chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild hives; Itching; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 55-year-old female patient who received HBV (Engerix B adult) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 10th January 2020, the patient received Engerix B adult. On 10th January 2020, less than a day after receiving Engerix B adult, the patient experienced hives and itchy upper limbs. On an unknown date, the outcome of the hives and itchy upper limbs were recovered/resolved.   It was unknown if the reporter considered the hives and itchy upper limbs to be related to Engerix B adult.  Additional details were provided as follows: The patient experienced mild hives and itching on both upper arms after receiving the shingrix vaccine. The reporter stated that, it resolved without the need of treatment. The reporter consented to follow up. This case has been linked with case US2020007365, reported by same reporter.
Pfizer #FK9729 received on 4/20/2022, removed from ultra-cold storage on that date. Manufacturer expiration date 8/31/2022, however, beyond use date after removal from ultra-cold storage was 6/29/2022. Vaccine inadvertently administered on 7/8/2022, past BUD.
N17.9 - AKI (acute kidney injury) N17.9 - Acute kidney injury
Seen @ clinic on 30JUL91 @ 12 hrs hx of fever (99.2 AX) @ MD office, vomiting & crying all day-screaming;
healthy woman dying within 48 h of vaccination; blood coming out of her nose; This spontaneous case was reported by a physician and describes the occurrence of DEATH (healthy woman dying within 48 h of vaccination) and EPISTAXIS (blood coming out of her nose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (healthy woman dying within 48 h of vaccination) (seriousness criteria death, medically significant and life threatening) and EPISTAXIS (blood coming out of her nose) (seriousness criteria death and life threatening). The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The subject stated that "there are many deaths related to the Covid vaccine and autopsies have been ordered."  The subject also stated that many deaths have occurred within 48 hours of the vaccination. He also reported that a healthy young woman was found deceased in her apartment within 48 hours of vaccination. The deceased was found with blood coming out of her nose.    No treatment information was provided by the reporter.  Very limited information regarding this events has been provided at this time.  Details regarding the exact brand of vaccine received, dosing dates, Medical history, concomitant medication, and date/cause of death are required for further evaluation. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Details regarding the exact brand of vaccine received, dosing dates, Medical history, concomitant medication, and date/cause of death are required for further evaluation. Further information has been requested.; Reported Cause(s) of Death: Many deaths related to the COVID vaccine
got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got very sick). At the time of the report, ILLNESS (got very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Patient was admitted to the hospital with COVID symptoms and was treated with typical COVID medications. Patient discharged home.
swelling in her Bicep and deltoid; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in her Bicep and deltoid) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling in her Bicep and deltoid). At the time of the report, PERIPHERAL SWELLING (swelling in her Bicep and deltoid) outcome was unknown.            Patient has been using ice to treat the ailments.
got positive after done taking the 1st and 2nd dose of Pfizer Vaccine; got positive after done taking the 1st and 2nd dose of Pfizer Vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an unspecified aged male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 for COVID-19 immunization. On an unspecified date it was reported as patient got positive after done taking the 1st and 2nd dose of Pfizer Vaccine. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Employee received influenza vaccine (.5cc) into left deltoid at 6pm. About 8pm began having left arm injection site soreness with left arm numbness from elbow down. Took MOTRIN pain decreased to a 4 along with decreased pain at injection site 10/16 - skin had heavy feeling in arm - resolved few days later.
Mother reports her being fussy along with redness, warmth and swelling to left leg injection site. She gave child Ibuprofen and applied warm compresses x 4 for about 3 seconds at a time. Follow up phone call 6/1/04: Mother stated child's leg was back to normal.
COVID infection, tested positive; COVID infection, tested positive; received Booster shot; Runny nose; Nasal congestion; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation in Workplace Clinic; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown, Manufacturer Unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history(No underlying conditions). There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021, outcome "unknown", described as "received Booster shot"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "COVID infection, tested positive"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "Runny nose"; NASAL CONGESTION (non-serious) with onset Dec2021, outcome "unknown", described as "Nasal congestion"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) negative; (19Dec2021) negative; (22Dec2021) positive.  Clinical course: the patient had a PCR test and results came negative on 14Dec2021(two days before vaccination). She received the Pfizer/BioNTech booster shot on 16Dec2021. She was informed on 17Dec2021 that she had been exposed to a classmate that tested positive to COVID-19 on this same day. She performed another rapid home-test on 19Dec2021 that came again negative. She tested positive using a rapid home-test kit in the evening of 22Dec2021. She had mild symptoms included runny nose, nasal congestion and headache.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache, sore joints  and high fever with temperature slowly rising from 6 AM and eventually peaking at 102 at about 2:00 PM.  Then holding steady at 101 till about 5 PM after which falling sharply to almost normal levels.  Continued with slightly elevated body temperature till the  morning.
pt recvd vax & slept all day & Thursday started not sleeping; refuses to lay on back; pt sseems to be more irritable will start crying for nothing; eating less, sleep 5 hours @ noc;
Pt immunized 9/3/99 w/ DTAP, IPV, HibTITER. Approx 9/7 pt noted to have jerking & gen siezure activity. EEG ordered 9/24. Showed hypsarrythmia pattern. Pt seen by ped neuroligist (Jules Constantinov) 9/27, rxed Topamox 15-7.5-15mg.
This spontaneous report was received from an office supervisor  medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017 (also reported as "since March 2017,") the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006643.
my mucus production started up again; After second dose gradually mucus and cough gone away; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (my mucus production started up again) and THERAPEUTIC RESPONSE UNEXPECTED (After second dose gradually mucus and cough gone away) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Watering eyes, Runny nose and Hormone replacement therapy. Previously administered products included for an unreported indication: PNEUMOCOCCAL CONJUGATE VACCINE in October 2019. Concurrent medical conditions included Chronic bronchitis (given gamma globulin shots, took up swimming and gradually the frequency for illness decrease), Pneumonia, Allergy to animal dander (cat hair caused  watery eyes, runny nose & stuffed head.) since 18-Dec-1972, Allergy to animal dander (dog hair caused  watery eyes, runny nose & stuffed head.) since 18-Dec-1972, Allergy to animal (cattle caused  watery eyes, runny nose & stuffed head.) since 18-Dec-1972 and Smoke inhalation (tobacco mix caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972. Concomitant products included TRIAMCINOLONE ACETONIDE from 05-Jan-2018 to an unknown date for Contact dermatitis, PREGNENOLONE from 09-Jan-2007 to an unknown date and PROGESTERONE from 09-Jan-2007 to an unknown date for HRT, CYANOCOBALAMIN (VIT B12), COLECALCIFEROL (VIT D3), KRILL OIL, UBIDECARENONE (COQ10 [UBIDECARENONE]) and CRANBERRY [VACCINIUM MACROCARPON] for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SECRETION DISCHARGE (my mucus production started up again) and THERAPEUTIC RESPONSE UNEXPECTED (After second dose gradually mucus and cough gone away). At the time of the report, SECRETION DISCHARGE (my mucus production started up again) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (After second dose gradually mucus and cough gone away) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, COVID-19: negative (Negative) NEGATIVE. On 11-Feb-2021, Chest X-ray: inconclusive (Inconclusive) New 5 and 7 mm ill-defined nodular densities are seen in the upper lobe compared with 2007. On 15-Feb-2021, Computerised tomogram: inconclusive (Inconclusive) Chest x-ray findings correspond with mild left upper lobe ground-glass opacities, likely infectious or inflammatory in etiology. Lungs, Pleura and Airways: Mild left upper lobe stellate peribronchovascular and subpleural ground-glass opacities. No airway narrowing or obstruction. No pleural effusion or pneumothorax..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO treatment medications were reported   This case was linked to MOD-2021-027423 (Patient Link).
I tested positive for COVID-19 on 11/16/22. I had a sore throat, congestion, and a low-grade fever. I contacted my doctor, but I was not prescribed medication. For about two months after testing positive, I had a lot of fatigue, brain fog, and depression. I am still struggling with this.
Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) 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 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) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Initial information received on 05-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a child patient received only the dtap/ipv component of PENTACEL vaccine (batch number, route and site of administration not reported) on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event 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. List of document held by sender: none.
7 year old with onset of gastroenteritis symptoms 2/13/05. Subsequently had positive brain scan determined to be cerebral infarction.
Initial misuse report received from a healthcare professional (Pharmacist) on 17 March 2014. An expire dose of TENIVAC (batch number U4173AA and expired date 17 March 2014) was administered on an unknown date. No adverse event was reported. List of documents held by sender: None.
Headache; brain fog; her ears and head feel full- it felt like a migraine; felt sensitive to sound and light and couldn't watch TV; felt sensitive to sound and light and couldn't watch TV; very stuffy in her sinuses; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 20Feb2021 14:00 (Lot number: EN6208) at the age of 41 years 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: HEADACHE (non-serious), outcome "recovering", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "brain fog"; MIGRAINE (non-serious), outcome "recovering", described as "her ears and head feel full- it felt like a migraine"; PHOTOPHOBIA (non-serious), HYPERACUSIS (non-serious), outcome "not recovered" and all described as "felt sensitive to sound and light and couldn't watch TV"; NASAL CONGESTION (non-serious), outcome "unknown", described as "very stuffy in her sinuses". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller reports she had a stiffness kind of headache probably from sleeping weird. She felt sensitive to sound and light; described this as a weird feeling, it was otherwise explained as a migraine. Caller clarified with the first dose, this feeling started on the second day after the vaccine. She states she received the first vaccine around 2 in the afternoon and within 6 to 8 hours, she felt sensitive to sound and light and couldn't watch TV. Caller clarified she was also very stuffy in her sinuses and it could be related to that too, but she did not know. Caller reports she still had fullness in her sinuses, her eye still hurts, but she did not have a cold. The events did not required visit to emergency Room, physician Office. Patient did not receive any other vaccine within 4 weeks. The events really bad headache- ears and head feel full; felt like a migraine after 1st dose. Sensitive to sound and light, couldn't watch TV, described as a weird feeling were reported as related to BNT162B2.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient had a 8month baby she had prior vaccination that she was planning to breastfeed; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Patient had a 8month baby she had prior vaccination that she was planning to breastfeed) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026p21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Patient had a 8month baby she had prior vaccination that she was planning to breastfeed). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient had a 8month baby she had prior vaccination that she was planning to breastfeed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a 8month baby she had prior vaccination that she was planning to breastfeed . Therefore, she was not yet breastfeeding when she received the vaccine. No Concomitant product details were provided by the reporter. No Treatment information was provided.   This case was linked to MOD-2021-271978.   See case MOD-2021-271978 for details regarding the child case.
Itchy throat; Face started to swell; A spontaneous report was received from a consumer concerning her daughter, a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy throat/ throat irritation and face started to swell/ swelling face.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, prior to the onset of the events, the patient received their dose of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced itchy throat and face started to swell.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event itchy throat and face started to swell was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Critical details such as the dosing date, onset date of the event, patient's age/ gender and medical history are lacking. Further information has been requested.
Changes in menstrual period cycles (for 8-9 solid weeks following my first vaccination shot)  I have not had COVID-19 as confirmed by many miserable tests.
itchiness on their leg; 'severe headache (described as the patient thought she was gonna stroke out); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on their leg) and HEADACHE ('severe headache (described as the patient thought she was gonna stroke out)) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Ulcerative colitis. Concomitant products included ATORVASTATIN for Cholesterol, MESALAZINE (ASACOL) for Ulcerative colitis, VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness on their leg) and HEADACHE ('severe headache (described as the patient thought she was gonna stroke out)). At the time of the report, PRURITUS (itchiness on their leg) and HEADACHE ('severe headache (described as the patient thought she was gonna stroke out)) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment includes heating pad.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Redness area on arm approximately 4" x 4" at shot site.  No treatment, we kept an eye on it at home and administered some children's Motrin to alleviate inflammation.
I had a rash on my back and my chest for 3-4 days.  ( It did not itch, just a rash)