chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 28 Jun 2023, 9 doses were administered at administration site 1. No treatment medication reported.   This case was for the 10th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Achy tired feeling with a sore throat runny nose congestion had chills and fatigue.
Post vax, the pt developed stomach pain, headache, weak all over, intermittent elevated temperature, decreased appetite. Taking Tylenol.
In 15 min I felt my tongue was numb  I left and my face on the right side was drupping  My eye was cold because the bottom lid was dripping so I held it closed 3 hour later it went back to normal.
Pt recvd vax & 1 1/2 wk p/vax exp enlargement & tenderness of breasts, abdo cramping & pregnant-like sx;
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches". Additional information: The reporter said he talked to 200 people who have a headache from that booster shot. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
Patient had intense joint and muscle pain, chills, unknown temp for a couple of days after vaccine, which she knew was not abnormal. However, now a week and a half later, still having intense lower back pain that had previously almost resolved prior to obtaining the vaccine. She reports she is still having a lot of joint and lumbar pain.
Diarrhea; Low grade fever; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014RH20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Obesity. Concomitant products included SAXAGLIPTIN (ONGLYZA [SAXAGLIPTIN]), METOPROLOL, AMLODIPINE, ATORVASTATIN, SERTRALINE, ASPIRIN [ACETYLSALICYLIC ACID], METFORMIN, UBIDECARENONE (COQ 10), BIOTIN and COLECALCIFEROL (D3 5000) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency and WATER ongoing since an unknown date at an unspecified dose and frequency. On 02-Mar-2021, PYREXIA (Low grade fever) had resolved. On 05-Mar-2021, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Presented to ED with fever, fatigue, shortness of breath, myalgias Was put on Bipap, treated with decadron Did not qualify for remdesivir and barticinib Developed sepsis, was given rocephin Developed cardiac arrythmia and ventricular fibrillation
stomach cramping; Diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration on 28Dec2020 at 11:45 at 62-years-old at SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced: stomach cramping and diarrhea; which was assessed as non-serious. The clinical course was reported as follows: The patient stated she had the vaccine on 28Dec2020 at 11:45 and "maybe an hour later", her stomach start cramping and then had diarrhea. The patient wanted to know if that was something "to be concerned about." In regard to having any laboratory test, the patient stated, "I went in November sometime for my annual checkup I think it was November" (as reported). When the patient was asked if they received any treatment for the events, the patient stated, "No. I am still at work, I got it today, I haven't taken anything but I was thinking that to just get some "Caper" (as reported) and "gentian soda" (as reported)." The clinical outcome of the events was unknown.
PVC heart rhythm lasting for 72 hours straight. Went away for a week and came back for 96 hours straight. Intermittent chest pain, tachycardia, shortness of breath.
High temperature, bad pain in injection site, redness, swelling, allergic reaction at injection site, Body chills, body aches. Went and seen a nurse who advised to ice injection site and take some Tylenol and to return to the Dr. who gave the shot if it doesn't subside.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil. Subsequently, about one and a half months after the vaccination the patient experienced muscle cramps in the back of the leg (unknown whether one or both legs). The patient visited the after-hours clinic for unspecified reasons. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Information has been received from registered pharmacist concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot No: 663369/1707X), in the left upper triceps. Secondary suspect vaccine included a dose of PNEUMOVAX 23 (Lot No: 661740/1408X). It was reported that the PNEUMOVAX 23 was used to reconstitute the dose of ZOSTAVAX (Merck). The registered pharmacist reported that on an unknown date, the patient's left arm was red and hurting where the injection site was given. The left arm was swollen and red around the elbow. The registered pharmacist reported that the patient mentioned that 3 weeks after ZOSTAVAX (Merck) was given she experienced these symptoms. On an unknown date the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested,
After 1st pill,  had a headache,  fever of 100.2, dizziness and nausea till next day.  Till tylenol which reduced fever and headache.  After pill #2, had severe nausea and slept all day.  After pill #3 had nausea.  No symptoms after pill #4.
Per Mom via telephone on 12/18/14: On 12/13/14 patient started having the sniffles and couldn't stop sneezing.  She got progressively worse with more stuffiness, hard to breathe (due to nasal congestion not chest congestion), her eyes were tearing excessively, like she was crying, and she started to cough.  She never had a fever that her Mom was aware of but her eyes got more swollen and red "like she was crying". She never had any green or yellow discharge.  Patient was sent home from school on 12/17/14 because her eyes were red and swollen and she was sick.  This afternoon (12/18/14) her Mom states she looks like she is getting better, her eyes are puffy and a little red, like she has been crying, not like pink eye.
Vertigo (new onset), nausea. Went to PCP; given meclizine; no resolution.
within 12 hours: tiredness, severe soreness at injection site, extreme swelling at injection site within 24 hours: swollen / sore lymph nodes within 4 days: severe leg joint pain (knees, hips) which  I still have >7 days post injection
sick; arm pain; redness at injection site; chest tightness; low grade fever of 99°F; severe and horrible chills; joint and muscle pain; joint and muscle pain; flu like symptoms; severely achy; This is a spontaneous report from a contactable other HCP. This other HCP (patient) reported that the 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included she had a heart attack 20 years ago and she felt similar chest tightness and she also has coronary artery disease and autoimmune deficiency (ATS) which is not a contraindication for the vaccine she checked with her physician before receiving. Concomitant medications included clopidogrel bisulfate (PLAVIX) and warfarin sodium (COUMADIN). The patient previously received first dose of COVID vaccine on 25Dec2020 and  experienced arm pain and redness that went away. The patient received second dose of COVID vaccine on 14Jan2021 and stated she did not think she was going to make it through the night because she was very sick. The patient states she had arm pain, redness at injection site, chest tightness, low grade fever of 99°F, severe and horrible chills, joint and muscle pain, flu like symptoms, severely achy. The patient states he did not have a reaction or feel any pain after either dose and he felt as though he received a placebo both times. The patient and her husband are on the line and the patient husband would like to know of the 5% that the vaccine was not effective did it lessen their symptoms that did get the virus and was their any fatalities. The patient would also like to know what the age group was between for the 5% that the vaccine was not effective. The patient would like to know when can you take an antibody test after receiving second dose of vaccine. The patient would like to know if you had a reaction or symptoms after second dose of COVID vaccine does it mean that you have antibodies. The patient states she is fine now will never take another MRNA vaccine again. The events started from Jan2021 and outcome of the events was unknown.   Information about lot/batch number has been requested.
Lymphatic node swollen on my left collarbone area. Has not reduced until today (three weeks past first noticing it)
First dose of the Moderna Vaccine: I got an optic nerve meningioma this summer and I've had a horrible migraine with accompanying nausea since I got the vaccine. It is not the 13th and I feel horrible. Moderna Batch 039K20A
within 30 minutes, I had facial drooping on my right side. with 2 hours, I had shortness of breath, chest pain, high blood pressure, tingling sensation on my right arms/legs
I'm getting more and more bloated; I'm missing my period for 12 days now; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (I'm getting more and more bloated) and MENSTRUAL DISORDER (I'm missing my period for 12 days now) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (I'm getting more and more bloated) and MENSTRUAL DISORDER (I'm missing my period for 12 days now). At the time of the report, ABDOMINAL DISTENSION (I'm getting more and more bloated) and MENSTRUAL DISORDER (I'm missing my period for 12 days now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications ere reported.   This case was linked to MOD-2021-163300 (Patient Link).
1. LEFT ARM NUMB FROM THE SHOULDER TO FINGER TIPS STARTING 9/10/2021 AND STILL CONTINUES. 2. NAUSEA FROM 9/10/2021 UNTIL 9/14/2021. 3.  DIARREA FROM 9/11/201 AND STILL CONTINUES. 4. EXTREME TIREDNESS FROM 9/10/2021.  SLEPT OVER 20 HOURS EACH DAY FOR 3 DAYS. STILL EXTREMELY TIRED. 5. VERTIGO STARTED 9/17/2021 WHEN I GOT UP IN THE MORNING AND STILL CONTINUES.
This spontaneous report as received from a medical assistant refers to a 16 month old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 15-FEB-2018, the patient was inadvertently administered both PROQUAD (lot # and expiry date were not reported) and MMR II (lot # and expiry date were not reported). No adverse effects were reported in the patient. No other information was available.
Approximately 5 minutes post vaccination, the patient displayed shaking features and called out for help.  He continued to shake wildly for approximately 30 seconds to 1 minute.  He asked for help throughout and was visibly very upset.  Staff implemented an emergency response, contacted EMS who responded in approximately 5 minutes from the time of the initial reaction.  Prior to EMS arriving the patient was slowly lowered the the floor while shaking and gradually calmed down.  He said "I think I just had a seizure."  He injured his leg during the episode by hitting it off of one of the shelves in the pharmacy waiting area.  He did not hit his head or appear to lose consciousness during the episode.  Patient was examined by EMS upon their arrival.  Vital signs were examined and noted by EMS (I do not have those numbers).  Patient was slowly moved to a seating position by EMS and monitored for approximately 10 more minutes upon which time the patient experienced a similar episode to the first.  At this point the patient was transported by EMS to the Hospital Emergency Department.  The patient contacted the pharmacy later in the afternoon indicating that he had been examined and discharged to home.
After about 10 minutes of injection the patient fainted and looked very pale. He was able to sit in a few minutes he took some water and snacks.
now on day 53 and has not yet received her second shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (now on day 53 and has not yet received her second shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (now on day 53 and has not yet received her second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (now on day 53 and has not yet received her second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment was reported for the events.
no adverse event; PEDVAX HIB and ROTATQ administered after temperature excursion; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 25-JUL-2022, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot # U039951, expiration date: 22-JUN-2024, dose, strength, vaccination scheme frequency, and anatomical location were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot # W004502), expiration date: 09-OCT-2023, dose, strength, and vaccination scheme frequency were not reported) for prophylaxis after a temperature excursion (temperature: 23.8 degree Celsius (C); time frame: 9 hours 45 minutes) (product storage error). It was reported there was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Posterior cervical reactive lymphadenopathy (on right side) 3 days following administration of FluMist.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 08-SEP-2009, a physician at a family practice administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 14-JUL-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Chills, fever of 101.2, body aches, skin sensitivity, inability to sleep,arm, where bad was given was very sore,  restlessness started the night received the third booster shot
I ended up with a rash Saturday; itch; pink color blister located on left (Lt) breast.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 10:15 (Lot number: EW0167) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TENORMIN taken for hypertension (ongoing); HYZAAR taken for hypertension (ongoing); GLUCOPHAGE XR taken for type 2 diabetes mellitus (ongoing); PRAVAZ taken for blood cholesterol increased (ongoing). The following information was reported: RASH (non-serious) with onset 31Jul2021, outcome "recovered" (03Aug2021), described as "I ended up with a rash Saturday"; PRURITUS (non-serious) with onset 31Jul2021, outcome "recovered" (03Aug2021), described as "itch"; BLISTER (non-serious) with onset 31Jul2021, outcome "recovered" (03Aug2021), described as "pink color blister located on left (Lt) breast.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus, blister.  Additional information: Patient had no family medical history. Patient had the vaccine done Friday this Friday and ended up with a rash Saturday. Patient had no prior vaccination. Patient noticed a cluster of pink color blister located on left (Lt) breast. Ugly. Itching was terrible. Patient immediately applied calamine lotion [treatment]. Privacy (sister) witnessed the heinous sight.  Follow-up attempts completed. No further information expected.
I95.9 HYPOTENSION 12/3/2021 URINARY RETENTION J96.00 ACUTE RESPIRATORY FAILURE 2/21/2022 URINARY RETENTION I95.9 HYPOTENSION 12/3/2021 ASTHMA, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 2/21/2022 ASTHMA, UNSPECIFIED
inappropriate schedule of vaccine; She had 103F fever for 3 days after 2nd shot.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine) and PYREXIA (She had 103F fever for 3 days after 2nd shot.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine). On an unknown date, the patient experienced PYREXIA (She had 103F fever for 3 days after 2nd shot.). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine) had resolved. At the time of the report, PYREXIA (She had 103F fever for 3 days after 2nd shot.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 103 (High) 103 degrees Fahrenheit.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact