chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke/cerebral vascular accident; cerebral infarction, unspecified; Cerebral infarction due to thrombosis of right middle cerebral artery; left facial droop; slurred speech; hemiparesis affecting left side as late effect of stroke (HCC); chronic microvascular ischemic changes with mild cerebellar atrophy; hemiplegia; acute-subacute lacunar infarct; right-sided lacunar stroke; left side numbness; dizziness; This case was reported by a lawyer and described the occurrence of hemiparesis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 14 August 2018 the patient received suspect Shingrix vial kit. As per medical record, the patient reports few days prior to hospital presentation on 16 August 2018 had received vaccine for shingles was not feeling well, generalized weakness, tiredness 2-3 days later he went to meet his friend at his work, friend noticed that his speech was slurred and was taken to the hospital for evaluation. The patient was weak in his left arm and left leg and patient's friend has noticed left facial droop. He was admitted to for stroke. He was noted to have left facial droop and slurred speech. The patient reports his symptoms have started to resolve within 8 hours of Admission and within 2-3 weeks most of his symptoms have resolved. He had MRI (Magnetic resonance imaging) of the brain which showed acute-subacute lacunar infarct in the subependymal white matter of the right cerebral hemisphere within the corona radiata, chronic microvascular ischemic changes with mild cerebellar atrophy. On 16 August 2018, the patient states he continues to had symptoms of left side numbness, difficulty walking, complains of not being able to grasp for long periods of time with left hand and states he feels slow and disconnected. The patient was admitted on 21 August 2018 and discharge on date 19 September 2018 for cerebral infarction, unspecified (admission diagnoses and final diagnoses). The patent diagnosis included right-sided lacunar stroke (HCC), hemiparesis affecting left side as late effect of stroke (HCC), hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side. As per record, the patient positive for chest pain (described as burning mid-sternal discomfort), gait problem , dizziness and weakness. On 14 September 2018, the patient had echocardiogram 2d complete with contrast showed positive agitated saline bubble study for right to left shunting, likely at the pulmonary level. The patient was admitted on 27 September 2018 and discharge on date 27 September 2018 for Cerebral infarction due to thrombosis of right middle cerebral artery (admission diagnoses and final diagnoses). On 27 September 2018, the patient encounter diagnosis was Cerebral infarction due to thrombosis of right middle cerebral/ CVA (cerebral vascular accident) (HCC) (primary), Hemiparesis affecting left side as late effect of stroke (HCC).
in a lot of pain; Fever; Vomiting; Severe headache, very bad headache; This is a spontaneous report from a contactable consumer (parent). A 12-years-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number and expiration date were unknown), dose 2 via an unspecified route of administration on 02Jul2021 02:30 (age at vaccination: 12-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Jul2021 at 02:30, the reporter's daughter just got her second dose of vaccine for the Covid-19 and at 03:00 in the morning, she started with the side effects which included fever since then, vomiting and severe headache, very bad headache. At 04:00 in the morning, the reporter further stated that She was in a lot of pain, her headache was killer her. The reporter thought that going to take her to the (unspecified, which was not clear) because she can't take the pain anymore. The outcome of the events was unknown.   Follow-up attempts are needed; information about lot/batch number has been requested.
w/in 12hr of vax pt devel large swollen area, tender surrounds MMR site & rash devel on extremities & then trunk, sl pruritic;rash was elevated erythematous;well circumscribed;
Cold sweats, headache, body aches, nausea and relative flu like symptoms that lasted for about a day and a half.
Child c/o itching around injection site (RD) & started hyperventilating; positioned in Trendelenburg; initial BP 98/68, AP 60/min; fought w/us when we attempted to give Epinephrine; called 911; child awake, conscious - BP 100/60. Father came & took child home in good condition.
Patient developed severe pain and tingling in left arm within 24 hours of administration.  Patient presented to E.R. for treatment because he believed symptoms were a heart attack.  Patient still experiencing numbness and tingling in left arm and numbness in last two fingers of left hand.  Stated that arm felt heavy.
I haven't had my period since I've gotten the vaccine. With that being said, I was on a couple different birth controls before, during and after getting the vaccines.. but I've now been off of all birth controls for several months now and have yet to get my period.
BLOODY NOSE; LOSE STOOL; FEVER; FATIGUE; SEVERE HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a  female of unspecified age  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced fatigue. On 08-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced lose stool. On 11-MAR-2021, the subject experienced bloody nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, fever, lose stool, fatigue, and body aches, and the outcome of bloody nose was not reported. This report was non-serious.
rash all over body/random, red raised patches and pop up; random, red raised patches and pop up; random, red raised patches and pop up; itchy rash; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8736) via an unspecified route of administration in the right arm on 28Apr2021 at 16:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included social anxiety, bilateral hip impingement, bilateral labral tears and exercised induced asthma. The patient was allergic to apples, peaches, carrots, red food dye and most plants. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP533) via an unspecified route of administration in the left arm on 07Apr2021 at 16:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 01May2021 at 03:00, the patient had rash all over her body. It was random, red raised patches and pop up and then went away. It was itchy but did not hurt in any way. It was the worst on her chest, torso, hips, and upper thighs. The arm where the patient got the vaccine was mostly fine. The patient had more immediate reaction there. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash all over body/random, red raised patches and pop up and itchy rash were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
So sick after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (So sick after the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (So sick after the second dose). At the time of the report, VACCINATION COMPLICATION (So sick after the second dose) outcome was unknown.            No concomitant medicines were reported. No treatment information were reported.  Action taken with the drug in response to events was not applicable.
Large (approximately 5 inches) rectangular red area, swollen, raised, red, warm, painful around injection site.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 2:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 2:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 49.62. No concomitant medications were reported. On 14-Feb-2021 at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit, at 10:00 A.M., the temperature recorded was 32 degree Fahrenheit, at 11:00 A.M., the temperature recorded was 32 degree Fahrenheit, at 02:00 PM., the temperature recorded was 35 degree Fahrenheit, at 03:00 P.M., the temperature recorded was 35 degree Fahrenheit, and vial was initially moved to the fridge on 09-Feb-2021 and beyond use date was 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Redness and swelling around injection site. Pain in lower back to the point of immobilization.
light headedness; back and neck stiffness; got lousy, feeling yucky; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), MUSCULOSKELETAL STIFFNESS (back and neck stiffness), MALAISE (got lousy, feeling yucky) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DIZZINESS (light headedness), MUSCULOSKELETAL STIFFNESS (back and neck stiffness), MALAISE (got lousy, feeling yucky) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (light headedness), MUSCULOSKELETAL STIFFNESS (back and neck stiffness), MALAISE (got lousy, feeling yucky) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Some pleuritic chest pain  started the next day.  Tachypnea 2 days after, then tachycardia. Chest pain on 12/30. continued on 12/ 31. was seen in ER. Was advised to increase prednisone, take NSAIDS. F/u with cardiology and rheumatology
J96.00 ACUTE RESPIRATORY FAILURE 9/6/2021 ACUTE MYELOID LEUKEMIA
Case number PHEH2014US000521 is an initial spontaneous report from the pharmacist received on 02 Jan 2014. This report refers to a 55-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 13402P) intramuscularly and PNEUMOVAX (batch number: not reported), both in the left arm on 29 Dec 2013. On the same date, after vaccinations his arm swollen and he had a pain with movement. The patient stated that he was in quite a bit of pain. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
allergic reaction; developed a rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 597C4, expiry date 04-AUG-2024) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Shingrix (right deltoid) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergic reaction) and rash (Verbatim: developed a rash). The patient was treated with medication unknown (Topical (Nos)). The outcome of the allergic reaction was not reported and the outcome of the rash was resolved (duration 2 weeks).   It was unknown if the reporter considered the allergic reaction and rash to be related to Shingrix.     It was unknown if the company considered the allergic reaction and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter was a pharmacist calling to report an adverse event for a customer.  Pharmacist reports that customer developed a rash on his abdomen 2 weeks after receiving his first dose of Shingrix.  Reports that customer went to a dermatologist, was diagnosed with an allergic reaction to Shingrix vaccine, and was ordered a topical cream as treatment.  Rash on abdomen resolved after 2 weeks of using unspecified topical cream.   Pharmacist states that were at pharmacy today for 2nd Shingrix dose and would like further instructions.   The reporter consented to follow up.
PARALYSIS; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was paralyzed (paralysis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211048907-COVID-19 VACCINE AD26.COV2.S-Paralysis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
acute appendicitis; nausea; belly bloating; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose or covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 23Dec2020 and on 10Jan2021 (as reported) was admitted for acute appendicitis with abdominal complaints 2-3 days prior. His second dose was scheduled today (13Jan2021) but had not yet taken it due to this AE. He was looking for information on age range and timeframe of appendicitis reports related to covid. General concern was whether he can still take the shot today. Additionally, physician reported that around the 06Jan2021 he started experiencing nausea and belly bloating. On 09Jan2021 (as reported) he was admitted with very acute appendicitis and had to have surgery in the OR. He just got home yesterday (12Jan2021). It seemed to him that the appendicitis occurred too close to receive the vaccine for him not have to consider that it could have been a vaccine related issue for him. He was pretty sick from this and he was happy that he was back home. He was asking if it was safe for him to take the second vaccine given what happened with the first dose. The outcome of events was unknown.; Sender's Comments: Based on the temporal relationship, the association between the event appendicitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rash developed between legs & at waist the next night. Put on itch cream. Woke up in the early morning and called emergency doctor on call. He saw me in the morning and recommended a steroid pack. Same routine the next day so I filled the prescription and began meds.Resolved after steroids.
was pregnant and received the vaccine; she is not feeling so strong; Not feeling well; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine), ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was unspecified date. On 13-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine), ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well). The cesarean delivery occurred on unspecified date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine) had resolved and ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment history was not reported .; Sender's Comments: This is a case of maternal exposure during pregnancy (vaccine exposure during pregnancy) for this 45-year-old female. The female underwent cesarean section and delivered a live baby10 days after the first dose of mRNA-1273. The patient also reports asthenia and malaise. Based on the available information, the events are confounded by preceding cesarean delivery. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Large bump under injection site. Red, sore. Warm to the touch. Arm has been weak for days, painful to move. Red splotches around injection site about 4 inches wide. Site bruising. Nearly 90 hours post injection my arm aches to use. No treatment other than warm compress and light massage to area to help dissipate the lump.
headache itchiness that started at my neck and head and has spread throughout most of my body. It is not unbearable but it is uncomfortable. I have had no treatment and am  monitoring at home.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 03/13/2023. I had congestion, sore throat and just felt bad.  I contacted my doctor and got a prescription for Paxlovid.  I tolerated the medication without any complications. As of today, I have good days and bad days. It seems like when I do too much, I feel bad the next day. I am an active person and athletic.