chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reaction or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored of VAQTA (lot number L013380 and expiration date 04-NOV-2017, lot number L043209 and expiration date 17-SEP-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On day 6 of vaccine woke up with extremely enlarged lymph nodes in axillary region of arm that injection was given.  Day 7 appears about the same maybe slightly larger but very painful with use of that arm.
Approximately 15 minutes post injection, patient complained of nausea, dizziness. Pt became very shaky BP 124/84 HR 123, RR 24 and O2 sat 97%. Pt took 2 salt tabs due to history of POTS, EMS called for evaluation. Pt taken to First Aid via stretcher for further evaluation.
headache; chills; didn't feel well; well. In the evening had a fever of over 100F; could not get warm; "not feeling great in her head"; arm became extremely sore /could barely lift it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm became extremely sore /could barely lift it), HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well) and PYREXIA (well. In the evening had a fever of over 100F) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm became extremely sore /could barely lift it). On 04-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well), PYREXIA (well. In the evening had a fever of over 100F), FEELING COLD (could not get warm) and HEAD DISCOMFORT ("not feeling great in her head"). At the time of the report, PAIN IN EXTREMITY (arm became extremely sore /could barely lift it), HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well), PYREXIA (well. In the evening had a fever of over 100F), FEELING COLD (could not get warm) and HEAD DISCOMFORT ("not feeling great in her head") outcome was unknown.            No relevant concomitant medication was reported.  Treatment details included, acetaminophen.
This case was reported by a health care professional on 16 April 2008.  A 53-year-old female patient received a left upper arm intramuscular injection of Adacel (lot number C2863AA) on 04 April 2008, after sustaining a scratch to the right hand.  Medical history included an iodine allergy; she was not ill at the time of vaccination.  On 10 April 2008 the patient presented to her physician with left arm soreness and swelling at the injection site, and was treated with Keflex four times daily.  On 11 April 2008 she experienced severe chest discomfort, syncope, and shortness of breath, and was airlifted to the hospital.  The patient subsequently recovered; no additional information was provided.  The reporter considered the events to be life-threatening.
I had long term Covid symptoms from early February 2020 to late February 2021 including, intense concussion like brain fog for months, coughing for months, problems with my fingers seizing up and twitching uncontrollably, and extreme exhaustion for months. I had finally started to feel Covid free, except for some problems with my left hand, by end of February 2021. I got the first dose and about 45 minutes or so later the exhaustion came back suddenly - like someone removed all my batteries - and I started having trouble talking, thinking, remembering. Reading and writing work, but talking is difficult. My hands feel swollen and lacking dexterity and strength. I had an odd headache in the middle of the night (on day 2) with some sharp pain that kind of seeped around my scalp. I thought at first I had been stung by a bee and it went away as quickly as it came. But then the pain would suddenly appear on another part of my scalp. There was a tingling/seeping/spreading out feeling just before it would disappear. I woke up the next morning with a more normal headache, took IBU and CBD gummies, ate breakfast and it?s gone. I feel like all I can do is lay in bed and stare at the wall. This is exactly as I felt when I had Covid (though without finger seizures and coughing). I find myself coming to tears with a fear that it won?t ever go away or I?ve brought it on again by getting the vaccine.
watering eyes and horrible taste in my mouth 1st day 5/5/21 today, 5/7/21  severe dry eyes (I had to buy Clear Eyes Maximum strength) and the joints in my fingers are hurting so bad that it's hard to use my hands. Shooting pains. I took 2 more ibuprofen.
This spontaneous case, initially received on 19-Nov-2016, was reported by a non health professional and concerns a(n) female patient. Weight: not provided; Height: not provided. At the time of the event the patient had Haemophilia B. Concomitant medication: Factor IX recombinant (Idelvion). Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for Indication not reported. Dose regimen: Not reported, Route of administration: Unknown. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient developed bleed in leg after flu shot (Medically Significant, outcome: Recovered / Resolved). It was reported that the vials and connection seemed defective (outcome: Recovered / Resolved). Special circumstances: Poor quality drug administered.; Reporter's Comments: Reporter's assessment: The events were considered non-serious. The causality assessment for the event 'bleed in leg' was related as the patient thought that the 'bleed legs' was the result of flu shot.; Sender's Comments: Listedness: Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, bleeding/haemorrhage and product quality issue are unlisted. Causality: Not Related. Patient had underlying bleeding disorder for which he was receiving factor IX. There were issues with administration of this product, which may have resulted in bleeding. Vaccination is considered not causally attributable.
This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, injection site pain, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, injection site pain and headache were recovered/resolved and the outcome of the general body pain was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, injection site pain, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid area. By that same evening, the patient developed flu like symptoms, fever, chills, body aches, pain at injection site and headache. The patient reported these symptoms were lasted for 48 hours and then resolved. This is 1 of 2 cases, reported by the same reporter for same patient.
From initial information received on 6/17/05 from a registered nurse, it was reported that a 17 year old male patient received a dose of Menactra, lot number U1574AA, administered IM in the left deltoid on 6/7/05. Seven days later, on 6/17/05, the patient developed a headache, vomiting, myalgia and a petechial rash over his entire body. The patient was diagnosed with ITP. At the time of this report, the patient had not recovered from these events. (OMIC)
Crohn's disease aggravated; Weight gain; Pain; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4188468-00 (AbbVie).  A 24 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1146119) at cf for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "Weight gain"; CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease aggravated"; PAIN (non-serious), outcome "unknown", described as "Pain"; HEADACHE (non-serious), outcome "recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: weight: gained. The action taken for adalimumab was unknown.  Causality Assessments: Headache assessed related and weight gain, crohn's disease aggravated, pain, assessed to not reported to BNT162B2. Since no determination has been received for events weight gain, crohn's disease aggravated and pain, the events are managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events weight gain, crohn's disease aggravated, pain and headache with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Patient had Pfizer vaccine #2 on April 22, 2021, at pharmacy.  He presents to the office today with fairly sudden left facial droop that started around noon today, April 28, 2021.  He has normal vision, normal hearing, and has incomplete paralysis of the left face (partially able to close eye).
symptoms began within 24 hours of injection in order of onset: general muscle soreness, flu like symptoms (tired, achy, felt fever like but no fever), loss of appetite, fatigue two days after injection:  above symptoms resolved. Pain, swelling, and soreness in left armpit. Same arm as injection.
C-reactive protein and Comprehensive metabolic panel with date 04Jan2022 result high; C-reactive protein and Comprehensive metabolic panel with date 04Jan2022 result high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: ER8727), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose1, Single, Anatomical Site of Injection: Left arm, Batch /Lot Number: EN6207), administration date: 11Mar2021, for COVID-19 Immunization. The following information was reported: C-REACTIVE PROTEIN INCREASED (disability), METABOLIC FUNCTION TEST ABNORMAL (disability) all with onset 04Jan2022, outcome "not recovered" and all described as "C-reactive protein and Comprehensive metabolic panel with date 04Jan2022 result high". The events "c-reactive protein and comprehensive metabolic panel with date 04jan2022 result high" required physician office visit. The patient underwent the following laboratory tests and procedures: C-reactive protein: (04Jan2022) High, notes: Rheumatologist ordered several tests; Metabolic function test: (04Jan2022) High, notes: Rheumatologist ordered several tests. Therapeutic measures were taken as a result of c-reactive protein increased, metabolic function test abnormal. Clinical course: Vaccination Facility Type: Pharmacy or Drug Store. Patient was seeing a rheumatologist and taking medications. Patient denied for taking any prior vaccinations. Patient had no family history of rheumatoid arthritis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300036627 same patient, different dose/event.;
receiving doses from vials affected by a temperature excursion; receiving doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022 at 6:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2022 at 6:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reportedly, 20 patients received doses from the lot number affected by a temperature excursion as their freezer went out of range. Patient received half dose. Vail number reported as 4. No adverse event occurred at time of administration or were reported thereafter. No treatment information was provided.
Asthma exacerbation. Difficulty breathing, dyspnea at rest, chest pressure and chest congestion, feeling of throat closing up. Symptoms started approximately 36hrs after vaccine was given. Was taking albuterol inhaler every 4hrs. After 1 week of no improvement, was treated with PO prednisone and a new long-acting, everyday inhaler.
patient received Moderna vaccine on 3/3/21 and received Pfizer vaccine on 3/27 by mistake  no symptoms reported
feeling horrible; hold on a second I'm going to go throw up; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling horrible) and VOMITING (hold on a second I'm going to go throw up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (feeling horrible) and VOMITING (hold on a second I'm going to go throw up). At the time of the report, FEELING ABNORMAL (feeling horrible) and VOMITING (hold on a second I'm going to go throw up) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Sore throat & ear, tickling throat, weakness, body felt heavy, sore all over, more difficult to breathe, slight chill, coughing.  I have had flu shots for past 3-4 years & NEVER had this reaction.  Took Benadryl & Robitussin.
Immediately after shot, arm began to get sore.  Soreness has continued to increase in severity.  Arm is swollen. Pt can not move arm above shoulder level.
Information has been received from a physician concerning a 10-year-old male with no pertinent medical history or allergies who on 06-FEB-1997 was vaccinated SC with a 0.5 mL dose of Varivax. There was no concomitant therapy. The physician reported that on 10-MAY-2006, the patient developed six chickenpox on his trunk. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the patient was recovering from the chickenpox. Additional information has been requested.
Periodic abdominal pain (10-15 minute intervals), lasting 20-30 minutes, with 2 episodes of watery stool, no vomiting. Symptoms lasting for 2 hrs, x2 days.
C/O headache 45 mins after receiving Hep B vaccine. Continued thru evening. Vomited 6x. Called ER. Nurse told her she had an adverse reaction to Hep B vaccine. Took Tylenol which did not help. Vaccine given at 1:45pm 07/08/02.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th January 2023, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 6th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 06-JAN-2023 Reporter's Comments: The patient received the first dose of Twinrix on 6th January 2023, yet the dose expired on 1st January 2023. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Twinrix, which led to expired vaccine used.
Severe chills which result in violent shivering, On-and-off fever, severe joint and muscle pain, headache, hives on left side of face, tenderness at injection site, sleeplessness (though that could also be a result of not being able to sleep due to the symptoms I'm experiencing)
Two days after I received the shot I had a headache and cold chills.  Then I started to notice red blots on my stomach and my neck was itchy.  Over the course of the next week, I now have several hives on my neck, a few on my lower back and about 20 from my stomach up to my armpits. Most of them are on or around my breasts.
Patient was accidentally injected with a used syringe & needle previously used to administer Flulaval to her daughter, needle was immediately removed & disposed in Sharps container, no immediate reprocussions, no adverse effects or events reported by patient at 48 hours and 96 hours post injection.
Blurred vision and inability to read things up close. Now require glasses in order to function.  Significant worsening of vision rapidly after receiving the vaccine.
I received my second dose on 4/24/21.  On 4/29/21 I had a required annual EKG.  The test indicated abnormal (inverted) T waves.  This was very uncharacteristic.  The abnormal EKG triggered a nuclear stress test and echocardiogram, conducted several weeks later.  All normal.  I'm fit and active for may age and in otherwise good health.  I had an additional issue on the same date as the abnormal EKG.  Foot pain and swelling in the right foot, and four weeks later, the left foot.  The rheumatologist's diagnosis is gout with appropriate treatment plan, but tests are inconclusive.
Varicella vaccine breakthrough.  Seen in office on 03/03/2006 and 03/06/2006 and diagnosed with Varicella.  Had 20 lesions- erythematous with no vesicles.  Rash dry with papules.  No fever.
Pt recv vax on 4/10/98; on same day pt exp red/ pain vax x 2 days, inflamed vax site x 30 mins
sore arm at the sight of injection 1/6/2021 Next day a red area about the size of a fifty cent piece1/7/2021 on that fri 1/8/2021 red area still there but not as sore O'Day 3 . 1/9/2021 sorness gone. Redness  gone. For from that day up until February  4th.no other symptoms.  I take 2nd dose on 2/5/2021
Information has been received from a nurse practitioner concerning a 6 year old female patient who was vaccinated with a second dose of VARIVAX (Oka/Merck) (dose, route, and date not reported) and developed a severe injection site reaction the same day. The patient developed a knot underneath the skin at the injection site and the site was red and warm to the touch. The patient sought unspecified medical attention. There was no fever and the adverse reaction resolved within 48 hours. The patient took over the counter ibuprofen. The patient had no reaction following the first dose of VARIVAX (Oka/Merck). No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. On 20-JUN-2014 the patient was inadvertently administered VARIVAX (0.5 ml, subcutaneous, lot# and expiry date were not reported) and PROQUAD (0.5 ml, subcutaneous, lot# and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (30Jun2022) Negative; (01Jul2022) Negative, notes: Days 6-11 testing negative; (03Jul2022) Negative; (04Jul2022) Negative; (05Jul2022) Negative; (06Jul2022) Negative; (08Jul2022) Positive, notes: testing strong positive both rapid and PCR; (08Jul2022) positive, notes: testing strong positive both rapid and PCR; (07Jul2022) Positive, notes: testing strong positive both rapid and PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Patient received treatment with Paxlovid  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Less than 10 minutes after the shot, patient reported a "Sore throat" but did not have any difficulty breathing and did not have any swelling of the mouth or tongue. Patient took two diphenhydramine 25 mg capsules about 10 minutes after the injection, and rested. She left the store around 10:25 AM about 30 minutes after the shot, and did not have any changes but continued to complain of a sore throat.
pt reported got very sick in Africa-fainted, had no appetite, had to cancel portion of trip;got home stayed in bed x3 days then took self to hosp; pt states that MD told her she had liver damage from  from hep vax;
Emesis x 4 (1/2 day) after shot (approx 12 hrs later) "Burning" mid arm area, nontender abdomen, hyper BS began 10 mins after shot. Side affect vs. acute gastroenteritis. Second admission in 72 hrs with AGE over last 2 wks. Fluids, phenergan, 24 hr quarters with 48 hrs light duty / rest?.
Itching, swelling and pain at injection site occurring at approximately third day after administration. Patient was advised to use Benadryl and cold compresses.