chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red and swollen arm a week after injection. The redness spread to the whole top part of the arm. The swollenness was so severe that it looked like muscle. Nodule formed under skin in the arm pit.
Left arm soreness around injection site that started about 3 hours after the injection and remained constant until the next morning. Fever (subjective as I did not have a thermometer at home) and chills that began about 14 hours after injection and last about 4 hours. Fever and chills resolved with 1000mg Tylenol.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 85 years old female patient who experienced extensive pain in the arm and unable to raise her arm or dress herself, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered. On 01-Oct-2018, the patient received a once 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AB; expiration date- 05-May-2019 via intramuscular route in the left deltoid. On an unknown date patient developed a non-serious extensive pain in the arm  and was unable to raise her arm  or dress herself following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also reported there was no swelling or redness at the injection site. (Other relevant tests included No lab test.) Final diagnosis was unable to raise her arm or dress herself and extensive pain in the arm.  It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for extensive pain in the arm and as Unknown for unable to raise her arm.
This spontaneous report was received from a physician assistant referring to a male patient (reporter's son) of unknown age. On an unknown date the patient was vaccinated with M-M-R II [lot # not reported]. Other suspect therapies included MENACTRA which was received in August or September 2013. On an unknown date patient was diagnosed at an unspecified time with "megaloblastoma" (medically significant) after he had received MMR. The patient received an autologous bone marrow transplant as part of his treatment. The reporter stated that the patient developed cellulitis and a sterile abscess of his left arm at the injection site after receiving MENACTRA in August or September 2013. He stated that his son's arm was edematous with "dark tissue" from his shoulder to his elbow (dates unspecified). The patient sought medical attention (methods unspecified). The action taken of the event with the suspect drug M-M-R II was assessed as not applicable. The causality of the events was unspecified. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose and route of administration were not provided) (lot # L027733 expiry date 13-SEP-2017, L029631 expiry date 17-AUG-2017). The Certified Medical Assistant (C.M.A) stated that RECOMBIVAX HB was exposed to the following temperature conditions: -7 degrees C for 36 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist and it refers to a 54 year old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 04-NOV-2014, the patient was vaccinated with expired VARIVAX (Merck) lot # H018448, exp.date: 09-OCT-2014, 0.5 ml, subcutaneously in the left arm. No adverse effects were reported. The outcome of the event was unknown. Additional information is not expected, the reporter does not wish to be contacted.
Within 5 minutes after the vaccine I developed severe tingling, itching and swelling of my tongue, lips and my entire mouth and I was administered plenty of water and prednisone to stop the symptoms. Was monitored for about 3hrs and released. At home I was so thirsty resulting in me drinking about 9 bottles of water. Self administered myself with levocetirizine 5mg later that evening because I still didn't feel well and fell asleep without eating that entire day and about 4am I woke up and all symptoms had subsided.
Itchy hands feet Swollen throat and ears Twitching muscles Tightening of shoulders lungs and back
AT APPROXIMATELY 10:40 AM PATIENT REPORTED FEELING DIZZINESS AND TIGHTNESS IN THE THROAT.  WHEN ASKED IF SHE WAS HAVING DIFFICULTY BREATHING, PATIENT STATED "NO.'  PATINET WAS CHECKED FOR BLOOD PRESSURE AND PULSE.  PATIENT WAS GIVEN DIPHENHYDRAMINE 25 MG AND PREDNISONE 10 MG.  PATIENT WAS LAYING DOW FOR 10 MINUTES AND PULSE AND BLOOD PRESSURE WAS RE-CHECKED.  PATIENT STATED THAT SHE WAS NOT HAVING ANYMORE TIGHTNESS OF THE CHEST NOR FEELING ANY DIZZINESS.  PATIENT WAS ABLE TO LEAVE FOR HOME.
First 5 days, had reactions of slight chills, muscle aches, dizziness, fatigue, all my joints were inflamed  and itching on injection site.  Took Tylenol, Motrin and Methylprednisolone for the reactions and joint pains with moderate relief. On June 2, 2022 woke up with a very painful sore throat, low grade fever between 99.2-99.8F,  muscles very sore, severe fatigue ?no energy the entire day,? dizziness and  difficulty swallowing.
FELT LIKE CRAP THE NEXT DAY; CHILLS; ALL JOINTS HURT; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported.  On an unspecified date, the subject experienced felt bad the next day, chills, all joints hurt, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome  felt bad the next day, chills, all joints hurt and fever was not reported. This report was non-serious.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter stated that with her first dose of Shingrix patient had a fever.  The reporter could not provide any details as to when she had the first dose. The reporter consented to follow up. For tolerance of 2nd dose refer case US2022AMR012131.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR012131:Same reporter, same product, same patient, different dose
Injection site (left shoulder) sore to touch almost immediately after injection.  Next few days pain increased, patient can barely lift arm to wash hair, put on clothes etc.  At night arm falls asleep, and to date the pain has started to run down arm into fingers.
A patient received expired Flublok vaccine, with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00814720) and transmitted to Sanofi on 15-Oct-2021.  This case is linked to cases 2021SA344561, 2021SA344654, 2021SA344871, 2021SA345043, 2021SA345033, 2021SA345139, 2021SA345306, 2021SA345389, 2021SA345424, 2021SA345646, 2021SA345761, 2021SA346021, 2021SA346022 and 2021SA346023 (same reporter).  This case involves a 57-year-old male patient who was received expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), and family history were not provided.  The patient had no other vaccine.   On 03-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2017, expiry: 30-Jun-2021, formulation: pre-filled syringe) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do"  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Side began to hurt on Tuesday, September 24.  I broke out with shingles on Thursday, September 26.  Went to see Dr. on Thursday, September, 26th.  She confirmed that it was shingles.  Shingles were on lower left side, from middle of back to middle of front.  Blisters began to form on September 29.
Approximately 10min after vaccine patient felt tingling in her lips which progresses to tip of tongue 1530 Allegra 60mg given.  Patient observed for 30min post dose. Symptoms began subsiding 10 min after receiving Allegra.   By end of the 30 min observation, patients reports feeling better back to baseline.  Patient advised if symptoms return or would worsen she should go to ER for evaluation.
29 1/2 weeks pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks pregnant). On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
The affected location(s): right and arm. Characteristics of the condition are redness, itchiness, pain and swelling. Patient has been exposed to a new medication. Pertinent negatives include no dysphagia, tongue/throat swelling or shortness of breath. Treatments tried: cold compress. Improvement on treatment: mild. Began 36 hours after getting pneumonia vax in that arm Got flu/TdaP in opposite with no problem.
5 minutes after injection, my feet and palms itched and I was lightheaded but I tried to shake it off and it faded over the next 10 minutes. I did report it and stayed longer and was ok. Then i went straight home and layed down because i did not sleep well night before (was on call ) i awoke 1 hour post injection dry heaving, very nauseated, mild headache, achy, itchy over different parts of my body and weak. Sat up and my face was getting itchier, lips started to swell, tongue started to swell and itch, throat felt like someone was strangling me, had trouble swallowing and trouble breathing. took 2 benadryls immediately and went out into cold air, thought about calling 911 but got better in 10-15 minutes. never have had a reaction like this in my life. have had hives  though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the benadryl worked and I slept due to the benadryl  for 5 hours, when I woke up the benadryl wore off and it started again. took more benadryl, and it improved. before bedtime, the benadryl wore off and I had a hard time swallowing my night time meds like my throat was swollen. Took 2 more benadryls, today I am weak and nauseated and ate very little and feel like my face is still red and itchy. I told my sister and she said she is allergic to PEG which i later noted was in the vaccine. i am very disappointed that I had this reaction- I have desparately wanted this vaccine as a medical worker with a lot of covid patients- I onlu hopr this one shot will protect me enough because it is clear to me that i cannot take this vaccine again.
Patient became ill on 5/15 and tested positive for covid-19 on 5/21/21.
This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 21-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that, the patient was administered the vaccine with a 0.5 inches needle, hence possibly received only a partial dose. It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Hearing problem; Arm is swelling and it itches like crazy; Arm is swelling and it itches like crazy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration at left arm on 25May2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient reported that, after receiving second dose of vaccine, it will be a week tomorrow (as reported) and then patient's arm was swelling and it itches like crazy on an unspecified date in 2021. Patient was just wanted to know what should be done about it. The patient have hearing problem and did not know what caller said on an unspecified date in 2021. Outcome of all the events were unknown.   Information on the lot/batch number has been requested.
Fainting after getting Shingrix shot; This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The reporter asked that fainting could happen several hours after getting the Shingrix shot. The follow-up could not be possible as no contact details were available.
administering Adacel instead of Fluzone Quadrivalent / no AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA272526 and 2019SA272536.  This case involves a 4 years old male who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6378AA, expiry date: 04-Jul-2021 via unknown route in unknown administration site on 28-Sep-2019and was supposed to give the consumers a flu shot vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
My vision got blurry; High blood pressure; Sinus pressure after the booster dose / Sinus Pressure behind my nose; Head feels tight; Both my right and left arms hurt; Soreness in her injection site left arm pit/ Both left and right arm pits hurt; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (Sinus pressure after the booster dose / Sinus Pressure behind my nose), TENSION HEADACHE (Head feels tight), VISION BLURRED (My vision got blurry), HYPERTENSION (High blood pressure) and PAIN IN EXTREMITY (Both my right and left arms hurt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037H21A, 039A21A and 026L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL SUCCINATE, LOSARTAN and METFORMIN for an unknown indication.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced PAIN IN EXTREMITY (Both my right and left arms hurt) and AXILLARY PAIN (Soreness in her injection site left arm pit/ Both left and right arm pits hurt). On 07-Dec-2021, the patient experienced PARANASAL SINUS DISCOMFORT (Sinus pressure after the booster dose / Sinus Pressure behind my nose) and TENSION HEADACHE (Head feels tight). On 08-Dec-2021, the patient experienced HYPERTENSION (High blood pressure). On an unknown date, the patient experienced VISION BLURRED (My vision got blurry). At the time of the report, PARANASAL SINUS DISCOMFORT (Sinus pressure after the booster dose / Sinus Pressure behind my nose), TENSION HEADACHE (Head feels tight), VISION BLURRED (My vision got blurry), HYPERTENSION (High blood pressure), PAIN IN EXTREMITY (Both my right and left arms hurt) and AXILLARY PAIN (Soreness in her injection site left arm pit/ Both left and right arm pits hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, Blood pressure measurement: 122/74 (normal) Normal, at 08:30 AM, 153/87 (High) High, at 12:01 and 160/91 (High) High, at 11:46. On 08-Dec-2021, Heart rate: 59 (Low) Low, at 08:30, 79 (High) High, at 12:01 and 88 (High) High, at 11:46.         Treatment information includes, patient used Vicks rubbing under her arm.   This case was linked to MOD-2021-406733 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jul2022 as dose 3 (booster), single (Lot number: FJ4991) at the age of 69 years, in left 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's relevant medical history included: "Osteopenia" (unspecified if ongoing), notes: Osteopenia, not on meds; "Adult pertussis" (unspecified if ongoing), notes: adult pertussis about 20 years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Treatment of COVID-19 with Paxlovid (Lot number: Lot 2707493) from 26Dec2022 to 28Dec2022.
15 minutes in post observation, patient reported feeling dizzy. Vital signs were taken. BP 152/87 HR 67 SPO2 98% @10:45AM Patient states: "I feel like my blood pressure went up." Offered a snack and water. Declines the snack but accepted the water. Monitored patent for another 15 minutes. 11:00AM Patient stated "I might just be feeling nervous." Reassured patient and continued to monitor. 11:05AM Rechecked vital signs BP 140/75 HR 55 SPO2 98%. Educated patient to monitor blood pressure at home and rest for the remaining of the day. Instructed to hydrate and eat. 11:10AM Patient felt "Much Better." patient was sent home accompanied by wife and son. 12:21PM Followed up with patient via phone call and stated "I am feeling back to normal."
16 days after vaccine I noticed some soreness at the site for the first time this morning.  Later this evening the site is red and itching.  I also noticed a sore lymph node on the left side of my neck.  I have not had any treatment for this.
Information has been received from a physician concerning a 68 year old female who on an unspecified day was vaccinated with PNEUMOVAX 23 (Lot # 664653/1337Y) for the prevention of pneumonia. Subsequently the patient experienced increased redness and pain at the injection site. The patient had sought unspecified medical attention. At the time of report, the outcome was unknown. This is one of several reports received from the same source. No further information is available.
Gangrene associated with diabetes mellitus,  PROCEDURE: Procedure(s): Left - Left below knee amputation. Recovered in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.