chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right armpit swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for in-jection, lot number and expiration date was not reported), via an unspecified route of administra-tion, administered in Right Arm on 12Jul2021 (Age at vaccination was 23 years) as dose 2, single for covid-19 immunization. The patient medical history, family history none and concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on Jun2021 (Age at vaccination was 23 years) as dose 1, single for COVID-19 immunization. On 13Jul2021 the patient had a reaction and he and his family were looking into it. The patient's right armpit which, was the arm that was vaccinated, was getting swollen. Patient wants to know if this is a normal reaction to the vaccine, He also said he read on the internet that it may last until 6 weeks. With that, he wants to know how long he should wait before contacting his HCP. Patient did not go to Emergency Room or Physician Office. The outcome of event was recovering.  Information on the Batch/Lot number has been requested.
My legs are completely numb from the knee down and so weak. Scared and unsure of whet to do as it?s getting Progressively worse throughout the day
(Adverse event onset time is estimated, not known) Redness, swelling, tenderness at injection site. Temp. 99.1, pharyngitis. Patient was given Rx for Augmentin. Advised Benadryl prn, ibuprofen prn, warm or cold compresses prn.
headache; fever; chills; nausea; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 as DOSE 2 (Age at Vaccination: 57-years-old), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 of bnt162b2 on 23JAN2021 for Covid-19 Immunization (Lot: EJ3247 or EG3247. She said that she cannot read the handwriting on the card). The patient experienced headache, fever, chills and nausea on 14Feb2021 at 04:00. Treatment was received for headache. Outcome of the events headache, chills and nausea was unknown, fever was Not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
RED SPOTS; LITTLE TIRED; SLIGHT HEADACHE; LOW GRADE TEMPERATURE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included severe anxiety, and sinus infection.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced little tired, slight headache. On 09-APR-2021 and low grade temperature. On 20-APR-2021, the subject experienced red spots.  Laboratory data included: Acid base balance (NR: not provided) Fine, CBC (NR: not provided) Fine, Platelet count (NR: not provided) Fine, and Red blood cell count (NR: not provided) Fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little tired, slight headache, and low grade temperature on 11-APR-2021, and the outcome of red spots was not reported. This report was non-serious.
36 week pregnant patient received an expired dose; 6 week pregnant patient received an expired dose; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number N959G, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was October 2022. The patient received FluLaval Quadrivalent 2022-2023 season at week 36 of the pregnancy. On 19th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and expired vaccine used were unknown. The pregnancy was ongoing.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, a 36 weeks pregnant patient received an expired dose of Flulaval, the vaccine expired on 30th June 2022. The consent for follow-up was not asked. Additional Supportive Information: A pregnant patient received an expired dose of Flulaval, which led vaccine exposure during pregnancy and expired vaccine used.
Systemic: Body Aches Generalized-Mild, Systemic: Fever-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient has previous diagnosis of Potts, patient had fever of 103 for 2 days after injection, is still having issues with heart rate as of 08/28/2021. patient has not sought ER care at this time as her tachcardyia is not bad enough for her to go to ER
Sever fever/chills/headache throughout the night. Awoke to no fever or chills, but continuing achey body and headache.
Patient called  after events occurred. She was administered the shot on 12/21. She stated that evening, she became short of breath however did not seek medical treatment. She stated she instead went to sleep and Tuesday 12/22 she was experiencing a back ache but also had a dull ache in her neck and forehead.   I suggested patient  be seen by their PCP.  Whether or not patient followed up with medical care is unknown.  I also encouraged her to call back if symptoms do not improve or if any new symptoms occur. Have not heard back from individual.
Positive covid test on 2/22/2021.  Symptoms began about 2/19/2021
Kinrix expired dose was administered to a female child 4 days expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired drug used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 30-MAY-2023, the patient received Kinrix. On 30-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired drug used (Verbatim: Kinrix expired dose was administered to a female child 4 days expired). The outcome of the expired drug used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-May-2023 The reporter consented to follow-up. The patient an expired dose of Kinrix, which led to expired vaccine used.
Since receiving the vaccine the patient has been experiencing a rash. She gets blisters that pop up and itch a lot. She also is having a lot of fatigue and weakness. Every now and then she also becomes shaky.
Pain experienced during vaccination.  In days, weeks and months that followed, inflammation, chronic pain and restricted mobility. Sought medical attention after four weeks.  It is believed that the vaccination was injected into my sub delta bursa sac instead of my upper deltoid muscle.  During November, December and continuing through January (and possibly beyond) ultra sound and cupping to reduce inflammation.  Physical therapy to regain mobility. Addition physical therapy to rebuild strength in arm, neck and shoulder muscles that had atrophied. Unable to perform normal daily activities.
Approximately 30 minutes after the vaccination, I felt a sensation (pressure in my ears and tingling throughout my body), then I could feel my heart start to race. My best estimate as the fast heartbeat last for between 60-120 seconds. I experienced the tingling feeling one more time, about 15 minutes later.
This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 01-MAR-2019, the patient was vaccinated with improperly stored M-M-R II (lot# R019684, expiry date: 09-JUL-2020 (also reported as 10-JUL-2020) for prophylaxis (product storage error). Nurse has reported that M-M-R II was reconstituted with properly stored Sterile diluent. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was eight of nine reports mentioned in the report. Lot number R019684 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Sender's Comments: US-009507513-1903USA009054:Master#.
Body aches, fever (101.4F), trouble concentrating, fatigue, listlessness
Chest pain; Weird metallic taste in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and DYSGEUSIA (weird metallic taste in my mouth) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 702174) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS (Cardiac symptoms started earlier in 2021 before the patients first Covid-19 vaccine injection).    On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) and DYSGEUSIA (weird metallic taste in my mouth). At the time of the report, CHEST PAIN (chest pain) and DYSGEUSIA (weird metallic taste in my mouth) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) negative.     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 was provided by the reporter. No treatment medications was provided by the reporter. patient received vaccine on 25-OCT-2021 and experienced chest pain and had wired plastic taste in his mouth. patient didn't have history of Myocarditis/Pericarditis and lab test of ECG and blood test was negative.
Metallic taste in mouth and mouth feels sore, happened after the vaccine 3 aphthous ulcers in mouth, with mucous infraction.
pt had a normal mense without clots between 01/04/2021  and 01/10/2021 but 2 days after receiving Pfizer covid vaccine had second onset of menstrual bleeding which is much heavier leading to leakage around the cup used to retain menstrual bleeding associated with clots (metromenorrhagia). pt on contraceptive and not attempting to conceive pt denies purpura or any other sx
Patient was administered an improperly stored ROTATEQ.; No adverse event; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 01-NOV-2019, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis, lot# 1660935 and expiration date on 06-OCT-2020 (anatomical location, route of administration, dose and strength date were not reported) which was improperly stored. The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vaccine underwent temperature excursions of 51.28 degrees Fahrenheit (°F) as a total time and highest temperature above 47 degrees Fahrenheit (°F) (9 degrees Celsius (°C) for a time frame of 2 hours and 16 minutes, which was not called by the digital data logger with a supported outcome. There were no previous temperature excursions reported.
PCV13: Extreme left shoulder pain and loss of arm use, 3days, (a 10);  10:30 AM hacking cough lasting 48 hrs; continual painful>hurtful>soreness still present today (5-13-2016). Using 600mg ADVIL 3x/day.  Went to emergency room 5-8-16, Dr felt it was work related, gave me exercises. 5-11-16 sinus congestion with headache & coughing started, using pseudo epinephrine.
Booster dose given to a 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 14 year old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (Batch number EW0185,Dose 1) on 17-Jun-2021, pfizer (Batch Number FA6780 andDose 2) on 08-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer and pfizer.    On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 14 year old). On 26-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose given to a 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
20 year old, referred for consideration by primary team for exemption to the COVID-19 vaccination.  The patient reports he was OK around 5-6 October.  On 6 October he received the Pfizer Covid-19 vaccine in the morning and then found that he injured/twisted his right ankle.  He injured it one more time that same day and then it had persistent numbness over the top of the foot and difficulty raising the foot.  About a week later he noticed, in addition to those persistent symptoms in the right foot, that his hands/fingers were tingling and he had some trouble with fine motor use.  He then received multiple other vaccinations recorded on 12 October are vaccinations for adenovirus, twinrix, polio, menveo, menactra, Tdap, varicella.  MEDPROS not available for confirmation (menactra and menveo would not normally be given together as they are both meningitis vaccines).  His symptoms persisted and he sought care from primary care, was referred for specialty care with physical medicine and neurology which ultimately led him referred for consideration of IVIG treatment for presumptive diagnosis of AIDP.  Here the neurology service feels the diagnosis may be AIDP or HNPP, but neither diagnosis is conclusive.  Past medical history is significant for receipt of most childhood vaccines with the exception of HAV and potentially one MMR.  He had HBVx3, Dtap x4, IPV x3, HiB x4, PCV x4, varicella x1 and MMR x1.  Mom reports that the patient had some developmental/speech delays and required an IEP and he had low muscle tone requiring physical therapy until the 2nd or 3rd grade.  She also noted he would get large swelling at the sites of the vaccines which concerned her (she has a medical background so could compare to others) and he would have several hours of an inconsolable cry after Dtap vaccination.  Other than that no surgeries, allergies, medications.  No recent illness prior to the onset of the symptoms in the foot.  No diarrhea, no fever before or after symptoms.  No rash including hives, angioedema, eczema at any time.
pt recv vax & exp total rash & fever which lasted for two weeks & worsened for tow days;pt was found to have perivascular lymphocytic dermatitis
severe crying w/body stiffening lasting 2 days;no significant fever;decreased to no sleep;
diarrhea; appetite not the same; upset stomach; just started eating meat because it was too hard to get down; bad nausea; headaches that would come and go; vomiting; pain on both arms; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down) and MYALGIA (pain on both arms) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (pain on both arms). On 14-Apr-2021, the patient experienced DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down), NAUSEA (bad nausea), HEADACHE (headaches that would come and go) and VOMITING (vomiting). At the time of the report, DIARRHOEA (diarrhea), APPETITE DISORDER (appetite not the same), ABDOMINAL DISCOMFORT (upset stomach), EATING DISORDER (just started eating meat because it was too hard to get down), MYALGIA (pain on both arms), NAUSEA (bad nausea), HEADACHE (headaches that would come and go) and VOMITING (vomiting) outcome was unknown. Not Provided          Patient was reported to be advised to take OTC generic Dramamine that I take every 24 hours, Gatorade and Pedialyte. Patient was also reported to be taking bland diet.   This case was linked to US-MODERNATX, INC.-MOD-2021-114509 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114509:dose1
RN reported a improperly stored PROQUAD administration; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy, and concomitant medication were not reported.  On 06-OCT-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # S027463, expiration date was reported as 02-JUN-2021, but upon internal validation established as 02-MAR-2021) for prophylaxis. The vaccine administered experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit, with an average of 11.8 degrees Fahrenheit for 31 hours as recorded by a data logger. There was no previous temperature excursion.
the patient lost her mind( started to behave like someone on drugs ); had  big open sores on back of her hands; patient didn't receive the second dose; " her mouth is mess"/developed rashes in mouth and lips; developed rashes in lips; developed rashes on her upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips) and CHEILITIS (developed rashes in lips) in a 59-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.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips), CHEILITIS (developed rashes in lips) and RASH (developed rashes on her upper body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (the patient lost her mind( started to behave like someone on drugs )), SKIN ULCER (had  big open sores on back of her hands), PRODUCT DOSE OMISSION ISSUE (patient didn't receive the second dose), ORAL MUCOSAL ERUPTION (" her mouth is mess"/developed rashes in mouth and lips), CHEILITIS (developed rashes in lips) and RASH (developed rashes on her upper body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment included antibiotics and topical steroids
Information has been received from a consumer concerning her sister, a 12 year old female who was vaccinated with Varivax. After the first dose of Varivax, the patient "broke out in chickenpox spots all over; there were quite a few." The consumer stated that the patient was taken back to the physician for follow-up. The patient's chickenpox spots persisted. No further information is available.