chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe hives/flare-up hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (severe hives/flare-up hives) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (severe hives/flare-up hives) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at a dose of UNK, prn; HYDROXYZINE for Hives, at a dose of UNK, prn and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (severe hives/flare-up hives) had not resolved.            No relevant concomitant medications were reported.  Patient reported that 10 days after getting the booster dose, he broke out into severe hives, initially he thought it might be food allergy and to went urgent care and was prescribed with medicines for 6 days. Patient went to an allergist on 1-Jan-2022, as the hives got flared up.  Company Comment: This is a spontaneous case concerning a 30-year-old, male patient with no medical history reported, who experienced the unexpected serious event of urticaria. The event occurred approximately 10 days after the booster dose of mRNA-1273 vaccine. The patient received treatment with methylprednisolone and antihistaminic drugs. Additionally, inappropriate schedule was noted for the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical condition.   This case was linked to MOD-2022-449257 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 30-year-old, male patient with no medical history reported, who experienced the unexpected serious event of urticaria. The event occurred approximately 10 days after the booster dose of mRNA-1273 vaccine. The patient received treatment with methylprednisolone and antihistaminic drugs. Additionally, inappropriate schedule was noted for the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical condition.
I did not have an adverse event after receiving the vaccine. I had a heart attack on 03/15/2023. I do have a family history of cardiac disease on my mother's side of the family. I went to the emergency and admitted having three stents put into my heart. Today, I am feeling better.
This solicited report was received from the mother of the patient, a 14 year old female as part of a Market Research. The patient's current conditions, medical history and concomitant medications were not reported. In March 2015 (also reported as spring 2015), the patient was vaccinated with GARDASIL 9 (strength 70 mg, frequency reported as 3 doses over 6 months)(lot number and expiration date not reported). It was reported that the patient received only 2 of the 3 recommended doses. The second dose GARDASIL 9 was administered on an unspecified date between spring and summer 2015. However, at the time of reporting, the third dose has not been administered yet. Additional information has been requested.
PATIENT REPORTS WAKING THE MORNING AFTER RECEIVING VACCINES, EXPERIENCING COLD SWEAT, DIZZINESS, AND BILATERAL WEAKNESS IN LOWER EXTREMITIES. PATIENT REPORTS THAT SYMPTOMS RESOLVED AFTER LYING DOWN AGAIN FOR ABOUT AN HOUR.
Patient was given the Pfizer vaccine instead of the Moderna (Should have been given Moderna)
Patient reports having reaction 1.5 hrs after receiving vaccination. Described reaction as localized hives on right upper arm and shoulder and generalized itching. Patient reported to PH and was advised to go to ER. patient went to ER 3/19/08 pm and received BENADRYL shot.
Chills; fever with a temperature max of 103 Fahrenheit; Headache; Malaise; This is a spontaneous report from a non-contactable physician (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 04Jan2021 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 for Covid-19 immunization. The patient's medical history was reported as none.  There were no concomitant medications.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient experienced chills followed by fever with a temperature max of 103 Fahrenheit for 1 day, headache, and malaise on 04Jan2021 (20:00). The patient was treated with Motrin. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2018SA226816, 2018SA226774, 2018SA226818, 2018SA226819, 2018SA226820, 2018SA227033 and 2018SA227019 (same reporter). This case involves adult female patient (age not reported) who was vaccinated with a 0.5 ml dose of MENACTRA (Batch number: U5833AA and expiry date: 25-Feb-2019) via intramuscular route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because stability on MENACTRA, the excursion was actually for 9 days, starting in May, and ranged from 48-49 F. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. Documents held by the sender: None.
39-year-old female with history of ADHD, anxiety, melanoma presents with palpitations.  Patient received a Covid vaccine today and started having palpitations, lightheadedness, shortness of breath and feeling flushed a few minutes afterwards. Rapid response called and patient taken to ED for assessment. Patient denies facial or oral swelling, rash. patient denies any recent fever, nausea, vomiting, cough, diarrhea.  Denies chest pain, abdominal pain.  Last menstrual period end of November.  Has allergies to Bactrim and clarithromycin.   Presentation concerning for possible vaccine reaction, no anaphylaxis.  EKG and labs within normal limits.  Patient was rehydrated in the ED.  Patient was discharged home on same day (12/20/2020). Pt alert and oriented x 4. Pt ambulated out of ED with a steady gait in no apparent distress.
Pfizer 3/3/21, 3/24/21, 11/27/21. Positive on 1/29/22
Patient complained that her arm became swollen the following day after receiving the injection. 10/14/2008 MR received for ER visit 9/30/08 with DX: Palpitations. Sinus Tachycardia following cardiac stent placement 9/18/08. Bruising noted  to R arm. Pt reports swelling and pain in R arm.
patient's daughter came to pharmacy to pick up medrol dosepack on same day as flu vaccine was given and told pharmacist her mother had trouble breathing around lunch time approximately 2.5 hours after vaccine and went to urgent care clinic. She had trouble breathing and heavy chest per daughter.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # and route no reported). The physician reported that few days after receiving her first dose on an unspecified date the patient developed a rash on her neck. The rash persisted for two weeks. It was unknown if the patient sought medical attention. Follow up information has been received from an office staff who reported that the doctor did not recall this adverse event or patient. He was unable to provide additional information. Additional information is not expected.
10/26 0235: Shaking, crying, screaming, vomiting, emergency room, gave suppository T 100.2, dx with tempermatic seizure per mom. 1130-1202 - Shaking, T 100.9, ibuprofen given.
Itching within 5 min. Redness, swelling, lump - hard within 20 min. Site reaction only. No treatment.
Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 22-JAN-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2016, the patient was treated by his physician at a Medical Center for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
some neurological issues; This spontaneous report was received from a nurse practitioner concerning a female patient, who was her daughter's friend. No concurrent condition, medical history or concomitant therapy was reported.   On an unknown date (reported as when the patient was younger), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and lot# were not reported) as prophylaxis.         On an unknown date, the patient had some neurological issues (preferred term: nervous system disorder). The reporter believed the patient had fully recovered. However, the patient had to have one on one care. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not applicable.   The causality between the event of some neurological issues and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.
Patient received his vaccine and went outside to the waiting area for his 15 min observation. While outside he became weak, pale and clammy.  The medical team was alerted and we went outside and patient laid on the ground.  His vital signs were obtained.  He stated he has passed out before.  He is diabetic and had not eaten today.  Patient was given water, candy and a nutrigrain bar.  He stated he felt better after he ate.  His skin color, condition and vital signs improved.  Patient stated he felt fine and could ride his bike home.
Fever following vaccination; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP. A patient of an unspecified age and gender received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 3, SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously, the patient received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single and dose 1, single dose for COVID-19 immunization and no events were reported. On an unspecified date, the patient experienced Fever following vaccination. Event took place after use of product. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date of 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius) and other one for 216 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Patient reported one month after the vaccine that her arm is still sore and difficult to raise.  Patient to see her personal physician 3/18/21.  Patient said she did not take any over the counter medicines or use ice.
Presented to ER on 9/16/21, dx with pneumonia and discharged Presented to ER on 9/17/21 with complaints of a fall and was discharged Presented to ER on 9/19/21 with altered mental status, dehydration, and was admitted to telemetry
12 minutes after injection - local itching/redness.  30 min. after vaccination anaphylaxis with multiple organ involvement - skin injection site and uvula swelling and eyes itchy.   Patient had angioedema of throat with swallowing difficulty.  Had mild asthma/wheeze.  Also had tachycardia and light headed when trying to sit up.  Patient given Epi 0.3 ml IM, Benadryl 50 mg  IM, and Pepcid 20 mg PO.  Transported to hospital by EMS for 4-6 hour observation.  Patient responded well to epi.
pt recvd 2nd dose of vax & several days later pt died d/t resp complications;lab eval upon autopsy in AUG95 revealed hepatitis B surface antigen 0.439 & 0.314;specimen was sent by the coroner's office to a blood bank for further testing;
mom states pt cried for 22 hr p/shots; pt also had a t100 & was given APAP q 4 hr; both legs were red & warm to touch;
Presented with a cough for the last 4 weeks. Went to the doctor for xrays, etc. covid testing came back negative. And prescribed z pack, cough has basically gone away now.
Came home from school about 2 hours post vaccine with 101 temp.  Father says quickly went up to 104.1 axillary with lethargy. No other symptoms reported.  Father called about 4:00pm.  I spoke with him at 5:15 and she was sleeping and fever down to 102.0.
Headache, Tachycardia, chills, body aches (unspecified), fatigue Narrative:
After about 3 days I developed a very dry mouth. It is like my salavery glands have stopped working. Very bad cotton mouth. Can not eat most foods, only those with high moister content.  ****I AM NOT SURE THIS IS A VACCINE REACTION***** I am reporting it just in case others report similar symptoms.
Vertigo for the past week straight.  Randomly on and off tingling and numbness in lips and chin for the past week.
fatigue, wt loss (18lbs), weakness, decreased appetite , slight hand tremors, excessive productive cough. elevated blood pressure, swollen ankle treated with meds, added BP meds, Lasix, Potassium, ASA
terrible sinus headache; ear pressure; burning eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (bivalent booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), 1st booster), for COVID-19 immunization. The following information was reported: SINUS HEADACHE (non-serious), outcome "unknown", described as "terrible sinus headache"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "ear pressure"; EYE IRRITATION (non-serious), outcome "unknown", described as "burning eyes".  Additional information: The patient has received the Pfizer Covid19 Bivalent booster (as her 2nd booster) and was asking has anyone else reported really terrible sinus headache and ear pressure and burning eyes after the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
loss of vision of right eye; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the vaccine, the pt suffered loss of vision of right eye. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental cost of suit, attorneys' fees, and all such other relief as the Court deems just and proper as well as: a. Compensatory damages to the pt for past, present, and future damages, including, but not limited to, pain and suffering for severe and permanent personal injuries sustained by the pt, health and medical care costs, together with interest and costs as provided by law; b. Restitution and disgorgement of profits; c. Reasonable pts' fees; d. The costs of these proceedings; e. All ascertainable economic damages; f. Punitive damages; and g. Such other and further relief as this Court deems just and proper. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event loss of vision of right eye to be disabling. Upon internal review, loss of vision of right eye was determined to be medically significant.
"Big red welts"; Were itchy "as crap.",Itchiness; Worried; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness). At the time of the report, URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication were reported.
pt recv vax & pt devel a fever;8/1/98 devel measles;
This case was reported by a consumer and described the occurrence of sore throat in a female subject of unspecified age who was vaccinated with Flu shot (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included TYKERB tablet for malignant breast neoplasm and previous Flu shot. On an unspecified date the subject received Flu shot. At an unspecified time after vaccination with Flu shot, the subject experienced getting sick, "always gets sick after". At the time of the report the outcome of getting sick was unknown. On an unspecified date the subject started Lapatinib (unknown) at 250 mg five times per day. On an unspecified date in October 2011 the subject received unspecified dose of Flu shot (unknown). On an unspecified date in October 2011, within one week of receiving the Flu shot and at an unspecified time after the initial dose of Lapatinib, the subject experienced sore throat and cold. The subject stated "had flu shot last week and always get sick after that". At the time of reporting the outcome of the sore throat, cold and sick were unspecified.
Received the vaccine during pregnancy in September of 2006 exact date unknown.  Due Date is 4 JUN 2007, LMP 28 AUG 2006.
BURNING SENSATION IN THROAT; FELT LIKE THROAT WAS CLOSING; DIZZINESS; COLD SWEAT; BURNING SENSATION; NECK AND CHEST WERE RED; VOMITING; RASH AROUND THROAT; FEVER AT 102 DEGREES; NAUSEA; This spontaneous report received from a patient concerned a 55 year old female. 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced burning sensation in throat, felt like throat was closing, dizziness, cold sweat, burning sensation, neck and chest were red, vomiting, rash around throat, fever at 102 degrees, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning sensation in throat, felt like throat was closing, rash around throat, dizziness, cold sweat, fever at 102 degrees, burning sensation, neck and chest were red, nausea and vomiting was not reported. This report was non-serious.