chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient only received the IPV and DTAP and not the HIB portion, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) via medical information (MI) (Reference number- 00577376) and transmitted to Sanofi on 26-Apr-2021.  This case involves a 7 month old male patient who only received the IPV and DTAP and not the HIB portion, while patient received a third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: UJ336AA, expiry date and other dosing details were not reported] on 24-Mar-2021 for prophylactic vaccination (product preparation issue).  Medical history, medical treatment, vaccination and family history were not reported.  Concomitant vaccinations included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) (PNEUMOC 13,).  It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day)  It was reported that, while doing inventory, reporter discovered an extra vial of Act HIB in a Pentacel box.   It was also reported that, recently the have had vaccinated 2 children in last 2-3 weeks with Pentacel but they could not tell which child only got the IPV/DTaP vial and not the powder Act HIB vial.   At the time of reporting, reporter was not sure that, the patient details reported for child that one if only IPV/DTAP portion and not the HIB portion of Pentacel or not.   About lot number it was reported that, the way they document the lot for Pentacel, it was reported to her.   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 the 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.
other immune symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in Sep2022 as dose number unknown, single. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "other immune symptoms".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a approximately 24 years old female patient with no drug allergies. The patient's medical history included high risk HPV with colposcopy. On 26-SEP-2013 the patient was vaccinated with 0.5 ml  GARDASIL lot # J006236, exp 25-FEB-2013, dose 2, intramuscular and shortly after reported breast tenderness and irregular periods and asked for a pregnancy test. Nurse reported that the patient's urine pregnancy test was positive, confirming a pregnancy, but nurse noted that patient was suppose to be taking MICROGESTIN. Nurse noted that patients weight was 160 pounds and height was 67 inches. Nurse reported that patient received her first dose of 0.5 ml GARDASIL on 11-APR-2013. Pregnant gestation or LMP was reported as approximately 5 to 6 weeks (approximately 14-AUG-2013), EDD was approximately 22-MAY-2014. The patient had sought medical attention by seen at physician's office. The pregnancy outcome was pending. Additional information has been requested.
I went to Clinic and had my 3rd shot, waited for 30 minutes and went back to my daily activity. Now 6 months later I had a fall and had to place band-aids and I broke out with welts. I had some medicine at home and am taking them now. I still have some welts but they are residing on their own.
This spontaneous report was received from a registered nurse refers to an unknown number of adults patients with unspecified age, gender, pertinent medical history or drug reaction/allergies. On an unspecified date, the patients were vaccinated with ZOSTAVAX (dose, lot numbers were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the reporting stated that unknown number of adults were vaccinated with improperly stored ZOSTAVAX. Treatment was not reported. The patient's outcome were not reported. No adverse event was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. This is a report from several reports from the same source. Additional information has been requested.
This case was reported in a literature article and described the occurrence of transverse myelitis in a 7-month-old subject of unspecified gender who was vaccinated with DTaP (manufacturer unspecified), Hib vaccine and PREVNAR (non-gsk). No past medical history, the subject was healthy. On an unspecified date, the subject received an unspecified dose of DTaP (administration site and route unknown, batch number not provided), an unspecified dose of Hib vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of PREVNAR (NON-GSK) (unknown). 14 days after vaccination with DTaP, Hib vaccine and PREVNAR (NON-GSK), the subject experienced transverse myelitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was possibly related to vaccination with DTaP, Hib vaccine and PREVNAR (NON-GSK). This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
pain in arm; A spontaneous report was received from a consumer concerning a female patient who received mRNA-1273 and experienced pain in her arm (Pain in extremity).  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On an unknown date the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in Dec 2020, the patient reported experiencing pain in her arm.  She asked if she could use ibuprofen for treatment, but it is unknown if ibuprofen was administered.  At the time of the report the outcome for the event was unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of the event was unknown/not reported.   The reporter did not provide causality for the event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a nurse referring to a currently 15 years old male patient. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 16-FEB-2016, the 12 years old patient was vaccinated with first dose of GARDASIL 9(lot#: L027282, Expiration Date: 21-SEP-2017) for intramuscular for prophylaxis. On 28-APR-2016, the 12 years old patient received the second dose of GARDASIL 9) (lot#: L024993, Expiration Date: 17-OCT-2017). On 12-FEB-2019, the 15 years old patient received the third dose of GARDASIL 9 (lot#: 1581027, Expiration Date: 03-JUN-2021)(inappropriate schedule of product administration). No adverse effects were reported.
6:30 - headache and nausea 7:30 - joint aches 8:00 - cold shivers and sweating
>120 lesions, bad headaches, tired;lesions appeared in waves;onset 13 days p/vax;
This spontaneous report as received from a physician refers to approximately 32 year old female patient. Patient current condition included diabetes. None of drug allergies / reactions was reported. On 30-MAY-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # K003074, expiry date: 13-MAR-2015), intramuscular. Other suspect therapies included RECOMBIVAX HB and ADACEL took on same day. Concomitant therapy included insulin. On 31-MAY-2014 (also reported as later that day), the patient developed pain in the left deltoid. The patient took TYLENOL (manufacturer unspecified). On 01-JUN-2014, the pain had partially resolved. However, she had developed a fever (temperature unspecified), and also a punctuate rash on the chest, the back, the shoulders, and on the stomach. On 02-JUN-2014, the fever and rash were gone. ON 03-JUN-2014, a "huge, red, hot patch developed from the left shoulder to 3/4ths down the length of the arm. The arm was very painful." The patient's present status was unspecified. None of the laboratory diagnostic studied was done. Patient sought medical attention and called physician. There was no product quality complaint. Outcome of the event pain in the left deltoid to be considered as recovering (partially recovered), fever and punctuate rash on the chest, the back, the shoulders, and on the stomach was recovered and huge, red, hot patch developed from the left shoulder to 3/4ths down the length of the arm was unknown. Causality of the reported events was unknown (not provided). Additional information has been requested.
Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition was not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot# K012432 with expiration date of 20-MAY-2016, lot# K016263 with expiration date of 26-JUN-2016, Lot# K010754 with expiration date of 20-OCT-2016) (dose strength and route unknown) orally. No concomitant therapy was provided. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  COVID infections completion of COVID vaccines series 06/16/21 COVID vaccine dose #1 07/22/21 Pt reports chills, cough, fatigue, fever, headache, loss of taste/smell, muscle pain, nausea, runny nose, shortness of breath that started 7/21; advised to report to local urgent care 07/23/21 Pt presents to ED reporting chills, fever, body aches, dry cough, headache, muscle pain; was not seen by provider due to wait time; rx given for ascorbic acid, cholecalciferol, DM/guiafenesin; COVID POSITIVE 07/26/21 Pt reports sore throat 07/28/21 Pt reports coughing fits, frequent diarrhea, significant fatigue, fever (temp 100.8), stiff neck, body aches, shortness of breath on exertion 07/31/21 Pt reports cough is mild but is worse at night, low grade fever 100.6 08/01/21 Pt reports temp 98.0 but is using ATC ibuprofen/tylenol, will attempt to stop medication to see if he remains afebrile 08/02/21 Pt clinically resolved
p/vax pt screamed x 3 days & had high fever 104; tx w/APAP;w/in 3mo pt withdrew drastically;lost developmentally what he already knew-speech stopped;no longer turned when name called;p/several visits to MD dx w/autism;poss hormonal balance
Got hot &cold chills for 2 days constant I was actually shivering.. Imediatly when got home got my period heavy bleeding and cramps..set off my ibs..The spot where I got the shot is red Around my arm and hot, still is but not as hot 6 days later.. got headache which I still have But not as bad 6 days later . feel really dry and thirsty still feel off a little..did not have a temperature at all.
excruciating headache at the top, left side of head; muscle pain; unusual heart rhythm; Pain Worsened; fever; chills; joint pain; arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (unusual heart rhythm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt). On 04-Apr-2021, the patient experienced ARRHYTHMIA (unusual heart rhythm) (seriousness criterion medically significant), PAIN (Pain Worsened), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 05-Apr-2021, the patient experienced HEADACHE (excruciating headache at the top, left side of head). On 05-Apr-2021, PYREXIA (fever) outcome was unknown. At the time of the report, ARRHYTHMIA (unusual heart rhythm), PAIN (Pain Worsened), VACCINATION SITE PAIN (arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (excruciating headache at the top, left side of head) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the events included aspirin.   Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
person wasn't able to receive vaccine so it was put back in refrigerator with the date and time so they could use it for a different patient, next morning a new nurse administered this same 0.25 ml prefilled syringe to a 6 month old/no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old patient who received 0.25 mL vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] after the 24-hour mark.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Incorrect product storage. The nurse states that the 0.25 ml prefilled syringe was ordered for a person on Friday. They accessed the syringe by putting a sterile needle on it and then the cap back on. She states that something happened and the person was not able to receive it so it was put back in refrigerator with the date and time so they could use it for a different patient. She states that no other 6-35 month old required it that day and it should have been wasted but that didn't happen. She states that it was a breach in their protocol. She states that this morning a new nurse administered this same 0.25 ml prefilled syringe to a 6 month old.  It was unknown whether the vaccines were administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
On the 26th of January I had pain all over my body, vomitting, and diarrhea.I went septic. I went to the hospital on the morning of the 27th and they thought maybe I had a UTI that had went down to my kidneys.
Information has been received from a laboratory technician concerning a 23 year old female who was vaccinated her second dose of Gardasil 23 days after the first dose and developed a rash. No further information is available. Additional information has been requested. 04/07/2008 Additional information is not expected.
I received the Johnson and Johson Vaccine on April 9th between 10:00 a.m.-10:20 a.m., at 10:30 p.m. that same day my legs and feet started to ache (pain level 3), by 11:00 p.m. my feet and leg (pain level rose to a 6), I drank two 500 ml pain-relieving pills. By 11:30 p.m. (pain level rose to a 9), at that time my pain traveled up to my rib cage, I felt nauseous, felt chills, felt contractions on my stomach and lower back, I felt pain and sensitivity on my skin and caught a fever. Between 12:00 a.m.-2:00 a.m. my (pain level rose to 12), I had a high fever, felt weak, disoriented, lost track of time, started to hallucinate, could not breathe normally, and experienced involuntary and uncontrollable laughter and crying. 911 was called.
Two nights later woke up not feeling well, trouble breathing. Increased oxygen next day.  Returned oxygen level to normal following day and oxygen appeared okay.  The next day,  so five days after vaccine, had trouble breathing again and high blood pressure.  Admitted to hospital and diagnosed with pneumonia.  Currently hospitalized.
Twitching at injection site (left arm) and feeling of flush ness as if I was blushing but only in my chest and left arm.
Red, swelling, severe itchiness, welts below injection site.  Approximately 6 inch diameter. Did not occur until 4th day post vaccine.
90 x 150mm erythema/swelling. On 03/01/2003 localized pain,swelling,warmth,burning left upper arm. Temp 103 degrees from 03/01/2003 to 03/03/2003. On 03/07/2003 sl redness remains, swelling decreased, skin warm, not hot to touch. Denies pain.
11/15: Child developed temperature and seizure like stiffness. Child was taken to local hospital and given rectal Tylenol and given two shots of abx. Mother was told that child had an ear infection. Child was kept in hospital for a few hours for observation then released home with rx of amoxicillin. Mother was instructed to follow up with private MD after child finishes abx. Mother states child is doing fine. No more temperature today. Medical Records received on 1/13/2005 states pt experienced vomiting and otitis media.
Exactly one week after receiving the first Moderns vaccine I developed a rash that spread from the vaccine site on my left upper arm. It is itchy and sometimes hurts a bit. I do not know if it will spread but it is exactly what happened after I had the first and second SHINGRIX vaccines in January 2020 and October 2020. I can provide photos of both the Shingrix vaccine reactions (which I reported) and this Moderna vaccine reaction.
pain; could barely move her arm; could barely move her arm, it was very painful; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer who reported similar events for three patients. This is the first of three reports. The report is for herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient has pain. She could barely move her arm, it was very painful. She stated for her pain it was just for two days and the second day she was better. The outcome was unknown.    No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021425740 Same reporter/drug, different patients, similar AEs;US-PFIZER INC-2021425734 Same reporter/drug, different patients, similar AEs
This spontaneous case reported by a consumer, describes the occurrence of malaise (felt unwell on a daily basis), feeling abnormal (little overwhelmed), bone pain (pain in bone), headache and nausea in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 4, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In January 2022, patient experienced malaise (felt unwell on a daily basis), feeling abnormal (little overwhelmed), bone pain (pain in bone), headache and nausea. In January 2022, bone pain (pain in bone) resolved. At the time of the report, malaise (felt unwell on a daily basis), headache and nausea: not resolved and feeling abnormal (little overwhelmed) outcome: unknown. No concomitant medication reported. The treatment information unknown. Most recent follow-up information incorporated: On Jan 12, 2022: Significant information: event added and dose number added.
2 weeks after flu vaccine, patient had severe dizziness and "vertigo"; Saw PMD and was given Rx for antivert.  As of 11/14/2006 patient had improved some, but still c/o some dizziness.
Hives on (R) cheek (L) chest (R) shoulder (L) buttocks and (R) thigh at injection site.
Flu like symptoms 12 hours after 1st and 2nd vaccination. Terrible body aches, headache.
Per doctor's note: "Right anterior thigh, 2cm X 4cm area of induration. Erythema in 2 areas, separated by a small area of clear skin".
This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 18-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (dose, lot # not reported). The nurse did not know if this was GARDASIL or GARDASIL 9. On 19-OCT-2015 the patient was vaccinated with a dose of GARDASIL 9. ON 21-OCT-2015, the patient was vaccinated with the second dose of GARDASIL 9 outside of the recommended series schedule. NO adverse symptoms reported. This is one of three reports from the same reporter. Additional information has been requested.