chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client c/o pain immediately following injection. Later called reporting swollen arm at injection site and pain, Ice pack and anti inflammatory suggested. Family says takes Tylenol. Later that night client c/o increased pain, edema, looked pale, so they took her to ER where she was admitted for infection. 12/19/06-records received and reviewed. DC Summary: DC DX: arthus reaction to repeat pneumovax hypokalemia Secondary diagnoses: hypertension hyperlipidemia hypothyroidism osteoporosis degenerative joint disease On admission had significant pain in right should at the administration site and a fluctuant soft tissue mass over the right deltoid and acromial area. Arthrocentesis into the subacromial space yielded 40cc of purulent cloudy fluid, joint space was not accessed. Fluid showed WBC 107,000 and a Gram stain without organism and 4+ WBC. This is a significant immunological reaction to repeat Pneumovax administration (previous doses 10/98 and 2005 and 10/23/06
Very light headed, confused, vomited within 1 hour of shot. Vomit a few times next 3 days.
Information has been received from a pharmacist referring to a 51 year old female patient. The patient was allergic to sulfanilamide and had no pertinent medical history. On 08-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, strength and route unknown). Concomitant therapies included omeprazole and RESTORIL. After the vaccination, on an unknown date of December 2015 the patient noted that the site of the injection was red, warm and itchy. On 10-DEC-2015, the patient came to the pharmacy for guidance. The pharmacist confirmed that it was not rash. No treatment was given for the event and no lab diagnostics was performed. The outcome of the events were not recovered. Causality was not provided. Additional information has been requested.
Swelling (R) side of face, drooping of (R) eyelid and (R) corner of mouth decreased sensation (R) side of face.
Total body rash within 2 hours, began scratching within 30 minutes. Response from CLARITAN 10 mg till it begins to "wear off" then rash returns, retreatment with same, also to begin HC 1% topically.
pharmacist  says she cannot give the information to fill in lot information pt reports fever 10.8 and ill with "flu-like illness for approx. 24 hrs; unable to work 9/15/21
Post vax, the pt's mom noticed induration in left thigh. Seen by physician.
Presented to office 12/09/11 with erythema, edema, pain (L) arm - shoulder to lower elbow. Pt states began several hrs after received PNEUMOVAX (presented to office approximately 27 hrs after adm). Rx given KEFLEX 500 mg QID x 10 D.
Severe reactivation of herpes simplex 1 (HSV1).  8 new herpes lesions since 2nd dose. Compared to 1 lesion per year.
This spontaneous report was received from a medical assistant refers to a male patient of unknown age. On 13-AUG-2013, the patient was vaccinated with an expired, second dose of GARDASIL, (lot number 0636AA, expiry date, 11-AUG-2013, route not reported). No adverse effects were reported. This is one of the two reports received  from the same reporter. Additional information has been requested.
Headache, Myalgia, Fever, chills, sore arm Narrative:
Headaches, strong right above nose between eyes.  Cognitive decline,  hospitalized for psychosis.
Information has been received from a physician concerning a 69 year old female with no drug reactions or allergies and depression, asthma and a history of breast cancer who on 09-JUL-2008 was vaccinated IM with the first 0.5 ml dose of PNEUMOVAX (Lot #661039/0248X). Concomitant therapy included PROZAC and albuterol. Within a few hours of vaccination, the patient developed a local reaction. Symptoms included redness, pain and swelling. Within 24 of vaccination, the patient developed systemic reactions including fever and myalgia. The patient was told to use ice and TYLENOL. The patient does not recall receiving PNEUMOVAX prior to this. Unknown medical attention was sought. Patient outcome was recovered on an unspecified date. The report is related to WAES # 0807USA04073 from the same source. Additional information has been requested.
Sudden Pain in the lower back, lesson L4 and L5, inflammation of transverse myelitis, numbness of legs, loss of motor movement in the right leg, not currently walking.
Mother called to report 2 small areas of redness at injection site on right thigh. Raised, looks like 'eczema' rash. Not fluid filled. Baby was 'fussy' over the weekend but mother did not report any fevers. No other rashes or signs of reaction other than on right thigh. No treatment taken other than watchful waiting.
Within 2 minutes of getting the vaccine I got the cold chill, light headed and dizziness,some trouble breathing, chest felt little tight and some chest pains not too bad, throat felt little constricted but not severe, cold chills lasted 2-3 days and head dizziness and chest for like 3-4 days
bee sting looking puncture at injection site; bainaid applied on spot other than injection site; injection site swelling; injection site redness; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness), INJECTION SITE INJURY (bee sting looking puncture at injection site) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (bainaid applied on spot other than injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On an unknown date, the patient experienced INJECTION SITE INJURY (bee sting looking puncture at injection site) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (bainaid applied on spot other than injection site). On 23-Apr-2021, VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness) and INJECTION SITE INJURY (bee sting looking puncture at injection site) was resolving. At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (bainaid applied on spot other than injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information is not provided
Pt came in for 2nd Pfizer vaccine. Pt had previously had anaphylactic reaction to 1st Pfizer vaccine. During first dose visit, pt was administered epinephrine, solu-medrol and diphenhydramine by staff and MD. Pt was then transported to ER.  Upon return for 2nd visit 21 days later, the pt stated to LPN that she had experienced an anaphylactic reaction to the 1st dose, which is a direct contraindication to receive the second dose. Pt also stated to LPN that ER doctor during her first visit, had said to receive the 2nd dose regardless of reaction. Per protocol, any anaphylaxis history needs to be reported to charge RN for closer observation. LPN administered 2nd dose of vaccine without informing charge RN. Approximately 5 minutes after administration, pt began to have severe shortness of breath and chest tightness. RN, and Charge RN, proceeded to recognize pt distress and began to take vital signs. Pt exhibited hypertension of 139/110, tachycardia of < 135 beats per minute, and expiratory wheezes bilaterally in all lung field posteriorly. Pt was transferred to wheel chair and moved to secluded area for further medical treatment. Occupational MD was called and arrived approximately 5 minutes later. Pt did take one puff of her prescribed albuterol inhaler in those minutes. Occupational Health MD arrived and 0.3ml of Epinephrine was administered. Repeat vital signs were taken 5 minutes later and vital signs showed improvement. Pt stated she experienced a decrease in shortness of breath and expiratory wheezes decreased upon auscultation. Pt was taken to ER for further evaluation and observation and instructed by health MD not to receive the 3rd dose due to severe anaphylaxis.  LPN was pulled aside after incident and re-educated on POD protocol and CDC guidelines with anaphylaxis reactions to COVID shots. Follow up email was sent to rest of POD nurses with POD guidelines and protocols.
Three days after first dose, I awoke in the early morning hours to go to bathroom.  I lost all strength in my body and fell injuring  my rib, arms, head and shoulder  I have been hospitialized for two days now.
Mom reported a rash the entire front of arm with red blotchy edges, warm to touch. Mom reported she administered Benadryl with a positive effect and rash cleared up and did not return.
stated that his friends father got covid three weeks after the first dose of vaccine; stated that his friends father got covid three weeks after the first dose of vaccine; This is a spontaneous report from a contactable physician reported for a patient. An male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 12Apr2021, 19:09:26 , as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not provided. Physician was reported that his friends father got covid three weeks after the first dose of vaccine. Patient underwent lab tests and procedure SARS-CoV-2 test (positive). Outcome of the events were unknown.   Information about Lot/Batch number is requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event and the suspect drug.
approximately 6-8 weeks after final dose of vaccine- irregular bleeding occurred for 6-8 months.  dx: N92.5 irregular mensuration
I started breaking out in red rashes on my arms and side of face. Started going away after two hours
Site of injection: sore, swollen, red, Itchy, warm. Rash?
felt fine when was about to leave after waiting around for 15-20 minutes started to feel dizzy, rapid heart rate, tongue became numb, and body started to feel tingly. We called 911 and they monitored the patient and they cleared her to leave on her own.
Within 30 minutes of vaccination, client experiences difficulty swallowing and breathing. Epinephrine was administered and EMS/911 activated. Respiratory symptoms slightly improved with epinephrine, and EMS arrive and transported to ER.
Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse over the next few minutes making it difficult to swallow.  At the same time I felt very fuzzy and numb all over my face and body and very light headed.  My arms and legs felt very heavy.  The EMT took my blood pressure and told me it was 174/125.  My normal BP is 110/60.  I have had my BP taken once a month over last 20 years at my monthly pain center appointments.  They hooked me up to a 4 lead cardiac monitor and said I had  A -Fib. They then hooked me up to a 12 lead ekg  monitor and said I didn?t have A-Fib.  I have had 3 EKG?s in last year because I was scheduled to have total knee replacement surgery which was rescheduled 2 times and all 3 EKG?s were completely normal.  After about 1 hour my symptoms improved to the point where I could go home.   I Have had between 20-30 knee procedures over the last 40 years and my reaction to the vaccine felt exactly like I was being put to sleep by sodium pentothal or a very high dose of Versed.
I was on my menstral cycle and the cramps were more intense. Dizziness and feverish though no fever. Tired and pain in shot arm
The patient was given PCV-13 and Hib in the morning of 4/12/12 around 9 am and a had a seizure at 3:26 pm later the same day. No associated fever, seizure generalized.
felt a little sick next day after receiving 2nd dose of Moderna Vaccine; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt a little sick next day after receiving 2nd dose of Moderna Vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003AZIA and 006M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Allergic to unspecified past drug.). Concomitant products included CITALOPRAM and OMEPRAZOLE for an unknown indication.   On 19-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (felt a little sick next day after receiving 2nd dose of Moderna Vaccine). On 21-Mar-2021, ILLNESS (felt a little sick next day after receiving 2nd dose of Moderna Vaccine) had resolved.            Patient was not hospitalized for the event. It was reported that patient had taken other medication within 2 weeks of starting COVID-19 treatment. Patient received COVID-19 vaccine previously. It was reported that patient had received PAXLOVID for treatment of COVID-19 on 01-Sep-2022 and date of last administration was 06-Sep-2022. It was also reported that patient received dose 3 of Moderna vaccine on 06-Dec-2021, Batch/Lot No: 030H21B Location of injection: Arm Left. On 19-Jul-2022 patient received dose 4 of Pfizer/BioNTech vaccine, Batch/Lot No: FN2908 Location of injection: Arm Right.  No treatment medications given for the event.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Positive, notes: tested Positive that morning on a home covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course:After 5-day dose of Paxlovid patient felt vibrant and healthy and normal and did about 4 days of heavy yard work because had felt so fit and back to normal. On Sunday 17Jul started sneezing a lot in the morning and becoming very lightheaded. By evening developed a bad headache that lasted until the next morning and tested Positive that morning on a home covid test and managing the headache with ibuprofen and had congestion and runny nose and extremely exhausted as if he cannot get enough sleep and writing this on day 2 of experience of returned symptoms. Anti-viral details product: COVID 19 Treatment (Brand Paxlovid), Treatment start date 04Jul2022 and  treatment stop date :09Jul2022 Indication was treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events and suspect drug cannot be excluded completely
Swollen eyelids, red eyes, runny nose & congestion. 1st time receiving high dose. Had low dose before with no adverse rxns per patient report.
Fever 30 hours after injection Nausea and epigastric pain - severe by 36 hours, vomiting, not responsive to OTC medications
Patient received his 2nd dose of the Moderna vaccine prior to hospital admission at unknown site. Patient reported generalized body aches and that his whole body hurts and feels likes he's "being poked with a knife." He endorsed associated symptoms of fever, nausea, back pain, and shortness of breath. The patient denies any sore throat, headache, cough, or vomiting. His back pain is at the tip of his shoulders, in the middle of his spine, and near his kidneys. The patient adds the abdominal pain is worst in the lower left quadrant. Patient  admitted for bilateral lower extremity weakness limiting him to ambulate and to rule out Guillain-Barré. During admission, had fevers, photophobia, phonophobia, and nuchal rigidity. On physical examination patient was  able to minimally wiggle toes,  had no plantar/dorsiflexion,  unable to move hip joints or knee joints bilaterally,  lift his legs against gravity.
Nausea; Fever; This is a spontaneous report from a contactable nurse. A 60 year old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unspecified) via an unspecified route of administration, administered in the arm. On 21Jul2021 as DOSE 1, SINGLE for COVID-19 immunization (at the age of 56 Years). Medical history includes Colon cancer on 08Jan2021 stage 2. The caller stated the patient is now in remission and is not on any medication for the colon cancer right now. And allergies on unknown date (The caller stated the patient does see an allergist and is on other medications, inhaler, albuterol and another allergy medicine.). Concomitant medication(s) included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE(Advair Diskus) 250mcg-50mcg twice a day). Albuterol Inhaler 90mcg, 2 inhalations as directed for allergies. On 22Jul2021 the patient experienced fever, until 27Jul2021 of 101. On an unspecified date patient experienced Nausea. The caller stated the fever has been persistent since 22Jul2021. Ratio of 101-103, today, 27Jul2021 at 1500 the fever was 103.6. This morning,27Jul2021 at 1000 the fever was 101.1 with Tylenol in the patient's system. The caller told the patient to take another dose of Tylenol and recheck temperature in 30 minutes. Product strength and count size dispensed: 650mg. The patient saw her primary care physician and was given Zofran 4mg for nausea. Outcome for fever was not resolved and the outcome for nausea was unknown. Information on lot/batch number has been requested.  Follow Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
herpes zoster queratitis; This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster keratitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingrix. On 26th June 2020, 3 days after receiving Shingrix, the patient experienced herpes zoster keratitis (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes zoster keratitis was unknown.   It was unknown if the reporter considered the herpes zoster keratitis to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported that a patient received the Shingrix and experienced herpes zoster queratitis /kertitis. The patient was currently being treated with Valtrex.
Metallic taste in mouth, two minutes post injection. Ongoing. Tinnitus, one hour, fifteen minutes post injection. Ongoing.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that doses of RECOMBIVAX were improperly stored and were administered (on an unknown date). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Arm was very sore first day/night, more than standard injection site soreness. On 10/28/2021, noticed a hard lump, redness at the injection site and nerve pain that traveled from the site down to my right thumb; my wrist was so sore I felt like it should be splinted. The redness at the site was the size of a dime and the pain continued to intensify. By today, 10/29/2021, the redness has spread to larger than a half dollar, it is hot to touch, it itches, the lump is as big as the circumference of the redness, and it remains quite painful. I plan to contact my PCP or urgent care for possible abx rx. I have never had an injection site reaction before.
Patient called me today on 1/6/2022 at the pharmacy stating she has pain in the arm at the injection site from the day she received the vaccine on 12/22/21 til now. She contacted the doctor who will see her in a week but her doctor said takes ibuprofen to help with pain or inflammation
DAY 1: After approx 30 mins after receiving vaccine: SUDDEN DIZZINESS/Loss of hearing/trouble breathing/heart palpitations/chest pain/nausea/confusion/blurred vision/feeling of doom. EPISODE LASTED 1.5-2minutes  DAY1: Approx 8 hours after receiving vaccine: moderate headache/moderate body aches/moderate fatigue/high grade fever not controlled by a combination of max allowed dosage given per instructions and not exceeding max in 24hr periods/dosage of the following, starting at 7pm, 1000mg acetaminophen(initial dose), 440mg naproxen sodium (initial dose) taken at same time, then 220mg naproxen (subsequent doses after 12 hours) and 1000mg acetaminophen(subsequent dose) , 99.8 (7pm), 102.5 (11pm), fever held through night into following morning 103.6 (1:30am-6:30am on 10/23/21)  DAY 2 10/23/21: fever held at 100.5 from 7:00am through following morning on day 3 despite regular use of recommended dosage of both fever reduces mentioned/swollen and painful axillary lymph nodes in left under arm (same arm where shot was given)/swollen and tender superficial cervical and submandibular lymph nodes on left side, also causing middle-inner ear pain in left ear.   Day 3 10/24/21 : fever still at 99.8 through 5pm, fever has finally resolved// INCREASED SWELLING AND PAIN in axillary lymph nodes under left arm/swelling in superficial cervical and submandibular has subsided.   Has recovered from all EXCEPT swollen and painful left axillary lymph nodes
Reports diaphoresis, swelling and pain of the left arm (injection site), redness of the left arm. New blood pressure elevation noted in office during examination of left arm redness on 03/19/2012.