chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a consumer on 24 OCTOBER 2013. At 55 years old female patients whose medical history was not reported and concomitant medication included antibiotics, had received a dose of FLUZONE (lot number, route was intramuscular and site of vaccination was left deltoid on 06 OCTOBER 2013). Caller reported that during the injection (on 06 OCTOBER 2013), a pain traveled to left ear to elbow which lasted 1 hour, left arm was sore for 2 days. On 10 OCTOBER 2013, she could not get up and she kept falling back and her head was spinning. She took vertigo medication from the pharmacy. On 16 OCTOBER 2013 she went to a neurologist, who did MRI and CT scans and diagnosed vertigo which continues when she turns to the left on the side she got the vaccine. Events were not recovered at the time of report. List of documents held by sender: None.
This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 26-OCT-2015 the patient was vaccinated with expired dose of M-M-R II lot # J010208, expiration date 23-AUG-2015, .5 ml, subcutaneous in the Anterolateral Left thigh (expired product administered). No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Vomiting; Fever; This spontaneous report was received from a consumer concerning a 43-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Her concomitant therapies included tozinameran (PFIZER BIONTECH COVID-19 VACCINE).   On 31-MAR-2022, the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, dose number, lot number, expiry date, and route of administration were not provided). Other suspect therapy included adalimumab (HUMIRA), citrate free, administered subcutaneously for moderate to severe hidradenitis suppurativa (strength, frequency, lot number, and expiry date were not provided).    On the same date (31-MAR-2022), the patient experienced fever and vomiting. At the time of reporting, the patient had not recovered from the events.  The action taken with adalimumab (HUMIRA) was reported as unknown.  It was reported that was unknown if the patient was enrolled in a coronavirus disease 2019 (COVID-19) vaccine trial.  The causal relationship between fever, vomiting and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
This spontaneous report as received from a physician refers to a female patient in her 60's. The patient's pertinent medical history, drug reactions/allergies were not provided. On 07-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that in August 2014, after receipt vaccin, the patient experienced vesicles at the injection site. One vesicle, at the injection site, was the size of a silver dollar and there were several smaller vesicles around the injection site. Patient had no generalized symptoms or malaise. The patient was prescribed antivirals as treatment. The patient sought medical attention buy seeing the physician. At the time of the report, the patient's outcome was unknown and the relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Patient accidentally received the Fluzone HD instead of the Fluzone Quad. vaccine; Patient accidentally received the Fluzone HD instead of the Fluzone Quad. vaccine; Patient accidentally received the Fluzone HD instead of the Fluzone Quad. vaccine; Headache; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who experienced headache (headache), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatments, vaccinations and family history were not provided.   On 18-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number: UJ281AA, Expiry date: 16-MAY-2020] via unknown route in the left deltoid.  On 19-Nov-2019, the patient developed a non-serious headache, one-day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also a case of actual medication error due to wrong product administered, product administered to patient of inappropriate age and overdose.  Other relevant tests included No lab data.  Final diagnosis was headache.  It was not reported if the patient received a corrective treatment.  On 20-Nov-2019, the patient recovered from Headache (reported as he was feeling fine today).   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.
20 minutes after shot given had small to moderate burning on roof of mouth and throat. No swelling or difficulty breathing. This sensation gone one hour after shot.
PT STATES THAT AFTER RECEIVING HER FIRST PFIZER VACCINE, HER MENSTRAL CYCLE HAS BEEN VERY PAINFUL.  PT STATES THAT THE PAIN FEELS LIKE SHE WAS IN LABOR.  PT RECEIVED FIRST VACCINE 16 SEP AND STATES THAT THE PAIN HAS LESSEN BUT DID RECEIVE SECOND PFIZER VACCINE 23 NOV AT 0953
One week after vaccine patient developed bumps on / near vaginal area. They were determined to be warts. Patient is not sexually active.
ACT-HIB was reconstituted with a different diluent than what it is supplied with with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 1 years old male patient for whom act-hib was reconstituted with a different diluent than what it is supplied with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix), Hepatitis A Vaccine Inact (Havrix), pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13), measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine live (OKA/MERCK) (Varivax) for Prophylactic vaccination.  On 30-Aug-2023, the patient received suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection lot UJ835AA via intramuscular route in the left thigh for prophylactic vaccination (strength, dose, expiry date: unknown), was reconstituted with a different diluent than what it is supplied with with no reported adverse event (product preparation error) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product preparation error.  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.
10/30/23 received COVID vaccine at approx 10.30am at -COVID received Moderna COVID vaccine 10/30/2023 at pharmacy , started chills same evening 10/31/23Body aches, sweats, nausea  11/1/23 new onset of pain under right shoulder blade pain, constant, also tight ribs and stomach cramps. No SOB musculature of ribs, tingling in tips of fingers and toes 11/2/23 dinner time: no change in symptoms 11/2/23 evening, went to UC, did EGK (reports it was normal)  11/3/23 woke up, felt totally fine and at baseline. All sx resolved.
client reports that she developed RA after 2nd pfizer vaccine that started 2 weeks after vaccine - low grade fever, body aches all over; joints and body hurt "like hell"; off balance; swelling in feet and hands;  Gave mobic and tramadol for pain; flexeril for muscle spasms; she was diagnosed at HCF and given medication listed above and referred to rheumatologist ( client has not been able to get into rheumatologist as of yet).  client reports that her symptoms seeme to be improving. client reports that she had an episode 2 weeks after 2nd pfizer and then has had another episode within the last month.
Patient received the vaccine on 10/3/2018 the next morning she called the pharmacy 10/4 and said last night she was really sick with fever and chills. Then 10/10 she called the pharmacy back to let us know she was admitted for afib and believes it was from the vaccine that caused all of this for her. Her doctor had to put her on Eliquis.
Pt had anaphylactic reaction including throat, mouth swelling and SOB, administered Epinephrine 0.3mg, sent patient to ER via ambulance.
48 hours after receiving the 2nd dose of the COVID19 Moderna vaccination I experienced fevers, chills, chest pains, heart palpitations, and headaches. Everyday since receiving the 2nd dose of the COVID19 Moderna vaccination I have experienced chest pains and an irregular heart beat. On December 5th, my heart rate fell so low I fell unconcious and was awoken by my roomate. Since that occurance the frequency and intensity of the chest pains and irregular heart beat has increased. I contracted COVID19 on December 23rd. Unable to see a cardiologist yet, but scheduled to in coming weeks. No treatment to report.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 11:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 11:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.86.  Concomitant medication was not provided.  On 29-Apr-2021, Excursion time was 10 AM and temperature was 33. Total doses given for the day was 201. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 19-Apr-2021 and was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021. On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45 and 4 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment information was not reported.
Fever; Diagnosed with covid-19; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Diagnosed with covid-19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Diagnosed with covid-19). At the time of the report, PYREXIA (Fever) and SARS-COV-2 TEST POSITIVE (Diagnosed with covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
inadvertently administered PENTACEL to a 15 month old patient instead of DTaP, with no reported adverse event; 4th dose of IPV too early, with no reported adverse event; Initial information was received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.  This case involves a 15 months old male patient who experienced inadvertently administered pentacel to a 15 month old patient instead of dtap, with no reported adverse event and 4th dose of ipv too early, with no reported adverse event while receiving vaccines Poliomyelitis vaccine (INACTIVATED) and 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 HIB vaccine CONJ (OMPC) (PEDVAXHIB) and Hepatitis A vaccine (HEPATITIS A) for Immunisation.  On 17-Mar-2022, the patient received 0.5 ml of suspect Diphtheria/tetanus/5 hybrid AC pertussis/ipv (MRC5)/HIB(PRP/T) vaccine (lot -UJ601AAA expiry -05-Dec-2022) via Intramuscular route in the left leg for immunisation. On an unknown date, the patient received a dose of suspect Poliomyelitis vaccine produced by unknown manufacturer (dose, lot, strength, formulation, and expiry: unknown) via unknown route in unknown administration site for immunization.   On 17-MAR-2022 the patient developed "inadvertently administered pentacel to a 15 month old patient instead of dtap, with no reported adverse event (accidental exposure to product) (latency same day) and "4th dose of ipv too early, with no reported adverse event" (inappropriate schedule of product administration) (latency; unknown) following the administration of Diphtheria/tetanus/5 hybrid AC pertussis/ipv(MRC5)/HIB(PRP/T) vaccine and Poliomyelitis vaccine.    Action taken-not applicable for both suspects  Outcome- unknown for both events   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.
10/17/14, PM, customer has swelling and inflammation in his left interior arm (side closest to chest). 10/18/14 PM customer informs me of issue. He declined over the counter analgesics. He was given hydrocortisone 12 cream.
VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs; This spontaneous safety report was received by the partner on 14-SEP-2023 and forwarded to company on 14-SEP-2023, from a health professional.   Due to the nature of the event, the causality between the event "VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs" and Vaxelis was not applicable.   Companion Case: MCM-005216.  Further information is expected.
pain in his left hand, pain in his left fingers; pain in his left wrist; A spontaneous report was received from a consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in his left hand and pain in his left fingers/pain in extremity, pain in his left wrist/arthralgia.  The patient's medical history included pneumonia and COVID-19 infection November 2020 (hospitalized for 5 days). Past/current medical conditions include carpal tunnel of left hand (diagnosed 10 to 15 years ago). No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch no: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 FEB 2021 patient experienced pain in his left hand, wrist and fingers.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain in his left hand, wrist and fingers that is ongoing.
Shingles presented on 3/1/2021; however, I had never experienced chicken pox symptoms in my childhood so I was not aware I could get shingles. I treated the rash as if it were dermatitis until 3/4 when a medical professional diagnosed shingles.
H/A c/w migraine, dizziness - room spinning - chills and myalagias
Body/joints aches, sore throat, injection site pain and tenderness, chills, low grade fever
Patient received vaccine at 5pm. Two hours later she noticed her throat tightening, tongue swelling, conjunctivitis, eyes red and oozing. She called her PCP who said go to ER. They gave her oral BENADRYL.
Complaint of extremely sore at injection site as well as numbness and tingling down arm-pronounced numbness and tingling in arm if injection area was touched lasting 2-4 weeks post injection
an expired IPOL vaccine was administered to a patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00395914) and transmitted to Sanofi on 16-Dec-2020.  This case involves a 17 months old female patient who received a 0.5ml standard dose of an expired of IPV (VERO) [IPOL] (lot number: P1F54, expiry date: 07-Dec-2020) once via intramuscular route in the right thigh on 15-Dec-2020 for prophylactic vaccination (expired product administered).  Medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included influenza vaccine for prophylactic vaccination.  It was an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  Reporter would like to know how to move forward in caring for the patient.  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.
delirious/uncontrolled laughing; loss of memory; 102 F fever; pied on self; dizzy; headache; A spontaneous report was received from a Consumer, concerning herself of 73 years old female, who received Modena's COVID-19 vaccine, and experienced headache, delirious/uncontrolled laughing, 102F fever, lost memory, peed on self, dizziness.  The patient's medical history was not provided.   Concomitant medication included Gabapentin for pain 80 mg 3 times a day, Amlodipine, Esomeprazole twice a day 40 mg, Furosemide 40 mg 2 in the morning, Citalopram 20 mg, Pentosan polysulfate 100 mg 3 times a day, Renoxin 1000 mg twice a day, potassium 20 mq twice a day, Atorvastatin twice a day, Trazodone 150 mg once a day, Linaclotide once in a while 290 mcg, vitamin D once a week, Clonazepam twice a day, Diphenhydramine, Alirocumab injection.   On 03 FEB 2021, the patient received their first of two planed doses of mRNA-1273 (Batch number 012M20A) on right non-dominant arm for prophylaxis of COVID-19 infection.   On 05 Feb 2021, 2 days after vaccination, the patient had headache and a day after had memory loss and fever ranging from 102 to 103, pied on self, dizzy, uncontrolled laughing and delirious, all of which lasted for 3 days but treated only for headache.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Gave flublok to 17 year old when only approved for 18 years and older. No symptoms or side effects known.
Vaccine was administered 6 August. 20 August began running fever that lasted until 21 August. Test for COVID came back positive.  Other symptoms were sneezing and slight congestion. Began accelerated hair loss 23 August which continues to date. Began running fever again on 2 September with no other symptoms. This lasted one day.
Local rash on left arm developed 7/15/07, 4d after vaccine. In next 48 hours rash spread to face, body,neck, leg - mac. papular in nature.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route of administration were not provided). No adverse events were reported. Follow up information has been received from the registered nurse on 06-NOV-2015. The nurse reported that on unknown dates, the doses of improperly stored VAQTA (lot # K012457, expiration date 04-JUN-2017) (dose and route were not reported) were also administered to unspecified number of patients. Follow up information has been received on 30-DEC-2015. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information was received on 07-JAN-2016 from the registered nurse. On 29-OCT-2015, the patient of unknown age and gender was vaccinated with a dose of VAQTA (lot # L018499, expiration date 25-FEB-2017; dose and route were not reported) that was involved in the temperature excursion. The nurse confirmed that no adverse events were reported. This is one of several reports received from the same source. Additional information has been requested. Patient tab, product tab, event tab and analysis were updated.