chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix was administered to a 3 year old; Was the 3rd dose in series for Dtap; received kinrix in Lt. Vastus Lateralis; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site were 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 patient received Kinrix in Lt. Vastus Lateralis, which led to vaccine administered at inappropriate site. The Kinrix was administered to a 3 year old and this was their 3rd dose in series for Dtap, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. No reactions reported. The reporter consented to follow up.
intense pain at injection site for 3-4 second duration of administration; moderate pain in upper left arm immediately after withdrawal of needle; inability to move left arm for 2 days after the injection  without moderate pain. Currently dull ache in upper left arm
Positive COVID case; Positive COVID case; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Feb2021 (Lot number: EL3247) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: sulfa drugs" (unspecified if ongoing), notes: Known Allergies: sulfa drugs; "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient took concomitant medications (Junel Birth Control). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 01Feb2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Positive COVID case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive. If Other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: Yes
Vomited; Short of breath; does not feel well; he was feeling like he was having a panic attack; feeling extremely anxious; This is a spontaneous report from a contactable consumer or other non-healthcare professional (parent).A 18-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation : solution for injection, Batch/Lot Number: EW0150; Expiration Date: 31Jul2021), via an unspecified route of administration in the left arm 09Apr2021 12:15 (at the age of 18-years old) as DOSE 1, SINGLE for covid-19 immunisation in hospital. Medical history included penicillin allergy, anxiety (He has anxiety issues).The patient previously took Amoxicillin and experienced allergy. There were no concomitant medications. History of all previous immunization with the pfizer vaccine considered as suspect was reported as none. No additional vaccines administered on same date of the pfizer suspect was reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine . On 09Apr2021 13:00, the patient experienced feeling extremely anxious and was feeling like he was having a panic attack. On 09Apr2021 13:45, the patient experienced vomited. On 09Apr2021 13:15, the patient experienced short of breath, does not feel well. The reporter was reporting on his son. They both had their first dose of the Pfizer vaccineon the day of reporting.The reporter appointment was at 12:00 and his son at 12:15.They waited onsite as instructed after the vaccine. They went home and then his son felt anxious. He has anxiety issues and he would get like this before so at first he did not think it was related to the vaccine. He had to lay down. He began feeling this way an hour later and then he puked.The Caller asked could it cause this. He has never had this.His son was anxious and walking around, does not feel well, short of breath.Caller thinks this may have anything to do with the vaccine, but that why he was calling to find out.As report proceeded, caller's son was still anxious, but had not vomited again. Caller added his son was allergic to Amoxicillin and Penicillin and the staff was told this prior to his son receiving his first dose. His son has not been diagnosed with anything like this. Caller was contemplating bringing his son back there. He does not know what to do and how to help his son.No emergency room/physician office visit was reported. The outcome of the event feeling anxious was not recovered .No relevant test was reported. The outcome of the events panic attack, vomiting, shortness of breath, does not feel well was unknown.  No follow-up attempts are possible. No further information is expected.
Pt uses a walker, upon moving to observation area, patient fell trying to sit down.  Pt states he simply missed the chair.  He has very thin skin and suffered several skin tears.  We applied pressure and bandaged wounds and observed pt for 30 minutes.  He did not hit his head.  Followed up with pt's wife next day and she reported that his arm was sore, but no other complaints.  I recommended they see a Dr. for his skin tears.
Patient came to receive her second dose of MMR, MMRV administered inadvertently IM in patient's left deltoid, Patient appeared to tolerate immunization well.  no obvious S/SX of ASE r/t inadvertent vaccine administration observed while patient remained in the clinic.
Pts parent reported hypotonic/hyporesponsive episode which occurred 24 hours post vax.
My stomach was in knots by evening, lots of gut issues, right arm was tender as expected but it extended to the underarm as well and radiated down. Felt malaise. Treatment was rest and Tylenol.
Positive for Covid-19 after receiving vaccine; burning; tingling; numbness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for Covid-19 after receiving vaccine), BURNING SENSATION (burning), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Respiratory disorder (Chronic respiratory conditions, asthma) and Obesity.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020 at 12:00 PM, the patient experienced BURNING SENSATION (burning), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness). On an unknown date, the patient experienced COVID-19 (Positive for Covid-19 after receiving vaccine). At the time of the report, COVID-19 (Positive for Covid-19 after receiving vaccine) outcome was unknown and BURNING SENSATION (burning), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up information included reporter details, patient demographics details , product details, event information and causality.
THROWING BLOOD CLOT; PNEUMONIA; DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, 01 total was administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, shortly after vaccination the patient health went south and was throwing blood clots, had pneumonia and could not get rid of it. The patient went into the hospital alive on 03-MAY-2022 left in a body bag on 12-MAY-2022 (hospitalized for 9 days) and on an unspecified date in MAY-2022  the patient died from unknown cause of death. It was unspecified whether an autopsy was performed or not. As per the consumer, "my sister had the same thing happen to her. She got the and shortly after her health went south and was throwing blood clots, had pneumonia and could not get rid of it. She went into the hospital alive 03-MAY-2022 left in a body bag 12-MAY-2022. The kill" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2022, had not recovered from pneumonia, and the outcome of throwing blood clot was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221163787- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20221163787- Throwing blood clot, Pneumonia. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
approximately 5 hours after receiving the vaccine, she noticed an elevated heart rate 99-138 bpm
Slight cough; raspy, asthmatic wheezing a little worse Sat morning. Coughing up some greenish phlegm.
Severe headache that lasted 2 days and prevented me from doing my day to day activities. 11/5/2009 MD records 10/27/2009, patient with c/o's headaches. Tx:  ES tylenol.
Sterile water instead of the sodium chloride  0.9% was used as diluent for the vaccine. NO POST VACCINATION SIDE EFFECTS NOTICED
This patient received MMR on 08/01/01 on 08/11/01 he broke out with severe rash and had a high fever of 102. On 08/13, he went to his MD, got a prescription for Atarax, still covered with rash and temp of 100.Is presently on quarantine.
FELT BILATERAL LUNG CONGESTION  (Lung congestion,  Pulmonary congestion)  BILATERAL SIDE PAIN  (Flank pain,  Flank pain)  VOMITING  (Vomiting,  Vomiting)  LEFT ARM PAIN  (Painful L arm,  Pain in extremity) DIFFICULTY BREATHING  (Difficulty breathing,  Dyspnoea) MISSED WORK TODAY  (Loss of personal independence in daily activities,  Loss of personal independence in daily activities)  PAIN WHEN BREATHS  (Painful respiration,  Painful respiration) FEVER OF 100 F  (Fever,  Pyrexia) FATIGUE  (Fatigue,  Fatigue) This spontaneous report received from a patient concerned a 52 year old male.  The patient's weight,  height,  and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s  (suspension for injection,  intramuscular,  batch number: 1805018,  expiry:  UNKNOWN)  dose was not reported,  administered on 10-MAR-2021  for prophylactic vaccination.  No concomitant medications were reported.  On 10-MAR-2021  (mentioned as yesterday),  the symptoms of the patient started,  and he missed work today  (loss of personal independence in daily activities)  and left arm pain  (painful  L arm)  because he was not feeling well.  The reporter advised him to contact his primary care provider,  but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room.  The patient agrees to go to the Emergency Room.  On 11-MAR-2021,  the patient experienced bilateral side pain  (flank pain) , vomiting,  felt bilateral lung congestion  (lung congestion),  difficulty breathing,  fever of 100 F,  fatigue,  pain when breaths  (painful respiration) . Laboratory data included:  Body temperature  (NR: not provided)  100 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from fever of 100 f,  had not recovered from bilateral side pain,  left arm pain,  fatigue,  vomiting, difficulty breathing,  feels bilateral  lung congestion,  and pain when breaths,  and the outcome of missed work today was not reported.  The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain,  left arm pain,  fatigue,  vomiting,  difficulty breathing,  feels bilateral lung congestion,  pain when breaths,  fever f 100 f and missed work today as possible.  Company causality between Covid-19 vaccine ad26.cov2.s  and event bilateral side pain,  left arm pain,  fatigue,  vomiting,  difficulty breathing,  feels bilateral  lung congestion,  pain when breaths,  fever of 100 f and of missed work today as possible.  This report was serious  (Other Medically Important Condition).
No additional AE reported; Temperature excursion of 47.9°C for 47 min; This spontaneous report was received from a medical assistant referring to a 2-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 01-DEC-2022, doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 47.9°C (Celsius degrees) for 47 minutes which occur as a result of a reading from a digital data logger (product storage error).  On 16-DEC-2022, the patient was vaccinated with previous doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #W006596 with an expiration date on 11-OCT-2024), administered intramuscularly in left thigh for prophylaxis (strength and dose were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1892784 with an expiration date on 03-DEC-2023), administered orally for prophylaxis (strength and dose were not provided).  No adverse events were reported.
In September 2007 patient had her very first seizure. Then on February 14 2008 she had a second seizure. On March 8 2008 she began to have some weakness in her right arm. I took her to the emergency room the next day when she was no longer able to move her arm. It was paralized, from her shoulder to her finger tips.After admitting her to the hospital, her arm became extremely painful.She was on morphine for 3 weeks. The pain went away but her arm is still paralized, with some slight improvem7/21/08-records received for DOS 3/08-3/23/08-DC DX:right brachial neuritis or plexitis. Right arm weakness and pain. Seizure disorders. Constipation. Previously healthy until September 2007, presented in September with altered level of consciousness. Asymptomatic until February 14, presented with altered consciousness.Two days prior to admission felt twitching in right arm, progressed to pain with noted weakness. Work-up negative for stroke. No seizure activity while in hospital.
I have an internal lump in my right armpit. It was disappearing for a few days but came back by the week's end following the Covid-19 vaccine.
Onset of rash 6/13 starting at inner thighs, progressing throughout legs and arms, more densely distributed at inner thighs and feet.  No rash on face or trunk.  Rash can be described as mildly pruritic marginated wheals most with central clearing.  There are no other positive findings such as fever, pain, lethargy, cold symptoms, lymphadenopathy, arthritis.  During office visit, patient alert, playful and in NAD.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not reported. On 04-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date; 21-JAN-2017; dose and route were not provided). The vaccines underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 16 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
7JUL92 pt recvd 2nd dose of Engerix-B & exp inject discomfort & hand tingling; 9JUL92 devel exhaustion & achiness all over; 12JUN92 devel myalgia, vocal cord paralysis & aperature of airway dec 50%; 14JUL92 clinic visit for voice problems;
Bexsero second dose 2 years apart; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 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.   Previously administered products included Bexsero (1st dose received in July 2019).   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: Health care professional (HCP) wanted to see how to proceed with the second dose because GlaxoSmithKline studies were developed upto 6 month apart but not with 2 years apart. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Bexsero, later than the recommended interval, which led to lengthening of vaccination schedule.
shaking; slowness; eye rolling up; Initial information was received on 01-May-2020 regarding an unsolicited valid non-serious case received from a physician  This case involves a 5 month old female patient who experienced shaking (tremor), slowness (bradykinesia) and eye rolling up (eye movement disorder), while she received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13); and ROTAVIRUS VACCINE.  On 30-Apr-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ214AAA, expiry date 23-Apr-2021, vial) once via intramuscular route in the left thigh for prophylactic vaccination  On 01-May-2020, the patient visited the physician.  On an unknown date in the morning, the patient was resting with father and it was noted she appeared on the slow side (bradykinesia), her eyes rolled up (eye movement disorder) and she began to shake (tremor) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.. The patient was normal except maybe alittle slower and had no history of seizures.  Final diagnosis was tremor, bradykinesia and eye movement disorder.   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown.
Information has been received from a registered nurse concerning an 18 year old female patient who on 14-SEP-2009 was vaccinated with the third dose of GARDASIL (lot # 0670Y, intramuscular route). The patient received her first dose on 31-DEC-2008 and her second dose on 19-Mar-2009. There was no concomitant medication. The registered nurse reported that 12 hours after the third dose the patient began to feel achy, tired and nauseous; about an hour to two after that, the patient experienced fever of 103.4 degrees F. The registered nurse reported that the patient took ADVIL throughout the night and on 15-SEP-2009 the patient had a low grade temperature of 99.6 degrees F. No lab diagnostic studies were performed. The patient sought medical attention by calling the physician's office. On 16-SEP-2009 the patient was recovered. Follow-up information was received from the registered nurse who reported that the 18 year old female patient with no known allergies, on 12-SEP-2009 was vaccinated at home with the third dose of GARDASIL (lot # 0670Y) intramuscularly into her right deltoid at 19:00 hours. The nurse reported that the patient's mother called on 13-SEP-2009, advising that she had given the patient 12 hours earlier HPV vaccine, and the patient reported feeling "achy" all day; and that at 19:00 hours the patient had a temperature of 103.4 degrees with fatigue and nausea. On 14-SEP-2009, the patient recovered. There was no illness at the time of vaccination. No further information is available.
Patient returned to pharmacy on 1/6/11 after receiving vaccine on 10/15/10 saying that she had an "allergic reaction" to a vaccine & wanted info. Says she had red, itchy eyes, swelling of lips/face (slight), cough/wheeze (but no compromised airway) for about 24 hours. Didn't see MD attention. Took BENADRYL (she is a nurse). Patient suffered no long-term complications & recovered 100% after approximately 24 hours.