chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urticaria, Pruritis, Medication Error. This case was reported by a registered nurse and described the occurrence of urticarial rash in an 18 year old male patient who received hepatitis A vaccine inactivated (Havrix) injection for prophylaxis. The patient's past medical history included unspecified allergies and asthma. Concurrent medications included fluticasone nasal spray (Flonase), albuterol and fexofendadine (Allegra). At the time of immunization, the patient was exposed to poison ivy. On 28 July 2003 the patient received the 1st dose of Havrix intramuscularly in the gluteus. This is not a recommended site for Havrix administration. On the same date, the patient received oral typoid vaccine (Vivotif, Berna). Two days post-immunization, on 30 July 2003, the patient experienced an urticarial rash and itching. The rash started on the extremeties and moved to the trunk. The patient was treated in an emergency room with an intramuscular injection of dexamethasone. The events resolved during the first week of August 2003.
Shortly after receiving the shot, my arm became sore. By about 2 hours later, it was quite sore and I moved it around. Overnight, it was tender to sleep on and stiff. The next day it was too painful to lift above my head for half of the day. By the evening of the second day (24 hours after shot) arm was significantly less sore. Easier to sleep on second night. No other symptoms.
Immediate shoulder pain, extending down full length of arm.  Worsened despite doses of ibuprofen x 5 days.  Eventually severe pain w/raising arm above head, driving, reaching etc.  3 weeks following vaccination, visited orthopedic surgeon.  Diagnosed w/severe bursitis of the shoulder.  Given a steroid injection to treat the bursitis.  Has been 5 days since steroid injection.  Only minimal pain at this point.
High fever & lethargy 24 hrs after. Urticaria 5 days after. Swollen IZ site.
Information has been received from a health professional concerning a 30 year old female who was vaccinated with RECOMBIVAX HB (manufacturer unspecified).  Subsequently the patient developed pulsation in her leg muscle.  No rash involved.  The symptoms developed in the evening on the same day that she was vaccinated.  Nurse thought the patient was vaccinated a month ago but she was not sure because the vaccination took place at the patient's employer.  Medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Swollen lymph nodes under left arm/ Day five right arm lymph nodes starting to hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 21Mar2022, when the patient was 64-year-old, for Covid-19 Immunization; Moderna (Dose Number: 2, Batch/Lot No: Unknown. , Location of injection: Arm Left), when the patient was 64 years old, for Covid-19 Immunization; Moderna (Dose Number: 3, Batch/Lot No: 065F21A,, Location of injection: Arm Left), when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Apr2022 at 23:00, outcome "not recovered", described as "Swollen lymph nodes under left arm/ Day five right arm lymph nodes starting to hurt". It was unknown if therapeutic measures were taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Mother reported visible vesicles/ rash on trunk, back, arms and legs on 10/8/2020
pt recv vax;exp fever of 102 for 2-3 days;pt decided to decline further immun;
11FEB91 "puffy eyes & face" - rash on face; 12FEB91 diarrhea, N&V; Hospitalized 14FEB91-17FEB91 VS- t 99.4, p 124, r 42 dx acute gastroenteritis. Mild redness of pharynx.
My period has been irregular. My cycle after the first dose was slightly shorter (23 days).  The next cycle was slightly longer (34 days).  The cycle after that was excessively long (107 days); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 (Lot number: EL3247) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: KYLEENA. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 07Mar2021, outcome "unknown", described as "My period has been irregular. My cycle after the first dose was slightly shorter (23 days).  The next cycle was slightly longer (34 days).  The cycle after that was excessively long (107 days)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Facility type vaccine was Workplace clinic. The patient did not have other vaccine in four weeks. Kyleena IUD in two weeks. The patient has been Covid tested post vaccination and result was negative. The patient did not have known allergies. The patient had bnt162b2 (BNT162B2) (Lot number: EN6203) on 12Mar2021 at right arm.  Response: It only recently dawned on me that there may be a connection. I don't know that there is for sure but when I looked at my period tracker to try to figure out what coincided with the gaps, I realized the only thing different was the vaccine. I did some quick searching online and saw that a number of women were having similar experiences. So I submitted a report right away.  No follow-up attempts are possible. No further information is expected.  Follow-up (05Aug2021): New information received in response to the mail trail sent regarding the confirmation of below mentioned query. Added the response in narrative.  No follow-up attempts are possible. No further information is expected.
Patient experience severe arm, hand pain/ swelling 2 days after the vaccine in the same side as injection.  Redness/Swelling/pain continues 3 weeks after the vaccine.
I am having some mild side effects from my booster yesterday; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (I am having some mild side effects from my booster yesterday) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced VACCINATION COMPLICATION (I am having some mild side effects from my booster yesterday). At the time of the report, VACCINATION COMPLICATION (I am having some mild side effects from my booster yesterday) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
Received COVID booster vaccine 10/12/23, flew 10/18/23 with return trip home 10/27/23. Took 10 mg rivaroxaban tablet 1 hour to each flight for VTE prophylaxis. Noted left leg pain 10/29/23. Underwent Ultrasound 11/3/23. Findings: Acute thrombosis of 2 branches of the left gastrocnemius vein.  Otherwise, no acute DVT of calf veins.. Started treatment with rivaroxaban 15 mg bid with meals X 21 days, then 20 mg daily with a meal thereafter.  Prior vaccine history was Pfizer COVID vaccine 11/9/21, 1/18/21 and 12/28/20. Moderna 9/19/22
LPN gave the DTAP/POLIO dose of the PENTACEL combination. No HIB was injected. Patient tolerated injection well with no physical adverse reactions. Plan to vaccinate patient with HIB vaccine and then return to the PENTACEL schedule.
pt began w/high pitched cry around 4PM; entire lt thigh red & swollen; painful to touch; high pitched cry cont until 10-1030PM;
9 hours after vaccine, severe headache, severe body aches, motrin taken, reduced a bit.  At midnight woke up soaked, then at 3 am in pain and with fever.  By 24 hours, fever gone, headache for another 12 hours.  In the 8 days since, feeling tired, sleepy.  History of chronic headaches, that are the same since.  Had covid in December, feeling more unwell after vaccine than disease
second dose if it was administered before the 2 month period to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 28-JUL-2023, the patient received the 2nd dose of Shingrix. On 28-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: second dose if it was administered before the 2 month period to a patient).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 02-OCT-2023 A pharmacist called in to request information about the validity of a second dose if it was administered before the 2-month period to a patient. The patient received 2nd dose before recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
On Friday, November 16, I requested a flu shot on a routine office visit.(my fourth year)The vaccine information statement notes that it is Inactivated Influenza Vaccine. For the next week, I had some pain/discomfort in my upper left arm.On Thursday evening, November 29, stabbing/jabbing pain in my left upper arm awakened me and I could not turn over. I took two extra strenth tylenol, rubbed flex-all 454 on my arm and went to work Friday. I could not lift my left arm at work. Upon returning home from work, I started having chills and cold/hot. I crawled up on the couch, I asked my son to get some advil so I could treat the pain with extra strength tylenol or inflamation with ibuprofen.This stabbing/jabbing/throbbing pain continued Saturday and Sunday.On Saturday, December 1, I called facility and an advice nurse called me back. I told her about the stabbing/jabbing pain, She asked if I had a elevated temp., I told her no. I told her how I was treating this pain. She said if it did not subside to come to urgent care at the Southwood facility.I used two absorpbine, jr. heating pads The pain decreased, the stiffness, range and motion was slow to return and Friday of this week, December 7, was my best day for movement, lifting my left arm. It has been a challenge getting dressed, especially putting on my bra. This has been a most physically painful experience.
Vaccine was administered using a 1cm needle, and some of it leaked out.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Shingrix. On 13th June 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comment: The reporter stated that, he was administering Shingrix a day before the date of reporting using a 1cm needle, and some of it leaked out. The reporter declined to provide date of birth of patient.  The reporter consented to follow up via postal. Additional Supportive Information: The reporter was administering Shingrix a day before the date of reporting using a 1cm needle, and some of it leaked out, which led to incomplete dose administered.
administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were 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: 18-Apr-2022 Reporter's comments: No patient's identifiers were provided.  The patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The vaccine administration facility was the same as primary reporter. This was 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
didn't feel well for two days; hot and itchy; still sore; bakers cyst; hot and itchy; very large bullseye rash at the injection site; not considered immunocompromised/Received 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), PAIN IN EXTREMITY (still sore), SYNOVIAL CYST (bakers cyst) and VACCINATION SITE WARMTH (hot and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F2119, 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease. Concomitant products included LABETALOL for Blood pressure high.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced OFF LABEL USE (not considered immunocompromised/Received 3rd dose). On an unknown date, the patient experienced MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), PAIN IN EXTREMITY (still sore), SYNOVIAL CYST (bakers cyst), VACCINATION SITE WARMTH (hot and itchy) and VACCINATION SITE RASH (very large bullseye rash at the injection site). At the time of the report, MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), VACCINATION SITE WARMTH (hot and itchy) and OFF LABEL USE (not considered immunocompromised/Received 3rd dose) outcome was unknown, PAIN IN EXTREMITY (still sore) had not resolved and SYNOVIAL CYST (bakers cyst) and VACCINATION SITE RASH (very large bullseye rash at the injection site) was resolving.            No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Significant Follow up contains added events: Malaise, pruritus, pain in extremity, synovial cyst, vaccination site warmth, vaccination site rash
There was no immediate reaction to the vaccine.  I received the bivalent Pfizer booster shot and the stronger dose (over 65 years old) flu vaccine in my left arm on Thursday September 8.  On Tuesday, September 13, I was stung by a yellow jacket on the inside wrist of my left arm.  My forearm swelled up dramatically such that I could not wear a watch and it was extremely uncomfortable.  I have never had such a severe reaction to a bee sting.  I went to urgent care on Thursday, September 15 and got prednisone oral treatment.  I described the situation to the practitioner and she said yes its possible your body had a more severe reaction due to vaccination but she really did not know.
Headache; chills; stomachache; was in the recliner covered up most of the day / could not do anything; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th July 2021, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced headache, chills, stomach pain and mobility decreased. On an unknown date, the outcome of the headache, chills, stomach pain and mobility decreased were recovering/resolving.   It was unknown if the reporter considered the headache, chills, stomach pain and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received Shingles vaccine and experienced headache, chills, stomachache and the patient could not do anything. The patient was in the recliner covered up most of the day. The patient stated he/she was good on the day of reporting. The follow up would not be possible as no contact details were available.
faulty syringe and we are not sure if the patient received the full dosage; A spontaneous report was received from a health care professional concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and was faulty syringe and we are not sure if the patient received the full dosage (Incorrect dose administered).  There were no medical history concomitant medications provided by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   While administering the vaccine to the patient, according to the reporter, health care professional was unsure if the patient received the full dose of the vaccine due to a faulty syringe. No additional information was available at the time of this report. No treatment information was provided for the event.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event was considered recovered on an unknown date.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Twinrix expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 16-AUG-2022 Reporter's comments: The registered nurse (RN) reported that a Twinrix expired dose was administered to a patient. The consent to follow up was granted by email. Additional Supportive Information: As patient received dose of expired vaccine, which led to expired vaccine used.
Reported developing arthritic pain, tingling sensation, headache, hip pain, and rash 1 week after shot. Physician dx him with Shingles.
This spontaneous report was received from a registered nurse and refers to a 7 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 22-AUG-2016. On 05-OCT-2016, the patient was vaccinated with an improperly stored ZOSTAVAX lot # M020921 with expiration date of 18-JUL-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 8 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014052.
pt recvd vax 15JUL94 & 17JUL94 exp tingling in the hands,fingers,& lower arms as well as soreness in the shoulders & numbness in the fingers;MD reported that pt's sx appeared to have occurred p/volleyball & it was felt poss carpal tunnel
Fever, chills, sweats, body aches,  fatigue, brain fog  Lasted 24 hours
Approx. 6 weeks after receiving this senior flu vaccine, I started expriencing extreme discomfort in both feet (like they were on fire). Also during this six week period, I was experiencing sharp pain on and off at the vaccine injection site. I saw multiple doctors concerning my condition, including 3 neurologist before I was finally diagnosed with Small Fiber Neuropathy. To reach this diagnosis a skin biopsy was performed at my ankle and upper most thigh area. Results were a 60% reduction of my sensory nerves at the ankle site and a 40% reduction at my thigh area. This test was performed on 6/24/2021. I am currently seeing a chief neurologist in my area. After speaking with him about this vaccine and my subsequent  condition, he suggested that I fill out this VAERS report. The only thing that I can contribute this medical condition to is the vaccine shot I received on October 5th, 2020. I cannot say with 100% certainty that this is what caused my current condition, but this came on very quickly right after I had this shot. It goes without saying I will not get another senior dose flu vaccine. I am not anti vax, I recieved all three Pfizer covid vaccines. The main reason I filled out this report is to compile stats on this condition from other people who have received this particular vaccine.
Vaccines given on 7/18/23 in L arm. Mom states today she noticed that L arm is red and swollen; about 70% of her upper arm. Area warm to touch. Not tender to touch or painful. Acting well otherwise.