chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2-20-2018 Typical side effects of sore arm (swollen and sore for 3 days) followed on 2-28-2021 be a red and very itchy rash at injection site.  This disappeared on 3-03-2021.  On 2-22- two instances of what felt like an extreme charley horse over both pectoral muscles.  One was mid morning and the other early afternoon.  Duration was 10-15 seconds.      3-20-2021 Moderna dose #2 given.  On 3-21 arm was sore and swollen.  Noises in head began.  These were like grains of sand being shaken in a paper bag.  The noise was continuous and did not change with activity or position.  The noise came in two's and three's.  Noises went away the next day.  On 3-22-2021 arm was almost back to normal but a flat red rash appeared from neck to belly button.  By evening the rash was very red and itchy.  Sometimes it felt like a bad sunburn.   On 3-23-2021 the rash began to fade and by evening it was gone.
Itchy Red swelling, 2 inches wide by 1 inch high , 2 inches below injection site
2/2/2021 red scaly skin rash dorsum right hand.  Next day pinpoint hemorrhagic 2-4 mm sized lesions on palmar surface of fingertips and sides of fingers, 21 in all. Diagnosed as clots by cardiologist and dermatologist on 2/25.Gradual resolution and healing by 3/14/2021.
Patient felt dizzy and nauseated. She had to lie down and have her feet elevated. After about 15 minutes she felt okay to leave. Her daughter drove her home. I called her daughter about 30 minutes after she left. Her daughter said she was doing much better.
Information has been received from a MA concerning a 57 year old white female with asthma (asthma attack approximately 03/09/04) who on 04/20/04 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 64777/0987N).  Suspect vaccination on the same day at approximately 1630 included a fourth or fifth dose in the Left deltoid (previously reported as right deltoid) of tetanus toxoid (Lot # U1024AA). There was no illness at the time of vaccination. It was noted that the pt had no incident with the "3-4" previous doses of tetanus toxoid. The pt was given the pneumococcal 23v polysaccharide vaccine and tetanus toxoid vaccine into the right deltoid within one inch apart per the pt. On  04/20/04, she began having pain in the right deltoid later that evening, at 24:00, with fevers and redness to deltoid. On 04/23/04, the pt was seen for cellulitis of the right deltoid. There were no diagnostic laboratory tests performed. The patient recovered on 30-Apr-2004. Cellulitis was determined to be an other important medical event (OMIC). Additional information has been requested. No further information is expected.
first dose of Shingrix in 2020; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose (batch number 3454N, expiry date 13th October 2020) received on 23rd August 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-June-2022 Reporter's Comments: The nurse reported that the patient who received the first dose of Shingrix in 2020 and would they get the 2nd dose on the day of reporting or do they need to restart the series. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Delayed injection site reaction; injection site redness; injection site swelling; injection site itchiness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Delayed injection site reaction), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itchiness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE REACTION (Delayed injection site reaction), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itchiness). On 30-Jan-2021, INJECTION SITE REACTION (Delayed injection site reaction) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itchiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Injection site had gotten better in the days immediately after administration but then got significantly worse on about day 7. Patient did not have any similar reactions after second dose.  No concomitant medications were reported. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up information received on 20-Apr-2021: Event added, second dose details
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 06-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot number N031492 (expiration date 02-MAY-2020) and a dose of VARIVAX, lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Narrative: COVID POSITIVE TEST AFTER COMPLETION OF COVID-19 VACCINE SERIES, ASYMPTOMATIC 01/13 COVID vaccine dose #1 02/04 COVID vaccine dose #2 04/13 tested for COVID for pre-procedure, no symptoms, tested positive 04/14 asymptomatic 04/15 low grade fever with slight chills, taking tylenol, hip pain 04/16 o2 sat94% room air, temp 99 after tylenol, cills resolved 04/17 cough more productive, yellow tinged sputum, o2 sat 97% RA 047/18 less hip pain, fatigue improved 04/19 continues to improve
The first thing that happened, 4:30 pm the following day, extremely nauseated and starting throwing up (I was driving and had to pull over) and felt super dizzy which was vertigo. Drove home, had severe diarrhea , chills, fever. My arm swelled up and hurt. My lower back was in severe pain. My upper right back thigh - between the buttocks and knee had a horrible pain in it. Very severe pain and it started radiating down my calf muscle and then to the front of shin. Stayed for days on the back of my thigh in my right leg. I continued having very severe vertigo. I would have to run and throw up if I tried to move or go back to bed. The nausea never went away. That was lasted for 8 days. I went to my doctor's office - I drove to the office - they moved all the doctor's across town for Sutter and I couldn't make it before they closed and I had to go home. I couldn't make it. Just driving there was impossible - It was really bad. Didn't have  a doctor visit at all then. The dr. prescribed a medication for vertigo. The pharmacist said to buy the OTC medication for vertigo so I bought it but it didn't help. That made me doped up and sleepy but still nauseated. I got a spike behind my ear on the right hand side of head - in that little pocket - headaches would come there.  I still have weird vertigo and dizziness - intermittently- although I always have a dull nauseous feeling. Every now and then I have to run and throw up - it's like my body is tired of feeling dizzy. Flying in the airplane - looking out the window - made me super nauseous  - so I had to close my eyes and not look at anything. Still have the nausea and vertigo. I have mild dull headaches still. Did have golf ball size lump on arm and couldn't raise it but now it's gone.
"Pt PMH not available to this writer besides a hx of DM.  Pt reports NKA. 9mins post vaccination pt c/o chest tightness. Vitals: @11:25 BP 113/61, HR 65, RR 18, Temp 98.1F, SpO2 96-100% -- > @11:45 103/59, 64, 17, 98.2, 100% -- > 12:08 101/59, 58, 18, 99% Stated that she was nervous coming to the vaccination site as she put wrong directions in her navigation. Denies numbness / tingling sensation in the left arm .Denies N/V/D/C. Denies having any other symptoms.Denies blurred vision.Denies slurred speech.Denies radiating pain to any other body part. Denies headache/dizziness. Denies having any h/o heart problems/family h/o heart problems. Patient states that she has borderline DM controlled well with diet. Pt given water, juice, and graham crackers.  Pt was given a surgical mask to replace her KN95 mask to help her breathe easier. @11:25 pt reports that chest tightness improving now 4/10 down from 8/10 originally. @11:45 chest tightness 3/10 @12:08 Pt reports being symptom free. @12:11 pt stable and NAD pt ambulated out of facility accompanied by RN."
This spontaneous report was received from a licensed practical nurse and refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 15-AUG-2016, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported) and ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.
This patient received dose one of Moderna covid19 vaccine on 2/10/21 at 110pm. At 330pm pt c/o sharp abdominal pain, nausea, vomiting, and diarrhea. She developed a rash to left deltoid area on 2/12/21. She continued to have these s/s. She was evaluated at Clinic by Dr on 2/16/21. He increased her Nexium to 40mg twice daily. Upon TC to patient on 2/23/21 she relates still having nausea, diarrhea, and occasional sharp abdominal pains.
had both of them and still got the shingles / suspected vaccination failure; shingles / I had spent 11 days on the hospital because they were so bad just this April 2022; scaring and the nerve damage; scaring and the nerve damage; the pain never ever goes away; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In April 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the patient experienced nerve damage, scar and pain. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage and scar were unknown and the outcome of the pain was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the nerve damage, scar and pain to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR126722   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter was a consumer who stated that, it did not matter if you get the vaccine, believe me. He/She had both of them and still got the shingles. He/She had spent 11 days on the hospital because they were so bad just this April 2022. It had been a nightmare ever since. The scaring and the nerve damage was indescribable and the pain never ever went away. The shingles vaccine was like the flu vaccine you could still get the shingles.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with US2022AMR126722 for same patient and other product. Follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR126722:same patient, other product
I had a lot congestion, sinus pressure, fatigue, and front headache. I tested positive for COVID-19 at home. I was prescribed Paxlovid. I went back to work on the 30th because I started to feel better and then that Tuesday I started to feel bad again. My entire head was hurting, fatigue and congestion. I believe it was rebound.
Severe headache Joint aches in large joints - lower back//neck//hips injection site red/swollen//hot very painful (area = 3 inch in diameter)
had titers drawn and they were low; patient received MMR II 2 doses as a child and 3 doses as adult; This spontaneous report was received from a physician refers to a 47-year-old female patient who was a health care personnel. Her concomitant therapies included sterile diluent. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On an unknown dates as a child, the patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) an three doses on an unknown dates as an adult (exact dose, route and site of administration, lot# and expiration date). On an unknown date, the patient had titers drawn and they were low. The outcome of low titers was reported as not recovered/not resolved. The outcome of inappropriate schedule of product administration is unknown. The relatedness between the low titers and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
4-5 7:30pm - chills, shaking fever 102.1 - took Motrin 4/5-4/7 - continued with high fever, chills, shaking and severe muscle pains in back and legs - took Motrin/Tylenol every 3 hours for fever 4/7-4/11 - severe brain fog - felt as if I could not think, dizzy, lightheaded, vision was off 4/11 7pm  - starting with hives on the back of both arms. Quickly spread to arms, elbows, right butt/hip and legs - felt itchy and then burning. Very hot to the touch. I had a teledoc appointment at midnight that night. Took Claritin and Benadryl and slept with ice packs to cool my skin. 4/12 - hives were gone in the morning but came back that evening. Took Benadryl and made an appointment with my PCP for the following day. Still feeling dizzy and lightheaded. 4/13 - had appointment with PCP and was instructed to continue with Claritin and Benadryl for a week. At this point I was feeling EXTREME worry, panic and anxiety. Hear rate was elevated so I had to stay until that came down.  4/13-4/17 - Still dizzy and lightheaded - brain fog - continued with anxiety and worry. Set my alarm for every hour at night to be sure I would wake up. 4/18 - Finally feeling like myself - still a bit of worry but so much better!
Fatigue - slept for16 hours straight; General achiness; Mild headache.
Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Sore arm for 3 days, headaches same day until current, chills same day to current, dizziness same day till current, fatigue, diarrhea increased heart rate
pt stated that broke out in a rash from head to toe 5 days p/vax; rash was red & itchy; pt was also using micatin on rt foot for a plantar wart soon p/pneumovax; foot swelled;
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 88 years old male patient who received Influenza Vaccine twice. At the time of the event, the patient had ongoing Dementia. The patient's concomitant therapy was not reported. On an unknown date in September 2018, patient received a dose of suspect Influenza Vaccine (lot number and expiry date not reported) and on 12-Oct-2018, the patient received another dose of suspect Influenza Vaccine (lot number and expiry date not reported). It was a case of actual medication error due to extra dose administered. It was unknown if adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-SEP-2017, the patient was inadvertently vaccinated with one dose of expired ZOSTAVAX lot # M041510, expiration date 27-JUL-2017, for prophylaxis. Concomitant therapies included sterile diluent lot # K023008, expiration date 25-SEP-2017. No adverse effects reported.
Severe pain. Could not move arm. I had to sit down so I wouldn't pass out or throw up from pain. I could not sleep in a bed for 6 weeks. The vaccine was given too high on the shoulder. On a scale of 1-10, the pain was a 10. At the emergency room, I was given an antibiotic, cyclobenzapr & Hydrocod/acetam. I saw Dr. at the Hospital. I saw her 2 more times and then had an x-ray that was negative. Also had some therapy.
Approximately 3 & 1/2 hours after injection I began to break out in large area hives.  Tge reaction first started in both arm pits. Wherever my skin touched something, like an arm resting on a chair; that  area would warm up and break out. I continued on braking out in various areas of my body, with my back being the worst. Each area that broke out swelled and itched for 2 to 4 hours before subsiding.  My breathing was not effected. The entire problem ran its course and was gone 28 hours after receiving the shot. I did not contact my doctor until a two days after the episode was over.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2016, the patient was vaccinated with a first dose of VARIVAX immunization series (lot# L043624 with expiry date on 03-NOV-2017 or lot# L040419 with expiry date on 14-OCT-2017 or lot# reported as M000156 with expiry date on 06-JAN-2018 (it was not specified which lot# was used); exact dose and route of administration were not reported) that were improperly stored. The vaccine was exposed to a temperature of -10, 1 Celsius degrees for 90 minutes. Data logger was used. No adverse effects were reported. No product quality complaint was involved. Lot number M000156 is an invalid lot number for varicella virus vaccine live (Oka/Merck). This is one of two reports received from the same reporter. Additional information has been requested.
Recovered from covid-19 December 2020. Mild case with antibodies but all covid tests were negative  After vaccine Arm soreness Fever above 102 Severe body aches Fatigue Headache