chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine administrated to patient subcutaneously instead of intramuscular/No AE; Initial information received on 26-Dec-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient who received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE] subcutaneously instead of intramuscular (incorrect route of product administration).  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) [lot number and other dosing details were not reported] via subcutaneous route in unknown administration site.  It was a case of actual medication error due to incorrect route of product administration.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Received vaccination around 9:20AM. At 7:30PM started feeling fatigued, chilled, headache, generalized muscle and joint pain. By 8:30PM was having severe chills and fatigue.  Went to bed, fitful night with waking every hour. Awoke at 7:20AM still fatigued and sore. No injection site redness or swelling, but minor soreness.  Have received flu vaccine every year since 1973 without incident.
Experiencing pain in the left arm/from the injection site down to the fingers; Experiencing pain in the left arm/from the injection site down to the fingers/Throbbing pain/painful, pain down to fingers; The problem is going extremely worse; She would stay awake at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Experiencing pain in the left arm/from the injection site down to the fingers"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Experiencing pain in the left arm/from the injection site down to the fingers/Throbbing pain/painful, pain down to fingers"; PAIN (non-serious), outcome "not recovered", described as "The problem is going extremely worse"; INSOMNIA (non-serious), outcome "unknown", described as "She would stay awake at night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller reported the Pfizer-BioNTech COVID-19 Vaccine which she received in 2021. She was still experiencing pain in the left arm, from the injection site down to the fingers. She describes it as a throbbing pain. She wanted to know if this side effect has been reported before. She said that nobody seems to be able to help her and the problem was going extremely worse. Stated she had the vaccine in left arm and her arm throbbed for months after. She had an X-ray. Throbbing was so bad, she would stay awake at night, painful, pain down to fingers. She doesn't know what to do. The throbbing hasn't gone away. Throbbing gets worse on a daily basis; never goes away. Caller felt that the report will just get sweeped under a rug. She was trying to fix this issue and wanted to speak to someone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Acute onset of vomiting and diarrhea. Has been ongoing for 6 hours. No fever or evidence of infection. No exposure to ill individuals, suspect foods or recent travel. Was healthy on day of vaccination.
Fever of 101.7 until 2/1/21 Blood pressure 169/110(with meds taken) Swollen lymph nodes under arm of shot site(to date) Stiffness in said arm Joint pain on left side of shot site
Per patient's wife the patient experienced severe head pain & confusion 2-3 days after receiving the flu vaccine. In the hospital the patient was told that his symptoms were consistent with a brain aneurysm. The doctor reportedly told the patient they did not think the symptoms were related to the flu vaccine but recommended that it be reported.
pt was vax on 9AUG94; brought to MD's ofc 25AUG; pt had devel a fatty dimple @ the Tetramune vax site; dx fatty necrosis; no tx prescribed;
Dizziness and nausea onset 17April. I went to the ER on 22April and there was also a man there with same symptoms and also had the Pfizer vaccine; Dizziness and nausea onset 17April. I went to the ER on 22April and there was also a man there with same symptoms and also had the Pfizer vaccine; This is a spontaneous report received from a contactable consumer (patient).  A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), at an unknown route at right arm on an unknown date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on unknown date as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 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 had dizziness and nausea on 17Apr2021. The patient went to emergency room on 22Apr2021 and there was also a man there with same symptoms and also had the Pfizer vaccine. The patient had not received any treatment for the events. The outcome of events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Low grade fever, Tylenol. Very bad lower intestinal distress (gas). No treatment
Patient assessed by this writer and PCP. Noted area of raised tissue to left deltoid, measuring approximately 12cmx6cm. Outer perimeter of induration noted to be mildly red. Effected area warm to the touch. Patient reports area is tender to the touch. Patient denies any further symptoms than described above. Patient alert and oriented. No shortness of breath.   Applied kerlix to area, secured with paper tape, per Dr.s' request. Patient advised, per Dr., to purchase OTC benadryl 25, take three times daily and ice the area.   Temperature at time of visit: 97.7 Fahrenheit.
This infant received vaccine at 9:30 AM, cried non stop from 12:30 -2:45 PM; per mom he was inconsolable. Seen at 4:50 PM and fussy, but exam was within normal limits.
Extremely aggressive behavior.  Is usually a very agreeable child, but was put in time out at school and kicked another child in the face.  Was aggressive at home and would not listen.  This behavior lasted for 2 days and gradually improved.
Client stated 3 wks. After injection in right deltoid he noticed a red spot on arm approx. 10 cm around that would weep a clear liquid when he rubbed it in his shirt.
Slight fever, L/arm 4x4 area red, nausea & vomiting, headache. Take Advil for H/A, ice to arm, Benadryl & fluids.
Information has been received from a physician concerning a 5 year old patient who on 22-MAY-2008 at 18:56 was vaccinated with a dose of ZOSTAVAX. The child was healthy and was not taking any medications. Additional information has been requested.
3 hrs p/vax pt devel fever (not measured) & vomited x 1; over next 24 hrs, devel photophobia & h/a w/persistence of fever & 2 more episodes of vomiting;
warm sensation and sense of impending doom TX: monitored - not reported to staff til later  Reported sxs to Urgent care on 1/5/21 - Fluids, Rest, OTC medication, covid testing 1/25/21- Allergy evaluation - adverse reaction not Allergic may have 2ND dose ~30min monitoring  2ND Dose 1/27/2021 - No problems
Information has been received from a nurse who heard from another healthcare professional about a male who this year, in 2010, was vaccinated with his first dose of GARDASIL. The nurse reported that the patient experienced fainted and tonic clonic movements immediately after vaccine administration in 2010. The outcome of the patient was not reported. No further information is available.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a fever, a headache and a blistered rash that first appeared on her stomach and spread all over. Three days post onset the pt recovered from the headache and 13 days post onset the pt recovered from the rash.
Severe tingling, aching, stabbing, piercing  pain in hip, left leg & left foot causing me to walk with a floppy foot.  I could not lift my left foot and I had no feeling in it for about 3 weeks. It was just numb. This started a few days after my second shot.  As of 04/12/21 the tingling, aching, stabbing, piercing  pain has subsided slightly.
Patient was administered an expired vaccine by MA. - No adverse reactions reported by mother.  Kinrix vaccine expired on 2/2/2021.  Vaccine was administered to patient on 2/3/2021.
Pt. had a syncopal episode after vaccines were administered.  She fell to the floor on her face from the exam table.  She was unconscious fro a few seconds, lower lip had a slight abrasion, no tooth pain, no loose teeth (confirmed by her dentist), pain  to nose and forehead, not bruising evident, slight amount of blood in both nostrils, no swelling.  Patient stayed in the office until 9:40am. 3/29 Mom called requesting a nose xray. 3/31 a follow up call made to Mom.  She had decided the xray would most likely not be necessary as pt. was doing better.
9 yo with no pmh presents with chest pain after second covid vaccine. Per mom got first dose in November and had many days of myalgias and fatigue. Was anxious to get second dose when when reviewing risks and benefits with pcp decided to get it on 12/2. He then developed similar fatigue and myalgias. No fevers. Tuesday evening he started to complain to chest pain and so mom called pcp and presented to the ED this morning. He is very active and participates in swimming and soccer.    In the ED he had stable vitals, normal ekg, and troponin elevated to 0.06. Transferred for management due to concern for post vaccine myocarditis.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: SEIZURE (medically significant), outcome "not recovered", described as "another who will be on anti-seizure medicine for the rest of their lives after taking the 2nd vaccine". Therapeutic measures were taken as a result of seizure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bumps on right side of face, swelling on right side of face, tongue, lip.  Light headed, diziness, sharp pain on right side of neck and right ear.  Bad headache for approximately 2-3 days with no relief even after taking 800ml Ibuprofen. Swelling has reduced and the bumps gone as of today but the pain in neck and ear comes sporadically.  Not back to normal or how I felt previous to shot.
Extreme abdominal pain with diarrhea, loss of appetite, nausea.  This adverse reactions are still present as of today's date at 12:21pm
swelling & redness 4" in diameter w/warmth present area hard to palpation; sx occurred w/in 24 hrs & lasted approx 1 wk; advised ice pack x 24 hrs, then heat to site w/eval by MD;
Patient received the vaccine and had slight chest tightness, had a slight headache and has mild nausea.   He worked the day and still has the symptoms at 1:30 pm
Child presented to physician on 8/8/06 with red, swollen area reported by NP to be size of baseball at injection site over left deltoid. On 08/09/06 child again seen by physician and swelling was subsiding. Parent report of slight fever 1-2 days, swelling lasted 3-4 days.
ON 1/21/2009 APPROXIMATELY @ 9:20 PM PATIENT RECEIVED A SHOT OF GARDASIL 0.5 ML IM.  PATIENT WAS ADVISED TO STAY FOR 20 MINUTES TO MAKE SURE SHE DID NOT HAVE ANY ADVERSE REACTION FROM RECEIVING THE GARDASIL.  ONE MINUTE POST IMMUNISTRATION PATIENT REPORTED FEELING WARM ALL OVER THEN FELL OFF EXAM TABLE.  PATIENT WAS OBSERVED FOR ANOTHER 20 MINUTES.  PATIENT REPORTED WAS FEELING FINE.  NO TREATMENT WAS NEEDED.  BY LEFT OFFICE AT 9:50 PM WITH MOTHER.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 01/27/2021 and 02/17/2021. They first tested positive for COVID-19 on 09/14/2021 at a clinic. They presented to emergency department on 09/17/2021 but it seems they were not admitted to hospital at that time. They were admitted to hospital on 09/28/2021 and an additional COVID-19 test was positive on this day. They were found to be having multiple complications and co-occurring conditions, including COVID-19 pneumonia, Psudomonas Pneumonia, Enterococcus Pneumonia, Acute Kidney Failure, and A-fib. A third COVID-19 test on 10/15/2021 was also positive. They remained hospitalized until their death on 10/22/2021.
Tiredness; Chills; GI tract cramps; Moderate pain during urination.; This is a spontaneous report from a non-contactable consumer, the patient. A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration on 10Mar2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration on 17Feb2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. On 10Mar2021, the patient experienced tiredness, chills, GI tract cramps and moderate pain during urination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, chills, GI tract cramps and moderate pain during urination was resolved on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
expired dose of Daptacel had been inadvertently given to a patient/No AE; Initial information was received on 13-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a two-year-old male patient who inadvertently received an expired dose (0.5 mL) of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (4th dose in series, lot C5367AA, expiry date: 30-Jan-2020) via an intramuscular route at the left thigh for prophylactic vaccination on 12-May-2020 (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due expired vaccine used.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PATIENT CAME TO WALK-IN VACCINE CLINIC WITH CARD THAT STATED SHE HAD ONLY ONE DOSE OF MODERNA.  SHE WAS GIVEN WHAT WE THOUGHT WAS DOSE 2 OF MODERNA AT THE CLINIC.  THE NEXT MORNING THE DOSE WAS BEING ENTERED INTO CAIR SYSTEM THAT REVEALED SHE HAD A JANSSEN VACCINE AND A MODERNA VACCINE AND WOULD NOT HAVE BEEN ELIGIBLE FOR THE VACCINE WE GAVE HER...IT WAS TECHNICALLY A THIRD DOSE SHE WAS NOT ELIGIBLE FOR.
On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.
lost sense of smell and taste; lost sense of smell and taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost sense of smell and taste) and AGEUSIA (lost sense of smell and taste) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (lost sense of smell and taste) and AGEUSIA (lost sense of smell and taste). At the time of the report, ANOSMIA (lost sense of smell and taste) and AGEUSIA (lost sense of smell and taste) outcome was unknown.            No concomitant medication reported. No treatment was provided. The action taken with mRNA-1273 in response to the event was not applicable.
sore arm; thrush; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ORAL CANDIDIASIS (thrush) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-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 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ORAL CANDIDIASIS (thrush). The patient was treated with NYSTATIN (NISTATIN) for Thrush, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and ORAL CANDIDIASIS (thrush) had resolved. Not Provided          Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Significant FU appended: Treatment medication nistatin was added and outcome of event thrush was updated to resolved.
Chest pain and trouble breathing ending in ER visits on Jan 11 and 16, intermediate cardiologist visit Jan 14.  Significant increase in blood pressure with any exertion (160/100 after 1 flight of stairs with "one sentence" dyspnea, my baseline ~120/80, baseline weekly exercise of 4 - 8 miles running and 1+ hours strength training).  Chest pain @ 2/10, some radiation to left arm.  Resolved in ER with IV Toradol.  Spontaneously resolved after ~2 weeks.  Subsequent persistent chostocondritis, no dyspnea.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Positive Flu B test; This case was reported by a other health professional via call center representative and described the occurrence of influenza b virus infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced influenza b virus infection. On an unknown date, the outcome of the influenza b virus infection was unknown.   It was unknown if the reporter considered the influenza b virus infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but it was selected as an adult as per vaccine indication. Twelve hours after vaccination, the patient was tested positive for influenza B virus. The reporter did not consent to follow up.       Lab Comments: Lab test performed on an unknown date
Fever Chills Fatigue Nausea Headache  Sore injection site