chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 7-year old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2302USA000400: US-009507513-2301USA010889: US-009507513-2302USA000401: US-009507513-2302USA000445:
severe pain at the site of injection; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced severe pain at the site of injection for five days.
1 week after receiving the vaccine, a rash at the injection site developed - red, itchy & warm to touch. She took Benadryl two days & symptoms have resolved
pt recv vax; fever of 105.8 on 4jun95 & was irritable;
I had the normal side effects after my second dose (chills, fever, achey, vomiting), but 4 days after my vaccination, I woke up in the middle of the night out of sleep having chest tightness and heart palpitations at 3:45am. I tried drinking water, using the bathroom, and taking deep breaths, but the tightness and racing heart didn't go away. By 4am, I was having a friend drive me to the ER.  The tightness was gone by the time I was admitted and they started running tests.
I got the bivalent vaccine and flu shot on Monday at 2:15 p.m. On Wednesday morning,  I woke up with a red, itchy, scaly rash around my mouth.
some child may have received 2 doses of NIMENRIX instead of GARDASIL 9; no additional AE reported; This spontaneous report was received from a consumer and refers to a child patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown dates, the patient may have been vaccinated with two doses of meningococcal vaccine A/C/Y/W conj (TET TOX) (NIMENRIX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) instead of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot #, expiration date were not provided) for prophylaxis (wrong product administered). There was no additional adverse event reported.  This is one of two reports from the same reporter.
Severe Chills and very high fever, headache, nausea, light headed, severe cramps
4 Days after 2nd injection I woke up having pulsing in my ears, I was very lightheaded and nauseous as if I was having motion sickness at 11 a.m.   I checked my blood pressure and it was extremely high,   Over the course of 15 minutes, I got a pain in my shoulders, and could barely walk.  I check my blood pressure again it was 180/120.  My stomach was upset and I had to crawl to the bathroom, too dizzy to walk.  I checked my blood pressure again and it was 178/130.    My head was pounding and I was losing my ability to walk.    I was taken to the Emergency Room, I wasn't sure if this was a stroke or Heart attack, or neuro problem.  I was admitted for two nights and released on January 19, 2021.   I still had extremely high blood pressure and motion sickness. The hospital did several tests and ruled out a heart attack and stroke.     As of today, I am still undergoing treatment for high blood pressure.  I had no issue with this before the vacine
Fatigue; soreness; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 32-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration in left arm on 06Mar2021 at 04:15 PM (at 32 years of age) as single dose for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient did not have COVID prior to vaccination. Concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and soreness. The patient was not tested for COVID post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
no adverse event---just mixing error---multi diluent vial was used more than once to mix with covid
Gave vaccine. Redness began. Patient started with redness. Increase spread on arm. Came to pharmacy. Referred to urgent care. Dr gave antibiotic.
Information has been received from a physician concerning her 20 year old daughter who wears eyeglasses and in the "end of August 2008" received her first dose of GARDASIL. The patient had no drug allergy. Soon after receiving the vaccination, the patient experienced a change in vision in one eye. The patient sought medical attention and it was diagnosed as keratitis by an ophthalmologist. The patient's keratitis persisted. Additional information has been requested.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant male patient who received FLULAVAL (batch number 5ZP94, expiry date June 2015). On an unknown date, the patient received FLULAVAL .25 ml. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: Nurse reports that she administered a FLULAVAL vaccine to a patient who is under the recommended age for FLULAVAL, no other AEs were reported. This case is one of the 2 cases reported by the same reporter for the same vaccine.
Pain and eventually rash on the back of neck, that was later diagnosed as Shingles.
Severe constipation, loss of appetite, severe aggression and behavioral health issues, worsening of eczema.
PATIENT BECAME FAINT, AND HOT AFTER RECEIVING VACCINE. PATIENT THEN WENT UNCONCIOUS, HIT HEAD ON FLOOR AND IS BELIEVED TO SEIZED FOR APPROXIMATELY 20 SECONDS. PATIEN THEN BECAME CONSCIOS, STATED HE WAS STILL FAINT AND LIGHT HEADED AND WAS SEATED UNTIL EMT ARRIVED. EMT CHECKED PATIENTS VITALS, RECOMMEND PATIENT BE SEEN AT NEARBY HOSPITAL TO EXAMINE PATIENT. PATIENT THEN WALKED OUT OF STORE WITH EMT PERSONELL AND GOT IN AMBULANCE
8 hours after receiving the vaccine, I started to experience fever, chills, and headache. Upon waking the following morning, I had body aches, headaches, and chills.  The 2nd day after receiving the vaccine, one of my lymph nodes, along my left collar bone (left arm injection) became swollen. Now is the third day and I have woken up with a headache. Still don?t feel completely back to normal.  No treatment taken to date. Going to see my PCP on 3/23.
Information has been received from a physician concerning her mother who on an unspecified date was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The physician reported that her mother got ZOSTAVAX (Merck) and on an unspecified date got shingles. The time frame from when the patient began taking ZOSTAVAX (Merck) to getting shingles was unspecified. At the time of the report, the patient was recovering from shingles. The patient sought unspecified medical attention. No further information is available.
My daughter received the shot of Prevnar on Tuesday evening. Wednesday she was fine all day until 6:45 PM. She woke up from a nap barely able to cry, when I picked her up she had thick mucus coming from her nose and mouth. As I had her on her side trying to suction it out of her mouth, she went limp and stopped breathing. About a minute later she was gasping for air while we waited for the ambulance to arrive. Her breathing was very shallow and she did vomit mucus. At the hospital she was hooked up to watch her heart and oxygen level, while she was being checked she vomited a lot of mucus again. They took x-rays of her chest to check her lungs which were clear. They sent us to another hospital with a pediatric ward. Once there they drew blood and also watched her heart rate and oxygen level which was at 100%. She had tests done for apnea and acid reflux which were all negative. The only test that came back positive was for RSV. Since her release from the hospital on the 13th, I have found out there were two more incidents identical to my daughters in our home town alone. Both had occurred within 24 hours of receiving Prevnar shot. I have also contacted the hospital in which our daughter and one other baby had gone to let them know of this possible connection and was told there has been numerous cases of RSV lately with infants. They said they are going to contact the doctors of those patient's to see if Prevnar was given prior to them being rushed to the hospital with breathing difficulties. I can only say from my own experience I am glad this happened before we went to bed for the night, my daughter probably would not be here with us right now. If there is a problem with this shot, I can only hope to warn others to monitor their babies closely.
Rash all over body, took Benadryl 50mg and the itching stopped, seen by Nurse Practitioner and given Loratadine 10mg to take daily.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Doxycycline and Cortisone). Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that hives became worse on fourth day.  Patient scheduled an appointment with HCP on 29-MAR-2021.  Event outcome was unknown.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021:
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm ) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm ). At the time of the report, PAIN IN EXTREMITY (Pain in arm ) had resolved.            Patient was taking  blood thinner, small dose of cholesterol medication as concomitant medication. No treatment medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non Significant information- Patient denied to follow-up.
Dizzy & past out after receiving shots. Client laid down until felt better. Prior to leaving clinic client vomited x 3.
Headache, Increasing fatigue and difficulty breathing over two weeks before 2nd dose -- exacerbated by 2nd dose.  Worsening condition led to visit to Primary Care   In office tests indicated presence of blood clots and need for emergency hospital treatment.  Emergency surgery to remove blood clots throughout her body and attempt to put her on ECMO were unsuccessful and patient succumbed at 12:06 AM 3/3/21.
This spontaneous report as received from a nurse refers to a various unspecified patients of unknown age. The patients drug allergies and concomitant medications were not reported. On an unknown date, the various unspecified patients were vaccinated with some form of M-M-R II reported as MMR vaccine. These patients currently had negative titers. The nurse reported that these various unspecified patients had received another dose of M-M-R II with no adverse effects. No product quality complaint (PQC) was reported for M-M-R II. Additional information is not expected.
Pt had mild reaction on Left arm in vicinity of DTaP vaccination site.  Redness, swelling, itching and warm to touch.  Pt reported mild fever on 24SEP08.  No fever, SOB or other symptoms at time of visit on 25SEP08.
arm swelled, warm & erythematous;mild constitutional sx including chills & myalgia;
Pt got 3 doses of Shingrix vaccine no other information given besides increased pain at injection site.
(I am not sure exactly which Tdap I received.) The morning after receiving my first Shingrix vaccine, my lower back/spine hurt so badly that I could not bend over the sink to wash my hair.
Breakthrough case admission after three vaccines Moderna 3/1/21 Lot# 023M20A;  Moderna 4/10/21 Lot# 018B21A;  Moderna 12/19/21 Lot# 058H21A
arm turned purple from shoulder to elbow and still has not fully gone away, intense lower back pain that is still affecting patient
pt recv vax & devel an unspecified rxn;no further details known as of the date of this report;this is one of 5 patients reported from this site;
Symptoms are fatigue, severe pain in knees, general aches and pains throughout body, and headaches.
Left arm with continuous muscle soreness since the day of when the vaccine was administered (4/1/21).   Have taken ibuprofen for the pain.
Initial report received from a consumer on 19 Nov 2010: This patient received RABAVERT (batch number) as a part of her pre-exposure prophylaxis exposure series. Three weeks ago on an unknown date, the patient developed paresthesia in the right side of body and pain in right wrist. At the time of this report, the patient was still experiencing the paresthesia (mainly numbness) in the right side. The reporter did not provide causality assessment between the events and RABAVERT vaccine. Follow up received from a consumer on 30 Nov 2010: The patient took rabies vaccine and not RABAVERT (manufacturer unknown; batch number 475011C) for pre-exposure prophylaxis on 08 Oct 2010. Follow-up information received from a physician on 14 Jan 2011: This patient received RABAVERT (4th booster) on 08 Oct 2010. The patient visited the Accident & Emergency Department on 17 Nov 2010 with progressive right-sided sensory polyneuropathy. The patient was hospitalised as a result. At the time of report, the patient outcome was unknown. The reporter suspected a possible causal relationship between the events and RABAVERT.
This case was reported by a physician and described the occurrence of lyme disease in a adolescent female patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. Co-suspect products included tuberculin purified unknown for product used for unknown indication. On 2nd June 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular) and tuberculin purified (unknown) at an unknown dose and frequency. On 9th June 2009, 7 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced lyme disease (serious criteria GSK medically significant and other: serious per reporter) and mononucleosis infectious (serious criteria other: serious per reporter). On 24th October 2009, the patient experienced sore throat (serious criteria other: serious per reporter), cough (serious criteria other: serious per reporter) and jaw pain (serious criteria other: serious per reporter). On an unknown date, the patient experienced lymphadenitis (serious criteria other: serious per reporter), swollen lymph nodes (serious criteria other: serious per reporter) and fatigue (serious criteria other: serious per reporter). The action taken with tuberculin purified was unknown. On an unknown date, the outcome of the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain were recovered/resolved. It was unknown if the reporter considered the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional detail: The age at vaccination was not reported. It was unknown if the reporter considered the lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain to be related to tuberculin purified. Initial information was received from a Physician via regulatory authority on 25th March 2019: Lyme disease, mononucleosis infectious, lymphadenitis, swollen lymph nodes, fatigue, sore throat, cough and jaw pain.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 28-AUG-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (dose and frequency were not provided), lot # reported as K022993, expiration date 20-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. Additional information has been requested.
expired Adacel was administered to patient, no symptoms reported; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient (normal age) who was administered expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5654AA and Exp. Date 27-Apr-2019, via unknown route in unknown administration site (vaccine was reportedly given on 17-May-2019 and 24-May-2019).  The patient past medical history and family history were not provided.  The patient did not receive any concomitant medication.  It was an actual medication error case due to expired vaccine used.  It was reported that the Adacel expired on 4/27/19. Caller stated that the vaccine was given on 5/24 and 5/17.   No symptoms reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender- none.
Pt recv vax on 10/8/97; on 10/9/97 pt exp erythema on arm w/ warmth x 1 wk
Jynneos administrated intradermally; The vaccine was opened for 23 hours, refrigerated, then given to a patient; Case reference number US-BN-2022-004064 is a spontaneous case report initially received on 17-Oct-22 from a nurse (reference number: USBAV22-1723) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00019), at an unknown dose, administrated intradermally, for monkeypox prophylaxis (explicitly coded as 'intradermal injection'). As reported, the vaccine was opened 23 hours before, it was also given to another patient, afterwards refrigerated, and then given to this patient the following day (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event.  This case is linked with the case US-BN-2022-004063 (same reporter).  No further information was provided.  Non-significant case correction performed for information received on 21-Oct-2022 from Bavarian Nordic included local case ID.  Non-significant case correction received on 08-Nov-2022 included new reference number.; Reporter's Comments: A patient of unknown demographics was vaccinated on an unspecified date with Jynneos vaccine. The vaccine was administered intradermally which is considered intradermal injection. Reportedly, the vaccine was opened 23 hours before, it was also given to another patient, afterwards refrigerated, and then given to this patient the following day which is considered expired vaccine used. Both events are listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and expired vaccine used are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated on an unspecified date with Jynneos vaccine. The vaccine was administered intradermally which is considered intradermal injection. Reportedly, the vaccine was opened 23 hours before, it was also given to another patient, afterwards refrigerated, and then given to this patient the following day which is considered expired vaccine used. Both events are listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and expired vaccine used are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.