chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered only the liquid portion of Pentacel to a patient and not the reconstitution portion, Symptoms: None reported; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a four months old female patient who received a second 0.5ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5426AA and Exp. Date 04-Oct-2019 via intramuscular route in the right thigh, on 09-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique.  It was reported that one of her other medical assistants administered only the liquid portion of Pentacel to a patient and not the reconstitution portion.  None symptoms were 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.  List of documents held by sender: none.
The pt got a fever one day after receiving the vaccines and it continued for five days. had a varicella appearing rash eight days after vaccines which covered entire body and lasted for four days.
Immediate pain in upper arm, continued through the next day. Had nausea that began in evening and fever. Started to improve by 4pm of the following day. Pain left deltoid area.
About 2 weeks after my vaccine, my wife had to call the emergency squad because I turned purple and swallowed my tongue.  I am back to it around noon at the emergency room.  They could not find out what happened they did all sort of test and could not find anyhting.  I just want to find out what happened.  I am currently think I am fine but my wife thinks I have gone down hill.  I just retired a few months ago.
It was reported that a 40 year old  female patient received a Fluzone SV '01-'02 vaccination on 10/11/01 administered in her right arm. Within 45 minutes of administration, the patient experienced severe pain in her right shoulder and neck. Warm packs and Tylenol were used  as treatment. Further information is requested.
Headache, soreness at injection site Narrative: Sore arm and mild headache about 3-4 hrs after vaccination yesterday. Today - runny nose, headache, sore throat. No fever. Arm still sore.
boosted; Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single and administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "boosted"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Red spot an injection sight. Spread to small red, hard spots on rt leg, back and stomach with small white spots in the middle.
Right after the shot I became very dizzy and had to get a ride home. The following day I felt very ill, low grade fever 99.9*F, body aches, sore arm for several days, very weak had to lay down.
Developed a large orange sized lump on the L deltoid area. Warm to the touch, circular, edematous and painful.
marked edema & cellulitis of arm, hand, chest & back w/12 hr p/receiving DTP in deltoid muscle;
Information has been received from a health professional concerning a male (demographics unknown) who on 8/2/01 was vaccinated with 1 dose of MMRII, in the left thigh (lot 637834/0696L). On 8/6/01, the pt experienced injection site reaction and was reported to be seeing the doctor, at the time of report. Reporter stated she would call with additional information. Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M204 and 001BZ1A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Smoker (Ex tobacco smoker three cigarettes a day) from 1969 to 1996. Concurrent medical conditions included Diabetes, Torn muscle since November 2020, Shoulder pain since November 2020, Fall since November 2020, Thyroid disorder NOS, Kidney stones since 1967, Depression, Arthritis and Allergy. Concomitant products included FLUTICASONE and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, SULFASALAZINE for Arthritis, VENLAFAXINE for Depression, METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE for Kidney stones, POTASSIUM for Potassium deficiency, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL, CICLOSPORIN (RESTASIS), PRAVASTATIN, VITAMIN D3, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]), PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) and PLANTAGO OVATA SEED HUSK (PSYLLIUM HUSKS) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In March 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Vaccination site pain) to be probably related.    Concomitant medication clopidogrel was as blood thinner, restasis as eye medicine, metamucil and psyllium husks helps to go to bathroom.  Patient abstains from alcohol.  On Nov 2020, patient fell down and experienced torn muscle and shoulder pain. Patient had concomitant therapy of C Pap Oxygen Level three. Patient underwent x-ray and magnetic resonance imaging on unknown date and was advised to undergo a surgery.  On 08 Feb 2021, patient underwent surgery and was treated with oxycodone and ibuprofen for the shoulder pain. Patient discontinued humira two to three weeks before the surgery and restart it two to three weeks after the surgery. On 09 Feb 2021, patient was discharged from hospital. Patient was on therapy and was recovering.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-SEP-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Redness and swelling of a previous vaccine injection scar, not related to the Covid-19 vaccine, like the BCG vaccine, which occurred two days after receiving the second dose of the Pfizer vaccine. Pain is experienced upon pressure to the area.
Pt felt shot given very high on arm - felt joint shoulder pain for 45 min after injection. Numb and weak by end of day in arm and fingers. Has pain and limited ROM. Ortho MD felt shot may have been given in AC joint. Referred for physical tx.
Day 0-2: Fever, chills, body aches, joint pain, headache, fatigue, pain at injection site Day 2-3: same as above but no fever (but felt feverish every so often; not consistent), new - sore throat, cough, stomach ache/light feeling of nausea Day 4-7: headache, fatigue, mild aches, sore throat, increased coughing, stomach ache/light feeling of nausea, some mild feelings of feverish, but no fever
Edma of eyelids, fluid edema, pruitis treated with Benadryl
Initial unsolicited report received from a healthcare professional (patient's parent) on 01 October 2014. An 11-year-old male patient, had received a dose of MENOMUNE, (batch number, dose in series and site of vaccination was not reported) subcutaneously on 30 September 2014. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 30 September 2014, few hours after vaccination, the patient developed headache. Headache became severe and interfered with his sleep. The patient also experienced photophobia. The patient was awake much of the night. Corrective treatments were not reported. No laboratory tests were performed. Documents held by sender: none. Follow-up information received from healthcare professional on 02 April 2015. Patient was vaccinated with a dose of TDAP and manufacturer: UNKNOWN (batch number, dose of vaccine and route of vaccination were not reported) in left deltoid on an unspecified date. Documents held by sender: None.
Patient received 2nd dose of Pfizer vaccine  14 days after 1st dose  instead of earliest possible day (day 17).   Pt did not experience any adverse events from the vaccine after the dose that we are aware of.
Rash on torso, upper thighs, legs, and arms. Some pus filled lesions. Confirmed with her doctor that it was an outbreak of chickenpox after the Varicella vaccine.
BECAME SYMPTOMATIC AND TESTED COVID POSITIVE ON 8/30/21. DEVELOPED ACUTE HYPOXIC RESPIRATORY FAILURE. DIED 9/30/21
Loss of consciousness, convulsive syncope or seizure (2 episodes) immediately following the administration of the flu and diptheria-tetanus booster vaccinations.  The patient was transported by ambulance to the hospital.  She is seeing a neurologist for further tests.
swelling and significant bruise at injection site; swelling and significant bruise at injection site; This is a spontaneous report from two contactable nurses. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular into the left arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were none. The patient developed swelling and a pretty significant bruise where the injection was given in her left arm. The caller noticed the bruise and swelling on 25Jan2021 but states it could be older. The events were reported as medically significant. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of vaccination site swelling and bruise cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
I have an IUD and usually have light, short periods. I began my period the day or two after the second COVID vaccine. It was somewhat heavier than normal and lasted a few days longer than normal. I am fine and required no treatment for this, but hearing about similar experiences I wanted to report this though some time has passed.
Having long covid since May 2020, my lingering symptoms have been fatigue, shortness of breath, chest pain, loss of taste. All were subsiding and have come back since the first injection and have not abated for 2 weeks. Fatigue is particularly intense in the morning, loss of taste is now constant.
After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (tree pollen, of which there is plenty right now), Penicillin allergy and Asthma. Concomitant products included ESOMEPRAZOLE from 30-Apr-2022 to 12-May-2022 and MESTRANOL, NORETYNODREL (ENOVID) from 28-Apr-2022 to 04-May-2022 for an unknown indication.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive.). At the time of the report, COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) After testing almost negative on a rapid test at day 5, positive (Positive) I got a strong positive on day 10 and positive (Positive) day 12, still strong positive.         The patient Conmed included Covid-19 treatment on 30Apr2022 and stopped on 04May2022 . The patient received other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient got a strong positive on day 10 with runny nose and slight body aches and also experienced one or two temporary bouts of unexpected fatigue. Treatment for the event was not reported.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected nonserious AESI event of COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive) which occurred 5 months 22 days after the third dose of mRNA-1273 vaccine. Ongoing pandemic of COVID -19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected nonserious AESI event of COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive) which occurred 5 months 22 days after the third dose of mRNA-1273 vaccine. Ongoing pandemic of COVID -19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Joint pain/arms, hot/cold flashes with sweating, nausea. Severe cramping/bleeding 45 minutes after vaccination (uterine).
Fully vaccinated with Pfizer vaccine. Admitted to Medical Center on 12/02/2021. Tested positive for COVID 19 on 12/18/2021. Expired on 12/21/2021 while still hospitalized.
patient got the flu shot and got sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer and transmitted to Sanofi on 10-Oct-2020.  This case was linked to cases 2020SA294125, 2020SA294157, 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294164, 2020SA294165, 2020SA294166, 2020SA294167, 2020SA294168, 2020SA294169, 2020SA294170, 2020SA294171, 2020SA294172, 2020SA294173, 2020SA294174, 2020SA294175, 2020SA294142, 2020SA294143, 2020SA294144, 2020SA294145, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294149, 2020SA294150, 2020SA294151, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same source).  This case involved a patient of unknown demographics who experienced got the INFLUENZA VACCINE shot and got sick (illness).  Relevant medical history, medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was patient got the flu shot and got sick.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
pt exp extreme fussiness & jerky movements lasted about 2 1/2 hrs; resolved spontaneously;
Skin eruption; Lump near my hairline was raised and painful; Lymph nodes had swollen to the size of a golf ball-protruding from my neck; Blister that is tingling and stings sharply; Blister that is tingling and stings sharply; Blister that is tingling and stings sharply; Shingles; This is a spontaneous report from a contactable consumer (patient). This 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an specified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to dogs, cats and horses all from unknown dates and unknown if ongoing. The patient had not been diagnosed with COVID prior to vaccination and had not received any other vaccines in the 4-weeks prior to vaccination. Concomitant medications included multi-vitamins from an unknown date for an unknown indication. The patient previously received amoxicillin on an unknown date for an unknown indication and experienced drug allergy; and received the first dose of BNT162B2 (lot number EN6198) on 03Mar2021 at 14:30 (at the age of 38-years-old) for COVID-19 immunisation. The patient reported that on 25Mar2021 at 12:00, about 27-30 hours after receiving the vaccine she noticed a skin eruption near her hairline, about the same hour she noticed her lymph nodes had swollen to the size of a golf ball, and the lymph node on her neck on the left side where she'd received the vaccine was visibly protruding from her neck. She further reported the lump near her hairline was raised and painful and the next day it turned into a blister that was tingling and stung sharply; she reported she was just diagnosed with singles and was an otherwise health adult with no major health issues, and was not under stress. She reported reading that the relationship between BNT162B2 and shingles was disproven but felt that these events were linked. The events were reported as non-serious and did not required hospitalization. The patient was treated with antiviral therapy and monitored by her doctor. The events required a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The clinical outcomes of skin eruption, lump near my hairline was raised and painful, lymph nodes had swollen to the size of a golf ball-protruding from my neck, blister that is tingling and stings sharply, and shingles were not recovered. It was also reported that since vaccination the patient had not been tested for COVID.
vision problems and was diagnosed with Wegener's granulomatosis; This spontaneous report was received from a lawyer referring to a patient of unknown age.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, dosage schedule, lot number and expiration date were not reported).  On an unknown date, the patient suffered vision problems and was diagnosed with Wegener's granulomatosis. The patient's symptoms have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. The patient sustained serious, progressive, severe, permanent, and incurable injuries personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a result of these injuries, the patient was seen and treated by medical providers and is still under their care (not recovered). The reporter considered Wegener's granulomatosis to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, Wegener's granulomatosis was considered a medically significant and disabling event.