chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Hib portion was reconstituted with 0.4% NACL saline but the DTAP portion was not yet administered with no reported adverse event; Initial information on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who was administered the hib portion which was reconstituted with 0.4% nacl saline but the dtap portion was not yet administered with no reported adverse event while receiving vaccine diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 12-Aug-2022, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (formulation, strength not reported; lot UJ674AA, U7136AA expiry date: 04-Jun-2023) via intramuscular route in the left thigh for immunization.  On 12-Aug-2022, the patient was administered the hib portion which was reconstituted with 0.4% nacl saline but the dtap portion was not yet administered with no reported adverse event (product preparation error) following the administration of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  It was reported, "they have administered PENTACEL separately. The Hib portion was reconstituted with 0.4% NACL saline but the DTAP portion was not yet administered as they stop vaccination after they realized they are not doing the right thing".   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the guidelines. 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.
The pt started itching, had welts all over body, then the face began to swell and she had problems with breathing. Mom and sister took her to the ER.
This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates starting on or after 02-JUL-2016, the patients were vaccinated with improperly stored doses of PROQUAD (dose, route, lot # and expiry date were not reported) for prophylaxis. The vaccine was exposed to the temperature of -13 degrees Celsius for 5 hours. No previous temperature excursion and no adverse effects were reported. The data logger was not involved. This is one of several reports received from the same reporter. Follow up information was received on 14-OCT-2016. All telephone attempts to obtain follow-up information had been unsuccessful. Follow-up information was received on 04-JAN-2017 from the nurse. On 17-AUG-2016, it was reported that the improperly stored PROQUAD was not administered to the patients. On 04-JAN-2017, the nurse confirmed that multiple patients (unspecified number) received the improperly stored vaccine on unspecified dates. PROQUAD was exposed to the conditions which were previously reported. No symptoms were reported. Information on specific patients who were vaccinated would be provided upon authorization from the reporter's supervisor. No further information was provided. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1608USA010530: US-009507513-1608USA010527: US-009507513-1608USA010529: US-009507513-1608USA010528: US-009507513-1608USA010531: US-009507513-1608USA009023: US-009507513-1608USA010533: MERCK 1608USA010532:Mfr number.
Severe rash covering entire lower back, severe sore throat and mouth with sores, cough, some shortness of breath,  low grade temp., extreme lethargy,  nausea, bloating, peeling of the tips of my fingers on the palm side, loss of appetite.
Burning sensation under tongue and gum.  Comes and hurts then leaves.  Drinking water and brushing teeth do not help.  Symptoms following Rabavert #4 for post-exposure prophylaxis.
This case was reported by a physician and described the occurrence of injection site redness in a 5 year old male subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix) for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. ON 5/4/2006 at 4:00 pm, the subject received 5th dose of Infanrix in the left arm (lot AC14B018AA). On 5/4/2005, the subject also received the 4th dose of inactivated poliomyelitis virus vaccine (Ipol, lot Y0241) at an unspecified site of administration. On 5/4/2006, the same day as the vaccination with Infanrix, the subject experienced crying, fever, and injection site redness, hardening and heat at the site of the Infanrix administration. The subject was treated with Ibuprofen Advil and compresses. The physician considered the events to be disabling. The events resolved on an unspecified date on or after 5/4/2006 and on or before 5/11/2006.
left arm pain; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o28l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications were reported.   Reporter did not allow further contact
Patient with nausea/vomiting and headache for days after injection. Spike fever on day 4, injection site erythematous and warm, WBC 18, transferred from mental health to inpatient unit to receive empiric antibiotics. Symptoms: Cellulitis. Treatment: Diphenhydramine, Ibuprofen.
pt had syncopal episode for about 1 min.  pt diaphoretic.  recovered well with rest, cold pack to back of neck and time.
Patient tested positive for COVID-19 after being fully vaccinated.  Symptoms started on 3/18 with runny nose, sore throat, cough and minor loss of smell
A report has been received from a Health Professional concerning a 36 year old, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres. FLUMIST Quadrivalent (Intranasal) started on 29-Jan-2016. The patient administered expired FLUMIST on 29-Jan-2016. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of expired FLUMIST administered to a patient is unknown. The report was considered to be non-serious.
PROLONGED SORENESS IN RIGHT ARM AT INJECTION SITE. PT STATES PAIN COMES AND GOES
This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (blood platelets were low (under 150,000)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced THROMBOCYTOPENIA (blood platelets were low (under 150,000)) (seriousness criterion medically significant) and BLOOD IRON DECREASED (iron low). The patient was treated with IRON (oral) for Iron low, at an unspecified dose and frequency. At the time of the report, THROMBOCYTOPENIA (blood platelets were low (under 150,000)) and BLOOD IRON DECREASED (iron low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, Blood iron: low (Low) low. On 01-Jul-2021, Platelet count: under 150,000 (Low) under 150,000.         Concomitant medication of the patient was not reported.  Treatment information for the event platelet count low was not reported by the reporter.  The consumer reported that she had the Moderna COVID-19 vaccine 1st dose on 03-Feb-2021 and 2nd dose on 03-Mar-2021. On 01-Jul-2021, she had her annual physical examination and her doctor noticed that her blood platelets were low (under 150,000). She was given iron tablet [sic] to take because her iron was also found to be low. She will have a repeat blood test on 03-Nov-2021.  This case concerns a female patient, of unknown age, with no relevant medical history, who experienced the unexpected, non-serious AESI of thrombocytopenia with an associated unexpected, non-serious event. The events occurred approximately 3 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. The event thrombocytopenia was automatically upgraded as serious as per IME list. However, based on the information available and as per medical judgement, the event was assessed as non-serious.; Sender's Comments: This case concerns a female patient, of unknown age, with no relevant medical history, who experienced the unexpected, non-serious AESI of thrombocytopenia with an associated unexpected, non-serious event. The events occurred approximately 3 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. The event thrombocytopenia was automatically upgraded as serious as per IME list. However, based on the information available and as per medical judgement, the event was assessed as non-serious.
Cosmetic, superficial 'indentation' in anterior deltoid area near site of vaccination.
Client presented to the vaccination site on 11/13/2021. The client notified PHN that he received a both doses of the Novavax COVID vaccine during a clinical trial on 4/29/2021 and 5/25/2021. PHN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Janssen. Patient reported no medical conditions and takes vascepa, atorvastatin, and multivitamin. Approval to proceed with COVID vaccine Janssen was obtained from medical consult team via text message from Vaccine Operations Lead per Dr. Client received COVID vaccine Janssen Lot#1855194 on 11/13/2021. The client did not report any symptoms during the 15 minute observation period. Vaccinator Pharmacist educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1300 walking with steady gait.
I had this spots on my head that were really hurting, I took a antihistamine and Advil, because my head was hurting. On the 20th of December I went to urgent care and they told me to go the hospital. They did not know at first, they thought it was spinal meningitis and had a spinal puncture performed. They diagnosed it was bad case of shingles. It was on my head, neck ears and face. It was miserable. I was prescribed hydrocodone, disodium soft gel for constipation, and gabapentin 100 to 200 micrograms. My first two vaccines were Pfizer and this 3 dose was Moderna.
Sudden onset SOB, flushed - eyes reddened, cough & sore throat. 148/84 pulse 86 T 98.8.
Initial and follow up information has been received from a registered nurse, concerning a 50 year old Caucasian female patient with a penicillin allergy, latex allergy, egg allergy, asthma, gastroesophageal reflux disease, fibromyalgia, and migraines, who on 12-DEC-2007 (previously reported as 11-DEC-2007) was vaccinated SC in the left arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658451/0963U), and with the first dose, IM in the left deltoid, of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (SP) (lot #C2889AA). On 12-DEC-2007 (previously reported as on 11-DEC-2007), 1/12 hour after the injections, the patient experienced fatigue, had severe pain in the left arm, and developed an injection site reaction, also described as an "intensely red inflammatory reaction with exquisite tenderness at left posterior deltoid/tricep area," measured 7 cm in diameter and warm to the touch. The patient visited the physician. At the time of this report, the patient had recovered (duration not specified). Additional information is not expected.
I started to have a slight sore throat on July 6th 2022, my husband had COVID-19 about 4-5 days prior. I did have a lot of nasal congestion. After taking a at home test and it came back positive, I then called my primary care office, they then prescribed me Paxlovid, and he also told me to stop taking the Atorvastatin for one week. After taking the Paxlovid my symptoms began to improve. I feel completely normal at this points.
Within a few hours post vax, this pt experienced "crushing" chest pain. She recovered within 4-6 hours post onset of symptoms.
fever; fatigue; muscle ache; This case was reported by a physician via call center representative and described the occurrence of fever in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, fatigue and muscle pain. On an unknown date, the outcome of the fever, fatigue and muscle pain were unknown.   It was unknown if the reporter considered the fever, fatigue and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The physician reported that many patients were hesitant to receive their second dose during the pandemic due to symptoms of fever, fatigue, and muscle ache which might be confused with symptoms of COVID-19. Did not consent to follow-up. This case has been linked with US2020059976, reported by same reporter.
Presented to emergency room on 12/2/2021 with shortness of breath and was found to be COVID-19 positive at that time. Patient was treated with supplemental oxygen, remdesivir, and dexamethasone. Patient was discharged home on 12/5/2021.
Leg swollen to twice the size of other leg. Area around injection site raised, bright red, and hot and hard to touch. White perimeter around red in some spots. Took patient to urgent care at 9pm, doctor did not think it was an infection, and told us to watch it. He outlined the red with marker so we could see if the redness spread. By 11am on 4/19, red area was no longer raised and was not as hard, but redness had spread. Bruising at injection site is starting to appear.
2nd dose administered beyond 35 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days). On 10-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered beyond 35 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Non significant follow up On 11-Oct-2021: Non significant follow up
INJECTION GIVEN, PATIENT WAITED -- GOT UP FELT FAINT AND FAINTED WHEN WE GOT BACK TO THE TABLE -- MOM THEN CALLED ABOUT 2 HRS LATER AND STATED THAT SHE HAD VOMITED, AND HAD A BAD HEADACHE -- WAS ASLEEP AND WHEN SHE WOKE UP, STILL HAD A HEADACHE, BUT WASN'T VOMITING. NEXT DAY WAS FINE, BUT STAYED HOME FROM SCHOOL.
Initial misuse report received from a health care professional on 10 February 2014. A patient whose age, gender, medical history and concomitant medications were not reported, received a dose of Tdap vaccine (manufacturer unknown, lot number, dose number route and site of vaccination was not reported) on 07 February 2014 and 10 February 2014 respectively. It was reported that the patient received a dose on Friday 2014, and another dose again on 10 February 2014 thus, an extra dose was administered. At the time of this report, the patient did not experienced any adverse events. List od documents held by sender: none.
Patient reported dizziness and mild headache right after the shot. Symptoms were resolved within 30 minutes.
A report has been received from a Health Professional concerning, female patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. In the year 2012, the patient received FLUMIST (intranasal) and FLUMIST did not protect her from getting the flu. The patient tested positive for the flu and had the flu after receiving FLUMIST. Action taken with FLUMIST, intranasal was unknown and the patient recovered from the event of patient tested positive for flu after receiving FLUMIST and had the flu. The report was considered to be non-serious by the reporter.
Fast heartbeat; Shortness of breath; Full body aches; Chills; Sweats; Headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm right on 04May2021 at 10:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included pure encapsulations ONE multivitamin and dysbiocide (MANUFACTURER UNKNOWN). The patient previously took DEMEROL and experienced Drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 08Apr2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 02:00, the patient experienced fast heartbeat and shortness of breath starting 16 hours after second dose administration and lasting several hours and the patient also experienced chills, sweats, full body aches and headache. The patient was not received treatment for the events. The clinical outcome of events fast heartbeat, shortness of breath, chills, sweats, full body aches and headache were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021) via DSU Amendment: This follow-up report is being submitted to amend previously reported information:Past drug event Reaction updated; Treatment received updated for all events.
From initial information received on 4/26/04 from a health care professional, it was reported that a 44 year old female patient received her fourth dose of IMOVAX RABIES, administered IM, on 4/22/04 as part of a pre-exposure series. The lot number was not reported. Two days post-vaccination, on 4/24/04, the patient complained of a swollen arm, flu-like symptoms and a high fever. Reportedly the patient recovered from this experience. The patient has a history of Lyme disease. She received a total of three doses of IMOVAX RABIES as part of a pre-exposure series. The dates of vaccination were 9/30/03, 10/7/04, and 10/28/03. All three doses were administered IM and were lot number W1419-2. No adverse events were reported after receipt of the first three doses. From additional information received on 6/10/04 from a health care professional, the patient's full name, address, and telephone number were provided. A correction was made to the responsible physician's name. No additional medical information was provided. The vaccination date for IMOVAX RABIES administered on 10/7/03 was previously entered in error as 10/7/04. The correct date of administration is 10/7/03.
Fever of 101 and strong body aches, leading to an increased difficulty breathing.  After two rescue inhaler attempts, used a nebulizer for twenty minutes which did work.
Wife of patient reports that she "saw him with both upper extremities flexed and rigid and with eyes rolling back, when (she) called 911. She did not observe both lower extremities. He was transported via 1st aid squad to ER.
About 15 minutes after injection, the patient became sweaty, light headed, saw black spots, and reported throat tightening. Patient began dry heaving but did not actually vomit.
Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. Treatment medications were not provided.  This case was reported for patient 3 of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
Was given shot very high up right below my shoulder.  Am still in a lot of pain.  Am now able to use that hand but unable to sleep in bed.  And unable to lift my arm above shoulder height without experiencing extreme pain. This is 2 weeks after receiving the shot.
Significant redness within hours. 1 day later arm was huge. ER report attached.