chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/26/08 in AM, noticed swelling of lymph nodes under left axila.  This was same arm that  ADACEL was administrated. Pt states she commonly will have inflammated lymph nodes with systemic infections. Left axilla also slightly reddened
This spontaneous case reported by a consumer, describes the occurrence of increased heart rate (heart rate was 180 for 3 days after Moderna shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced increased heart rate (heart rate was 180 for 3 days after Moderna shot). At the time of the report, increased heart rate (heart rate was 180 for 3 days after Moderna shot) outcome: unknown. Diagnostic results: On an unknown date, heart rate: 180 (inconclusive). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Pt had a syncopal episode that evening of vaccination, the following morning he had 2 episodes of syncope. The last one that happened on Friday morning at 7am  the patient was reportedly convulsing, diaphoretic and disoriented- blood pressure was 220/100. Son also reported he was not responsive to sound or voice and his breathing became labored for a short time after the convulsing stopped.
Information has been received from a consumer concerning his 72 year old brother, with no pertinent medical history and drug reactions and allergies reported as "I don't know for sure", who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported). In "last Spring" (in approximately March 2010), the patient experienced rash after receiving ZOSTAVAX (Merck). The rash was not at the injection site. The consumer did not believe his brother had itching. The patient did not seek medical attention. On an unspecified date, the patient had recovered from rash. No further information is available. This is one of two reports from the same source.
Pt had blotchy area around leg, where injection site was, also hives on body, Benedryl given.
Patient with initial right arm pain and hand pain in the arm vaccine was given.  He also had stiffness and loss of dexterity in the hand.  He later developed arm swelling from elbow down to fingertips. That swelling resolved in about 1 month.  The stiffness and dexterity  of hand has improved but not back to normal  4 months later. Interestingly, patient developed same symptoms on his left arm after he had his second Moderna Covid vaccine on 3/4/21 in the left arm.  That swelling is just now resolving.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication was not reported. It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. It was reported that HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.   Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
using his oxygen during the day as well at night/been going down to 90 without it, with it goes back up to his normal 93; This spontaneous case was reported by a patient and describes the occurrence of OXYGEN SATURATION DECREASED (using his oxygen during the day as well at night/been going down to 90 without it, with it goes back up to his normal 93) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Arrhythmia and Diabetes mellitus.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (using his oxygen during the day as well at night/been going down to 90 without it, with it goes back up to his normal 93). At the time of the report, OXYGEN SATURATION DECREASED (using his oxygen during the day as well at night/been going down to 90 without it, with it goes back up to his normal 93) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patients due date for second dose was on 02 apr 2021   This case was linked to US-MODERNATX, INC.-MOD-2021-063946 (E2B Linked Report).   Reporter did not allow further contact
Headache, Myalgia & Rash Narrative: first dose- rash around injection site 7x7.5cm up to 8 days after injection second dose: day 2- headache, general body aching, chills
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 2 year old male patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 17-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Following flu shot developed deltoid pain/deep aching, usually 2-3/10 on pain scale, some movement 6-7/10/ Declined medical treatment.
arm began itching intensely on 18DEC96;mom brought pt in for consult;lt arm from shoulder to elbow was swollen, hot inflamed & showed obvious signs of finger nail scratching;parent was referred to ped for tx;
2 days post injection pt. was seen. There was redness at the site measuring 10cm x 6 1/2 cm. Pt. complains of moderate pain. The pt. is being treated with Benadryl.
Dolor, inflammation, heat and hardening, to palpation, in the muscle area where the vaccine was given, about 5 cm of radius that appeared 3 days after the vaccination. There was no color change in the skin, neither difficulty to make movement of the arm in any direction. After a day and a half the symptoms disappeared. It was not necessary to take medication for the pain only the application of ice compress symptoms improved
Generalized diffuse blanching maculopapular rash on face, trunk, extremities and Papule. Nodule, mildly erythematous on posterior left thigh with scab formation overlying nodule. Advised to continue use of warm compress to nodule 15-20 min BID-TID. No fever. Immunizations given 10/8/20, rash started 10/18/20, rash started 10/18/20, visit to Dr. office 10/20/20.
Information has been received from a nurse concerning a 91 year old male with anaemia, prostatic nodule, hypertension and lactose intolerance who on 07-MAY-2007 was vaccinated intramuscularly in the left deltoid with Pneumovax 23 (Lot#654977/0888F). Concomitant therapy included finasteride, aspirin and lisinopril. Subsequently, the patient experienced that from his left elbow down to his left hand became grossly swollen. It was reported that the area "was very hot, very erythematous, and very red". The nurse reported that the reaction was described as a "boggy elbow" (mushy) and was the texture of the skin of an orange. It was also reported that it was difficult for the patient to raise his arm. The patient was treated with prednisone (dose not provided) immediately and then prednisone, 20mg daily for two days. The patient was also treated with Benadryl, dose not specified. The nurse reported that the reaction resolved in 3 to 5 days. The nurse considered the events to be disabling and a serious other medical event. Additional information has been requested.
Immediately after receiving vaccine I had a pain go across my chest and symptoms of tachycardia and palpitations. They continued off and on throughout the evening. Approximately 24 hours after receiving the vaccine, I had an episode where my heart rate climbed to 135, I could barely lift my head up, my right arm went numb, and could not form a sentence. I was sent to urgent care where they took an EKG which was normal, although I was tachycardic. I was told to follow up with my PCP, which I did a few days later.  A complete blood workup was done, which was normal. I was put on atenolol and told to get the second vaccine. I was not able to tolerate the atenolol so I decided against getting the second dose. Over the course of the last month, I have had more and more symptoms come up, including low blood pressure, feeling faint, vertigo/rocking/balance issues, tingling in the back of my head, and tingling/numbness/heavy feeling in my arms and legs. I saw my neurologist, who prescribed methylprednisone. I am on day 5 of that medication, with my symptoms not improving. In fact, the numbness/tingling in my extremities is only getting worse. Currently waiting for further direction from my PCP and neurologist.
For several hours I had no side effects, including soreness at the injection site. In the evening, maybe 6-8 hours after the injection, the site became sore. After midnight, I started having severe chills and needed several layers of clothing and blankets to stay warm. I checked for a fever and did not have one. In the morning the chills were gone but I had a strong headache that lingered with varying intensity throughout the day. It is unclear if the headache was more from the vaccine or more from a lack of sufficient sleep because I couldn't sleep with the chills. The injection site has continued to be sore and seems to be increasingly sore. After waking up on 1-13-2021, I found myself feeling fatigued and lethargic, not dissimilar to the fatigue I felt when I had COVID. The fatigue has somewhat subsided over the course of the day, with lots of rest helping. The headache and soreness are ongoing, and the fatigue is present but less than earlier today. There's been somewhat of an ongoing lack of appetite, but I've been able to eat in small amounts and keep down what I eat. The chills have come and gone a couple times throughout the day today, but that doesn't seem to last long.
@1352 reported feeling dizzy, clammy and pale, Nauseous, hand tingling and light headedness. Given water and provided support.  @1357 patient reported symptoms are resolved.  @2:20 Patient left the vaccination site with no complaints. V/S 116/72 mmHg, o2 sat 98% on RA.  Encouraged to contact his PCP for further evaluation and as needed.
Information has been received form a registered nurse concerning a 60 year old male who on 3-JUL-2008 was vaccinated with ZOSTER and "5 to 6 weeks later" on approximately 6-AUG-2008 the patient called the office because he had 3 very tiny bumps on his face. The patient was diagnosed of a mild case of shingles by a physician. On an unspecified date the patient recovered from mild case of shingles. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a registered nurse concerning a 28 year old male patient with dysthymic disorder, reactive airways disease and osteoporosis and a history of hypotension, hypercholesterolaemia, tracheostomy and congenital trachimylasia who on 09-OCT-2007 at 14:00, was vaccinated IM into the left deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot# 658555/0964U). Concomitant therapy included amlodipine besylate (AMLODIPIN), diclofenac Na (VOLTAREN), hydrocodone bitartrate, gabapentin (NEURONTIN), simvastatin, montelukast sodium (SINGULAIR) and tizanidine hydrochloride. On 11-OCT-2007 2 days after receiving the vaccine, the patient experienced painful swelling and redness at the injection site of the left deltoid muscle reported to last about 3 days. On 12-OCT-2007, the patient was examined in the office and the exam revealed a 3 inch x 5 inch area of redness and swelling at the injection site. The physician diagnosed the area as possibly cellulitis and prescribed levofloxacine (LEVAQUIN), acetaminophen (+) hydrocodone bitartrate (LORTAB) and NSAIDs. An MRI of the left humerous was ordered to rule out abscess. On 15-OCT-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Pt reports: 6/2/08 noticed redness in inner corner of pt eye (skin area) with soreness, "started down face onto cheek, increasingly becoming worse with slight swelling.  6/4/08 increased redness and soreness with 2 small blisters.  Was seen by ophthalmologist 6/5/08, started on acyclovir 400mg one QID and mometasone furoate cream.  Skin had "open lesion".  6/9/08 lesions are dried.
Low fever 99; Swollen facial fillers; fatigue; flu-like; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 36-years, on 09Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low fever 99, swollen facial fillers, fatigue-flu-like on Apr2021. Events took place after use of product. Events outcome was unknown.   Information on the lot/batch number has been requested.
No additional adverse effect reported; VARIVAX that underwent temperature excursions was administered; This spontaneous report has received from a reporter of unknown qualification (reported as other) concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.     On 07-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursions (lot# T024285 has been verified to be a valid lot number and expiration date was 15-JUL-2022; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). The administered dose experienced the following temperature excursions: -14 Celsius degree to -10 Celsius degree (-10.9 Celsius degree) for 34 minutes and -14 Celsius degree to -10 Celsius degree (-10.8 Celsius degree) for 49 minutes. The previous excursion was reported as -14 Celsius degree to -10 Celsius degree (-11.1 Celsius degree) for 1 hour 2 minutes. No additional adverse effect was reported.
This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable female consumer received PREVNAR 13 at single dose, on 06Feb2017, for immunisation.  Before vaccination she thought she was getting a sore throat, ears popping: symptoms that she usually had before getting a cold. Concomitant medications were not reported. The consumer was feeling a little stuffy and was sneezing since an unspecified date in Feb2017. Events outcome was unknown.
Initial unsolicited report received from a pharmacist on 08-Dec-2015. This case involves a 61-year-old female patient who was vaccinated with an intramuscular second dose of FLUZONE QIV (batch number- UI464AA, expiry date- 30-Jun-2016 and site of administration was not reported) on 16-Oct-2015. It was unknown whether patient had an illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions included penicillin allergy. Other medical conditions and concomitant medications were not reported. On 16-Oct-2015, within two hours after vaccination, patient had experienced fluttering of the heart, tachycardia, fluttering and ringing in her ears. Lab tests and corrective treatments were not reported. On unspecified date, patient recovered from the events. Upon internal review, case was considered as serious due to important medical events: heart fluttering and tachycardia. Documents held by sender: none.
the patient complained of excessive hair loss/shedding from his head; Information has been received from the patient's mother referring to a 14 years old male patient. The patient had none drug reactions/allergies, concomitant medications or pertinent medical history.    On 05-MAR-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1621931, expiration date: 26-JAN-2022 for prophylaxis(also reported as normal childhood vaccinations) (strength, dose, frequency and route were not provided).    On around 12-MAR-2020, the patient complained of excessive hair loss/shedding from his head. The patient had not complained of any other symptoms. The patient's mother had spoken with physician. At this time the physician would monitor the situation as she did not want to prescribe corticosteroids (unspecified) during the Coronavirus/corona virus disease (COVID) 19 pandemic. There was no treatment given to the event. The outcome of the event was not recovered. The causality assessment was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
swollen arm with hard lump, itchy rash over entire upper torso - appeared two days after shot. Itchy rash is going down, hard lump still there on day three. Also extreme exhaustion one day after shot, slept for 24 hours in a 30 hour period.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 27-AUG-2014 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot# J006242, expiration date 03-AUG-2014, 0.5 ml) intramuscularly. No adverse effect was reported. Additional information is not expected because no consent to contact.
I had a really fast rate which freaked me out so then I had an even faster heart rate; I feel it had a lot to do with anxiety but as well I've never had it spike that high with anxiety; This is a spontaneous report from a contactable consumer via Medical Information Team. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, warm transfer received from Pfizer agent withheld ( withheld, Reportum withheld). It was reported that, the caller was a consumer (25 years old, male) inquired about information regarding the side effects of the Pfizer Covid-19 vaccine. Stated that, the caller as understood, done some research recently and read that blood clots are a possibility as well as TTP. The caller stated that, there was too little information to rule anything in or out and was there anything else that caller may not have heard of. Stated that, the he had gotten the first vaccine, but he really didn't know whether he wanted to get the second one and it doesn't matter who its coming from. Stated that, he had a really fast rate which freaked him out so then he had an even faster heart rate. The caller questioned were the blood clots caused from the TTP or were those two symptoms separate. The caller stated that, he didn't know whether they have seen or can debunk this, but there was an study that showed it was linked to TTP. Stated that, he had all his questions answered and he will weigh the risks and rewards and see how he feel. The caller stated that, he thought, since this was already a symptom that has been expressed, he will not but he appreciate that and he will skip on documenting that. Stated that, he had a fast rate and then calmed himself down and brought his heart rate down, then it would spike back up when he was standing. Stated that, the patient felt it had a lot to do with anxiety but as well he have never had it spike that high with anxiety. The caller declined warm transfer. Response included was confirmed Pfizer Covid-19 vaccine. Provided disclaimers and referred caller to healthcare professional. Enquired, caller asked does the myocarditis happen minutes or hours after receiving the shot. The caller asked, was there anything else he need to know that he may not have heard of. Response included was referred to healthcare professional. The outcome of the events was unknown.
Progression of Guillain-Barre Syndrome sxs Sx started June 30, 2019. Appt with PCP on July 2, 2019-preliminary dx of GBS Inpatient Hospitalization July 6, 2019 Discharged July 11, 2019 with a dx of Acute Inflammatory Demyelinating Polyneuropathy
Got flu #3 rather than Hep B #3 in error. Was off schedule due to moving and mother serious medical problems postpartum.