chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWELLING IN RIGHT HAND/SWELLING IN THE PALM  AND BACK OF RIGHT HAND; ITCHING IN RIGHT HAND/ ITCHINESS IN THE PALM  AND BACK OF RIGHT HAND; HAVING A LITTLE HEAT TO IT AS WELL; MILD INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, ragweed allergy, pet dander allergy, molds allergy, and environmental allergy. The patient experienced drug allergy when treated with cefalexin, and cefixime. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200096,and  expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced swelling in right hand/swelling in the palm and back of right hand. On 24-AUG-2021, the patient experienced itching in right hand/ itchiness in the palm and back of right hand. On 24-AUG-2021, the patient experienced having a little heat to it as well. On 24-AUG-2021, the patient experienced mild injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in right hand/swelling in the palm and back of right hand, mild injection site pain, itching in right hand/ itchiness in the palm and back of right hand, and having a little heat to it as well. This report was non-serious.
Information has been received from a licensed practical nurse concerning a patient who on 23-DEC-2008 was vaccinated with PNEUMOVAX (lot number 662663/0980X). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX administration. The patient had symptoms, which included swelling, redness, pain and heat at the injection site. The patient went to the express Clinic for a sore arm. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. This is one of several reports received from the same source. Additional information has been received from the office manager who confirmed that several patient had injection site reactions. Additional information has been received from a licensed practical nurse concerning a 79 year old female patient who on 08-JAN-2009 10 AM was vaccinated IM with the first dose of PNEUMOVAX (Lot number 662663/0980X). Subsequently, the patient developed fever, body aches, edema, redness, heat from shoulders to below elbow. Subsequently, the patient was recovered from the adverse events. The patient went to ER to sought medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Agency and was released. No further information is available.
Passed out for 10 minutes; This spontaneous report was received from the patient's parent, who was a friend of the company representative, concerning a 15 year old female patient. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 09-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dosing, dose number in the series, frequency, route of administration, lot number and expiration date were not provided) and also with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided). No laboratory diagnostics/studies were carried out and the patient did not seek medical attention. On the same date, the patient passed out for 10 minutes (loss of consciousness) while in the car as a passenger. The patient recovered from loss of consciousness on the same date. The causality assessment was not provided.        Upon internal review, loss of consciousness was determined to be a medically significant event.
Dose Number: 3; Verbally unresponsive; Temp of 101.9F; red face; Weakness; This is a spontaneous report received from contactable reporter (Pharmacist). A 78-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Oct2021 (Lot number: FD0810) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: MS. Concomitant medications included: ACETAMINOPHEN; AMLODIPINE; AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]; ACETYLSALICYLIC ACID; BENAZEPRIL; DALFAMPRIDINE; DICLOFENAC SODIUM; FLUTICASONE; MELATONIN; OXYBUTYNIN; SENNA [SENNA ALEXANDRINA]; GLYCOLAX; MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; VITAMIN D [COLECALCIFEROL]; ATARAX [HYDROXYZINE HYDROCHLORIDE]; MILK OF MAGNESIA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Feb2021, when the patient was 78 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 18Jan2021, when the patient was 78 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 28Oct2021, outcome "unknown", described as "Dose Number: 3"; UNRESPONSIVE TO STIMULI (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Verbally unresponsive"; PYREXIA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Temp of 101.9F"; ERYTHEMA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "red face"; ASTHENIA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Weakness". The patient was hospitalized for immunisation, unresponsive to stimuli, pyrexia, erythema, asthenia (hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: body temperature: (28Oct2021) 101.9 Fahrenheit. It was unknown if therapeutic measures were taken as a result of unresponsive to stimuli, pyrexia, erythema, asthenia.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of event unresponsive to stimuli, pyrexia, erythema and asthenia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
sore throat; swollen lymph nodes; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 67-year-old male patient (reporter's husband). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Aug2021 (Batch/Lot Number: FC3182; Expiration Date: 31Oct2021) as DOSE 1, SINGLE for covid-19 immunisation at Health Department. Medical history included covid-19 from Feb2021 to an unknown date (received the antibody infusion/husband had an infusion when he had Covid 19), ongoing type 2 diabetes mellitus Type 2 Diabetic (this is under control), prostate cancer from 2018 to an unknown date (Prostate Cancer with radiation treatment States this was 2 years ago), radiation treatment from 2018 to 2018 (Prostate Cancer with radiation treatment States this was 2 years ago), ongoing immunodeficiency. There were no concomitant medications. Wife called on behalf of husband, male, aged 67, DOB: (withheld), received first dose of the Pfizer BioNTech Covid 19 vaccine on 17Aug2021 around 10am. That afternoon he developed a sore throat and swollen lymph nodes. He was still having these symptoms today. He has tried gargling with Chloraseptic and with coffee. If these symptoms were too bad guess, he just won't take the second dose? (made this comment in passing and did not specifically address during call, just stated in general that she needed to talk to her husbands HCP). Therapeutic measures were taken as a result of sore throat. The clinical outcome of the events was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
Pt with history of Afib, IDDM2, and is being admitted with COVID pneumonia.  He has had onset of generalized weakness over the past 10 days.
Pt. stated, "It feels different when I swallow."  Patient stated the feeling started 5 minutes after getting the vaccine.  At 12:59 pm patient stated she is feeling ok and wants to go home.  She is swallowing fine.
Case number PHEH2016US032718, is an initial spontaneous report received from a pharmacist on 12 Dec 2016. This report refers to a 52 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated from multi dose vial of FLUVIRIN (batch number: 1619901, expiry date: May 2017) subcutaneously at a dose of 0.5 ml which was reached 69 Fahrenheit for no longer than 24 hours on 10 Dec 2016. No adverse event was reported following this administration error. The seriousness of the event was reported as non serious.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 23-JUN-2015, the patient was vaccinated with a dose of improperly stored VAQTA lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 3 times with the following lowest recorded temperatures: 34F (1.111 Celsius degrees) for 88 hours, 32F (0 Celsius degrees) for 40 hours and 33F (0.555 Celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
HIGH FEVER AND HEADACHE . TOTAL DURATION APPROXIMATELY ONE HOUR. FULLY RESOLVED WITHOUT ADDITIONAL TREATMENT.
Patient presented to ED for evaluation of headache, body aches, agitation.  Increased O2 needs once admitted, requiring high flow O2.  Greater than 14 days post J&J vaccination.  Patient passed away 8/2/2021
Patient came back one day after receiving the vaccine to show the inject site. The injection site seemed red, swollen, and warm to touch. Patient stated that the injection site was itchy.
patient described intense pain at the site of the pneumonia vaccine. States that the pain was so intense the next day, she had limited range of motion.
Infant napped 4 hrs. post vax, then awoke screaming for 1.5 hrs. Red swollen areas on both legs, cold compresses applied, tx w/tylenol.  Infant would only breastfeed one side.  Two hrs. later, infant quit crying and both legs were clear of redness.
1.  A few days after the 2nd moderna vaccination, the lymph node under my right armpit had swollen for around two months (from mid April to mid June). 2. Once my lymph node became normal in the middle of June, cutaneous reactions (hives and rash) had occurred chronically in different parts of my body (lips, face, arms, and legs) for the next two months (from mid June to mid August), despite the same dietary and environments as usual. These symptoms gradually but slowly disappeared in August. 3. However, since August, I have had dyshidrotic eczema on my fingers and it is periodically reoccurring close to my menstruation.
Very swollen glands in neck, high fever for several hours, 103?-104?, low grade fever lasting several days, hallucinating bugs
Vacinated on March 8th. Sent home from wsork next day at noon with feaver and fatigue. Next 4 days with fever, fatigue, headache, and muscle pain. Fever broke Friday night. Saturday noticed vision loss. Macula neuroretinopathy worsens each day. Disabled. Treating with 60 mg/day prednisone starting 4-13-2021.
non-ST elevated myocardial infarction. ED to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine,
received second Pfizer COVID dose on 1/24 to left deltoid.  On 1/26 began with pain in bilateral arms and hands. On 2/1 had limited range of motion.  Receiving Tylenol PRN for pain.  On  2/7 new order for ibuprofen 600mg Q8hr. PRN.  On 2/10 rating pain 10/10 sent to ER for eval and treat.  Labs work CT negative, dose of morphine and returned to facility same evening.  On 2/12 rated pain right 5/10 and left 8/10, continue to monitor and follow up with physician
The patient got 2 shots on 2/3/2023 on separate arms (flu vaccine on right arm and shingles vaccine on left arm).  The patient came back on 2/5/2023 and showed her lower right arm  being very sore and bruised-like redness. The patient verified it started on the night of 2/3/2023 and she had taken Tylenol to help with the pain. The arm that got the shingles shot was sore but manageable. The right arm that got the flu shot was the one very swollen and hurting her.  She verified she changed to Goody powder on 2/5/2023.  The patient also verified she used ice compress to help the soreness. She had taken flu vaccines before but it is just this time that she had a big reaction. She is currently having issues with her blood pressure being high because she has missed a few doses for a while and that's why she came to the Pharmacy on 2/3/2023 to get her refills from the doctor. She has not reached out to her doctor yet to report her BP and to get additional relief.  The pharmacist advised her to stop the Goody powder and stay with Tylenol. She was also advised to continue to use ice compress and reach out to her PCP if not any better. Also,  the patient was counseled to get the BP controlled by always making sure not to miss her dose and continually monitor BP and reach out to her Primary Care Doctor if still not controlled.
Presented to hospital on 6/19 with severe frontal headache, mild speech changes, and motor deficits without fevers, shortness of breath, chest pain, or neck rigidity.
Presented to hospital 9/10/2021 with decreased appetite and increased cough.  Her COVID  test was positive 9/10/2021.   On 9/12/2021 due to fever patient begin Decadron, oxygen per protocol, vitamin C, vitamin D3 and zinc. She had some desaturation and required to transition to oxygen at 2L with continued  concern for the possibility of aspiration pneumonia so her antibiotics were adjusted.  Patient continues to progress slowly with therapies and was weaned to room air, VSS.  Patient discharged on 9/21/21.
Hearing loss in right ear; Tinnitus; Aural fullness; This literature-non-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in right ear) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.    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 DEAFNESS UNILATERAL (Hearing loss in right ear) (seriousness criterion medically significant), TINNITUS (Tinnitus) and EAR DISCOMFORT (Aural fullness). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in right ear), TINNITUS (Tinnitus) and EAR DISCOMFORT (Aural fullness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in right ear), TINNITUS (Tinnitus) and EAR DISCOMFORT (Aural fullness) to be possibly related.    Concomitant medications were not provided.   This study includes identifying 18 patients with post-vaccination otologic symptoms. In this case, patient had no prior hearing loss associated issues. The adverse effect was seen in right ear. The days to onset of symptoms was set as between 10-14 days.  Lab test included were the mean pure tone average (PTA) was 52.2 ± 30.6 dB HL for the affected ear, and 21.2 ± 12.5 dB HL for the unaffected ear. The word recognition score (WRS) was 60.6 ± 38% for the affected ear, and 90 ± 23.0% for the unaffected ear.  Most of the patients were still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. The extent of hearing recovery and/or symptom resolution is currently unknown.  Company comment:  This literature-non-study case concerns a 39 year-old male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of hearing loss in right ear, tinnitus, and aural fullness. The events occurred about 10-14 days after the first dose of mRNA-1273 vaccine. No further information on clinical course, investigations performed and treatment received on this specific patient was available in the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338010 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Upon internal review on 13-Jun-2023, significant correction was performed to upgrade the event deafness unilateral to serious medically significant.
I started having normal side effects such as sore arm,  extreme tiredness and headache within 2 hours. By later that night I was in a dazelike state, had a lot of forgetfulness and lived life but as if I was sleepwalking and started having seizures over the next few days. A week later  I'm still having seizures, have no recollection of anything starting from the night of the day I got vaccinated
On 11/05/2001 pt saw physician for tendonitis. Given ibuprofen 600mg. On 11/06/2001 had 1st hep B dose about 3:30 PM. On 11/07/2001 pt reports itching prior to bed. On 11/08/2001 mother obtained Benadryl 25 mg, gave the pt some. Pt continued to take ibuprofen and a drug (minocycline) for acne. On 11/11/2001 noon mother informed nurse that pt was itching all night. Told to increase Benadryl to 50 mg and consult physician if not improved by tomorrow. On 11/12/2001 pt saw physician who thought she had developed hepatitis. He stopped all medication and sent her back to school. On 11/13/2001 pt saw pediatrician. Pediatrician did numerous tests, placed pt on bedrest and told mother he thought she may have Hepatitis A and this probably had nothing to do with immunizations. Live enzymes markedly elevated from results obtained. Immunization nurse called to follow up with mother on how pt was feeling and was given this information. On 11/14/2001 pt returned for results of blood test. Tests were negative for hepatitis. Further tests will be done on 11/16/2001. More blood tests and a MRI were done on 11/16/2001. Results are not known at this time. Mother was informed that I am filling out this form. On 11/19/2001 no results from test to date. mother will sign release of information form so the doctor will send test results to school nurse.
Fever 101, chills, itching, large red area 24X10cm.  Right arm.
general pain at the injection site; experienced edema; has swelling in her fingers and between her knees and ankles; knee swelling/ ankle swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain, edema, swelling of fingers and swelling of knees. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the edema, swelling of fingers and swelling of knees were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, edema, swelling of fingers and swelling of knees to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The patient received 1st dose of Shingrix and 2 months after receiving the injection, she experienced edema. The patient claimed that she had swelling in her fingers and between her knees and ankles that was still unresolved. The patient also experienced general pain at the injection site. The reporter consented to follow up directly with him or her health care professional.
Woke up next morning with no energy gave Ibuprofen. That evening he was running a high fever and vomiting. Restless all night until next day. Then he started to recover. Almost went to hospital.
Pt was present for 1st dose covid vaccine & stated he was very nervous, although he appeared fairly calm.  Pt did not mention any history of lightheadedness or fainting  after injections.  RN reviewed screening questions/eligibility for vaccine w/ pt.  RN answered pt's questions.  Pt was seated in chair for vaccine administration.  Pt was reassured during injection.  After injection completed, pt appeared relieved & stated "That was it?"  Pt got up from chair, as nurse was scheduling his 2nd dose appt.  Pt then c/o nausea.  RN assisted pt  to chair immediately & gave pt  emesis bag.   Pt sat there a minute & stated he didn't feel well.  RN assisted pt up from chair, with as secure hold as possible under pt's left  underarm/side area.  RN was trying to get pt to padded couch to lay down, which was about 4-5 steps away.  Pt took about 2 steps & began fainting/falling to floor.  RN eased him to ground as best as possible.  Pt landed on his bottom & right side.  Pt never hit head on anything.  Pt was responsive right away.  Pt was rolled on side in case of emesis.  Pt assisted to sitting position a few minutes later.  Pt then assisted to standing position & then sat on couch.  Monitored for 30 min by RN.  Alert, oriented, awake.  RN called pt later in day - said he was feeling fine.