chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of local swelling in a female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local swelling, extremities hot feeling of, pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the local swelling, extremities hot feeling of, pain in arm, erythema of extremities and swelling arm were recovered/resolved. It was unknown if the reporter considered the local swelling, extremities hot feeling of, pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who was a nurse. The age at vaccination was not reported. For about 1 week following SHINGRIX vaccination (timing unknown), the patient had a large lump which travelled down her arm with pain, redness, swelling, and heat, which had fully resolved. The GlaxoSmithKline account manager did not have lot number or expiry date for vaccine.
Severe chest pain (severe weight on chest); Night sweats after second shot; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Severe chest pain (severe weight on chest)) and NIGHT SWEATS (Night sweats after second shot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL, LEVOTHYROXINE, VITAMIN C [ASCORBIC ACID], MAGNESIUM, CALCIUM and MELATONIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CHEST PAIN (Severe chest pain (severe weight on chest)) and NIGHT SWEATS (Night sweats after second shot). On 14-Mar-2021, NIGHT SWEATS (Night sweats after second shot) had resolved. On 15-Mar-2021, CHEST PAIN (Severe chest pain (severe weight on chest)) had resolved.            Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-045999 (Patient Link).
Patient came to HD on 09/02/2021 for a booster dose of Moderna vaccine. She did not mark that she was immunocompromised on her COVID pre vaccine questionnaire. As such, she was given her Moderna booster dose. She called HD today to inform us that her physician said she needs an immunocompromised Moderna dose due to her congenital heart condition. She was given her immunocompromised full dose today. She has not had any adverse events post COVID vaccine in the past. She was informed her CDC guidance that she can now get her official "booster" dose 5 months after today, but that the guidance may be changing to 3 months post 3rd dose. I am writing this to officially say that the booster dose was given in error even though we did not know it at the time.
BURNING IN THE AREA, SWOLLEN, RED AND WARM TO TOUCH.  SWELLING SPREAD TO SIZE OF A HAND. LASTED ABOUT 3 WEEKS.
This spontaneous report as received from a physician as part of a marketing research program conducted by agency refers to a 65 year old female patient. Patient's medical history and concurrent conditions were not reported. In approximately August 2013, reported as two years ago, after the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot No. were not informed) for prevention of shingles but she developed shingles about 1-2 weeks later, approximately in August 2013. Concomitant medications were not described. At the time of this report, the outcome of the event mentioned above was recovered (also reported as not recovered-conflicting information). The reporter physician considered the event to be related to ZOSTAVAX. Additional information is not expected as reporter did not provide consent for follow up.
pt recvd vax 1FEB94 1PM & on same day 6PM pt became very fussy 5 hrs later, t101 ax, constant crying lasted x 4 hrs & temp was 103 ax; remained very fussy, @ intervals throught the noc; devel cough & dyspnea 28 hrs later, seen by MD in ER;
I received my second dose of the moderna vaccine on 1/20/21.  I tested positive for covid on 4/14. I have mild symptoms.  My youngest daughter also tested positive for covidZ.
hospitalized with clotting/clot; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (hospitalized with clotting/clot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder NOS.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (hospitalized with clotting/clot) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (hospitalized with clotting/clot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Concomitant medications and Treatment information was not provided.  Company Comment: This case concerns a female of unknown age who experienced thrombosis after receiving second dose of the Modern Covid 19 vaccine. Medical history of blood disorder is a confounder. Dechallenge was not applicable and Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a female of unknown age who experienced thrombosis after receiving second dose of the Modern Covid 19 vaccine. Medical history of blood disorder is a confounder. Dechallenge was not applicable and Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Severe bruising on lower right leg  same side I got injection in arm in 2 massive brushes with several smaller ones to follow with leg pain and discomfort only right leg bruises hurt to touch
Patient developed massive unrelenting headache, extreme fatigue, and brain fog that lasted greater than 3 weeks
I have a black and blue mark on my left arm; It's red and blue and its all over the front of my arm; This is a spontaneous report from a contactable consumer. This 91-year-old female consumer reported for herself  A 91-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: ER8727 and expiration date: not reported) via an unspecified route of administration in left arm on 25Mar2021 (at the age of 91-years-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on 2021, the patient experienced i have a black and blue mark on my left arm, it's red and blue and its all over the front of my arm. It was reported that her shoulder down to elbow like five inches, have a black and blue mark on my left arm. The patient stated that she had the vaccination Thursday and I had Pfizer vaccination and now where she injected me from my shoulder down to my elbow like five inches. I have a black and blue mark on my left arm. And it is all around its look like that I had a 'short lead". It doesn't hurt. It is big mark it's like five inches down that's how big it is it looks like I have something on my arm. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
vaccines were warm to touch, and were administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 31-OCT-2022 Reporter's comment:  The pharmacist had called to inquire on how to proceed with the vaccine. The pharmacist had stated that the patient received a Flulaval delivery and vaccines were warm to touch with ice packs melted. Another Pharmacist had placed the vaccines into quarantine. Afterwards, three patients were administered the vaccines by another healthcare professional in their facility.  The patient was administered on 27 October 2022.  The pharmacist was unable to provide any additional details. The reporter did not consent to follow-up. This case had been linked with US2022157186 and US2022157185 , same reporter.; Sender's Comments:  US-GSK-US2022157186:same reporter US-GSK-US2022157185:same reporter
Patient began to have large hives on his arms a couple of days after the vaccine.  They continued to get worse and finally this morning (1/2/22) he broke out in full hives all over his neck, face and body.  We did Benadryl and over the counter antihistamine but they kept coming back so we got prednisone from The doctor.  His hives have been building for 2 days now but got very bad today.
12 day post vax pt developed maculopapular rash on trunk, hand and feet; Koplik's spots on buccal, labial, soft palate mucosa. Pt complained of GI cramping and nausea, emesis. No fever.
Wrong dosage - should have been .25 insteade of 0.5.   12-9-22 - Called and spoke with patient mom, patient mom reports patient had pain at injection site.   Patient is doing well today, patient mom denies symptoms of fever, dizziness, headaches, cough, shortness of breath or fatigue.
RT arm very sore on the night of the shot.  Soreness slowly receding with soreness still evident 2 days later.  Headache and muscle aches also started the night of the shot.  Light nausea  started the next day.  After 2 days, only arm soreness remains.
This spontaneous report was received from a 60 year old female patient who is also a pharmacist via a company representative regarding herself. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported), subcutaneously. No concomitant medications were reported. On an unknown date, the patient experienced a reaction on her lips similar to cold sores, lingering spots above the top lip and shooting pain up the side of the face. One of the reactions became infected with pus and came to a head. The Pharmacist reported that she started the use of ABREVA and stated this did not work well for her. The Pharmacist stated that, after ABREVA (unspecified dose, frequency and manufacturer) failed to work for her, she began therapy with doxycycline (unspecified dose, frequenct and manufacturer) and LYRICA (unspecified dose, frequenct and manufacturer) and both medications worked well. Patient sought medical attention (office visit on an unspecified date). The patient was recovering from the events. Additional information has been requested.
Woke up with chills at 3:15am with labor breathing. Did not go to ER. Raised area at local site with itching (think Hep A and TD site).
Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headedness). At the time of the report, DIZZINESS (Light headedness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and Treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Updated Reporter' Address and E-Mail ID.
Patient has had increased tiredness and significant tenderness over the immunization area associated with mild swelling and redness of the area.
On the night of the vaccine, I started running a fever which is usual when I get the vaccines.  I woke up around 4:00am to go to the restroom and it burned when I urinated.  I was shivering.  I had a temperature of 93.  I went on my health tracking app at 6:00am in the morning and was diagnosed with urinary tract infection.  I was prescribed Nitrofurantoin Monohydrate and have started to feel better.
body hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sepsis (It was painful). Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case US2023AMR039596).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, [the patient experienced general body pain (Verbatim: body hurt).Rechallenge with Shingles vaccine was positive. The outcome of the general body pain was recovered/resolved.   The reporter considered the general body pain to be related to Shingles vaccine.     The company considered the general body pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR039596   Additional Information: GSK receipt date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had 2 shingles shot. They made his/her body hurt for days so he/she didn't want to know what shingles was. The reporter had sepsis once that was painful. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR039596:same patient, different dose US-GSK-US2023AMR039596:same patient, different dose
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a adult patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced itchy rash and erythematous rash. On an unknown date, the outcome of the itchy rash and erythematous rash were unknown. It was unknown if the reporter considered the itchy rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the age group was captured as adult based on vaccine indication. The patient presented about 2 weeks after vaccination with SHINGRIX to the pharmacist with a very light itchy red rash and the patient stated it had previously been more red and itchy. The patient's physician did not seem concerned. The pharmacist was asking if this was considered normal for this vaccine (seems prolonged) and based on having a prolonged rash and itchiness, would that prevent the patient from getting the second dose? No additional information was obtained.
Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 13 year old female who received her second dose of GARDASIL (lot no. 660620/0571X) "a few weeks ago." The patient come in the office on 26-SEP2008 with a fever, cold and was diagnosed with an upper respiratory infection. The patient also took pregnancy test on 26-SEP-2008 and it was confirmed she is 4 months pregnant. Physician referred patient to an obstetrician/Gynecologist and the third dose of GARDASIL will not be given. Additional information has been requested.
first dose was 2 years ago not received 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 10th March 2020 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose was 2 years ago not received 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 16-AUG-2023 A pharmacist intern reported that a patient received their first dose was 2 years ago from reporting. The reporter wanted to know late second dose of Shingrix and the efficacy data for one dose only. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. This case was linked with US2023111553 with same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023111553:secand case created for second patient
48 hrs. after vaccine, (R) deltoid was hot to touch, hard lump, rash down upper arm that conitnued to spread til 36 hrs later. Itchy rash still present, though lighter, 8 days later took BENADRYL 25 mg to relieve itchiness.
Severe migraine; dry nose; sore throat; fever (spike at 102.8F); This is a spontaneous report from a contactable consumer (patient reported for himself). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration on 08Apr2021 approximately at 14:40 as a dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On 09Apr2021 approximately at 11:00 the patient experienced severe migraine, dry nose, sore throat and fever (spike at 102.8F). Outcome of all the reported events was recovered on 10Apr2021 approximately at 16:30.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
red itchy very sore area near the injection sight, but not the injection sight; very sore area near the injection sight/but not the injection sight.; red itchy very sore area near the injection sight, but not the injection sight; tender; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 16:00 (Lot number: 301308a) at the age of 60 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Bp" (unspecified if ongoing), notes: Bp; "asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 27Sep2021, outcome "not recovered" and all described as "red itchy very sore area near the injection sight, but not the injection sight"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021, outcome "not recovered", described as "very sore area near the injection sight/but not the injection sight."; TENDERNESS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "tender". Therapeutic measures were not taken as a result of pruritus, pain in extremity, erythema, tenderness.  Additional information: 3 days post injection I have red itchy very sore area near the injection sight, but not the injection sight. It had been 5 days now and it is still red, and very tender. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination: Many but this was my 3rd injection. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
she received her first dose of GARDASIL 9 in February of 2020 and due to COVID-19 never completed the series; No additional AE; This spontaneous report was received from a female patient of unspecified age, reporting on herself. Her medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in February 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis.  On an unknown date, the patient called to report that she was at the pharmacy store trying to restart series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) which due to coronavirus disease-19 (COVID-19) never completed the vaccination schedule, and for that was requesting to restart the series (Inappropriate schedule of product administration). No additional adverse events were reported.
Weakness, unable to move, Nauseous, unresponsive, sweaty, hot, no fever, felt dehydrated.  Similar to an Addisonian Crisis.  Lasted about an hour.  Took an extra Cortef, drank water and diet coke, rested.  Then ate bowl of soup.  Same thing happened after 1st vaccine, but 7 days later.  Didn't realize it was from the vaccine.
fever; myalgias; headaches; This is a spontaneous report from a non-contactable physician (patient, who is a healthcare provider/oncologist). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in left arm on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of PFIZER BIONTECH COVID-19 VACCINE given on 26Dec2020 in the left arm for COVID-19 immunization. She is not pregnant. The patient had no covid prior vaccination. The patient had no covid prior vaccination and she had not tested for covid post vaccination. On 17Jan2021, a day after receiving the second dose, patient said that she was down all day in bed with fever and myalgias and headaches. After taking ibuprofen, she felt better. Therapeutic measure was taken as a result of the events. The outcome of the events was recovered in Jan2021.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
when my shot was inserted into my arm it felt like the whole inside of my arm from shot injection cite to my wrist was constricting, I was in a lot of pain. woke up at 2 am with a searing headache, felt like I was going to throw up, my arm throbbed at my injection cite, I had a lot of diarrhea. got maybe 2 hours of sleep that night
Initial report received from a nurse on 05-MAY-2014. A male patient, with no reported personal and family medical history and no reported concomitant therapies, had received a dose of Tdap (manufacturer, batch number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced "vasovagal" response which lasted only a few minutes and then the patient had no symptoms. The outcome was reported as unknown. No further information was provided. Documents held by sender: None.