chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller reports that she did have injection site pain after her first dose; This is a spontaneous report from a non-contactable consumer (patient).  A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced injection site pain after her first dose. Patient concerned that she did not got proper dose of vaccine because she has not had side effects after getting second dose of vaccine and reported a little bit spilled on her armed, once needle removed from her armed. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Covid Arm: large red lesion around the injection site, pain on left arm, shoulders, hips
the arm soreness is normal and she felt that with the first dose; had a slight headache with first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 08Feb2021 16:20 (Lot number: EL9261) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "the arm soreness is normal and she felt that with the first dose"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "had a slight headache with first dose". Therapeutic measures were not taken as a result of pain in extremity, headache.  Additional Information: The patient received the vaccine at care home for disabled. No investigation assessment was performed. It was reported that the patient knew "the arm soreness is normal and she felt that with the first dose". She had a slight headache with first dose. She did not take anything for it after the first dose and rode it out.  No follow-up attempts are possible. No further information is expected.
I started feeling nauseous. I had a fever. It got up to 102-degrees at its highest. I had a very sore throat. I didn't lose my appetite or sense of smell, but I had a weird taste in my mouth. As the day progressed, I started feeling worse. I got chills and couldn't get warm. I tested for COVID-19 at home that evening. The first test I took was a false negative. I tested again, and it came back positive. It progressively got worse. My sore throat got really painful for the next two nights. My doctor prescribed PAXLOVID. I took my last dose this morning.
Following dose 2 of Engerix-B pt exp pain @ inject site; pt thinks that MD may have injected vax in bone (arm);
Fever up to 103 degrees, vomiting (intractable without PHENERGAN) and large area of redness and induration 7cm x 11cm on L upper thigh where vaccine was given; also, child had leukocytosis 48 hours later.
FEELING TIRED/SICK, FEVER, HEADACHE, MUSCLE PAIN, RUNNY NOSE
Patient had received 2 primary Moderna vaccines at a different facility in March 2021 and April 2021 at the age of 16 before Moderna was approved for patients 12 and older. Patient's guardian failed to provide us with the information on the error previously made by the other facility. When asked if patient wanted to stay with Moderna for their booster the guardian agreed to it and failed to mention any previous errors or problems with previous vaccination.
1 hr p/vax n/v, 2 hrs p/vax n/v & pt became limp; transported to Er by pvt car;
Patient was given dose 1 of Pfizer 19MAY2021 at the vaccine clinic. Patient had surgery a few weeks later, and was told by separate staff that did their Covid test that they needed to restart their series because they were outside of 42 days since their first shot, incorrectly and against studies. The patient came back to the vaccine clinic and told staff they needed dose 1, and was given a dose of Moderna. Patient has had no known reaction since either vaccine, and is seen as dose complete.
I've gotten heart palpitations for several years. They are pretty minor, but for two days after getting the second dose of the Pfizer vaccine they got much stronger and more regular. After about a week they settled back to baseline, but I'm currently using a Holter monitor to check my heart.
After the first 24 hours I developed typical low grade fever and chills, but it was accompanied by random itching on my body, but not severe. However, on Sunday late afternoon (48 hours after injection), I developed hives on my neck, chest (predominantly) , inside of elbows, top of my feet and hands. It resolved overnight as if nothing happened. The neck area still had a rash, but controlled. The following Wednesday night (15th), I broke out in hives on the back of my legs, buttocks and back. Again, it resolved overnight, although my neck rash remains.
After Vaccines patient cried in pain for hours upon hours. She was completely unconsolable. She wouldn't drink anything or sleep. She just screamed in pain. This contained for about 5 hours until she finally passed out in my arms. She continued to wake up throughout the night screaming in pain. About 4 days after receiving the vaccines she developed a rash all over her body. Doctor said it was severe eczema. She stated that she had never seen a case so bad in an infant. She stated she had eczema in places where only adults normally get it.
Sleepy; Dizzy; Heavy weakness in left arm; Swollen lymph nodes above left clavicle; Flushing at night; Pain shooting up neck on left side; Still weakness; Not as alert/very disturbing; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 08:00 (at the age of 70-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on an unspecified date in 2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from 2009 and known allergies to sulfa and derma bond. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (DIOVAN) and unspecified statin; both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 13Apr2021, the patient experienced sleepy, dizzy, heavy weakness in left arm, swollen lymph nodes above left clavicle, flushing at night, not as alert, pain shooting up neck on left side that lasted more than a week first and second doses, the patient still had weakness and was very disturbed. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events  sleepy, dizzy, heavy weakness in left arm, swollen lymph nodes above left clavicle, flushing at night, not as alert, pain shooting up neck on left side that lasted more than a week first and second doses, the patient still had weakness and was very disturbed was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Bexsero given instead of Trumenba; This case was reported by a nurse via other manufacturer and described the occurrence of interchange of vaccine products in a adolescent patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 8th November 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of TRUMENBA. On 8th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was unknown. The reporter stated that, the patient received initial dose of Trumenba.  On 8th November 2021, the patient visited the clinic to receive second dose of Trumenba but was given Bexsero, which led to interchange of vaccine products. The reporter was contacted to find out what should be done, whether the patient be given a second dose of Bexsero or Trumenba, was the patient at risk or not. The reporter had no answers. The reporter consented to follow up.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 14-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is sone of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.). On 03-Nov-2021 at 2:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 73.38 years.  No concomitant products were provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 03-Nov-2021, temperature excursion at 10 AM, temp was 35 degree F , total doses given for the day was 117, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vial were moved to clinic. Vaccine BUD date was 05-Nov-2021. Vial was stored on cooler 1 , on 03-Nov-2021, Temperature log details were as   8 Am: 36 degree F, 9 AM: 36 degree F, 10 AM: 36 degree F, 11 AM:35 degree F, 12 AM:36 degree F, 1PM : 37 degree F, 2 PM : 36 degree F, 3 PM: 36 degree F, 4 PM: 37 degree F and 5 PM : 37degree F.  Vials were only punctured right before administration.  No treatment information was provided.
67 year old female admitted to local Hospital with chest pain.  The chest pain has been pesent for 2-3 weeks prior to admission. The patient was scheduled for a stress 10/7, overnight she had intermittent worsening chest pain . The chest pain was substernal, radiated to her left arm, and was described as an aching sensation. In the  EC she was hypertensive (185/74) and tachycardic (110's). A Level I AMI was paged due to EKG concerning for ischemia, with ST elevation in aVR and diffuse ST depression. Due to patient's hemodynamic instability and critical left main disease, patient was scheduled for emergent CABG on 10/7/2022. The patient was taken to the operating room on 10/07/2022 and underwent the
Woke up in middle of night. Left side of body covered in hives from head to toe. Left side side facial swelling.
Received Covid and flu vaccines in right deltoid on 11/23/22. Developed headache and right axillary lymphadenopathy on 11/24/22. 11/25 had metallic taste in mouth.
an 11 year old was given Daptacel instead of Adacel with no adverse event; an 11 year old was given Daptacel instead of Adacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00732363).  This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).   The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 18-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5743AA and expiry date: 06-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).   It was reported that "the child received Daptacel instead of Adacel and they knows "there is more in there" but wanted to know what to look for and if they should do anything?"   This was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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.
Patient had dizziness, but alert and oriented. Requested to lay down. Has hx of dizziness with needles. Dizziness resolved, patient stable, released from vaccination site.
No adverse affects reported.; Nurse called reporting improperly stored VARIVAX was administered to patient on 15-MAY-2020.; This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies or concomitant medications were not reported.  On 15-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error) (lot number S012036, which has been verified to be valid, expiration date reported and validated as 17-APR-2021), as prophylaxis (route of administration, dosage regimen and anatomical location were not reported). The administered dose of the vaccine experienced a temperature and time frame of 48.2 (units not reported) for 4 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects were reported.; Sender's Comments:  US-009507513-2005USA008243:
Red warm area 4x4 cm at site of VARIVAX administration at right thigh. Oral BENADRYL administered in office.
Presented in ED for rapid onset rash with itching from L shoulder to above elbow . ED noted this as probable COVID vaccine reaction and prescribed Claritin 10mg daily as needed for itching. Use cool compresses as needed.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: BLISTER FORMED 2 INCHES AWAY FROM INJECTION-Severe, Additional Details: LOOKS LIKE A BURN BLISTER JUST ONE ON ONE END OF BAND AID CONTACT SPOT
Developed a real stiff neck above the left arm, above the vaccine location.  Don't know if it's related to the vaccine, or not.
Case number PHEH2012US003706 is an initial spontaneous report received from a nurse on 13 Feb 2012 and a follow up received from the nurse on 29 Mar 2012: This report refers to four patients of unknown age group and gender. They were given only MenA component of MENVEO vaccine (Batch number: X100062) reconstituted with another diluent instead of MenCYW component intramuscularly on undetermined dates. The reporter stated that they were not sure if the vaccines were properly mixed. The patients were doing fine and not experienced any adverse events. The physician made a decision to revaccinate these four patients in a month. Follow up information received from the nurse on 29 Mar 2012: Updated number of patients involved, and decision taken by physician for the drug administration error.
My PMS was more painful than usual; Period post vaccine was more painful than usual; My basal body temperature was unusually high during the luteal period of my menstrual cycle; And was later than usual; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unknown date, patient basal body temperature was unusually high during the luteal period of menstrual cycle, premenstrual syndrome painful and period post vaccination was more painful than usual and was later than usual. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event basal body temperature was unusually high, premenstrual syndrome painful, period post vaccination and was later than usual was more painful than usual was unknown.   No follow-up attempts are needed. No further information is expected.
Fever reaching 102.5, chills, muscle aches 9 hours following vaccination Acute appendicitis - approximately 20 hours following vaccination
Left arm 6" x 4" oblong circle of red, warm, swollen, painful around site of injection.
Multiple 1mm macular rash all over body, fever, <1cm cervical and preauricular lymphadenpathy x 3.
Localized redness at injection site. 1 week post shot temp 101 degrees F.
Approximately 48 hours after receiving injection she began developing papular, erythematous rash to left arm spread throughout the day.  Following day same rash description occurred to right arm.  Papules clustered to left posterior leg, faint to anterior legs, anterior superior chest.
The following morning I was experiencing swelling in that arm along with  significant pain and tenderness. That lasted 48 hours, followed by swelling and tenderness in the armpit of the same arm. Along with bouts of intestinal pain throughout the following two days.
Highest temp measured 102, high pitched abnormal crying/screaming greater than 4 hrs;
nasal congestion and watery eyes directly after second dose Narrative: During COVID vaccination clinic appointment symptoms arose and was treated with cetirizine
Rash, itching 1 day post treatment.  Patient went to MD-received prescription for cyproheptadine 4 mg 2 times daily.
Patient presented one week pos vaccination with 2 days of easy bruising and petechiae.  Platelets were 4K.  Seen by doctor of hematology. Started on steroids with improvement to  21K and discharged.  Came back a week later with presyncope and chest tightness.  Platelets again 4K.  Treated with IVIG
Injury date 9/15/2009 - short of breath 9am Friday went to work still tired and SOB. Saturday felt more SOB not able to walk up/down halls w/o stopping. Chest hurting and felt disoriented 2am went to WLED got breathing TX. Sunday 4pm still SOB. Came to MCOH w/symptoms of SOB, PFT, 02 sat, XANAX, DX mild Gilliam - Barre reaction by Dr.
No symptoms until 8 days after shot was given. Symptom includes at site of injection and around the injected area, swelling, redness, inflamed, rash/hive like, at point of injection raised pimple like sympton
Fatigue, headache, malaise, chills, myalgia, pain at injection site, few hours after vaccine administration until the following day.
Information has been received from a 34 year old female research scientist who was vaccinated with a dose of what she thought was MMR II as a child. The reporter was then vaccinated with a booster dose of MMR II at college age. Within the last 2 months, in approximately February 2010 her titers were drawn. She failed to seroconvert. Her titers came back too low. At the time of the report, the outcome was unknown. Additional information is not expected.
1wk /p immun site of inject became itchy, reddened (size of an iron) swollen almost to elbow;
Abruptly started fever of 103.5 degrees Fahrenheit. She told me she was seeing spots and that her legs were tired. The following morning she woke up with a stomach ache and she threw up 3 times that morning. She has lost appetite and is not wanting to eat or drink much. I called the doctor's office and they said that it couldn't be from the vaccine that she probably got a stomach virus. She did not throw up again and still is complaining of stomach ache. The fever started getting lower and lower. I really don't think that it was a virus due to the quick onset of symptoms. She has not fully recovered, and I am hoping that she is back to normal within the next couple of days.
Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakness. Stroke Code activated at clinic where she works CT head neg TPA administered, transferred to ED for CTA and stroke care CTA neg  MRI pending but clinically improved