chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Menactra was administered to a patient on today, No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves unknown demographic patient who received a dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Lot No: U6016AA, Expiration date: 09-Oct-2019) via unknown route in unknown administration site on 18-Oct-2019.   The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  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 holders 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.
I26.99 ACUTE PULMONARY EMBOLISM 4/11/2022 ANEMIA DUE TO ANTINEOPLASTIC DRUG I26.99 ACUTE PULMONARY EMBOLISM 4/11/2022 OBSTRUCTIVE JAUNDICE I26.99 ACUTE PULMONARY EMBOLISM 4/11/2022 RECTAL BLEEDING I26.99 ACUTE PULMONARY EMBOLISM 4/11/2022 ANEMIA
Pt recv vax on 3/13/98; on 3/14/98 pt exp vax site rxn w/ redness, swelling, tender & numb; tx=ice
Next morning felt general aches took ibuprofen. Went bowling and 30 minute walk. Late in afternoon around 5-6 pm did not feel right. All of a sudden couldn't move head to toe. Tried to stay calm because it was frightening to be paralysed. It was 20 minutes before could get up and went to bed. Did not have phone in bedroom to call for help. Felt sleep after a while and woke up around 4 am to go to the bathroom; legs were loose enough by then to go to the bathroom. Went to kitchen and waited until 8:30 am to call doctor; doctor called back 1.5 hours later. Paralysis was starting to leave but couldn't move arms or head. By 3/10, 2 days later, finally movement on arms and head came back -- these were the last 2 parts to get back to normal. Felt back to new by 3/11; recovered completely. Did not go to the doctor at any point. During paralysis episode had chills but not sweaty.
My Daughter had a 104.6 fever that wouldn't break with childrens Advil or with cool baths. She also had a rash all over her body, little red marks. This lasted for about 24 hours.
Patient known reaction after first vaccination. Cognition and movement progressively slowing. Vital signs were taken x2 and neuro assessment completed. Evaluated by EMTs on site. Wait time was increased. Fluids provided. Patient refused transport to emergency room via EMT and was driven home by co-worker.
i got the shingles vaccine that my Dr said i should get.  A few days after the shot every muscle in my body hurts so bad i cant stand it.  And exhausted bad.  I have fibromayalgia with same symptoms but this vaccine seems to have multiplied the problem 300%.  All pain meds over the counter havent helped at all.  Its been 11 days since injection and i feel no better
Day 1 and 2 after vaccine was fever, headach, fatigue, nausea, body aches, weakness, unable to eat or drink much.  Day 3 after vaccine was red, flat rash down arms and legs, some fatigue, headache.
got sick; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involved a patient with unknown demographics who got sick every winter, while patient received vaccine INFLUENZA VACCINE.  It was reported that, patient received flu shot (influenza vaccine) couple of time and always either caught a different strain, or unluckily got sick every winter. Medical history, medical treatment, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, from past 20 plus years patient refused the flu shot and never caught the flu and the past 10 plus years did not even caught a winter cold.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for illness.  There would be no information available on the batch number for this case.
nausea; bleeding at injection sight; sore arm; chills; fatigue; joint pain; muscle pain; A spontaneous report was received from a consumer concerning a 70 year old, female patient who experienced bleeding at injection sight / Injection site hemorrhage, chills, fatigue, sore arm /pain in extremity, joint pain /arthralgia, muscle pain /myalgia, nausea.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 18 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, the patient experienced the event(s), bleeding at injection sight, chills, fatigue, sore arm, joint pain, muscle pain and nausea.   Treatment for the event included acetaminophen.    Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the event(s) bleeding at injection sight, chills, fatigue, sore arm, joint pain, muscle pain and nausea were unknown.
Headache, Fever,  FATIGUE, CHILLS Narrative:  Other Relevant History:
Pretty typical as others have reported... Fatigue, body aches, fever. But the most surprising was what I thought was horrible heartburn around 5pm the day after I got the second dose (about 25 hours post vaccine). It was the worst heartburn I'd ever felt; intense, deep chest pain. It lasted until I went to bed that night, around 9pm. I didn't really give it a second thought until now when there's all this news about myocarditis following vaccination, so I thought I'd at least report it somewhere.
15 weeks pregnant (3rd pregnancy) at time of injection. EDD 05/31/22. Wednesday 12/15/21 I started getting a bad headache which quickly progressed to a migraine including sensitivity to light and noise as well as additional movement felt jarring. The pain was localized to the right side of my face and felt as though my bones were broken. Thursday, 12/16 and Friday 12/17 I was unable to work due to the pain. The migraine was from the moment I woke up until the moment I went to sleep, I spent three days in a dark room unable to move. Thursday 12/16 and Saturday 12/18 I reached out to my OB/GYN to see if anything could be done as I can only take Tylenol for pain. By Saturday evening 12/18 the pain became more intermittent. Currently as of Wednesday 12/22/21 it comes and goes but doesn?t last nearly as long as it did before. I am reporting this because while I have had migraines in the past and headaches in the first few weeks of this pregnancy, I have NEVER experienced a pain like this before and the only change had been the vaccine.
p/shot was given pt eyes rolled back in head, fists clenched, body jerked, incontinent of urine, lips cyanotic;unresponsive for greater than 10 seconds;child lowered to floor;once responsive placed on bed, mom called,child taken to ER;
Fever of 102.4 for two days, cough, runny nose, headache, chills, flu-like symptoms for three days. Two days in bed with bed rest.
01/02/2023 - I woke up with a sinus headache, congestion, an earache, fever, coughing and wheezing. I contacted my telehealth service and was prescribed a round of antibiotics. The symptoms gradually progressed and I went to Urgent Care on 01/27/2023 I was tested for Flu, RSV and COVID-19. All were negative. I was prescribed another round of antibiotics; Prednisone; Erythromycin; Inhaler Albuterol Sulfate; Fluticasone nasal inhaler; Singulair; Benzonatate.
Mental confusion; Memory loss/Symptoms like those of early Alzheimers, patients could not remember family members; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE and AMNESIA in a  patient of an unknown age and gender 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 CONFUSIONAL STATE and AMNESIA. At the time of the report, CONFUSIONAL STATE and AMNESIA was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications provided. No treatment medications provided.
Expired Engerix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Engerix B. On 20th January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
lt arm red, swollen, hot & hard, 5" diameter;rt arm red, swollen, hot & hard, 3" diameter;denies any pain;local rxn only
Pt presented with vomiting, intermittent Lethargy to office x 2-3 hours. Instructions given on Feeding + hydration. but parents also instructed if sx continued (> 3 more hours), to ED for Eval. Pt went to ED about 6 hours later. DX intussusception
Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist (patient herself). This case involves female patient (age not reported) who got exposed to vaccine, while she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient got exposed to a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (injection suspension) lot N1K801M, expiry date: 15-Oct-2019. It was a case of actual medication error due to occupational exposure to product and exposure via skin contact. During injection, the vaccine exploded and went all over the pharmacist who was injecting. It was reported that the piece of the syringe where the needle attaches got separated, fell apart. The syringe was defective because she had given plenty of vaccines. The tip of the syringe separated, fell apart as she was giving the vaccine causing the vaccine to get mostly on her. It was also a case of syringe issue. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
FUNGUS; ALL BODY PAIN/BODY HURTING; NOT ABLE TO WALK; BILATERAL FOOT PAIN/BILATERAL LEG PAIN; FELT TIRED; MISSING TOE NAIL; BILATERAL FOOT NUMBNESS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient have unspecified allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: paracetamol. On 16-APR-2021, the patient experienced bilateral foot numbness. On 23-APR-2021, the patient experienced missing toe nail. On 23-APR-2021, the patient experienced felt tired. On 23-AUG-2021, the patient experienced bilateral foot pain/bilateral leg pain. On an unspecified date, the patient experienced fungus, all body pain/body hurting, and not able to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral foot numbness on 23-APR-2021, had not recovered from bilateral foot pain/bilateral leg pain, felt tired, and missing toe nail, and the outcome of all body pain/body hurting, not able to walk and fungus was not reported. This report was non-serious.
Presented w/ sickle cell onset X 2 wks ago, body aches, myalgia and SOB. Covd+, likely to cause sickle cell crisis. Tx w/ Remdesivir, O2, Decadron
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 08-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions varying from 28.9 degree Fahrenheit (-1.72 degree Celsius) (lowest recorded temperature) for 48 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius) (highest recorded temperature) for 24 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About two weeks after the vaccine I woke up with a brain fog that will not go away. It's been over a week and the brain fog still remains. Focusing, holding a conversation, and multitasking have turned into very difficult tasks. My body is fine but my brain fog makes me constantly feel lethargic even when I know I have energy.
Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included RABEPRAZOLE SODIUM (ACIPHEX), METOPROLOL SUCCINATE (TOPROL), GABAPENTIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Sore shoulder). On 11-Feb-2021, ARTHRALGIA (Sore shoulder) had resolved. Not Provided          This case was linked to MOD-2021-017442 (Linked Report).; Sender's Comments:  MOD-2021-017442:same reorter, different patient
Patient with POTS fainted within 15 minutes of vaccination.  Patient declined transport by EMS; she felt better after resting and was released to home with her father.
little feverish,little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little feverish,little fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema, Anxiety, COPD, Chest pain (Might be due to stress) and Hypoxemia.    On 29-Aug-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 PYREXIA (little feverish,little fever). At the time of the report, PYREXIA (little feverish,little fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were provided. No treatment information was  reported. Patient had low oxygen level.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received event  outcome updated from unknown to recovered.
Classic shingles rash developed in L1-L2 dermatomes on right three days after immunization on the left (first dose of varicella given in right thigh in 2014). Rash was not vesicular but otherwise had classic red, bumpy appearance in clusters along dermatome distribution. Child complained of itching but not pain. 18 days after this child's shingles rash erupted her father (normal immune system, wild-type chicken pox in childhood) erupted in his first ever outbreak of shingles.
Severe neck pain, headache so bad she held her head screaming in pain, drop in white blood cell count to 1000, very high fever, uncontrollable shaking, hurting from head to toe, numbness in arms.  10/6/2008  MR received for DOS 8/21-26/2007 with D/C DX: Viral Syndrome.  Pt presented with onset of severe headache, myalgias, arthralgias, and fever beginning on 8/18/07. Seen in local ER for meningitis w/u which was (-). Found to be pancytopenic so admitted for further w/u.  Severe H/A tx with IV and po pain meds. Fevers up to 103 with ID w/u all (-), so abx d/c after cx (-). Pancytopenia improving. Had some electrolyte imbalances to be f/u as outpt.  LFTs abnormal to f/u as outpt.
Patient ID:   81 y.o.    Admit Date:  7/31/2022   Discharge Date: 8/6/22   Principal Dx/ Final Dx: Colitis   Relevant Inpt Dx: Principal Problem:   Colitis Active Problems:   AKI (acute kidney injury)   COPD (chronic obstructive pulmonary disease)   COVID-19 virus detected       HPI:   Hospital Course:    This 81 year old woman was admitted with diarrhea.  She had recent covid.  She had ct abdomen that showed colitis of descending colon.  She was treated with iv antibiotics and is improved.  She was seen by GI and they recommended colonoscopy in future..  Today her abdomen is soft.  Outpatient follow up with pcp and GI.   She did have acute kidney injury on admission.  /theis was felt to be due to dehydration and did resolve with iv hydration.     She has copd and did cough up purulent phlegm.  Home on antibiotics as above.   She did test positive for covid but did not require treatment for this.    She did have paroxysmal atrial fibrillation.  He was seen by EP cardiology.  Sotalol was stopped and amiodarone was started.  She remains in sinus rhythm today.  She will go home on aspirin.  She is not on further anticoagulation due to recent colitis.          Consults:   IP CONSULT TO GASTROENTEROLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO CARDIOLOGY IP CONSULT TO AIMS PROGRAM     Disposition:  home   Discharge Condition:  fair
24MAY94 unconsolable crying for >3 hrs, not eating, lasted until 25MAY94; pt not dehydrated-urinating well; induration & sl swelling on lt leg;
THE PATIENT CALLED AND SAID HE WAS IN THE EMERGENCY ROOM ON WEDNESDAY MORNING 4-14-21 BECAUSE OF SEVERE CHEST PAIN. THE PATIENT STATED HE HAD A HEART ATTACK AND HIS TROPONIN LEVELS WERE ELEVATED. THIS IS ALL THE INFORMATION WE HAVE RECEIVED
I was late starting my menstrual cycle the month of May by 8 days; now been on my cycle for 7 days.  My normal cycle is 4-5 days.; Had bodyaches the entire time.; This is a spontaneous report received from a contactable nurse (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 15:30 (at the age of 42-years) as single dose for covid-19 immunization. Medical history included rheumatoid arthritis, hyperlipidaemia, covid-19 (prior to the vaccination the patient was diagnosed with COVID-19); all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient was not pregnant at the time of vaccination. On 15May2021 at 19:00, the patient reported that it was late starting her menstrual cycle the month of May by 8 days and now been on her cycle for 7 days. Her normal cycle was 4-5 days and had body aches the entire time. The patient did not receive any treatment for the events. Since the vaccination the patient was tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test): negative on an unspecified date in 2021 (post vaccination). The outcome of events menstruation delayed, menstrual cycle prolonged and generalized aching was not resolved.  Follow-up attempts are completed. No further information is expected
Reactions were even more significant than the first two doses; Bone pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reactions were even more significant than the first two doses) and BONE PAIN (Bone pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Severely immunocompromised).    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, the patient experienced VACCINATION COMPLICATION (Reactions were even more significant than the first two doses) and BONE PAIN (Bone pain). At the time of the report, VACCINATION COMPLICATION (Reactions were even more significant than the first two doses) and BONE PAIN (Bone pain) outcome was unknown.            No concomitant medications provided.  No treatment medications provided.  Patient was severely immunocompromised who received 3rd dose of Moderna COVID-19 vaccine. The reactions were even more significant than first two doses as patient has bone pain now.   Reporter did not allow further contact
12 Hrs. after initial administration woke up with a pounding headache and was dizzy. Since vaccinated, I've experienced a mild constant headache, extreme tiredness, muscle/joint soreness, and lack of concentration.
This report refers to a 16 year old patient of unknown gender. Historical condition and concomitant medication were not reported. On 05 Feb 2015, the patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly at a dose of 0.5 ml. The reporter stated that, before vaccination the MENVEO had a temperature excursion. On 14 Jan 2015, it was stored at 0.4 degree Celsius for 16 hours; on 24 Jan 2015, it was stored at 0.8 degree C for 36 minutes and on 31 Jan 2015, it was stored at 0.6 degree C for 35 minutes. No adverse event was reported following this administration error.