chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; schedule for MRI to rule out sciatica; pain in the left thigh area/constant pain in the left leg; rash on the left thigh area; first dose of the Shingrix vaccine on 07/02/2019 and then the second dose on 2/27/2020; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 8 years after receiving Zostavax, had an episode of shingles on the left side of her body). Previously administered products included Zostavax (approximately 12 years before the date of reporting) and Shingrix (1st dose received on 2nd July 2019). Concurrent medical conditions included sjogren's.   On 27th February 2020, the patient received the 2nd dose of Shingrix. On 27th February 2020, unknown after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles, sciatica, leg pain and rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir), hydrocodone and steroids nos (Steroids). On an unknown date, the outcome of the shingles, sciatica, leg pain, rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles, sciatica, leg pain, rash and drug dose administration interval too long to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The patient received 2nd dose of Shingrix in the left arm later than recommended schedule, which led to lengthening of vaccination schedule.  Few days after vaccination, the patient was complaining of pain in the left thigh area and few days later noticed rash on the left thigh area and severe, constant pain in the left leg.  The patient was schedule for magnetic resonance imaging (MRI) to rule out sciatica. The patient was started on steroid dose pack, Hydrocodone and Valacyclovir.  Husband stating approximately 12 years ago wife received the Zostavax vaccine and about 8 years after receiving that vaccine, she had an episode of shingles on the left side of her body. The reporter consented to follow up. This case has been linked to US2020053225, reported by the same reporter.
Severe headache within 3 hours of the shot, followed by pulsatile tinnitus which I have never had.  Later in the evening I had a fever of 102 with body aches and chills.  The fever resolved in 24 hours, but felt extremely tired and sore for 3 days.  My ears have remained plugged since (4 weeks later) and I still get the pulsatile tinnitus throughout the day.  Additionally, I have had a headache everyday.
Patient called on 12/27/19 around 7 PM and stated that he has had flu-like symptoms all week. He had extreme muscle pain to the point that it hurt to even bend over, and he stated that he had diarrhea all week as well. He stated this was the first day that he was starting to feel some relief all week.
Dizzy/ light headed; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy/ light headed) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Dizzy/ light headed). At the time of the report, DIZZINESS (Dizzy/ light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified diabetes and high blood pressure medications.   No treatment information was provided.
No adverse event Child was given booster dose (0.2 ml) instead of primary dose (0.25 ml) - child was underdosed. Second primary dose (0.25 ml) to be given 8 weeks after 4/27/23 dose. No booster will be given
red lump; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Patient states being allergic to some food and medications but never experienced a reaction), Allergy to allopathic drugs (Patient states being allergic to some food and medications but never experienced a reaction), Blood pressure high, Osteoporosis and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis, MULTIVITAMINS [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for No adverse event, at a dose of 1 dosage form once a day. At the time of the report, ERYTHEMA (red lump) and PAIN IN EXTREMITY (sore arm) had resolved.            This case was linked to MOD-2021-323808 (Patient Link).
injection site pain-ongoing headache-24 hours body aches/joint pain-24 hours fatigue-24 hours fever-12 hours
Patient received vaccine after published expiration date. Moderna company analyzed vaccine and advised lot 007B21 maintained activity  necessary to protect against covid 19. Patient also  did not call in to report  any adverse event. This was administrative error without adverse evant.
Information has been received from a physician concerning a male who on 12/27/01 was vaccinated with one dose of MMR II (lot 640562/1374L). Subsequently in approximately January 2002, the physician's office was notified by telephone that the pt developed localized rash and temperature. The pt sought unspecified medical attention. The physician requested a lot check on the lot because there were "more phone calls than ever before." The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. This lot complies with the standard of the Center for Biologics Evaluation and Research and was released. Follow-up info on 3/7/02, from a physician noted there were no more adverse events to report other than those that were previously reported. The physician stated that the reason she used the phrase "more calls than ever," was because she has been in practice for a number of years, and always gave pt/parents standard info on the benefits/risks of a vaccine before its administration and also instructed them to call the office if the child experienced any problems post-vaccination. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post-vaccination reaction. It was very unusual for their office to receive as many calls as they did in January 2002. Including this pt and other pts who were vaccinated and experienced similar events (WAES0202USA03018, 0202USA00428, 0202USA00429, 0202USA00430 and 0202USA00432). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10 post-vaccination. It was noted that there were no additional cases reported and the increase in calls was just in the month of January 2002. They did not experience any unusual volume of calls in February or thus far in March 2002. Additional info has been requested.
Patient received Zostavax vaccine on 07/10/2009.  She returned to the office today with a rash on her back and left side, painful for six days.  Shingles.
Fever of 100.6 Chills Fatigue- slept all day Body aches Headache
Lymph nodes swollen over collarbone and stiff neck on left side, after two weeks left eye is blurry and may have a swollen nerve .  MRI  done to be sure nothing else is causing the nerve swelling.
Employee reported vaccine reaction to (Rt) deltoid as large redness, swelling & painful on 4/3/12 approx 24 hrs after shot administered - TX - ice, Ibuprofen - symptoms improved no swelling/redness 4/6/12.
recieved 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (recieved 0.5ml Moderna instead of 0.25ml booster dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (recieved 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (recieved 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-396492 (Patient Link).
Client called and reported running a fever of 103 degrees, body aches & swollen armpits.
spontaneous vomiting, usually every three months after receiving the shot.  The last one was 06/11/22; last shot: 11/3/21.
Within the next week or one week after and a half after the vaccine, I had a low grade fever, flehm, stuffy nose, congestion and unable to work. I also have had extreme exhaustion. I have a lot of pressure in my ears like I am underwater and cannot hear this lasted for about a week.
24hrs later pt developed arm soreness and found red swollen area on (R) arm where injection given. Pt. also experienced chills and fever and flu-like symptoms. Redness spread around lower area of arm as well.
Excessive sleepiness about 12 hours after injection lasting almost a day and a half.  A large hard red itchy bump at injection site starting about a week and 44 minutes after injection. (I still have it and so I don't know how long it will last so far it has been almost 14 hours)
A week later, my arm had a round red rash that was hot and hard to the touch. No fever or other symptoms  I began cephalexin on January 22. The rash grew. On January 24 the rash migrated down the arm. By January 27, it abated with the end of the antibiotics round
Per NP note (1/1/22) Symptoms started: 1/1/22 COVID positive 1/1/22. Vaccine status: Moderna x2 (5/2021), no booster.   Patient is a 50 yo female with a h/o asthma, COPD, smoking and chronic pain on high risk medications who was diagnosed with COVID-19 on 1/1/2022. Since then she has had fevers (improving), cough, shortness of breath with activity, wheezing, chest tightness, abdominal pain, nausea, and fatigue.  Sp02 averaging 91% - 93%. Treating with albuterol inhaler "throughout the day", unsure of exactly how often. Is also using albuterol nebulizer twice per day with some temporary improvement. Has Flovent inhaler in her med list but states she doesn't take it due to side effects of thrush. The Flovent she has is expired.  Has a h/o C diff. - Patient requesting antibiotics today to treat possible pneumonia. Due to recurrent c diff, advise against this and instead, recommend she have a chest x-ray to confirm if PNA is present. X-ray ordered to be done at HRH walk-in radiology.    Strict ED precautions discussed. Plan discussed with patient. Patient verbalizes understanding and agrees with plan. - Please let patient know that she should take Prednisone 40 mg once per day.
Symptomatic, started on 7/9/21 with cough, runny nose, nasal congestion, and fever
13 DAYS AFTER VACCINATION PATIENT EXPERIENCED SWELLING, REDNESS AND HIVES AT INJECTION SITE.
Pt recvd Engerix-B & 24 to 48 hrs p/1st dose had peeling of skin, aching joints, stiff neck, pleurisy, chest wall myalgia; pt was hospitalized;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/05/21 2nd dose01/26/21 Diagnosed covid positive:08/25/21 Symptom onset:08/25/21 Exposure:community Symptoms:cough, fatigue,runny ose,headache.
LIGHT HEADEDNESS, WEAKNESS, DIZZINESS, UNBALANCE, NAUSEA
Puritic raised red papular rash also with 3-4 raided red welt-like lesions over right deltoid, shoulder, upper back and chest.
Tinnitus - increasing in intensity - continuous - moderate to severe.  Finished a medal pack 2 days ago - no  relief (?worsening).  Can't get in to see an ENT specialist for another month.  We are snow birds - so I saw another MD (actually his PA) who checked my ears with an otoscope, removed some ear wax.  No change in symptoms
This spontaneous report as received from a pharmacist refers to a 64 year old male patient with diabetes, heart condition (unspecified) and hypertension and no known drug reaction/allergies. On 24-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000493, subcutaneous, in the left arm, for prevention shingles. Concomitant therapies included nitroglycerin, metformin, glipizide, PROTONIX, enalapril maleate (manufacturer unspecified), VITAMIN D2, CRESTOR, FLOMAX and NORVASC. On 25-JUN-2013, the patient had a black and blue and red area at the injection site, which was also burning and itching. The patient called the pharmacist on 25-JUN-2013 reporting the adverse reaction but was not seen by the pharmacist until 27-JUN-2013. No lab diagnostic tests were performed. On 27-JUN-2013, the pharmacist recommended the patient put ice on the site but provided no further treatment recommendations. The outcome of the events was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
cough with progressive dyspnea, pt found to be in biventricular systolic heart failure being treate with Milrinone, lasix,  Patient has diabetes type 2 most recent HGB A1C was 12, with a BMI of 40.  Hospitalized
Admin 10/19/09 sub Q. Bruise at administration - no flesh broken in 24hrs - more bruising and some itching.  By 10/21/09 rash appeared extending from injection in oblong shape @ 3-4" wide towards elbow. Rash itching, tender. Flushing experienced on upper torso. BENADRYL OTC responded symptoms. Fading away - slight redness still on 10/30/09. (Did have poison Ivy at time of administration).
This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During administration, there was some general leakage from the administration site. It was clear and patient was concerned that the vaccine has seeped out. Patient was wondering if it's sufficient dosage. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt complaining of Headache and itchy throat. Pt crying and shaking.  0.25cc of Epi administered to pt sq at 6:45pm. No noted improvement in pt symptoms. 1cc Benadryl given IM at 6:55pm. Within 5 min pt stating that throat was feeling better. Dr contacted and pt instructed to go to ER for evaluation
pt noted w/red rash to entire body on 4FEB97;no fever, n/v or resp problems noted;mom encouraged to take pt to PMD ASAP for further eval;
no additional AE; Use of GARDASIL 9 outside of prescribing information. Second dose administered almost 6 months after first dose was administered in 3-dose series.; This spontaneous report was received from a pharmacist concerning a 27 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not report.      The patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (at the dose of 0.5 ml, intramuscularly; batch/lot# was not reported) on 30-NOV-2020 via a recommendation from a pharmacist as prophylaxis. She received her second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (at the dose of 0.5 ml, intramuscularly; batch/lot# was not reported) on 18-APR-2021 as prophylaxis (inappropriate schedule of product administration). The second dose was almost 6 months after the first dose in a 3-dose series and was given further apart than recommended.  No additional adverse event (AE) was reported.
Parent called to report swelling around mouth and hives on body approximately 44 minutes after inoculation. Sent to ER now with parent taking child directly in.  Denied difficulty with swallowing or SOB.
On 10/12/17 patient was shopping in the store and mentioned that she still had a bruise at the injection site. Upon clarification patient had bruising and soreness at the injection site starting the day after the injection and bruise still visible on 10/12/17.
Heart palpitations began approximately 25 minutes after my second covid shot. They have continued still today. All day, all night.
Pt vax w/DTP/HIB/OPV day 3 unconsolable crying w/high pitched cry x 12 hrs.
flu like symptomps; Fever; chills; exhausted; vaccines were improperly stored; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT STORAGE ERROR (vaccines were improperly stored), INFLUENZA LIKE ILLNESS (flu like symptomps), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhausted) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure.   On 15-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) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (vaccines were improperly stored). On 13-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptomps), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhausted). At the time of the report, PRODUCT STORAGE ERROR (vaccines were improperly stored), INFLUENZA LIKE ILLNESS (flu like symptomps), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhausted) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
Itchiness to chest area. Increasing in intensity and with rash over next 18 hours. Skin "hurt" to be touched. No fever, no difficulty breathing but reported chest tightness. Reported to nearest Emergency Department. Treated with Pepcid, Benadryl and dexamethasone with effect.
Patient reported urticaria down arm on vaccination side, with spread across back. At time of evaluation by occupational health provider, rash was resolving and patient reports it was no longer itching
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case contains information for the 57th out of 100 adult male patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved.  Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Started out with a painful arm with weakness in affected arm to the point of difficulty in using affected arm. This lasted about a week. Then patient started experiencing a deep throbbing pain in the joints of all the patient's fingers but not affecting her wrists. This event is also present in her knees and ankles. This event is still ongoing. PCP seen advised patient to take OTC Ibuprofen TID PRN.
Dry throat and later voice was scratchy and hoarse within 10 minutes of the vaccine Two hives two hours after the vaccine