chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed lumps (hives)in her face which have been on and off.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed lumps (hives)in her face which have been on and off.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Developed lumps (hives)in her face which have been on and off.). At the time of the report, URTICARIA (Developed lumps (hives)in her face which have been on and off.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
Vaccine administered 10/13/05 at 9:30 AM.  Pt. subsequently worked in warehouse, experienced an asthma attack, vs. MD and was treated with a nebulizer and recovered. Evening of 10/13/05 pt. experienced severe pain and stiffness in entire R. arm which continued through 10/14/05.  On 10/14 at 5:00 PM pt. noticed confluent red,raised quarter sized areas (no itching)extending to elbow directly below where vaccine was given on R arm. 10/15/05 erythematous area spread to back of R arm. Pt consulted MD and advised to use warm compresses on affected arm. 10/16/05 eryythema and pain and stiffness resolved.
fatigue; had sore in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing); "thyroid problem" (unspecified if ongoing); "blood clotting" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for coagulopathy, start date: 01Jun2020, stop date: 16Mar2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "unknown", described as "had sore in the arm"; FATIGUE (non-serious) with onset 30Mar2021, outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have continued mental fogginess, Lack of proper visual  focusing- It's hard for me to focus on things. Extreme tiredness. The first full day, Saturday, I had a splitting headache all day. I still do have a swollen lymph node under my left arm pit, the swelling is the size of almost 3 quaters of an inch, and now It's about a half inch, and it's very hard.  I find it difficult to walk a straight line, it's like I am drunk and that continues today. Last night, I had a pull water slip cover on my bed for sweats, and my tshirt and the bed was soaking wet this morning. The doctor said i would experience that down the road with having leukemia, but I experienced it last night. I had a decreased appetite. Last night I had a half of sandwich, but since Friday, I have not eaten anything, just fluid intake. Also Arm pain from injections site that crept down my arm a bit.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J001700 and expiry date: 08-MAY-2014, reported as 08-JUL-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Recurrent daily R breast discharge (mild) started again only during showering by 1/19/22 after COVID Moderna booster shot on 1/14.  Hx- Initially daily R breast discharge (small) mid-May 2021 to mid-Dec. 2021 after COVID series completed (see #23).  A 7/8/21 OB/GYN evaluation at women's health physical noted an elevated 7/10/21 Prolactin level (35.57) by Dr. at a local Medical Center.  A 10/13/21 appt. with the CNP resulted in no lab. recheck but was pt. informed that R breast discharge/hx elevated Prolactin level was due to COVID vaccination; not aware if previous VAERs report completed by this provider.  R breast discharge ceased in mid-December 2021 without intervention until restarted 1/19. Pt. transitioned between 3 different health insurances with gaps between 7/21- 12/1/21- so had to wait or use ins. aligned providers.   No current recheck scheduled at this time-pending CDC follow-up on this VAERs report; hx Flu quad. shot 10/13/21 also
Awakened by very painful left arm (7 on 1-10 scale), headache (3-4), general discomfort and restlessness.  Within one hour, progressed to bone-rattling, teeth-chattering chills and inability to get warm for several hours, neck and low back pain (7-8), general intense fatigue but inability to sleep because of other discomforts.  Over-the-counter Tylenol and a warm magnesium bath temporarily diminished symptoms, but relief was short-lived.  Symptoms progressed in early afternoon to diarrhea for about 2 hours and increased fatigue, temperature up to 100.2 (my normal 97.6), headache pain progressed to 4-5, neck and low back remained 7-8.  Tylenol seemed to have no effect.  Evening (5pm) brought nausea and increased overall discomfort, fatigue, and pain.  Aspirin - no effect.  At 11:30 p.m. I took Motrin 600 mg and was then able to doze off and on.  Throughout I remained very thirsty and consumed many glasses of water and herbal tea. Awoke at 3:45 a.m. 2/22 with only very slight headache, no nausea.  Slept soundly until 6:30 a.m.  Some fatigue persists, with left-sided pain (5-6) in neck and low back.  Left arm remains sore (3-4).  No great appetite, but no nausea
Lightheadedness/complains of dizziness; This is a spontaneous report from a non-contactable other healthcare professional. A 68-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration on 25Mar2021 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 25Mar2021, during 15-minute waiting period after the injection, the patient began to experience light headedness. The patient denied rash. The patient complained of dizziness. Therapeutic measures were taken as a result of light-headedness and dizziness; removed mask and provided calming measures and follow-up response to treatment was good. The clinical outcome of the event light-headedness was recovered on 25Mar2021.   No follow-up attempts are possible. No further information expected.
Patient reports getting the vaccine that morning and by 5pm that same day her arm was extremely sore and hurting and she began to have fever. Chills and by that evening a few hours later she was vomiting. She was in bed and felt very weak for about 2 1/2 days. Her arm was purple color and warm to touch where the injection was given and almost the entire circumference.
No additional adverse effect reported.; ROTATEQ, M-M-R II and VAQTA that underwent a temperature excursion were administered.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 25-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1707591, expiration date reported as 10-MAR-2022, but upon internal validation established as 11-MAR-2022) (exact dose not provided) for prophylaxis. The administered dose was stored in temperature above 46 Fahrenheit degrees (F) (46.8 F) for 30 minutes. No previous temperature excursion occurred. Digital data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006607: US-009507513-2106USA003899: US-009507513-2106USA003901:
Patient called the pharmacy this afternoon to say he was breathing fine now but that at 2:30 AM till about 4:30 AM this morning he had difficulty breathing after receiving the first dose of Moderna vaccine yesterday. He said he could not take deep breaths and had to breath very gently. He said he took a hot shower for 45 minutes and then could breathe better and feels fine now. He said he does not have a primary care doctor here yet.
Breakthrough case Dose 1: Pfizer, EL9261, 1/25/2021 Dose 2: Pfizer, EN6201, 2/15/2021
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) in a 41-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2022 at 12:42 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Mar-2022 at 12:42 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 degree Celcius thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
will she have another series of acid reflux again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "will she have another series of acid reflux again". Additional information: Patient was asking if she will be vaccinated of the Pfizer covid19 vaccine again, will she have another series of acid reflux again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8:15am. Itching in face, then back and hands 8:20 am tightness in chest,
Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm all the way down to elbow is red, very itchy and the right arm also has 2 or 3 nickel sized red dots that are itchy as well; Left arm looks slightly swollen and a little larger than the right arm; This spontaneous report was received from a pharmacist refers to a 83 year old female patient with immunisation.    On 03-JUL-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) lot # R018732, intramuscular in the left arm for immunisation.    Concomitant therapies included cetirizine hydrochloride(ZYRTEC).   On 03-JUL-2019, 1 day after onset of therapy the patient experienced injection site erythema, injection site reaction, vaccination site pruritus and peripheral swelling.    The outcome of injection site erythema, peripheral swelling, injection site reaction and vaccination site pruritus was reported as not recovered/not resolved.
Fatigue / Being tired; Mouth sores; Difficulty swallowing; This case was reported by a consumer via other manufacturer and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fatigue, sores mouth and swallowing difficult. On an unknown date, the outcome of the fatigue, sores mouth and swallowing difficult were unknown.   It was unknown if the reporter considered the fatigue, sores mouth and swallowing difficult to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in July this year and developed really bad side effects. No additional information was provided. The reporter requesting consent to follow up.
died; This is a spontaneous report from a contactable healthcare professional via medical information team and via a Pfizer-sponsored program. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The healthcare professional reported that they were definitely seeing a rise in COVID and that a 55-year-old guy died in their hospital the other day (unspecified date), he was vaccinated in May with Pfizer. It was unknown if an autopsy was done.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious event Death cannot be totally excluded. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, concomitant medications and dates of vaccination.This case will be reassessed once additional information is available.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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died
Dizziness, blurred vision, vomiting 5 minutes after vaccine. Lasted about 10 minutes.
Patient came in several months after administered that she was not going to get her 2nd dose due to the fact that she had a reaction. day 1 she had a fever of 99.2, days 2 9/28 100.8 fever, swollen site size of a baseball, raised hot circular. Day 3 normal temp, still raised and hot and took 2-3 days to go away. Explained to patient, injection site reaction and low grade fever can happen with all vaccinations. She was concerned due to the length of her reaction and asked that we report it.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with hypertension and type II Diabetes. Drug reactions/allergies were not reported. On Friday 21-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot number reported J001692; expiration date 08-MAY-2014), subcutaneous in the left arm. Concomitant therapies included atenolol, losartan potassium (+) hydrochlorothiazide (manufacturer unknown), metformin, glipizide, amlodipine and VICODIN. On 22-JUN-2013, the morning after receiving ZOSTAVAX the patient developed a rash, located around the injection site (left arm) and the rash travels up her arm and around to her back. On Sunday 23-JUN-2013, the patient visited the emergency room (ER) and was prescribed VICODIN. The patient visited her physician and was diagnosed with shingles and prescribed VALTREX. The outcome of the patient developed a rash the morning after receiving ZOSTAVAX, located around the injection site (left arm) and the rash traveled up her arm and around to her back was unknown. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient's mother). This mother reported for her 2 daughters. This is the 2nd case (younger daughter) out of the 2 cases. A female patient of an unspecified age (going to be 2) and ethnicity received PREVNAR 13 (Lot # not available) via an unspecified route of administration at single on an unspecified date for immunization, following the CDC schedule for vaccination. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced persistent sinus infections with outcome of not recovered, strep 2 infection with outcome of unknown, they were vaccinated but yet she was not having immunity with outcome of unknown, persistent problems with illness with outcome of not recovered. Therapeutic measures were taken as a result of persistent sinus infections, strep 2 infection. Course of events: After the vaccinations, the child was fine but fast forward a year or so later she was having persistent problems with illness with recurrent infections. Heavy growth strep was diagnosed at the end of Nov2016. Nasal swab test turned out that it was a Strep in the category of 2 which was puzzling to the paediatrician because she had been vaccinated for the strains that are covered in that type 2 category. The Pneumo titers were done and has immunity for 4 out of the 13 and actually that was not true, it was 4 out of the 23. [not reported clearly that out of the two children which child has immunity of 1 out of 13 and which child has immunity of 4 out of 2]. So the mother did not know if it was the 13 or if there was some that were outside of that has been vaccinated, she did not know but next one will be 4th. There was improvement for her and her younger sister for a few days while she was taking an antibiotic and then they had infections again. A pneumonia titer was done 22Dec2016 and it came back that the older child did not have immunity to any of the 13; she only had immunity to 19F. For the rest of the serotypes, the immunity was all under 2. Nasal Swab Test (Date unspecified): Strep type 2 infection. The family actually had different paediatrician during that time because they moved from one state to another but they were right on time with vaccinations, like within a day of the next eligible time period and the mother was calling about PREVNAR 13. The mother called since she was not sure but the children were vaccinated but then they found that they are having some repeated continual sinus infection problems. Her younger sibling has persistent sinus infections and there is the same situation with the younger sibling as with the oldest daughter. The mother concern was the fact the child was vaccinated but yet she was not having immunity towards she was vaccinated for and as a result have become quite ill. There is  a very resistant form of Strep and so the mother was wondering what was the percentage of efficacy when you go through the CDC recommended schedule of the 2 month, 4 month, 6 month and then between 12 and 15 month schedule. A Product Complaint was filed.
Headache, NauseaVomiting, fatigue, chills/shakes Narrative: 1st fatigue, second headache in the afternoon, third nausea in the evening, fourth severe chills/shakes at about 10 pm lasting until 2 am. No further symptoms/reactions.
Acute Onset Dysautonomia (POTS), Acute onset Bradycardia, Fainting, Tremors, Blurred Vision, Confusion, Nausea Unable to stand up without a severe blood pressure drop, unable to walk to the bathroom or shower without getting light headed and passing out. Unable to leave bed without assistance,  had to withdraw from college for the semester (Doctor ordered medical leave) Basically, his life has been ruined, he is mostly bed-ridden. He is only 21 years old, a college student who just got engaged. His cardiologist said it was triggered by the vaccine. No improvement to date.
I awoke days after my second C-19 shot with acute cardiac arrhythmia.  After several days when the problem continued, I took myself to the Emergency Room at local Hospital where the attending physician examined me and alerted me that I needed the care of a cardiologist immediately:  prior to vaccine, I had never been under the care of a cardiologist or treated for any heart-related ailments.
I developed a very high fever 104.4,  pulse was extremely high and my blood pressure became elevated, I was very dizzy to the point of passing out
This report describes the occurrence of reoccurring sinusitis in a 38-year old male who received 3 injections of Lymerix. This report has been received from & patient has not been verified by a physician. Between 1993 and 1994, the pt received 3 Lyme vaxs in a clinical trial protocol. Pt reported that he "experienced severe sinusitis and informed the study investigator and reports that he was told that he had nothing to do with the Lymerix." Pt also reported that he "was told after the study was complete, that he received study drug versus placebo. He also experienced an upper respiratory tract infection during the study and it lingered for a few weeks." Once the study was complete, the pt reported that he continued to experience frequent and severe sinusitis. he saw ear, nose and throat physicians who "would not touch him due to severity." He was referred to and ENT specialist and had four separate surgical procedures on his sinuses. He was hospitalized on 05/20/2000 for this fourth surgery where they "removed infected tissue, removed part of septum, and drilled holes so sinuses could drain." He also stated that he has seen an allergist who attempted desensitization but "discontinued as he kept getting sinusitis." He alleges that he has suffered from depression and memory loss over the past couple years and stated that he feel these events are due to the stress over all the surgeries. Pt reported that what prompted his call to manufacturer on 07/10/2000 was that "he read an editorial in his local paper written by a man who also was in a Lymerix study and claimed that information was withheld about Lymerix compromising the immune system." The most recent information received indicates that the URI resolved and the sinusitis, depression and memory loss are ongoing.
fever of 102 & lethargy p/1st & 2nd dose in series;had 1 dose in 1991;no further vaccine will be given -check titer;