chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine: The PQCF was reviewed with the patient who stated that she was feeling ok today: no cough, diarrhea, vomiting and didn't require a tetanus shot for an injury. The patient did state that she was allergic to Penicillin and that she had just completed a course of antibiotics Cipro 500mg for an UTI. After she was administered the Moderna vaccine 1st dose, the patient was advised to sit for a couple of minutes near the pharmacy area where she had just taken her shot while her husband was administered his vaccine and then they would be walked up together to the Post-Vaccination Sitting Area. The patient sat near the pharmacy for roughly 5-10 minutes and then walked over to one of the pharmacy Counseling windows to let us know that she was feeling funny and weird. No sooner than she uttered those words, she collapsed and fainted. 911 was called. Once conscious the patient stated that she truly wasn't feeling the best before getting the vaccine but wanted to go ahead and get her vaccine today. EMTs checked vitals. Her blood pressure and blood sugar were normal; however, her heart rate was low and skin turgor was poor. Her preliminary diagnosis before being transported to a nearby hospital was dehydration. I truly do not think that the vaccine caused her syncope spell but reporting since event occurred shortly after Moderna was administered.
Client vaccinated with Moderna vaccines for Covid on 1/26 and 2/26/2021.  Symptoms started 11/25 - chills, fever x 2 days, sore throat.  PCR + on 11/29.  Had not received booster dose.
No adverse event; 6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023) and NO ADVERSE EVENT (No adverse event) in a 15-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 057B22A) for COVID-19 prophylaxis.     It was unknown patient received  any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 02-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023).    No concomitant medications was provided. No treatment medications was provided.
Pt developed a fever about 30 hours, post vax, with bulging fontanel.
felt like his throat was closing up; dizziness; trouble with his vision/couldn't see right; numbness in the face; the feeling of this AE as being "intoxicated"; 15 minutes after, he started to not feel well/not feeling good at all; was not able to drive; high temperature; having chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 20Jan2021 10:30 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got the Pfizer COVID-19 vaccine today (20Jan2021) at 10:30AM. Within the 15-20 minutes after getting the shot, he felt fine. About 15 minutes after, patient started to not feel well. He said he was not able to drive, he had a high temperature, he was having chills, and not feeling good at all. Patient mentioned that he also had trouble with his vision. Patient also experienced numbness in the face and dizziness. He had an ambulance check him and they told him that his blood pressure was fine and his heart rate was at 92. Patient added that he felt like his throat was closing up. He described the feeling of this AE as being "intoxicated". Patient also emphasized that he "couldn't see right". Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Noticed shortness of breath, extreme trouble breathing that worsened over 3 days. Cat scan was performed at hospital finding blood clots on lungs. Surgery was performed to eliminate the blood clots.
redness on the injection arm; soreness on the injection arm; itchiness on the injection arm; swelling on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on the injection arm), PAIN IN EXTREMITY (soreness on the injection arm), PRURITUS (itchiness on the injection arm) and PERIPHERAL SWELLING (swelling on the injection arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (redness on the injection arm), PAIN IN EXTREMITY (soreness on the injection arm), PRURITUS (itchiness on the injection arm) and PERIPHERAL SWELLING (swelling on the injection arm). At the time of the report, ERYTHEMA (redness on the injection arm), PAIN IN EXTREMITY (soreness on the injection arm), PRURITUS (itchiness on the injection arm) and PERIPHERAL SWELLING (swelling on the injection arm) had not resolved.            No relevant Concomitant medications were reported.  Treatment includes Cold wash cloth, Ice Pack   Reporter did not allow further contact
Vaccine given at 7:38am, at 7:45 pt complained of feeling weak going to pass out. Laid flat on cot, legs elevated. BP 12/57, HR 114, RR 16. 7:53 used ammonia pouch without relief, denies shortness of breath 7:58 BP 120/90, HR 100, RR 16 continues to complain of feeling weak. 911 called.
Arthralgia  pain in right shoulder; fatigue; chills; pain in other joints OTC Advil as needed
RASH ON BOTH ARMS ON THE INSIDE OF THE ELBOW, PETICHAE ITCHY RASH
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 24-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    No concomitant medications were reported.  On 13-Oct-2022, the patient received first dose of 25 microgram of monovalent Moderna vaccine (batch/lot number: AR9236B). Patient did not receive the third dose.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Same reporter
2nd dose given less than 2 months; This case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21st October 2021, the patient received the 2nd dose of Shingrix. On 21st October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Nurse reported patient was administered the 2nd dose of Shingrix less than 2 months interval after dose one. Earlier than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up. No other vaccine details was provided.
I was very fatigued. I could not even eat anything because of how tired I was until 8 pm. I also had a pounding headache. I felt like I had the chills. I thought I had a fever but when I checked, it was 98.7. My left arm was very sore in that area. The next day I felt a lot better and the soreness in my arm was a lot less.
Myocarditis, extreme chest pain on ocations, and acid reflux.  1 week of hospitalization on november 28th, 2021 Aspirin Ibuprofen 3 times a day and colchicine once a day Outcomes: while the chest pain has releived, I am now NOT able to lift heavy weights or do any exercise.
One or two minutes after administration, patient said we was feeling light-headed, and then that he didn't feel well. He was instructed to focus on his  breathing. He did this for a moment (maybe a minute) and then his head fell forward and he slumped forward in the chair. He was held stable in the chair by the pharmacist.  After a short time (less than a minute) the patient's upper body (bilateral arm and hand) muscles contracted (maybe a seizure?) and then he relaxed and sat up. He was alert, a little disoriented initially and had no recollection of his reaction other than feeling light-headed and unwell. He then became sweaty and felt a little nauseated.  The pharmacy called 911 and the patient left with the medics. At that time he was alert and oriented, but still not feeling well.
This spontaneous report was received from a register nurse and refers to a patient of unknown age an gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that on 24-APR-2017, the patient inadvertently received an expire dose of PNEUMOVAX23 lot # K020215, expiration date May 2016 (dose and route were not reported) for prophylaxis. No adverse effect was reported. Additional information has been requested.
reports a rash all over the body; This non-serious case was reported by a nurse via call center representative and described the occurrence of generalized rash in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 3 days after receiving Menveo, the patient experienced generalized rash (Verbatim: reports a rash all over the body). The outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Menveo.     It was unknown if the company considered the generalized rash to be related to Menveo.   Additional Information: GSK receipt date: 25-Oct-2023 The reporter was nurse.   The reporter reported that an adverse event for Menveo vaccine.  A patient received a Menveo vaccine and 3 days later reports a rash all over the body. Adverse event was documented with limited information.  The reporter called and only provided the name, phone number and zip code of the medical facility. It was unknown the date when the event happened.  It was unknown the patient's initials, sex, date of birth, lot/ expiry date of the vaccine.  No additional information was provided.
BRUISING AND SORENESS AT INJECTION SITE NOTED 6 DAYS AFTER VACCINATION
Small cell carcinoma; cancer of pancreas / metastasized; Metastases to lungs; Metastates to bone; Metastases to brain; Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of SMALL CELL CARCINOMA (Small cell carcinoma), METASTASES TO PANCREAS (cancer of pancreas / metastasized), METASTASES TO LUNG (Metastases to lungs), METASTASES TO BONE (Metastates to bone), METASTASES TO CENTRAL NERVOUS SYSTEM (Metastases to brain) and WHEEZING (Wheezing) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion hospitalization). On an unknown date, the patient experienced SMALL CELL CARCINOMA (Small cell carcinoma) (seriousness criteria death, hospitalization and medically significant), METASTASES TO PANCREAS (cancer of pancreas / metastasized) (seriousness criteria death, hospitalization and medically significant), METASTASES TO LUNG (Metastases to lungs) (seriousness criteria death, hospitalization and medically significant), METASTASES TO BONE (Metastates to bone) (seriousness criteria death, hospitalization and medically significant) and METASTASES TO CENTRAL NERVOUS SYSTEM (Metastases to brain) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 25-Apr-2021 to 10-May-2021 due to METASTASES TO BONE, METASTASES TO CENTRAL NERVOUS SYSTEM, METASTASES TO LUNG, METASTASES TO PANCREAS, SMALL CELL CARCINOMA and WHEEZING. The patient died on 10-May-2021. The reported cause of death was Cancer of lung, Bone cancer, Metastases to brain, Pancreas cancer and Small cell carcinoma. It is unknown if an autopsy was performed. At the time of death, WHEEZING (Wheezing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Product use was not provided.  LABORATORY / DIAGNOSTIC TEST: Ultrasound, computerized tomography (CAT) scan and numerous other tests; result was not provided.   Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: cancer of lung; bone cancer; metastases to brain; pancreas cancer; small cell carcinoma
redness at injection site; swelling at injection site; joint aches/pain; fever; feeling wiped out; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   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 injection site erythema, injection site swelling, joint pain, fever and worn out. On an unknown date, the outcome of the injection site erythema, injection site swelling, joint pain, fever and worn out were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, joint pain, fever and worn out to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter said that no side effects from 1st shot, but was not so lucky with the 2nd one. The patient experienced redness and swelling at injection site along with joint aches/pain, some fever, and basically feeling wiped out for about 3 days. The reporter said all worth it to have both doses of Shingrix as the patient did not want shingles. Follow-up could not be possible as no contact details were available.
recently sneezing; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (recently sneezing) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 939904, 006M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU (Yearly IM Flu vaccine Fall 2021) in 2021. Past adverse reactions to the above products included No adverse event with FLU. Concurrent medical conditions included Pollen allergy and Dust allergy.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced SNEEZING (recently sneezing). At the time of the report, SNEEZING (recently sneezing) outcome was unknown.            No concomitant medications were reported.  The patient had not been test or diagnosed with COVID.  The patient reported that, she had been recently sneezing but thought it was related to pollen and dust.  No treatment medications were reported.   This case was linked to MOD-2022-548215 (Patient Link).
Patient received a covid vaccine moderna 0.5mg instead of the covid bivalent booster.
Since the vaccine, I have experienced extreme paraesthesia throughout my left head  and face.  It is chronic and lasts from the moment I wake up to the moment I go to bed. I am also experiencing a watering, itchy left eye and tingling behind the eyeball. Extreme neuropathy in brain, it feels like electric shocks coursing through my head and crabs pinching at the brain tissue. I have also deal with temporarily facial paralysis on the left side of my face, though those symptoms have since abated. I am on Lyrica, prednisone, indomethacin, and xanax in an attempt to get some relief but there are very few doctors who seem to understand what is causing this debilitating adverse reaction.
Information has been received from healthcare (certified medical assistant) worker concerning an unspecified number of unspecified patients. On unknown dates the patients were vaccinated with improperly stored GARDASIL (dose and route were not reported, lot # K009482, expiry date: 06-MAR-2017). No adverse effects were reported. Additional information has been requested.
Itchiness at the injection site; Burning and painful rash of 6 inches long and 4inches wide at the injection site; Sore armpit; Redness at the injection site; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Burning and painful rash of 6 inches long and 4inches wide at the injection site), AXILLARY PAIN (Sore armpit), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Burning and painful rash of 6 inches long and 4inches wide at the injection site), AXILLARY PAIN (Sore armpit) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Burning and painful rash of 6 inches long and 4inches wide at the injection site), AXILLARY PAIN (Sore armpit), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included antihistamine.   Reporter did not allow further contact
The vaccine was reconstituted with sterile water instead of normal saline and administered to the patient.  The patient did not report any adverse effects.
Information has been received from a registered nurse concerning a male student who in 2003 was vaccinated with a dose of varicella virus vaccine live (lot # 644572/0013N). It was noted that titers did not show seroconversion post vaccination. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.