chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills 3p-8p , extreme fatigue, head ache on & off, entire body aches..in bed for over 30 hours...some diarrhea after 30hrs...injection area still sore after 4 days
pt recv vax; broke out in approx 50 lesions; it was reported that pt 's brother broke out in approx 15 pox;
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 28 year old female patient, who was diagnosed with group B streptococcus in pregnancy (in 2014, exact date unspecified), fibrocystic disease of the breast and none drug reactions or allergies. On 11-NOV-2014 the patient was inadvertently vaccinated with VARIVAX (Merck) (lot # K002913, expiry date: 26-FEB-2016, dose, units, route of administration, anatomical location were not reported). None concomitant medication were reported. The patient became pregnant with LMP (last menstrual period) of 21-AUG-2014 (reported as 11 weeks and 5 days) and EDD (estimated delivery date) of 28-MAY-2015. Initial exposure to VARIVAX (Merck) was at 11 weeks. The pregnancy outcome was not reported. It was reported that none treatment was given for the adverse event. It was reported that none diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.
Ear pain within first week Bells Palsy about week after pain treatment anti viral meds prednisone.
beginning about 2.5 weeks after injection site became itchy and a hard amber colored "plug" came out of the site.  It was definitely not a scab.  The same symptom occurred a second time about a week later.
Ended up with shingles even after received vaccine/ suspected vaccination failure; Shingles; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Ended up with shingles even after received vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she ended up with shingles even after received Shingles vaccine. The patient stated that hopefully it helps some peoples. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Achy legs; Felt weak and tired; Little short of breath; Lightheaded; Headache and Head hurt; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded) and HEADACHE (Headache and Head hurt) in a male patient of an unknown age 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 27-Jul-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 PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded), HEADACHE (Headache and Head hurt) and MYALGIA (Sore arm). At the time of the report, PAIN IN EXTREMITY (Achy legs), ASTHENIA (Felt weak and tired), DYSPNOEA (Little short of breath), DIZZINESS (Lightheaded), HEADACHE (Headache and Head hurt) and MYALGIA (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.  No treatment information was provided.  The patient is scheduled to get the second dose on 27Aug2021.  Patient mentioned that the J&J vaccine is known for causing blood clots. After the first dose patient  experienced achy legs, headache, sore arm, felt weak and tired. Their head hurt and immediately after the shot felt a little short of breath and  lightheaded. Patient  provides consent for Safety to follow up.
6hr p/vax pt became nauseated w/emesis x2, mild SOB, SOB inc w/activity;light headed, shaky;by 27JUL96 5PM completely recovered from flu-like sx
On 11/5/09 received HPV#1, MCV4, Tdap, FluMist. On 11/10/09 experienced hard time catching breath, chest tightness, and dizziness while doing a long distance run.  Dx with bronchspasm on 11/16/09. Given Proventil inhaler for excercise induced bronchospasm. Continued to complain of fatigue and reduced endurance during endurance sport activities. Got HPV#2 on 1/7/10 with no problems.  Got HPV#3 5/6/10. On 5/17/10 at 10:00AM experienced itchy, full body rash which was red blotchy raised with small welts.  Took Benadryl the rest of the day and night.  The next morning at 7:00 the rach was mostly gone.  Continues to be fatigued.
Pt with bilateral upper arm edema induration, erythema and warmth after pre K vaccines, approximately 2 hours , lasting 3 days R  and 4-5 for L,
Patient developed shortness of breath/chest tightness ~15 minutes after receiving second shot. Called paramedics who assessed the patient and referred to urgent care. Patient's blood pressure measured ~15 minutes post vaccination was 134/86 and HR 91.
Fat atrophy left leg: Mom denied any immediate problems with immunization. Noticed that about 7-10 days later an area of induration began to develop 1/2 inch below the injection site on left thigh. Denies any trauma or other injury to the area, and denied problems with previous immunizations. No problems with ambulation and does not appear to be in any discomfort. Assessed by plastics dx. Fat, atrophy, no immediate treatment.
3 hours after severe flu symptoms for 36 hours then severe headache, chills, nausea, malaise , for 8 days after
Inappropriate age at vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 03-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Within 10 minutes of receiving vaccine I started blacking out, ears ringing, sweating and low oxygen. Immediate abdominal pain and urge to empty bowels.
Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient complained of severe nausea 15 minutes after his pfizer vaccine and threw up in the bathroom.
Moderate to severe pain at injection site; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids.; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; 2 days after vaccination I had swelling, redness, hives and itching on both eye lids; This is a spontaneous report from a non-contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 12:00 at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Asthma and Ehlers Danlos, and Known allergies: Hives with amoxicillin and anaphylaxis with shellfish. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), ethinylestradiol/levonorgestrel (QUARTETTE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Moderate to severe pain at injection site, and 2 days after vaccination I had swelling, redness, hives and itching on both eye lids on 25Dec2020. Treatment received for the adverse events included Benadryl 50mg once. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 day p/vax pt devel inj site rxn of "softball-sized" area of redness,warmth & induration.
Local reaction at site of injection of MMR and varicella. Redness & mild inflammation immediately after injection.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
GAVE EXPIRED MED; USED A VIAL THAT HAD BEEN USED / OPENED AND RETURNED TO THE REFRIGERATOR OVERNIGHT; This spontaneous report received from a pharmacist concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 18-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JUL-2021, the subject experienced gave expired med. On 06-JUL-2021, the subject experienced used a vial that had been used / opened and returned to the refrigerator overnight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the gave expired med and used a vial that had been used / opened and returned to the refrigerator overnight was not reported. This report was non-serious.
Information had been received on 18-JUL-2016 from a field representative who learned of the adverse event from a registered nurse. On an unknown date, a 17 year old female received an injection of GARDASIL 9 (dose not reported). The nurse called in to report that the patient's left arm where GARDASIL 9 was administered was sored, numbed and hard to the touch (date not reported). Outcome of events was not reported. Concomitant medication included MENVEO. No other information was provided for documentation. Additional information is not expected.
I felt my body ache initially then fever sometimes. Headache. I was developing Rashes on my body  I went to urgent care and they took a blood sample. At 8:30 PM I got a call from Dr the I have to visit urgent care immediately for a few more tests. Skin: Positive for rash (noticed rash on the trunk and abdomen yesterday. papular rash ). Neurological: Positive for weakness (feels tired and fatigued for last 2-3 days.). Negative for dizziness, tingling, numbness and loss of balance. Psychiatric/Behavioral: The patient does not have insomnia.
super lethargic; warm to the touch; arm feels dead, heavy; Breast, elbow, and shoulder - her whole arm - feels uncomfortable; big red circle; little circles closer to where the shot was given; hands and fingers are arthritic; arm was sore; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (hands and fingers are arthritic), PAIN IN EXTREMITY (arm was sore), LETHARGY (lethargic), LETHARGY (super lethargic) and VACCINATION SITE WARMTH (warm to the touch) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination site erythema: Tetanus vaccine and Influenza vaccine. Past adverse reactions to the above products included Vaccination site warmth with Influenza vaccine and Tetanus vaccine.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and LETHARGY (lethargic). On 20-Apr-2021, the patient experienced ARTHRITIS (hands and fingers are arthritic), LETHARGY (super lethargic), VACCINATION SITE WARMTH (warm to the touch), LIMB DISCOMFORT (arm feels dead, heavy), FEELING ABNORMAL (Breast, elbow, and shoulder - her whole arm - feels uncomfortable), VACCINATION SITE ERYTHEMA (big red circle) and VACCINATION SITE RASH (little circles closer to where the shot was given). At the time of the report, ARTHRITIS (hands and fingers are arthritic), PAIN IN EXTREMITY (arm was sore), LETHARGY (lethargic), LETHARGY (super lethargic), VACCINATION SITE WARMTH (warm to the touch), LIMB DISCOMFORT (arm feels dead, heavy), FEELING ABNORMAL (Breast, elbow, and shoulder - her whole arm - feels uncomfortable), VACCINATION SITE ERYTHEMA (big red circle) and VACCINATION SITE RASH (little circles closer to where the shot was given) 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.   Concomitant product use was not provided by the reporter. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-May-2021 does not contain any new information.
Moderate arm soreness/stiffness for 24-36 hrs followed by axillary lymphadenopathy for a week+.
Approx 2.5 hrs p/immun, pt exp hives over the lt eye & lt side of face; Seen in office; tx DPH; w/in 8 hrs p/immun pt asymptomatic; Had runny nose @ time of immun & had taken a dose of triaminic;
On Booster 3 I experienced a severe 9 day Diverticulitis event, thought to be random and surgery was considered, but being in middle of a covid surge, it was avoided. I got a CT abdomen and antibiotics, fever to 104, negative covid test x 3.  Then I got Covid shot 4 last week.  Within a day I started to experience again symptoms of Diverticulitis, same symptoms, pain, inflamation, abdominal bloating, LLQ pain, fever: I started the Levoquin and gram negative antibiotics within 6 hours of definitive symptoms. They still lasted four solid days, but not to the extent as the first major event after Moderna 3.  Moderna 4 had the same time of onset of symptoms, and when the connection was made to the proximity of both events, I felt it important to report this adverse reaction. Going forward what do I do wrt vaccination, a different type or do I pre treat with Levoquin before the vaccine.
Headache-Tylenol-24 hours, chills-none-6 hours, fatigue-sleep-12hours, body aches-Tylenol-24 hours.
lump underneath her left underarm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (lump underneath her left underarm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VENLAFAXINE, HYDROCHLOROTHIAZIDE, HYDROXYZINE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SKIN MASS (lump underneath her left underarm). At the time of the report, SKIN MASS (lump underneath her left underarm) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow document contains no new information
Rash, redness, pain, itching, hot, very swollen and hard at the injection site.  This started one week after vaccination and has slowly got better but is still current.
developed shingles after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. On 27th May 2022, between 4 and 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: Pharmacist reported that the patient developed shingles after first dose of Shingrix. HCP (Health Care Professional) could not provide lot number, expiration date and exact date of first vaccination. The reporter consented to follow-up.
Pneumonia; A spontaneous report received from a healthcare professional concerning a 40-year-old, male patient who received Moderna's COVID-19 vaccine and developed pneumonia.  The patient's medical history provided were, severe developmental disabilities, chronic constipation and allergy induced asthma. No relevant concomitant medications were reported.  On 18 Jan 2021, patient received their first of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, within 3 days after injection, the patient was hospitalized for pneumonia. Patient received the vaccine because he received supported living services. The reporter was reluctant to agree to him receiving the 2nd dose. Treatment for the event was not provided.  Action taken the first dose of mRNA-1273 in response to the event was not reported.  The outcome of the event pneumonia was unknown.; Reporter's Comments: This case concerns a 40 year old male subject, with history of allergy induced asthma, among others, who experienced a serious unexpected event of pneumonia after first dose of mRNA1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.
Cried continuously x 15 min then became limp in car x 1 hr; the awoke screaming non stop x 4 hrs; no fever appeared; lethargic for next 6 days then cleared; site was sl swollen;
mixed Pentacel powder with sterile water instead of diluent and gave patient injection, did not reconstitute with the D-TAP/ IPV and is unsure if diluent used was 0.4 percent saline or sterile water , no problems reported; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old female patient who suppose to vaccinated with a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UI953AAA and Exp. Date 30-JUN-2020) via unknown route in the left thigh on 24 Jan 2019.  The patient's medical history not reported and concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique.  It was reported that, mixed pentacel powder with sterile water instead of diluent and gave patient injection, did not reconstitute with the D-TAP/ IPV and is unsure if diluent used was 0.4 percent saline or sterile water.  No problems were reported.  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.
Skin rash mostly on the right side of upper arm and back  Developed low case of Shingles.
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non-significant follow-up received includes reporters address updated and email address confirmed.
Fainting on and off for about 20 minutes.  Had difficulty moving hands at one point.  Got client on a bed to lay down, applied cold compress, and encouraged deep breathing.
Pain at injection site,  fatigue,  chills, fever,  achy skin,  headaches.  5 days after shot,  a rash of small blisters appeared all over both forearms, on the back of both hands,  and some around ankles.  Day 7 rash appeared on neck.  Headaches remain consistent after 10 days,  and rash is still present after 10 days.  Minimal itching.
Upon waking the morning after the booster shot, I immediately noticed the ringing in my ears/tinnitus was markedly louder.  It remains consistent and loud, a month later, like a hive of bees with a high pitch tone as well.  It is challenging to sleep and to concentrate with this condition.  I reported, at the suggestion of doctor, this symptom after the 2nd vaccine, note e report 560886 and ID 1406331.   I have seen an ENT and an audiologist after the first report, no hearing loss of structural problems.  I now take medication to sleep, run an air purifier on high for white noise. Doctor requested I report this incident as well.
4th of 5 scheduled Rabies Immunizations given 02/12/08 at 1611. Approx 2000 on 02/13/08 donor noticed area of injection slightly firm, red, warm. No other complaints reported. Denies any pain or other complaints. Came to plasma center on 02/14/08 to donate plasma and reported symptoms. 2 "diameter area of red warm, slightly firm.
Patient's arm was extremely sore the next day, and the pain radiated to her armpit & left breast the day after.
I believed she was presenting for booster (0.25 mL) dose of Moderna.  Moderna COVID-19 0.25 mL administered to left deltoid.  After vaccine administration, stated this was her first dose.  Moderna COVID-19 vaccine website consulted, unable to find instruction of what to do if less than 0.5 mL dose administered for primary doses.  Moderna COVID-19 0.25 mL administered to right deltoid, so she received a full 0.5 mL dose, although divided dose given in two injections.