chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to vaccination site for the Janssen Covid-19 vaccine on April 09, 2021. After receiving the vaccine, given by a Medical Assistant, he stated that he was ?not feeling himself and was lightheaded?. Medical Assistant, told him to put his car seat back and that she was going to get the automatic BP cuff to take his BP. Medical assistant also let two RNs, know about the incident and they also observed the patient when he was getting his BP taken by Medical Assistant at 9:10am. The first BP was taken on the left arm and was 199/119 and pulse was 72. The second was taken immediately after on the right arm by a RN and was 191/116 and pulse was 78. At 9:22am, RN called our Pharmacist and explained the symptoms the patient was having. She advised the nurses to call EMS. The RNs then took BP again at 9:23 am on the left arm, this time it was 199/116 and pulse was 72. The RNs explained to the patient they were going to have to call EMS to take him to the hospital due to his hypertension. Patient refused EMS transport and stated he would go to his doctor, but that he wants a manual BP taken. The RNs stated he would need to call someone to pick him up to transport him to his doctor. Patient called wife to pick him up. RN stated at 9:27am that a staff member was going to get the manual BP cuff. At 9:35am second RN checked patient and he stated he ?felt fine?. At 9:45am, second RN checked patient again, and he stated he was ?feeling better?. At 9:55am, second RN checked BP with the manual BP cuff on the left arm and it was 215/118 and pulse 75. At 10:00 am second RN gave patient a bottle of water, because he stated he was thirsty. Second RN asked to check BP again at 10:01am on the left arm, manually and it was 194/115 and pulse was 81. Second RN took manual BP again at 10:06 am and it was 190/110 and pulse was 82. Crackers were also given to patient at this time. At 10:18am wife picked up patient and took him to his MD office at 10:18.  On April 10th, 2021, at 10:27am, RN reached out to patient via phone but patient did not pick up or call back.
This spontaneous report was received from a nurse regarding unspecified number of patients of unknown age and unknown gender. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (Lot# L024255, expiry: 01-JUL-2017; Lot# L041204, expiry: 20-OCT-2017; Lot# L025207, expiry: 07-JUL-2017) (route, dose and strength were not reported), which were improperly stored at -12.7 degree Centigrade for 9 hours 58 minutes. No adverse effects were reported. There were no previous excursions involved and data logger was involved. This is one of the several cases from same reporter. Additional information has been requested.
This spontaneous reprot as received from a registered nurse refers to multiple unspecified patients of unknown age. No information on their medical histories, concurrent conditions or concomitant therapies was provided. On unknown dates the patients were vaccinated with PROQUAD (Merck) (lot number, expiration date, dose, route of administration not specified). The reporter stated the vaccines were improperly stored. There was no adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recv 28MAY96 & 21MAY97 pt devel chicken pox w/30 lesions;
Child had acute onset of right exotropia and pupillary dilatation.  Brain MRI negative.  Eye doctor thought that eye findings may be post-inflammatory reaction to flu vaccine.
Received vaccine on 08/18/08, on 08/19/08 patient had 4x6" area of erythema, tender and warm to touch at site of injection on left deltoid, had a fever of 101/5 and malaise. Symptomatic care advised.
she didn't feel good; she was feelin bad; she tested positive; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, caller reports that, his wife received her first dose on Sunday, 14 Apr The Tuesday after she received her first shot she didn't feel good and then wednesday "she was feeling bad" and Friday "I took her to the ER and she tested positive". The adverse event she was feeling bad and she tested positive was resulted in emergency room visit. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423380 same reporter/drug, different patient/AE
Severe aches  around pelvic girdle making it difficult to sleep at night. Also very sore arm.
high pitched abn crying x 20 mins; DPH given; t102.3 both thigh had pain, swelling, inc warmth, rash, hives no joint pain, etc;
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), on Jan 29, 2021; and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), on Feb 26, 2021; both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had lymphadenopathy/swollen lymph nodes, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient received Shingrix vaccine on Friday 4/21/23 and notified pharmacy on Sunday 4/23/23 that she had spent all day Saturday (4/22/23) in bed with fever, was very weak, had developed a red saucer-like rash around injection site, also had red marks appearing on chest, neck and arms which she stated was normal for her when she had a fever.  She had contacted her physician but he had not returned her call at this time.  She also stated that she had a very sore arm which she could not use all day Saturday.  Patient stated that as of today (Sunday) she was feeling better and that she could use her arm although it was still sore and the red rash was still apparent on arm as well as chest and neck.  Patient advised to contact physician for follow-up and not to receive the second dose of Shingrix without her physician's approval.  Pt also advised to go directly to ER if condition failed to continue to get better or got any worse.
Information has been received concerning a person who experienced a swollen arm with hive like red rashy skin. She also developed 3 lumps that were 2 inches in diameter each at injection site. The pt sought unspecified medical attention.
This spontaneous report was received from a licensed practical nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAX 23 (lot # M043424 expiration date: 06-JUN-2018 and lot # M038359 expiration date: 13-MAY-2018). The vaccines were exposed to 32 to 35 Fahrenheit degree for 2 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004034: US-009507513-1704USA004040: US-009507513-1704USA004041.
Started with left arm pain in shoulder that would shoot down to wrist, muscle spasms in that arm, then head started itching.that night had pain in right thmb and it got red,swollen,hot to touch,itchy,painful. During that night entire body hurt,had sternum pain,especially when swallowing.Following morning had a rash on thighs,torso,very itchy and raised.Both knees very swollen,red,hot to touch and painful. Could feel my heart racing..Went to emergency room that day and was given a Medrol dose pack(which by the end of the day helped with the rash and joint pain) That night the bottom of my feet hurt bad when walking.Developed pain in the neck, couldn't turn head.On Thursday Nov.12 felt heart racing,broke out in a cold sweat,got lightheaded,had to lay down because almost passed out. Had seen  Dr and was referred to a cardiologist. Had an event montor and a tilt table test and diagnosed with POTS. Have continued with tachycardia even though taking Midodrine 5mg TID.
Patient reported soreness/painful up into clavicle area of right side where injection occurred. Patient also reports swollen and painful lymph nodes on right side where injection occurred.
Major Leg swelling encompassing most of upper thigh, redness, warm to touch, fevers, pain with ambulation. Yes
Information has been received from a physician concerning his wife, a 64 year old white female with hay fever and a pcn allergy who on 10/18/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641532/1353L). Concomitant therapy included Lipitor, Niaspan, Volmax, Mavik, Allegra, influenza virus vaccine and Foltx. Within six hours after the administration of her first dose of pneumococcal vaccine 23 polyvalent. On 10/18/02, the pt experienced pain and her right upper arm had swollen two to three times its size. She also develped erythema and heat with immobility of her right arm. The pt felt warm and may have had a low grade fever but measurements were not taken. The physician also noted that a blood test following the injection indicated that the pt's serum creatine kinase (CPK) was elevated to 512. Subsequently on 10/18/02, the pt was treated with rofecoxib 50mg tablet, 50mg once a day for two days. Thereafter, the dose of rofecoxib was decreased to 25mg once a day along with Vicodin. On 10/21/02, a complete blood count, "SMA-20," serum creatine kinase test, urinalysis and a serum immunoglobulin E test were all within normal limits. On 10/22/02, after four days of oral therapy, a heating pad four times a day and elevation of the right arm, the pt recovered from the pain, swelling, erythema, and heat with immobility of her right arm as she had remobilization of her right arm and the swelling was 80% down. The pt sought unspecified medical attention. The pain, swelling, erythema, and heat with immobility of her arm were considered to be disabling for 96 hours and other important emdical events (OMIC) by the physician. Additional info is not expected.
Covid Shot 1st dose 1/19/21 left arm (fever for two days) arm ache Covid Shot 2nd dose 2/12/21 right arm (full body aches/all joints felt on fire for 7 days/fever) arm ache Heb B 1st dose 3/5/21 left arm (no initial reaction) Shingles began 3/7/21 lasted 3 to 4 weeks (Diagnosed 3/9/21 at Patient First, Valacyclovir 1gm 3 x a day and OTC Shingles ointment  Heb B 2nd dose 4/16/21 left arm no reaction
Information has been received from a medical assistant referring to a 3 month old female patient. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Pt described injection site reaction.  Says tolerated  first shot well with minimal reaction.  This was 2nd shot & pt reported redness & swelling at injection site (approx 1.5 inches diameter) & feeling like had "flu".  Pt called pharmacy the day after having 2nd shot to report adverse reaction.
Moderna COVID?19 Vaccine  Severe confustion, can not communicate, can not walk without help. Same symptoms as with first shot.
Woke up at 1:00 a.m. shivering could not get warm, had severe headache and backache, week and light headed.  Spent entire day in bed on the 16th.
interstitial lung disease (ILD) exacerbation; This literature-non-study case was reported in a literature article and describes the occurrence of INTERSTITIAL LUNG DISEASE (interstitial lung disease (ILD) exacerbation) in a 72-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       Concurrent medical conditions included Interstitial lung disease.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced INTERSTITIAL LUNG DISEASE (interstitial lung disease (ILD) exacerbation) (seriousness criterion medically significant). At the time of the report, INTERSTITIAL LUNG DISEASE (interstitial lung disease (ILD) exacerbation) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered INTERSTITIAL LUNG DISEASE (interstitial lung disease (ILD) exacerbation) to be related.    No concomitant and treatment medications were reported.  Company comment: This case concerns a 72-year-old male patient with medical history of interstitial lung disease, who experienced the unexpected, serious (medically significant) event of interstitial lung disease 5 days after the second dose of mRNA-1273. The patient experienced an exacerbation of his interstitial lung disease, which is a confounder. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 72-year-old male patient with medical history of interstitial lung disease, who experienced the unexpected, serious (medically significant) event of interstitial lung disease 5 days after the second dose of mRNA-1273. The patient experienced an exacerbation of his interstitial lung disease, which is a confounder. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Patient went to the hospital in May for Vertigo. Patient wanted to know,an increase of people reporting vertigo as a side effect after receiving the vaccine. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-644588 (E2B Linked Report). This case was linked to MOD-2021-053248 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644588:MOD-2022-644586 ( Case For Female Patient)
Became dizzy approx 30min p/inject, became nauseated approx 45 min p/inject, 5 hrs later all sx were gone;
Tingling in my fingers. Opposite side of body of injection. Shortness of breath. Fatigue.
1245:Pt c/o SOB, Anxiety, Dizzyness,BP:122/74, P:99, T:98.1, Spo2 99% RA. Pt given water and observed for additional time.1255:Pt stated feeling much better, Pt instructed to get hydrated and call PCP for concerns. Pt released.
Reported on 12/8/13 at 2pm. Pt had fever for 2 days. Followed by pain in the arm ever since. Pt showed up on 12/8/13 at 2 pm saying he had pain in the arm. Had it ever since shot. Had Dr visit 12/5/13 on Naproxen. Pt reported the symptoms not until 12/8/13 at 2 pm to pharmacist.
Pt developed redness, swelling, warm to touch at vaccine site. Also developed a rash on his face.
Soreness at injection site. Severe headache. Loss of appetite, drowsiness. Treatment: aspirin, sleep. This was dose #2 - time course around 36 hours.  Symptoms for dose #1 (05/04/2018)  lasted 2-3 days.
About 9 days after vaccine pt developed rash-erythematous papular itchy on buttocks, arms, legs
"I have to watch my balance on the stairs; I fall asleep more easily; my ability to work has been effected; lightheadedness; mild flu-like symptoms; more difficulty focusing kind of spacy feeling; symptoms mainly similar to the ones he experienced before during last stages of Pneumonia; found difficulty working; Moderate soreness in the arm; Foggy feeling in head; Fatigue/kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working) and PAIN IN EXTREMITY (Moderate soreness in the arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (Fatigue/kind of tired). On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working), PAIN IN EXTREMITY (Moderate soreness in the arm) and DIZZINESS (lightheadedness). On an unknown date, the patient experienced BALANCE DISORDER ("I have to watch my balance on the stairs), SOMNOLENCE (I fall asleep more easily) and IMPAIRED WORK ABILITY (my ability to work has been effected). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (mild flu-like symptoms), DISCOMFORT (more difficulty focusing kind of spacy feeling), ILLNESS (symptoms mainly similar to the ones he experienced before during last stages of Pneumonia), ASTHENIA (found difficulty working), PAIN IN EXTREMITY (Moderate soreness in the arm), FEELING ABNORMAL (Foggy feeling in head), BALANCE DISORDER ("I have to watch my balance on the stairs), SOMNOLENCE (I fall asleep more easily) and IMPAIRED WORK ABILITY (my ability to work has been effected) outcome was unknown and DIZZINESS (lightheadedness) and FATIGUE (Fatigue/kind of tired) had not resolved.            Treatment included Acupuncture and vestibular therapy.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Signifcant Follow-up received provided additional events, event outcome update and reporter details.
Patient received immunization on 6/10/20 and experienced muscle pain for a few days, then on 613/20 noticed that both hands were swollen, red, and experiencing tingling with numbness.
Patient's first dose was Moderna on 10/24/2021, patient received their second dose today with Pfizer. Patient showed me their vaccine card on their phone since they didn't have it in person, the card showed Pfizer, and gave the patient Pfizer. But when we processed it through insurance, we saw that he got Moderna the first time. We are not sure what happened but we think patient might have accidentally shown their spouse's card. When giving the patient the vaccination, confirmed with him that we were doing Pfizer 2nd dose. Tried to call patient 4 times but patient did not pick up.
Nausea, Diarrhea, Extreme chills, Fatigue, Bad dreams during nap, waking up in a very excessive sweat, gradually increasing high amount of motivation despite symptoms
Rash on one side of my stomach, it was red and sore/ two red spots on my stomach; Rash on one side of my stomach, it was red and sore; pain; burning sensation; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that he received BNT162B2 on 02Apr2021 and 3 or 4 days later he noticed a rash on one side of his stomach, further specified as red and sore as if it had been burnt with hot water; further reporting two separate red spots on his stomach, a burning sensation and pain. He inquired what he could take for this to go away. He reported calling his doctor who told him to call Pfizer. The clinical outcomes of rash on one side of his stomach, it was red and sore, two red spots on his stomach, burning sensation and pain were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
fatigue, insomnia, headache, nausea, bloating, irritability, dry mouth
Headaches, fever (101.6 orally), chills, c/o feeling of numbess with hands, feet, body aches.
Developed cellulitis at injection site; treated with Kelfex for 5 days.
Tuesday night 10/12 had chills, fever, nausea, whole body inflamed, neck and spine so painful I couldn?t move. Swelling of lymph nodes and throat hurt to swallow. Then Wednesday night 10/13 started excruciating burning sensation in toes and fingers. All extremities turned deep red and developed chilblains. Felt like someone had lit every finger and toe on fire. Couldn?t walk or use hands or feet. Worst pain I?ve ever experienced. Didn?t sleep Wednesday or Thursday night due to pain. Also developed lesions and puss filled cracking red splotches on my face starting Thursday afternoon 10/14. Doctor told me to go to ER Friday morning to check circulation and compromised blood vessels. ER gave me Tylenol and was sent home. Swelling redness and burning sensation in hands feet and face lessened Saturday afternoon and  was gone by Sunday with residual blisters and splotches from chilblains. Scheduled doctor appointment to review long term autoimmune side effects.
permanent hearing loss; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced the incidence of permanent hearing loss. The reporter did not consent to follow up.