chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17AUG92 woke up fr nap w/elevated fever; pt recvd APAP & cool aid-pt vomited @ 6PM; mom noticed eyes looked like rolled back in head; t103ax; called MD was told to keep pt cool & watch; pt would jump,jolting, unresponsive, sz; febrile seizu
Pt. developed swelling & pain on left side of neck 24-48 hrs. after getting flu shot. She also had itching & a rash. It went away after a week.
pt recvd vax & devel thrombocytopenic purpura; It was noted that the pt was on multiple other medications; No further details were provided;
Patient developed abdominal pain about 3 weeks after her first covid vaccine. Her pain continued, progressed and eventually she got admitted to the hospital  and diagnosed with a superior mesenteric vein thrombosis 8.14.2021
I received the flu shot on my left arm and it become very painful. I am having trouble lifting it at the shoulder and the pain is in my bicep and down my arm. The shot did not hurt me and the pain I am feeling is not in the injection site.I called my pharmacist twice to ask him about this and he told me it should go away and to take Advil. It has not gone away. I am having trouble sleeping because of the pain.
Sharp pain in the underarm area; Sharp pain in the neck where the trap muscle is; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 at 17:00 (Lot number: FD0809) at the age of 24 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER2613, Anatomical location: Arm Left, Administration Time: 10:00, Route of administration: Unspecified), administration date: 18Mar2021, when the patient was 23 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0151, Anatomical location: Arm Left, Administration Time: 11:45, Route of administration: Unspecified), administration date: 13Apr2021, when the patient was 23 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 at 17:00, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious) with onset 14Dec2021 at 09:00, outcome "recovering", described as "Sharp pain in the underarm area"; NECK PAIN (non-serious) with onset 14Dec2021 at 09:00, outcome "recovering", described as "Sharp pain in the neck where the trap muscle is". Therapeutic measures were not taken as a result of axillary pain and neck pain. Additional information: It was reported that patient had researched it and it said lymph nodes could be a cause, the supraclavicular and axillary lymph nodes. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tingling in arms and lips burning/numb, no difficulty breathing was monitored in store for 1 hour, no epipen needed, advised to take benadryl
Trigger thumb; This spontaneous case was reported by a patient and describes the occurrence of TRIGGER FINGER (Trigger thumb) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    It was reported that patient had no history of COVID diagnosis. It was also reported that patient did receive other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Trigger thumb (had for 30-40 yrs ago).   On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient received dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRIGGER FINGER (Trigger thumb). The patient was treated with IBUPROFEN in February 2023 at an unspecified dose and frequency. At the time of the report, TRIGGER FINGER (Trigger thumb) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that patient was a recipient of all Moderna vaccine and was supposed to receive second bivalent dose. Patient received Shingrix vaccine 2 to 3 weeks ago.  It was also reported that the previous condition of trigger thumb which was almost completely resolved was triggered with another episode due to use of iPhone and editing pictures. Patient saw the doctor on 10-Feb-2023 and took ibuprofen which continued on 24-Feb-2023 too. Four weeks ago on 24-Mar-2023, patient received steroid injection in the tendon surrounding the thumb.
Starting on day 10 - delayed skin reaction described online as "covid arm": spreading, hot, itchy, bright red rash which covered the top of the right arm near the injection site and decreased once started topical steroid cream and benedryl.  By day 17 gone.
Patient started 5/1 4 days after shot with sweating aches chills headache nausea fatigue and has lasted for 48 hours also low fever.
It started out with extreme fatigue, nasal congestion, deep cough, headache, and sore throat. I tested positive for COVID-19 at home. I talked to my doctor on the phone, and she prescribed me PAXLOVID. I start to feel better and then I get sick again.
The lymph nodes in left armpit and surrounding areas became swollen, achy, and tender to the touch; The lymph nodes in left armpit and surrounding areas became swollen, achy, and tender to the touch; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0173) via an unspecified route of administration in the left arm on 05May2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity (body mass index (BMI) was 35). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medication included spironolactone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 23:45, roughly 36 hours after the second dose of vaccination (roughly midnight on Thursday, 06May2021), the patient's lymph nodes in her left armpit and surrounding areas became swollen, achy and tender to the touch. The swollen area included the entire armpit and upper portion of the bicep. It was reported that the swelling did not began to decrease for over 48 hours after it began (until Sunday, 09May2021). It was reported that even once swelling reduced, the area was tender to the touch for several more days. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events the lymph nodes in left armpit and surrounding areas became swollen, achy, and tender to the touch was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number Z3YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix 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: 19-APR-2022 Reporter's Comments: An expired dose of pediarix  was given to the patient. The reporter consented to follow up. Additional Supportive Information:  The patient received vaccine after it's expiry date, which led to expired vaccine used. This is one of three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066910:Same reporter US-GLAXOSMITHKLINE-US2022066911:Same reporter
12/29 Pain + swelling at injection site, nausea, headache, muscle and joint pain, fever  12/30 Pain + swelling at injection site, muscle and joint pain  12/31 Pain at injection site 1/1 No symptoms
Patient was administered flublok on 12/1 had sore arm that night, noticed redness, swelling  and "heat" from injection site. Patient started using cold compresses. Patient presented at pharmacy on 12/4 and showed pharmacy a picture of her arm on 12/1 and her physical arm on 12/4 . Redness and swelling looks better but still tender per patient. Patient has dr's visit on 12/5 in AM.
On my injection site I have a swollen lymph node by my collar bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EN6204) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XARELTO. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Mar2021, outcome "unknown", described as "On my injection site I have a swollen lymph node by my collar bone".  Additional information: Consumer stated, "On my injection site I have a swollen lymph node by my collar bone (Clarification unknown) and I looked it up and it says it is common. My question is should I get the second shot when it comes up? Should I take the second shot if it is still swollen?"  No follow-up attempts are possible. No further information is expected.
Arm started hurting really bad after about 5 hours of receiving my 2nd dose. By the next day it was extremely red and hot in the injection spot. Over the course of the next few days it started to move down my arm and was still extremely hot. The redness started to grow rapidly and my arm was swollen. After 6 days it was just getting worse so I went to my PCP and she prescribed me Cephalexin 500 3x per day and told me to take 50mg of Benadryl at bedtime.
I started having chest pains within approx. 10 minutes. Four Doctors came in and told me I wasn't having chest pains, I must just be nervous from receiving an injection.  I was sent home.  I really thought I was going to die that night.  I was EXTREMELY thirsty, I had overall weakness, EXTREME muscle weakness, chest pain, nausea and felt like fainting, and felt hot, not like a fever just hot.  I felt really bad for months after that, in Feb of 09, my legs stopped working, my bowels stopped working and my arms became clumsy and hard to use. Also general extreme fatigue. Eventually I regained use of my arms and legs.  My bowels function with stool softeners and extra fiber pills.  I am in pain constantly, it just varies on the level of pain.  The pain is all over my body but is usually worse in my legs.  Sometimes a spot will hurt real bad, then a lump will come and sometimes bruising.  Sometimes I have a firestorm of pain, it will shoot all over my body in different spots and even my skin will hurt. ` `` DC summaries received 12/15/09 for dates 3/23/09 to 3/25/09 and 3/26/09 to 3/27/09. DX: Noncardiac, gastritis, hypothyroidism. CC: pt was transferred from another ER w/ c/o severe chest pain. Pt states was followed by cardiologist but was not pleased with the care received. All previous cardiac workups were WNL. Pt had cardiac cath performed which was WNL. Pt later expressed concern for PE and DVT, both evals were WNL. Unknown etiology of chest pain, cardiac condition has been r/o. DX: for 3/26 to 3/27  Syncope. CC: Pt states sx started last fall after the flu vax, with HA, chest pain. Upon this visit pt passed out while signing into ER. Pt states worsening of sx. Unable to find etiology of pt symptoms.
Severe sore throat radiating to the right ear during swallowing  With tender thyroid on palpation the symptoms are not regressing till now
Rash on hands and legs; itching.  Swelling to knees started about 3 days after injection.
fever day p/inj in pt which resolved in 24hrs;5 days later devel stiff neck;concerned because used WV instead of SV;neck stiffness is getting better;no other details expected;
got very sore reaction from the vaccine/it hurts a lot; got very sore reaction from the vaccine/it hurts a lot; She cannot put her arm by her ear without excruciating pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "got very sore reaction from the vaccine/it hurts a lot"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious), outcome "unknown", described as "She cannot put her arm by her ear without excruciating pain".  Additional information: Patient got very sore reaction from the vaccine. She mentions that it hurts a lot. She cannot put her arm by her ear without excruciating pain. She is wondering if she needs to put a cold pack or a warm pack. Patient was wondering if she can go get Botox (Dysport) on her face, does it have a contraindication with he vaccine, does she have to wait some days and asking information regarding the use of the Pfizer-BioNTech COVID-19 Vaccine in people who have cosmetic fillers or Botox.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2022 at 12:22 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Feb-2022 at 12:22 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 19 Feb 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient received second dose vaccination time was given as 12.22.23. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24 Dec 2021. This vaccine was administered up until its manufacturing expiry date of 04 Apr 2022. Treatment medications were not reported.   This case was linked to MOD-2022-542869 (Patient Link).
Redness at the injection site and hot to touch. Dr gave Cephalexin 500 mg.
sore arm the next day; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Feb2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing); "Autoimmune disease" (unspecified if ongoing); "meniere's diseas" (unspecified if ongoing); "Polypharmacy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: EL0142), administration date: 12Jan2021, for COVID-19 immunization, reaction(s): "arm pain", "fatigue", "malaise", "Periodic migraine headaches", "Increased ringing of affected ear". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Feb2021, outcome "unknown", described as "sore arm the next day".  Additional Information: It was reported that, the next day (13Jan2021) followed by vaccination dose 1 of BNT162B2 patient experienced fatigue and malaise for 7 days. On 08Aug2021, patient received booster dose of Pfizer lot # FC 3180.  No follow-up attempts are possible. No further information is expected.
Vaccine administered BUD (on day 32); Vaccine administered BUD (on day 32); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vaccine administered BUD (on day 32)) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vaccine administered BUD (on day 32)). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) and PRODUCT STORAGE ERROR (Vaccine administered BUD (on day 32)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No Treatment medications were reported  Reporter was office manager.  Reporter wanted to hear from Moderna for instructions about what to do with the 8 patients who received a dose from a vial that was stored refrigerated for more than 30 days. Vial was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit. HCP provided identifiers for all 8 patients. All patients were given their second dose, except for the last one that received their first dose. Patient didn't show signs of any side effect.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Suspect dosing details updated
Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection site soreness, fatigue, slight mental fog.
Dermatographia that started 15 days after the third covid vaccine (the booster). Has been ongoing.
6/7 hours after vaccine- chills, fever (100.8), very weak *Felt miserable and restless, radiating heat in body *Trouble sleeping *Small pinpricks of pain in different parts of body *Muscle soreness *Blood seemed to be throbbing *Nausea in morning, but ate crackers (so did not throw up like after flu vaccine) *Skin more sensitive than normal (when shaving and when bumped foot into wall accidentally)  Next day (6/2)- no energy, easily overexerted; had to sit down after standing, like in shower 6/3- light-headedness after eating chocolate products 6/4- light-headedness, blood appeared to be pooling in legs some when standing (legs would turn red) *Blood still feels weird 6/5- Pinprick feeling in parts of body, still feeling weak during the day 6/6- Weak feeling/headache (stamina is bad still), veins look more red than usual (existing spider veins) 6/7- Feel much better, still feeling rough in the morning when I wake up  (Monitored own symptoms, but need not need to go to Dr. or hospital)
5 min after MMR administration pt developed red patches on right thigh. BENADRYL administered. Rash improved 15 min after BENADRYL administration. F/u call on 6/27/12 (the next day) pt doing fine and rash resolved per mother.