chrisvoncsefalvay/vaers-outcomes huggingface dataset:
general pains around her heart; injection site pain in the left arm /injection site on her left arm is still painful; general pains down the left side of her neck; general pains on her left shoulder; General pain down her left arm /Arm pain; This case was reported by a consumer via call center representative and described the occurrence of cardiac pain in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (diagnosed at the of age 50). Concomitant products included tramadol.   On 12th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced cardiac pain (serious criteria GSK medically significant), injection site pain, neck pain, shoulder pain and pain in arm. The patient was treated with ambiguous medication nos (Neurontin (Nos)). On an unknown date, the outcome of the cardiac pain, injection site pain, neck pain, shoulder pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the cardiac pain, injection site pain, neck pain, shoulder pain and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left arm. The patient reported that the Shingrix shot was the most painful vaccine she had received. The patient reported that within 3 to 4 days of receiving the first dose of the Shingrix vaccine, she began to experienced general pains around her heart, down the left side of her neck, on her left shoulder, and down her left arm. The patient went to her neurologist and was prescribed Neurontin.  The patient said that symptoms now come and go but he injection site on her left arm was still painful. During the call patient said she had pain around her heart. The patient felt that these symptoms were due to how the product was administered to her, not due to the product itself. The patient did not elaborate further. The reporter consented to follow up.
Very large, red area, swollen and hot to the touch, starting 3 days, post vax to 1 week, post vax. Treated with ice, Motrin and Benadryl.
Pt vaccinated with DTP/OPV/HIB developed temp, crying constantly, local rx X 3-4 days. Rx Advil (Ibuprohen); saw neurologist.
From shoulder to elbow swelling with itching around injection site appeared 7 days days after 2nd shot of Moderna
Patient reports having felt feverish and sweating, followed by pain in the shoulder area which has since abated. She then developed diarrhea which lasted for approximately 3-4 days, and a rash near the injection site. Rash is still present currently, 5 days after the injection. Patient states will visit her doctor to follow up on Monday, 11/25/19.
I have had hives on my thighs and shoulders everyday since I had the second vaccine. some days they are worse than others. they have continued to be present up to and including today. I have treated them myself
peed the bed and on second day the patient had entire bladder leaks; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via unspecified route of administration in the left arm on 24Mar2021 at 08:45 am (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN) used for unknown indication. On 25Mar2021 at 00:00 (on first night of the vaccination), the patient peed the bed and on second day the patient had entire bladder leaks. The patient did not receive treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event was not resolved.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event description and vaccination facility information updated.
11/3/21 booster vaccine received half dose: more severe headache lasting til stroke on Sunday, 11/07/2021; mild fever first day or two after booster, body aches at least Wednesday, 11/03/2021 to Saturday, 11/06/2021. Numbness and tingling in tip, lateral border and dorsal surface of tongue, maxillary and mandibular lips, hard palate, all on the left side beginning at 3:47PM, Sunday 11/07/2021. Numbness also in pads of fingers, left hand. Did have mild tingling in face on left, and post-auricular on left side as well. Taken by EMTs to Medical Center. Had CT, CTA, MRI BLOODWORK, EKG, ECCHOCARDIOGRAM. Diagnosis: stroke, Treatment: PLAVIX (300 mg, THEN 75 MG DAILY), 21 DAY  Adverse event Continued Crestor 30mg daily beginning 11/08/2021 also instructed by neurologist to take 81 mg aspirin in addition to the 2 other medications. Discharged Tuesday 11/9/2021 Cardiologist and neurologist in private practice. Followed up with specialist within days of event. CONTINUE TO HAVE NUMBNESS IN THE SAME LOCATIONS ON LEFT TIPS, TONGUE, HARD PALATE AND SEVERAL TIPS, DIFFERENT TYPE OF HEADACHES SINCE STROKE SINCE STROKE EXTREME FATIGUE. Records available from hospital.
Redness, soreness, inflammation at inj. site. Patient received a Z-pak for treatment.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2011-12 season) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza vaccine unspecified 2011-12 season. On an unknown date, less than a year after receiving Influenza vaccine unspecified 2011-12 season, the patient experienced injection site pain. Rechallenge with Influenza vaccine unspecified 2011-12 season was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine unspecified 2011-12 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 7 of the 9 cases reported by the same reporter for the same patient.
since the vaccine pt has been experiencing tingling in arms, hands and body. she also reported having weakness and episodes of vomitting.  recommended pt follow up with prescriber
fast heart beat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (fast heart beat) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (fast heart beat). At the time of the report, HEART RATE INCREASED (fast heart beat) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.    Reporter did not allow further contact
Information has been received from a pharmacist, concerning her 21 year old daughter with an allergy to animals, who was vaccinated IM (date not reported), with the first dose of Gardasil (lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 13-NOV-2007 and after the first vaccination (time duration to onset not indicated), her daughter developed a runny nose, followed by dizziness, balance problems and impaired vision. Her daughter missed classes due to the dizziness. She visited the physician's office, and was diagnosed with an infection of the 8th cranial nerve. A diagnostic magnetic resonance imaging (MRI) of the head was negative. At the time of this report, the pharmacist's daughter was recovering from the events. The pharmacist considered the events to be disabling/incapacitating, due to the associated dizziness. Additional information has been requested.
This spontaneous report as received from a licensed nurse practitioner refers to a 15 year old female patient experienced inappropriate schedule of vaccine administration. On 21-AUG-2008 the patient was vaccinated with 1st dose GARDASIL. On 08-DEC-2011 the patient was vaccinated with 2nd dose GARDASIL. On 17-FEB-2012 the patient was vaccinated with 3rd dose GARDASIL. No adverse event reported. Additional information is not expected.
Patient received a lower dose than what is recommended for dose 2 in a primary COVID vaccine series.  He received the Moderna Bivalent Booster vaccine for 6mon-5yrs, which is a lower dose than the Moderna Bivalent vaccine for 6mon and older (Primary series).  Therefore, patient received a lower dose than recommended.
after recv vax temp 102, shaking all over, lt leg knotted up, high pitched scream, cried all night
Patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 25th May 2022, the patient received Havrix. On 25th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The medical assistant supervisor reported that the patient received an expired Havrix dose. The reporter consented to follow up by email. Additional Supportive Information: The patient received Havrix which was already expired which led to expired vaccine used.
Breakthrough case after three vaccines: Moderna 4/6/2021 batch/lot# 026B21A; Moderna 5/4/2021 batch/lot# 024C21A; Moderna 11/8/2021 batch/lot# 939906.
After pt's shot,  patient was standing while waiting for family member to get a shot. Patient at first was short of breath and felt faint and dizzy. Eventually fainted and fell. May have hit head on wall. Pt was put in a chair and given a granola bar and apple juice. Seemed to make a recovery after 15 minutes
1) Dried blood in upper nostrils for 5-7 days noticeable 12/24/2020   2)Loss of smell from 12/24/2020 ongoing since then with mild congestion 3)Local effects-  swelling and mild pain at the site of injection for 24 hours after 2nd vaccine on 1/11/2021 4)Fatigue for 24 hours  after  2nd vaccine on 1/11/2021 5)3 short episodes of dizziness since 2nd vaccine on 1/11/2021
2 sores on the face appeared. 1 presented itself lateral to the lips & the other was inferior to the lips. 1 centimeter in diameter by 1.5 centimeters in length. Have not disappeared for 7 days now. Child has had no prior medical conditions including but not limited to the skin.
Client started to feel nauseous and light headed after receiving vaccines.  Client found sitting on floor in bathroom with parent, client was brought back into clinical suite.  Vitals were within normal parameters (BP = 106/68, temp = 97.6, pulse = 78).  Client was given water to drink and allowed to rest for 15 minutes.  Client stated that he was fine after the 15minutes and left with his parent.
Initial information received from a health care professional on 22 October 2012. A female patient whose age, medical history and concomitant medications were not reported was MA at facility and upon administration of FLUZONE (Lot no: U4544EA) did not see barrel flange was broken with rough edge exposed. She administered vaccine to patient however when pushing on plunger rod cut her finger on broken barrel flange and there was "small cut" which did not need stitches. Laboratory details and corrective treatment were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Cough; Fever; Chills; Headache; Bodyache; This spontaneous case was reported by a pharmacist and describes the occurrence of COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache). At the time of the report, COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.     This case was linked to MOD-2021-208905.
Vaccine administered on 3/6/2021. On 3/8/21, symptoms of small fiber polyneuropathy greatly amplified and continue to present.  On 3/12/2021, woke up with left side of face feeling slightly swollen extending from jaw up through eyelid-appearance unchanged, no loss of facial muscle control; sensation still present-has not improved or worsened. This symptom has not been a symptom previously experienced as part of the small fiber polyneuropathy. On 3/14/2021, woke up with upper and lower gums feeling slightly swollen across entire expanse (left and right);  sensation still present-has not improved or worsened. This symptom has not been a symptom previously experienced as part of the small fiber polyneuropathy.
Information has been received from a registered nurse concerning a 34 week old patient who on 23-MAR-2007, 29-MAY-2007 and 19-SEP-2007 was vaccinated PO with the first, second and third dose of Rotateq.  At 34 weeks old the patient was administered the third dose.  No adverse experience was related to this event.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Immediate numbness/tingling in left arm and left hand and both feet.  Left arm/hand  symptoms lasted ~15 minutes.  Symptoms in both feet lasted 5-6 hours and continue intermittently.
Treatment of COVID-19; Treatment of COVID-19; 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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Dec2021 as dose 3 (booster), single (Lot number: FJ8757) 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: "Asthma" (unspecified if ongoing); "Thrombocytopenia" (unspecified if ongoing); "known allergies: mango" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Sep2018; THORNE, start date: Sep2022; NORDIC NATURALS DHA, start date: Sep2022. Past drug history included: Ceclor, reaction(s): "known allergies: Ceclor". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Negative, notes: negative test 4 days after final dose of Paxlovid; (Feb2023) Positive, notes: positive COVID-19 test 7 days after final dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Pt reports she developed a severe infection at the injection site beginning a few days after the vaccination. She had severe swelling and redness and temperature over 102 degrees. She sought care for this reaction from another physician whose name she would not provide. On 10/26 she still had swelling, pain and superficial erythema x 3 cm.
Expired Vaccine Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Havrix and Havrix 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 detaails were provided as follows: The patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up.
really felt down and out; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (really felt down and out) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced FEELING ABNORMAL (really felt down and out). At the time of the report, FEELING ABNORMAL (really felt down and out) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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.   No concomitant medication were reported.  Dosage text was reported as Unknown. The caller reported that she has one friend who received her Moderna Covid-19 vaccines and really felt down and out after receiving Moderna Covid-19 vaccines. No treatment information was provided by the reporter.
Patient 12 years of age or older who received the original mRNA formulation (aka monovalent formulation) as a booster dose. Due to the FDA's abrupt revision of booster recommendations means that administering the monovalent to individuals 12 years of age or older is considered a medication error as of 8/31/2022 and been advised that a VAERS be completed.
Red patch developed on 02/25/2021 at injection site (approx. 2? across) warm to touch and occasional slight itch.   Used cold compress twice to ease down.   On 02/26/2021 -  Red patch increased in size to 3? across and still warm to the touch.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe
Feeling fatigued, stuffy nose, nasal drainage, sneezing, fever 101, cough. On 10/18 went to Dr. Placed on Prednisone and Amoxicillin.
I was diagnosed with oral and genital herpes; I was diagnosed with oral and genital herpes; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EL9269) (at the age of 42-years-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant. The patient's concomitant medications were not reported. There were no other vaccines received in four weeks. The patient previously took droperidol and experienced allergy; nortriptyline and experienced allergy. The patient was not diagnosed with COVID prior to vaccination. The patient was diagnosed with oral and genital herpes on 08Mar2021, which was a complete shock to the patient. The patient stated that it's some kind of side effect to the vaccine. The events required a visit to the doctor's clinic. The event was treated with an unspecified medication. The reporter considered the event as serious (disability). The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 20Mar2021. The outcome of the events was recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
Patient presents to clinic for symptoms of illness which began 5/5. She received her second Moderna vaccine around 6:00 pm on 5/5. Late evening into early morning on 5/6 patient developed nasal congestion which has worsened over the last several days. She also reports watery eyes, post nasal drip, scratchy throat, headache, sensation of fullness in ears, low grade fever with tmax 100, chills, and malaise. She feels that her symptoms have peaked today. OTC medications include advil cold and flu which has not helped with symptoms Pain with headache 6/10 currently, has not taken anything today.   Patient was treated for upper respiratory infection with cough and congestion.  Symptoms likely due to viral infection. At this time supportive care is recommended. This includes drinking plenty of fluids, rest, and continuing to monitor symptoms at home. You may take Tylenol for your headache, decreasing pain level should help reduce BP. Monitor BP closely at home. Do not use decongestants as they may increase your BP. You may take a product approved for HTN patients ie Coricidin.   Patient was advised of the following quarantine instructions:  There are multiple viral infections that could be causing your symptoms. However, due to the current global pandemic with COVID-19 and increase in community spread, it is in your best interest to self-quarantine. It is recommended to return after 10 days since symptoms first appeared AND 24 hours with no fever without the use of fever reducing medications AND COVID-19 symptoms have improved.  A test-based strategy is no longer recommended to determine when to discontinue home isolation, except in certain circumstances. Only follow up in the ER if you are in respiratory distress or your fever continues to elevate. In order to protect your family, you need to stay as isolated as possible within your house, ideally in your own room. You can take Tylenol to help lower your fever, drink plenty of fluids, and get rest until your immune system fights off the virus.  For more information, please visit www.cdc.gov  Guidance provided from https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/end-home-isolation.html.