chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Work up in the middle of the night itching profusely.  Checked all documentation on possible side effects after receiving vaccine.  Based on my findings, the itching I'm experiencing is listed as a possible side effect for the other vaccines but not this one.  There are no visible signs of rashes or hives, but extremely itchy.
vaccinated three years ago, got shingles now/Suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's comment: The case was reported by patient. The reporter stated that he/she was vaccinated three years ago with both the doses of Shingrix. The patient had shingles at the time of reporting. The reporter had also asked that if they need to get vaccinated again. Additional supportive information: This case was considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not reported at the time of reporting.
Patient passed out at the milk department but the patient says it is not due to the vaccine he just did not eat.
on 12/13/05 0915am DtaP, IPV and MMR vaccines given by nurse at health center.  Patient and mother left 1015am without problems.  Patient saw another Dr. for removal of earwax at 1315pm and left 1345pm without problems of ears, nose or throat.  Returning home at 1500 pm mother said patient complained of pain right eye and rubbed.  Mother noted swelling of eye and hive right cheek.  Mother called health center at 1545 and described preceding events.  Mother gave patient 5cc of Benadryl PO at 1530pm.  After speaking with nurse, mother took child to ER at 1600.  Dr. noted hives on both sides of face and right hand.  According to mother Dr. said "It looks like an allergic reaction to a preservative in the vaccine patient was given."  Mother said patient has history of asthma and eczema.  Dr. prescribed continuation of Benadryl 4-6 hrs and Prednisone 2 tsp (15mg/tsp) daily to be started.  Parents took child for evaluation 12/14/05 1100.  Father called 1215pm said child still had hives and Dr. advised to continue Benadryl but to stop Prednisone so would not interfere with immunizations.  Father said Dr. advised future vaccinations be given in a physician office under supervision.
Loss of consciousness Vasovagal response Immediately after Covid-19 vaccine patient vasovagal response brief LOC approximately 6-7 seconds, diaphoretic, pale.   VS: 100/65, P 54, Sp02:100% RA   EMS on scene-assumed care
Patient began to feel similar feeling in throat as if she had just eaten peanut butter (patient has known peanut allergy).  Patient given water and observed for additional 10 minutues where patient reported that her throat felt better, however her skin began to break out in a hive like rash.  Patient transferred to emergency department for further workup as per facility protocol.
Baby cried unconsolably x 3 hours with last set of vaccines at 2m. Very fussy x 3d.
Headache, Myalgia, NauseaVomiting, Injection site pain, Injection site erythema, Injection site swelling, Fatigue Narrative:
Severe swelling and fever at injection site on left leg, as well as bruising.  The swelling and fever were immediate.  Within a day, he broke out in rash at the site, which spread to his genetials and up his torso.  The rash lasted for 2 weeks.
He got his vaccine, had some weakness and not feeling good, then had fever and chills at night.  This was for about 2-3 days fever and chills.  He got blisters all over his body, not itchy, particularly on his foot.  He went to UR, and they gave him some antibiotics and the blisters recovered.  He was having fever and chills for 4-5 days, then after about a week he started having very heavy itching on the same foot.  He had to check with his doctor and they said that maybe was going on with his back that possibly the COVID vaccine exposed or popped up and it caused more of a disc herniation.  This was pretty painful initially from the itching, and it took about a month for him to recover from it.  He is still recovering from it, he is still having itching, but his doctor told him he would recover form it with stretching and exercises.    Due to his reaction he does not want to have anymore vaccines in his life.
Pt was fine fol shot. Woke up the next morning, couldn't move arm, "hives" at site, red, warm, swollen, very painful, pain at joint. Was instructed to come into office. Provider said pain was not in joint but in deltoid muscle. Pt was instructed to use ibuprofen and ice.
This spontaneous report was received from a certified medical assistant concerning to a 23 years old female patient. On an unspecified date from 15-OCT-2014 through 27-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot #K009811, expiration date: 19-JUN-2016) (route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
2-4-10 mother called 330 PM. Stating child got 4 shots yesterday - This AM redness swelling and tenderness to to leg - cried when moved - mom at work all day - did not know how it looked now- Told to call sitter- Returned call still red appt made - Pt leg cellulitis - Started on SEPTRA 1/2 teasp BID. BACID 1/2 Cap BID.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX. Concomitant products included amlodipine, cetirizine hydrochloride, lansoprazole, Meclizine, Montelukast, Amlodipine-Benaz. On 7th May 2018 12:00, the patient received the 1st dose of SHINGRIX. On 7th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injection site itching. On 8th May 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site itching were recovering/resolving and the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site itching, injection erythema and injection site swelling to be related to SHINGRIX. Additional information was reported as follows: The patient reported that the healthcare professional pulled the needle out, pressed and rubbed on the injection site immediately after injecting. It hurted and later on the same day of vaccination towards the evening it started to itch. One day after vaccination, the patient experienced injection site erythema and injection site swelling. The next day of the vaccination with SHINGRIX, there was swelling and redness. She called the office and was instructed to put ice on it for 2-3 days. On the day of reporting, the redness was bigger than what is was earlier, it was the size of a silver dollar. The pain was better unless the area was bumped. It was still painful when ice was applied. The itching was still present as she felt it either last night to the day of reporting or morning on the day of reporting. The patient couldn't say exactly. The patient provided permission to contact the doctor mentioned in the report.
Extreme tiredness 8 hours after the vaccine. Fever over 100 that evening continuing intermittently for four days after vaccine. On the fourth day, I woke up with a reddish purple rash over most of my body. My doctor advised me not to take the second dose.
This spontaneous report was received from a physician via two company representatives from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-AUG-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 16 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
sore throat, aches, chills, h/a, tight chest devel by pt 1 day post vax;
8/10/09 - Pt in for HEP B #3 - Reports "I had a reaction to the TETANUS".  TDAP given 04/01/09 right arm IM.  Pt states initially had some "redness" yet arm became swollen/ warm to touch "from injection site to elbow".  Symptoms resolved on own/ did not seek medical care.
patient has not received second dose it is past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient has not received second dose it is past 42 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included METFORMIN, AMLODIPINE, HYDROCHLOROTHIAZIDE, GLIMEPIRIDE, BENAZEPRIL and ATORVASTATIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient has not received second dose it is past 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient has not received second dose it is past 42 days) had resolved.            No concomitant drugs included; Reporter's Comments: Case to be considered for deletion.
11/5/12: Vaccine administered; 11/6/12: Patient said does not feel well - chills (advised to call MD but refused); spouse came into pharmacy said 103 degree fever advised to go directly to urgent care - given tel & address 11/7: spoke to pt 4 PM - he feels much better - did not go to urgent care; fever broke 1 AM & has felt a lot better since; advised him to contact us if feels bad.
12X12 can area of redness + swelling +warm painful to touch on Rt med thigh esp where TETNUS / ADACEL was given GARDASIL suspect + TDAP.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/16/21pfizer,Lot#EN5206 2nd dose 04/07/21Pfizer,lot#EP7533 Diagnosed covid positive:08/02/21 Symptom onset:07/19/21 Exposure:Community Symptoms:SOB,cough,Loss of smell/taste,sore throat, runny nose, fatigue,headache.
The following day i had chills and was tired had body aches and joints hurt a lot. just rested for the whole day and wasn't able to do anything.
Both feet swollen, generalized muscle weakness, worse in BLE.  Generalized joint pain.
Brain fog with disorientation starting the day after the injection and lasting for two days. Abdominal pain/cramps starting the day after the injection that lasted for 5-7 days that ended with a bout of energy draining diarrhea for several hours on the last day of abdominal pain/cramping.
lower left leg vibration sensation; pain in the injection site; muscle fatigue; muscle tightness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain in the injection site), MUSCLE FATIGUE (muscle fatigue), MUSCLE TIGHTNESS (muscle tightness) and LIMB DISCOMFORT (lower left leg vibration sensation) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event, Diabetes and Asthma. Concomitant products included DULAGLUTIDE (TRULICITY), METFORMIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, METFORMIN HYDROCHLORIDE (XIGDUO XR), PIOGLITAZONE and GLIMEPIRIDE for Diabetes, MULTIVITAMINS [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (pain in the injection site), MUSCLE FATIGUE (muscle fatigue) and MUSCLE TIGHTNESS (muscle tightness). On 13-Feb-2021, the patient experienced LIMB DISCOMFORT (lower left leg vibration sensation). At the time of the report, INJECTION SITE PAIN (pain in the injection site), MUSCLE FATIGUE (muscle fatigue), MUSCLE TIGHTNESS (muscle tightness) and LIMB DISCOMFORT (lower left leg vibration sensation) outcome was unknown.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Sore arm, rash at injection site, fever, chills, upset stomach, headache, body aches
This spontaneous report as received from a registered nurse via a company representative refers to a currently 22 year old female patient. After competing her 3rd GARDASIL (lot # unspecified) (dose, route and location unspecified) for vaccine, the patient experienced swollen lymph nodes. The patient went to an unspecified Primary Care HCP, who reached out to her physician, who then referred patient to an unspecified Infectious Disease HCP. The reporter reported that a blood test discovered the patient had "elevated sugar" on an unspecified date. The patient had sought medical attention via went to Primary Care HCP. At the time of report, the outcome of the swollen lymph nodes and elevated sugar was unknown. Additional information has been requested.
Loss of appetite, refusal to nurse, very fussy, unable to sleep, high fever of 104.6F and a rash. Fever ranged from 102F to 104.5F through 8/19/00. Treatment: Motrin and Tylenol.  Follow up 11/01/2000: "I don't know the lot #."
Itchy red rash at site of injection.  This was my first Moderna shot as I had Pfizer all previous times.  I believe it is resolving.
first dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) outcome was unknown.        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 relevant concomitant medications were provided. No treatment information was provided.  The nurses never checked temperature throughout the day and did not keep track. Reporter reported that the temperature was  definitely above 46 degrees F and believed it was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times. She stated the vaccines were kept in hot weather during transport, and believed the vaccine could have been exposed to temperatures around 90 degrees F in the car.    This case was linked to MOD-2021-250547 (Patient Link).
Narrative: Patient with weakness and fatigue following administration of 3rd vaccination with Moderna COVID vaccine. Also complaining of bad dreams, hallucinations, and confusion.
I developed Tinnitus in both ears. The noise was so loud I could sleep, concentrate or go about daily life. Two weeks after the first vaccine shot it started. It wasn?t terrible at that time. Then, one week after the second shot it became terrible. I went to the urgent care. They sent me to the ER and they did a CAT Scan to rule out tumors. I then found out other people have gotten the same thing from the vaccine and was directed to a doctor who put my on a prednisone antibiotic. With no relief I went to an ENT who tested my hearing. I had moderate hearing loss from the Tinnitus. I started sound therapy and had to get hearing aids a few weeks ago on June 25, 2021. The hearing aids are helping to mask the noise of the tinnitus.
I received the 1st dose of modern and now I am missing my menstrual cycle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION IRREGULAR (I received the 1st dose of modern and now I am missing my menstrual cycle) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (I received the 1st dose of modern and now I am missing my menstrual cycle). At the time of the report, MENSTRUATION IRREGULAR (I received the 1st dose of modern and now I am missing my menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Redness at Injection Site-Mild, patient called back about 8 hours after injection. Reports small bumps on her stomach, thinks it is a rash/hives, has no other symptoms.
Pfizer 3/14/21, 4/11/21, 10/18/21. Positive on 7/6/22
Patient parents intentionally falsified patients birthdate to get the COVID vaccine before the patient turned 16 years old. Mother said "her only concern was for her almost 16 year old daughters wellbeing and the Dr. said get her vaccinated ASAP"
Pain and inflammation at the injection site, fever of 101, chills, body aches, headache, fatigue.  Symptoms lasted for the first 36-48 hours after vaccination.  Treated with tylenol, ice on the injection site, increased fluids and bed rest.
This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-APR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # L012480, expiration date: 10-APR-2017, dose and route of administration were not reported) reconstituted with sterile diluent (MRK) (lot #L012345, expiration date: 23-JAN-2018). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA006401:
Burning  sensation in abdomen  & upper track lasted for approx 3 hours.   Bruise (black & blue) on the  injection site (right arm).
Area feels slightly warm to the touch; 4-inch diameter that is slightly pink around the area; Itch around injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area feels slightly warm to the touch), VACCINATION SITE PRURITUS (Itch around injection site), AXILLARY PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (4-inch diameter that is slightly pink around the area) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced AXILLARY PAIN (Sore arm).   On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itch around injection site).   On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Area feels slightly warm to the touch) and VACCINATION SITE ERYTHEMA (4-inch diameter that is slightly pink around the area). The patient was treated with CORTISONE for Application site reaction NOS, at an unspecified dose and frequency.   On 01-Feb-2021, AXILLARY PAIN (Sore arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (Area feels slightly warm to the touch) and VACCINATION SITE ERYTHEMA (4-inch diameter that is slightly pink around the area) outcome was unknown and VACCINATION SITE PRURITUS (Itch around injection site) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
administered Engerix-B and Pediarix at the same visit; Pediarix (instead of Pentacel); This case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-week-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On 26th August 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and Engerix B. On 26th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Engerix B, the patient experienced overdose and wrong vaccine administered. On an unknown date, the outcome of the overdose and wrong vaccine administered 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: 26-AUG-2022.  Reporter's Comments: The nurse reported a patient was administered Engerix-B and Pediarix (instead of Pentacel) at the same visit.  The patient received two doses of Hepatitis B in same visit.  The consent to follow up was granted via email. Additional Supportive Information: As patient had Engerix-B and Pediarix having same antigen on the same day, which led to overdose of hepatitis B component. As patient received Pediarix instead of Pentacel, which led to wrong vaccine administered.
achy feeling in her arm/ pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but she was in her 60's. The patient received Shingrix vaccine and experienced pain at the injection site with an achy feeling in her arm. The reporter consented to follow up. This case has been linked with the case US2019GSK213841, reported by the same reporter.