chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not comfortable, like having covid symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of discomfort (1st dose received on an unknown date, refer case US2022AMR185054).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR185054   Additional Information: GSK receipt date: 08-DEC2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received his/her 2nd shot and stated that same as the 1st shot it was not comfortable. It was like a Covid symptoms once again. But he/she glad to he/she was protected. Additional Supportive information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR185054:Same reporter
Chills, headache, fever, muscle aches, body aches, lethargic, could not get comfortable, lost sleep Approx. 30 hours
Pt here for pregnancy verification. Positive pregnancy screen. Normal signs of pregnancy. Sore breasts, nausea, small amount of cramping. No spotting or other danger signs. Pt had no PMD assess currently - to establish with department at some later date. Wanted Tdap. DTaP was inadvertently given.
no adverse effects; multiple unspecified patients have received improperly stored PROQUAD.; This spontaneous report was received from an office supervisor and refers to multiple patients of unknown gender and age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  Since 14-DEC-2018, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, (PROQUAD) (recombinant Human albumin (rHA)), lot# reported as N023779, expiration date 08-AUG-2019 (dose and route of administration were not reported) and lot# reported as N024701, expiration date 08-SEP-2019 (dose and route of administration were not reported), for prophylaxis. The vaccines were improperly stored between 12/3.18 from 15 degrees Fahrenheit to 46 degrees Fahrenheit (26.3 F) for 2 hours and 30 minutes and between 11/7 from 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.3 F) for 40 minutes. Previous excursion was also reported (6-14 degrees Fahrenheit for 95 minutes and 15-46 degrees Fahrenheit for 1 hour 30 minutes). Data logger was involved. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported.  Lot number N023779 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live )(PROQUAD), recombinant Human albumin (rHA). Lot number N024701 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live )(PROQUAD), recombinant Human albumin (rHA) .  As of 09-OCT-2019, all telephone attempts trying to obtain additional information has been unsuccessful.
This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 26-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Skin bruises easily, and displays as bloody bruise.  Cuts are hard to stop bleeding.
Redness and swelling from elbow to shoulder 14 cm long. 4 cm x 5 cm welt area at site of injection. Afebrile.
Medication given early for age group No Symptoms for patient Reeducation with Physican and Resident staff
This case was reported by a healthcare professional and described the occurrence of arm redness in a 34- year- old female subject who was vaccinated with FLULAVAL. The subject had no relevant medical history. There were no concurrent medications and the subject received no other vaccinations on the date of receipt of FLULAVAL. On 13 October 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). Less than one week after vaccination with FLULAVAL, on an unspecified date in October 2008, the subject experienced arms redness, swelling arm, skin bruise on arm (ecchymosis) and arm felt warm to touch. Medical attention was required at a doctor's office. The subject was treated with KEFLEX. At the time of reporting the arms redness, swelling arm, ecchymosis were improved and the outcome of the warm to touch was unspecified. On 16 October 2008, a nurse in a clinic reported a female in their office noted that she had redness, swelling, warmness to touch in her arm following FLULAVAL injection. One of the docs in the clinic treated her with a rx of KEFLEX.
Initially, full-body tingling which led to muscle weakness. After three days from initial symptoms, paralysis from neck down, inability to breathe on own, elevated heart rate, major pains, hypersensitivity to touch, perceived (but not actual) extremely high skin temperature. Treatment was critical care, ventilation, breathing treatments, pain management, physical therapy and rehab, occupational therapy. Current status is: independent and working full-time but with neuropathy (limited/different physical sensation and limited strength) in feet. This makes running and quick movements infeasible currently.
I am currently under the care of my doctor with the neurology department at the Hospital who has diagnosed my headaches as chronic migraines.; headaches but now in the form of extreme pressure.; 102 temp; Nausea; Muscle pain; extreme crushing headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (I am currently under the care of my Doctor with the neurology department at the Hospital who has diagnosed my headaches as chronic migraines.) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PYREXIA (102 temp), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (extreme crushing headache). In April 2021, the patient experienced HEAD DISCOMFORT (headaches but now in the form of extreme pressure.). On an unknown date, the patient experienced MIGRAINE (I am currently under the care of the doctor with the neurology department at Hospital who has diagnosed my headaches as chronic migraines.) (seriousness criterion hospitalization). On 18-Mar-2021, PYREXIA (102 temp), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (extreme crushing headache) had resolved. At the time of the report, MIGRAINE (I am currently under the care of the doctor with the neurology department at Hospital who has diagnosed my headaches as chronic migraines.) and HEAD DISCOMFORT (headaches but now in the form of extreme pressure.) had not resolved.            No concomitant medication information was provided. No treatment product information was provided.  patient had MRI of brain, cervical spine x-ray and numerous blood tests.; Sender's Comments: This case concerns a 63-year-old patient of an unknown gender with no medical history who experienced the unexpected event of migraine. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as the event occurred after the second dose. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event was assessed as serious per regulatory authority reporting due to hospitalization.
VACCINE WAS DILUTED WITH 1.4 ML PRIOR TO ADMINISTERING A 0.3 ML DOSE.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced small bump at injection site on an unspecified date with outcome of unknown. The information on the batch number has been requested.
The patient on 11/17/2021 received a 1st dose of the 10mcg/0.2ml vaccination (5-11 yr old).  This patient based on the birthday should have received the Pfizer 12+ vaccination of 30mcg/0.3ml.  The nurse thought the system had made a mistake and she proceeded to vaccinate with the inappropriate vaccine. The patients were notified and they returned on 11/18/2021 and the nurse administered an additional 20mcg/0.4ml to complete the total recommended dose of 30 mcg.
Deltoid and shoulder red, hot, edema, pain. Redness streeaking all the way to elbow and under arm.
Excruciating pain in shoulder, neck and arm. Swollen shoulder area. Began within an hour of receiving shot. Shot given very high on arm, almost at the top.
deviation from dosing schedule; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (deviation from dosing schedule) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (deviation from dosing schedule). At the time of the report, PRODUCT DOSE OMISSION ISSUE (deviation from dosing schedule) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was reported by reporter. No Treatment Medication was reported by reporter.   Reporter did not allow further contact
itching on the arm; red patch below injection site; red patch below injection site and warm to touch; sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th January 2022, the patient received the 1st dose of Shingles vaccine. In January 2022, several hours after receiving Shingles vaccine, the patient experienced pruritus, skin red, skin warm and pain in arm. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the skin red, skin warm and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, skin red, skin warm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had his/her shot yesterday (before the time of reporting).  Hours later, the patient started itching on the arm and also he/she now had a red patch on his/her skin below the injection site and warm to the touch. Itching went away at the time of reporting but the red patch was still there and sore arm.
2nd day after vaccine, felt very tired/sleepy and achy, headache, chills and intense sneezing (sneezed so hard I got a sore throat, and general exhausted - oh, sinus froze-up, couldn't breathe through nose....
No adverse event; They have more or less a170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less a170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less a170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less a170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less a170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant live follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Rash and tremendous itching at the site of injection and spreaded to the other arm/per pt. Had flu shot on Nov 2nd & itching & rash started on the 3rd & it is painful from itching. Went to Emergency. On antihistamine & steroids.
Headache, Myalgia, low back pain exacerbation, body aches, missed 3 days of work Narrative:
this is 1 of 3 elderly patients in a nursing home to devel pneumonia 6wk p/vax;pt hosp;the type of pneumonia was not specified;
Resident found unresponsive found at 1545, CPR done, EMS responded and resident Pronounced Dead at 1615
I had routine bloodwork in September my 6 month A1C checkup. I was told my A1C went up to 7.3 and I've always been in the 6's or 5's and never had to take medication. My doctor then put me on Metformin.  I was then diagnosed with breast cancer on July 7, 2022 and I had the Moderna shot 10/5/21. I'm currently on chemotherapy.
Significant hair loss that began 02/2021 to date.  Treatment non-medical. I have added a multi-vitamin, b-complex, liquid Collagen, biotin and prayer!
I believe the vaccine kick started her gastro paresis.; Nauseous; Periodic vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. This 55-year-old female consumer (patient) reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0217) on 03Sep2021 08:30 AM single dose at right arm for COVID-19 immunization. Age at Vaccination: 55 years old. Medical history included Type 1 diabetic, stage 3 kidney disease, known allergies: Sulpha, talniflumate (ENSED), sulfamethoxazole, trimethoprim (BACTRIM). Concomitant drugs included unspecified medication. On the evening of 03Sep2021, 11:30 PM, she became nauseous. She has been nauseous, periodic vomiting, and diarrhea. After several days of treating this ourselves. Sometimes she has recovered on her own, she went to the emergency room on 09Sep2021. They started an IV of Saline, took blood, and gave her two shots of metoclopramide hydrochloride (REGLAN). Then they sent her home. They told her to come back in two or three days if she has not improved. She was still nauseous. The reporter believed the vaccine kick started her gastro paresis. The outcome of the events was not resolved.
Initial unsolicited report received from a Non Healthcare Professional (office staff) on 27-Oct-2017. This case is link with 2017SA211778, 2017SA244642, 2017SA244847, 2017SA244854, 2017SA244856 (same reporter). This case involves child patient (age also reported as 4-10 years old, gender not reported), who was vaccinated with a dose of FLUZONE (batch number: U1856AB, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Medication history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had a severe, localized reaction, injection site swelled to baseball size, was very red and painful. Lab data and corrective treatment was not reported. The outcome of the events were not reported. List of documents held by sender: none.
Swelling, redness and pain of injection site that started 1 day after vaccine. Examined on 8/24/18 and was swollen about 15 cm diameter around the injection site.
After two days of second Moderna vaccine my blood aresion was pretty low and I start to vomited pure blood badly. I start to have diseas after 1 hour that I got this vaccine very tired, not breathing normal. I am vomiting, diaradh, etc. & November went in emergency care Hospital.
Headache, Myalgia, Fever, Rash, Body aches started around 7pm, so bad myalgia that interfered with sleep. Next day headache and fever (100F); then rash developed 6/16/2020; body aches resolved 6/16 at night, then body rash hives on chest and back and arms; left arm pain 6/16/2021, but n Narrative:
his lymph nodes to his neck are swollen; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 19Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's lymph nodes in his neck were swollen on 19Jan2021 at 17:30. It was more on the left side. The patient has not recovered from the event.  Information on the batch/lot number has been requested.
Extreme pain in right arm and inability to move right arm. X-ray and ultrasound at ER, Dilaudid given. X-ray next day at orthopedic, more pain meds and prednisone given along with Flexeril.
bilateral muscle spasms in calves and feet 2-3 x per week lasting 5-10 minutes at a time. Electrolytes drawn (lab work), robs in muscle relaxer prescribed, also using massage and stretching exercises, trying OTC remedies (mustard, tonic water). Treatment is ongoing.  right arm tremors. Referred for physical therapy. Treatment is ongoing.
Both at time of first vaccine (12/19) and second vaccine (1/5) I had the same symptoms: headache, muscle and joint aches, malaise, fatigue, and pain at injection site
SECONDARY TRANSMISSION NON-VACCINEE: c/o a left forearm pustule since this past Friday, 12/16/05.  The patient noticed itching in the area on Friday.  The itching is what drew his attention to the left forearm. He then noticed a lesion which was a pustule.  The lesion has yielded initially yellow pus and now more watery fluid.  The pustule sits on an area of redness.  The patient became more concerned as the redness began to move up the forearm towards the left armpit.  He has also noticed some left axillary soreness in the last few days.  The patient went to one medic who told him the lesion was a spider bite.  He was not impressed with that opinion and wanted to see a PA.  The PA said the lesion is possibly a smallpox lesion.  Another medic saw the lesion and thought it was smallpox as well.  The patient denies ever receiving smallpox vaccine.  He does know several of his colleagues have been immunized with SPV.  The patient has had interaction with them through playing football and "rough-housing" (They received their SPV around 11/10/05). The patient denied trauma, scrapes, cuts or wounds to the left forearm area prior to the pustule development.  He has not been out in the field recently and denies any insect bites.  The patient lives at home with his wife and son. Evaluated at  Dermatologist; cultures obtained.
Patients may have received a vaccine which undergo a temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients may have received a vaccine which undergo a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients may have received a vaccine which undergo a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients may have received a vaccine which undergo a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  Temperature went out of range several times for a total of 7 hours 20 minutes 50.7° F Max and 37°F Min. It was an hour here and an hour there at 49°F on 6 different days, all non consecutive days.
Saturday morning after waking up I felt extreme dizziness, fever, cold sweats, aches throughout shoulders, spine, and hips, and after getting up passed out twice.
My chest has been tight like something squeezing my heart causing massive discomfort since the booster. This also happened after my second Pfizer shot on April 13. My chest was tight for over a month, I just ignored it back then. Since it happened again, I went to the ER.
NO COVID symptoms. Person is a kidney transplant recipient, felt weak, legs gave out, admitted to hospital, database shows admission on 3/22, person reports being in the hospital for at least 2 weeks. Hospital dx and tx for UTI, currently on prednisone, previously on daily Rx for "transplant maintenance", possibly an immunosuppressant, Person could not name.
Pt has a reddened wheal 2"x3" on his arm, that started 24 hrs after admin of the vaccine.
This spontaneous report as received from nurse refers to unspecified number patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ (lot# was not reported). Nurse reported the vaccine administered were improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Got the vaccine. I have had them twice/ Suspected vaccination failure; I have had them twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient did not have shingles till he/she got the vacine and had shingles twice after vaccination. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. Follow-up could not be possible as no contact details were available.