chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little redness on shoulder; Muscle pain ("a lot stronger"); Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (a little redness on shoulder), MYALGIA (Muscle pain ("a lot stronger")) and ARTHRALGIA (Joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Biopsy in 2004. Concurrent medical conditions included Myopathy (Tubular Aggregate Myopathy) since 2004 and Allergy. Concomitant products included MORPHINE, CARISOPRODOL (SOMA [CARISOPRODOL]), HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), DIGOXIN, SOTALOL, OLMESARTAN MEDOXOMIL (BENICAR), EZETIMIBE (ZETIA), ADENOSINE (TRICOR [ADENOSINE]), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), VITAMIN D [VITAMIN D NOS], MAGNESIUM, VITAMIN B1 NOS, LORATADINE and PSEUDOEPHEDRINE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced ERYTHEMA (a little redness on shoulder), MYALGIA (Muscle pain ("a lot stronger")) and ARTHRALGIA (Joint pain). At the time of the report, ERYTHEMA (a little redness on shoulder), MYALGIA (Muscle pain ("a lot stronger")) and ARTHRALGIA (Joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-114419 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114419:Case for first dose
Within 17 hours of second Pfizer COVID-19 vaccine, I was diagnosed with Atrial Fibrillation; at time of diagnosis I experienced flu-like symptoms, including body and joint aches, headache, feeling flushed or feverish.  Diagnosis was confirmed by EKG and I was referred to cardiologist.  I started diltiazim within a few days to control heart rate (over 100 in doctor's office); I am now on diltiazim and Equis to prevent stroke.  No previous history of Afib, no heart disease.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Lot number: En5318) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP; "prediabetes" (unspecified if ongoing), notes: prediabetes. There were no concomitant medications. Past drug history included: Lisinopril, reaction(s): "known allergies Lisinopril", notes: known allergies Lisinopril; Losartan, reaction(s): "known allergies losartan", notes: known allergies losartan.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "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 drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Super bad headache & exhaustion. Woke up 4-7-21 with headache that Motrin doesn?t seem to help. Hurts to hold head up
received dose from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  No treatment information was provided. The vial was initially stored in the refrigerator on 21-Oct-2021. The vaccine was expired on 24-Oct-2021. Patient experienced no adverse events after the vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up information received contains Additional details related to the Event.
received an expired dose of Menactra with no reported adverse event; Initial information was received on 06-May-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00590371).  It was reported that on 05-May-2021, a 16-year-old female patient received 0.5 ml of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (batch number: U6486AD) which was expired on 10-Jan-2021 via intramuscular route at an unknown administration site for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event 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.
At 1551, patient stated having itching lips and feels lips slightly swollen.  Patient received second dose of covid vaccine at 1533.  RN assessed and noticed slight swelling and reddness.   Patient offered and given benadryl 50mg PO at 1553 and monitored for another 15 minutes.  Patient stated she feels better and experiencing less itching and swelling at 1608 and requested to leave vaccine clinic.  Patient stated she works in Dr. office on hospital grounds and will notify him and have staff continue to monitor a the docotr's office and will come back to hospital if signs or symptoms worsen.
Missed her period by 11 days; This is a spontaneous report from a non-contactable consumer (patient herself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 28Jun2021 at 17:00 at the age of 19 years old (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The vaccination facility type was a pharmacy or drug store. Relevant medical history included COVID-19 prior vaccination on an unknown date. There were no concomitant medications; no other medications in two weeks. The patient had no other vaccine in four weeks. The patient was not tested for COVID-19 post vaccination. The patient missed her period by 11 days on 28Jun2021. The patient did not receive any treatment for the adverse event (AE). The patient was not recovered from the event at the time of the report.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to an unspecified number of patients (age and gender unknown). On an unknown date, the patients were vaccinated with ROTATEQ, oral (dose, lot not reported). It was reported that ROTATEQ reached 54 degrees F for 192 hours which was not supported by our in house stability data and was administered to an unknown and unspecified number of patients. No adverse effects reported. A different batch of ROTATEQ reached 52 degrees F for 8 hours and also reached a temperature of 30 F for a total of 171 hours. This was supported by our in house stability data, but some of the ROTATEQ was administered to an unknown and unspecified number of patients. No adverse effects reported. Additional information is not expected.
Mother states child started running fever on Mon. 1/21/02/. Was taken to ER via ambulance 1:00 am. Wed 1/23/02 informed ER Dr of recent immunizations. Dr told mom he didn't think it was vaccine related. Is being treated for pneumonia and ear infection. To f/u with PP. X 10 days.
This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 39-year-old female patient who received SHINGRIX. On 20th January 2018, the patient received the 2nd dose of SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 20th January 2018, the patient experienced inappropriate age at vaccine administration. On 21st January 2018, the patient experienced fever, injection site pain and weakness. On an unknown date, the outcome of the influenza-like symptoms, weakness and inappropriate age at vaccine administration were unknown and the outcome of the fever and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. The reporter considered the fever, injection site pain and weakness to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The 39 year old patient received SHINGRIX, which led to inappropriate age at vaccine administration. Last night from the day of reporting, less than a day after vaccination, the patient experienced flu like symptoms. One day after vaccination, the patient had weakness, fever and injection site pain.
Nausea; Head congestion; Diarrhea; This non-serious case was reported by a consumer and described the occurrence of nausea in a 68-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number 2450472-09827) for prophylaxis.   Concomitant products included dutasteride (Avodart (Dutasteride)) and duloxetine hydrochloride (Cymbalta (Duloxetine)).   On 19-SEP-2023, the patient received RSV vaccine. On 21-SEP-2023, 2 days after receiving RSV vaccine, the patient experienced nausea (Verbatim: Nausea), head discomfort (Verbatim: Head congestion) and diarrhea (Verbatim: Diarrhea).  The outcome of the nausea, head discomfort and diarrhea were not resolved.   It was unknown if the reporter considered the nausea, head discomfort and diarrhea to be related to RSV vaccine.     It was unknown if the company considered the nausea, head discomfort and diarrhea to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-OCT-2023 It was reported that patient suffered from nausea, head discomfort and diarrhea after receiving RSV vaccine.
This spontaneous report as received from a 71 year old male patient, reporting on himself. The patient's medical history included enlarged prostate. On 05-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported), upper left arm. Concomitant therapies included finasteride, SPIRIVA and SEREVENT. "Three weeks ago", approximately on 30-MAY-2013, the patient experienced itchy rash that was blistering across both shoulders. Some blisters were drying over and scabbing over, but he was still getting new blisters. No other adverse symptoms have been noted. The patient did not seek medical attention. No treatment was given. None lab diagnostics studies were performed. The outcome of patient was reported as not recovered/not resolved. Causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
I have Horner's Syndrome / onset coincides with receiving dose 1 of Shingrix; my right eye is effected with partial closings; experiencing headaches, pretty much constantly; This case was reported by a consumer and described the occurrence of horner's syndrome in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced horner's syndrome (serious criteria GSK medically significant), lagophthalmos and headache. On an unknown date, the outcome of the horner's syndrome and lagophthalmos were unknown and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the horner's syndrome, lagophthalmos and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingrix and pretty much in the days after, the problems started. The patient stated that he/she had located very minimal information on a link with Shingrix and Horner's Syndrome and he/she had Horner's and the onset coincides with receiving dose 1 of Shingrix. The patient had a brain scan, lung scan and carotid artery scan to rule out tumors as a cause of the Horner's Syndrome and the scans had all been good, but his/her right eye was affected with partial closing and he/she was experiencing headaches, pretty much constantly. The patient wanted to know if we had any reported information on a link with Shingrix and, if so, was that information we would share with patient. The patient was concerned about the financial aspect of all the testing, concerned about the constant headaches and also about the eye and certainly, concerned about the 2nd dose. The patient mentioned that he/she did like information to get an idea of how long this might last and if it would resolve and wanted to let him/her know if we had any information.
Redness and swelling at injection site. 7 cm x 10 m area. Warm to touch.
Temporary hearing loss and ear discomfort.  Felt like ear pressure when changing altitude quickly, but added with warm burning sensation. Mostly return to normal 6 hours later. Also experienced warmth and uncomfortable tight feeling in right side of neck. Neck discomfort mostly resolved 6 hours later.
Started at approx 1145 am with pain in left side of neck/shoulder that radiated up left side of head, around to the front & down right side of head & neck.   Severe throbbing/pulsating headache 9/10 on pain scale that lasted for an hr. Repeat episodes at approx 27 & 40 hrs post vaccine with episodes lasting longer & more severe each time. Headaches hit instantly with no warning & forced me into fetal position, screaming out with pain. Intense feeling of  pressure like something in my head was about to burst. Took Tylenol & motrin, used ice packs & remained as still as I could as movement made the headaches significantly worse. Eventually throbbing/bursting pressure would subside to a dull overall headache with each episode lasting 1 hr, 1.5 hrs & 1.5 hrs respectively.
Patient was newly pregnant, received 2nd dose of covid vaccine.  Patient then began bleeding on 2/13/21.  On 2/15/21 confirmed with OBGYN that HCG levels were low and that she was having a miscarriage.  Patient has a healthy 2 year old living child.  No past history of miscarriages, no family history of miscarriage.
Anaphylaxis; Initial information received on 17-Mar-2021 regarding an unsolicited valid serious courtesy case received from an other health care professional via consumer in the United States.  This case involves a 68 years old female patient (166 cm and 81.65 kg) who experienced anaphylaxis (anaphylactic reaction), while she received MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE.  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  At the time of the event, the patient had ongoing hypertension.   On 27-Oct-2009, the patient received a dose of suspect MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE (batch number: UP006AA, expiry date: 15-MAR-2011) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in Oct-2009, the patient experienced a serious anaphylaxis (anaphylactic reaction) after few days following the administration of MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. This event was assessed as medically significant  The event (Anaphylaxis) qualified for Adverse Event of Special Interest.  It is unknown if the patient experienced any additional symptoms/ events.   It is unknown if there were laboratories data/ results available.  It was not reported if the patient received a corrective treatment for the event (Anaphylaxis).  At time of reporting, the outcome of event anaphylaxis was unknown.; Sender's Comments: This case concerns a 68 years old female patient who experienced anaphylaxis few days after vaccination with MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE. The time to onset is compatible. The patient's medical condition at the time of vaccination was hypertension. However, lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
COVID-19 Treatment; COVID-19 Treatment; Pfizer 4 th dose: 07Oct2022/Moderna 3 rd dose: 16Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 56 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 16Aug2021 at 12:00 as dose 3 (booster), single (Lot number: 037A21B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure and Known allergies were None .Concomitant medication(s) included: LISINOPRIL, start date: 01Jun2014.The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Oct2022, outcome "unknown", described as "Pfizer 4 th dose: 07Oct2022/Moderna 3 rd dose: 16Aug2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Less than 15 minutes after vaccination alerted lead of itching and hives.  Noted rash.  Has had similar reactions to medications in the past.  No respiratory compromise.  Per standing order was given Benadryl 50mg po with water at 1519.    1520  VS:  158/79-82-16-96.9 and 96% on room air.  1534  VS:  140/73-76-16-96.6 and 95% on room air.    Employee was observed for an additional 15 minutes with no progression of symptoms.  Instructed to call lead if any further symptoms develop.  Returned to lab department to work.
Flu like symptoms for about 3 hours starting at 26 hours post vaccine. I took Ibuprofen at about 3 hours from onset of symptoms and symptoms were gone within 30 minutes.
Pt developed red, itchy rash on and off at injection site. Per mother, the rash goes away and then comes back 1-2 wks later. Initially there was a red spot which lasted x 1 month after immunization. It went away and then a small red spot came back and spread 2 wks later.
Information has been received from a 22 year old female with a history of pregnancy, for the pregnancy registry for GARDASIL, who in June 2008, was vaccinated with a 0.5 ml first dose of GARDASIL. Shortly thereafter, the patient found out she was pregnant with her second child. The remaining doses of the vaccine regime were deferred until resolution of the pregnancy. Subsequently, the patient developed gestational diabetes during the pregnancy,, however the baby was fine when it was born. The patient subsequently experienced vaccine exposure during pregnancy and inappropriate schedule of vaccine administration while on therapy with GARDASIL (MSD, WAES #0911USA02821). Additional information has been requested.
While conducting a door to door vaccination and covid testing campaign on 7/1/21 I administered a third dose of the Pfizer vaccination to a Elder.  She had received her first two doses 4/21 and 5/11/21.  The family reported to us that she was due for her second dose.  The patient is HOH and we were using the family as interpreter as well.  We do not have access to patient records while doing these kinds of public health operations in the community.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 2 month old male patient. Patient had no history of chickenpox. On 10-SEP-2014, the patient was vaccinated with incorrectly stored dose of ROTATEQ (first dose, lot # J004875, expiration date: 17-OCT-2014, 2 ml, orally). Concomitant therapies included first doses of DTaPHBIP (default manufacturer GlaxoSmithKline reported as "GSK"), HIB (unspecified carrier) (default manufacturer: Sanofi reported as "AVP") and PCV13 (unspecified) (default manufacturer: Pfizer reported as "PFI"). On 11-NOV-2014, the patient was vaccinated with incorrectly stored dose of ROTATEQ (second dose, K001194, expiration date: 06-NOV-2015 2 ml, orally). Concomitant therapies included second doses of DTaPHBIP, HIB (unspecified carrier) and PCV13 (unspecified). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
3rd dose given in error. Mother notified on 1/21/10. Asked her to call us if he had any side effects as discussed on 1/21/10.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions. It was reported that, there are no adverse reactions to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up document contains non significant information, Second reporter Information added.
pt recv vax; states upper arm became swollen & reddened up into neck; fever of 102 for several days;