chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to office with a 5"x4" area that is pruritic with erythema on left thigh where vaccine had been given 48 hours prior. Second case today. Consulted pediatric doctor for second opinion, treated with Atarax.
Patient states that she is suffering  from extreme arm pain since her vaccination on 10/06/2020. The pain is not specific to the injection site, she state the pain is "up and down" her arm.  Patient state she has visited her primary physician and urgent care. She was given instructions to ice and to give 1-2 for the pain to subside per urgent care. Patient says pain is so extreme she has her arm in a sling. I have given advice to patient  to contact primary physician again so that the issue can be further researched.
This spontaneous report as received from other health professional refers to multiple patients of unknown age and gender. On an unknown date the multiple patients was vaccinated with GARDASIL injection (strength, dose unit, route, lot# and expiry date unknown) that was exposed to a temperature of 31F for 720 hours. No adverse effect reported. The outcome of patients received a dose of GARDASIL that was exposed to a temperature of 31 F for 720 hours and no adverse effect reported was unknown. This case # 1402USA007528 is linked to case # 1402USA010413 via same reported link. Additional information has been requested.
Weeks after I receive the second dose I started feeling heart flutters and pain in my chest as well as some trouble breathing went to the hospital but did not see a doctor because of the 12-hour wait but I'm pretty worried about the outcome of the results when I do .
T99.5   Tylenol taken with help Sore throat  Bodyache  Fatigue
Janssen covid booster give after beyond use room temperature time. Puncture 10:25AM, at room temperature until 1:30PM. Dose administered at 1:25PM.
Arm was warm at injection site and patient developed redness and hives on arm and scalp.
sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-339291 (Patient Link).
given Adacel within a 18 month window without looking in chart; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA202447, same reporter.  This case involves a 48 years old male patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (HEPLISAV B) and HEPATITIS A VACCINE INACT (VAQTA).  The patient received first dose for suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, lot number unknown on 21-Aug-2018. On 22-Jul-2018, the patient received a pre filled syringe, first dose 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6226AA, expiry date 10-Apr-2021 via intramuscular route in the left deltoid.  It was an actual medication error due to Drug dose administration interval too short.  It was reported that given Adacel within a 18 month window without looking in chart.  It was unknown whether patient experienced any adverse reaction after the injection.   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.  List of documents held by sender: none. Information on batch number was requested for this case.
insomnia; hives on her back; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia) and URTICARIA (hives on her back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INSOMNIA (insomnia) and URTICARIA (hives on her back). On 24-Feb-2021, INSOMNIA (insomnia) and URTICARIA (hives on her back) had resolved.            Concomitant medications taken by the patient were not provided. Treatment activities for the events was reported as none.
patient received an expired dose of Menactra with no adverse event; Initial information received on 27-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (Medical Assistant) via Global Medical Information (Reference number-00448383).  This case involves a 51 years old male patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6486AC, expiration date: 10-JAN-2021, strength: standard) via intramuscular route in the left arm for prophylactic vaccination on 12-Jan-2021 (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant medication given.  It was an actual medication error due to expired vaccine used (latency: same day).  Description: A Medical Assistant wanting to know how to proceed after a consumer received an expired dose of Menactra. Product used and still using product: yes.  At the time of report 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 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.
it was the stress from  having a fever; he has 101°F fever; This morning he also vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (it was the stress from  having a fever), PYREXIA (he has 101°F fever) and VOMITING (This morning he also vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Advanced prostate cancer since September 2021 and Immunocompromised.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced STRESS (it was the stress from  having a fever), PYREXIA (he has 101°F fever) and VOMITING (This morning he also vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning). At the time of the report, STRESS (it was the stress from  having a fever), PYREXIA (he has 101°F fever) and VOMITING (This morning he also vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 101°f (High) Fever.         Concomitant medication was not provided.  patient has 101°F fever, wanted to know if that could possibly be from the moderna shot. Morning also he vomited a little but it was bile, stated it was the stress from having a fever. Just a little bile this morning.  Treatment information was not provided.   This case was linked to MOD-2021-403905 (Patient Link).
Larger red spot and tender to the touch.  Also very hot to the tough.  Also Stiffness The Left Arm.
A bag (swelling) of fluid formed on arm below the site of injection and got bigger each passing day down to my elbow and about 1/4 was around the arm. Site of injection was red, hard and hot and sore also. 6 months ago- (4-24-2017) I got a Pneumococcal Conjugate Vaccine (PCV 13) when the nurse gave me this shot she told me to come back in 6 months to get another on because it was a series of 2 shots.
Information has been received from a registered nurse regarding a 4 year old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The PROQUAD was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
The day after my second shot toes on both of my feet turned purple and I developed blisters.  It largely went away within about 24 hours.  One week after the shot, these symptoms have returned, and they are worse.  I have blisters on both feet, and I feel like I have some nerve sensitivity.
Hives on face, neck, arms and legs.  AM after vaccination.  Recommended over the counter hydrocortisone cream and benadryl.
suspected vaccination failure; have them 2 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot experienced shingles 2 times. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
pt had first-time sz, generalized lasting approx 10 mins resolved assoc w/feeling hot, recorded temp in ER 101.8; no prior hx of st, sibs /whx of feb sz;
Within 15 minutes of receiving vaccine pt complained of nose, throat & ears closing up. Also c/o tightening in chest.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with an expired dose of VARIVAX (dose, route and lot # not provided). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Started 4/30/06 with pains and numbness that progressed until hospitalization on 5/2/06. Progressive weakness requiring intubation/ventilater. Treated with 5 treatments of IV immunoglobulins for diagnosis of Gullain-Barre Syndrome. Pt gradually improved and discharged from hospital on 5/16/06. Discharge summary states pneumothorax, emphysema, dysphagia. msv
1 day after injection, headache + fever + elevated heart rate.  This went away by the next day. 2 days after injection, swollen and sore lymph node left arm pit.  Still there
Received his first dose on 15APR2021 and has not received the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received his first dose on 15APR2021 and has not received the second dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received his first dose on 15APR2021 and has not received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received his first dose on 15APR2021 and has not received the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication was provided by the reporter.  No treatment information was reported by the reporter.
couldn't walk for two days; All I could do was stand and that was hard; It felt like nerve pain; Was so frightened; pain in legs/"the pain was down my legs"/"the pain was ridiculous"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in legs/"the pain was down my legs"/"the pain was ridiculous"), GAIT INABILITY (couldn't walk for two days), DYSSTASIA (All I could do was stand and that was hard), NEURALGIA (It felt like nerve pain) and FEAR (Was so frightened) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and OLMESARTAN for Blood pressure management.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in legs/"the pain was down my legs"/"the pain was ridiculous"). On 28-Feb-2021, the patient experienced GAIT INABILITY (couldn't walk for two days), DYSSTASIA (All I could do was stand and that was hard), NEURALGIA (It felt like nerve pain) and FEAR (Was so frightened). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 02-Feb-2021, PAIN IN EXTREMITY (pain in legs/"the pain was down my legs"/"the pain was ridiculous") had resolved. On 02-Mar-2021, GAIT INABILITY (couldn't walk for two days), DYSSTASIA (All I could do was stand and that was hard), NEURALGIA (It felt like nerve pain) and FEAR (Was so frightened) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included Mexican yam hormone supplement pills The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Burning sensation when vaccine given with immediate right arm pain stiffness in right side neck 5-6 hours following vaccination lasted 2 days. Used ice pack on right arm, heat pack on neck, used TYLENOL, too.
I had joint pains a couple days after vaccination. On 11/29/2022 I got this horrible infection. I had sinus pain and pressure, severe headache, and sinus congestion. I am a physician, so I cured myself and I took an antibiotic. I had blood coming out of my nose with phlegm and a cough. I was feeling weak and no energy for 4-5 days. I also lost smell and taste. I took two COVID-19 tests and they were negative.
only administered the liquid form instead of mixing the diluent with no reported adverse event; Initial information received on 28-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who experienced only administered the liquid form instead of mixing the diluent with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Suspension for injection at dose pf 0.5ml  lot UJ663AAA via intramuscular route in the right thigh for immunization.  On 28-NOV-2022 the patient developed a non-serious only administered the liquid form instead of mixing the diluent with no reported adverse event (wrong technique in product usage process) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE for Immunization.  It was reported " MA requests to speak with someone about an AE with the PENTACEL that occurred on accident. MA states that a patient needed the PENTACEL but one of the coworkers only administered the liquid form instead of mixing the diluent and Medical assistant reporting that the liquid portion of PENTACEL was given not the lyophilized portion containing ACTHIB".  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the event (only administered the liquid form instead of mixing the diluent with no reported adverse event).  At time of reporting, the outcome was Unknown for the event only administered the liquid form instead of mixing the diluent with no reported adverse event.  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.
Gave Pfizer (grey cap) to 11-year-old patient instead of Pfizer (orange cap).
14yr old female arrived to ED with complaints of stomach pain which started about 2 hours ago at work. She had to leave work because the pain was too bad. Rates pain 10/10. She has not taken anything for the pain. Pain is located in upper abdomin, constant ache. States she feels nauseated. Had a bowel movement this afternoon, normal for her. She also started her menstrual cycle 3 days ago.  ASSESSMENT/PLAN/DECISION MAKING:   Epigastric Pain   Zofran ODT, nausea improved.     GI cocktail, pain improved.     Observed  For about 30 minutes in the ED,  bowel sounds were reassessed and were normal.     Autonomic dysfunction addressed with osteopathic manipulation : HVLA to thoracic spine.     Administered omeprazole 20 mg in the ED , prescribed Prilosec CP DR twice daily before meals.   She is advised to push fluids.    She is to follow-up with NP at GI office, as EGD and possible impedance study were proposed.    Given body habitus consideration should be given to investigation for Ehlers-Danlos syndrome.
Information had been received on 03-MAY-2017 from a pharmacist who reported that an unspecified patient (age and gender not reported) who received ZOSTAVAX vial 19400 PFU (dose and lot#/expiration not reported) with sterile diluent on 02-MAY-2017 was scheduled to start therapy with prednisone on 03-MAY-2017. Pharmacist was not certain of the reason but stated "it could be an acute inflammatory process". Pharmacist could not clarify whether this issue started after patient received ZOSTAVAX so this adverse event was being filed as a precaution. Outcome of acute inflammatory process was not reported. No additional information is available. Additional information has been requested.
red, warm, painful indurated area @influenza site; smaller react @ pneumonax site;
14x14.5cm area or edema and induration over injection site. Complaints of fever, body aches and pain rated up to 7/10. Temp up to 38.2. All other vitals within normal limits.
Initial report was received from a consumer on 14 December 2012, who is also the patient's mother. A female infant (age not reported) received an injection of Hib vaccine (manufacturer, lot number, route, site, and date of vaccination not reported) and an unspecified amount of time later experienced shortness of breath, hives, swelling, bad swelling in the legs, and fevers. Illness at time of vaccination was not reported. Pre-existing allergies and medical conditions were not reported. The patient's outcome was not reported. Documents held by sender: None.
I felt like I was going into shock. Severe chills, feaver, bad body and head aching, nausea, weakness, coughing.The chills went away after the first night, but I'm still feeling aweful and will be calling out of work on Monday (the shot was administered on Sat.)
Day of vaccine (1/16/21) arm pain and migraine, 1/17/21. Still had a migraine and felt flushed/feverish with highest temp only 99 degrees Farenheit. Migraine subsided with 2 doses of sumatriptan nasal spray and naproxen 500mg tablet. Felt fine until 1/26/21 around 10PM extreme congestion and runny nose with some sneezing. 1/27/21 headache, dry cough, runny nose, extreme fatigue, eye pain, chills and nausea. Today 1/28/21 feel feverish, headache, nausea, extreme fatigue, body aches and chills, runny nose. Have been taking 400mg ibuprofen. Every 4 to 6 hours since morning of 1/27/21 bit no relief in body aches.