. The site was not healing and got larger and red. It was like a wound, round, raised, itchy and warm.  On 1/6/21 the area scabbed over and was still warm. Employee placed colloidal silver over, which helped her itching. She never had a fever but noticed temp is lower than usual past few days. She had headaches, denies fatigue and muscle aches. Dx is cellulitis On 1/8/21 provider ordered docycycline hylate 100mg PO BID for 10 days. On follow up employee stated that she felt much better.