chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reports stopping xeljanz xr for 1 week in Jul as directed for covid/coronavirus booster (date unknown). while off for booster he tested positive for covid/coronavirus (date unknown).; reports stopping xeljanz xr for 1 week in Jul as directed for covid/coronavirus booster (date unknown). while off for booster he tested positive for covid/coronavirus (date unknown).; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "reports stopping xeljanz xr for 1 week in Jul as directed for covid/coronavirus booster (date unknown). while off for booster he tested positive for covid/coronavirus (date unknown).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he tested positive for covid/coronavirus (date unknown). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: patient reports stopping xeljanz xr for 1 week in Jul as directed for covid/coronavirus booster (date unknown). while off for booster he tested positive for covid/coronavirus (date unknown). off xeljanz xr for month of Jul. unable to determine change in arthritis symptoms due to being sick with covid/coronavirus. date unknown as to when patient resumed xeljanz xr and/or if change in symptoms after resuming. reports feeling better. still has lingering productive cough. no additional information/details or dates were provided by the patient.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Injection site reaction - vaccination administered high on the arm to avoid scar tissue. Inflammation and slight scarring occurred after.
Gave lyophilized powder only to a child; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a child patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Gave lyophilized powder only to a child) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-AUG-2023 The vaccine administration facility was the same as primary reporter. The reporter said that he/ she was not sure if it was reconstituted with normal saline water, but it had to be reconstituted with something other than what was supplied buy Menveo. The patient was gave with lyophilized powder only to a child, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No additional information provided and unknown if follow up is permissible.
varicella type rash; low-grade fever; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant medication was not reported. In or around 28-JAN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a varicella type rash on her body and a low-grade fever. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events varicella type rash on her body and a low-grade fever was not recovered. The lawyer considered varicella type rash on her body and a low-grade fever to be related to zoster vaccine live (ZOSTAVAX).  The lawyer considered the events varicella type rash on her body and a low-grade fever to be disability.
Intense back pain that confined me to my bed. Doctors told me to take Nsaid and my prescription muscle relaxant Flexeril.
Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PALPITATIONS (Palpitations). On 16-Jan-2021, PALPITATIONS (Palpitations) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Arthralgia, Fever, NauseaVomiting ,dyspnea Narrative:
Day of vaccine: swelling and blister at injection site. 5 days following injection, she developed urticaria and swelling of posterior calves bilaterally. Rash limited to calf area only. Progressed to a symmetrical vertical linear erythematous dermatitis, consistent with phlebitis or lymphangitis. Remained very tender to touch. Also chest "heaviness", headaches, and fatigue.
pretty sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR142042   Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comments:  The reporter stated that it was a little bit of a rough shot, but way better than getting Shingles. The patient did not get covid or flu shots of course they would vary from person to person. The patient was pretty sick after 1st shigles shots, but the patient heard, getting shingles was considerable worse and recommend getting the shots. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR142042; Sender's Comments:  US-GSK-US2022AMR142042:Same reporter
Information has been received from a healthcare worker referring to a 42 year old female patient. No relevant medical history or concurrent conditions were reported. On 24-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Got her vaccine with no problem, got her vaccine and felt dazed as she was going to the waiting area.  She was anxious and then started feeling heaviness in her chest.  She felt dazed, nothing registered and was not focused on anything, and sat for 25 minutes.    She then got up and walked to the car, felt like she was in the clouds and her right lung was really, really bothering her by the time she got home and tired.   Her heart rate was 140 and very fast.  She didn't feel as if she was anxious but just blaise.   She was really winded and exhausted by the time she got home.  She had not eaten before she got the vaccine, made herself a sandwich and fell asleep and slept for about 3 hours.  When she woke up she had a very, very sore arm.  Then on Saturday, she woke up around 3:00 AM, and could not go back to sleep as she was wide awake.  Then every task that she did just exhausted her and still felt heaviness in her chest and back and the right lung was really bothering her like she had worked like an animal for a period of time.  She has a small apartment and it doesn't take any energy to walk to the kitchen.  Saturday she felt fine, was cleaning and felt good.  Sunday she slept all day and her right lung was still hurting her.  Yesterday was still exhausted and winded feeling.  Today, 3/16/21 she is still feeling the same way and exhausted doing simple tasks.  She has a nodule in her right lung and several spots in her left lung but nothing is being done for them.  The vaccine seems to have exacerbated the symptoms and made them worse.  The injection site is a little sore but nothing out of the ordinary for a vaccine.  She took two Advil for her symptoms which did help as she had pain in her head with this which will last for 5-10 minutes and then goes away.  She has notified her doctor and she has an appointment on Friday at 11:00 AM.
nurse, stated she just gave a Pentacel vaccine that was 1 day expired (with no reported adverse event); Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old male patient and Nurse stated she just gave a Diphtheria/Tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] vaccine that was 1 day expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ (pneumococcal conjugate vaccine), Rotavirus Vaccine and Hepatitis B vaccine, all for Immunisation.  On 28-APR-2023, the patient received a dose of 0.5 mL (dose 2; 1x) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] suspension for injection (batch/lot number: UJ673AAA and expiry date: 27-Apr-2023; frequency: once; strength: standard) that was 1 day expired via unknown route in the left thigh for  Prophylactic vaccination (immunization), with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fussiness, smiling less per mom (although smiling on exam) crying intermittently.
Within a few minutes of receiving the shot while seated in waiting chair my left hand started to feel numbness and i felt faint.  The attendant at the center noticed and had me move to the tent.  I was actively passing out and the physician had me drink Benadryl.  I recovered in the tent but still had numbness in my left hand.  Over the next few hours my left arm became more numb.  My left arm stayed semi numb especially distally for 10 days.  Both of my feet also started having numbness to the point that from my toes to halfway up my foot they became discolored grey, cold and numb.  Then my heart started to have issues: racing, weird fluttering, shortness of breath.  My physician called in my condition to vaers/cdc .  I did not realize that I had to also report on the Vaers until now so that is why reporting now.  Even now my finger tips are numb, my feet go numb about every other day and my heart races and I have shortness of breath.
Right Axillary Lymphadenopathy; Difficulties raising right arm above the head with associated swelling discomfort; Difficulties raising right arm above the head with associated swelling discomfort and difficulty expanding the lungs to breath and; Difficulties raising right arm above the head with associated swelling discomfort; difficulty expanding the lungs to breath; difficulty expanding the lungs to breath; right side chest discomfort; This is a spontaneous report from a contactable other hcp. A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FF2589), via an unspecified route of administration, administered in Arm Right on 07Sep2021 13:30 as DOSE 2, SINGLE (at the age of 41-year-old) for covid-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously took avelox and experienced drug hypersensitivity, biaxin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received dose 1 of bnt162b2 on 10Aug2021 03:30pm, Lot number: EW987. On 08Sep2021 02:15, the patient experienced right axillary lymphadenopathy within 13h of vaccine administration, difficulties raising right arm above the head with associated swelling discomfort and difficulty expanding the lungs to breath and right side chest discomfort. AE resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Myalgia & Fever Narrative:  body aches, chills, ears hurt, temp recover on 1/27
pt recvd vax & devel pain on inject; 2 days later devel abdo cramping, constipation & clay colored stools;
Information regarding PREVNAR was received form a consumer regarding a 5-month-old male patient who experienced multiple seizures. The patient received the first dose on 16-Dec-2008. The patient also received the first dose of TRIPEDIA (Connaught Medical Research Laboratories) on 16-Dec-2008. On 18-Dec-2008, 48 hours post-vaccination, the patient experienced multiple seizures characterized by cyanosis and unresponsiveness. The child was hospitalized where he experienced several more episodes of "staring and not responding to anything". Treatment included phenobarbital and evaluation from neurologist who commented, "This type of thing has been seen with pertussis". Further continuation with the vaccine schedule has not been determined. The outcome of the event was unknown. No additional information was available at the time of this report.
Dose administered out of schedule: 3rd dose administered 9 months after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered out of schedule: 3rd dose administered 9 months after 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 068G21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Multiple sclerosis since 1990, Allergy to antibiotic (Augmentin), Drug allergy (Bactrim) and Seasonal allergy. Concomitant products included BACLOFEN and OCRELIZUMAB (OCREVUS) from 20-Oct-2021 to an unknown date for Multiple sclerosis.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered out of schedule: 3rd dose administered 9 months after 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered out of schedule: 3rd dose administered 9 months after 2nd dose) outcome was unknown.            Other vaccines given within 1 month prior to Moderna COVID-19 vaccine  was unspecified pneumonia vaccine 2 weeks before the infusion. Multiple sclerosis was worsening and hence, she got Ocrevus infusions on 20Oct2021.  No treatment details were provided.   This case was linked to MOD-2022-477957, MOD-2022-477945 (Patient Link).
1 Days following vax, the pt developed hives and flu like symptoms. It was reported to the MD who told the pt the reaction was related to the flu vaccine. The pt had hives with a prior vaccine in 1999.
After being vaccinated, patient began to experience numbness of the tongue that later extended to the throat.
Sharp pain from left shoulder down to elbow at time of injection. Unable to lift arm up or outwards. Pain continued to increase throughout the evening. Placed call to doctor's office following morning. Told to ice and use ibuprofen. Pain continued into Thursday and contacted doctor's office for appt. which was scheduled for 6:30 p.m. on Aug 25, 2016. Doctor checked with infectious disease to see if there were any reports of similar symptoms and none had been reported. We were instructed to use ALEVE starting the next morning 8/26/16. The ALEVE was used for a full day and did not help. Went back to 3 doses of ADVIL each day and continued with ice. On Monday a call was placed to the doctor's office to report the continued symptoms and were referred to Pediatric Neurology for an appt. on 8/30/16. Following appt with Neurology it was determined there was no nerve damage and that patient should receive Physical Therapy and be placed on a non-steroid anti-inflammatory med Diclofenac for 10 days. PT was scheduled for 8/31/16 and the new medication was taken on 8/30/16.
KIND OF LIKE COLD SYMPTOM; SEVERE CRAMPING IN LEFT FOOT THAT WAS GONE OVERNIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the patient experienced kind of like cold symptom, and severe cramping in left foot that was gone overnight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from kind of like cold symptom, and severe cramping in left foot that was gone overnight on MAY-2021. This report was non-serious.
Had 1st dose on  2020,  need to repeat  or just get 2nd?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comment: The patient reported this case via interactive digital media. The patient asked did he/she need to repeat 1st dose or could he/she just get 2nd dose now. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. The follow-up would not possible, as no contact details were available.
Patient called to report back muscle pain and spasms as she left the store and got in her car that lasted 15-20 minutes, but is fine now. She also reported severe soreness along her entire arm and shoulder this evening. No redness or swelling is reported.
side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided
On April 3,2021, dose 1 of the vaccine after couple of hours I started itching. It progressed over during the night. It started looking like hives. The hospital didn't know what to do with me. It started at 6:30PM. I can't even wear any kind of clothes at all. It itched severely. I only wore clothes to go to see my doctor. My doctor gave me medication which are Atarax 10mg every six hours 1-4 tablets, I was taking Claritin which really saved my life. 10 days to 2 weeks, my discomfort stopped but it all depended on the medication I was taking.
Pt started crying uncontrollably. Extremely irritated for no apparent reason. Tantrums, screaming, crying during the night. Started jumping out of his crib. The night of the vaccination we gave him Tylenol fever. Developmental and computer test scores dx: autism,PDD< ADHD and hearing loss. Annual follow up on 01/28/04: "The vaccine recipient has not recovered from the adverse events that were reported for this vaccination.  Immediately after vaccines were given pt started crying uncontrollably. Extremely irritated for no apparent reason.  Tantrums, screaming, crying out during the night.  Pt started jumping out of his crib.  The night of the vaccination we gave him Tylenol. Fever.
Hives on face and neck, Swollen lymph node in armpit under left arm. Both continued for 7 days and resolved on their own