chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbareable Headache that pain relievers  will not help; Continues eye twitching; Exteremly tired; This is a spontaneous report from a non-contactable nurse (patient).    This female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   On unknown date, the patient experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, and extremely tired. The outcome of the events was unknown.  No follow-up attempts are possible. No further information expected. Information about lot/batch number cannot be obtained.
Significant shivering, especially from hips down through legs and feet and heat in kidneys area, headache, muscle weakness in both legs, energetic fatique, painful digestive bloat with pain wrapping around front and back of left-bottom of rib cage and radiating up left side of spine into back of left shoulder--this pain was so significant that it was difficult to take full breaths. Taking an NSAID helped to reduce this pain. Digestive distress continued daily for approximately 12 days, not as painful as the first attack.  Bottom of left side of ribcage remains slightly tender to date.
PER DR.'S  NOTE ON DATE OF EXAM 10.17.2019: here with mom   here today c/o allergy reaction to vaccine last seen 10/15/19 and got MMRV, Dtap-IPV, Flu vaccines left shoulder yesterday redness/warmth to area and some itchiness, applied cool compress then alcohol wipes today less redness/swoolen appearing never had fevers, n/v, facial sx or swelling; o/w acting normal.
I experienced fatigue, loss of taste and smell, rash in mouth and my feet became swollen.
At  12:00pm I experienced chills, shakiness at work and kept working throughout the day. I asked my supervisor if I could leave work bit earlier because I did not feel well.  I went to the break room, sat down when I started feeling lightheaded and passed out in a chair. I had a syncope.  Under my right and left arm, my lymph nsodes felt inflamed  and the ER doctor said they were not inflamed but upon palpation were tender.  I was put on oxygen, my BP was extremely low.  My BP resumed to come back up within a few minutes.   At this time Iam still having trouble with my lungs, Iam on an albuterol inhaler as needed.  I had a folllowup with my PCP on 01-13-21, she extended treatment for Azithromax and  continue with Albuterol inhaler.
jerky movements & staring spells had just had DTP in MD office;adm for observation & workup (LP/EEG);
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 10-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
LEFT VESTIBULAR WEAKNESS- SEVERE SLOWLY IMPROVED THEN 12-13-22 SEVERE AGAIN
Next day it added red spots on my arms, legs and back shoulders; Next day it added red spots on my arms, legs and back shoulders; very red skin on my lower back; Had very bumpy skin and very itchy; Had very bumpy skin and very itchy; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiration date: unknown, solution for injection), via an unspecified route of administration, administered in left arm on 01Feb2021 10:30 (age at vaccination: 72 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history included cystitis interstitial and allergy to sulfa drugs. Concomitant medication(s) included calcium, fish oil, bifidobacterium lactis (PROBIOTIC), colecalciferol (VITAMIN D). On 01Feb2021 14:00, the patient experienced very red skin on my lower back, had very bumpy skin and very itchy. Next day it added red spots on my arms, legs and back shoulders. The itching comes and goes. The patient received Clobetasol Propionate and Prednisone 20 mg as treatment for the events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
felt very cold/shakes; muscle and joint pains; muscle and joint pains; Fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (felt very cold/shakes), MYALGIA (muscle and joint pains), ARTHRALGIA (muscle and joint pains) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING COLD (felt very cold/shakes), MYALGIA (muscle and joint pains), ARTHRALGIA (muscle and joint pains) and PYREXIA (Fever). At the time of the report, FEELING COLD (felt very cold/shakes), MYALGIA (muscle and joint pains), ARTHRALGIA (muscle and joint pains) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2022 at 3:54 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 25-Aug-2022 at 3:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified / Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         Dose 1 vaccine administered in deltoid region. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions were reported. The nurse reported that temperature excursion that had occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines had that underwent several temperature excursions going back to August 2022.  It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.  Treatment Medication use information was not reported.
pt cried uncontrollably, hysterically, head jerking side way x 30min;finally stopped then took bottle;MD appt;
Patient presented to the clinic on 2/22/19 with redness and swelling to left deltoid. Dr. gave verbal order to send patient to ER for further eval and TX.
At about 06:15 PM after receiving the Moderna vaccine, patient left hand (the same arm the shot was given) began to turn blue-grey. The nurses there kept her in a room for about an hour, and monitored her vital signs. Everything seemed to be normal except for the discoloration in the skin. She had trouble breathing and some lightheadedness, but it was ruled to be an anxiety response as everything looked normal. Over the time spent in the clinic, the color began to become less intensely blue and fade back to a normal skin color -- but not completely. At about 7:30 PM, she got up to walk and started feeling pins and needles in her arm and upper chest, but this may be due to anxiety.   The feeling disappeared not long after, and we were able to make it home and eat. Everything else that night went OK, except for the fact that her hand is, at the time of this report, still blue-ish in color.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    No relevant concomitant medications were reported. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medication reported.   This case was for the 36th patient out of 77 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Patient received vaccine on 12/4/22 and then a few days later she noticed that her neck was stiff and sore and spasming.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old male patient who had fluzone HD while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB, expiry date- 31-May-2019 in the right deltoid. It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. It was unknown if any adverse event occurred. 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.
Big lump near the right elbow mentioned as getting larger; Feel some pain when I apply pressure to my elbow.; Right elbow has swollen up and is constantly swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Big lump near the right elbow mentioned as getting larger), ARTHRALGIA (Feel some pain when I apply pressure to my elbow.) and JOINT SWELLING (Right elbow has swollen up and is constantly swelling) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 an unknown date, the patient experienced LIMB MASS (Big lump near the right elbow mentioned as getting larger), ARTHRALGIA (Feel some pain when I apply pressure to my elbow.) and JOINT SWELLING (Right elbow has swollen up and is constantly swelling). At the time of the report, LIMB MASS (Big lump near the right elbow mentioned as getting larger), ARTHRALGIA (Feel some pain when I apply pressure to my elbow.) and JOINT SWELLING (Right elbow has swollen up and is constantly swelling) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No new information
Arm hurt badly right after injection, swelling after a couple hours, then in the night got sick vomiting, then incontinence in the morning due to weakness not being able to get to bathroom in time, then had shakes and chills and fever for the rest of the night and into the day for at least 6 hours.  Very weak and shaky for another 24 hours.
Patient requested the Bivalent booster, his third COVID shot. The medical assistant incorrectly drew and injected him with the original vaccine series. Patient will be notified and re-vaccinated as recommended.
SEIZURES STARTED ALMOST IMMEDIATELY AND THEN CONTINUED FOR 16 HOURS EVEN AFTER GIVEN LORAZEPAM RESCUE MEDICATION AND NOW IS HAVING ANXIETY AS A RESULT
has a sinus infection for which he is taking antibiotics; This is a spontaneous report received from contactable male consumer (patient) from a Pfizer-sponsored program .  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unspecified), via unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient was taking antibiotics for his sinus infection, second dose of the vaccine was scheduled on 06Feb2021 (Saturday). The outcome of the event was unknown. Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sore arm. It is red and hot.; Sore arm. It is red and hot.; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Sore arm. It is red and hot.), INJECTION SITE ERYTHEMA (Sore arm. It is red and hot.) and INJECTION SITE PAIN (sore arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, HYDROXYZINE, PREGABALIN (LYRICA) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced FEELING HOT (Sore arm. It is red and hot.), INJECTION SITE ERYTHEMA (Sore arm. It is red and hot.) and INJECTION SITE PAIN (sore arm). At the time of the report, FEELING HOT (Sore arm. It is red and hot.), INJECTION SITE ERYTHEMA (Sore arm. It is red and hot.) and INJECTION SITE PAIN (sore arm) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the drug was not applicable   This case was linked to MOD-2021-075283 (Patient Link).
Dose administered to adult patient from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine).    This case contains information for the second patient out of 26 patients as described by the reporter.  No concomitant medication information was reported.   The reporter stated that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster doses. The reporter was not aware of any adverse events after the vaccines were administered.  Treatment information was not provided.
FEVER (103.5F). SITE IS HARD, SIZE OF GRAPEFRUIT. NAUSEA. PRESSURE IN THE HEAD.
STINGING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced stinging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging. This report was non-serious.
PER PATIENT:  REC'D TETANUS SHOT ON 11/15/06.  MY ARM THAT EVENING WAS REDDENED AND WARM TO TOUCH FROM MY WRIST TO MY SHOULDER.  IT WAS ALSO HARD AND I WAS UNABLE TO MOVE IT.  WENT TO CLINIC ON FRIDAY AND REC'D CARE FROM PHYSICIAN. PER TX CLINIC:  LT SHOULDER CELLULITIS/ALLERGIC RX   STARTED ON ANTIBIOTIC, MEDROL DOSE PACK, AND ANALGESIC RTW 11/20/06 WITHOUT COMPLICATIONS.
Pt received DTaP, Comvax and MMR on 10/31/2001, site UNK where received. On 11/02/2001 developed left arm cellulitis approximately 4" oval diameter area of cellulitis/erythema and tender.
Vasculitis (Henoch-Schonlein purpura), diagnosed Oct 2021.
Patient has had a very sore left arm.  He has sharp shooting pains if he lifts his left arm up, especially over his head, and then this leads to persistent achiness.  No redness or swelling has occurred.  Symptoms have persisted now for 3 weeks.
After receiving two Pfizer vaccine for COVID-19 and a Moderna booster, I experienced several side effects. I had fever, moderate chills, body aches, joint pains in my hands and swollen lymph nodes in my armpit. I received the vaccine on Monday and just noticed the swelling today (Thursday.) I went from a restless night the day that I received the vaccine to fatigue the next day.
Rash - red flat patch on upper chest 24 hours after administration of INFLUENZA and ZOSTER vaccines. Treated with BENADRYL po.
DIARRHEA; DIZZINESS; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, dizziness, and chills. This report was non-serious.
Bump on Left leg where vaccine was given redness on area, reaction on same day as vaccine was given, pt will put cold compresses for 10 min. 3-4 times a day return in 1 day to follow-up.
The pt received the flu shot on 11/21/00 without complications. The pt was found ill at home by his son and subsequently died at 5:00pm that same day.
PT SUFFERED PAIN IN MUSCLE/ARM AND COULD NOT LIFT ARM FOR 2 WEEKS FOLLOWING INJECTION, PT HUSBAND SAID THEY WERE GOING TO TAKE IBUPROFEN AND SEE IF IMPROVED. WAS TOLD TO BE ASSESSED BY PHYSICIAN FOR FURTHER TREATMENT. PT HUSBAND SAID THEY WOULD PROBABLY SEEK TREATMENT
Patient reported a knot, swelling, warmth and redness at injection site.  Knot and swelling were mostly gone by 1pm but redness had spread across upper arm and was still warm.
Raw throat, coughing, headache, throat then started to get hard to swallow, face and neck turned all flush, eyes burned all over body ache, lips went numb.
After receiving injection pt states very sore, then after some time started to swell and became very tender. Is still swollen, red tender measured around arm 43cm left where inj was given right is 36 1/2 cm.