chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 08-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was scheduled to receive 1st dose of Pfizer (pediatric) dose (0.2ml/0.10meq). She received the Pfizer (adult) dose (0.3ml/30meq). There were no signs/symptoms from the time of injection and departure.
Vaccination small pox, left shoulder, excess redness est. 70 x 55mm; gauze dressing placed recommend air dry 30min at hs; TYLENOL. Seen 16 JAN 09, less red states less itching.
the shipment had been in transit to long with no AE; FLUZONE HIGH DOSE QUADRIVLAENT administered after the vaccine was in transit to long with no AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old male patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ546AA, expiry date: 30-Jun-2021) via intramuscular route and left arm site on an unknown date for prophylactic vaccination which was administered after the vaccine in the shipment had been in transit to long (product storage error and product distribution issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was given to the patient.  It was an actual medication error due incorrect product storage.  It was a case of product shipment delay.  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.
Sore right underarm and right side of neck.  Swollen lymph nodes right underarm, upper chest on right side and right side of neck in front.
MD stated that a boil had formed at site of injection - area of skin around site (about 1" x 1/2") was red & hard.
pt recvd vax; 1 & 1/2 days later  exp stomach cramps, d & n;
Swelling the size of an orange under the armpit of the same arm that received vaccine dose two days following injection. Followed by swelling in same side hand 24 hours after swelling under armpit. Sought medical care and was told to take 600 mg, 3 times daily ibuprofen and to elevate hand. Hand was also wrapped to provide compression. After 2 days of beginning treatment, sx resolved.
3/31/13 - 11: A.M. Chills, fever. Upset stomach - vomit thru 4/2/13. 2 1/2 days after shingles vaccine.
Initial report received from a healthcare professional on 08 August 2013. A 10-year-old male patient had received first dose of DT (For Pediatric Use) (batch number: C4161AA, expiry date: 27 October 2014) intramuscularly in the left deltoid and first dose of BOOSTRIX vaccine (other manufacturer product, batch number: 739Y2, expiry date: 19 April 2015) intramuscularly in left deltoid on 06 August 2013. The patient had no illness at the time of vaccination. The patient was allergic to eggs and peanuts and his concomitant medications were not reported. The patient received DT and BOOSTRIX vaccine on the same day instead of MENACTRA. On 07 August 2013, 1 day after vaccination, the patient developed redness, swelling, warmth and discomfort at the injection site. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from the event. Follow-up information received from a healthcare professional on 23 September 2013. On 08 September 2013, the patient had recovered from events. Documents held by sender: none.
First symptoms were headache, tiredness, and body aches. Later on in the evening, I was extremely nauseous and bloated. I vomited and had chills. I vomiting food, but during the night was only vomiting/burping air. The vomiting and nauseous happened throughout the night. In the morning, I felt better and my body aches was decreasing. But I am still bloated and gassy. The vaccine seemed to trigger back my acid reflux that I've dealt with months ago. Also, I feel tired still
Mother states, "When child got up this morning his right arm,  shoulder, neck and back was swollen and red." No fever reported.
yet to experience a herpes cold sore type outbreak/herpes outbreak suppression; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (yet to experience a herpes cold sore type outbreak/herpes outbreak suppression) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Concurrent medical conditions included Oral herpes (Semi-annually for the last 10 years).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (yet to experience a herpes cold sore type outbreak/herpes outbreak suppression). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (yet to experience a herpes cold sore type outbreak/herpes outbreak suppression) outcome was unknown.            No concomitant medications were reported.  It was reported that, since getting COVID-19 and the subsequent 2 doses of the Moderna vaccine (approximately since Jan-2021), the patient yet to experience a herpes cold sore type outbreak.   No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Rec'd Vaccine and at 2:38 associate C/O burning/tingling in throat. Advised to take Benadryl but declined.
the injection site is red, itch, hot and swollen, as it would be if I having an allergic reaction to a bee sting. Benadryl creme and ice are the two things that give some momentary relief.
Pt. reported to vaccinator (EMS), and nurse, present in Pfizer vaccination area at a Health Center, that she was beginning to experience numbness to her lips and itchiness to her tongue at approximately 0935 after receiving her second dose of Pfizer per proper protocol. The information was reported to this nurse. This nurse obtained Pt?s VS at 0937: 98.0-140/101-88-20 and 0939: 98.0-140/98-88-20. Pt.?s symptoms did not subside. Pt. remained alert and oriented x4. Pt. gave consent for this nurse to administer Epinephrine. Epinephrine administered at 0942 per proper protocol. EMS contacted. Administrative Manager contacted and informed. Pt.?s symptoms subsided. EMS arrived at 0950. Pt. agreed to transport to ER for evaluation/ treatment. Pt. transported via gurney at 0955.
p/vax pt devel tingling & pain;pt devel fevers & an itchy, real rash over lt breast;pt c/o numbness of tongue & diff speaking;pt c/o fevers, sweats;whole lt side of body numb & tingling;dx mononeuropathy mult vs brachial plexopathy;
34wk 4d pregnant at time of shot.  Experienced mild fatigue and malaise day after shot.  Three days after shot developed sciatica on right side.  Likely pregnancy induced.  Not yet resolved.
face, lips & arm swollen w/in 10hr, feeling bad;tx w/Medrol dose pak;many flu vax in the past w/o incidents;
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Per pt on left thumb  - developed itchy callus on thumb pad that has not resolved.  Happened 7 days after vaccine administration, not diagnosised by md
This spontaneous report was received from a other health professional and refers to multiple patients of unknown age. On unknown dates, those patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M039060 for prophylaxis. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010566: US-009507513-1708USA006667.
Tested positive for covid 19; female patient ( in late 70s or early 80s) got the Pfizer covid vaccine first dose in mid Jan and a  week later she was tested positive for covid. Caller stated its been 90 days can the patient get her second dose or they need to start all over again; This is a spontaneous report from a contactable pharmacist. An elderly female patient in her late 70s or early 80s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included neoplasm malignant. Patient was a cancer survivor. The patient's concomitant medications were not reported. On unspecified date two weeks later of the first dose she tested positive for covid 19, she was given an antibody injection in the beginning of February and is now wondering if she still needs the second dose or should she start the series over with the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Only 16yrs and older approved for booster.  Gave a 14 yo male a booster when not approved.
Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX in 2013 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2016, patient was treated by a physician for the onset of a painful vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient experienced mild soreness for the first 2-3 days as expected from the flu shot. First severe pain occurred about a week after the shot. It was dull pain at the time but every now and then, he is experiencing excruciating pain that feels like he was stabbed in the neck or shoulder which lasts about 1-3 minutes, then returns to dull pain.
7 patients have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Date the vial was initially stored in the refrigerator on 8-Mar-2022 (5 doses) and 30-Mar-2022 (2 doses) Dates of administration of vaccine on 29-Mar-2022 gave 1 dose, 31-Mar-2022  gave 4 doses and 05-Apr-2022 gave 2 doses. The vial did not undergo any temperature excursions. The patient did not experienced any side effects.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up information included-Dates of vaccine Administration updated
G47.33 OBSTRUCTIVE SLEEP APNEA 11/11/2021 PRESENCE OF CARDIAC DEFIBRILLATOR J96.00 ACUTE RESPIRATORY FAILURE 5/6/2021 PRESENCE OF CARDIAC DEFIBRILLATOR R57.0 CARDIOGENIC SHOCK 11/6/2021 PRESENCE OF CARDIAC DEFIBRILLATOR G47.33 OBSTRUCTIVE SLEEP APNEA 11/11/2021 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 5/6/2021 ACUTE RESPIRATORY FAILURE R57.0 CARDIOGENIC SHOCK 11/6/2021 ACUTE RESPIRATORY FAILURE G47.33 OBSTRUCTIVE SLEEP APNEA 11/11/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED    CHF, STAGE D J96.00 ACUTE RESPIRATORY FAILURE 5/6/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED    CHF, STAGE D R57.0 CARDIOGENIC SHOCK 11/6/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED    CHF, STAGE D G47.33 OBSTRUCTIVE SLEEP APNEA 11/11/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 5/6/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 11/6/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G47.33 OBSTRUCTIVE SLEEP APNEA 11/11/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 5/6/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 11/6/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G47.33 OBSTRUCTIVE SLEEP APNEA 11/11/2021 CARDIOGENIC SHOCK J96.00 ACUTE RESPIRATORY FAILURE 5/6/2021 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 11/6/2021 CARDIOGENIC SHOCK G47.33 OBSTRUCTIVE SLEEP APNEA 11/11/2021 PALLIATIVE CARE J96.00 ACUTE RESPIRATORY FAILURE 5/6/2021 PALLIATIVE CARE R57.0 CARDIOGENIC SHOCK 11/6/2021 PALLIATIVE CARE
It looks like the patient received a 3rd dose of Moderna. 1st dose listed - 1/20/21. 2nd dose listed - 3/14/21. 3rd dose given 4/13/21.
Peripheral neuropathy; Testicle pain; This spontaneous case was reported by a pharmacist and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy) and TESTICULAR PAIN (Testicle pain) in a male patient of an unknown age 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, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy) and TESTICULAR PAIN (Testicle pain). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy) and TESTICULAR PAIN (Testicle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment details was not provided by the reporter. It was reported that the patient's primary care physician (PCP) was suggesting that he get Pfizer as his second dose.  Company Comment This case concerns a male patient with unknown age, with no reported medical history , who experienced non-serious unexpected events of peripheral neuropathy and testicular pain which occurred on an unknown date with the 1st dose of mRNA-1273 Vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the events is unknown. . The benefit -risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.; Sender's Comments: This case concerns a male patient with unknown age, with no reported medical history , who experienced non-serious unexpected events of peripheral neuropathy and testicular pain which occurred on an unknown date with the 1st dose of mRNA-1273 Vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the events is unknown. . The benefit -risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.
Rash developed 1 week ago. Has lesions on abdomen and groin some have crusted over. Currently 3 pustules.
A nurse reported that a 3 month old child received the 2nd shot with Tetramune vaccine as well as the 1st with Orimune on 3/11/1995. The child then received 2 doses of ACT-HIB DTP on 6/21/1995 and 3/18/1996, respectively. Subsequent to completion of the primary series of DTP-HIB vaccines, the child developed a headache on 5/27/2000 and was seen in the physician's office. The child was hospitalized where a dx of haemophilus B infection was made. The child was treated with Ceftin and recovered.
Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been given a flu shot early that day. Patient died after receiving a HIGH DOSE flu shot on the morning of 11/21/12. The shot was administered at pharmacy. The shot was given to the patient at approximately 11:00 am on November 21, 2012. By late afternoon the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion. The patient spoke with his eldest son late that evening by phone and told his son of his symptoms and the fact that he had been giving a flu shot early that day. At approximately 10:30 pm on 11/21/12 the phone conversation ended with the patient stating that he was going to the bathroom because he did not feel well. The next morning the patient did not respond to phone calls or knocking  on the door by relatives. Upon gaining entry to the home, the patient was found dead on the floor between his bedroom and bathroom hallway. The patient was naked and face down on the floor when found. The patient had no history of heart problems and had never experienced a heart attack.
tired and cold; tired and cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date 11Nov2021 10:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "We contracted Covid 19", start date: Nov2020, stop date: Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time (24hr): 11:45 AM, Anatomical site of the injection: Right arm, Batch/lot number: EL32A8), administration date: 28Jan2021, for COVID-19 immunization, reaction(s): "Chills", "fever", "fatigue"; Bnt162b2 (Dose 2, Time (24hr): 11:50 AM, Anatomical site of the injection: Arm), administration date: 18Feb2021, for COVID-19 immunization, reaction(s): "Little tired". The following information was reported: NASOPHARYNGITIS (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "tired and cold".  Additional information: Patient contracted Covid 19 in Nov2020. Had it for 5 weeks. At one point, they checked into the Emergency Room at their local (Hospital withheld) because they were not well, and wanted to make sure that they didn't have pneumonia. He was coughing a lot, along with the other Covid 19 symptoms such as extreme fatigue. The hospital ran them through their protocols for Covid 19, and determined that their lungs were clear. The patient was given 5 steroid tablets and sent home to recuperate. Fortunately they have good neighbors who checked on them, and brought them groceries. The patient didn't feel as bad as his wife did after booster, he was tired and cold, but his reaction lasted for about one day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial information was received from consumer refers herself, an approximately 38 years old female patient (weight 145 unit not specified, height 61 inches) with allergy to all narcotics, codeine allergy and valium allergy, who in November 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). No other co-suspects were reported. Concomitant medications included tramadol hydrochloride and steroids (unspecified). It was reported that the patient had a case of shingles on 14-NOV-2011, had a tingling sensation on her back and had "little reddish pimples" the size if the hand. Treatment was given for the event. No laboratory test was performed. It was reported that the patient sought medical attention. The patient's outcome was unknown. Additional information is not expected.
Reported warmth of right upper extremity after vaccine given.  States "feeling weird" within 24 hrs. of vaccine.  On 12/20, approx. 1923 hrs. presented to the ER with twitching, fasciculations of the facial muscles, ataxia, vertigo, severe headaches with photophobia and "feeling weird".
Trunk erythematous rash along elastic wait band and few scattered pink papules on the knees that blacken.
on 05/28/2021 Client recieved a pfizer (covid 19) vaccine lot ew0180 expiration 08/2021 which was diluted with 0.8ml of the correct diluent lot 6023824 expiration 03/23 instead of 1.8ml. patient was injected 0.5 ml by IM route to right arm at 05:15pm. patient was contacted by pharmacist "invalid phone number". no adverse effects reports.
Case number PHEH2015US025338, is a spontaneous report initially received from a nurse on 02 Dec 2015. This report refers to a 32-year-old female patient. Past medical history and concomitant medications were unknown. The patient was a smoker. Vaccination history included administration of FLUVIRIN and it was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 1516401) via intradermal route at a dose of 0.5 ml on 30 Nov 2015 at 4 pm. On the same day after vaccination the patient experienced redness, swelling and itching at the injection site. The patient experienced 3 centimeter redden raised area where flu vaccine was given intradermally that was to be a Tine test (TB) given by mistake. The patient was given lidocaine/hydrocortisone cream. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported. Follow up information received from a Nurse on 12 Jan 2016: Vaccination history, patient's history and events description was updated.