chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a booster dose with a different brand; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGCOCOCCAL AC VACCINE for prophylaxis.   Previously administered products included Bexsero (1st dose received on 28 January 2019, Batch number 177201, Expiry date 31 January 2020, vaccination site was Right deltoid).   On an unknown date, the patient received the 2nd dose of Bexsero and MENINGCOCOCCAL AC VACCINE. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: received a booster dose with a different brand).  The action taken with MENINGCOCOCCAL AC VACCINE was unknown. The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2023 The pharmacist reported that a patient received the two doses of Bexsero then received a booster dose with a different brand which led to interchange of vaccine products. The reporter consented to follow up.
by the next morning I was very tired and could not stay awake.  I could not get warm. I had the chills.  Went to bed at 1pm and sleep until 1030 am the next day .  Only got out of bed for advil and to use the bathroom.  I missed  one and half days of work.
Headache began around 8:30 PM and went from my temples and forehead to the base of my neck, followed a while later by pain in both arms between my shoulders and elbows.  Knowing sleep would be difficult, I stayed up until 2:00 AM and fell asleep about 3:00 AM.  I awoke at 3:20 AM trembling so badly that I couldn't hold a thermometer in my mouth.  So, it was time for "chills and fever" and I put sweat pants and a sweat shirt over my flannel Pjs, heavy socks on my feet, and socks on my hands.  My entire body felt ice cold.  Back under the covers, I finally warmed up and slept off and on for almost eight hours.Woke up around noon on Saturday, feverish, feeling nauseous, exhausted, and still feeling the headache and arm pains.  My "normal" temperature runs from 97.1 to 97.6, but ranged from 100.2 to 100.5 for two days after the vaccine.  Slept off and on around the clock on Saturday and Sunday, and by Monday the headache, pain, and fever were gone.  Slight nausea remained as well as the fatigue on Monday.  On Tuesday, my legs felt wobbly, like "sea legs."  By Wednesday, I was back to normal catching up on email and reading my books, and on Thursday drove out to the county to bring food to my sister and fix her PC.  I understand that seniors do not usually get the side effects as I did, because the immune system declines with age.  Apparently, my immune system is not aware of my birth date.  Can't help but wonder if taking Co-Q-10, as I've done for almost twenty-four years, has anything to do with it.
Has difficulty making out the writing on the card.  Also has difficulty reading LOT number; the girl gave her the shot and then took it out and stated that it did not have a seal on it; she received 2 shots yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2021 10:15 (Lot number: EN6198) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing), notes: Verbatim: COPD. Family history included: "Heart Disease" (unspecified if ongoing), notes: Heart disease; "Cancer" (unspecified if ongoing), notes: Cancer. Concomitant medication(s) included: LOSARTAN POTASSIUM taken for blood pressure abnormal (ongoing); DILTIAZEM taken for cardiac disorder (ongoing); RANOLAZINE EXTENDED RELEASE (ongoing). Vaccination history included: Bnt162b2 (Provides Information for First Dose that she received on 22Feb2021:  LOT EM9810, Route: Injection, Anatomical Location: Right Arm), administration date: 22Feb2021, when the patient was 70 years old, for Covid-19 immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 15Mar2021, outcome "unknown", described as "the girl gave her the shot and then took it out and stated that it did not have a seal on it"; OFF LABEL USE (non-serious) with onset 15Mar2021, outcome "unknown", described as "she received 2 shots yesterday"; READING DISORDER (non-serious), outcome "unknown", described as "Has difficulty making out the writing on the card.  Also has difficulty reading LOT number".  Additional information:  Vaccination Facility Type was Drive Through, Hospital Facilitated, Mass Vaccination Event. There was no emergency room visit or physician's office visit due to the adverse events. Concomitant products Ranolazine extended release started about 2 years ago.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning herself, a 60 year old female patient with high blood pressure, allergy to certain antibiotics and back pain who received her first dose of PNEUMOVAX 23 (manufacturer and dose unspecified) (Lot # and route not reported) on an unspecified date 12 years ago (in approximately December 1999). The nurse reported that she received the second dose of PNEUMOVAX 23 (manufacturer and dose unspecified) (Lot # and route not reported) on an unspecified date 2 years after she received the first dose of PNEUMOVAX 23 (in approximately December 2001). Nurse reported that she experienced pain and swelling at the injection site following the second dose of the vaccine. Nurse reported that she received intramuscularly a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) in her left arm on 13-DEC-2011, and 3 hours later the nurse experienced pain and swelling at the injection site and in the nurse's upper back. Nurse reported that she also developed, "flu like symptoms" on 13-DEC-2011 and the "flu like symptoms" had persisted for the past 7 days. Nurse reported that she was, "deathly sick" for the 24 hours after receiving the PNEUMOVAX 23. Nurse reported that she developed a fever as high as 102 degree Fahrenheit on 14-DEC-2011, and the fever lasted for 1 day. Nurse reported that the injection site swelling "moved" from the injection site after several hours. Nurse reported that she then developed swelling in her arm, wrist, and hand. Nurse reported that with the swelling in her arm, she had also experienced numbness and a sensation described as, "feeling like my circulation was cut of to my arm." Nurse reported that she continued to experience pain and numbness in her left arm. Nurse reported that she took ZITHROMAX (dose and manufacturer unspecified) and the nurse experienced a severe reaction where her "throat closed" and she had to be admitted to a hospital for emergency treatment. There was no laboratory studies performed. The patient sought medical attention by calling the physician and was treated with BENADRYL as needed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
pt recv vax in first month of pregnancy;in approx NOV98 pt delivered child;the child was born w/o a lt eye;19JAN99 CT scan revealed lt orbital roof defect, lt orbital mass w/encephalocele & lt suprasellar arachnoid cyst;Annual follow-up dated 11/27/00 provided no additional data.
Local reaction began 2 hours after vaccination. Progressively spread. To about 10 cm oval the next day. Then 12x15 cm oval on 2/7/2014. So basically a large cellulitis-like reaction.
Patient noticed at noon of 9/30/2020that her left arm became swollen, it extended to underneath the arm ,armpit was swollen and tended. Pt had a headache at night and nausea. She took Tylenol and iced the area. She felt better .
The patient said there was a huge red circle about 2" in diameter around the injections site and that it was red, puffy, and itchy. She came into the pharmacy on 09/29/2018 to show the pharmacist the red circle that was around the injection site.
Not sure if its related to vaccine but week after I got the vaccine, I came down with a really bad cold. It did not go away for about 10 days. I went to an urgent care and they diagnosed me with an upper respiratory infection. I took medication and it went away and recently it came back. I went to doctor again yesterday and they gave me a different script and told me if it didn't clear they would give me a chest x ray. Other vaccines I've had were Pfizer, this is the first time I take Moderna.
eyes feel hot/burning and also states she sees 'sparklers'; eyes feel hot/burning and also states she sees 'sparklers'; developed red eyes with  red veins in her eyes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient developed red eyes with red veins in her eyes; eyes feel hot/burning and also stated she sees 'sparklers'. It was unclear from the patient when she developed these side effects. She was wanting to know if these have been reported and if so how long will it last. Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Infant cried vigorously after injections given. Lifted up from table and placed over shoulder of dad to comfort.  Immediately quieted and looked as if was asleep.  Appeared limp.  Heart rate and respiratory rate OK (AR 126 RR 60). No crying. Unable to disturb, arouse to alertness. Color pale pink to pink.  No cyanosis or extreme pallor. In approx. 15 minutes seemed to be decreasing floppiness, moro present. Discharged...sucking on pacifier, but still sleepy.
Patient called pharmacy between 4-5 pm. She reported "lips swelling up." She reported taking Benadryl. She was advised by the pharmacist to go to the ER if condition worsened. At follow up check at 7 pm, patient reported ER visit due to "face swelling" where she received a steroid shot and was discharged.
On 11/14/16 patient called Emp Health to report that she got a flu shot in her (L) arm on 10/25/16 and that her arm has hurt ever since. She states that it's hard to get dressed and undressed since the muscle where the vaccine was given is so painful. I instructed her to see her healthcare provider and compete incident report.
MA gave vaccines ordered by provider. Grandma noticed hives on face, chest, shoulder immediately. RN and provider responded. Pt denied SOB, swelling of lips/tongue/throat. Pulse 92, SPO2 98%. A dose of BENADRYL given in clinic. Hives/redness disappeared w/in 1 hr.
Experienced numbness/loss of sensation/tingling in right lower leg approximately one week after second vaccine that was also felt to a lesser extent in right lower leg.  It lasted for approximately six months and was starting to clear up.  I then got a booster in November of 2001 and it started all over again a little more severe this time and continues to today.
My son received the Varivax and Prevnar vaccines on the same day. Ten days later, he developed a minor case of the chicken pox,which one pox got infected. He was put on antibiotics for the infection. Six days later, he was admitted into the ER for losing consciousness, which was caused by low blood sugar
Patient reported delayed rash in the arm that started 7 days after receiving Moderna COVID vaccine.
bottom lip and chin have gone numb on my left side(same side as the shot), like the effects of Novacaine. Started the day after vaccination and still numb 2 weeks later.
Information has been received from a nurse concerning a 25 year old female, who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil. Subsequently, on an unspecified date the patient developed a low grade fever after being vaccinated. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Information has been received from a health professional concerning a 5 year old child with no known allergies who on 12/05/2000 was vaccinated with a dose of varicella virus vaccine live. On 01/28/2002 the pt broke out in chickenpox, 4 spots were noted on the right side of trunk and four spots on their back. No fever was noted. Unspecified medical attention was sought. Additional info has been requested.
Drunk stare, drooling, swelling of injection site. SOB, passed out completely. No response X 10 min. This occurred several hours after the injection went ER.
about 14 hrs after receiving the second vaccine I  had extreme chills, severe body aches and headache, pain in my eyes, moderate arm pain and fatigue.  I began feeling better about 10 hrs later but continued to feel fatigued the rest of the day and had body and head ache a couple more days.  I had had covid in Sept 2020 and felt worse those 10 hrs than when I had covid.
I63.9 - CVA (cerebral vascular accident) (HCC) I63.9 - Acute CVA (cerebrovascular accident) (HCC)
Itchy injection site area 4? diameter irregularly shaped red skin at injection site area Slight pain at injection site area when pressed ?Hard? skin at injection site area
COVID-19 positive on 9/24/2022. I had a sore throat, some cough, body aches, slight fever 99-99.9; chills.
After my first vaccine, I inexperienced myalgia and about ten days later I began to have low back pain.
Left upper arm soreness/swelling x 1 week; fatigue x 1 week; headache x 1week;
excessive swelling  injection site; tingling of whole body; Felt tongue was on fire.; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site swelling, tingling and burning tongue. On an unknown date, the outcome of the injection site swelling, tingling and burning tongue were unknown.   It was unknown if the reporter considered the injection site swelling, tingling and burning tongue to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's comments: The patient woke up at night after dose of Shingrix. She had excessive swelling at site of injection, tingling of whole body and felt like tongue was on fire. The reporter consented to follow-up.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 02-JUN-2015, the patient was vaccinated with VARIVAX (Merck) subcutaneous (dose, strength and lot number were not reported) that was improperly stored at -13.6 degrees C for 17 minutes on an unspecified date. It was unknown if this was the first or the second dose in the vaccine series of VARIVAX (Merck). No adverse effects reported. Additional information has been requested.
PATIENT REPORTS SORNESS & MUSCLE STIFFNESS.  WHEN ASKED STATES DID NOT LOSE RANGE OF MOTION, BUT MOTION WAS UNCOMFORTABLE IN LEFT ARM/SHOULDER.
This spontaneous report as received from a registered pharmacist refers to a 62 years old male patient. The patient was vaccinated subcutaneously with a 0.65 ml dose of lot # (669639/0613AA; Exp date 30-JUN-2012), ZOSTAVAX on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the patient was inadvertently vaccinated with an expired vaccine. No adverse effects reported. Additional information has been requested.
Dose administered after 12 hours of vial puncture.; Dose administered after being more than 24 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  On11-Oct-2021, the vial was stored in the refrigerator. On 12-Oct-2021, at 8AM they were taken to room temperature, and on 12-Oct-2021 at 10AM the vial was punctured. After puncture, the vial was stored at room temperature, and 5 doses were drawn and administered on 13-Oct-2021, first dose was administered at 10:40 AM EST of 13-Oct-2021, and 5th dose administered at 1:06PM EST of 13-Oct-2021.  Reporter stated that the total amount of time the vial was exposed to room temperature range was around 30 hours. Reporter assumed the patient was immunocompromised but didn't confirm it,
Patient experienced extreme neurological pain in shoulder, radiating through neck, numbness in extremities, and loss of use in the left arm w/i days after the shot. He saw his PCP, was scolded for using "people that don't know what they're doing" and told to use a hot compress.
Information has been received from a male who in approximately 1978 participated in a study for and was subsequently vaccinated with RECOMBIVAX HB.  In approximately 1978, the patient developed human immunodeficiency (HIV) virus.  At the time of the report, the patient had not recovered.  The consumer considered HIV virus to be immediately life-threatening.  The consumer felt that HIV virus was related to RECOMBIVAX HB therapy.  No further information is available.
Rash and edema appeared on (B) vaccinated legs the same day of the vaccines. The following day the patient started with fever. Presented to our office the day after vaccinations with Temp 102.3, HR 216 and RR 60.  (Febrile, tachypnea and tachycardia). Sent to ER. Erythema and edema persisted x 1-2 days in leg that received the PENTACEL.
I still had lingering back pain and the feeling that something was sitting on my chest since the first dose of my vaccine. The day after the dose of the vaccine I had a headache and body aches with severe back pain in my lower and mid back. My arm became swollen to the size of a baseball around the site of injection. It was a lump on the side of my arm and my arm was numb every once in a while. My arm was very painful and swollen and itchy. I had the issues with my arm for 10 to 14 days after each dose of the vaccine. I have been having severe backache and like something is sitting on my chest. I still very fatigued after 10 weeks and I have severe back ache. I have been using Lidocaine for the pain and Naproxen and a muscle relaxer at times.
Big red swollen area all around site of injection. Slightly itchy... painful.   Also I have had the chills and fever like symptoms for the past 2 days. These symptoms seem to be abating and now my arm is swelling!!
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On 20-AUG-2014, 2 patients were vaccinated with a dose of M-M-R II (lot number, expiration date, dose and route were not reported) that was improperly stored at 48F for 39 minutes. No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
She ended up on the ER, where they stated that it must have been an allergic reaction to; Very painful hives that went from the back, up to her neck and head; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Very painful hives that went from the back, up to her neck and head) and HYPERSENSITIVITY (She ended up on the ER, where they stated that it must have been an allergic reaction to) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced URTICARIA (Very painful hives that went from the back, up to her neck and head). On 07-Feb-2021, the patient experienced HYPERSENSITIVITY (She ended up on the ER, where they stated that it must have been an allergic reaction to). At the time of the report, URTICARIA (Very painful hives that went from the back, up to her neck and head) and HYPERSENSITIVITY (She ended up on the ER, where they stated that it must have been an allergic reaction to) outcome was unknown. Related      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.   Other concomitant medications include high blood pressure medication Patient was administered a steroid injection and an antihistamine.    This case was linked to MOD-2021-248302 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received on 06-JUL-2021 and contains significant information and deleted the events which were related to dose 2 and reporter contact details were updated.
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: patients wife called reporting severe dizziness, nausea and lack of energy in husband with booster dose administered 10/8/21.  He had experienced the same but to lesser degree following dose 2, and this time it was worse and well into 4 th day.  Suggested they call their doctor, she stated that they will not be getting any further doses if recommended in the future
Lt upper thigh at injection site, redness, and slightly raised area, 8 cm around. Slightly warm to touch. No s/s of pain. Instructed pt's mom to apply cool compress and notify us/MD immediately if it gets worse.
Pt received her 1st Moderna covid vaccine at Clinic on 3/11/21. She noted a history of bee stings and that she has an epi pen at home so was given the shot and monitored for 30 minutes. 20 minutes post vaccine, patient noted she felt dizzy and somewhat disoriented. She noted a dry throat and like her arms and legs felt funny "like jello". Her husband alerted staff at the vaccination site and EMS assessed her. She said she was told her blood pressure was high for her but otherwise vitals were fine. She denied itching, or shortness of breath or trouble breathing. She actually asked her husband to go home and get her epi pen and he returned with it and was given a dose of epi and sent to the local emergency room for evaluation. She said she felt better by the time she got their but was monitored for a number of hours. She felt completely fine by the time she was discharged. She noted for a few days following the vaccine she felt fatigued and a slightly itchy spot at injection site but that's it.