chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive antigen test 1 week after finishing full course of Paxlovid.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Positive antigen test 1 week after finishing full course of Paxlovid.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Allergy.   In February 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. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 17-May-2022, the patient experienced COVID-19 (Positive antigen test 1 week after finishing full course of Paxlovid.). At the time of the report, COVID-19 (Positive antigen test 1 week after finishing full course of Paxlovid.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  On 17-May-2022: patient experienced return of cold-like symptoms (no fever) and positive antigen test 1 week after finishing full course of Paxlovid.  No treatment information provided.  Device date reported as 18-May-2022. COMPANY COMMENT: This is an spontaneous case concerning an 70-years-old male patient with  medical history of PAXLOVID on May, 7-2022 for 5 days who experienced the unexpected AESI event of COVID-19 unknown days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 70-years-old male patient with  medical history of PAXLOVID on May, 7-2022 for 5 days who experienced the unexpected AESI event of COVID-19 unknown days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt. recvd. vax & developed measles rash,cough,coryza,conjunctivitis, & Koplik spots.
about an hour after vaccine. First left hand weakness. Hand stopped at local grocery store on the way home.  Right hand dominant but use left hand a great deal. Dropped everything I lifted or put in my left hand. Light or heavy. Embarrassed at first, then concerned. Stopped at pharmacy to pick up unrelated med and mentioned to pharmacist. We both laughed. Returned home and told husband. It continued.  Later started feeling numbness in fingers and hand on left sixths left leg and numbness and tingling up left neck and face and scalp.  Lasted 30 min to an hour. Weakness in hand got better over days .  Waited until recently to report it to Anyone and chose Dr as he follows me for other issues and I have a second dose due and became frightened.
?COVID arm? Rash developed 15 days after first shot at site of shot. Large patch about 2? X 5?.  Itching, swollen, warm to touch. No treatment given.  Awaiting resolution.
This spontaneous report as received from an unspecified refers to a patient of unknown age and gender. On 05-FEB-2015 the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
At 1pm, I received my Janssen Vaccine. Soon thereafter, I still felt tenderness at injection site. At around 9pm, I started feeling very tired, and my body ached from my neck down to my LE bilaterally; it began hurting (dull, muscle-like pain, that remained constant) until the following day 9/25/21 at 6pm when it subsided after taking 2 tabs of 500 mg of Tylenol in the morning (9/25/21 at 830am) and 1 tab of Motrin 800 mg at 430 pm 9/25/21. The evening of 9/24/21 at 1145pm, I was feeling so fatigued, I had to lay down and once I did, I began with severe chills that would not subside with warm clothing (pants, socks, sweater & thick blanquet) that lasted 1-2 hours. On 9/25/21 in the am, I had a moderate headache, intermittent, pulsating with a mild low grade fever in the evening about 630pm.
Pt. complains of "itching" hives/upper & lower extremities. C/o congestion denied SOB, erythema noted on ears and face. BENADRYL  given 25mg IM q 15 min. x2. Pt. symptoms decreased vitals remained stable. BENADRYL lot#020333 2/2012.
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Four days after Shot 8/24/21 - Started feeling dizzy and lightheaded.  Felt a pressure in left side of chest and around left shoulder blade area on 8/26/21 that evening of 8/26/21 felt like heart was racing and very dizzy.  8/24/21 was the peak of all my symptoms.  Felt dizzy 8/24/21 through 8/28/21 and did not exercise during this time and tried to rest and drink more fluids.   On 8/29 the daily feeling of dizziness and lightheaded went away and was able to get back to normal daily activity.  Still feeling the chest pressure at times but intermittently and not every day.   8/30/21 - Tried to start my daily walks again but became dizzy and had to stop.  Felt dizzy upon waking up again on 8/31/21.  Started feeling good and no more dizziness with normal daily activity but still feel the pressure in chest at times.  Tried to start walking again on 9/13/21.  Was able to walk my normal distance but felt lightheaded and still feel off but not dizzy like have been feeling.  9/14/21 - in the morning feeling lightheaded again but able to complete normal daily activities without feeling dizzy.
received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The vial was initially stored in the refrigerator on 22-Oct-2021. The vial did not undergo any temperature excursions.
Patient developed a "mask-like" rash on her face that started around her eyes and spread down her cheeks. The rash was warm and itchy.
Beginning March 14 pain in right thigh and right calf. Went to family doctor March 19th said could be dry skin used skin cream no change. Went to hematologist on 26th blood test for blood clots came back normal. On March 29 had ultrasound on right leg for blood clots came back normal. On April 5 went back to famil doctor with pain still in right leg and thigh awaiting blood test results.
Slight rash, soreness, stiffness, patient reported 3 days after vaccine, slight shortness of breath.
Injection site red; Tennis ball sized hard lump; Injection site pain; Injection site Swollen; Facial pain; Fatigue; Headache; This is a spontaneous report from a contactable other Health Professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), intramuscularly in left arm on 10Jan2021 08:00 at single dose for COVID-19 immunization.  The patient medical history was not reported.  Known allergies: No. Other medical history: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. Other medications in two weeks: No. Facility type vaccine: Hospital. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) on 20Dec2020 for COVID-19 immunization. The patient experienced injection site pain, swollen, red, tennis ball sized hard lump, fatigue, headache, facial pain, all on 11Jan2021 06:00 with outcome of recovering. No treatment received for all the events. If COVID prior vaccination: No. If COVID tested post vaccination: No.
allergy/ allergic reaction to hair dye; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case The age at vaccination was not reported. The patient got Shingrix vaccine and enquired could the vaccine cause allergic reaction to hair dye. The follow-up would not possible as no contact details were available.
No additional AE reported.; Pharmacist reported that an adult patient received MMR II on 8/27/2023, and then two weeks later received VARIVAX on 9/10/2023. Whenever patient filled out vaccine paperwork, she selected no that she has not received any vaccines lately. However, aft; This spontaneous report was received from a pharmacist, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 27-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 10-SEP-2023 (also reported as two weeks later), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W011622, expiration date was reported and validated as 06-APR-2024) as prophylaxis (inappropriate schedule of product administration). It was reported that whenever the patient filled out vaccine paperwork, she selected no, that she had not received any vaccines lately. However, after the fact pharmacist reviewing records and noticed patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) two weeks before. No additional adverse event reported.
Pt recvd 1st dose vax & devel "extreme" fussiness. Pt seen by MD 1 day p/vax. This is 1 of 3 pt to devel rxn p/vax of Acel-Immune, different lots.
This spontaneous report was received from a physician concerning an 11 year old female consumer with chronic proteinuria who on an unknown date was vaccinated with the first dose of GARDASIL 0.5 mL (route and lot # not provided) and on 11-JUN-2012 received the second dose of GARDASIL 0.5 mL (route and lot # not provided). Concomitant therapy included chronic treatment (unspecified) for protein in the urine. The physician stated that on 11-JUN-2012, the patient became extremely nauseated for 10 days. The patient was treated with REGLAN. On 21-JUN-2012, the patient recovered from the event. The patient sought medical attention. The patient's mother was curious and wanted to know if her daughter should continued with the third dose since she had the adverse experience with the second dose. The patient's mother wanted to seek the advice of her primary care physician. Additional information has been requested.
Patient received influenza vaccine on 11/1/23. On 11/2/23, patient started having pain on left side of neck and fatigue. Neck pain resolved after 24 hours. On 11/6/23 patient started having left arm pain. Pain has continued until day of report, 11/8/23. Patient was seen 11/08/23 in clinic with no signs of infection or mobility issues. Recommended OTC ibuprofen for symptoms.
Patient reports, dizziness, nausea, shakiness, and vomiting about 10 minutes after vaccination . Called the ambulance and arrived at 2:35 pm.  Patient is alert and breathing normally.
Rash on mid section, looks bad; This case was reported by a consumer via call center representative and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 5 days after receiving Shingrix, the patient experienced rash. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-March-2022 Reporter's Comments: The patient got the first shingrix vaccine 8 weeks ago and about 5 days post the vaccine she developed a rash on her mid section. The rash had not gone away. She had been using a steroid cream on the rash. She also stated that the rash wasn't itchy or painful, but just looks bad. She had no further information such as lot number or expiration date for the vaccine. Additional Supportive Information: The patient self-reported this case. The reporter did not consent to follow-up.
Received Pneumovax 250.5 cc IM 10/18/2005 L deltoid L upper arm swollen red for two days. It is still uncomfortable to reach behind myself. Reported 11/17/2005 to Health Dept.
Information has been received from a registered nurse concerning a 64 year old female who on 19-APR-2007 was vaccinated with a single dose of Zostavax. It was reported that the patient visited the office on 24-APR-2007 for an unrelated issue and she reported redness and swelling at the injection site after receiving Zostavax. She did not remember exactly when it had started, but reported that it was improving each day. At the time of he report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
balance issues; vestibular neuritis; nerve function in one ear and partial loss in the other ear; vertigo / severe case of vertigo; conjunctivitis / conjunctivitis in the eye; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2020, 5 days after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vertigo and conjunctivitis. On an unknown date, the patient experienced balance disorder, vestibular neuronitis and nerve injury. On an unknown date, the outcome of the vertigo, conjunctivitis, balance disorder, vestibular neuronitis and nerve injury were unknown.   It was unknown if the reporter considered the vertigo, conjunctivitis, balance disorder, vestibular neuronitis and nerve injury to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient developed vertigo and conjunctivitis 5 days after the Fluarix vaccine. No other vaccine data was provided. The patient thinks that it was given in the left arm but was not sure.  5 days later she had a severe case of vertigo with balance issues and conjunctivitis in the eye.  The patient reported having cleaned the eye out with a washcloth, but eventually had to go to the ER and visited the ENT doctor where they performed a bunch of different tests and was diagnosed with vestibular neuritis and complete loss of nerve function in one ear and partial loss in the other ear.  The patient had been suggested to did physical therapy.
Patient was given the 0.2 ml dose of the Pfizer vaccine in his left deltoid by RN. He went to observation and his mother  called me over. She stated that a lot of the vaccine ran down his arm at the time of administration, The nurse states that it was a drop. I spoke with Clinical Lead who advised that the patient get another dose of the vaccine. Patient was given a second 1st dose in his right deltoid by another RN at 9:28 am. He sat for another 15 minute observation with no ill effects. The mother was given my cell number to call in case of any adverse events.
Pt noticed weakness in fingers of right arm 8/27/12. Patient noticed swelling in right hand 8/30/12. On 8/31/12 rash developed. No blisters but pain. Pt went to ER MD DX, as shingles. Treated pt as outpatient
Slight head and eyes pressure; slight head and eyes pressure, light a cloud in his head; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration, administered in arm right on 23Feb2021 08:15 as single dose for covid-19 immunisation. Medical history included Heart issues, 10 attacks, 11 stents. The patient's concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. The patient previously took metoprolol and experienced allergies. The patient experienced slight head and eyes pressure, light a cloud in his head on 23Feb2021 08:15. No treatment received. Gone by the time he got home 1/2 hour later. The outcome of events was recovered.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
The patient's son called to let us know that his father was sent to the ER due to a spike in blood pressure and heart rate. He believes one of the vaccination is the cause of this.
Itching, rash, blisters on arms and hands starting 48 hours after injection.  Worse on elbow near injection site.  Using antihistamine (Zyrtec) and OTC steroid cream.
Patient became lightheaded, blacked out for a few seconds, became sick to stomach and had diarrhea. Patient was given cold rag on head/back of neck kept patient laying down. Provided pt with ice water and orange juice. BP at time of reaction 80/52, BP after feeling better 118/74.
Severe muscle pain in area of injection, soreness and redness around injection site, fever above 100F, weakness, dizziness, chills, the following day (10/30/2014) developed respiratory congestion. Ibuprofen for pain...
expired Shingrix Vaccine was given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-AUG-2023, the patient received Shingrix (intramuscular, unknown arm) .5 ml. On 01-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired Shingrix Vaccine was given to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 02-AUG-2023 The reporter reported that an expired Shingrix vaccine was given to a patient the day before reporting which led to expired vaccine used. No other information known. The reporter consented to follow up.
Initial report received on 17 March 2009 from a literature collection. "An 8 month old female patient developed a left sixth nerve palsy 6 weeks after DPT Immunization (manufacturer and lot number not reported). The motility disturbance gradually resolved over the next 6 months. The following year the ophthalmoplegia recurred 3 months after DPT booster immunization, followed by resolution of the sixth nerve palsy over 2 months." The reporter of this case is the same as case number 2009-01116. List of Documents held by Sender: none.