chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had some redness; induration; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Patient had some redness) and INDURATION (induration) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 006B21A and 048F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Patient had some redness) and INDURATION (induration). At the time of the report, ERYTHEMA (Patient had some redness) and INDURATION (induration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The Doctor received her first Moderna Covid-19 vaccine on February 19, 2021, lot number 024M20A expiration date was not known. Patient had redness and induration went away after 24 to 48 hours.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-645549 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-645549:same patient bivalent case
No additional adverse events reported.; a dose of ROTATEQ was given during a temperature excursion; This spontaneous report as received from a certified medical assistant refers to a 3-month-old patient of unknown gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 20-NOV-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter administered orally, lot # 1660954 has been verified to be a valid lot number, expiry date 07-MAR-2021, for prophylaxis. The administered dose underwent a temperature excursion between 48.8 degrees Fahrenheit and 32.7 degrees Fahrenheit for 47 hours and 15 minutes. There were no previous temperature excursions. Digital data logger was not involved. No additional adverse effect was reported.
received 1st MMR 1-10-02, rash, fever noted 1-19-02, started on forehead and spread to full body by 1-21-02, sister developed rash and fever 1-22-2
ON 10/4/2010, PATIENT WAS GIVEN FLU AND PNEUMONIA VACCINES.  10/6/2010 PATIENT WENT TO SEE DR DUE TO RIGHT ARM AT INJECTION SITE HAD RED, SWOLLEN, HOT TO TOUCH, PAIN, REDNESS WAS ON INTERASPECT OF RIGHT ARM.  WAS SEEN AT DR'S OFFICE AND WAS GIVEN STEROID INJECTION.  PATIENT TAKES BENADRYL 50 MG BID USUALLY FOR ALLGERY.  HAD PREVIOUS PNUEMOCOCCAL INJECTION 3 YEARS AGO AT DR'S OFFICE. DIDN'T TELL THIS TO NURSE UNTIL AFTER INJECTION WAS GIVEN. SEE MEDICATION LIST
Woke up at 7:30am the morning after the vaccine and had a loss of voice.  It is very strained sounding while talking, voice is unrecognizable.  It has not gotten better or worse throughout the day, just a perpetually strained voice.
PROFUSE SWEATING; This spontaneous report received from a consumer concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOW) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced profuse sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of profuse sweating was not reported. This report was non-serious. This case, from the same reporter .
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 40-year-old female patient who received FLUARIX quadrivalent (batch number 2F5P4, expiry date 30th June 2016). Previously administered products included Flu vaccine with an associated reaction of injection site pain (previous vaccination, refer case US2015GSK152650). On 15th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 15 October 2015, less than a day after received FLUARIX quadrivalent, the patient experienced pain in arm. On an unknown date, the patient experienced injection site pain. On 15th October 2015, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the pain in arm and injection site pain to be related to FLUARIX quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. The patient was a pharmacy technician. The healthcare professional stated that the day after receiving the vaccine, the patient reported that her arm was hurting. The arm that was hurting was not the one in which the vaccine was administered. In October 2015, less than a week after receiving the vaccine, the patient experienced injection site pain which was more severe than she had ever experienced before with the flu shot.
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351 and 2020SA038352.  This case involves a 6 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left deltoid for Prophylactic vaccination on 14-Jan-2020.which was exposed to the temperature of 29.1F (incorrect product storage).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient inspite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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
Urticaria over face/scalp.  Lacey erythmeatous macular rash with areas of confluence over trunk.  Tx Atarax syrup, cool compress.
Pt developed rash in groin area that spread to include buttocks, low back and few spots on legs, arms and face. He will start ZYRTEC BID and OTC hydrocortisone then follow up if needed. In addition, he was advised to D/C new hair shampoo.
Paralysis - entire body - breathing on her own, difficulty swallowing, weakness arm and legs at 2200 then progressed this AM. 2/27/09-records received-for DOS 2/5-2/8/09-DC DX: weakness. Presented with whole body weakness status post Gardasil and Depo provera shot. Initial C/O all over body aches and joint pain. Weakness began in arms.
This spontaneous report was received from a health worker referring to 9 unspecified patients of unknown age and gender. The patients medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot# L008271; expiration date 11-MAR-2017) dose and route of administration were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Woke up with extreme joint pain and muscle pain.  It worsened over the next several days until I could hardly walk or sit.  Equally the same on both sided of my body.
received the Shingrix adjuvant only on 06Jul2023; received the Shingrix adjuvant only on 06Jul2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number Y77XY, expiry date 21-AUG-2024) for prophylaxis.   On 06-JUL-2023, the patient received Shingrix. On 06-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received the Shingrix adjuvant only on 06Jul2023) and inappropriate dose of vaccine administered (Verbatim: received the Shingrix adjuvant only on 06Jul2023). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 6 Jul 2023: A pharmacist reported that a the patient received the Shingrix adjuvant only. The reporter consented to follow up via email. The patient received Shingrix adjuvant only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report was received from a registered nurse referring to a 12 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Patient had fever, chills, body aches and fatigue the next day.  Sunday she felt better.  Monday she had fever, chills, congestion, dry cough.  Tuesday she also had diarrhea, decreased appetite, loss of smell and taste and headache.  She is having pressure in her chest with taking deep breaths.
chills; fever; body ache; swollen lymph glands; This is a spontaneous report from a contactable Other-Hcp (patient). This 31-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number=Ek9231), via an unspecified route of administration on 08Jan2021 at 04:45 PM at single dose on left arm for COVID-19 immunisation. No medical history and no known allergies. Concomitant medication included ethinylestradiol / etonogestrel (NUVARING). The patient did not have other-vaccine-in-four weeks. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination. The patient previously received the first dose of BNT162B2 (lot number=Ek5730), via an unspecified route of administration on 18Dec2020 at 10:45 AM on left arm for COVID-19 immunisation. The patient experienced chills, fever, body ache and swollen lymph glands on 08Jan2021 at 11:45 PM with outcome of recovered in Jan2021. No treatment received for the events.
No additional adverse events reported/ There were no adverse reactions or experiences; His daughter received an extra dose of MMR II / She had previously completed MMR II series.; She was supposed to get GARDASIL 9 but received MMR II instead; This spontaneous report was received from a pharmacist and from the father of the patient (also reported as a health care professional), concerning an 11-year-old female patient. She had no primary diagnosis, no comorbidities, and no reported drug allergies; concomitant medications were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and it was reported that she completed the vaccine series (strength, dose, route of administration, anatomical location, lot number, and expiration date of any of the vaccine were provided). On 06-APR-2022 (approximately at 12:40), the patient was vaccinated with an extra dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (extra dose administered); dose reported as 1 dose, administered as prophylaxis, on her left deltoid, by a pharmacy tech, (lot number: U006488 has been verified to be a valid lot number, and expiration date: 26-FEB-2023; strength and route of administration were not provided). She was supposed to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but she received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) instead (wrong product administered).  On 19-APR-2022, through the continued follow-up with the patient, it was reported that there were no adverse experiences (also reported as no additional adverse events reported); and that the father was more concerned about long-term effects.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
sleepiness; "more intense" pain; pain upon injection administration; tiredness; "burning feeling" under left armpit; "pinching feeling" under left armpit; "pinching feeling" by left breast; "burning feeling" by left breast; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), SOMNOLENCE (sleepiness), VACCINATION SITE PAIN (pain upon injection administration), AXILLARY PAIN ("pinching feeling" under left armpit) and BREAST PAIN ("pinching feeling" by left breast) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) and AMLODIPINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 24-Mar-2021, the patient experienced AXILLARY PAIN ("pinching feeling" under left armpit), BREAST PAIN ("pinching feeling" by left breast), BURNING SENSATION ("burning feeling" by left breast) and BURNING SENSATION ("burning feeling" under left armpit). On 30-Mar-2021, the patient experienced FATIGUE (tiredness), SOMNOLENCE (sleepiness), VACCINATION SITE PAIN (pain upon injection administration) and PAIN IN EXTREMITY ("more intense" pain). On 01-Apr-2021, FATIGUE (tiredness) and SOMNOLENCE (sleepiness) had resolved. At the time of the report, VACCINATION SITE PAIN (pain upon injection administration), AXILLARY PAIN ("pinching feeling" under left armpit), BREAST PAIN ("pinching feeling" by left breast), BURNING SENSATION ("burning feeling" by left breast), PAIN IN EXTREMITY ("more intense" pain) and BURNING SENSATION ("burning feeling" under left armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
#1:  Fever, chills, Lots of pain in joints. lasting about 24 hours  #2:  Fever, chills, Higher fever, Nausea & vomiting , lasting about 36 hours
48hrs p/flu shot raised red rash started @ ears, neck spread to chest, abd, hip/groin-scalp; Seen by MD rash dx viral exanthum given DPH for itching; no further flu vax t99.3; some itched areas were sl hive-like;
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The pharmacist reported that the patient called the pharmacy and stated she received ZOSTAVAX on 21-FEB-2013 and developed the shingles on 23-FEB-2013. Pharmacist was offered the VZVID packed and declined, stating he had never seen the patient and he had no idea if the patient would call again. He did not know anything about the patient. The outcome of shingles was unknown. Additional information is not expected.
Child had a febrile seizure lasting approximately 3 minutes.  Parents report that she went apneic and required rescue breathing.  They are not healthcare providers but have had CPR training.  She did not require compressions.  She went to Urgent Care for fever (to 102) earlier 7/30.  EMS was called for the seizure; it had resolved by their arrival and she was not transported.  Mom took patient to the ED later that night where they were advised to observe her.  She was brought to see me this morning in follow-up.  I prescribed home rectal diazepam in case of future events.
Vacc. given at 1:00 p.m. 11/17/99, few hours later pt stated arm got swollen, red, warm, painful to touch. Took Tylenol with no relief, sleepless noc.  L/deltoid is red, warm, painful to touch, swollen at this time 11/18/99 8:00.
Patient began having tremors of arms and hands, very flushed, BP 200/100, HR 116, Benadryl 50 mg IM, Transported to ER for further treatment.
p/vax pt began around time period between 1st & 2nd shot;sx: memory loss, lethargy, pt still symptomatic;local rxn pain only to shot #4 with other sx continuing;
I have had a series of slow heart palpitations from early June 2021 and continuing until today
Week 1 - headache and light sensitivity Week 2  - Thoracic spine pain and left sided rib pain that escalated to finally resulting in shingles outbreak. Week 3- horrible rash on left torso from t-spine to front of abdomen and excruciating pain. Week 8 - horrible torso pain continues with rash fading.  I am currently at week at time of this report.
Day 1 post-immunization: localized erythema; Day 3 post-immunization: localized vesicular rash & surrounding tissue erythematous and swollen; Treatment: patient prescribed acyclovir & gabapentin on Day 3 post-immunization.
This spontaneous report was received from a physician refers to a 40 year old male patient. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
The patient involved developed a rash all over the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 2-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 13Jun2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "The patient involved developed a rash all over the injection site".  Additional information: Pharmaceutical Rep calling in to report an adverse event with Prevnar 13 on behalf of a clinic. The patient involved developed a rash all over the injection site. They are not 100% sure that Prevnar 13 caused the rash because he also received 4 vaccines total at that same time. The patient received all 4 vaccines, including the Prevnar 13, on 13Jun2022.   Follow-up attempts are completed. No further information is expected.
Vaccine received at approximately 1010 on 1/11/21.  I felt fine...just some soreness at the injection site. Overnite, intense HA noted that slightly subsided after 400mg ibuprofen, completely subsided by end of day 1/12/21.  Body aches, malaise and a feeling that my left axillary lymph nodes were enlarged.   All of these symptoms were at the worst in the middle of the night but all pretty much subsided by eve of 1/12/21.
Some of the shot leaked out and some went in the patient,no AE.; while administering fluzone HD to a male patient,the needle might have failed or was not on correctly,no AE.; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case from an other health professional.  This case involves male patient (age unknown) who was vaccinated with vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ311AB and expiration date 30-Jun-2020) and some of the shot leaked out and some went in the patient (underdose) , while administering  and  also the needle might have failed or was not on correctly (needle issue)  on an unknown date.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to underdose.  It is also a case of needle issue.  No adverse event reported at the time of reporting.  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.
Weakness, dizziness and headache approximately 12 hours later. Injection site pain.
Injection site red, swelling,  severe headaches, nausea, body aches.    body aches lasted 5 days or more. Doctor suspects Reiter's Syndrome
County notified our program that the client had a previously reported COVID-19 vaccination (Pfizer) through pharmacy on 2/21/2021.  This was not reported by the client to our vaccination program on 5/11/21 when he received the Janssen COVID-19 vaccination.  Pre-vaccination screening conveyed the client had not had a previous COVID-19 vaccination of any kind. Client received the Janssen COVID-19 vaccine without reported incident by staff or client.
About 10 mins after receiving Pfizer Covid booster, and after walking around the store, came to counter to pick up RX and fainted. Her daughter caught her midfall. Did not hit head. We sat her down, raised her feet, made sure ABC and alert, but pt was sweating, getting pale looking and intermittently losing consciousness. EMS called. Gave one dose Epi 0.3mg. Waited for EMS
1. cramping and pain at site for 4-5 months, woke me from sleep. 2.I have invisilign braces and after the shot my mouth developed areas of irritation every time I used the elastics at night. I had to discontinue the elastics to clear the problem. (I am not allergic to latex)  3. I developed problem with my contact lenses.  I (have wore contacts for 59+ years) and they have not been a problem 4. increased urinary frequency, urgency and pressure with urination. Tingling up both arms post voiding.
BlurredVision, Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Eyes felt "gritty"  Narrative:
Contracted transverse myelitis. 2 months motor sensor problems, 4 months numbness, tingling, weakness right shoulder and arm and torso.
T101 x 2 days, sore throat, chills, fever, achy, joints that hurt, felt like hit by truck, rhinitis, congestion now going into lungs, weakness w/in 24hr inj site sore also;