chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Same day sever reaction. High fever 104/105 and trouble breathing took to ER. Was told by ER PA that it was just a cold and to alternate Tylenol and Motrin for fever. That weekend she continued to get worse. She was losing color. She could not focus. She could not stand or hold her head up. Er visit was Friday or Saturday night. I took her in Monday morning first available appointment with her PCM. She was immediately admitted. Her oxygen saturation was dangerously low. She was in the hospital for almost 2 weeks. She now has asthma allergies, allergy shiners, and stomach pains.
patient was administered Tenivac instead of TDAP with Pertussis; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Regulatory Authority (Reference number-00372219) and transmitted to Sanofi on 25-Nov-2020.  This case involves a 27-years-old female patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (TENIVAC) (lot number U6669AA, expiration date 15-May-2022, prefilled syringe, standard dose) once via an intramuscular route in left deltoid for prophylactic vaccination, on 23 -Nov-2020 instead of DIPHTHERIA TETANUS ACELLULAR PERTUSSIS (DTAP) not produced by Sanofi Pasteur (reported as another manufacturer's TDAP with Pertussis) (wrong product administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was administered concomitantly.  This was an actual medication error case due to wrong vaccine administered (latency same day).  At the time of reporting, no adverse event was reported.  Reporter stated that this was first time this product was used in patient. Reporter asked if the patient could get the rest of the ingredient vaccines in the TDAP with Pertussis so the patient could receive the intended full vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
I experienced symptoms consistent with heart attack which prompted be to visit the local ER.  The symptoms experienced were: breath shortness, chest pain, numbness in left arm, feeling of doom, heart palpitations, elevated blood pressure.  ER conducted X-ray, blood markers & EKG tests which all were indicative of normal behavior and I was dismissed with instructions to followup up with a cardiologist.  Cardiologist visit occurred on May 21st and concluded good heart health with no indications of damage.
This spontaneous report as received from a pharmacist refers to a 15 year old patient of an unknown gender. The patient's current conditions and medical history were not reported. On 05-MAY-2015, the patient was accidentally vaccinated with dose of ZOSTAVAX (unknown route, strength and anatomical location) instead of VARIVAX. Concomitant medications were not reported. No adverse effect was reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Infected after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infected after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced INFECTION (Infected after vaccination). At the time of the report, INFECTION (Infected after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
On the 14th of Oct, I started feeling bad because my asthma medication wasn't working and I kept on for a few days because nothing was working. I went to the urgent care on the 17th and they gave me a Z Pack and 20 mg Prednisone.  On the 18th, I went to the ER because my nose started running and when I wiped it, I found it was blood. They gave me Albuterol treatments and Prednisone 50 mg and they put me on the nebulizer. I then followed up with my doctor and she told me to continue with the meds they gave me. Last week, I started feeling better and each day that goes on I start feeling better.  Doctor Seen. 1st Event: Urgent Care 10/17. 2nd Event: ER 10/18. Follow Up: PCP Visit 10/21
patient received an ACT-HIB vaccine on 08MAR2022 that contained a diluent which had expired on 07MAR2022, vaccine portion in the single-dose vial was not expired but the diluent with no reported adverse event; patient received an ACT-HIB vaccine on 08MAR2022 that contained a diluent which had expired on 07MAR2022, vaccine portion in the single-dose vial was not expired but the diluent with no reported adverse event; Initial information received on 23-Mar-2022 regarding an Unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient received HIB (PRP/T) VACCINE [ACT-HIB] vaccine on 08-Mar-2022 that contained a diluent which had expired on 07-Mar-2022, vaccine portion in the single-dose vial was not expired but the diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) with Lot number UJ423AA with an expiration date 20-May-2022 for Prophylactic vaccination.  On 08-Mar-2022, the patient received a 4th dose of suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml via intramuscular route in the left thigh with Lot number UJ423AAA ,Expiry date: 07-Mar-2022) for Immunization.  On 08-Mar-2022, the patient developed a non-serious event patient received an act-hib vaccine on 08mar2022 that contained a diluent which had expired on 07mar2022, vaccine portion in the single-dose vial was not expired but the diluent with no reported adverse event (product preparation issue)(Expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken: Not applicable.  Outcome: Recovered on 08-Mar-2022.  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 guidelines. 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.
Left leg and hip joint pain; Left leg and hip joint pain; Headache; Nausea; elevated blood pressure on phase 2 (146/93); I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (elevated blood pressure on phase 2 (146/93)), PAIN IN EXTREMITY (Left leg and hip joint pain), ARTHRALGIA (Left leg and hip joint pain), LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.) and HEADACHE (Headache) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep disorder. Concomitant products included MELATONIN for Sleep disorder, ZINC, VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 24-Oct-2021, the patient 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 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 24-Oct-2021, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.). On 25-Oct-2021, the patient experienced HYPERTENSION (elevated blood pressure on phase 2 (146/93)), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left leg and hip joint pain) and ARTHRALGIA (Left leg and hip joint pain). The patient was treated with LOSARTAN for Blood pressure high, at a dose of once or twice daily. On 24-Oct-2021, LIQUID PRODUCT PHYSICAL ISSUE (I also noticed that the vial I got was cloudy. It looked like water with a drop of cream in it.) had resolved. On 27-Oct-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. On 28-Oct-2021, HYPERTENSION (elevated blood pressure on phase 2 (146/93)) had resolved. At the time of the report, PAIN IN EXTREMITY (Left leg and hip joint pain) and ARTHRALGIA (Left leg and hip joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Blood pressure measurement: 146/93 (High) 146/93. On 26-Oct-2021, Blood pressure measurement: both diastolic and systolic were high (High) both diastolic and systolic were high. On 27-Oct-2021, Blood pressure measurement: systolic was high (High) systolic was high. On 28-Oct-2021, Blood pressure measurement: normal (normal) Normal.         Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: non-significant follow up appended
Woke up a chills Nd a fever of 102. This is higher than I had when I had Covid.
Itchy and erythemic papules on both hands and elbows;  most proximal to joints (knuckles). Very few on Palms. Started on dorsal surface and moved distally towards figertipis and joints.
While completing COVID tracking sheet for doses given, I noticed an older lot number (015B22A), verified expiration date with Moderna Vial Expiration Checker. Per Moderna Vial Expiration Checker, lot 015B22A has an expiration date of 02/12/23.
Johnson and Johnson Janssen COVID-19 EUA vaccine  At the time of the injection, the vaccine burned as it entered my arm. (I have never felt that burning sensation with any other vaccination that I have had in the past. Twenty minutes after the vaccination, I became lightheaded and dizzy.  I could walk but I was wobbly. At one hour after the vaccination, I felt a sharp stabbing pain in the left side of my tongue and then the left side and only the left side of my tongue began to go numb. Within a couple of minutes, I realized that my left jaw was going numb, too.  The numbness slowly but surely began to move up the left side of my face all the way to the top of my head.  I had a sharp but brief headache on the left side of my head  that subsided quickly but the numbness remained.  I went home and talked to two people on the phone for several hours because they wanted to be sure that I was OK. At two hours after the vaccination, my face was still numb but I could think and talk clearly, but I was clearing my throat and coughing a lot.  At that point, I also realized that my whole left arm was a little numb and my fingers on my left hand were tingling.  That numbness lasted about 20 minutes and then subsided. The facial numbness lasted for hours.  I wasn't scared and I wasn't in pain but it was very strange.  It felt a little bit like the after affects of dental anesthesia but it wasn't just in my mouth it was the whole left side of my face.   I believe that this must have been an allergic reaction to one of the chemicals in the vaccine but I don't know which one.  If you can tell me which chemical it might have been, I will avoid it in the future.
pt given DT instead of Aplisol intradermally on forearm; arm red & indurated;
Grandma called 2 days after the vaccines were given and reported: Injection site the evening after the vaccines were given had become swollen to the size of a softball and it "welted up" and became very red, hot and painful.  There was no improvement the following day. The day that she called (1-9-20)  she stated that there was a little less redness, same amount of swelling, hot to touch and painful.  No fever was reported. An appointment was schedule for that evening in the office. Patient was put on antibiotics, benadryl and was told to do cold compresses to the area. Was instructed to call back if not improving over the next 24 hours or if appeared to get worse. Grandma did not call back.
tiredness and fatigue started 8 hrs after shot, ringing in ears started 8 hrs after shot, body aches started 16 hrs after shot, tiredness and fatigue resolved 32 hours after shot, ringing in ears has continued some days are worse than others
There has been and still is a spongy lump in the arm at the injection site.  It has caused pain in the arm when I lean on my elbow when rolling over in bed as well as when I extend my arm straight out. .  It has as caused some limitation of movement with the arm, such as reaching around to my back to put on a shirt or jacket.
Itchiness at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness at injection site) and INJECTION SITE RASH (Rash at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INJECTION SITE PRURITUS (Itchiness at injection site) and INJECTION SITE RASH (Rash at injection site). At the time of the report, INJECTION SITE PRURITUS (Itchiness at injection site) and INJECTION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included coconut oil.
Information has been received from an RN concerning many pts who were vaccinated with varicella virus vaccine live. The RN reported "an awful lot of kids are getting chickenpox after being vaccinated". Unspecified medical attention was sought. The RN also reported 2 siblings developed chickenpox while on therapy with varicella virus vaccine live (WAES01041410 and 01041029). Additional information has been requested.
Myalgia, anorexia, extreme fatigue, chills, sweats and temp ~100.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On 01-JAN-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown). The patient developed shingles after 6 months(in June 2013) of having the shot. The outcome of event was unknown. Additional information is not expected.
received the first dose of Shingrix on 25th May, 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details could be grabbed during call. Attempted to attain patient and vaccination information from healthcare professional (HCP), but they did not provided. The reporter did not consent to follow up.
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult female patient who received SHINGRIX for prophylaxis. On 9th August 2018, the patient received SHINGRIX. On 9th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were unknown. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient had denied permission to contact their physician. The caller terminated the call. No other questions were asked for this report.
Guillain Barre syndrome- symptoms of BLE numbness with ascending bulbar weakness developed 4/18 and diagnosed on 4/27
Developed hives within 24 hours of vaccine administration - no wheezing or shortness of breath.
I began to experience symptoms on 05/20/2022 and tested positive (PCR) on 05/21/2022. Fever for two days.  I continued to experience other symptoms for 7 days.
I have had 3 doses, each one produced the same issue. I am reporting this as people with cluster headaches will wind up in the ER if they have the problems I did and am also wondering if this might be a bad choice of type of vaccine for people with cluster headaches. 9 hours after the first dose I wound up in the ER and received 2 shots into my head, the pain was an ice pick like jabbing every 10 seconds and was completely debilitating.  After this event I went to a headache specialist that was recommended to me, he diagnosed cluster headaches and prescribed sumatriptan nasal spray, which does seem to work but not nearly as well after each of my vaccines.   9 hours after the second vaccine the headache began and continued for 8 hours, I used 2 of the sumatriptan nasal doses. 16 hours after the third dose the headaches came on and were much harder to mitigate, I used 3 doses over 12 hours and I?d say after 13 hours it lessened .  After each dose I experienced body aches along with the headache but I deemed this to be normal and wouldn?t bother reporting that. The aches were more severe every place that I have arthritis.
Arthralgia Injection site pain, Fatigue, Chills Narrative:  Other Relevant History:
no adverse reaction medication was expired form the day before was not aware when given it had been pulled out wiht no date and placed in the  bin to be punctured stated the time it had been pulled was at 6:49 am so that it had been pulled this morning
Received covid 19 first dose on 12-23-20 and on 01-01-21 insertion site became red and itching.  On 01-04-21 the redness measures 4cm x 8cm.
Patient in clinic for second dose Pfizer Covid 19 vaccination. Patient received Moderna vaccination instead.
1000 - Patient c/o headache. States she is a diabetic. Took meds for diabetes this morning and ate breakfast. States she experiences headaches when blood sugar out of control. States she feels dry. Gave water. Swallowing without difficulty. Has a glucometer patch on left upper arm and took out wire free glucometer and scanned arm.  Glucose is 161.  1002 - experiencing blurred vision. States headache aching in temple area across forehead. Denies dizziness. Stood and ambulated independently to private observation area without difficulty.  1004 -  EMT at site in attendance. BP 144/98; HR 100; )2 sat 99% on room air. No SOB noted. States she took her BP meds this morning, but not her Lasix. States that is unusually high BP for her. EMT and nurse recommended transport. Patient agrees. States she drove to vaccination site alone and will leave car in lot. States she has a 2009 Honda Accord 2 door coupe with disabled woman veteran on her license plate with tags reading VD....... (can't recall numbers). Assured security will be notified so that vehicle will not be towed if left overnight. Wants to go to THR Southwest Fort Worth ED.  1012 - having difficulty focusing eyes. Headache remains. PERL; 3-4 cm bilaterally. Equal hand grasps, no drift. speech clear 1014 - BP 136/92; HR 97; O2 99% on r/a 1016 MedStar activated per EMT in attendance. Patient states H/A pain is 8/10 aching. Still has blurred vision, c/o dry mouth. Continues to drink water without difficulty swallowing. Now describes having general tingling throughout upper body, along both arms. Denies itching.  1036 - States she feels drowsy, remains oriented x 3. States H/A now 9/a0  1044 - MedStar arrived and patient immediate  ly placed on stretcher and  patient transported to  hospital. Patient speaking to paramedics as leaving building.
Temp 103 w/APAP p/shot-for 3 days; very irritable, lethargic 3 days, vomiting x 1; MD called advised to watch infant if temp doesnt come down will be admitted;MD order ped DT next time;
I have always had soreness at the injection site of flu shots, but this time it has not gone away after a couple days. It is now almost 2 months since the injection soreness is not felt when arm is at my side, is felt when arm is over head (backstroke - swimming), holding hair dryer, combing hair, etc.
Case number PHEH2016US023460, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 30-year-old patient of unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml on 16 Feb 2016. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Patient received a second flu shot in the 2022-2023 flu season. She was supposed to get the Moderna Bivalent booster. She previously received a flu shot in September 2022.