chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; rash at vaccine site which is hot, red, itchy; rash at vaccine site which is hot, red, itchy; rash at vaccine site which is hot, red, itchy; rash at vaccine site which is hot, red, itchy; This is a spontaneous report from contactable other healthcare professionals (one was patient herself). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 01Feb2021 at single dose in left arm for COVID-19 immunization at Hospital. Medical history included HTN (Hypertension). No Known allergies. No covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks included valsartan, ibuprofen, multivitamin, vitamin b complex (VIT B COMPLEX). The patient previously took first dose (at 49-year-old) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) intramuscularly on 11Jan2021 03:00 PM at single dose in left arm for COVID-19 immunization. The patient experienced fever, rash at vaccine site which was hot, red, itchy on 03Feb2021. No treatment received for adverse events. No covid tested post vaccination. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
received the first dose of Shingrix on 2018 / have not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 23rd December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix on 2018 and came back today to receive the second one.  Till the time of reporting did not received 2nd dose which led incomplete course of vaccination. Consented to follow up. This case has been linked with case US2020254932, reported by same reporter.   Follow up information was received from pharmacist on 23rd June 2021: The batch number and expiry details were updated. On 23rd December 2020, the patient had received second dose of Shingrix (0.5 ml) Intramuscularly, which led to lengthening of vaccination schedule. The VAERS details were updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254932:same reporter
Information has been received from a health professional concerning a 6 year old white female (previously reported as male), with no known medical history or allergies, who on 8/10/99 was vaccinated in the left arm with a dose of varicella virus vaccine live (lot # 02935). There was no concomitant medication. On 9/15/04, the patient developed a moderate case of chicken pox. It was reported that the patient developed classic chicken pox lesions on the hands and feet, which spread to other parts of the body and were mostly scabbed over. Unspecified medical attention was sought. At the time of reporting, the patient was recovering. There was no product quality complaint. Follow up information from a health professional that on the morning of 9/15/04 she developed several papules on her hands and feet. It was reported that most lesions were scabbed over on approximately 9/20/04. The patient has subsequently recovered. No further information is expected.
Fever chills weak muscle aches all over my body and right arm swelling at site & very very sore to touch & raise my arm
Patient complained of a flushed feeling in her neck, shoulder and arm areas at 1:00 PM and a sensation of feeling her heart beat. Areas noted to have skin redness; no uticaria or hives present. Denies any shortness of breath or difficulty breathing.  States "scratchy feeling in throat and a heaviness in chest when asked to take a deep breath."  Pulse- 122 Respirations- 18.  Benadryl 25mg po given @ 1:10 PM. EMS called and transported via ambulanced to hospital for further evaluation.
High fever 102+ and lethargy for 72 hours following the vaccination. Rotated Tylenol and Motrin and used a cool cloth/tepid bath to bring down fever that reached 104.9 (02/15/2017).
My arm was sore and swollen at the vaccine site 3 hours after inoculation and thru the following 48 hours. On 1-23-21 I started feeling very short of breath, began using my Albuterol inhaler every 4 hours; and continue using it. On  1-29-21 my upper arm at vaccine site started itching and had some red spots, this stopped the next day.
Patient says that he felt cold, shivering, whole body ached and could not urinate.  This started the evening after his vaccination and finally fell asleep about 1 am and slept till 10 am the next morning and felt somewhat better.  He is able to urinate as of 8/7/19 and he is going to follow up with his primary doctor.
high fever, hallucinations, entire body ache, chills, sweats, low grade fever, nausea, vomiting, extreme swelling of injection site (was red and hot to the touch), fatigue for a number of days, loss of appetite, lack of thirst, muscle pain, dizziness,
The very next day after vaccine I developed a severe headache with sensitivity to light and sound. Then I had tingling and numbness in extremities, loss of bowl movement and bladder function. Eyes moving up and down. Metal taste in mouth, all over body twitching and muscle spasms, sever burning and neuropathy and much more. Lost 30 pounds in weight. After almost 1 year testing at neurologist and various doctors got Lyme disease test and tested positive. The flu shot suppressed my immune system so much that I developed Lyme.
Received H1N1 vaccine @ school. C/O N/V, dizziness, cold to touch, Sa02 98%-HR 75, 120/70, no local Rx. Mother p/u at school-No ER visit.
pt recv vax & exp pain @ inj site;the needle used to give the inj was inspected & noted to contain a burr;QA review is pending;
INJECTION SITE PAIN AND REDUCED ROM-REPORTED TO OCC HEALTH X2 AND WAS TOLD UNRELATED TO VACCINE.
This spontaneous report was received from a physician and refers to a 17-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, reported as "last week", the patient was vaccinated with PROQUAD injection (dose, frequency, route of administration, lot # and expiration date were not reported). The vaccine was reconstituted with sterile diluent. The outcome of event was unknown. No causality assessment was provided.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032LZ0A) for COVID-19 vaccination. The patient's past medical history included Crohns disease aggravated. Previously administered products included for an unreported indication: STELARA (Manufacturer janssen Biotech). Concomitant products included USTEKINUMAB (STELARA) for Crohns disease aggravated, PROBIOTICS NOS, MULTIVITAMIN [VITAMINS NOS], CALTRATE + D PLUS and MILK THISTLE [SILYBUM MARIANUM] for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (itching) and RASH (rash). The patient was treated with HYDROCORTISONE (topical) for Symptomatic treatment, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (oral) for Symptomatic treatment, at an unspecified dose and frequency. On 12-Jan-2021, PRURITUS (itching) and RASH (rash) had resolved. This case was linked to MOD-2021-007588.
Injection site reaction; redness; widespread rash on her chest, back, neck and face / rash hurt from the inside; "zinging" feeling on her face and lips; hurt to wear clothes; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th November 2020, 1 days after receiving Shingrix, the patient experienced injection site reaction, erythema, painful rash and abnormal physical sensation. In November 2020, the patient experienced pain. The patient was treated with prednisone. On 20th November 2020, the outcome of the injection site reaction, erythema, painful rash, abnormal physical sensation and pain were recovered/resolved.   The reporter considered the injection site reaction, erythema and painful rash to be related to Shingrix. It was unknown if the reporter considered the abnormal physical sensation and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received the 1st dose of Shingrix in left deltoid and one day after the vaccination, the patient experienced a reaction at the injection site, redness and a widespread rash on her chest, back, neck and face. The patient reported that a zinging feeling on her face and lips and also the rash hurt from the inside and it hurt to wear clothes. The patient received prednisone as treatment and later symptoms resolved. The patient declined to provide healthcare professional's information. The reporter did not consent to follow up.
"I was so bad I could not get out of my bed, even my toes curled when they hit the floor"; "I was so bad I could not get out of my bed, even my toes curled when they hit the floor"; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), PAIN IN EXTREMITY ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), PAIN IN EXTREMITY ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). On 11-Apr-2021, ASTHENIA ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), PAIN IN EXTREMITY ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.   No corrective treatment was provided.
Patient called 1/9/17 complaining of increased redness and pain around injection site.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 07-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 injection, in the upper arm, lot # L035686, expiry date 16-FEB-2017 (dose, route of administration and anatomical location were not specified). Other suspect therapies included FLUZONE HIGH-DOSE, lot # UI666AB, expiry date 13-APR-2017 (dose, route of administration and anatomical location were not reported), in the same arm, administered on the same day. On 07-OCT-2016, later that day, the patient experienced same soreness and a red area on her upper arm in the area of the injections. It was reported that the red area increased in size until 10-OCT-2016 and was extending from the injection sites down to the patient's elbow. The reporter stated that the soreness disappeared on an unspecified date in October 2016, but the redness remained. The causality assessment between the events and suspect vaccines was not provided. Additional information is not expected as there was no consent for further contact.
Had both doses, continues to have outbreaks /suspected Vaccination failure; Shingles outbreak on the outside corner of her left eye; Continues to have outbreaks; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and shingles (Family History) (had a family history of family members with shingles outbreak including her mom, sister and brother who even had outbreaks when they were young, before they were elderly).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2021252868, US2022AMR180119   Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The patient had a history of shingles outbreaks. The patient had shingles outbreak before taking dose 1 of Shingrix. The patient had taken both doses of Shingrix and yet continues to have shingles outbreaks. The patient did not remember how many years ago she had the doses of Shingrix. The shots were given at an unspecified pharmacy. The patient did not have the records of Shingrix shots or the lot numbers. The patient currently had a shingles outbreak on the outside corner of her left eye. The patient was currently taking Valtrex to treat this outbreak. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252868:Same reporter US-GSK-US2022AMR180119:Same reporter
sore arm; 2nd dose not administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the did not receive 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm) and incomplete course of vaccination (Verbatim: 2nd dose not administered yet). The outcome of the pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter reported that at least one patient was late for their second dose of Shingrix due to a sore arm.  The reporter declined to provide more information. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient had prior positive test for Covid-19 September 1st, 2020  Headaches & Fatigue for 3 months Dose #1: Patient self reports: Mild Sore arm at site, Nausea & Headache - 1st night Mild Sore arm at site, nausea, headache, jount aches, fatigue, shortness of breath, chills - Day 2 Moderate Sore arm at site, nausea, headache, joint aches, fatigue, chills, fever, depression - Day 3 Moderate Fatigue, Depression, Irritability, right eye pain & redness - Day 4 Moderate Fatigue, Irritability, right eye pain & redness - Day 5 Moderate Fatigue, Irritability, right eye pain & redness  - Day 6 to Day 14  Mild Fatigue, Irritability, right eye redness persists (only eye pain subsided day 20, (+L-Lysine supplement)  Item #22
Woke up, vomited once, then spit up mucus about 3 times, no fever at all stomach ache in the lower area, lasted about 2 hours, fell back to sleep for about an hour, woke up and was fine, no more stomach ache, no more vomiting, like it never happened. This has happened every weekend about 7 days apart since receiveing H1N1 nasal vaccine. No other symptoms, the problem arrives and goes all within a 3 hour period, and there has been no change in menu or environment.
Pt recvd vax & exp pain during the 2nd inject; approx 2 wks later devel a lump the size of a golf ball @ the inject site along w/an achy feeling from the shoulder to the forearm;
Temperature ~100', restless, legs feel like jelly fatigue, crawled into bed with Dad, swelling, redness left arm.
A consumer reported that the mother of an 11-year-old female said that her daughter received a tetanus vaccine 7 years ago and ended up in a wheelchair, and cannot talk or take care of herself. Source does not want to be contacted and provided no further information.
Seven days after vaccination, the site of the injection became very itchy, inflamed, red and bumpy. It was somewhat painful and tender, as well. It is an generally round and 4.5 inches in diameter, as an estimate. It initially looked like a cluster of hives, but the swelling filled in the whole area.  It is quite tight and inflamed.
Information has been received from a registered nurse concerning a female between 19 and 26 years of age, who was vaccinated with a first dose of Gardasil. In June 2007, "a couple of weeks ago", the patient experienced soreness, stiffness in the shoulder after receiving the vaccination and was unable to raise her arm above her head. Unspecified medical attention was sought. The outcome was not reported. Additional information has been requested.
I began feeling a heaviness in my chest approximately one month after the 2nd does of the vaccine. It ended up being pericardial effusion. I was hospitalized for a week. I ended up with fluid in my heart sac and lungs and thickening of the sac wall.
Patient described lightheadedness and left arm tingling approximately 15min after receiving vaccine. Vitals WNL, patient elected to stay additional 15min for monitoring. Patient discharged from clinic at 9:40am.
Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 58-year-old female patient (race not provided) was administered with HEPLISAV-B that was reported to be stored at the wrong temperature. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the first injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor, Distributor, on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on Distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of product storage error as non-serious. The event of product storage error is unlisted per HEPLISAV-B USPI.
Information has been received from a female consumer who on an unknown date was vaccinated with a dose of Gardasil. It was reported that the consumer missed her third dose of vaccine, which she was suppose to get on 22-JUN-2007, because she was taking antibiotics for an unknown reason. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort.  Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.
Vaccine exposure during pregnancy; Soreness at injection site; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Morning sickness. Concomitant products included METOCLOPRAMIDE for Morning sickness, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Nov-2020 and the estimated date of delivery was 03-Sep-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, Pregnancy test: positive (Positive) Positive. On 22-Feb-2021, Ultrasound foetal: normal (normal) Normal.     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.   No treatment information was provided.  Previous pregnancy date was reported as 18-Mar-2021.
paresthesia, weakness, muscle fasciculations, neuropathic pain, bladder spasms, confusion started 9/8/21 started 23 days after vaccination and progressively worsened causing significant disability.