chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report received from a health professional via Pfizer concerning a patient of unknown gender. The patient was allergic to codeine, BACTRIM, TRAVATAN, LUMIGAN, statin and DEPO-MEDROL. Patient's concomitant medications included pregabalin, methylprednisolone acetate, diclofenac, misoprostol, lactobacillus reuteri, diltiazem hydrochloride, theophylline, dexlansoprazole, furosemide, valacyclovir hydrochloride, nicotinic acid, magnesium, calcium, cholecalciferol, biotin, fish oil, acetylsalicylic acid, vitamins nos, xantofyl, chondroitin sulfate, glucosamine, hypromellose, tears, prednisone, ipratropium bromide, salbutamol, levofloxacin and ketotifen. On an unspecified date, patient received Influenza Virus Vaccine Live (Intranasal). It was reported that patient had live flu vaccine allergy (Preferred Term: Allergy to vaccine). Vaccine used in patient (age more than 59 years) (Preferred Term: drug administered to patient of inappropriate age) considered as an off label use (Preferred Term: off label use). The outcome for Live flu vaccine allergy, inappropriate age at vaccine administration and off label use was unknown. The report was considered to be non-serious by company physician. The events of off label use and inappropriate age at vaccine administration was identified by company physician from source narrative and assessed to be non serious. Corrected Report 19-Sep-2016: New event added as off label use and inappropriate age at vaccine administration. Narrative updated.
NauseaVomiting Narrative: Experienced mild nausea starting within the first 4 hours after the vaccination, which persisted for 2xdays. Associated with fatigue, but no other common adverse effects including vomiting, diarrhea, abdominal cramping She was able to tolerate normal po intake and did not try any therapies.
This spontaneous report as received from a certified medical assistant (C.M.A.) (also reported as a nurse) refers to unspecified number of unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses or ROTATEQ (therapy route default to oral, dose and frequency were not specified by the reporter, lot# and expiration date were not reported) that were improperly stored. No adverse experiences were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & pt fell over;reporter let pt go down slowly & called for help;head was turned to side & eyes rolled back;body became very stiff w/back arched;BP 170/110;began responding to questions w/in a min;color pale, skin warm & dry
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date the patients was vaccinated with PNEUMOVAX 23 (lot # L031459 with expiration date 30-APR-2017 and lot # L019835 with expiration date 23-MAR-2017, strength, dose and route were unknown) that were improperly stored. No adverse effects reported. Additional information has been requested.
Headache, Sedation, Fever, RespDepression, CoughWheeze, NauseaVomiting,  CHILLS AND PAIN 9 OF 10  Narrative:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number and injection site were not reported) (0.65 ml, subcutaneous) as shingles vaccine by a different unspecified pharmacy. The patient had complained of a headache on 27-JUN-2013 after receiving the ZOSTAVAX and called her unspecified physician. The physician told the patient to give it 24 hours. When the patient woke this morning (on 28-JUN-2013) she noticed that her right eye was red and appeared to have "popped a blood vessel" in the eye. There was no treatment given for adverse event. The outcome was reported as not recovered/not resolved. The action taken was not provided. The patient had called her physician for medical attention. Additional information has been requested.
Injection site swelled up, welt the diameter of a baseball, lower arm has blisters, both on right arm.
The pt started with a sore throat on 4/21/00 which progressed to laryngitis, low grade fever, headache, stomach distress. A rash appeared on 4/24/00. Strep test was negative. No treatment was given.
Fever, chills, muscle aches, headache, nausea, fatigue. Felt like a scalpel was digging under my kneecaps.
Information has been received from a pharmacist concerning a 14 year old female patient, who on 19-MAR-2007 was vaccinated in the right arm, with the first dose of Gardasil (yeast). There was no concomitant medication. On 19-MAR-2007, "within one hour of the vaccination," the patient developed swelling and coldness in the right arm and hand. The patient was reported to be recovering at the time of this report. The patient sought unspecified medical attention. Additional information has been requested.
Initial report received on 30 January 2007 from a health care professional. A five-month-old female patient, who was diagnosed with an "URI" (upper respiratory infection) and diarrhea on 22 January 2007, and was being treated with Rondec DM, nystatin, and "Tylenol products", had received, on 29 January 2007 at 16:00 pm, a second, right leg dose of ActHib,  lot number UF085AA (lot number Z1038-2), a second, left leg, intramuscular injection of Daptacel, lot number C2553AA, a second, left leg of IPOL, lot number Z0326-2, and a second, right leg dose of Prevnar (manufacturer reported), lot number B08672K. The route of administration was not reported for the ActHib, IPOL, and Prevnar vaccines. The patient's pediatrician's office was notified by the coroner that the patient had been found dead by the father sometime in the morning, on January 2007. The patient had no history of birth defects or known allergies. She weighed 4 pounds 11 ounces at birth and has a twin sister. Reportedly, the patient had no adverse events with prior vaccinations. She received her last immunizations (vaccine not provided) on 27 November 2006. No other information surrounding the death was available at the time of this report.  4/7/07 Received Autopsy Report which reveals COD as SIDS.
Tinnitus in both ears within a hour after 1st dose. Tinnitus became worse after 2nd dose. Occasional vertigo also. Has not gone away.
Shingles. Woke up with facial pain and slight redness. This progressed into very painful full blown right sided facial shingles. In addition my 6months old baby contracted  the chickenpox from my shingles.
Fever, chills, sweats, headache, body aches, arm pain, extreme exhaustion
This spontaneous report as received from a other health professional refers to a 14 year old male patient. On 13-JUL-2017, the patient was vaccinated with VAQTA in the left deltoid for prophylaxis. Concomitant therapies included GARDASIL 9. In July 2017, the patient experienced injection site pain, injection site swelling, injection site warmth and injection site erythema. The outcome of injection site pain, injection site swelling, injection site warmth and injection site erythema was recovering.
received Tdap and Hepatitis A vaccine on 5-1-07 at approximately 1:00 p.m. at 3:00 p.m. on 5-1-07, he started breaking out with a rash on his face which whelped up all over the body by 5-3-07; referred to ER; received Prednisone and took Benadryl.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinial course: Patient received other medication in 2weeks(product- Levothroxine).  Antiviral details: Product- COVID 19 Treatment with Brand- Pfizer Treatment of COVID-19 start date on 26May2022 and treatment stop date on 30May2022 with Lot number-Not sure. - rx # 923861 After 5 days of taking Paxlovid patient symptoms returned  No follow-up attempts are possible. No further information is expected.
GRAND MAL SEIZURE 12/3/09 TRANSPORTED TO ER FOR ANTI-CONVULSANT GRAND MAL SEIZURE 12/9/09
This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients concurrent condition and medical histories were unknown. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, (Lot # and expiration date unspecified) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to one patient of unknown age and gender. Patient's medical history was not reported. On an unspecified date in December 2013 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, anatomical location, lot#, expiration date not provided). VARIVAX (Oka/Merck) was exposed to 10.5 Fahrenheit (F) since October 2013. No adverse symptoms reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
patient was afraid of needles to begin with, she recived her vaccine and within 1 minute she felt dizzy and fainted for around 15 seconds, her color turned from pink to very paole,  we called 911 and her bp was 110/60 and ok pulse, after waiting for 15 minutes she vomitted t wice and her father  pickeed her up, she did not want to go hosptial
Dyspnea, chest pressure. ER evaluation 8/21/21 normal. Symptoms have been slowly improving..
MODERNA COVID-19 Vaccine. Lymph node swelling around 6pm day of vaccination, Jan 16th. Fever, headache, injection site pain, fatigue upon waking up around 10am on Jan 17th. Symptoms continued majority of the 17th and subsided by the morning of Jan 18th.
Swelling and redness at injection site, pain as well with nausea, vomiting and fever within 12 hours lasting until seen on 3/29/10.
A large group of flat white blotches on my skin on my right side near the bottom of my ribs towards my back.
Patient request Moderna bivalent injection in her buttock.  , CMA  Under supervision of CNP to administer Moderna to her right Buttock. After 15 mins wait Patient did not report adverse reaction to injection.
w/in 3hr of vax pt devel staring spell, pallor color, lip discolored (?cyanotic), irritability, inconsolable
Bells Palsy: Valacyclovir 1g x 1 dose Pt prescribed Prednisone 20 mg  tab, starting 3 tabs per day - tapered down over 9 days Tears Naturale Ophthal = 1 gtts to  L eye, TID
I had reactions FOR DAYS from BOTH vaccinations AND the BOOSTER!  Reactions included fever, muscle aches, dizziness, flu-like symptoms, exasperation of my MS for days, could not get out of bed for 3 days.  My heart started to race and with it my head pain.  My heart is now subject to Several weeks later some of the symptoms continued.  And my heart palpitations have come and gone since the first vaccine.  Never had them before!
administration site hurt and sore; Initial information was received on 09-Nov-2020 regarding an unsolicited valid serious case from a pharmacist.  This case involves a 65-year-old female patient (160 cm and 86.18 kg) who experienced administration site hurt and sore (vaccination site pain), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination and family history were not provided.  On 07-Nov-2020, the patient received a unknown dose of suspect PREVNAR 13 (not produced by Sanofi Pasteur, manufacturer: Pfizer) [Solution for injection in pre-filled syringe, lot number and expiry date not reported] via unknown route at the left arm muscle as concomitant medication.  On 07-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route at the right arm for prophylactic vaccination.  It was reported that, patient had no problem with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE given at same time in right arm on 07-Nov-2020 but on an unknown date, patient developed non serious administration site hurt and sore (right arm) (vaccination site pain) (unknown latency), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and PREVNAR 13. It was reported that, no problem or redness observed at the same site. It was reported that, the patient could breathe normally and did not have a rash on her body.  It was also reported that, On 07-Nov-2020, the patient developed hurting of left arm (about 3-inch width), on 08-Nov-2020, the patient developed redness and swelling of areas of the left arm (about 3-inch width), muscle stiffness with inflammation (all the way across the front of her arm) and skin over the muscle itself was very pale.  On 08-Nov-2020, in night, patient felt chills, feeling bad, did not feel very well.   On an unknown date, patient was recovered from vaccination site pain.
very thirsty; couldn't get up from bed; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (very thirsty) and FATIGUE (couldn't get up from bed) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced THIRST (very thirsty) and FATIGUE (couldn't get up from bed). At the time of the report, THIRST (very thirsty) and FATIGUE (couldn't get up from bed) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant medication was not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-114394 (Patient Link).
I had a huge swollen area come up under my left arm the next day after vaccination.  a reaction to the vaccine and recommended a follow-up mammogram in 3 months and an ultrasound as needed.
Redness and swelling at immunization site. Swelling developed a pustule and the pustule drained with the parents squeezing it.
Red bump increasing in size, by 6/1/2011, increased to the size of half dollar, painful to move arm, tingling, tightness in arm, swelling. Went back to clinic and was prescribed 875 mg of Augmentin 2x day and told to take 800 mg of Motrin 2x day.
Per ED note: Brought in ED by EMS at 1945 for acute shortness of breath and hypotension. Patient was placed on supplemental oxygen and covid test completed. Patient was placed on BiPAP to maintain oxygen greater than 90%. Found to be in metabolic acidosis. Patient became unresponsive and pulse could not be palpated. Chest compressions were initiated. ACLS medications given and pulses regained. Patient lost pulse 30 mins later and never regained pulse. Per ED noted; likely developed a PE. Passed away at 2127
This spontaneous report as received from a currently 87 year old patient regarding him/herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient had no known drug allergies. On 05-DEC-2012 the patient was vaccinated with ZOSTAVAX (lot, expiry date and dose were not reported) subcutaneously for prophylaxis. Approximately on an unknown date of 2018 (also reported as now), the patient suffering from shingles. The outcome of herpes zoster was reported as not recovered. The causality assessment was not provided by the reporter.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling lousy/yucky), MALAISE (Not feeling well), DIARRHOEA (Loose Bowels), NASOPHARYNGITIS (Cold symptoms) and PAIN IN EXTREMITY (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 medical history reported).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling lousy/yucky), MALAISE (Not feeling well), DIARRHOEA (Loose Bowels), NASOPHARYNGITIS (Cold symptoms) and MYALGIA (Feeling achy). At the time of the report, FEELING ABNORMAL (Feeling lousy/yucky), MALAISE (Not feeling well), DIARRHOEA (Loose Bowels), NASOPHARYNGITIS (Cold symptoms) and MYALGIA (Feeling achy) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported.  Description: The patient mentioned that they were not feeling well despite being scheduled for the second dose of their Moderna COVID-19 vaccine on 17 Mar 2021. She stated she was not feeling well, had loose bowels, was feeling achy, lousy, yucky and had cold symptoms.She mentioned at that time she received first dose she had a little bit of the sore arm symptom.  No treatment information was provided.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 15 month old patient who was vaccinated on 30-NOV-2022 with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024, intramuscular (IM). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
Very itchy; Small rashes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy) and RASH (Small rashes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Very itchy) and RASH (Small rashes). At the time of the report, PRURITUS (Very itchy) and RASH (Small rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported  Treatment medication information were not reported
This patient was given MMRV (Proquad) by mistake. This patient is not in the age range for Proquad. The provider had this patient come back to the office to get a titers blood test. We are waiting to see if the patient is vaccinated or if she will need to get another vaccination.
A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the ages of 6-35 months who were inadvertently administered Fluvirin in the vastus lateralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update (1) 12/27/02: A report received from a health care professional indicated that a 2 year old male vaccinee inadvertently received Fluvirin vaccination on 10/16/02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.
Patient complained of pain in upper left shoulder starting several hours after injection.  The pain was not severe but has persisted for at least 2 months.
tested positive for COVID after getting first shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID after getting first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID after getting first shot). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID after getting first shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-Significant Follow up. Reporter first name and address updated
A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Sep-2012. The patient experienced fever. FLUMIST was discontinued on 27-Sep-2012. The outcome of the event of fever is unknown. The report was considered to be non-serious.
Hives less than 12 hours after vaccines.  Given Clarinex 5mg per mouth every AM for 10 days.