chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Smallpox vaccination site scab still present 91 days after vaccination.  Patient had a major take and reported fever, body aches, soreness and itching at vaccination site and lymphadenopathy.  Scab is dry.  Patient is wearing tegaderm with gauze while at work and gauze alone when not a work. Follow up: Was vaccinated on April 15,2003. In July 2003, developed reduced exercise tolerance. At end Required Emergency Room/Doctor vist of January, she developed chest pain, shortness of breath, lightheadedness, and nausea. On February 23rd, she reported to work, but had to go to the ED 3 hours into her shift. She has been on sick leave ever since.
Headache; Tired; Diarrhea; Sore nipples; Sore injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the left arm on 09Jan2021 (08:15) at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 09Jan2021, the patient had headache; was tired; had diarrhea; sore nipples; and sore injection site. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache', 'tired', 'diarrhea', 'sore nipples' and 'sore injection site', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.  Information about lot and batch number was requested.
Erythema and swelling of (L) deltoid on morning 8/20/12 says erythema/swelling started within hours of inj. worse on Tues/Wed with pruritus but better now.
pt recv vax 11OCT95 & 7NOV95 pt exp a mild case of varicella w/a vesicular rash;there was no history of varicella exposure @ the time of vax;
5"X7" RED, SLIGHTLY RAISED CIRCLE TO LEFT OUTER ARM AT INJECTION SITE- REPORTED AS ITCHY AND SLIGHTLY WARM OBSERVED ON 3/12/2021
Pt. said that she had a reaction to the shot. She noticed that night that she had redness and swelling in the shot area. Also, she experienced discomfort in area. When pt. came into pharmacy the next day, I noticed that shot area was red and swollen.
it is itchy; Big rash about 3 inch by 2 inches size around injection site; Soreness of left arm; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm), VACCINATION SITE PRURITUS (it is itchy), HEADACHE (headache) and VACCINATION SITE RASH (Big rash about 3 inch by 2 inches size around injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Anxiety and Blood pressure abnormal. Concomitant products included LISINOPRIL, RALOXIFENE, PAROXETINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm) and HEADACHE (headache). On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (it is itchy) and VACCINATION SITE RASH (Big rash about 3 inch by 2 inches size around injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of left arm), VACCINATION SITE PRURITUS (it is itchy), HEADACHE (headache) and VACCINATION SITE RASH (Big rash about 3 inch by 2 inches size around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included medications for Blood pressure, osteoporosis, anxiety.
Suicidal thoughts, felt like hurting myself; swallen all over body; I have trouble peeing; fever; fatigue; vomiting; Anxiety; really scared; crying and very upset, many bad reactions; upset; This case was reported by a consumer via call center representative and described the occurrence of suicidal ideation in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetic.   On 21st July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than 2 weeks after receiving Shingrix, the patient experienced generalized swelling, urination difficulty, pyrexia, fatigue, vomiting, anxiety, fear, crying and emotional distress. On 28th July 2022, the patient experienced suicidal ideation (serious criteria GSK medically significant). The patient was treated with diclofenac. On an unknown date, the outcome of the suicidal ideation, generalized swelling, urination difficulty, fatigue and anxiety were not recovered/not resolved and the outcome of the pyrexia, vomiting, fear, crying and emotional distress were unknown.   It was unknown if the reporter considered the suicidal ideation, generalized swelling, urination difficulty, pyrexia, fatigue, vomiting, anxiety, fear, crying and emotional distress to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporters comment:  The reporter was a Spanish-speaking patient. Her call was transferred to me by a non Spanish speaking agent. She was crying and very upset. The patient stated she received Shingrix dose 1 ( on left arm) on 21st July,22. Had many bad reactions to it. swollen all over her body and hands, troubled peeing, fever, fatigue, vomiting, anxiety. She went to the physician on 28 July 2022 and he given to her shot and a pill diclofenac. she did not know what else to do. she was really scared because had suicidal thoughts, she stated she was alone and has nobody that could help her.  The reporter did not consent to follow-up.
ON 09/21/22 THE PATIENT RECEIVED MODERNA 2ND BOOSTER WHICH HAD EXPIRED ON 09/15/22. PT WAS OBSERVED FOR 30 MINUTES POST VACCINATION, NO ADVERSE REACTION NOTICED AT TIME , PT WAS TOLD TO GO TO THE EMERENCY ROOM IF ANY ADVERSE EVENT. PT VERBABLIZED THAT SHE DID NOT FEEL ANY SYMPTOMS OF ADVERSITY.   CONTACTED MODERNA TO REPORT THE EVENT. AWAITING REPORT FOR LOT NUMBER ANALYSIS FROM MODERNA .
Fever; lasted 24 hours Body aches; lasted 24 hours  Burning sensation in eyes; 24 hours  Slight headache; 24 hours
Nerve pain and muscle pain was only in left arm at first but has continued to spread up to left shoulder, left side of neck, and  left ear/eye/side of head.  It has not been one week since the vaccine and the muscle tension, nerve pain, and numbness has continued to increase and spread
Moderna vaccine given to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 16 year old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-significant information provided
PATIENT SAID RIGHT EAR WAS HURTING AND SENSITIVE. SHE SAID IBUPROFEN HELPED WITH PAIN. I ADVISED HER TO SEEK URGENT CARE IF PAIN WORSENED AND TO KEEP TREATING HER SYMPTOMS WITH OVER THE COUNTER PAIN THEARPY.
Tested COVID-19 positive, resulted in hospital stay and abnormal chest x-ray. Symptoms include cough and shortness of breath.
Information has been received from a physician concerning a patient who was vaccinated with two doses of VARIVAX (lot#, route and site of administration not reported). The patient still had a low titer after vacciantion. The physician did not want to answer any questions for the report. No further information is available.
Patient is a78y.o. year oldfemale with a h/o afib, Diabetes, CAD, HTN, Hyperlipidemia, lung cancer S/p RUL lobectomy in 2015, PE and non O2 dependent COPD presented to BH secondary to SOB at rest.  Symptom onset 3 day PTA, denies cough. States chronic DOE, but worsening SOB at rest. No N/V/D, no F/C, no loss of taste or smell. No known sick contacts Tested positive for COVID 5/15 Completed COVID vaccination with Moderna on 4/26 Afebrile with normal WBC. Tachypnic on ED arrival and placed on 2L O2 for comfort, no recorded desats. States feeling much better and anxious for DC.
I received multiple shots at once during this appointment. As soon as the shots were given, I went to stand up and felt like I was going to pass out. I blacked out and my mom told me that I arched my back and fell onto the table and made some horrible noise like I couldn't breathe. I regained consciousness soon after blacking out and was given apple juice and a cold cloth to put on my forehead. The doctor watched me for about 10-15 minutes and once I felt well enough, I left and went home. A few months later I began feeling extremely tired all the time. I could not keep myself awake no matter what I did. It felt like I was trapped inside my body and I couldn't keep it from falling asleep. I would go to bed early (10PM) and wake up early (6-7AM) and still fall asleep in school. I could sleep for 14 hours at night and I would still fall asleep 30 minutes after waking up and continuing to need to take naps throughout the day. I tried to go to bed and wake up at the same time everyday and get around 8-9 hours of sleep and it did not change how tired I was feeling. I saw doctors who tested me for Mono, Anemia, thyroid disorders, etc. multiple times. I was told to exercise, eat healthy, sleep well, etc. I would do everything the doctors suggested and nothing changed. I was tested for the same things over and over with the results always coming back negative. I finally saw a sleep specialist and was diagnosed with Narcolepsy in January 2014 after completing a full sleep study. I have been taking Ritalin to control the tiredness and keep me awake since December 2011. When I had my second dose of Gardasil on December 2, 2008 and was laying down when given the shot since I had a bad reaction the first time. I remained lying down for a while after the shot was given and when I tried to stand up, I felt as though I was going to pass out again. I immediately layed back down and was able to keep from fainting. I also began having gastrointestinal issues at the same time the tiredness began. I saw a gastrointestinal specialist and had a colonoscopy/endoscopy, breath hydrogen test, and tried multiple medications, among other tests. Nothing was ever conclusive and for now, it is assumed that I have Irritable Bowel Syndrome.
Information has been received from a consumer concerning two of her friend's children who were each vaccinated with a dose of MMR (second generation). Subsequently the patients developed autism, as a result of receiving MMR (second generation). Medical attention was not sought. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Nauseous day 1; fever; Swelling/ lasting for 3+ days; redness/ lasting for 3+ days; pain lasting for 3+ days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A patient (no qualifiers provided) received meningococcal group b rlp2086 (TRUMENBA) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "recovered", described as "Swelling/ lasting for 3+ days"; ERYTHEMA (non-serious), outcome "recovered", described as "redness/ lasting for 3+ days"; PAIN (non-serious), outcome "recovered", described as "pain lasting for 3+ days"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous day 1"; PYREXIA (non-serious), outcome "unknown", described as "fever". The patient experienced swelling, redness, pain lasting for 3+ days. Nauseous day 1 with fever. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3-4 days ago started having red eyes and runny nose, then on 4/28/15 (Tuesday in the am) developed red spotted rash on face that spread to body, arms and legs (measles like rash after vaccination).
Syncope ~2 min after administration of injection. Was supported by mother and was sat to ground. Once able to stand, patient was supported on chair to sit. Patient took about 30 minutes to recover.
rash all over body; This is a spontaneous report from a non-contactable consumer (parent) or other non HCP via  Information Team. This consumer reported for a male patient (son)   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash all over body. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Fatigue, nausea, terrible head ache, loss of appetite from evening of 3/23 until late evening 3/24
Revaccination with different COVID-19 vaccine; Interchange of vaccine products; No Adverse Event; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Pfizer vaccine as a first dose). Past adverse reactions to the above products included Vaccination adverse reaction with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products).    No concomitant medications were reported. The reporter stated that she was at high risk because of her weight. No treatment medications were reported.
7.5 x 6 cm Local reaction with swelling, redness, warmth and induration
1300: Pain to L upper arm 1400: increasing pain to L upper arm 1600: increasing pain from shoulder to elbow  1630: face feels hot, mild sweating, temp of 100.3  1700: fatigue, exhaustion; pain in L arm extends to forearm, pain with lifting L arm  2000: rotating between episodes of chills and sweating   0700 on 12/24/20: continued fatigue; no longer have chills/sweating/fever; significant decrease to L arm pain
Headaches, Soreness, Swelling and redness at vaccination site, Nausea, Fever, Blurred speech and vision, Seizure like episode for about a minute. MOTRIN, TYLENOL, Ondansetron.
This spontaneous report as received from a registered nurse via field representative refers to two patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot # K014834, expiration date 14-DEC-2015, dose, route not provided) for prevention of shingles. On an unknown date, the patients experienced unspecified reactions to ZOSTAVAX. The outcome was unknown. Additional information has been requested.
Presented to Clinic on 8/12/06 with c/o sneezing, ear pain, throat pain, painful swollowing body aches, chills, and sweats x 1 day. Afebrile at time of visit. Diagnoses as smallpox flu like symptoms and allergies. Orders given for quarters x 24 hours, Allegra 180mg po q day, Robitussin prn and push fluids, RTC TMC PRN. Was then seen at ER later that day for Respiratory Distress/difficulty breathing. O2 sats were in the 80's in the ER but improved initially on O2. CXR showed a questionable fluffy infiltrate along the right cardiac border. Patient was admitted for O2 and IV therapy and breathing treatments. Pt. received IV Levaquin 750mg every 24 hours as well as Solumedrol 125mg every 24 hours IV. Patient was maintained on 2L of O2 during hospital stay. O2 sats maintained in the 90's when O2 was removed. Wheeze persisted on discharge. D/C'd 8/13/06 with light duty orders, Albuterol MDI 2 puffs tid and every 2 hours as needed, Prednisone 40mg daily through 8/17/06, Levaquin 750mg po daily through 8/21/06. Discharge diagnoses: RAD, Pneumonia.
Information has been received from a consumer concerning her 21 month old white daughter with no medical history who on 20Jun2003 was vaccinated SC in the right anterior thigh with a first 0.5ml dose of varicella virus vaccine live. Concomitant vaccination the same day included a third 0.5 ml dose of Streptoccocus pneumoniae vaccine (PREVNAR) given IM in the left anterior thigh and a fourth 0.5 ml dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) given IM in the right anterior thigh. There was no illness at the time of vaccination. the reporter indicated that the child had a fever of 103 degrees for "a week after the vaccination". the child also developed a "horrible cough" that made her vomit. The reporter also believed that the child "has chickenpox now". the child's fever decreased after the first week, but she was still coughing. The child was taken to the ER on 21Jun2003  but was not admitted. The child was also taken to the physician two times since being vaccinated. The child was treated with acetaminophen (TYLENOL), guaifenesin (ROBITUSSIN) and azithromycin(ZITHROMAX) and had two breathing treatments to treat the adverse reactions including fever and cough. A chest X-ray was performed but no results were reported. At the time of the report, the patient had not recovered. The reporter also noted that she is 23 weeks pregnant but did not report any adverse reactions for herself. Follow up information from the physician indicated that the pt was see in the office on 14Jul2003 because of 2 "red bumps" one on her forehead and one on her back which developed on 13Jul2003. The diagnosis was "papules" most likely insect bites. The physician reported that there was no history of cough or vomiting. No further information is expected.
5 minutes post vax, the pt experienced a very sore arm that she could barely move. In addition, the pt's arm was red and swollen down to her fingers. The symptoms progressed to generalized pain on the whole right side of her body. The pt thinks she also had a fever, but no temperature measurement was taken. 24 hours later, the pt recovered.
pt recvd vax & 1 wk following vax pt devel serum sickness, arthralgias of the knees & hands, angioedeema of feet & erythema nodosum; No further details were provided;
Pt recvd vax & 2 wks post vax rash on face appeared;
I received my 5th dose of the Bivalent COVID-19 vaccine on 09/09/2022. On 10/31/2022 my COVID-19 symptoms started in the morning. I had headaches, cough, fever, and not feeling well over all. On 11/01/2022 my symptoms were worst and I took the home COVID-19 test which was positive. On 11/02/2022 I called my doctor and did telehealth. My doctor prescribed me with PAXLOVID for 5 days. I started taking the PAXLOVID on 11/03/2022 because I took my regular medications that day, according to my doctor's advise. I had a regularly scheduled check up with my Cardiologist on 12/01/2022 he did X-ray and everything was normal. My lungs were fine.
On 27JAN injection area started to itch and kept itching throughout the night; little rash broke out around area; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (little rash broke out around area) and VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included THYROID for Thyroiditis NOS, APIXABAN (ELIQUIS) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (little rash broke out around area).   On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE RASH (little rash broke out around area) and VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.