chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised which was administered to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via The Agency via call center (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310763, 2020SA310761, 2020SA310769, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310762 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (lot number: UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route and administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hours guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was 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.
unbearable abdominal pain; extremely sick; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (unbearable abdominal pain) and ILLNESS (extremely sick) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 039BZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (unbearable abdominal pain) and ILLNESS (extremely sick). At the time of the report, ABDOMINAL PAIN (unbearable abdominal pain) and ILLNESS (extremely sick) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Developed fever, chills and body aches, which peaked at 101.3° by the following morning. Severe headache. Nausea, no eating for over 24 hours. Symptoms began to resolve at about 5 PM the following day with resolution at 6:30 PM on April 27, 2018. Muscle soreness at site of injection. Symptoms managed with aspirin.
about 1 min and 30 sec to 2 mins after getting the vaccine, I felt as if I was about to faint (felt a draining in my body and my arms got very weak) my HR had gone from resting 85bpm to 108bpm (recorded on my watch) this lasted for about 30 seconds and went away
Patient received 0.5mL instead of 0.25mL of Moderna covid vaccine.
Vaccine given Thursday. Sunday while outside playing and doing farm chores patient started falling down repeatedly at a walk and a run.  The next day she started holding her hands in a fist, high stepping in her right leg, limping with an abnormal gait and complaining about a tingling feeling in her feet.  I called doctors office and they told me to give her ibuprofen and not let her run.  10 days later she was evaluated for headaches and referred to neurology for evaluation of headaches and neuro signs that followed vaccines. 3 months later on December 3rd she was evaluated by the pediatric neurology department. She was diagnosed with migraines but by the time she was evaluated her neuro signs were gone with just occasional limping in her right leg and weakness noted in her right hand by School.  This is not the first time she has had issues with neuro signs after her vaccines. On November 11, 2014 she received vaccines at Pediatrics, DTap-Hib-IPV, Rotovirus and pneumococcal. Within an hour of vaccinations she had hemorrhagic diarrhea. Approximately 2 weeks later she loss use of her right arm. It was blown off by the doctor at Pediatrics and later thought to be viral. On 2/26/16 vaccinated for DTap pneumococcal and HIb and continuously fell down. Was told by nurse it was just a clumsy child
Patient in observation area.  Complains of chest tightness and shortness of breath.  Does have a history of anaphylaxis to bee venom.  Carries EPIPEN at home.  Brought patient to the ED with worsening SOB, Chest tightness. Administiered IM Epi en route to ED.
invalid dose greater 37 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose greater 37 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose greater 37 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose greater 37 days) outcome was unknown. Not Provided      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 relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-083534 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083534:
This spontaneous report was received from a nurse manager and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored GARDASIL 9 (lot #: N007931, expiration date: 17-NOV-2019, dose, strength, frequency and route of administration were not provided) for prophylaxis. Administered vaccine experienced multiple temperature excursions of 32-35 degrees Fahrenheit (33 degrees Fahrenheit) for 7 days. Data logger was involved. There was no previous excursion reported. No adverse effects were reported.
Extreme chills, shakes and then sweats. Continued ultimately for over 5 days. Hospitalized (3rd day)11:00 AM 3/15/2021 to 4:00 PM 3/16/2021 Was observed  for elevated troponin levels. Given IV's and Heparin. Follow up with Primary and cardiologist
Did not feel good at all; Broke out in rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash). At the time of the report, FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash) outcome was unknown. No concomitant medication information provided.  It was reported that, patient had not taken the fourth booster dose.  No treatment information provided.   This case was linked to MOD-2022-550427, MOD-2022-550512 (Patient Link).
hasn't received second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (hasn't received second dose) 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 13-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 PRODUCT DOSE OMISSION ISSUE (hasn't received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (hasn't received second dose) outcome was unknown.        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 were provided. No treatment details were provided.
Information has been received from a Registered Nurse concerning a female who was vaccinated with her second dose of GARDASIL 0.5 ml (therapy route not reported).  Subsequently the patient experienced syncope.  No other information was reported.  Additional information has been requested.
Patient reports waking up 3 days post vaccine with a swollen neck under her left ear and jaw. She states she experienced pain with checking and her neck was hard and swollen.
Passed out while leaving the mass vaccination for meningitis B (Trumenba Vaccine).
Had raised bump on my face, very itchy - occurred 5 hours after getting my 2nd dose of the Pfizer vaccine. Took a Benadryl and it went away. Since getting the 2nd dose vaccine, I've been having insomnia and would randomly wake up in the middle of the night and not aware of when I fell asleep every night.
Patient got shingles are completing the Shingrix series; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 2nd October 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 453B2, expiry date 11th February 2022) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In October 2019, between 3 and 5 months after receiving Shingrix and between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting. On 21st June 2019, the patient received 1st dose and on 27th August 2019 received 2nd dose of Shingrix. The reported batch number for 2nd dose may or may not be adjuvant. In early October 2019, the patient experienced shingles and was still having trouble with it. The reporter consented to follow up.
mom reports pt cried for 3 hrs unable to console; lt leg became red, swollen then blue/purple in color; mom did not take pt to MD or ER; lt leg cont to have discolored area size of fify cents piece;
Experienced the typical symptoms described on fact sheet, fever, chills, tiredness, headache, injection site soreness, and body aches. My body aches were severe and I had severe episode of my fibromyalgia symptoms to reoccur. I was totally wiped out for a full day (literally stayed in bed) my arms and legs were heavy and hard for me to lift so I was extremely weak;  and thus far for today I am still not 100% as the pain is still very noticeable and I?m totally exhausted. Fibromyalgia symptoms are still present and just don?t feel well at all.
Patients mother called reporting child had rec'd vaccines this Am and was having hives/rash on abdomen and was itching. Wanted to know if she should give him Benadryl. Was instructed by nurse to take child to ER for evaluation by physician. Nurse F/U with mother today (8/24/15) mother states they did not take child to ER but gave him Benadryl and symptoms subsided. No further issue following Benadryl administration. States no further side effects.
pt recv vax 4APR95 & exp significant pain @ the inj site radiating to axilla;no further details were provided;
A few weeks after the vaccine I developed a rash that was itching, stinging and burning. I tried cortisone, Gold Bond, and some other home remedies which did not help. The rash went away around 12/24 but it came back in Jan much worse. I went to the doctor in Jan and she gave me cream and prednisone.
Sudden death on 5/18/03.  Autopsy results show atherosclerotic heart disease.
Treatment of COVID-19; Treatment of 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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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-202200935280 same reporter/patient, different product/AE;
About 40 minutes after, I started itching: on face and scalp primarily. But also arm. I didn't have any rash, bumps or redness. No visible symptoms. I emailed my Dr. and the nurse supervisor and they were messaging with me to tell me what to take. Over the next hour, it progressively got worse. After I got home - about an hour or so  after symptoms beginning, I took 50 mg Benadryl. After about an hour or two later, I took Zyrtec. Before bed, I repeated dose of Benadryl. I was up at night with itching. In morning, I may have taken a third Benadryl very early morning and so when I woke up for the day, I didn't take it. And the itching resolved about 12:00 or 1:00 pm that next day. I did have a sore arm the day after the vaccine. I took ibuprofen about noon the following day of the vaccine. At 7, I noticed fatigue; chills and body aches.  was very tired, as well. At 10:00 I took another dose of ibuprofen for these symptoms and I felt much better after that and the next day, I was fine.
A nurse reported that an 11.5 year old female with a medical history of asthma received an injection of Pnu-Imune 23 on 05/14/01. That same day, she developed an injection site reaction characterized by left leg stiffness and swelling. On 05/15/01, the patient developed a red rash the size of a small dinner plate, swelling and tenderness at the injection site. She was seen by the physician that day and a diagnosis of cellulitis was made. She was treated with Cephalexin for 10 days. This is 1 of 2 patients from this facility who experienced cellulitis following experienced this event following receipt of Pnu-Imune 23 lot 463-748.The patient recovered.
10/05/2007 P/C from Mom.  States patient started complaining of discomfort right arm the  morning of 10/03/2007, before school.  Stated it hurt to lift her arm.  After school that day she had swelling and redness right arm. Thursday, Oct. 4, complained of increased redness to elbow, hurt under right armpit.  Still had swelling.  Site was warm to touch.  On Friday, Oct 5th, less sore, decreased swelling, decreased redness - improving.  On Sunday, Oct 7th, site was "itchy".  On Mon, Oct 8th, no more complaints of discomfort.  Took Motrin while having discomfort, "don't know if it helped."  Never developed any fever.
Hospitalization for a fall and then testing positive for COVID-19 (6/19/2022)on dates 6/18/2022-6/25/2022.  Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Patient reported slurred speech, swollen tongue, blurry vision, dizziness at about 10:30am. Patient finally agreed to benadryl and swallowed one 25mg tablet about 10:47am. Patient's throat was getting itchy and tight and agreed to epinephrine 0.3mg injection in the right anterior thigh at 10:58am. Patient refused wanting us to call 911. Patient threw up at 11:06am, and refused 2nd epip shot. She did report she felt better by 11:09AM. At 11:12am, she reported less tongue swelling and throat tightening.
pt recv vax; 2 days later,devel flu like sx of HA, n,d, v, fever of 103-104; chills, dizziness, abd pain & myalgia,lasted 13 days;5apr94,recv 2nd dose & exp a recurrence of her previous sx, resolved in six days;tests neg anti HBs;
Severe fatigue 36 hours after injection Within 48 hours of the injection, I regained my sense of smell, which I lost 20+ years ago due to chronic sinus infections and polyps.  On 04/03/2021, I could smell water, shampoo, soap. I have not had such an acute sense of smell in decades.
Large, localized reaction, at injection site.  Approximate size of palm of mom's hand with redness and swelling.
My friends just topl one and are already sick; Initial information received on 26-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves patient (unknown demographics) for whom it was reported my friends just topl one and are already sick (illness) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient already sick (illness)  unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
My COVID-19 infection started on 12/15/2022. I had a headache, congestions, and weakness. On 12/16/202 in the evening about 06:30PM - 07:00PM I was having a drink and I couldn't smell or taste anything. I tested with a home COVID-19 test on 12/16/2022 which was positive. On 12/18/2022 I went to the local clinic and they prescribed me with  PAXLOVID for 5 days.
Shortness of breath. Went away after 2 days. This was after the booster. Had the same reaction after dose #2. All good now.
Pt received the wrong Pfizer vaccine. Pt received the orange top instead of the purple top.
3 x 5" erythema with 2 blisters around site of injection on (R) arm. 2 x 3" erythema around site of injection on (L) arm.
About 1 week later after the vaccine, both breast started to swelling for 2 and 1/2 weeks.  I also had abdomen upset, diarrhea, tired and generally felt unwell. I had diarrhea for a few days then it changed to loose stool for 1 week.   My joints started to hurt (hands and feet) which lasted for couples of weeks on and off.  A few days after, about 3 week after vaccine,  I had a persistent pain in my abdomen under the right rib cage.  I felt extremely fatigued and 1 night I would have chills (no fever).   I also had  a very heavy menstrual period on 3/3/2021. After that I have not had a period since for 3 months.   On 3/19/2021 I had a routine mammogram and ECHO since  my breast was still swollen. Results were inconclusive.  I got a covid test on 3/26/2021- negative.  I saw the NP on 4/5/2021 and did bloodwork (came back normal) and ultrasound of the liver (showed fatty liver infiltration) and I was referred to surgeon. I went to the surgeon, who concluded I may be having a viral infection or steato-hepatitis . I was prescribed Ursodil to help with the thinning of the bile in the liver, which has helped with relieving my abdominal pain.  I am currently still very fatigued (not normal for me)  and have not fully recovered.  I have an appt with GI for colonoscopy and endoscopy.
Vomiting; a 101 F fever; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a 101 F fever), CHILLS (Cold chills) and VOMITING (Vomiting) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (a 101 F fever) and CHILLS (Cold chills). On 26-Aug-2021, the patient experienced VOMITING (Vomiting). At the time of the report, PYREXIA (a 101 F fever), CHILLS (Cold chills) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) The patient had COVID..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 03-AUG-2011 the patient was vaccinated with GARDASIL (route, dosage and lot number not reported). On 19-AUG-2013 the patient was vaccinated with GARDASIL (route, dosage and lot number not reported). No known adverse effects. Additional information is not expected.