chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives, which continued to worsen over the course of 3 weeks.  The hives started the day after receiving the first dose of the Pfizer vaccine. The hives seemed to spread mostly at night. The hives progressively got worse and more frequent as time went on. I got prescribed a 10-day dosage of Prednisone 3 weeks after the first shot. For the first 3 days of taking the Prednisone, the hives disappeared. The hives came back, although to a lesser degree, at day 5 of the prednisone treatment.  I then started taking Zyrtec and Pepcid AC twice daily and the hives appear to have stopped, starting on 7-16-2021.
Initial report received on 26 September 2013 from a nurse. A female patients whose age, medical history and concomitant medicaitons were not reported, received a dose of MENACTRA vaccine (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received the MENACTRA. The nurse reported that she had a severe reaction a week after receiving her shot. She said her arm had a baseball growing out of it. She called her doctor to report the issue, only to find out the product has been expired since May 2013. List of documents held by sender: none.
Information has been received from a nurse referring to a 21 year old male patient. Information about concurrent condition, concomitant medication and medical history was not provided. The patient was administered a first dose of GARDASIL (dose, lot# and expiration date were not reported) intramuscularly for prophylaxis when he was 13 years old in 2010. On 09-JUL-2018, the patient was administered his second dose which would be GARDASIL 9 (dose, lot# and expiration date were not reported) intramuscularly for prophylaxis (Inappropriate schedule of vaccine administered and Interchange of vaccine products). No adverse effects were reported.
Pain on upper arm with swallowing and inflammation where the shot is apply  I was take 2 Tylenol 600 mg for the event and also a cool pad for the inflammation
pt recv vax 13AUG97 & 14AUG97 pt devel a macular rash & back & legs w/urticaria which cont for 6wk;given DPH;5SEP97 anti-hepatitis B surface antigen revealed no immunity;
Information has been received from a registered nurse concerning an 8 week old female (born at 37.4 weeks gestation at 2396 grams) with a history of a NICU admission (3 days) at the time of birth due to a right pneumothorax (unspecified cause) and a normal MRI of the lumbar spine done for a sacral dimple who on 3/14/06 was vaccinated, PO, with the first 2.0 mL dose of ROTETEQ  (lot 0145F). Concomitant vaccinations administered on that same day include a dose of PEDIARIX and PEDVAX HB and a dose of PREVNAR. There was no other concomitant therapy at the time of vaccination. The RN reported that on 3/15/06, the patient's mother called the office reporting her daughter had a bloody stool as she had blood in her diaper. The patient's mother indicated that she did not test the stools with guiac paper for blood. No other symptoms were reported. The RN indicated she had spoken with the patient's mother several times since 3/15/06 and the child did not have any other occurrences of blood in her stool. At the time of this report, the patient was noted to be well and was considered to be recovered. Additional information has been requested. Information has been received from a registered nurse (RN) concerning an 8-week-old female (born 37.4 weeks gestation at 2396 grams) a with a history of a NICU admission (3 days) at the time of birth due to a right pneumothorax (unspecified cause) and a normal MRI of the lumbar spine done for a sacral dimple who, at her 2-month check-up, on 14-MAR-2006, at approximately 1200, was vaccinated, PO, with the first 2.0 mL dose of ROTATEQ (Lot #652964/0145F). Concomitant vaccinations administered on that same day included a dose of PEDIARIX a dose of PREVNAR. Ther was no illness or other concomitant therapy at the time of vaccination. The RN reported the patient's mother called the physician's office indicating that on 15-MAR-2006, at about 0955, her daughter had a bloody stool as she had a small amount of blood in the stool in her diaper. The patient's mother indicated that she did not test the stools with guiac paper for blood. No other symptoms were reported and no laboratory/diagnostic tests were performed. The patient did not require an Emergency Room or doctor visit. The patient was not hospitalized. The mother was advised to monitor her daughter and report any abnormal pain or vomiting. The patient's mother indicated that her daughter's nex stool was normal. As of 16-MAR-2006, the patient was noted to be well and was considered to be recovered. The RN indicated that she has spoken with the patient's mother several times since 15-MAR-2006 and the child did not have any other occurrences of blood in her stool. No further information is available.
I passed out 6:30pm that night. My legs won't work right from that moment and I have a pain that goes up to my hips.
Arm pain near injection site immediately following injection at 8am. No other symptoms besides arm pain until that evening. Around 9pm began to experience fatigue and muscle pains all over body. I took a dose of Tylenol and went to bed. Woke up the next morning with a fever of 101 degrees F. Continued to have fatigue, muscle pains, chills through the next day until about 9pm (symptoms lasted about 24hrs).
Patient's arm became more sore over time until she got a MRI 6 weeks after vaccination, which shows a tear in rotator cuff. She will begin physical therapy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected 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-202200934657 Same patient, different drug, different event;
We received from a nurse via the Medical Communication the following information on 03 DEC 2007: A 58-year-old man was vaccinated with Fluvirin, batch-no. 80435, i.m. on 16 OCT 2007. Severe headache was reported on 18 OCT 2007 and the patient was admitted to hospital. Laboratory result: elevated IGE of 993. The patient is receiving Prednisone and still has daily mild headaches at the time of report (03 DEC 2007). Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated due to the long duration and intensity of the symptom. Expectedness assessment according to manufacturer label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No meaure necessary. NA07-006827
patient received Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a nurse practitioner.  This case is linked to case 2020SA268090, 2020SA268091, 2020SA268094, 2020SA268089 and 2020SA268093 (same reporter).  This case involves a 84 years old female patient who was vaccinated with 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes, lot number UJ498AA and expiration date:30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant was given to the patient on the same day.  It was an actual medication error case due to incorrect product storage.   It was reported that the boxes were cold, but the ice packs were not hard frozen, they gave 6 doses before they got call not to use product because it was too long in transit and asked if they should revaccinate patient.  No adverse event reported at the time of reporting.  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.
fever; chills; muscle aches; This is a spontaneous report form a contactable other healthcare professional (Other HCP) reporting for herself. A 22-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EK9231, expiry date: not reported) via an unspecified route of administration, on 07Jan2021 on Arm Left at a single dose for COVID-19 immunization. COVID-19 vaccine was administered at a hospital. Medical history was not reported. The patient has no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had undergone Nasal Swab tests on 08Nov2020 and 05Dec2020, both with negative results. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: not reported) via an unspecified route of administration, on 17Dec2020 03:30 PM on Arm Right at a single dose for COVID-19 immunization (at the age of 22-year-old). On 08Jan2021 02:45 AM, the patient had a fever, chills and muscle aches in the middle of the night into the morning of the following day. Treatment was not received for the adverse events. Outcome of the events was recovering.
blood clotted in her lung and her leg; blood clotted in her lung and her leg; almost died; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 31 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), THROMBOSIS (medically significant), outcome "unknown" and both described as "blood clotted in her lung and her leg"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost died." The reporter called the adverse events an experiment, where one might die and other no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received my booster 08/18/21 five month later I contracted Covid-19. I was sick for two weeks. I was not hospitalized, after the two weeks I recovered. Currently still getting runny nose.
On 12/3/01 at 6 months of age, the pt was given vaccinations at approx. 15:30. At approx. 08:00 on 12/4/01, the pt had an afebrile partial seizure with generalized features. She was taken to ER where she was fount to have a fever of 38C. The fever decreased without analgesics in 1 to 2 hours. She was admitted to the PICU for observation overnight. She did well and was discharged the next day.
No adverse symptoms were reported; received the third dose in the GARDASIL-9 series three days early; This spontaneous report as received from a consumer referring to her son of unknown age.  The patient's pertinent medical history, concomitant medications, concurrent condition and drug reactions/allergies were not reported. On 07-DEC-2019 (three days early), the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis (inappropriate schedule of product administration).  No additional adverse symptoms were reported. No product quality complaint (PQC) was reported. No other information was available.
tingling in my hands; arm has been extremely sore and painful; couldn't brush my hair; couldn't stretch my arm straight out, it started shaking; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my hands), PAIN IN EXTREMITY (arm has been extremely sore and painful), HYPOKINESIA (couldn't brush my hair) and TREMOR (couldn't stretch my arm straight out, it started shaking) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE and ATENOLOL for an unknown indication. Treatment details include Tylenol to help with the pain.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (tingling in my hands), PAIN IN EXTREMITY (arm has been extremely sore and painful), HYPOKINESIA (couldn't brush my hair) and TREMOR (couldn't stretch my arm straight out, it started shaking). At the time of the report, PARAESTHESIA (tingling in my hands), PAIN IN EXTREMITY (arm has been extremely sore and painful), HYPOKINESIA (couldn't brush my hair) and TREMOR (couldn't stretch my arm straight out, it started shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Based on MSA comment, Pain in extremity changed to Vaccination site pain and listed in all RSI
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 39 years old female patient who was exposed to vaccine FLUZONE QUADRIVALENT in context of to report drug exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. Drug exposure during pregnancy occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had <<XX>> previous pregnancy/ies. On 02-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI980AB via intramuscular route in the left arm. Relevant prenatal testing after exposure included was not reported. No lab data reported. Additionally, at time of reporting, the outcome of the pregnancy is unknown. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
vaccine was administered outside of Facility - reported by patient  J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 6/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED
pt started having seizures and was given ativan.  EMTs were called and patient was taken to the ER
Patient reported that she noticed a diffuse rash on 1/25/2021. The rash was located on her wrists down to her fingers, both upper thighs, on her right arm and elbow. She described the rash as "raised bumps that are chickenpox-ish but not dark red dots". She also said that they look like, "hives with the welts and the white-ish area around that focal part of the rash". She said it is not painful. She said the rash is mostly not itchy, except for her right elbow which is very itchy.  She added that on the day of vaccination, 1/14/2021 (she received the vaccine around 2:30pm), she noticed some intestinal cramping between 6:30 and 7:30pm. She had no nausea or vomiting. She stated she did have two or three episodes of loose stool, but not outright diarrhea. She said she had no GI symptoms beyond 1/14/2021.
Pt received in private observation room, laying on exam table with HOB at 45 degrees, HOB placed flat and legs elevated; pt in no distress, responds to all questions, alert, slightly diaphoretic and warm; VS at 1353: 107/59, HR 62 regular, RR 18, SaO2 98%; Pt states that he felt cold and hot and knew that a syncopal episode was starting as he was sitting in a chair so he immediately requested a soldier to put him somewhere to lay down; VS at 1405: 100/61, Hr 64, regular, RR 18, SaO2 100%, pt states that this is his usual BP reading; pt states that his last syncopal episode was approx 1 year ago; pt does not want an ice pack, states that he is feeling better; VS at 1420, 110/73, HR 66 regular, RR 18, SaO2 98%; pt states that he feels fine, HOB placed at 45 degrees, then 90 degrees and pt has no c/o, drinking water; VS at 1440 106/65, HR 56-66, regular, RR 16, SaO2 99%, pt ambulated in room and then in hall and has no c/o; states that he feels fine and plans to drive home; Pt left clinic at 1445, stable and no c/o.
Patient got the shot back in Oct 2010, (didn't report adverse event till now). Within an hour after getting the vaccination he started to feel hot, later that night he spiked a fever (103.4F), headache, malaise, myalgia, chills, and severe "shakes".  The symptoms lasted about 3-4 days.
Patient fully vaccinated (Moderna) but not boosted, admitted to the hospital on 01/21/22 with COVID-19 and associated hypoxia. Patient was discharged on 02/04/22.
ZOSTAVAX administered on 7/26/10. She came in 8/2/2010. She has skin discoloration on both arms (more on left arm, which is sight of injection). Discoloration is of maroon color, spots, streaks (thin, long) randomly on her arm.
Patient received 0.5 mL of Pfizer instead of 0.3 mL as a result of a preparation error. Patient did not report any adverse events.
Mild erythema 4cm X 6cm at injection site on L thigh, tenderness, normal gait. Rec: ice, ibuprofen. Matthew's mother wanted this reaction reported to VAERS.
A health professional report has been received. The report concerns a 10 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated inadvertently gave expired FLUMIST QUADRIVALENT (Preferred Term: expired drug administered) which started on 15-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Chills, muscle aches, headache, fatigue, low grade fever, sore arm
This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. On 31st October 2018, 1 days after receiving SHINGRIX, the patient experienced myalgia. In November 2018, the patient experienced injection site rash, erythema, skin warm and tenderness. On an unknown date, the outcome of the myalgia, injection site rash, erythema, skin warm and tenderness were unknown. It was unknown if the reporter considered the myalgia, injection site rash, erythema, skin warm and tenderness to be related to SHINGRIX. Additional details were provided as follows: As per PA, the patient complained of myalgia for a day after the vaccine, but came to the clinic a couple days after the vaccine with a itchy rash that was about 1 inch below the presumed injection site. There were about 5 to 6 areas of redness that were warm and tender to the touch. The patient did not have any other systemic symptoms at that time.
ISSUE: Now realize 1st injection NOT in upper, center arm: deltoid. Needle inserted  at side/rear inches lower and behind correct sites as shown and pictured on instructions, photos of correct site.  SC not IM. Second dose administered correctly. Want infornation as to level of protection now. Should I consider self NOT fully vaccinated and continue safe practices as actually only received 1 dose, since SC injection worthless with Pfizer va cine
Admit for COVID pna. Lives with daughter who was sick with COVID. Rocephin, Zithromax, steroids, O2. She was weaned to room air or at least 1 L oxygen. Improved and was discharged to SNF.
Patient had redness and swelling in the injection site the following day after the vaccination. He had no pain or fever and did not take any medication to alleviate the symptoms. He came back to the pharmacy 4 days after the vaccination 11/29/17 but the redness and swelling has already significantly subsided and was advised to see his doctor if the situation get worse or does not improve.
This spontaneous report was received from a register nurse concerning a female patient of unknown age who on 05-SEP-2012 was vaccinated with an 0.5 ml., intramuscular dose of GARDASIL that had expired on 25-JUN-2012, lot number 665607/1332Y. No adverse events were reported. Additional information has been requested.