chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) ongoing since an unknown date for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient previously received doses: 1st Dose administered on 21-JAN-2021 with Lot/batch no: 032L20A, 2nd Dose administered on 18-FEB-2021 with Lot/batch no: 024M20A, 3rd Dose administered on 21-NOV-2021 with Lot/batch no: 020F21A, 4th Dose administered on 19-APR-2022 with Lot/batch no: 056M21A. Patient states that patient received 5 doses of the Moderna COVID-19 vaccine so far and was just diagnosed with COVID yesterday and symptoms include runny nose, sore throat, headache, cough and aches. Patient was on Paxlovid for his symptoms. Patient was "on the mend" at that time.
Severe Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on an unknown date in Aug2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received cefalexin monohydrate (CEPHALEXIN) antibiotic and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 28Jul2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. On 31Aug2021 at 20:00, on the 11th day after taking the second dose of Pfizer vaccine, the patient experienced a delayed reaction of severe hives all over body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with unspecified antihistamine tablet. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe hives all over body was resolving at the time of this report.
fever of 103 for 4 days, severe chills, headaches, body aches, blurry vision, dizzy even laying down.  no appetite, soreness at injection site, malais,  exhaustion lasted for 2 weeks
No additional adverse events; patient was administered an improperly stored VARIVAX; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was reported. On 17-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S035125, expiration date 04-NOV-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). On 17-JUL-2020, the vaccine underwent a temperature excursion with the temperature from 15 Fahrenheit degrees to 46 Fahrenheit degrees (45.9) for 10 hours and 30 minutes. There was no previous temperature excursion. The call was not because of a data logger. No additional adverse events were reported.
Pt recvd 1 dose of Engerix-B & 48 hrs later exp GI upset, severe burning in stomach, fever, h/a, vomiting, diarrhea, malaise, flu-like sx & felt nauseated; events lasted for 48 hrs & pt missed 2 days of work;
severe pain in her upper stomach/stomach cramp and was puking; stomach cramp and was puking; diarrhea every 15 minutes; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date patient received 1st shot of the vaccine and 2nd shot is due on Saturday. She experienced a stomach cramp and was puking. She added that she had severe pain in her upper stomach. She is also experiencing diarrhea every 15 minutes. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had suspected immunological vaccine failure (exposed to someone with Covid). Laboratory data included: antibody and COVID-19 virus test was negative.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210830362-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
About a week after first dose, developed dull pain in upper buttocks. Weeks later, could not move shoulders upward under pillows when sleeping. Then month later, shoulders and upper arms began to hurt terribly when moved  different ways - ie. fixing shirt collar, putting on shirt and jacket, reaching straight out for things in back of fridge. Kept getting worse and more painful in both arms, though worse in left shoulder and arm. Month later, first left hip area then right gave mild pain and clicking noise when putting or taking off pants then when standing up  from a seated position. Most physical difficulties manifested and increased in severity after the second recombinant Shingrix vaccine of February 5, 2022. First being about November 25, 2021.
Lethargy; Fever; Chills; Nausea; Muscle aches; This is spontaneous report from non-contactable consumer (patient herself). An adult non-pregnant female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration in left arm on 17Mar2021 as 2nd dose, single for COVID 19 immunization. Patient medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration in left arm on 24Feb2021 as 1st dose, single for COVID 19 immunization. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. On 17Mar2021, patient experienced fever, chills, nausea, muscle aches and lethargy. No therapeutic measures were taken as a result of events. The clinical outcome of events fever, chills, nausea, muscle aches, lethargy were not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Since only initials were reported, so was only captured in patient first name field for duplicate searching purpose, event onset date for the event Lethargy was captured as 17Mar2021 per source reported, information such as "Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No" and "Allergies to medications, food, or other products: no" were not captured in consolidated narrative, "None" was removed from "Concomitant Therapy " field since only reported "Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No" in source, not mention if took any drug.
This spontaneous report was received from a pharmacist concerning a 69 year old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose/frequency reported as 1 rod inserted) as recommended for patient over the age 65 (route of administration, lot number and expiration date were not reported). On an unknown date, following the vaccination, the patient experienced pain, swelling and flu like symptoms. The patient sought medical attention and was prescribed by his physician unspecified antibiotics for the adverse reactions. The outcome of pain, influenza like illness and swelling and the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Swollen lymph nodes on outside of left breast. Feels like a lump. Still continuing as of November 30, 2021 at 4:30 PM.
Sore arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 11-Mar-2021, VACCINATION SITE PAIN (Sore arm at injection site) had resolved. Not Provided          No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was Not Applicable.  No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-048160 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048160:
Diffuse maculopapular rash to lower back and abdomen starting 3-4 hours after vaccine. No local site reaction. No fever or irritability. Rash slightly improved today.
Pain throughout body; I have been feeling fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO167) via an unspecified route of administration in the right arm on 30Apr2021 at 10:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included hashimotos. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO158) via an unspecified route of administration in the left arm on 09Apr2021 at 10:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. On 01May2021, the patient was feeling fatigue and pain throughout body since vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events feeling fatigue and pain throughout body since vaccine was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 10-OCT-2016, the patient was vaccinated with the expired dose of PROQUAD, lot # K025765 with expiration date on 08-JUN-2016, albumin status: human serum albumin (HSA), (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
redness and swelling in arm where vaccine was administered starting about 9/10 days post vaccine.
had "reactions"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (had "reactions") 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (had "reactions"). At the time of the report, VACCINATION SITE REACTION (had "reactions") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication were reported. no treatment medication were reported.   This case was linked to MOD-2021-396523 (Patient Link).
Lump the size of a baseball near injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump the size of a baseball near injection site) and VACCINATION SITE PAIN (Soreness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump the size of a baseball near injection site) and VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE MASS (Lump the size of a baseball near injection site) and VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "menopausal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Symptoms returned 3 days after Paxlovid- much worse. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200998305 same reporter/patient, different drug/ AE;
Pt verbally reported that one week after recieving a Tdap she experienced redness, swelling and tenderness at the sight.  She stated there was NOT any drainage or any type of fluid filled mass. She stated she had NO fever.  She did have it examined by her OB/GYN while being seen for routine appt who dx MRSA and placed her on an Bactrim.  A culture was not obtained as "there was nothing to culture".
Hurt really bad/stung really bad/little sore; It really burned; He wake up and the area was completely red; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; A little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation; Really sleepy; He did not feel good like, he had no energy; He did not feel good like, he had no energy; His arm hurt really bad; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history included blood pressure high. Concomitant medications included lisinopril from an unspecified date, once daily (25-20 mg, one time a day), for blood pressure high. On an unspecified date, the patient experienced pain ("hurt really bad/stung really bad/little sore"), burning sensation ("it really burned"), redness ("he wake up and the area was completely red"), mass, swelling, inflammation ("a little bit of bump there like the serum had not spread, visibly swollen, protrusion of the inflammation"), sleepy, feeling unwell, energy decreased ("he did not feel good like, he had no energy") and pain in arm ("his arm hurt really bad"). Clinical outcome of the adverse events was unknown at time of this report.  The information on the lot number has been requested.
Death LEG SWELLING N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism K92.2 - GI bleed K92.2 - Upper GI bleed
Son died 10 days after his first moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Son died 10 days after his first moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  A male patient of an unknown age who received mRNA-1273 died 10 days after his first dose of vaccine. No medical conditions or conmeds were provided.  Very limited information regarding these events has been provided at this time. Further information is being pursued.; Sender's Comments: A male patient of an unknown age who received mRNA-1273 died 10 days after his first dose of vaccine. No medical conditions or conmeds were provided.  Very limited information regarding these events has been provided at this time. Further information is being pursued.; Reported Cause(s) of Death: Son died 10 days after his first moderna vaccine
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. On 03-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0467AE, expiration date 04-APR-2013), (0.65ml, subcutaneous). No other suspect therapies or concomitant medications were reported. The registered nurse stated that the patient was administered a ZOSTAVAX that had expired. No adverse effect reported. Additional information has been requested.
Starting 06/24/2022, she had a sore throat. On 06/25/2022, she had a mild sore throat. On 06/26/2022, she still had a mild sore throat and a croupy sounding cough. She tested negative that day with an at home test. On 06/27/2022, she started feeling worse and was wheezing in the morning. I tested her for COVID-19 that day and she was positive. So, because we had just moved and the doctor couldn't see her yet, we had to bring her to the ER solely to get her albuterol. We gave her the albuterol a few times over the next few days. On 06/27 was the only day she felt sick. Otherwise, she started feeling better on 06/28 and by 06/29 she was feeling much better (only had a minor cough that did not require albuterol). After that day, she was fine.
Pt received DTaP, MMR, Varicella and Hib on 01/09/2002 at 3:30-4pm. At 8pm that evening she had hives on abdomen and both legs which was resolved by 01/12/2002. Post dose Altural.
arm of the injection becoming puffed up with getting red and angry; arm of the injection becoming puffed up with getting red and angry; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves elderly female patient who experienced arm of the injection becoming puffed up with getting red and angry while receiving vaccine Tetanus Toxoid.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concurrent condition includes allergies to two types of antibiotics (drug hypersensitivity), allergies to the coating on tablets (allergic reaction to excipient), allergy to yeast (food allergy) and sensitivity to other drugs (drug hypersensitivity).    On an unknown date, the patient received suspect Tetanus Toxoid produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination.  On an unknown onset and latency, the patient developed a non-serious arm of the injection becoming puffed up with getting red and angry (vaccination site erythema and vaccination site swelling).  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for both events.
Information has been received from a health professional concerning a 60 year old female with a history of shingles, who in August 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). It was reported that the patient developed an injection site reaction after vaccination and now has shingles. It was reported that the patient complained that it "messed her arm up for weeks". The patient currently has zoster in her ears. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Body Aches, Chills, Fatigue, Headache, Cough, stuffy nose