chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my 2nd shot Thursday evening and by Friday evening I started to have some pain in the vaginal area. It progressively got worse over the course of the weekend. I called my regular doctor and OB/Gyn Monday and was seen by my gyn Tuesday. My regular doctor told me to stop taking the Terbinafine to see if it would help, ut my gyn said I had a vaginal lesion outbreak.  I've never had anything like this before. I'm currently taking a steroid and an antibiotic to help relieve pain and discomfort.
This spontaneous report as received from a physician via field representative refers to an approximately 41 years old female patient. On 29-NOV-2012, the patient was vaccinated with PNEUMOVAX 23 lot # H011780, expiry date 16-FEB-2014, standard dose/one injection, injection, for the prevention of the pneumococcal virus. On an unknown date in November 2012 (also reported as within twenty-four hours of receiving the injection), patient had developed pain in the arm that had received PNEUMOVAX 23 vaccine. Onset time of the reaction was within twenty-four hours of receiving the injection. On an unknown date in December 2012 (also reported as four to five days after receiving the injection), the patient had recovered from the pain. Action taken with respect to PNEUMOVAX 23 was not applicable. Causality was not provided. No product quality complaint (PQC) reported. No further adverse event information provided. Additional information has been requested.
Profound weakness initially attributed to viral illness.  Required intubation on 11/11/2009 secondary to respiratory failure.  Subsequently diagnosed with GBS with significant morbidity and prolonged recovery time.
Subsequent to receiving one dose of varicella virus vaccine live on 8/9/98, the pt experienced nausea, fever and vomiting.  The next day, the fever subsided but then returned with lesions. Pt sought unspecified medical attention and was treated with acyclovir and the case minimized.
This spontaneous report as received from a pharmacist refers to a 23 year old female patient. It was reported that patient had no concomitant medications and medical history. The patient's concurrent conditions and past drugs were not reported. On an unknown date reported as "when she was younger", the patient was vaccinated with RECOMBIVAX HB 3 complete dose series for immunization whose dose, frequency were not reported. The lot number, route and expiration date were unknown. On an unspecified date, the patient had hepatitis B titers (serum hepatitis B surface antibody) were drawn and the titers were negative. The outcome and causal relationship of the event with RECOMBIVAX HB vaccination was not reported. No further information was provided. Additional information has been requested.
This spontaneous report was received from a  licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. It was reported that improperly stored doses of ROTATEQ (lot # L028645, expiry date 25-MAY-2017, orally (dose was not reported) were given to unspecified multiple patients on 07-APR-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
trouble in breathing; Itchy; Shortness of breath; I got an hives all over my face. This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187, Expiry date was not reported), via an unspecified route of administration on 20May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient had received first dosage of Pfizer vaccine on Thursday night. Yesterday on 23May2021, Patient broke out with hives all over the face and today on 24May2021 it's itchy and patient was having shortness of breath and trouble in breathing. Is this normal. The events assessed as non-significant. The outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
per death certificate, pt died at home; pt had hospice. causes of death are:  Adenocarcinoma of lung, stage IV; Renal Failure; lymphoma history, ARF Coronavirus Pneumonia;
Muscle pain; This is a spontaneous report from a contactable consumer(patient).A 77 (unknown units) old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number : not provided), via an unspecified route of administration on an unspecified date Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date Feb2021, Patient experienced muscle pain. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine yesterday (at the point of this report) and when he filled the consent form, he read that you should mention your HCP if you are immunocompromised or are on a medicine that affects your immune system before receiving the vaccine, this list included steroid medications. At that time, he was not using this medications however he has an appointment with his doctor scheduled today about a problem he has in his hand and usually he receives a steroid injection to treat this condition. He would like to know if the steroid shot will affect the vaccine he received. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
I first noticed a slight rash around 8 PM when I undressed to take a shower--it was on the left of my navel. It could have been there before that but no way I would have noticed before undressing. Today 4-1-21 on arising I see it has spread to the right side of my navel and a bit upwards in the center between my breasts. Also on my forearms. Not itchy, and not very red, just pink and patchy with some unaffected areas within its perimeter. I have no other symptoms besides a sore arm at the location of the shot. I have not sought treatment yet as I see posts online that rashes are a side effect known, and it is not uncomfortable and no other symptoms.
pt recv vax; apap given following vax; exp sz lasting undetermined amt of time; T 105;tepid baths given; ear infect dx on 20aug95; tx w/ atbs
Chills, fever, muscle aches, fatigue, headache. Minor soreness in arm where injection was given.
HISTORY: (1) November 27, 2018 called the eye Dr. - Horrible Headaches - Left eye was drooping - (also called Retina Dr) (2) November 28th : Went for eye check up - Dr suggested testing -  prescribed: Valtrex, Neurontyn, + topical Durezol drops. (3) November 29th : Pain increased - double vision starting - eye drooping further - went to Emergency Room at Medical Center. They suggested CT scans and MRI. (CT scan had already been done the day before) came back normal. (4) December 3rd : office visit with Dr - he tentatively diagnosed 3rd cranial nerve palsy - (5) December 5th 2 MRI's were done, they came back normal - (no growths or tumors.) (6) December 7th office visit with Dr - his diagnosis was : Pupil Sparing non compression partial third nerve palsy. (A) Continue with Neurontin - ( times per day). (B) Put patch on the eye glasses to aid with double vision. (7) December 17th Dr suggested neuro ophthalmologist visit. (8) January 3rd office visit with Dr, neuro othamologist he agreed with Dr's diagnosis-+ suggested a timeline of 3-6 months for spontaneous recovery. (9) Condition lasted for 3 1/2 months til March 11, 2019-> eye not 100% yet. Doctors mentioned in the previous page time line are: (1) Eye doctor (office visits were on :) 11/28.2018 11/30/2018 12/03/2018 12/07/2018 12/17/2018 Jan 3, 2019
infected with COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (infected with COVID 19) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced COVID-19 (infected with COVID 19). At the time of the report, COVID-19 (infected with COVID 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant follow up received - Patient demographics, suspect product details and event details were updated.
some of the liquid spilled from the needle,  did not receive the full dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2022, the patient received the 1st dose of Shingrix. On 4th April 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: The reporter stated that they were administering a first dose of Shingrix to a patient and when he went to administer the reconstituted vaccine, some of the liquid spilled from the needle and was not administered. The reporter was not sure if the syringe was screwed on correctly but he stated this one came ready from the packaging and did not have to change the needle. The reporter believed the patient did not receive the full dose although he does not know how much was administered or left over. Reporter stated there was no accidental exposure as the medication sprayed onto the floor not the patient or himself. The reporter did not consent to follow-up. Additional Supportive Information: The reporter believed the patient did not receive the full dose, which led to accidental underdose.
pt vax hepta B. pt ex light-headedness, chest pressure, vomiting 30 min aft first dose. sx remitted spont. no other doses admin.
This case was reported by a pharmacist and described the occurrence of viral illness in a 20-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 15 January 2008, the subject received 1st dose of TWINRIX (1 ml). Six days after vaccination with TWINRIX, on 21 January 2008, the subject experienced influenza-like symptoms, low grade fever, headache, nausea and vomiting. The subject's mother had contacted the primary care physician and stated that the physician believed that it was a viral illness. The mother questioned whether the events could have been caused by the TWINRIX. At the time of reporting, the outcome of the events were unspecified. Follow-up received via the pharmacist on 20 February 2008. She reported that the events resolved and she considered that they were not serious. It was also noted that the vaccination series was going to be delayed as the subject wanted to wait until summer to continue. She noted that the events were possibly related to the use of TWINRIX.
Pt states that she began to feel pain in her left deltoid, as well as intense itching which began on 6-11-16. Pt presented with an induration 30 mm in diameter on her left deltoid. Pt still complained of pain and itching at this site on 6-23-16.
[ Pfizer Covid-19 vaccine ] treatment under Emergency Use Authorization(EUA): pt experience numbing in hand of injection site on day of injection of dose one then experience numbing again three weeks later (before the second dose).
05/05/200 Received call from mother at 08:15 AM stating that left IZ site swollen, which expected but with pain under arm - armpit and left side of chest.  Just to call primary care physician.
Redness, Swelling at site of injection and distally approx. 7 inches.
Patient became dizzy, had heaviness in her limbs, was pale,had blurred vision - none of these symptoms improved, so 911 was called.
Pt feeling weak in observation area while sitting down after vaccine administration. Pt slowly lowered to ground by clinical staff,911 called lost consciousness for less than 2 mins aprox., pt afterwards aaox3, ambulance arrived, transported to ER
Severe Dizziness; cold extremities; Nausea; vomiting; headache; This is a spontaneous report from a contactable consumer (patient).  A 73-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 28Feb2021 15:30 (Lot Number: Not reported) as single dose for COVID-19 immunization.  Medical history included medication for high blood pressure from an unknown date. Concomitant medication(s) included Verapamil, Fenofibrate; acetylsalicylic acid (ASPIRIN) and multi-vitamin. No known allergies had been reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021 23:00, the patient experienced severe dizziness, nausea, vomiting, headache and reported about cold extremities with sudden onset. The patient went to doctor or other healthcare professional office/clinic visit for these events. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID-19. No corrective measures were taken for the reported events. The event outcome was reported as unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Took Janssen shot back in 05/15/2021, got the shot around 10am and by 11pm all the feelings of covid were present. Took pfizer at 11:30 on 08/16/2022, something happened. By 9pm that same night all symptoms of covid had been present. Throughout both nights,  there was lack of sleep, muscle spasms, headache, night sweats, fever, cold chills, and feeling of burning up. Both times told no one had issues with each shot. Yet in these 2 cases, both times felt as if covid had taken over. Even though negative for covid.
12NOV around 430 or so devel fever, cold sx, runny nose, turned pale & weak; mom states had 3 episodes of above; next day 13NOV 2PM & again @ 7PM; went to MD between two episodes; MD call reaction shock collapse;
benign muscle facilitation/ constant muscle twitches at my calf's and lower Quadricep muscles.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for Covid-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset Feb2021, outcome "not recovered", described as "benign muscle facilitation/ constant muscle twitches at my calf's and lower Quadricep muscles."  Additional information: It was reported that patient diagnosed with benign muscle facilitation since receiving covid vaccine in Feb2021. Since from second injection, patient experienced constant muscle twitches at calf's and lower Quadricep muscles. Patient never experienced anything like this prior to the vaccine and symptoms started the day after second injection. The frequency of these muscle twitches has not changed since Feb and don't seem to be regressing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hives on lt arm w/in 10 mins; puffiness of eyes p/exercise; 90 mins closed in feeling of chest throat scratchy, voice hoarseness in 90 mins this lasted 1 hr & then felt better; hives went away in about 2 hrs;
Symptoms: Tingling, numbness, and weakness beginning in the lower extremities and spreading upwards up to and including the face. Extreme muscle weakness, difficulty walking. Symptoms similar to those previously experienced with severe allergic reaction to insect stings, for which the patient has allergies documented by bloodwork.   Time course: symptoms emerged in the first 5-10 min after the injection. Sensation to the face and upper torso began to fade in one hour, however symptoms persisted until several hours into administration of prescription antihistamines.   Treatment: approximately 1 hour and 15 min after the injection, the patient self-administered 25 mg hydroxyzine, every 12 hours for 3 days.
Moderna COVID-19 Vaccine EUA 4/7/2021 pain, swelling, pink by 7:45pm on right arm.  All initial symptoms gone in 4 days 4/14/2021 New redness and heat noticed at 7:40 pm.  This spread from vaccine area down right arm to just above elbow.  Redness and heat gone by 4/22/201 5:30pm.
pt recv vax 1MAY97 & pt exp hives @ the inj site 2 days later on 3MAY97;
swelling on the left arm; Hardness; Redness; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (swelling on the left arm), INDURATION (Hardness) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling on the left arm), INDURATION (Hardness) and ERYTHEMA (Redness). At the time of the report, PERIPHERAL SWELLING (swelling on the left arm), INDURATION (Hardness) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drugs were not provided concomitant drugs were not provided.
SOB, feeling hot. Started 5 minutes after injection, lasted a few minutes. Did not recur with second dose.
Systemic: blisters around lips and dark and purple lips-Mild, Additional Details: patient states he started getting blisters around his lips and lips started to look darker and more purple. Patient experienced this up to 3 weeks post injection. No issues breathing
Regarding for Health on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
permanent pain on her fingers/on her feet, particularly toes and ankles; Permanent pain on her feet, particularly toes and ankles; permanent pain on her fingers with difficulty to bend them; Gain of weight (suddenly and quickly); Permanent headache; Permanent fatigue; Memory issues; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), at the age of 49 years old, dose 2 via an unspecified route of administration in left arm on 23Jul2021 at 12:00 (Lot Number: FA6780) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history was none. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. The patient previously received BNT162B2, dose 1 via an unspecified route of administration in left arm on an unspecified date at 12:00 (Lot Number: EW0196) as single dose for COVID-19 immunisation. The patient did not receive other vaccine in four weeks or other medications in two weeks. The patient experienced permanent pain on her fingers with difficulty to bend them. Huge pain and struggle when she had to put pressure (e.g., opening a bottle or opening doors with keys). Permanent pain on her feet, particularly toes and ankles. Gain of weight (suddenly and quickly). Permanent headache. Permanent fatigue. Memory issues. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment received. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 78-year-old female patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix. In June 2018, 1 day after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced muscle pain, localized erythema and pain upon movement. On an unknown date, the outcome of the muscle pain and fatigue were recovered/resolved and the outcome of the localized erythema was not recovered/not resolved and the outcome of the pain upon movement was unknown. It was unknown if the reporter considered the muscle pain, fatigue, localized erythema and pain upon movement to be related to Shingrix. Additional details were provided as follows: In early June 2018, the patient received 1st dose of Shingrix. Less than a year after receiving Shingrix, the patient experienced muscle pain close to the injection site. The patient hurt a little bit when she raised her arm up and around. The patient also experienced redness close to the injection site, that quickly disappeared. The patient also felt wiped out with fatigue on the following day after receiving the injection with both injections. The patient said that her symptoms were not exactly where she got the injection, but slightly below, like three inches below her band aid from the shot. For tolerance to 2nd dose refer linked case US2018149464. This case has been linked with US2018149466 and US2018GSK153538, reported by the same reporter.
Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and felt numb and swollen. A few minutes after that began, the back of my throat was scratchy. I took Benadryl 30 minutes after symptoms began and within 45 minutes all symptoms resolved. 7 hours following the Benadryl dosing, the symptoms returned. I took another dose of Benadryl. The symptoms resolved and did not return.
Patient developed a "faint" while sitting down about 1 min after (2) immunizations. Fainted lasted about 10 seconds and pt had shaking (? seizures) of head on awakening. Lasted about 5 seconds.
I slept all day the next day after taking the 3rd dose. On 10/14/2021, I was shivering a lot. I was nauseous and I vomited multiple times. I went to Urgent Care. I did a rapid test, which was negative. I was sent to the ER. I took some tests. I was given medication for the nausea and received some treatment.
No additional AEs or PQC reported; PROQUAD was administered after temperature excursion; This spontaneous report as received from a medical assistant refers to a 2 year old male patient with no illness at time of vaccination or pertinent medical history. On 02-JAN-2023, the patient was vaccinated with the first improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (lot # W029552 exp date dose 14-MAR-2024) (dose not reported) subcutaneously in the right leg at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2302USA001040: US-009507513-2301USA001095: