chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 58 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
This case was reported by a physician and described the occurrence of autism in a 3-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), and ENGERIX B (GlaxoSmithKline). On unspecified dates in December 2005 and February 2006, the subject received unspecified doses of PEDIARIX (.5 ml, unknown, left thigh). On an unspecified date in September 2006, the subject received an unspecified dose of ENGERIX B (unknown). On an unspecified date in May 2008, approximately 20 months after vaccination with ENGERIX B, and 27 and 29 months after vaccination with PEDIARIX doses, the subject experienced autism. A physician evaluating a claim reported that the mother of the vaccination subject stated that her child has autism due to exposure to thimerosal in ENGERIX B and PEDIARIX. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Myalgia MASSIVE BODY ACHES AND MUSCLE CRAMPS AND INTENSE INJECTION SITE PAIN Narrative:
Pt seen in ER for swelling of right arm and swelling right eye. Treated by ER with steroids.
Few hours after the vaccine started feeling twitching in both legs, but more dominantly in the left one. I also had pressure/ pain in the left side of chest where the heart is. I can't sleep well, because of the involuntary twitching in the legs. It's mainly my left part of the body that is affected. I feel like this vaccine messed up my nervous system. Not going  for the second shot. Consulted my GP who said some people have these side effects and to go to ER if I have problems breathing or severe pain in the chest.
Subsequent to exposure at a group home, pt developed full blown varicella, with fever, associated right otitis media and early impetigo involving a few lesion right arm, all skin and mucosal surfaces involved. Pt also has otopic dermatitis, no recent topical steroids.
Information has been received from a licensed practical nurse concerning a 19 year old female with penicillin allergy and sulfonamide allergy and history of tachycardia who on 18-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, IM. Concomitant therapy included metoprolol. Since 19-AUG-2008, the patient experienced fever, nausea, vomiting, chills, dizziness and fatigue. On 09-SEP-2008, the patient sought medical attention calling to the office because her symptoms had not resolved. Additional information has been requested.
Moderna Covid 19 Vaccine EUA  Patient hospitalized inpatient for a planned total knee replacement with no complications
59 y/o female presented with burning, searing left sided chestpain , pleuritic chest pain and moderate sob that started within  4 days of 2nd booster immunization and became increasingly worse until the day of admission. Patient was admitted to the ER on 4/4/22 around 5pm. Initial vital signs were stable. Rule out MI protocol was initited. Initial EKG was normal, Echocardiogram was normal, CXR was normal, Chest CT was normal . Patient continued to complain of moderate to severe chest pain and sob. Patient was admitted for observation and further work up.
I was diagnosed with Covid-19 on 12/29/2022. I started having cough fever and runny nose on 12/27/2022. After testing positive I was prescribed PAXLOVID. Symptoms are still ongoing.
A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Nov-2012. The patient experienced inadvertently gave patient with asthma FLUMIST. The outcome of the event of inadvertently gave patient with asthma FLUMIST is unknown. The report was considered to be non-serious.
I had history of asthma from 2 years to 18years old and I was on allergy treatment for all that time. I was completely clear at age 15. And so, no asthma attack since I received the second dose of the vaccine, I  started to experience worsening of respiratory symptoms, many allergy symptoms like sneezing, coughing and  very severe nose congestion Following several episodes and a severe asthma attack, I was prescribed with albuterol inhaler and claritine  (allergy medication) treatment. I am on that treatment since months now and it doesn?t get better.
Soreness arm; General ache; Tenderness at the injection site; Chills; Headache; A spontaneous report (United States) was received from a female patient concerning herself, a 23 years old female patient, who received Moderna (mRNA-1273) and developed soreness arm, general ache, tenderness at the injection site, chills and headache.   The patient's medical history was not provided. Concomitant product use was not provided.   On 17 Jan 2021 10.30 AM, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 17 Jan 2021, after vaccination, the patient experienced soreness arm, general ache, tenderness at the injection site, chills and headache. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events soreness arm, general ache, tenderness at the injection site, chills and headache were considered not recovered at the time of this report.; Reporter's Comments: This case concerns a 23-year-old female who experienced a NS unexpected events of pain in extremity and pain and NS expected events of Vaccination site tenderness, headache, chills.  The events occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
About one week after receiving Pfizer booster shot I started experiencing a strange smell as if something is burning/burnt, on/off during the course of the day but more so in the late evening
Patient was given her 2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose. Per CDC, doses administered with an interval error after October 25, 2021
**No lot number in patient record for 1st dose lot number**  Pt received both doses of the Moderna vaccine, on 1/14/21 and 2/10/21.  Pt later became ill with COVID 19 , tested positive on 8/1/21, and then was hospitalized at a med level of care.
Fevers and chills overnight afterwards (this was the second shot).  Also experienced intermittent severe tinnitus and moderate hearing loss that is slowly getting better but continues 3 weeks after the injection.
Patient slumped over in chair while waiting the required 20 minutes after the vaccine.  Her father stated that she had a loss of consciousness but did regain consciousness.  Patient had low blood pressure when taken by the pharmacist of 85/65.  Patient was very pale, gray coloring in face and extremities.  Rescue squad was dispatched and transport to hospital was ensued.
A hot blood rush up to my head; A hot blood rush up to my head; Face was red; Lost the strength of facial movement; Lost the strength of facial movement; Muscles of face turned very weak; Mouth was shivering; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious), DIZZINESS (non-serious) all with onset 28Jan2021, outcome "recovered" (28Jan2021) and all described as "A hot blood rush up to my head"; ERYTHEMA (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Face was red"; FACIAL PARESIS (non-serious), ASTHENIA (non-serious) all with onset 28Jan2021, outcome "recovered" (28Jan2021) and all described as "Lost the strength of facial movement"; CHILLS (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Mouth was shivering"; MUSCULAR WEAKNESS (non-serious) with onset 28Jan2021, outcome "recovered" (28Jan2021), described as "Muscles of face turned very weak". Therapeutic measures were taken as a result of hot flush, dizziness, erythema, facial paresis, asthenia, muscular weakness, chills.  Additional information: The reported events occurred after use of the product. Treatment with lot of water & Gatorade. All symptoms were gone after 40 minutes. There were no other product(s) that were taken together with those indicated above.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache and fatigue the day after injection, lasted at least 24 hours. Sore arm at the injection site, the day of and up to at least 4 days after.  Swollen lymph nodes under left arm (injection site arm) the day after and lasted at least 4 days.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 4:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 4:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 18.85 years.  Concomitant products were not provided.  On 03-Mar-2021, Excursion time was 09 AM, 10 AM and 1 PM temperature was 51, 34 and 35 respectively, total doses given for the day was 200, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Severe itch all over body with tongue swelling. Treated with Epi and Benadryl sent home. No further problems. Left town x 3 weeks after receiving flu shot. Contact made due to this.
CMET on 12/16/21 Last day worked: 12/15/21 Day called in sick ?day absent?: 12/19/21 Date Tested/Results: 12/16/21-  POSITIVE Covid-19 Vaccine Yes:      Date of last dose: 3/19/2021 Pharmacy Notified: N- they are already aware of her situation Notes: 12/16/21 body aches and fatigue, thought it was from working so many shifts in a row, took a CMET test which resulted (+).  DOH released on 12/27/21. Patient without symptoms since 12/21, has not taken any fever reducing medications in >24hrs.  Patient is cleared to RTW at this time.  Email sent to Patient and manager.
On 12/15 I had TB test. On 12/18 it was clear. On 12/22/17 I had Tetanus, Diphtheria, Pertussis and on 12/27/17 I had the Hep A and B. On 12/28 I had a blister on my right hand along with tingling and pain. The pain got more severe and my hand started breaking out more. That Sunday I was diagnosed with Shingles. Seven days later I was diagnosed with influenza, severe dehydration, a UTI and resp. issues. I am still having severe pain in my arm and right side even though all the blisters are gone except one.
The patient was given Pfizer Bivalent Booster vaccine one day past beyond use date on 12/02/2022.  The patient was not able to be reachable and we are not able to gather any information on any symptoms, sings, time course, etc.
Ill on Nov 11 with sore throat, chills, fatigue, cough. Reports that sx lasted about 1 week. Spoke with her 11/11 and 11/24/09 and 12/17/09.
Over a week later I started noticing signs of a yeast infection. I wasn?t sure for about another week when I finally used over the counter meds to treat. I have had no sex in about 6 months and my periods are regular. Yeast infections are very rare for me. The last one I had was at least a couple years ago. Even though doing the one day Monistat treatment, a week later I still feel some symptoms and I just had my 2nd Covid dose of Pfizer 2 days ago.
This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored VAQTA (lot N005274; expiry date: 03-APR-2018). The vaccine was exposed to temperature range of 9°C to 25°C for 16 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. This is one of the reports received from the same reporter. Sender's Comments: US-009507513-1708USA004166.
Pt had URI,  small dot on right inner thigh on 01/29/2002. When immunizations given about three hours after  child got mild tactile temperature and seconddlot on right inner thigh and 01/30/2002 had mild tactile temp and dots turned into burn/blisters got bigger and child seen in ER on 01/31/2002 with a fever on 104.6 deg. F. diagnosed with "skin reaction"  On 02/01/2002 the child had staph impetigo at site.
Left lateral thigh noted to have moderated redness around injection site. Heat also noted to site. Doctor evaluated site. Pass allergic reaction per doctor.
LESS THAN 24 HOURS WITH ONSET OF CHEST PAIN/TIGHTNESS.  ADMITTED FOR OVERNIGHT OBSERVATION TO R/O MI--NEGATIVE ENZYMES, NL ECHO, NL STRESS TEST.  6/23/09 Medical records received DOS 6/16/04 to 9/29/04. Assessment: Unspecified acute pericarditis temporally associated with the receipt of the smallpox vaccine, palpitations, arrhythmias. Patient presents with c/o of chest pressure, palpitations, and dyspnea. "Easier to breath sitting up"; "my heart rate is hight and at times it flutters". Chest pain relieved by nitrates. Stress at work and mild anxiety. ICD-9 Codes: 420.9, 785.1, 427.9
Nausea, muscle aches, vomiting, diarrhea, chilled,  supportive care
In January, I went to the doctor for high blood pressure. The initial day my blood pressure was 199/95. I had several days when it was really high. He put me on amlodipine to try to lower it. I had a follow-up about three weeks later. The medication helped some, but my blood pressure wasn't coming down low enough. The readings fluctuated. He added olmesartan. He asked me to come back a few weeks later. When I came back, it was back to normal, but I still had an elevated heart rate issue. It was causing fatigue. He took me off amlodipine. He cut the dosage for olmesartan in half and added olmesartan. He asked me to come back in a few weeks. The medications worked this time. He thinks the high blood pressure is a result of genetics, but it hit everyone else in my family a little later. As of now, I'm responding well to the medication. I go back for another follow-up in a week.
11x7 cm small raised red area with red area flattened around. - fever minimal pain usually to touch only.
This spontaneous report was received from another healthcare professional refers to a 2 year old patient of unknown gender. On 17-NOV-2014 the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # 1666AA, 0.5 ml, subcutaneous. Reporter stated that they expiry date was 08-NOV-2014. No adverse effects reported. Additional information has been requested.
one had triple bypass; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR GRAFT (one had triple bypass) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VASCULAR GRAFT (one had triple bypass). At the time of the report, VASCULAR GRAFT (one had triple bypass) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my chest and neck that lasted for about an hour. No itching or hives. 1/9/21 at 3am my heart rate started to increase to about 110bpm while sleeping and continued till 4am. 1/9/21 at 4am my apple watch alerted me to my heart rate was above 120bpm while resting. This is when I realized I was sweating and felt like I had a fever.  I drank water and went back to sleep. 1/9/21 5am heart rate was at 135. then 6am 148bpm. 7am around 161bpm. Kept trying to go back to sleep. 1/9/21 8am got up and took an adult benadryl tablet and drank plenty of water. Tried to relax to lower my heart rate.  1/9/21 9am took another adult benadryl tablet and was able to get my heart rate just below 120 while sitting. Then ate breakfast and went back to bed. If heart rate was not going to lower, I was planning on going to the ER. 1/9/21 10am till next day. Heart rate was then under 100bpm. I was then so tired that I slept all day and did not eat anything else.  1/10 I experienced severe body aches, chills and headache. This was all day. 1/11 I woke up feeling mildly nauseous for about 3 hours and then dizzy for about an hour. after that I just had a sore arm. 1/12 Had a mildly sore arm.
Arterial bleed into her deltoid muscle that was then festering; High dose of flu vaccine administered; Provider who administered the vaccine injected it into her artery; Arterial bleed into her deltoid muscle that was then festering; This is a spontaneous case, reported by other non-health professional to agency[reference number: SEQ19-07068] and initially received on 27-Nov-2019, concerning an 83-year-old, female patient.  The patient's medical history included rheumatoid arthritis, hypertension and diabetes. The patient was taking unspecified concomitant medications, however, the brand names were not provided.  On 05-Nov-2019, the patient was administered unspecified Flu vaccine [Influenza vaccine, batch number: 260397, route of administration: into the artery, anatomical location: right arm, dose reported as 'high' and expiration date: not reported] (explicitly coded as 'Inappropriate route of vaccination' and 'Inappropriate dose of vaccine administered') for influenza prophylaxis.  On 06-Nov-2019, one day after vaccination, the patient experienced slight soreness.   On an unspecified date in Nov-2019, reported as a week later, the patient had significant pain in her entire right arm.  On 22-Nov-2019, the patient was still experiencing severe pain, and she lost most of the ability to use her arm.  On 24-Nov-2019, the patient was taken to the emergency room (ER) due to severe edema, heat, hardness of her upper arm along with bruising from her shoulder to elbow. In the hospital it was noted that the vaccine was injected into patient's artery, causing arterial bleeding into the deltoid muscle that festered until the pain became unbearable. The patient started treatment with unspecified pain killers and antibiotic, and her blood thinners were stopped for a week. The patient was not hospitalised.   At the time of initial reporting, the patient had not recovered form the events. It was reported that the patient continued to have no use of right arm, and she still had heat, swelling and bruising from shoulder to arm, and was unable to use her cane.   The event of 'arterial bleeding' was assessed as serious (medically significant) per company.  The reporter did not provide causality assessment.  Company Comment: The patient experienced arterial haemorrhage and infection (reported as arterial bleed into her deltoid muscle that was then festering) after incorrect route and dose of product unspecified Flu vaccine administration. Chronology is plausible. Medical history of diabetes may have contributed to events. No concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced arterial haemorrhage and infection (reported as arterial bleed into her deltoid muscle that was then festering) after incorrect route and dose of product unspecified Flu vaccine administration. Chronology is plausible. Medical history of diabetes may have contributed to events. No concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.