chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid + from Assisted Living. Hospitalized Per ED Note:  History of Present Illness   This is an 87-year-old gentleman   This is an 85-year-old gentleman with a history of hypertension dyslipidemia atrial fibrillation and intracerebral bleed that was transferred to this facility for inpatient medical management after being found to be Covid positive in assisted living.  Patient has been vaccinated.  Patient currently denies any chest pain shortness of breath lightheadedness dizziness patient denies any fever chills diarrhea loss of taste or smell
This case was reported by a consumer via call center representative and described the occurrence of ankle swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th December 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, 1 week after receiving Shingrix, the patient experienced ankle swelling, joint pain and tingling of extremity. On 15th December 2020, the patient experienced malaise, tiredness, pain, tremor and shivering. On an unknown date, the outcome of the ankle swelling and joint pain were not recovered/not resolved and the outcome of the malaise, tiredness, pain, tremor, shivering and tingling of extremity were recovered/resolved. It was unknown if the reporter considered the ankle swelling, joint pain, malaise, tiredness, pain, tremor, shivering and tingling of extremity to be related to Shingrix. Additional details were provided as follows: The case was reported by patient herself. The patient received her first dose of Shingrix and 12 hours after experienced tingling in her hands and toes. Next day after vaccination, the patient experienced shivering, shaking, achiness, tiredness and malaise. The patient stated that one week after the first dose she experienced joint pain, and swelling in her ankles, and this remained unresolved. On 13th February 2021, patient had received her second dose of Shingrix vaccine. The reporter was provided with medical disclaimer, medical information phone number for health care professional reference and was referred to the health care professional. The reporter consented to follow up.
Injection drawn up, during injection RN noticed needle malfunction (hole in hub), patient given some of dose but not full dose.  Supervisors made aware, Agency notified, Johnson & Johnson notified.
laying down is worst than sitting up; Covid arm; ringing in the ear; pain in her right ear; dizziness got worse; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness got worse), DISCOMFORT (laying down is worst than sitting up), TINNITUS (ringing in the ear), EAR PAIN (pain in her right ear) and VACCINATION SITE REACTION (Covid arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo since January 2020, Seasonal allergy, Penicillin allergy, Tetanus and Allergy to molds. Concomitant products included PRAVASTATIN from 15-Feb-2010 to an unknown date for Cholesterol, BIOTIN from 01-Jan-2012 to an unknown date and VITAMIN B12 NOS from 01-Jan-2015 to an unknown date for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (dizziness got worse). On 25-Apr-2021, the patient experienced TINNITUS (ringing in the ear) and EAR PAIN (pain in her right ear). On an unknown date, the patient experienced DISCOMFORT (laying down is worst than sitting up) and VACCINATION SITE REACTION (Covid arm). On 31-May-2021, DIZZINESS (dizziness got worse) was resolving. On 01-Jun-2021, TINNITUS (ringing in the ear) had resolved, EAR PAIN (pain in her right ear) outcome was unknown. At the time of the report, DISCOMFORT (laying down is worst than sitting up) and VACCINATION SITE REACTION (Covid arm) was resolving. Not Provided     This case was linked to MOD-2021-090477 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: from the follow up VARES form is attached, additional AE for dose 2, AE outcome; pt also included description for dose 1 AE; conmeds
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the  Information Team. The reporter is the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Jan2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". 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-2021391297 Same reporter and suspect drug; different patient.
Pt reported throat felt tight approx. 45 min. after admin of shot. Advised pt to go to ER - pt was not in apparent distress. At ER pt was given an Epi shot & BENADRYL & was sent home. Pt recovered well - spoke to her approximately 2 hours later.
Patient is a pleasant 69 year old male with PMH significant for recently diagnosed Kappa light chain multiple myeloma with extensive lytic lesions throughout skeleton at time of diagnosis, hyperlipidemia, who is a direct admission from office due to shortness of breath and acute hypoxia. Patient was evaluated at the office today and found to have O2 sats of 90% on RA at rest, however O2 sats dropped to 77-80% with ambulation and in need for 3L O2.
flu like symptoms; body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 23Mar2021 05:00, outcome "recovering", described as "flu like symptoms"; PAIN (non-serious) with onset 23Mar2021 05:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 23Mar2021 05:00, outcome "recovering", described as "chills". Additional information: On 22Mar I received my second dose of the COVID-19 vaccine. Today on 23Mar, I woke up at approximately 5 AM with flu like symptoms. The symptoms including body aches and chills are getting steadily better over the course of the day.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PURPLE FINGERNAILS for over a month Severe leg pain in my right calf.  So much that my doctor did a scan to make sure it wasn't a blood clot
Extreme headache, nausea, vomiting, panic attack ER; IV compazine, Benadryl, Tordal, NS
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: AS7165B) at the age of 27 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jun2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), on 07Apr2021 as dose 2, single (Lot number: EW0151) and on 23Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation. The patient's relevant medical history included: "MCAS" (unspecified if ongoing); "POTS" (unspecified if ongoing); "EDS" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid form 18Aug2023 to 22Aug2023.
I noticed a persistent cough that would not go away. I used a at home COVID-19 test it was positive.  I contacted my PCP and was prescribed a drug by Merc called Lagevrio.
itching during the waiting period after the vaccine; itching through the night; chest hurts; chest discomfort; pain in the center of her chest; feels achy; felt like she had COVID again; head starting hurting; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and VITAMIN D3 at an unspecified dose and frequency. At the time of the report, PRURITUS (itching during the waiting period after the vaccine; itching through the night), CHEST DISCOMFORT (chest hurts; chest discomfort; pain in the center of her chest), PAIN (feels achy), MALAISE (felt like she had COVID again) and HEADACHE (head starting hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 110 (High) 110. On an unknown date, Oxygen saturation: 98 (Inconclusive) 98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
02Oct90 pt vax w/ expired hepta B.  TOR no adverse ex.
Leg cramps in both legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps in both legs) 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 MUSCLE SPASMS (Leg cramps in both legs). At the time of the report, MUSCLE SPASMS (Leg cramps in both legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
67yo male without significant medical comorbidities presented with near syncope on 12/20/2022 with subsequent assessment by CT imaging demonstrating a submissive bilateral pulmonary embolus with right heart strain and US of the extremities demonstrating a previously unknown LLE DVT. Patient underwent initial thrombolytic therapy with dissolution of the right sided PE, but the left sided PE required suction catheter thrombectomy. Patient recovered and post-treatment echocardiogram demonstrated mostly resolution of the right heart strain (mild to moderate RV dilation with normal LV and RV function). Patient will be on (at least 6 months) apixaban therapy. Of note, the patient received teh Pfizer booster vaccination on 10-14-2022 (previously received primary and initial booster vaccinations). Bo prior history of DVT/clotting disorders. History of Gilbert's, GERD. No history of cardiovascular, pulmonary, liver, GI, renal or other diseases. No history of diabetes, hypertension, clotting disorders. No change in exercise status, work activity or travel (vacation trip by plane in November, but this has been the routine for the past 12 years). Medications included: omeprazole (40mg qd), Metamucil. No family history of DVT/PE or clotting disorders. Being reported as a possible serious adverse event related to the Pfizer COVID booster vaccination.
Prolonged crying stopped by 2030 hrs 16JUn; tx w/ice pack & APAP;
This case was reported by a nurse via sales rep and described the occurrence of fever in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, eye symptom, cranial nerve disorder, headache and rash. On an unknown date, the outcome of the fever, eye symptom, cranial nerve disorder, headache and rash were unknown. It was unknown if the reporter considered the fever, eye symptom, cranial nerve disorder, headache and rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the healthy individual (patient) who developed symptoms of ophthalmic -1st division of the 5th cranial nerve, fever, headache and rash. The reporter agreed to contact for the follow up.
Initial report received on 2/10/2006 from an investigator participating in the above mentioned trial under the reference number P3T11. A four year old male subject was diagnosed with probable immune Thrombocytopenic purpura two days after he had received an intramuscular, left arm, first dose injection of Daptacel, lot number C2207AA, on 1/25/2006. The parent had reported a three week history of bruising on 1/27/2006 (two days post vaccination). A physical examination, on that date, revealed small ecchymotic areas on the knees and elbows. the subject had a platelet count of 103 and was referred to a specialist. The investigator considered the event an important medical event (OMIC). At the time of this report, the subject had not recovered. According to the investigator, the event was related to the study vaccine.
open IPOL vaccines were exposed to a temperature excursion/ No AE; Initial information was received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from an other health professional (office staff).  This case involves a 10 months old female patient who on 22-Jul-2020 received third dose of IPV (VERO) [IPOL] vaccine (lot R1B252 and expiry date 13-Mar-2021) via intramuscular route in the left thigh for prophylactic vaccination and that vaccine was open and exposed to a temperature excursion (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No other conacamittent vaccines were given at the same time.  Case details: Reporter stated that he would like to know if he should re-administer IPOL vaccines that were exposed to a temperature excursion and mentioned that they had stability issue for open Ipol but had given the product already by the time they found out they should not have given it and no adverse event has been reported to the office.  It was of actual medication error due to incorrect product storage.  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.
T98.3 (tympanic) last PM;T97.0 today;went to bed 630PM last noc woke 12AM ate slept to 830AM;mom c/o pt lethargic;had 1 loose stool;pt seems to have tenderness in thigh @ inj site;
Forgot to dilute the vaccine before giving it to the patient. Called patient and he has no side effects except a sore arm.
Started on day 4 after vaccine.  All over body rash on body felt like it was prickly and like it was on fire or like a sunburn feeling, Increased resting heart rate 105 (my normal is around 68 to 75 resting).  BP 156/73 ( my normal is 119/80) headache.  Very shaky.  Normal breathing O2 was 98 to 99.
Patient started experiencing intense chills and aches early morning of November 6 (day following flu shot), approximately 4AM. Felt hot to the touch. Stayed home from school and slept for most of the day, alternating between feeling too hot or too cold. Seemed better in the evening, but then had trouble sleeping during night due to chills and aches. Morning of November 7, had 102.3 degree fever. Feels terrible, ache-y and hot, and is home from school a second day.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender who on 27-JUN-2012, was vaccinated with the first dose of PNEUMOVAX23 (route and lot# not reported). On 14-SEP-2012, the patient received another dose of PNEUMOVAX23 (route not reported, lot# 1418AA, exp: 25-MAY-2013) inadvertently. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a 35 year old female who 15-Mar-2005 was vaccinated with a first dose of VARIVAX (Oka/Merck). On 26-Apr-2005 the patient was vaccinated with a second dose of VARIVAX (Oka/Merck). On an unspecified date VZV antibody titer was preformed and the result indicated it was negative. The event persisted. Additional information has been requested.
BUD was 01-Nov-2021 but the vaccine was administered on 25-01-2022; Stored Moderna vaccine in their refrigerator and administered past the BUD date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 25-01-2022) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered past the BUD date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 25-01-2022) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 25-01-2022) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered past the BUD date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  CDC Expiration date was reported as 19 Mar 2022. It was reported that One of the providers was storing their Moderna vaccine in their refrigerator and administering past the BUD date. The administrations have been summarized by date, lot and BUD date was reported as 01 Nov 2021.
Patient received influenza vaccine on 10/30/08. Approximately 30 seconds after receiving vaccine patient patient exhibit very short seizure like activity and loss consciousness, she was incontinent of bladder. Pattient was lowered to the floor by public health nurses and oxygen was applied. An ambulance was called but mother refused transport. Mother was strongly encouraged to have patient seen in the ER and to follow up with patient's physician. Mother stated she would do this.
After my J&J vaccine, my right arm felt hot and was red and I also ended up with an upset stomach, had diarrhea and felt sick to my stomach. I also experienced chills, low grade fever of 99.8 and had swelling to my joints in my fingers and toes. My right arm pain radiated upwards to my neck. These symptoms lasted 12 hours and as of today I still have pain in my neck. Since 03-15-2021, I have been seeing a chiropractor for my neck pain. I see him on a weekly basis. At the chiropractor's office they apply ice, heat and do a muscle rub help with my neck pain that still is present.
her second dose was a bad batch, that the battery pack went down and it was no good; her second dose was a bad batch, that the battery pack went down and it was no good; had a headache; freaking out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team from a Pfizer sponsored program Support.  A 40-year-old female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: Sep2021, for Covid-19 immunization, reaction(s): "little sick". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "had a headache"; FEAR (non-serious) with onset 2021, outcome "unknown", described as "freaking out"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset Sep2021, outcome "unknown" and all described as "her second dose was a bad batch, that the battery pack went down and it was no good".  Additional information: Reporter was calling on behalf of her granddaughter who received two doses of the vaccine. Reporter stated that her granddaughter, saying her second dose was a bad batch, that the battery pack went down, and it was no good. Reporter stated patient was not sure of the dates but in early September she got the second shot and was fine had a headache, some symptoms which was good it worked. Patient got the vaccines in Sep2021, three weeks apart. Reporter stated today patient got a phone call saying the second shot was not good because the battery went out in the refrigerator and to come in for another shot. Reporter asked if she should wait and get an antibody test or wait and get a booster? Reporter stated patient had it in September and they just figured it out today? She stated it should not have happened and they should've monitored it, what happens if she gets another dose? (As reported). Received phone call stating the second dose experienced a temperature excursion. Reporter was asking if patient needs to retake the dose. Stated the patient was freaking out. With the first dose, patient did get a little sick and that was fine. Patient did not want to come in for another shot. Reporter advised patient to get an antibody test. Patient has to get the booster and in eight weeks. Reporter stated this would be four COVID-19 Vaccine shots. Patient was worried. Patient asked the caller should she get the other shot to make up for the bad second dose, or should she wait to see if it worked and then just get the booster? Reporter advised the patient to get a blood antigen test. Reporter seriousness for Second dose batch was bad reported as unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.