chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6203), on 19Mar2021 as dose 2, single (Lot number: EN6208) and on 09Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 02Oct2022 as dose 5 (booster), single (Lot number: 057F22A) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Apr2022 as dose 4 (booster), single (Lot number: 001M21A) for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulinaemia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: nutmeg" (unspecified if ongoing). Concomitant medication(s) included: OXCARBAZEPINE; SYNTHROID; VITAMIN D3. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Nov2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient started Paxlovid (Lot number: 1919256A) on 15Nov2022 and stopped on 19Nov2022 for treatment of COVID-19.
Fever, severe congestion (pneumonia ?), slept 2 days, could not eat (3 days). Almost died, slept 3 days c/o weakning, high fever, sweats, weak for 3 months.
Pt received the covid vaccine on 12/30/2020.   Approximately at 8:30 pm she felt a sudden on of "chills" and noted her eyelid are swollen bilaterally. The swelling persist, L eye > R eye.  Denies pain, discharge, redness, or blurred vision.  No fever, HA, rash, or dizziness.  "My eyes feel heavy".  Denies taking a new medicines/herbal/supplement. No new meds, make-up or , skin care products. No food allergy.
Patient had an episode of syncope resulting in him hitting his head immediately following the vaccination. EMS was dispatched and the patient was cleared after being monitored. Patient stated that he has passed out in the past after giving blood. The patient had said no to having any history on this on his vaccination consent form. EMS cleared the patient to go home.
EXTREME body/muscle aches. Nausea, dizziness, flu like symptoms, migraine, hard to breathe
syringe was leaking at the connection of the needle and syringe/ NO AE; syringe was leaking at the connection of the needle and syringe/ NO AE; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (Reference number- 00812927) and transmitted to Sanofi on 14-Oct-2021.  This case was linked to case 2021SA342449 (CLUSTER).  This case involves a 68-year-old female patient who experienced syringe was leaking at the connection of the needle and syringe (device leakage)(Vaccine underdose), while received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.  On 14-Oct-2021, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, Strength: standard except for Fluzone HD ,lot UJ743AA, expiry date: 30-Jun-2022] via an unknown route at an unknown administration site for prophylactic vaccination.  On 14-Oct-2021, the patient developed a non-serious syringe was leaking at the connection of the needle and syringe(device leakage)(Vaccine underdose), on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported"Caller requesting information regarding FLUZONE high dose (HD). Caller stated that when she went to administer the vaccine, the liquid came out around the place where you attached the needle. Caller stated that part of the liquid was still in the syringe, but she was not sure if any was entered into the patient. Caller wanted to know what to do. Agent warm transferred to MIS. Additional Description of event Adverse events: The caller stated that when she gave the vaccination of Fluzone HD Quad, some of the product leaked out of the patient's skin and a lot of it got on her pants. The syringe was leaking at the connection of the needle and syringe."  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.
pt recv vax JUN96 & 27JAN97 pt devel lesions & a fever of 101;it was reported that the lesions total about 20 on chest under nipple, 1-2 on arm & hand;began as red bumps & now look like pimples;
A non-serious spontaneous report of pleurisy manifested with pain across chest and pain across back has been received from a health professional concerning an adult female, subsequent to FLUMIST. The patient's past medical history included pain across chest and pain across back two years ago in 2009 following flu injection. No concomitant medications have been reported for this patient. The patient received FLUMIST on 18-Oct-2011. On 18-Oct-2011, the patient experienced pain going straight across her back and chest immediately after FLUMIST administration. Patient stated that it felt like pleurisy. The reported stated that the reaction was not like a typical allergic reaction that she had seen in the past. No medications were given. Only monitoring the patient. The outcome of the event pleurisy was not recovered.
Missed abortion - received first shot while pregnant (did not know), missed abortion of ~5 weeks gestational age, diagnosed Feb 2021
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. In July 2019, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.  Additional details were provided as follows: The health care professional stated patient received the 1st dose of Shingrix and currently had Shingles. The pharmacist called in to questioned any information available how to proceed with 2nd dose. The reporter consented to follow up.
Started with sensitivity in the right lower leg on Thursday. Developed rash 2 d later. Started using OTC hydrocortisone without relief.  More pain in the last 2 d. Started with rash into the right gluteus. Advil did not help rash pain. More pain with sitting and contact to the area.  He received the first of 2 shingles vaccines the week before rash started.    Zoster w/out complications: This is the first visit for this problem.  Valacyclovir 1gram 1 tablet orally three times a day x 7 d was started.  Shingles (Herpes Zoster) handout was given.  Patient was given Drug Info Sheet today with medication change.  He is getting adequate pain control without multiple medications at this time.  We discussed additional options if needed.  I did opt to report this to VAERS Given the close proximity to the shingles outbreak with the shingles vaccine.
acute onset of lt facial nerve paralysis 4 days p/vax;no antecedent illnesses or medical problems;no fever noted;5wk later there is very little facial movement & prognosis is not known;
Skin morphing; Skin grew under her skin; the skin grew under her skin and is itchy, red and is circular; the skin grew under her skin and is itchy, red and is circular; This spontaneous case was reported by a consumer and describes the occurrence of MORPHOEA (Skin morphing), SKIN DISCOMFORT (Skin grew under her skin), ERYTHEMA (the skin grew under her skin and is itchy, red and is circular) and PRURITUS (the skin grew under her skin and is itchy, red and is circular) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MORPHOEA (Skin morphing), SKIN DISCOMFORT (Skin grew under her skin), ERYTHEMA (the skin grew under her skin and is itchy, red and is circular) and PRURITUS (the skin grew under her skin and is itchy, red and is circular). At the time of the report, MORPHOEA (Skin morphing), SKIN DISCOMFORT (Skin grew under her skin), ERYTHEMA (the skin grew under her skin and is itchy, red and is circular) and PRURITUS (the skin grew under her skin and is itchy, red and is circular) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Vaccination on 10-20-06. Started experiencing burning sensations and weakness in both arms - with the right arm being significantly worse. The pain originated from the arm pits and went down the arms. From there the weakness got progressively worse and I started dropping things. Then it turned to excruciating throbbing pain which was so intense it was difficult to sleep. I was diagnosed with brachial neuritis and 13+ months later, still suffer from the effects. I have severe weakness and don't have full use of my thumb and index finger in my right hand. I also have weakness in both arms with the right arm being significantly worse. I also have sensory issues. I was told my condition will probably be permanent due to the severity. Per 60 day follow up: I am still suffering from Brachial Neuritis in my right arm and extending into my hand. My diagnosing Dr. feels this condition was by the vaccinations I received. He also feels the prognosis for recovering is not very good most likely be a permanent considering the lenght of time that has gone by and all the problems still have, and the extent of my problem.
complained of vague complete LEFT arm Itching with NO others symptoms ; vitals stable; refused further treatment; itching completely resolved on it's own in the next ten minutes and  pt. left to go home.
HEADACHE BUT DID NOT FEEL LIKE AS SEVERE AS A MIGRAINE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 09:00 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021 11:00, the subject experienced nausea. On 06-MAR-2021 12:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 06-MAR-2021, and had not recovered from headache. This report was non-serious.
pt recvd vax & devel apparent serum sickness-like synd; No further details were provided
I started having eye problems, itchy eyes and issues with them being dry and red. The ophthalmologist in June, discovered that looking at my transplants had swelling and the transplant was being rejected. They gave me steroids to help with the issue, and after this they are much better. The ophthalmologist was indicating that it could be related to the vaccine. They gave me  perezone 4 times a day in June. Restasis 2 times a day a few weeks later. They also gave me refresh eye drops and miral128. I'm still seeing a doctor for this, and they are not trying to change my prescription so they can see improvements. I still have appointment, I saw him in October 11 and I see him again in Feb. I'm seeing a Dr., he's a cornea specialist.
Microscopic blood in stool; Rashes around anus; Allergic reactions; This spontaneous case was received on 24-Oct-2023 from a other non-healthcare professional (patient's father) (reference number: SEQW23-03709) and concerned a male patient of unreported age.  The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication.  On 18-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza immunization. The batch number was not reported.  On an unspecified date in Oct-2023, reported as within a few days of the shot, after receiving Flucelvax Quadrivalent, the patient was having allergic reactions. Microscopic blood was found in the patient's stool and rashes developed around the anus.   The outcome of the events 'blood in stool', 'anal rash' and 'allergic reaction' was not reported.  The reporter did not provide a causality assessment. The patient had prior history of allergy, but it was not sure if the present one was related to the vaccine.  The events of 'blood in stool', 'anal rash' and 'allergic reaction' were considered to be medically significant by a Physician within Pharmacovigilance Department.  This case is linked to 202305512 (the same reporter).  Company comment: A patient was vaccinated with Flucelvax Quadrivalent. As reported, within a few days after vaccination, the patient was having allergic reaction. Microscopic blood was found in the patient's stool and rashes developed around the anus. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events hypersensitivity, haematochezia and anal rash with the currently available information and chronological plausibility.; Reporter's Comments: The patient had prior history of allergy, but it was not sure if the present one was related to the vaccine.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent. As reported, within a few days after vaccination, the patient was having allergic reaction. Microscopic blood was found in the patient's stool and rashes developed around the anus. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's concurrent conditions included allergic to potato, corn, and other foods. The patient was not taking any concomitant medication. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events hypersensitivity, haematochezia and anal rash with the currently available information and chronological plausibility.
ATM aches site of injection, body aches, menstrual cramps, pain right side of rib cage, back hurts, sluggish
Pt was having a rash and swelling in both arms (had flu vaccine in 1 arm and pneumonia vaccine in other arm). Pt also had a lump in right arm.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Flu like symptoms; Redness in the injection area; Tender and redness in the injection area; Swelling, tender and redness in the injection area; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date 14th May 2022) for prophylaxis.   On 22nd August 2020, the patient received Shingrix. On 22nd August 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness and injection site swelling. On 23rd August 2020, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site swelling were not recovered/not resolved and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site swelling and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced flu like symptoms.  The patient also experienced swelling, tender and redness in the injection area, side effects she still had until the day of reporting. The reporter consented to follow up.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 25-JUN-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L000450 and expiration date 09-MAR-2016) 0.65 ml once, subcutaneous. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 and of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (for both, doses and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced her first menstrual cycle which was extremely heavy. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Severe Chills onset 11pm on 9/30/21, muscle/joint pain/fever/loss of appetite/fatigue onset 10/01/21 AM and lasting through 10/02/21 11pm, headache onset 10/02/21 and lasting 12 hours, covid arm onset 10/03/21 itching, swelling, redness, and warm to the touch.
Vaccinator injected patient with empty needle, rather than syringe filled with vaccine. She then corrected her mistake and the dose was administered correctly.  Mother assured the first needle was not contaminated.
Inflammatory reaction; Pain in her shoulder; Tingling in fingers; Diarrhea; Headache; Nausea; Inflammatory reaction with swelling, redness and heat; Inflammatory reaction with swelling, redness and heat; Induration to her arm; Sub q injection; A spontaneous report was received from a physician assistant concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sub q injection, nausea, headache, diarrhea, significant swelling, redness and induration in her arm, inflammatory reaction, pain in her shoulder and tingling in her fingers.   The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient was given the injection in the posterior lateral arm and it appeared to have been given subcutaneously.  On 14 Jan 2021, the patient was nauseated, had a headache, diarrhea, and significant swelling with redness and induration to her arm. The skin reaction resolved on day 8, however it returned on day 9 at which point she visited her family practice.   On 22 Jan 2021, she had an inflammatory reaction with swelling, redness and heat for which she was given diphenhydramine and loratadine. The patient also complained of pain in her shoulder and tingling in her fingers.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, sub q injection, was considered resolved on 13 Jan 2021. The outcome of the events, nausea, headache, diarrhea, significant swelling, redness and induration in her arm, inflammatory reaction, pain in her shoulder and tingling in her fingers, was unknown.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced non-serious unexpected events of Incorrect route of product administration, Paraesthesia, Diarrhea, Inflammation, and non-serious expected events of Injection site induration, Injection site swelling, Injection site erythema, Arthralgia, Headache and Nausea. The events of Injection site induration, Injection site swelling, Injection site erythema, Diarrhea, Headache and Nausea occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A).  The events of Inflammation, Paresthesia and Arthralgia approximately nine days after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A). Treatment included diphenhydramine and loratadine. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Patient experienced a syncopal episode with possible generalized seizure activity, with urinary incontinence after receiving 5 vaccinations at approx. 4:45-5 p.m. on 10/21/08. She was immediately aroused with smelling salts by the RN and the supervisor was notified.  After the incident the client was pale, slight diaphoretic,cool,clammy, and sluggish.  Vitals signs after syncopy were BP 90/76, HR 70, RR 32 with repeat set after 15 mins. BP 90/76, HR 56, RR 32. Pt. was laid down, placed on 4-5L oxygen per mask, and observed for 30-45 mins. She then was alert, and oriented to person, place, and time, more verbal, and without balance problems.  She was then referred to urgent care hours at her drs. office for follow up.
Patient did sat in the clinic after administration for 15 minutes with no initial reaction. Patient went home and noticed her arm was warm red and swollen later that day. Attempted to decrease her symptoms with ice and zyrtec but no relief was received.  Patient was seen by PA on 2/1/2021 as her symptoms continued and was placed on abx.
Feeling flushed but no fever, headache, pressure/aching of eyes, nausea. Symptoms not relieved with aspirin or Benadryl.
The first dose of vaccine gave me nasal bleeding on the ninth day and the second dose gave me nasal bleeding on the second day.