chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious report of fluid in both eyes, rash, fever, pain in head and pain in abdomen has been received from a consumer, patient's mother, concerning an eight-year-old female subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on Oct-2009. She received a total of one dose of FLUMIST before the onset of the events. The night after receiving FLUMIST, on 07-Oct-2009, the patient experienced fever 103.4 degrees, pain in head, and pain in abdomen. By the next day, 08-Oct-2009, the patient was covered with spots, had fluid in both eyelids (unable to open eyes fully). The reporter, patient's mother, did not take her daughter to the pediatrician since her pediatrician was not at the office. She spoke with another pediatrician on the phone, and he recommended to use diphenhydramine and cetirizine. Fever, pain in head and pain in abdomen were resolved on 10/09/2009, and fluid in both eyelids and rash were resolved on 10/10 2009.
Within 20 minutes I began to feel heart racing, shaky/jittery - resting heart rate was around 140 per FitBit watch; I was in the 30 minute observation line due to allergies with other medication; staff provided me with 50 mg. of liquid Benadryl - needing to help me hold/bring to lips due to shaking; called on-site medics - noted increased HR, increased BP, conducted EKG ; attempted IV x4; called paramedics for transport to the Hospital - attempted/placed IV but infiltrated; at hospital 6th attempt at IV was successful and provided Saline; PVC's were noted on monitor but EKG was normal; HR remained increased; BP gradually returned to normal; HR decreased but did not return to normal until 24+ hours post-vaccination; released from hospital after about 4 hours of observation
body aches and tiredness but not fever etc.  pain in left underarm (side of shot) - pain still persists.  Pain across upper chest and breast bone area.  pain remains (intermittently) across the upper; body aches and tiredness but not fever etc.  pain in left underarm (side of shot) - pain still persists.  Pain across upper chest and breast bone area.  pain remains (intermittently) across the upper; body aches and tiredness but not fever etc.  pain in left underarm (side of shot) - pain still persists.  Pain across upper chest and breast bone area.  pain remains (intermittently) across the upper; body aches and tiredness but not fever etc.  pain in left underarm (side of shot) - pain still persists.  Pain across upper chest and breast bone area.  pain remains (intermittently) across the upper; This is a spontaneous report from a contactable consumer or other non hcp (Patient) via a regulatory authority.  A 57-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Apr2021 10:45 (Age at vaccination: 57-year-old) as dose number unknown, single for covid-19 immunization. Medical history included slight reflux and Dry eyes both from an unknown date. Concomitant medication included sertraline hydrochloride (ZOLOFT), ciclosporin (RESTASIS), pantoprazole all taken for an unspecified indication. patient did not receive other vaccine in four weeks. Patient had no covid prior vaccination. It was reported that on 20Apr2021 02:00, patient experienced body aches and tiredness but not fever etc. pain in left underarm (side of shot) pain still persists. Pain across upper chest and breast bone area. Pain remains (intermittently) across the upper chest. Winded but not hard to breath and not short of breath. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested for covid post vaccination. Therapeutic measures were taken as a result of events with Advil 2 tablets 2xs day for 7 days. The outcome for the events was unknown.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
AS SOON AS VACCINE WAS ADMINISTERED, CHILD'S MUSCLES, LIMBS STIFFENED UP FOR A FEW SECONDS, LOOK SEIZURE LIKE, NURSE YELLED FOR DR AND CHILD CAME OUT OF TRANCE.
I don't know whether this is coincidence or an adverse event secondary to vaccination. On July 24, 07 I received an injection of Shingles vaccine. On the morning of July 27 or 28 I had premonitory pain around my right lower rib cage. The morning of July 31st I had a rash typical of shingles in the same distribution on the right.
Behavioral changes; scratch; weakness; localized redness, arm; Swelling of arm; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 6-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included MMR (received MMR vaccine on an unknown date in 2019) and Varicella (received varicella vaccine on an unknown date in 2020). Concurrent medical conditions included neurogenic bladder.   On 23rd March 2021, the patient received the 1st dose of Kinrix (intramuscular) .5 ml, Kinrix Pre-Filled Syringe Device and the 1st dose of Hepatitis B vaccine. In March 2021, 2 days after receiving Kinrix, Kinrix Pre-Filled Syringe Device and Hepatitis B vaccine, the patient experienced erythema of extremities and swelling arm. In August 2021, the patient experienced weakness. On an unknown date, the patient experienced behavior abnormal and scratch. On an unknown date, the outcome of the erythema of extremities, swelling arm, weakness, behavior abnormal and scratch were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, weakness, behavior abnormal and scratch to be related to Kinrix, Kinrix Pre-Filled Syringe Device and Hepatitis B vaccine.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR037928, US2022AMR037929  Additional details were provided as follows: The reporter was the mother of the patient.  The patient had not received any prior vaccinations prior to this with the exception of MMR in 2019, and Varicella in 2020. She stated that her daughter received her first dose of Kinrix in right arm. The patient also received Hepatitis B vaccines (undisclosed manufacturer) at the same time as the Kinrix vaccinations.   Approximately 2 days after the first vaccination, the patient experienced localized redness and swelling of her arm.  The patient also self inflicted scratches to both arms and made herself bleed. The reporter stated that between 4 and 6 months after vaccination she had noticed that her daughter experienced weakness since August 2021 (had an MRI in November 2021). On an unknown date, less than 5 months after vaccination with 1st dose of Kinrix the patient experienced behavior abnormal and scratch. The reporter gave consent to follow-up with health care professional. Note: it was stated that the patient experinced weakness in Aug 2021 and patient received 2nd dose on 3rd Aug 2021, hence weakness was coded as event in this case conservatively. For tolerance of 2nd dose refer case US2022AMR037928 and for tolerance of 3rd dose refer case US2022AMR037929.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022035983:FU1- Deleted US-GLAXOSMITHKLINE-US2022AMR037928:Same reporter, same patient, different dose US-GLAXOSMITHKLINE-US2022AMR037929:Same reporter, same patient, different dose
Severe abdominal cramping that lasted for hours with vomiting and dry heaving. Headache and neck stiffness. Symptoms appear resolved as of 4/14/21 at 8 am.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX. On 26th December 2017, the patient received SHINGRIX. In December 2017, 12 hrs after receiving SHINGRIX, the patient experienced fever, myalgia and general body pain. On 27th December 2017, the patient experienced feels awful. In December 2017, the outcome of the feels awful was recovered/resolved. On 28th December 2017, the outcome of the fever, myalgia and general body pain were recovered/resolved. The reporter considered the fever and myalgia to be unrelated to SHINGRIX. It was unknown if the reporter considered the general body pain and feels awful to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist was the patient. The age at vaccination was not reported. On 27th December 2017, the patient woke during the night with fever, myalgia and severe body aches. On 27th December 2017, 1 day after vaccination, the patient felt terrible for about 12 hours and then symptoms resolved on their own. The hospital or physician's intervention was not required. The pharmacist called from home on her day off, so lot and expiration date were not available.
Vaccine 8/27/09 8/29/09 Urticaria swollen eyes, nose, lips.  Given EPINEPHRINE 0.15 mg IM and BENADRYL 12.5 mg orally.
Chills, shaking, sweats, nausea, abdominal pain, vomiting and hemorrhagic diarrhea from 1:30-4 am 12/18/2022.  I was so sick from being sick all that time, that I missed the bed, fell into the bed frame and fractured my 9th rib on my right side. hit my right arm and bruised my left leg.  I am recovering but still have pain and additional pain from compensating.  I also had extreme fatigue for two days after.
Within hours very painful where shot was given, the next morning swelling redness went to work by that night sick to my stomach pain was awful couldn?t sleep couldn?t touch my arm, had to use left arm to move right arm.  Called doctors on 03/17/2020 got me in immediately, blood pressure very low excruciating pain in arm numbness , right hand was white and cold to touch they put me on Keflex.  No improvement getting worse on  03/19/2020 called doctors my regular doctor was in, got me in right away blood pressure very low no sleep going on 4 days right hand ice cold numb tingling whole right side cannot use.  Diagnosed me with brachial nerve neuritis.  Put me on Prednisone.  I have Currently one day left on medication, still have some issues with arm but doing excersises to help going to attempt back to work on 03/30/2020.
This spontaneous report was received from a currently 68-year-old female patient of who was reporting on herself. The patient's concurrent conditions included high blood pressure and allergy to tetanus vaccine (details were not reported). The patient's medical history included shingles from which she recovered before vaccination with ZOSTAVAX. The patient reported that on an unknown date "before 25-JUL-2013", she had contact with shingles. On 25-JUL-2013, the patient was vaccinated with ZOSTAVAX, subcutaneously "as a booster" for prevention for herpes zoster dose (lot number, expiration date and anatomical location were not reported). Concomitant therapies inducted many unspecified medications. On an unknown date, the patient experienced shingles. The patient also reported that her current case of shingles gotten in her eye and she could not breathe and write anymore (onset dates of the events and details were not provided). The patient sought medical attention and was seen by her physician on an unknown date. On an unknown date, the patient was hospitalized and received an unspecified treatment for the events. During her hospitalization, the patient was taken off an unspecified medication. There were no laboratory tests performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of herpes zoster ophthalmic was considered to be medically significant. Additional information has been requested.
Redness and swelling of arm; Redness and swelling of arm; Headache; Chills; This is a spontaneous report from a contactable nurse (patient's mother) reported for son. A 15-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left upper arm on 13May2021 07:20 (Batch/Lot Number: EW0167) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Patient received dose 2 via an unspecified route of administration, administered in right arm on 03Jun2021 07:20 (Batch/Lot Number: ER8736) as 2nd dose, single. Medical history included patient is immunocompromised and oral steroid dependent due to asthma and adrenal insufficiency, ongoing Hypothyroidism Diagnosed about 10 years ago, ongoing Acid reflux Diagnosed since birth, ongoing Adrenal insufficiency Diagnosed about 2 years ago, Asthma Diagnosed since birth, ongoing allergies Diagnosed since birth/infancy, ongoing Pseudotumor cerebri since 2015. Concomitant medications include acetazolamide sodium (DIAMOX) taken for Pseudotumor cerebri from 2015 and ongoing, fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma about 8 years and ondoing, Fluticasone taken for asthma about 4 years and ongoing, Budesonide for Sinus rinse from sinus surgery care about eight years and ondoing, Hydrocortisone for adrenal insufficiency since 16May2021 and ongoing, lansoprazole (PREVACID) taken for acid reflux since 2006 and ongoing, levothyroxine sodium (SYNTHROID) taken for Autoimmune hypothyroidism hashimotos and ongoing. Patient experienced pretty big redness and swelling of arm on 14May2021, and got worse about 2 weeks later, which was odd, like a delayed response. Had headache on 13May2021 around 14:00, lunch and took two regular strength Tylenol and drank water. Classifies as medically significant since patient had to miss two days of school. Other symptoms went away after 24 hours like the chills and normal vaccine symptoms, headache. His blood pressure and all vitals were all normal. The outcome of redness and swelling of arm was recovering but still has faint bruising color, other events outcome was recovered on 14May2021.   Information on the lot/batch number has been requested.  Follow-up (03Jun2021): New information reported from a contactable nurse (mother) includes: removed event "15 years old patient received t vaccine", add events "headache", "chill", "redness and swelling of arm". Case upgrade to serious.
This spontaneous report as received from a medical assistant refers to an approximately 67 year old male patient with drug allergy to erythromycin and no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on an unknown date. No other co-suspects were reported. There were no concomitant medications. On unknown date the patient developed shingles 18 months later. The patient had sought medical attention via office visit. The treatment with VALTREX, prednisone and TOPICORT were given for the shingles. There were no laboratory diagnostics studies performed. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Had 102-99.5 degree fever for 5 days (2 weeks after shot). Previously had one day of 102-103 degree fever 5 days after shot.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0186) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog". Additional information: Both her vaccines were the same LOT numbers. Had severe brain fogs after the vaccines. With the first vaccine, the brain fog went away after the first night. But it came back after the second vaccine and she is now having cognitive problems. After the second vaccine, she didn't feel good for a couple of days. On the fifth day, she stood up and completely fell over. Ever since then she been recovering. She fell over on 12Sep2021. Received the second dose on 07Sep2021. Due to AE patient experienced after receiving vaccine, it was suggested to her that she could've gotten a bad batch or something. Her biggest concern is just the LOT. She was really terrified that she may have had something different than everyone else.
On the day following his vaccination, he experienced body aches and possible fever (patient did not check it) lasting about 5 hours.
patient given a dose of Pfizer vaccine that was in the fridge in syringe from the day prior. it had expired at 2030 on 5/19/22 and was administered 5/20/22 around 10 am because the nurse did not check the date on the syringe label and assumed it had been drawn up on 5/20/22 AM. Submitted safety report at facility and contacting pharmacy and nurse education coordinator.
This is a spontaneous report from a contactable consumer, the patient. An 84-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route administration in right arm on 10Mar2021 at 12:00 (at the age of 84-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown the patient allergic to food medication or other product. It was unknown the patient received any other vaccine within 4 weeks prior to the covid-19. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 the patient experienced flu-like symptoms, hoarse voice, weakness, hard to walk. The patient received vaccine on 10Mar2021 and still had some of the symptoms today, that is on 23Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures and treatments were not taken for the reported events. The clinical outcome of the events experienced flu-like symptoms, hoarse voice, weakness, hard to walk were not resolved (still have symptoms today i.e., 23Mar2021) at the time of reporting.  Information on lot/batch number has been requested.
tingling all over body; itching; swelling of upper lip; partial swelling of roof of mouth; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling all over body), PRURITUS (itching), LIP SWELLING (swelling of upper lip) and MOUTH SWELLING (partial swelling of roof of mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA (tingling all over body), PRURITUS (itching), LIP SWELLING (swelling of upper lip) and MOUTH SWELLING (partial swelling of roof of mouth). At the time of the report, PARAESTHESIA (tingling all over body), PRURITUS (itching), LIP SWELLING (swelling of upper lip) and MOUTH SWELLING (partial swelling of roof of mouth) outcome was unknown.            Upon in internal review on 24 May 2021, the age was corrected to unknown age.  Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications were not reported.  Treatment information in response to events was not provided.
Appointment was at 1:30 pm on 4/13/2021 but was seen by nurse and received vaccine at 2:00 pm on 4/13/2021. All was well until Saturday 4/17/2021 at 3:00 am when my body broke out in hives. I took a generic loratadine 10 mg around 3:30 am and by morning it subsided. No other symptoms until 4/18/2021 when hives returned at 7:00 am but it was not as widespread or as severe and I was too sleepy to get up and do anything about it. It went away.  Around 8:30 pm I felt body aches and fatigue but no fever. Did not take anything and the symptoms dissipated.
Localized redness x4 days starting the day after vaccination. Told pt to call MD 8/30.
i developed white lesions all over my body (which was diagnosed as vitiligo--autoimmune disorder); sudden traumatic mental shock; have lost my smile/confidence; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 at 13:00 as dose 2, single (Lot number: EL3247) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL0142,, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM), administration date: 04Jan2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: PSYCHIATRIC SYMPTOM (disability) with onset 25Jan2021, outcome "not recovered", described as "have lost my smile/confidence"; VITILIGO (disability) with onset 25Jan2021, outcome "not recovered", described as "i developed white lesions all over my body (which was diagnosed as vitiligo--autoimmune disorder)"; MENTAL DISORDER (disability) with onset 25Jan2021, outcome "not recovered", described as "sudden traumatic mental shock". Therapeutic measures were taken as a result of vitiligo, mental disorder, psychiatric symptom.  Clinical course: I developed white lesions all over my body (which was diagnosed as vitiligo autoimmune disorder). I do not have family history of this. My overall health prior to vaccine was excellent. These lesions spread rapidly. This affected me very badly in such a way that I avoided going outside, public meeting/social contacts, hiding the lesions by wearing long sleeves/dresses. This was a sudden traumatic mental shock to me. I was a very cheerful person before but have lost my smile/confidence since then. Sometimes I feel like I would have preferred dying with corona instead of taking this vaccine. The patient was undergoing phototherapy. No COVID prior vaccination. No other vaccine in four weeks and no other medication in two weeks.
PT WAS ADMINISTERED 0.2 ML (OF A 0.3 ML DOSE) DUE TO SYRINGE MALFUNCTION. BASED ON  RECOMMENDATIONS, PT WAS NOT REVACCINATED
Patient received vaccine at 12:22 pm on 3/4/21 and was initially feeling well. Patient was waiting out her 15 minute observation period and between 10 and 15 minutes after vaccination started feeling warm and like she was going to faint. Patient sat down and elevated her feet, drank water, and used wet cool cloth on face and started feeling better. Patient is approx 12 weeks pregnant.   Checked blood pressure. First reading was 113/72. Second reading was 110/70. Patient stated that this is a normal blood pressure reading for her. Monitored patient for approx 1 hour from time of vaccine. Walked around facility to monitor for any further symptoms upon standing. Patient was asymptomatic after initial episode.
CNS POSTURE ASSUMED, KICKING AND TIPPING HEAD BACKWARD EVERY 5-10 MINUTES FOR FIVE HOURS
runny nose - symptoms started approximately 8 p.m; diarrhea - symptoms started after 9:30 p.m. chills and fever - symptoms started after 10:00 p.m. used inhaler for breathing troubles - first known inhaler use 7:00 a.m. currently sleeping with bouts of chills and fever. time 8:45 a.m. has not gone to doctor or medical facility yet. Requesting to just get warm.