chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like her lips were numb; left ear pressure; left jaw numbness; drooling; Mld left sided headache; left sided lower facial muscle weakness; left sided lower facial muscle weakness / diagnosed / left sided bell's palsy / facial drooping; had left ear pain; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number J2N44, expiry date 17th May 2022) and (batch number 7TB74, expiry date 17th May 2022) for prophylaxis.   The patient's past medical history included cervical cancer, thyroid papillary carcinoma, chronic back pain, thyroid gland cancer and hysterectomy. Concurrent medical conditions included hypertension. Concomitant products included thyroxine sodium (Levothyroxine), amitriptyline and amlodipine.   On 18th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. In November 2020, less than a day after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and ear pain. On 18th November 2020, the patient experienced numb lips, sensation of pressure in ear, numbness facial, drooling, headache and facial muscle weakness. The patient was treated with prednisone and valaciclovir (Valacyclovir). On an unknown date, the outcome of the bell's palsy, numb lips, sensation of pressure in ear, numbness facial, drooling, headache and facial muscle weakness were not recovered/not resolved and the outcome of the ear pain was recovered/resolved.   It was unknown if the reporter considered the bell's palsy, ear pain, numb lips, sensation of pressure in ear, numbness facial, drooling, headache and facial muscle weakness to be related to Shingrix.  Additional information received as follows: The age at vaccination was not reported. The patient received Shingrix in left deltoid and had left ear pain for less than 3 days. She stated that, on the day of vaccination for the past hour she felt like her lips were numb and she went to an urgent care that day within an hour or so of reporting her concerns and reported that she had left ear pressure and left jaw numbness and a little bit of drooling.  She had a mild left sided headache.  Her diagnosis was left sided lower facial muscle weakness including the left side of her mouth and lower left side of her face without anything on the right side.  She was diagnosed with left sided bell's palsy on 24th November 2020.  She was prescribed prednisone 60 mg. daily for 7 days and 1 gram of valacyclovir three times per day for 7 days.  On27th November 2020, she was taking the prescribed medication and she felt that her symptoms were the same but no new symptoms.  On 30th November 20, she reported feeling that there was slight improvement in her facial drooping.  She had a recent primary care visit on 21st Octo 20 with no mention of any concern.   The reporter consented to follow up. Lot number provided was listed in the patient's medical chart with two separate vials for the vaccine.
patient developed a lot of pain in the arm, swelling and rash after administration, developed bruising in the area several days later
12/12/21 presents to ED for "dyspnea". PMHx of "ADPKD, CKD s/p renal transplant, AFib, HTN, RCC w/ mets"
sore arm; A spontaneous report was received from a consumer concerning a unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced the events sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 14 Jan 2021 the outcome of events sore arm was resolved.; Reporter's Comments: This case concerns a female of unknown age who experienced a NS unexpected event of Pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Slight fever; chills; diarrhea; swollen lymph nodes (left arm pit); low back pain; This is a spontaneous report from a contactable Consumer (patient) reported for herself. A 65-year-old non pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: 301358A) via unknown route of administration in left arm on 14Oct2021 at 14:30 (at the age of 65 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included Kidney disease, Stage 1. The patient did not have allergies. The concomitant medication included rizatriptan for an unknown indication from an unknown date ( reported as other medication in two weeks). The patient historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6199) via unknown route in left arm on 08Mar2021 at 09:00 AM (at the age of 65 years old) as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: ER8737) via unknown route in left arm on 30Mar2021 at 08:30 AM (at the age of 65 years old) as DOSE 2, SINGLE for covid-19 immunisation. Patient did not receive other vaccine in 4 weeks. On 14Oct2021 at 21:00, the patient experienced slight fever, chills, diarrhea, swollen lymph nodes (left arm pit) and low back pain. It was reported that Fever, chills lasted 24 hours, but lymph nodes still swollen and back pain was persistent. Patient did not have covid prior vaccination and not tested for covid post vaccination. The lab data included body temperature was slight fever on 14Oct2021. It was also reported that the events were non-serious. Patient did not receive the treatment. The outcome of the events Fever and chills were recovered on 15Oct2021 and other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that they had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 11 out of 18.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
C/O swelling, tenderness, pain in R delt. Client states unable to lift R arm above head r/t pain. Client demonstrated only able to lift R arm 20 degrees laterally to body, demonstrated full range of motion w/ L arem. Client reports pain to touch, denies fever.  Minimal swelling noted along R delt and behind R tricep. No redness, bruising noted. All submandibular, submental and axillary lymph nodes nonpalable. Client states employer will not allow him to return to work without note from physician. Referred to PCP for eval.
couple of bumps; This case was reported by a consumer via call center representative and described the occurrence of swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. Recently from the date of reporting, the patient received a dose of Shingrix and developed a couple of bumps afterwards. The reporter declined to provide any personal information for this case.  No other details are available, caller disconnected. The follow up consent was not granted. This case has been linked with case US2019222796, reported by same reporter.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age. The patient was vaccinated with her first two doses of GARDASIL (Lot # not reported) "a few years ago" and received her third dose of GARDASIL (Lot # not reported) on 19-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
81yr old female presents ambulatory with complaints of asthma. Patient was seen by provider in the clinic yesterday no medication changes made. Husband states he would like patient to be on Z-pak and Prednisone. Patient does not appear to be in distress, oxygen saturation above 90%. Patient has dementia and does not answer all questions. Has been using nebs and inhalers as ordered.
This spontaneous report as received from a pharmacist refers to a currently 21-year-old male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with M-M-R II injection (dose, route of administration, lot# and expiration date were not provided). On an unknown date the patient received VARIVAX injection (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient came to the pharmacy to receive booster vaccines of M-M-R II and VARIVAX at his school request due to his antibody levels were low. The mumps antibody was reported low at 9 and varicella antibody level was low at 135. The outcome of the adverse event was unknown. The relatedness between the adverse events and M-M-R II and VARIVAX was not reported. Additional information has been requested.
Headache, Myalgia, Arthralgia, Developed HA,chills, myalgias,arm soreness and low back pain 2 hrs after 2nd COVID 19 vaccination. Narrative:  Developed HA,chills, myalgias,arm soreness and low back pain 2 hrs after 2nd COVID vaccination. Missed 2 days of work.
Information has been received from a 61 year old female patient. The patient had allergies and "borderline pneumonia" in December 2005, born with organs reversed and monitored for cardiac problems. The patient could not take pain medications due to severe stomach distress after codeine. On 24-OCT-2006 the patient was vaccinated with PNEUMOVAX 23 (lot # 651374/0485F; dose and route not reported). In "late October 2006", the patient developed a severe injection site reaction shortly after receiving PNEUMOVAX 23. She developed a lump that was red, warm, painful, and very swollen. The arm "burned" to the point where putting ice only helped the "top layer of skin" but nothing more. On an unspecified date, an ultrasound of the arm was performed. The patient reported that "it looked like an elephant pacifier". The lump was drained and came right back so the physician recommended surgery and performed a surgery in the office in December 2007 to remove the lump. He did not cut into muscle but said it might take up to 1 year for the nerve endings to heal. It continues to swell up and throb from that time on to the present. She can't use this left arm to lift anything and is restricted in her movements. She can't use her personal trainer. The patient considered her experience to be disabling. Additional information has been requested.
39 yo M admitted 9/3 w/ fever, blurred/double vision, fatigue. He got a 3rd COVID vaccine (Pfizer) on 8/31 (he received Pfizer for initial series in March/April).  He had a rash a few hours after the vaccine on 8/31 which has mostly resolved - looked more petechial from what he describes; still has a few lesions on his thighs and back.  On 9/1, he developed fatigue. Took tylenol and benadryl, and called in to work. On 9/2, began having double vision, and had a fever to 103. On 9/3 he was feeling winded when walking down stairs, and he felt miserable, so he and his wife went to the ED.  Pt has been on infliximab for CD; last infusion 8/10.  Pt was afebrile in the ED but began having high temps soon after admission. CXR and respiratory viral panel was negative. BC sent. Lactate was normal and WBC 11. LP was attempted in ED but no fluid could be attained. CTX and vanc were begun due to fever and immune compromise.   All imaging and work up has been negative to date. CTX and vanc were stopped today.  The double vision has stopped now, he feels fevers are a little better, rash is nearly resolved. Still has a HA - a little worse or the same as before. Still feels worn out. He hasn't felt winded when he has taken walks in the halls.  Afebrile today, Tm 9/5 101.1, 9/4 104.2, 9/3 102.2 WBC normal except 9/5 @ 13  Denies sore throat, dysphagia, cough, chest pain, abd pain, N/V, join paints, join swelling. Has had some loose stools since symptoms started. CD feels stable to him.
Had dinner around 7:00 PM while working. Started to "feel funny" around 8:30 PM and had jerking movements - uncontrollable. Asked co-worker to take her BP because she didn't feel well and started to have tonic clonic grand mal seizure.
administered / expired dose of Hiberix/ expiration date: 04/18/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received Hib (Hiberix) (batch number 4A99Z, expiry date 18th April 2021) for prophylaxis.   On 18th May 2021, the patient received the 1st dose of Hiberix. On 18th May 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The nurse reported that the patient received vaccine of Hiberix which was already expired on 18th April 2021. No further events were reported at the time of the call. The health care professional declined follow up and it was obtained from the internet.
Evening of administration had chills; afebrile. Right deltoid next day became painful, swollen. Swelling continued with hard induration approx 1" across, swelling to right side of neck; swollen and tender lymph node to right axilla within two to three days. Was seen in physicians office 1/28/11. No treatment, resolved without difficulty.
13JUL92 pt recvd 1st dose of Engerix-B & 13AUG92 pt recvd 2nd dose of vax & devel severe unresponsive h/a for 4 days; pt recvd APAP & Kronofold A;
Breakthrough case admission after three vaccines  PFizer x3; Pfizer 3/8/21 Lot# EN6199;  Pfizer 3/29/21 Lot# Lot# ER8733;  Pfizer  10/6/21 Lot# EW0164;
Pt vaccinated 8/16/06 with Smallpox vaccine, apparently had good take and since he deployed 4-5 d later. Scabbed/healed by end Sept/early Oct. No problems till June 07. Pt had short sleeve short, exposed arm to sunlight for 6-7 hrs, developed redness, inflammation, swelling and 1/2 of scar area was fluid filled (clear fluid). Resolved over 1 week without tx. No current lesion. Scar area 7x10 mm. This occurred 2-3 times Jun - Jul 07. No lesions since Jul 07 even with sun exposure.
This spontaneous report was received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ. 19 doses were administered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Day after the shot (March 3)  he started having shortness of breath and then continued up until March 16 started running fever of 102.9 and still having difficulty breathing-went to ER and then diagnosed with blood clots in lung "acute pulmonary emboli" and pulmonary infarct and his heart was enlarged-by CAT scan.  In ICU for 3 days and discharged at that time out of ICU to home.
Bump that has come back but is not pinkish; bump has come back but not pinkish but is itching; very pinkish-red raised bump/red arm; lump within arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (lump within arm), VACCINATION SITE PAPULE (Bump that has come back but is not pinkish), VACCINATION SITE PRURITUS (bump has come back but not pinkish but is itching) and VACCINATION SITE ERYTHEMA (very pinkish-red raised bump/red arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE MASS (lump within arm) and VACCINATION SITE ERYTHEMA (very pinkish-red raised bump/red arm). On 19-Feb-2021, the patient experienced VACCINATION SITE PAPULE (Bump that has come back but is not pinkish) and VACCINATION SITE PRURITUS (bump has come back but not pinkish but is itching). At the time of the report, VACCINATION SITE MASS (lump within arm), VACCINATION SITE PAPULE (Bump that has come back but is not pinkish), VACCINATION SITE PRURITUS (bump has come back but not pinkish but is itching) and VACCINATION SITE ERYTHEMA (very pinkish-red raised bump/red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient got red arm and lump within arm after receiving the first dose of the vaccine and was disappeared but came back after 9 days. Concomitant medications were not provided. The patient did not receive any treatment medications.   This case was linked to MOD-2021-169362 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Contact information and additional event updated. On 25-May-2021: No new information reported
Elevated fluttering heart rate 90 BPM while resting blood pressure 135/80. Fever 101°
103.2 temp, vomiting x 2 at 2AM 6/12/12 - fever & vomiting resolved by 1:00PM on 6/13/12. Pain in legs - no redness. Mom called back at 4:30PM 6/13/12 - left leg - thigh broken out in rash - redness/soreness worse - pt tolerating food, no temp.
Patient was pale, sweating, stated that she was experiencing back pain, she was having discomfort when breathing, but not difficulty breathing. Blood pressure was 135/72, patient stated that was slight higher than normal. Patient rested in the pharmacy for 10 minutes than stated she felt fine. Patient declined any emergency type of service.
Symptoms began with mild rash on torso on 12/12/21. Rash spread to face on 12/13/21 which was noticed after waking from a nap at 5:00 pm., the injection site was also inflamed. By 6 pm the rash was significantly worse on thighs, torso, arms, neck and the hives on her face intensified. By 7 pm her face was nearly fully covered with hives, rash had also intensified in all other areas of her body and the site of injection was more inflamed. Due to the rapid progression of the rash/hives across her body, I took her to the ER where she was given Prednisone and Benedryl. Two days later the hives have gone down a bit, but are still quite significant, along with the rash over her body. It's interesting that she has hives on her face, but the rest of the affected areas have a rash. All of the affected areas are itchy, painful and feel like they are on fire. She is four days in and has only experienced mild relief from the medicines provided and also from using cool washcloths to help reduce all her symptoms.
Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. No further information is available. The patient's also had an adverse experience after vaccination with zoster vaccine live (Oka/Merck) (WAES # 0804USA03492).
Bright red, hot agitation at the site of Varicella vaccination. Dizziness, nausea, and weakness.
Initial rash, very pruritic. Then prolonged pain involving left arm, where vaccination was given.
Patient is a 74 y.o. male admitted to the hospital on 10/24/2022 for acute on chronic hypoxemic respiratory failure as well as COVID-19 infection.  Patient was found to have acute exacerbation of his chronic lung disease.  He suffered a complicated hospital course ultimately resulting in endotracheal intubation.  Patient was unable to be weaned from the ventilator and the decision was made on hospital day 26 to pursue compassionate extubation.  Patient passed away in the hospital on 11/19/2022.  Please see previous notes for full detailed hospital course.
pt recv vax 18MAR96 & screamed for 3hr;pt was recovered as of the date of this report;
A few minutes after inoculation, the patient felt chest tightness.  She rested for a few minutes.  Her chest tightness did not ease.  She used her asthma inhaler to try to relieve the symptoms.  Immediately (but not necessarily because of the inhaler) her symptoms worsened.  I called over the attending EMTs, who put the patient on 02.  Soon after, a pulse oximeter showed the patient's 02 sat at 100, pulse at 110.The feeling of tightness continue but the oxygen immediately relieved the patient's distress.  After a few more minutes, the patient took another hit of albuterol.  That brought immediate relief.  Her pulse gradually slowed to the mid-70s.  She said she felt tired, as often she does after an asthma attack, but soon felt well enough to leave.  She planned to take an cab or equivalent to home, and said she had taken the day off.  She said her doctor warned her that because she has a history of reactions (details unknown) to vaccines, she might react badly to Moderna, but the doctor and patient agreed that it was worth the risk. She said her reaction to NSAIDs has been anaphylaxis.