chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they were all home sick with the flu; They were all home sick with the flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves five patients who were all home sick with the flu (illness and influenza), while they received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patients were all home sick with the flu (illness and influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patients received any corrective treatment or not.  The outcome of the events was unknown at the time of reporting.  There will be no information on the batch number for this case.
Patient reports to clinic after receiving Moderna #1 on 4/18 and experienced acute illness beginning 4/19 She reports that she developed significant nausea and has vomited multiple times since 4/19. Vomiting x3 today. No diarrhea. No fever. Has been able to tolerate fluids and soup and is voiding per normal.  She received the vaccine at location LOT: 046B21A  Pain 0/10 but significant nausea is uncomfortable  OTC pepto bismol  Provider initiated ondansetron ODT 4mg every 8 hours as needed for nausea and vomiting.  Patient instructed to take medication as prescribed Follow up in ED if abdominal pain worsens, even marginally. Soreness likely related to use of accessory muscles with vomiting.  If you new or evolving symptoms seek care immediately. Patient expressed that she understood the care plan. Stay hydrated and follow BRAT diet.
sterile water was used to reconstitute Menveo; sterile water was used to reconstitute Menveo and administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number M23G5, expiry date 30-NOV-2024) for prophylaxis.   On 06-OCT-2023, the patient received Menveo. On 06-OCT-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: sterile water was used to reconstitute Menveo) and inappropriate dose of vaccine administered (Verbatim: sterile water was used to reconstitute Menveo and administered).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The medical assistant called to report sterile water was used to reconstitute Menveo and it was administered to a patient. Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter consented to follow up via email.
This spontaneous report as received from a nurse refers to a 10 months 8 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Extreme chills; 101.5 F fever; Headache; Pain in teeth and upper palate.; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 18May2021 at 10:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The medical history not reported. The patient had known allergies to tree nuts and penicillin. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on an unspecified date 2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19May2021 at 08:00, the patient experienced extreme chills, 101.5 F (body temperature) fever, headache and later pain in teeth and upper palate. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the event's extreme chills, 101.5 F fever, headache and later pain in teeth and upper palate was recovering at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 03-MAY-2016 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (rHA (recombinant human albumin), lot #L003856, expiration date 05-FEB-2017, strength, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 904 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
egg shape bump on arm; flu like sympotoms; fever , <100F; headache; chills; nausea; fatigue; fever , <100F; headache; chills; nausea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of the first episode of PYREXIA (fever , <100F), the first episode of HEADACHE (headache), the first episode of CHILLS (chills), the first episode of NAUSEA (nausea) and the first episode of FATIGUE (fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM, PRAMIPEXOLE and GABAPENTIN for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 24-Feb-2021, the patient experienced the first episode of PYREXIA (fever , <100F), the first episode of HEADACHE (headache), the first episode of CHILLS (chills), the first episode of NAUSEA (nausea) and the first episode of FATIGUE (fatigue). On 23-Mar-2021, the patient experienced the second episode of PYREXIA (fever , <100F), the second episode of HEADACHE (headache), the second episode of CHILLS (chills), the second episode of NAUSEA (nausea) and the second episode of FATIGUE (fatigue). On an unknown date, the patient experienced MASS (egg shape bump on arm) and INFLUENZA LIKE ILLNESS (flu like sympotoms). On 24-Mar-2021, last episode of PYREXIA (fever , <100F), the last episode of HEADACHE (headache), the last episode of CHILLS (chills), the last episode of NAUSEA (nausea) and the last episode of FATIGUE (fatigue) had resolved. At the time of the report, MASS (egg shape bump on arm) and INFLUENZA LIKE ILLNESS (flu like sympotoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Treatment information was not provided.   This case was linked to MOD-2021-093096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: New events added.FU for both Dose Case On 27-May-2021: FU of second dose case
Saturday morning I woke up with my upper arm in pain and feeling extremely itchy.  When I went to check it, there was a red circle area that look like a rash around the area of the shot. The area looked a bit raised and felt like a lump. It also hot to touch. The red area on Saturday was maybe 3-4 inches in diameter. The area looked like it was spreading and I wasn't sure until this morning, it has spread to where its almost wrapping around my arm. It is still painful, hot, and itchy.  I have not seen a doctor because I don't have healthcare.
Patient called complaining of entire injection site and shoulder area red, inflamed and hot to the touch with some soreness.  No itching.
Vaccine was administered at a health fair. Pt was calm during vaccine and said it didn't hurt but 5 min later said she didn't feel good.  She then became clammy and responsiveness was minimal.  MDs were present and called over for help - patient was moved from chair to floor and feet were elevated.  Pt became alert and stated she felt some better. 911 was called and paramedics arrived.  Pt was brought to standing position but her condition worsened again so she was taken by ambulance to ER for further evaluation.
Every since my second Moderna shot on May 10, I've had a stomach ache whenever I try to walk (i.e. from my car in a parking lot to a store, walk my dog, etc.). It didn't happen even once before the second shot. It doesn't seem to matter whether I took a probiotic on that day or not, whether I have an empty or full stomach, or anything else I can figure out. It's just a typical stomach ache.
The injection site became red, about the size of a golfball. It was red, hot, and itchy. This lasted for 4 days and was painful. On the 4th day post injection, the area was completely normal. No other reactions.
pain in the left arm; This spontaneous report was received from a registered nurse, via company representative and refers to a 69 year old female patient.  No information was provided regarding the patient's concomitant medications, medical history or concurrent conditions.   On 03-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R033080 with expiration date on 06-JUN-2020, one shot of 0.5 milliliter, intramuscular in the deltoid of the left arm as Centers for Disease Control and Prevention (CDC) recommendation based on age. On 04-MAY-2019, the patient called the practice's office and reported that on an unknown date, after vaccination, experienced pain in the left arm (vaccination site pain).      The outcome of vaccination site pain was reported as resolved. The causal relationship between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the event was not reported.
Hospital Principal Problem (Discharge Diagnoses): 1. Intraparenchymal hemorrhage of brain  2. COVID-19 infection 3. Neuropathy bilateral lower extremirties 4. Hypertrophic cardiomyopathy 5. HTN 6. Hypertrophic cardiomyopathy 7. Fall 8. Permanent atrial fibrillation 9. Hyperlipidemia 10.Type 2 diabetes mellitus 11.BPH 12.Overweight
Generalised Body aches/a little soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Generalised Body aches/a little soreness in the left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, PRAVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (Generalised Body aches/a little soreness in the left arm). The patient was treated with FAMCICLOVIR (FAMCLOVIR) for Herpes infection, at a dose of 250mg 2/day. At the time of the report, MYALGIA (Generalised Body aches/a little soreness in the left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-250562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received; Vaccine information updated, concomitant medications updated.
Left shoulder blade/shoulder has been hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left shoulder blade/shoulder has been hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Left shoulder blade/shoulder has been hurting). At the time of the report, ARTHRALGIA (Left shoulder blade/shoulder has been hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.  It was reported that patient left shoulder blade and shoulder has been hurting ever since patient got a dose of Moderna covid-19 vaccine
vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range; expired ipol vaccine administered to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to cases 2019SA125047, 2019SA125066, 2019SA125008, 2019SA125094, 2019SA125041, 2019SA125033, 2019SA125072 and 2019SA125087 (same reporter).  This case involves a four years old (also reported as 5 years) male patient who was vaccinated with a 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number N1K931M and Exp. Date 19-Nov-2018) via intramuscular route in the deltoid NOS and a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and Exp. Date not reported) via intramuscular route in the deltoid NOS both on 04-Mar-2019, which were exposed to multiple excursions.   The patient's medical history not reported and concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD via intramuscular route in the deltoid nos on 04-Mar-2019.  It was an actual medication error case due to expired vaccine used and incorrect product storage.  It was reported that, vaccines (Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra) stored at temperature outside the recommended range. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown whether the patient experienced any adverse event post vaccination.  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 and Module VI of the 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.  Information on the batch number was requested.  List of documents held by sender: none.
Overall achiness (still experiencing after 3 days) Nausea (still experiencing after 3 days) Headache (still experiencing after 3 days) Weakness (still experiencing after 3 days) Fatigue (still experiencing after 3 days) Injection site soreness (still experiencing after 3 days) Lightheadedness (still experiencing after 3 days) Unstable (still experiencing after 3 days) Lack of appetite (3 days) Low grade fever no higher than 99.9  (2 days)
Low grade fever, myalgias, redness & swelling at vaccination site left deltoid. Symptoms developed 24 hours following PNEUMOVAX administration.
Moderna COVID-19 Vaccine: I received the first dose on Moderna on Monday, April 5, 2021 at 4:16pm. That evening, my arm was sore. The next day, I was very tired and my arm was quite sore. Monday morning, April 19, 2021, I awoke and saw a red blotch or rash at the injection site. The redness is hot to the touch. My arm is sore again. And I'm exhausted and feel "run down." I was surprised by this on day 14.
20 minutes after injection, she felt warm, flushed, nauseated, short of breath and had a funny feeling in her chest.  This lasted about 45 minutes.  Then on 2/13, she saw physician with complaints of soreness, warmth and redness at injection site.  Motrin and ice advised.
67 year old vaccinated male was admitted for Covid-19 pneumonia and treated with Remdesivir. He also developed a fib with RVR and required Amiodarone drip and HR returned to sinus rhythm, Cardiology finally saw the patient and started rate control. TTE showed normal study. He will finally be able to return in stable condition today.
had vaccine still got shingles/suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included surgery. Previously administered products included chemotherapy and immunotherapy (for a year).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had vaccine still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient's wife via interactive digital media. The patient went through surgery, chemotherapy and immunotherapy for a year. The reporter stated that only to get shingles vaccine.  The patient had the shingles vaccine and still got shingles.  The reporter further stated that yet, he never complained, not once and he was her hero. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
NDC: 70461012103    Patient had severe pain the minute it was administered. Has had ongoing L shoulder pain ongoing since then, which was 4 days ago
Date of admission: 10/26/2022    Date of discharge: 11/8/2022   Admission diagnosis: Severe aortic insufficiency   Discharge diagnosis: Severe aortic insufficiency
Covid #1 shot in left arm IM resulted in minor sore arm for about 24 hr then no adverse effects afterwards. Covid #2 shot in left arm  IM 30 days later resulted in significant sore arm with swollen lump in muscle for about 3 days. Additionally, day 2 had some flu-like symptoms for entire next day: sore muscles everywhere, lethargic, very thirsty, temp only 98.1.  Day #3 had only sore arm at IM location but no other symptoms.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore on the left side of the throat), EAR PAIN (Throbbing earache on the left side), OCULAR DISCOMFORT (Problems with my left eye), POOR QUALITY SLEEP (These symptoms are affecting my sleep and speech) and DYSARTHRIA (These symptoms are affecting my sleep and speech) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ZINC for an unknown indication.    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 OROPHARYNGEAL PAIN (Sore on the left side of the throat), EAR PAIN (Throbbing earache on the left side), OCULAR DISCOMFORT (Problems with my left eye), POOR QUALITY SLEEP (These symptoms are affecting my sleep and speech) and DYSARTHRIA (These symptoms are affecting my sleep and speech). At the time of the report, OROPHARYNGEAL PAIN (Sore on the left side of the throat), EAR PAIN (Throbbing earache on the left side) and OCULAR DISCOMFORT (Problems with my left eye) had not resolved and POOR QUALITY SLEEP (These symptoms are affecting my sleep and speech) and DYSARTHRIA (These symptoms are affecting my sleep and speech) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines include Zinc, Vitamin D, Vitamin c  Treatment medicines include Antibiotic, Pain killer medications  Action taken with mRNA-1273 in response to the event was unknown
Aches; Low fever; Slept most of 3 days; No appetite; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, low grade fever, sleepiness and appetite absent. On an unknown date, the outcome of the pain, low grade fever, sleepiness and appetite absent were recovered/resolved.   It was unknown if the reporter considered the pain, low grade fever, sleepiness and appetite absent to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced aches, low fever, slept most of 3 days and no appetite after that patient was fine. This case has been linked with cases US2018239609 and US2018AMR240000 reported by the same reporter.
patient became light headed and sweaty after getting vaccines patient laid down. patient felt better. blood pressure was taken 106/62 patient stayed for 10 more min. and blood pressure was taken again 132/67 patient was allowed to leave.