chrisvoncsefalvay/vaers-outcomes huggingface dataset:
with 1st shot - numbness in her whole arm 2 days later for 10-15 minutes.  would occur 2x a week since. with 2nd shot - increasing arm pain and numbness, fingers going numb 2 days after.  occurring almost daily now.  only her left arm is affected
had the 2 shot vaccine / shingles/suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had the shingles vaccine and got the shingles. The patient stated it did not do him/her any good to get vaccinated and he/she got shingles anyway. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 20-NOV-2018, the patient was vaccinated with expired dose of GARDASIL 9 lot # M024261, expiry date: 30-JUL-2018 (dose and route of administration were not reported) for prophylaxis. No adverse symptoms were reported.
graves' disease; thyroid storm; thyroid eye; TIA; heart disease; This spontaneous case was reported by a consumer and describes the occurrence of BASEDOW'S DISEASE (graves' disease), THYROTOXIC CRISIS (thyroid storm), ENDOCRINE OPHTHALMOPATHY (thyroid eye) and TRANSIENT ISCHAEMIC ATTACK (TIA) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BASEDOW'S DISEASE (graves' disease) (seriousness criterion medically significant), THYROTOXIC CRISIS (thyroid storm) (seriousness criterion medically significant), ENDOCRINE OPHTHALMOPATHY (thyroid eye) (seriousness criterion medically significant), TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant) and CARDIAC DISORDER (heart disease). At the time of the report, BASEDOW'S DISEASE (graves' disease), THYROTOXIC CRISIS (thyroid storm), ENDOCRINE OPHTHALMOPATHY (thyroid eye), TRANSIENT ISCHAEMIC ATTACK (TIA) and CARDIAC DISORDER (heart disease) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Very limited information regarding the events has been provided at this time. Further information have been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information have been request.
p/vax seen in ER where a Dx of intussusception made;surgery performed; intussusception & a duplication cyst noted at surgery;cyst resected & pt doing well; Doc 198118 states that report is cancelled.Also reported that follow-up information indicated that the patient received tripedia (PMC USA) not Acel-Immune.
No adverse event; 1st dose on 8-Nov-2021 and 2nd dose on 11-Apr-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 8-Nov-2021 and 2nd dose on 11-Apr-2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis). Concomitant products included ADALIMUMAB (HUMIRA) from an unknown date to 10-Jun-2022 for Rheumatoid arthritis.   On 08-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 8-Nov-2021 and 2nd dose on 11-Apr-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 8-Nov-2021 and 2nd dose on 11-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2022-627944 (Patient Link).
All-over tingling of body while laying down in bed to go to sleep . . . tingling not unlike that felt when an arm or a foot "falls asleep" but much more intense and sharp and almost electrified" in sensation. It did not dissipate but slowly decreased in intensity over the next few weeks. The epicenter of the feeling . . . nerve central . . . seemed to be those couple vertebrae between soldier blades. Sharp tingling sensation continued intermittently and sporadically in various body parts at different times. Back and shoulders and neck were particularly sore.
Localized allergic reaction to left arm. 7-8 cm area of erythema, warmth and swelling. Non tender to palpitation. Pt complained of itching, not pain.
Significant flare up of ulcerative colitis symptoms (extreme diarrhea, gas, bloating, belly pain, bleeding) for about 48 hours after injection. This occurred for all three Covid shots I had. I didn?t associate it with the shot the first time, but after the second and third time it happened it seems clear they are connected as the onset and nature of symptoms were the same in all three cases. Symptoms resolved on their own after about 72 hours. This did not occur with the flu shot that I had about 2 months ago (or with flu shots or other vaccines  previously).
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 23Jan2017; LEVOTHYROXINE, start date: 05Feb2018; also reported as other medication in 2weeks. Past drug history included: Zithromax, reaction(s): "Known allergies: Zithromax". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 15May2022 to 19May2022. Clinical course was reported as, patient experienced Return of sore throat, phlegm and coughing 2 days after completing paxlovid regimen on 21May2022. No treatment received for symptoms and patient Not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a 18-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in June 2016 (reported also as "last monday"), the patient was vaccinated with a dose of GARDASIL 9 (dose, lot#, expiration date, route of administration and vaccination site were not reported). On the same day, the patient received an unspecified meningococcal vaccine (dose, route of administration and vaccination site were not reported). Immediately after vaccination (reported also as "on saturday"), the patient felt very nauseated and had vomiting. The patient received PHENERGAN for nausea. The symptoms subsided 30 hours later (recovered on an unknown date in approximately 2016). The relatedness between the events and GARDASIL 9 was not provided. Additional information has been requested.
Patient admitted to local hospital for diagnosis other than +COVID. + Covid on 8/23/2022. Discharged on 08/28/2022.
Had vaccines Gardasil and Trumenba. Complained of severe pain to right arm. Injection sight of Trumenba.
On April 5th, 2021 I went to the E.D. , for shortness of breath and severe right shoulder pain. While there they got a chest x-ray, ran labs, and did a chest CT. The CT revealed that I had one blood clot in my left lung and two blood clots in my right lung, as well as slight pleural effusion in the right lower lobe. They put me on Xarelto for the next 3-6 months and monthly follow up visits with my primary care provider. I was also given Hydrocodone as need. I experienced extreme pain with breathing and sort of movement for a week and half but currently only have occasional shoulder and back pain usually at the end of the day.
significant amount, huge hives were probably 2 inches in diameter all over her body; hives on her trunk breast little on legs, arms, and hair; A spontaneous report was received from a family member concerning an 80-year old, female  patient who developed hives on her trunk, breast, hair, a little on legs and arms, hives were huge and a significant amount(Angioedema, Urticaria).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 18 Feb 2021, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch number 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb. 2021, the patient experienced hives on her trunk, breast, hair, a little on legs and arms. The hives were huge and a significant amount. They were probably 2 inches in diameter all over her body. The patient took  a 7 days course of prednisone as advised by her HCP. The symptoms went away after finishing a 7 days course of prednisone but returned 2 days after finishing the medication. The patient is currently taking over-the-counter claritin and pepsid as advised by her HCP to help alleviate the symptoms. Treatment for the event included a 7 days course of prednisone, over-the-counter claritin and pepsid.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of events were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 23-MAY-2016, the patient was treated at a medical center, for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
-Swelling, sore throat: lasted about 8 hours, exacerbated by continuous use of n95 mask. -Injection site swelling: so far, started upon injection, has stayed swollen for 3 days. Measures  ~6cm wide, still itching and tender. Redness comes and goes. -Myalgia: Lasted about 4 days, exacerbated by physical nature of job.
1st dose 12Jul2022/ 2nd 27Sep2022/ Shingles 05Jan2023 / suspected vaccination failure; Shingles (light case); This case was reported by a consumer and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 12th July 2022, the patient received the 1st dose of Shingrix (intramuscular). On 5th January 2023, 100 days after receiving Shingrix and 177 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir (Zovirax Tablets). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2023004775, US2023AMR005517   Additional Information: GSK receipt date: 11 JAN 2023 and 12 JAN 2023 Reporters comment: The reporter is the patient. The patient reported that received the 2 dose series of Shingrix vaccine.  The patient stated that both doses were administered in her right at a pharmacy facility.  The patient reported that the episode of Shingles started on 5th January 2023. The patient described it as a light case, was prescribed Zovirax tablets to treat the condition it was not resolved. The patient still had a light case that has dried over but they were not gone. Additional supportive information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. Reporter consented to follow up.; Sender's Comments:  US-GSK-US2023004775:Same reporter / FU1 US-GSK-US2023AMR005517:Shingrix
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19 Clinical course included Paxlovid, 4 days later it has come back full force. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician and refers to a 31 year old, no pregnant female patient who, on 06-JUN-2015 had low immunity to mumps (0.21 units not provided) and low immunity to rubella (3.07 units not provided). On an unknown date in 2015, the patient was vaccinated with a first dose of M-M-R II, subcutaneous, (dose, anatomical location, lot number and expiration date were not reported), shortly after, titers were drawn on an unspecified date (results were not reported). Later, on an unspecified date in 2015, about a month after the initial dose, the patient received the second dose of M-M-R II, subcutaneous, lot number L005291, expiration date 17-FEB-2017, (dose and anatomical location were not reported). On an unknown date in approximately October 2015, the patient had repeat titers drawn which showed her immunity to rubella "came up" but her immunity to mumps "did not improved" (Mumps antibody test negative). The patient sought medical attention but no treatment was given. At the time of the report, the outcome of the mumps antibody test negative was not recovered. The relatedness between the event and therapy with M-M-R II was not reported. Additional information has been requested.
Pt experienced a prolonged seizure and apneic spell. Pt had no problems with previous immunizations.
This spontaneous report was received from healthcare worker and refers to a multiple unspecified patients of unknown age and gender with no pertinent medical history or drug reaction/allergies. On an unknown date, the patients were vaccinated with a doses of GARDASIL (intramuscularly, multiple lot numbers and expiry dates were not reported). There was no concomitant therapy. On an unknown date, immediately following the administration of GARDASIL, the patients complained of pain at the injection site. No treatment was given for the adverse event for the patients and no laboratory test diagnostic was performed. The patients recovered from pain at the injection site (unknown date). Relatedness between pain at the injection site and the vaccination with GARDASIL was not reported. This is one of several reports from the same reporter. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: EW0151) at the age of 57 years, in left arm 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's relevant medical history included: "Hepatitis B" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive for COVID; (May2022) Negative, notes: Tested negative for three days and then symptoms returned; (16May2022) Positive, notes: Fourth days after completing paxlovid, I tested positive again for COVID. Therapeutic measures were taken as a result of covid-19. Report stated that event as non serious. patient did not have any known allergies.
Pt experienced severe abdominal pain, nausea and vomiting and fever. This lasted 10 days.
Urticara over left shoulder, N/V/D, itchy throat, SOB about 8 min after the shot. S/p EpiPen,  diphenhydramine, cetirizine in clinic.  Given additional diphenhydramine in ED. Discharged from ED with EpiPen
Chest pain (myocarditis)  Leg nerve pain in both thighs and calf?s  Hand and wrist weakness  Neck pain
COVID Arm Itchy rash & swelling at injection site No treatment just doing my duty in reporting it.
This spontaneous report was received from a Registered Nurse referring to an adult patient of unknown age and gender. No concurrent or historical conditions were reported. On 09-NOV-2015, the patient was vaccinated with a pediatric dose of VAQTA (lot # K012457, expiration date 04-JUN-2017) 0.5 ml, intramuscularly (anatomical location not reported), instead of the recommended 1.0 ml adult dose. No concomitant medication was reported. No adverse effects were reported. No PQC was involved. This is one of two cases received from the same source. Additional information has been requested.
The right foot has previously been diagnosed as a dropped foot. In the week since the episode, the patient reports sustained improved sensation in the right foot; Intense pulsing pain in her right foot; interfered with her ability to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-2021277060.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: Unknown) at the age of 67 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "spinal fusion" (unspecified if ongoing), notes: Verbatim: 2 x spinal fusion surgery; "Breast cancer" (unspecified if ongoing), notes: Verbatim:2 separate episodes of breast cancer, in remission not in active treatment; "Neuropathy" (unspecified if ongoing), notes: Verbatim:Neuropathy diagnosed in both legs; "cellulitis", start date: 2013 (unspecified if ongoing), notes: Verbatim:2013 cellulitis episode in the right foot. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 ({product=COVID -19, lot unknown=False,, dose number=1}), for covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 04Mar2021, outcome "recovered with sequelae", described as "The right foot has previously been diagnosed as a dropped foot. In the week since the episode, the patient reports sustained improved sensation in the right foot"; PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "recovered with sequelae", described as "Intense pulsing pain in her right foot"; INSOMNIA (non-serious) with onset 04Mar2021, outcome "recovered with sequelae", described as "interfered with her ability to sleep". Therapeutic measures were taken as a result of pain in extremity.  Additional information: A family member received their second dose of Pfizer's Covid-19 vaccine COMIRNATY and began experiencing intense pulsing pain in her right foot 12 hours after administration that interfered with her ability to sleep. Patient administered castor oil and alpine arnica to treat the pain. The pain progressively resolved over the next 24 hours (36 hours post-administration). The right foot has previously been diagnosed as a dropped foot. In the week since the episode, the patient reports sustained improved sensation in the right foot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It started with running nose while I was on a cruise ship. On Wed and Thurs, didn't feel good when I made it home took a COVID home test. I tested a week later results positive. I had a Telehealth phone call for treatment and tested again was negative.
patient's throat swelled up and couldnt breath quite easily. gave epipen and 10ml of benadryl solution. patient was able to breath more easily within minutes
Rash noticed on back, neck and face examined by Dr., Benadryl given 50Mg ice Pack Placed Monitored 30 minutes