chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 56 years old female patient refers to herself. Patient's concurrent condition included fibromyalgia, anxiety and other unspecified medical issues. She was allergic to LYRICA and penicillin. On 06-JAN-2015 the patient was vaccinated with ZOSTAVAX 0.65 ml, injection in the right arm (route, lot # not reported). Concomitant therapies included acetaminophen, NORCO, OXYCONTIN, PRELONE, diazepam (manufacturer unknown), 37.5 (units not provided) EFFEXOR, PROTONIX and 1 mg estrogen (unspecified). On 06-JAN-2015 within 30 minutes after receiving the vaccine the patient felt "dopey and foggy headed". Then later on the same day she experienced itching all over her body and the injection area became swollen, painful and hot as well. The patient sought medical attention and spoke with the physician. As a medical treatment she took hydroxyzine and iced the injection site. There were no lab diagnostic studies performed. The adverse events lasted "6-7 days" and by the time of the report were improving (recovering). Relatedness between the events and ZOSTAVAX was not specified. Additional information has been requested.
Headache, diarrhea, muscle soreness and terrible pain at injection site within 2 days  WITHIN 6 DAYS SEVERE RASH AT INJECTION SITE  WHICH MOVED TO CHEST 1 day later.  Terrible itch and some open sores.
experienced blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (experienced blood clot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden mutation. Concomitant products included RIVAROXABAN (XARELTO) for Factor V Leiden mutation.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced THROMBOSIS (experienced blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (experienced blood clot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with blood thinner Xarelto (rivaroxaban) on a daily basis for  factor V mutation and was treated with the same for blood clot.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Lack of efficacy COVID-19 infection confirmed through rapid test; Lack of efficacyCOVID-19 infection confirmed through rapid test and characterized by fever (100-101F), aches, pains, lack of smell, chills, shortness of breath; fever (100-101F); pain/aches; lack of smells; Chills; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10May2021 (Lot number: EW0173) at the age of 30 years as dose 2, single and intramuscular, administered in arm left, administration date 19Apr2021 (Lot number: EW0170) 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: VACCINATION FAILURE (medically significant) with onset 22Nov2021 17:00, outcome "recovering", described as "Lack of efficacy COVID-19 infection confirmed through rapid test"; COVID-19 (medically significant) with onset 22Nov2021 17:00, outcome "recovering", described as "Lack of efficacyCOVID-19 infection confirmed through rapid test and characterized by fever (100-101F), aches, pains, lack of smell, chills, shortness of breath"; PYREXIA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "fever (100-101F)"; PAIN (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "pain/aches"; ANOSMIA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "lack of smells"; CHILLS (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "Chills"; DYSPNOEA (non-serious) with onset 22Nov2021 17:00, outcome "recovering", described as "shortness of breath". The events "lack of efficacy covid-19 infection confirmed through rapid test", "lack of efficacycovid-19 infection confirmed through rapid test and characterized by fever (100-101f), aches, pains, lack of smell, chills, shortness of breath", "fever (100-101f)", "pain/aches", "lack of smells", "chills" and "shortness of breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) result unknown, notes: (100-101F); sars-cov-2 test: (24Nov2021) positive, notes: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pyrexia, pain, anosmia, chills, dyspnoea.  No follow-up attempts are possible. No further information is expected.
expired vaccine was stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine was stored and then administered) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine was stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine was stored and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  It was mentioned that the vial was initially refrigerated on 29-Oct-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medication was provided by the reporter.
quite a bit of muscular or joint pain in the area where he received the shot; quite a bit of muscular or joint pain in the area where he received the shot; quite a bit of muscular or joint pain in the area where he received the shot; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Co-Worker). A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021, mid-afternoon, unsure of exact time (Batch/Lot number, Expiry Date and NDC number were not reported) as dose 2, single for covid-19 immunization. Medical history included Celiac and Irritable bowel syndrome (IBS) diagnosed about 10 years ago. The patient's dad had autoimmune stuff, Celiac and IBS as well. The patient previously received first dose of bnt162b2 via an unspecified route of administration, administered in Arm right on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. There were not any additional vaccines administered on same date of the pfizer suspect, no Prior vaccinations within 4 weeks. The patient's concomitant medications were not reported. In Apr2021 the patient experienced quite a bit of muscular or joint pain in the area where he received the shot, the patient has nothing other than soreness. The reporter stated that, his employee had the Pfizer shot and had quite a bit of muscular or joint pain in the area where he received the shot and its ongoing. The patient neither visited to Emergency Room nor to Physician Office. The reporter verified that they all received the Pfizer Covid Vaccine and they had it done around the same time and around the same dates. The patient received his second dose last week, he thinks the second one was last Wednesday. The patient thinks he received his second dose on 14Apr2021, and he had his first dose exactly 3 weeks to the day from the second so that would mean his first dose was around 29Mar2021. The outcome of the events was not recovered and ongoing at time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Given the adult dose (1ml) instead of the pedi dose (0.5 ml) of ENGERIX only. There was no error with the Japanese Encephalitis vaccine.
This spontaneous report was received from a medical assistant referring to a 2 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 11-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiration date were not reported) at an unspecified location out of state, for prophylaxis (wrong product administered). No adverse effect reported.
A few hours after the vaccine was administered, patient experienced increased shortness of breath. Baseline O2 requirement is usually 2-3 Liters; required 7L on home O2. Was using nebulizers 2-3 times a day afterward as well (typically uses 1-2 times a month). Patient does not have history of COPD exacerbations that present similarly. Presented to the emergency department  and now admitted to the ICU.
COVID breakthrough. Patient presented to the ED on 3/29/22 from nursing home because he asymptomatically tested positive for COVID. He was discharged on 3/30 in stable condition.
Starting shortly ( a few weeks) after having COVID and receiving the booster, I started having shortness of breath.  After many doctor's appointment and ECHO, stress test, heart cath, the determination was I have the lower left chamber of my heart not pumping at the rate it needs to be.  I do not know if COVID or the booster had anything to do with this, but I know two years earlier I had a clean bill of health following a heart cath and appointment wth a cardiologist.
PATIENT WAS ADMINISTERED A SHOT WITH AN EMPTY SYRINGE (NO VACCINE OR DILUENT WAS PRESENT) IN THE LEFT ARM. THE PATIENT WAS INFORMED OF THE MISTAKE AND WAS GIVEN THE CORRECT VACCINE IN THE OPPOSITE ARM. NO ADVERSE EFFECTS WERE NOTICED OR REPORTED BY THE PATIENT BEFORE LEAVING THE PHARMACY.
08/08/2006  Immunizations administered at 08:30 am.  08/10/2006 About 12 noon called complaining of pain, site at right deltoid "hot" to touch, 2:00, parent took child to child hospital emergency room. Doctor diagnosed as "cellulitis and prescribed SEPTRA 200mg, Transil (under treatment).
Nausea, achy, slight headache,  joint aches, runny nose, head feels full
This report describes the occurrence of lethargy in a 2-month-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. This report was received from the pt's father and has not been verified by a physician or other health care professional. The pt's medical history, concurrent conditions and concurrent medications were not specified. In April 2002 the pt received her first injection of Infanrix. At that time, she also received an injection of Haemophilus influenzae type b conjugate vaccine (manufacturer unknown). Later on the date of immunization, she became lethargic. The event resolved one week later. She was subsequently immunized with diphtheria and tetanus toxoids and reportedly had no adverse experiences.
Itchy Rash; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 23Aug2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 31Aug2021, the patient experienced itchy rash. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itchy rash was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Gastrointestinal Problems; Severe Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (Gastrointestinal Problems), HEADACHE (Severe Headache) and NAUSEA (Nausea) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced GASTROINTESTINAL DISORDER (Gastrointestinal Problems), HEADACHE (Severe Headache) and NAUSEA (Nausea). At the time of the report, GASTROINTESTINAL DISORDER (Gastrointestinal Problems), HEADACHE (Severe Headache) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Received live attenuated H1N1 vaccine 11/20/2009 Lot # 500803P exp 2/21/2010. 12/02/09 Antenatal records received for DOS: 10/05/09; 10/28/09 G1 P0; EDC 03/31/10
Fever, chills, aching palms, hands/fingers, shoulders, burning sensation in feet
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ATENOLOL, ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.   This case was linked to MOD-2021-275443 (Patient Link).
The patient is a 55 y.o. female with a PMHx of CVA with residual left facial drop, anxiety, DDD, HLD, HTN and nicotine dependence presented on 4/6 with cc of AMS. Septic shock suspect secondary to PNA with COVID 19 infection. Also found to have AKI and mastoiditis.      Acute respiratory failure with hypoxia COVID 19 Infection Suspect secondary to PNA and COVID infection CT chest: Extensive multifocal pneumonia. Findings most pronounced in the right lung. Near complete lobar atelectasis/consolidation of the right middle lobe.  transitioned to 5L NC from HHF SpO2 goal 93% or higher Dexamethasone 10 mg for 5 days (stop date: 4/11) Albuterol nebs PRN Pulmonary hygiene ID following,  Started Remdesivir after improvement in creatinine last dose 4/11/23 End of isolation 4/16/2023 Patient eager for discharge.  Attempting to wean off O2. Dc 4/11 after last dose of Remdesevir   Septic shock POA Suspect PNA & Mastoiditis Procalcitonin - 20.10 UA benign but reveals ketones, blood, and hyaline casts MRSA probe, urine antigens, urine culture and sputum NGTD Blood culture coagulase negative staph 1/2 likely contaminant Off levo 4/7 Repeat blood cultures NGTD Cefepime and vancomycin ID following  - recommend 2 weeks clinda and levaquin   Acute Metabolic Encephalopathy, improving  H/o CVA with residual deficits Suspect AMS multifactorial from Presented on 3/12/23 with stroke like symptoms - MRI was negative CT Head Symmetrical lacunar infarcts involving the putamen bilaterally, seen previously. Can be seen in hypoxic injuries or from carbon monoxide, methanol or cyanide toxicity Supportive care  Continue PT, OT  Start ASA Continue Lipitor AKI, improving  NAGMA Initial bicarb 18; likely secondary to AKI Lactate unremarkable, BHB 2.2 potentially starvation ketosis vs AKI Initial VBG pH 7.26, CO2 37, bicarb 17, metabolic acidosis CT nonobstructive NAGMA likely secondary to decreased chloride  Was treated with bicarb drip now discontinued  Creatinine 8.29-- >6.25-- >5.61-- >4.06-- >1.53 -> 0.61 Nephrology followed   Hyponatremia, improving Initial sodium 122, 3 weeks ago sodium was 141, now 136 Serum osm 300, urine osm 293, urine sodium  Trend RFPs Nephrology followed   Right otitis externa Right otitis media Right mastoid effusion Acute sinusitis CT head: Bilateral maxillary sinus air-fluid levels.  There is also right otitis and mastoiditis. Right ear tender to palpation, no erythema no swelling of pinna nor mastoid. Purulent otorrhea from right auditory canal, unable to visualize TM due to otorrhea   Ofloxacin drops BID for 10 days (stop date: 4/16) On Cefepime & Vancomycin  - continue outpatient oral abx therapy as above Hard of hearing on right  ENT & ID following FU ENT after discharge   Elevated BNP Initial BNP 14,000, no comparison Small pericardial effusion seen on CT chest  Echocardiogram results normal EF
I developed swollen lymph nodes in my armpit on the side of the injection. Two days after injection developed a bruise about an inch below the epicenter of the painful node that spread toward my breast over 5-6 days into a very large and colorful bruise; it was and remains tender underneath but the bruise is finally disappearing.  I had no bruising at the injection site. Had fever for 2 days and tired and head foggy for 4 days as well, same as with shot #2.
Vaccine is causing issues with my arthritis; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA6780, Expiration date was unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 Immunization. Patient stated, I just wanted to, I was not sure if I was actually having side effects from the vaccine or if it was just because of my physical issues. I was almost sure that the vaccine was caused issues with my arthritis and I just wanted to let you guys know about it. I did not know if that was something to be concerned about or I should just report any possible side effects. Patient stated, I had got both of them, but I did not have any issues until after the second one. The outcome of event was unknown.
pt recv vax;devel fever up to 103 & a rash; in ofc w/ a nl T but fine red rash all over body;
Shortness of breath and apneic spells when feeding; Seizures within 36-48 hrs of admission (treated aggressively then ceased within 48 hours).
Patient administered with expired vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration) in a 70-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Vial did not undergo temperature excursion.  Total of 173 doses were given from LOT 070H21A after expiry date of 07 Apr 2022 Date vial was initially stored in the refrigerator was unknown. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant followup received.
chills overnight; reported experiencing a fever of 101; This case was reported by a consumer via call center representative and described the occurrence of chills in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020, the patient received the 2nd dose of Shingrix. On 11th February 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and experienced a fever and chills overnight. The fever had come down today. The follow up consent was granted.
Feeling a little dizzy, woozy, tired at various times of the day, Also started itching  the first night in bed and had a rash,  It;s gone now.  I don't know if the dizziness if from the  vaccine or Vertigo?
20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022 at 1:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022 at 1:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  The patient received half dose.  It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications was not reported.