chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.; No adverse event; Doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.).    Concomitant product use was not provided by the reporter.    Temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction.   No treatment information was provided.
Developed head congestion, coughing, turning into body aches, chest congestion, fatigue over the next few days. Started taking Paxlovid medications around day 4, felt good and home test was negative about 5 days later. Three days later had same symptoms returned, felt fully over it within a week.
Pt was given an expired vaccine exp. 10/18/22 Tdap (Boostrix). Pt Did not have adverse reaction
Developed a delayed local skin reaction with redness, itching, thickened red skin and stinging
On the 03/15/18 my left arm got swollen and got painful on the site of the injection. Next day, 03/16/18, I got throat sore, body ache, headache and mild fever. Also it felt like my neck lymph nodes got swollen. As of now, 03/17/18, the symptoms persist.
About three days following second dose of Moderna vaccine, experienced shortness of breath for ~36 hrs.    Doctor was not consulted, no treatments administered.  Symptoms resolved on their own after approximately 36 hours.
Case number PHEH2012US008927 is an initial spontaneous report received from a consumer on 24 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that on 18 Apr 2012, he was vaccinated with MenA lyophilized conjugate vaccine component of MENVEO (batch number: A11032) intramuscularly on to unspecified site and did not receive the MenCYW-135 liquid conjugate. No adverse reaction was reported following the maladministration.
High fever, sore throat, dizziness, body aches. Gave him Tylenol meltaways for pain and fever.
This spontaneous report as received from a 76 year old female nurse with PROCARDIA allergy and TENORMIN allergy refers to herself. The patient's medical history included generalized neuropathy of the leg. On 09-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route unspecified). Concomitant therapies included estrogens, conjugated PREMARIN. On 10-OCT-2013 (the next day), the patient's arm became extremely sore. Later in the day on 10-OCT-2013 the patient developed swelling, soreness, pain and warmth in an area about 6 inches around the injection site. The nurse stated that she also developed a fever, headache and swollen lymph nodes on 10-OCT-2013. In addition, the nurse developed a rash on the upper part of the arm in which ZOSTAVAX was administered. The patient had sought medical attention via called physician's office. No lab diagnostics studies performed. MOTRIN was given for headache treatment. The nurse reported that she was recovering, on an unspecified date, her fever, headache and swollen lymph nodes went away and the adverse injection site reactions had decreased to only cover an area of about 1.5 inches. The patient stated it was okay to send VZVIP packet to her physician. VZVIP packet faxed. Additional information has been requested.
Monday Eve.: Typical flu-like symptoms: Dizziness, Nausea, Headache, Bone Pain, sore arm Tuesday:  Arm hard, warm, very sore --continued Wednesday: Black and Blue around injection site Thursday:  Red rash that extended to elbow.  Checked with NP who said could be cellulitis or inflammatory reaction --put topical Hydrocortisone on it and watch. It did shrink some, but still present through this evening.
Symptoms described by patient: "Round like a pancake at the spot", red, splotchy. Confirmed with patient that this was not a reaction to bandage adhesive, as patient did not use one. Clinically, the symptoms were those of an allergic reaction.
Vaccine at 8 am approx 11:00 am hives - at pm 8:30/9:00 pm running fever increase itching. Next am - started vomiting, fever progressing all day. Gave Benadryl/Tylenol/Motrin next morning. Total illness lasted about 3 days.
Body aches; chills; This is a spontaneous report from a contactable consumer (patient)  A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration in Arm Left on 16Mar2021 at 11:00 (at 50 years)as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  No allergies to medications, food, or other products . Prior to vaccination and since the vaccination the patient was not diagnosed with COVID-19. Previously on 25Feb2021 at 13:00  (at 50 years)patient took first dose of the vaccine (lot EL3247 )  in right arm for covid-19 immunisation.On 16Mar2021 at 22:00 the patient experienced body aches and chills. No treatment given. The outcome of the events was recovered on an unknown date in 2021.No follow-up attempts are possible. No further information is expected.
Patient complained of left arm itching. Was monitored for 30 minutes.    Presents to BYLAS HL CT Pharmacy on 02/12/21 12:00 Said she had itching from Moderna vaccine received in San Carlos at drive thru. Given 1 dose of diphenhydramine now, checked and monitored by nurses. Said she was filling better and wanted to leave. Given prescription for diphenhydramine  to take home.   Medications: DIPHENHYDRAMINE 25MG CAP  #12 (3 days) TAKE ONE (1) CAPSULE BY MOUTH FOUR TIMES A DAY AS NEEDED FOR ALLERGIES
Herpes breakout; This is a spontaneous report from a contactable consumer (patient). This contactable consumer reported 2 reports for different patients. This is one of the 2 reports. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced herpes breakout (non-serious) on 10May2021 with outcome of not recovered. The event was considered as non serious by the reporter.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from an administrator (also the patient's relative) referred to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates (reported as 3 years ago), the patient had completed taking the series of GARDASIL (dose, route, lot and expiry date not reported). The administrator reported that the patient was diagnosed with Guillain-Barre syndrome on an unknown date after completing her final dose of the GARDASIL. The patient was treated for the event but her current status was not known. The reporter did not provide a causality assessment for the event.  Upon internal review, the event Guillain-Barre syndrome was determined to be medically significant.
Received above vaccines at approximately 2pm on 11-11-13. Mom reported redness from her toes to hips on both legs at about 5pm on 11-11-13, went to urgent care at 9pm on 11-11-13. Resolution of symptoms by following day. Assessment per urgent care = hives.
Difficulty breathing, wheezing after vaccination. Given Epinephrine & Benadryl - responded with improved breathing. Sent to ER. Observed treated with steroids and released in stable condition.
Stuffy nose; Chills; Strong heartbeat; Severe diarrhea; Headache; This is a spontaneous report from a contactable consumer. The consumer reported for herself that the 69-years-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Lot number: EL9262)  via an unspecified route of administration on 17Feb2021 13:00 on Left arm at single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included simvastatin, ropinirol [ropinirole] (ROPINIROL [ROPINIROLE]), vitamin d3 (VITAMIN D3). The patient previously took first dose of bnt162b2 (COVID 19 Pfizer Bio Tech) on 27Jan2021 01:15 PM on Left arm for covid-19 immunisation, montelukast and experienced drug hypersensitivity. The patient experienced stuffy nose, chills, strong heartbeat, severe diarrhea, headache all on 18Feb2021 01:15AM with outcome of recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. The event was assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
The Fluarix Quadrivalent vaccine was given to the patient and was not wanted by the parent. The patient has not had any adverse recations from the Fluarix and was seen a few hours later when parent came in to get a copy of the vaccine given. Dr saw the child and child was playing and running around. LPN worked up siblings one a 2wk visit and the patient in question for vaccines. Nurse in her words described what happened. I gathered charts the slip on outside of charts read 2wk/Flu shot. Proceeded to gather visit materials, prepared flu shot called patient back to triage room, informed mom sibling needed to be undressed for 2wk appt and asked mom if patient was here for vaccine only she said yes. I informed her we would go ahead and do vaccine.  I administered vaccine, continued to triage sibiling after finishing  we went to room  4 to finish questioner. Left room and Front Deck hands me the VIS forms for DaPT and HIB I go back in the room and ask mom is she also getting DaPT and HIB and she tells me yes I thought that's what she received. It is there I had realized I had given the wrong vaccine. I immediately let her know that I had given the Flu Shot  due to paperwork stating so. I apologized and continued visit. After leaving room I informed Dr of incorrect administration.
Client received a pediatric dose of Pfizer Covid Vaccine (age 12) instead of an adult dose.  No adverse event occurred.
Pt began spitting up formula, developed a cold and congestion, fever of 102.4 and a pulse of 160.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Dizziness, lightheaded, pale, diaphoretic, afraid of needles.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer BioNTech vaccine on 2/9/2021, 3/2/21 and 10/27/21. Presented to ED from rehab yesterday w/AMS and decreased PO intake. Prior admission to rehab after being hospitalized and tx'd for COVID, discharged 9/8/22. COVID + this admission as well. She was hypoxic on arrival to ED and placed on supplemental O2. Head CT negative for acute process. Lactate was 4.0. Admitted to the medical floor and started on decadron and Zosyn. That evening she went into Afib RVR. Transitioned to comfort care and expired on 9/22/22. Tx'd with cefepime, decadron, vancomycin, metronidazole, and zosyn.
SMALL LUMP AT INJECTION SITE; COVID-19; SWOLLEN LYMPH NODES/LITTLE SWOLLEN GLAND; This spontaneous report received from a patient concerned a 7 decade old female. 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced small lump at injection site, covid-19, and swollen lymph nodes/little swollen gland. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small lump at injection site, and swollen lymph nodes/little swollen gland, and the outcome of covid-19 was not reported. This report was non-serious.
Physical shaking, extreme headache, stiffness of neck and shoulders, heaviness of body, slowed speech.
The evening of 12/17/2020 pain started in the left deltoid. Over night the muscles in the left arm contracted and would no release, a hematoma developed, and constant pain was through the entire left arm. The morning of 12/18/2020 the muscle contractions and hematoma were still present and tachycardia and fatigue developed. Highest heart rate at that time was 147 with a blood pressure of 148/82. Was a pt. in the ED and received benadry, dexamethasone, and pepcid. Swelling and muscle contraction subsided and heart rate was stable in the 100's. Later in the evening tachycardia and fatigue started again with the highest heart rate being 210 (when resolved nearly immediately with rest). Heart rate was 110-130 until I went to bed. Heart rate waking up this AM was 110bpm. Injection sight is slightly painful.
DUE TO MISCOMMUNICATION, PATIENT WAS ACCIDENTLY VACCINATED WITH A 3RD DOSE OF PFIZER VACCINE (ONE IN APRIL, ONE IN MAY, AND ONE IN JUNE)
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
9-15-17 Pt. report arm soreness. Used BEN GAY at home. Seeked Tx at hospital. Told to use ice and BENADRYL PRN. 9-28-17 stopped in clinic due to continued sore Rt. arm. Told to continue ice/heat and TYLENOL. 10-2-17 X-ray Rt. humerus, Sed. rate, CBC negative.
Pt recvd vax FEB92 & in JUN92 devel intermittent nausea & vomiting;
tingling in mouth at 5 minutes, shortness of breath and chest pain, pt states they are dizzy and feel like passing out.   the HR is elevated at 127, and pt is diaphoretic, with nausea and retching
twitching of lower lip on 04/02/21, progressed to upper lip on 04/05/21, progressed to tongue on 04/09/21, progressed to roof of mouth & back of throat on 04/11/21
The patient had come to our pharmacy expecting the 2nd dose of her Pfizer vaccine but instead received flu shot Afluria instead due to misunderstanding.  We unfortunately typed up the flu shot instead of the Pfizer vaccine and after verification all info with the patient the pharmacist administered the flu vaccine. Patient later came back and showed the tech the leaflet and states she didn't want this vaccine.  Pt appeared well, no signs of adverse reaction but was upset she had wrong shot.  Pharmacist apologized to patient and offered the 2nd covid shot which the patient received at another time.
Flushed, pink cheeks with distinct sensation of weakness in the very center of my chest developing within 1 to 2 hours after vaccination and lasting all day.  Mild sore throat, mental fogginess, generalized fatigue and weakness during the day of vaccination.  I did not feel like myself all day on the day of vaccination.  Localized pain and swelling vaccine site lasting several days, right arm.  Overall, I have felt fatigued and with less physical and mental stamina since I was vaccinated on March 3rd, 2020.
no adverse event --just mixing error ---multi dose diluent vial was used more than once to mix with covid
This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (spots forming on her tongue within 2 days of the shot, for a couple of days) and MYALGIA (achy feeling for about a day) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TONGUE DISORDER (spots forming on her tongue within 2 days of the shot, for a couple of days). On an unknown date, the patient experienced MYALGIA (achy feeling for about a day). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TONGUE DISORDER (spots forming on her tongue within 2 days of the shot, for a couple of days) and MYALGIA (achy feeling for about a day) outcome was unknown.            No concomitant medication details were reported.   This case was linked to MOD-2021-404738, MOD-2021-404817 (Patient Link).
Had Varicella vaccine on 06/22/00.  Now diagnosed with chickenpox by MD.  # of pox=<50 mild case. Vaccine storage in freezer WNL's at 3 F consistently.  Follow up on 07/19/04 states: "Diagnosed with chickenpox 05/04/04."
Information has been received from a nurse concerning a 22 year old female who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #658554/0928U), 0.5 ml, injection. Concomitant therapy included varicella virus vaccine live (MSD), hepatitis A virus vaccine inactivated (HAVRIX), and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On 19-OCT-2007, after receiving four vaccines, one being the first dose of GARDASIL vaccine (yeast) the patient experienced nausea, dizziness and decrease in appetite. The patient also received varicella virus vaccine live (lot# 658589/1274U) that same day. On 22-OCT-2007 the patient recovered from nausea, dizziness and decrease in appetite. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report as received from a pharmacist, also reported as an "employee" and as a "pharmacy manager", refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number were not reported). Concomitant medication was not reported. On an unknown date, 1 week after receiving ZOSTAVAX, the patient came down with a case of shingles. The reporting pharmacist stated that this event occurred in a different pharmacy. The outcome of the event was not reported. Causality was not reported.  Additional information has been requested.
Ache from the Moderna shot; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Ache from the Moderna shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (Ache from the Moderna shot). At the time of the report, MYALGIA (Ache from the Moderna shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
From the time of immun mom states child cried continuously & could not be consoled for approx 3hrs; rt leg became very "touchey"; MD advised Ped DT when seen for well baby check up APR91;
Happened at home per parent: Fever of 103 F, vomiting, loss of appetite, fatigue, facial redness. Gave Tylenol approximately 1-2 doses for her weight (per parent) and let her sleep. Seemed to improve more in the evening. Back to normal the next day.
9-20-2012 low back pain, right leg pain, foot numbness, 9-22-2012 weakness both legs. Flu shot on 9-17-2012.
Pt recvd DTP @ 330PM; suddenly awoke @ 7PM crying inconsolably w/high pitch, became pale, hypotonic, somnolent for 2 hrs, then resolved over 2-3 hrs;
I was fine the first day. The 2nd day I wasn't feeling well, my stomach was bothering me. At 8:30 PM I went to bed because I didn't feel good, I laid in bed for a few minutes and then jumped up because I began to violently vomit. After I vomited I felt weak, I was sitting with my back against the wall my husband came to check on me.  He walked away and when he came back I was unresponsive, laying on the floor and he said my eyes rolled in the back in of head. He called 911. I was unresponsive for about a 1-2 minutes. EMS arrived, by the time they had arrived I had crawled into bed, and they took my vitals and they were fine, they asked me if I wanted to go to the hospital but I declined as I was afraid to go. I went to sleep. The next day I felt weak and tired, I had a burning feeling in my stomach, I took some TUMS, I didn't much that day. I rested most of the next day. Yesterday I felt a little better and today I am fine. I have a doctor's appointment 2/26/2021 at 2PM to see the ARNP at my doctor's office.