chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 51-year-old female patient. The patient's medical history included a heart attack in April 2017. The patient's concurrent conditions included diabetes and allergy to PHENERGAN. On 30-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, in the left deltoid, lot # N012127, expiration date: 20-JAN-2019 (dose was not reported) for prophylaxis. Concomitant therapies included metformin, PLAVIX, BENICAR and atorvastatin. On 01-DEC-2017, the patient developed shortness of breath, fever, weakness, headache/body ache, and soreness/redness at injection site (left deltoid). On the same day, the patient was admitted to the hospital due to the events. The patient had unspecified laboratory tests performed and was given an unspecified treatment for the events. The patient was hospitalized for 3 days (discharged approximately on 04-DEC-2017). The patient came to the office on 11-DEC-2017 for a follow up visit. The outcome of the events was reported as recovering. The causality assessment was not provided.
Slight malaise after first dose. After second dose, she complained of body aches throughout the rest of the day until she was transported to the hospital.
Patient sparked a high fever shortly after receiving vaccine, was treated with Tylenol suppositories and Morphine. Patient was on 1.5 liters of Oxygen. Hospice refused any additional treatment including IV fluids or doctor visit requested. Patient stopped eating and drinking and lapsed into unconsciousness. He died on June 29. 2021 after Hospice nurse recommended removing Oxygen. At home nurse insisted on maintaining oxygen until his death a few hours later.
Dizzy headache fatigue swollen arm rash  itching  nasea diarrhea nausea
Pt rec'd vaccine 2 days later, was with grandmother had seizure (length of time 3 minutes). On way to ER had 103 temperature. Went clinic rec'd CSF, blood no signs and symptoms. Was hospitalized for 3 days. D/C home and doing OK. Pt also developed rash after 5 days at home from head to toe, with resolving after 2 days.  Hospital ER record received for ER visit for c/o seizure and URI symptoms 2 days s/p vax..  HPI: Seizure at home with grandmother. Temp.=103'F, runny nose (clear) and congestion. Cough and diarrhea. Erythema of TMs bilaterally. Child was alert and responsive upon arrival to ED.  Impression:  Febrile seizure, Sepsis.
Information has been received from a nurse at a physician's office concerning a female who was vaccinated with a single dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced shingles. The patient's shingles persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Initial information has been received from a nurse at the physician's office and follow up information was received from the physician concerning an 83 year old female with allergic to SEPTRA who on 02-APR-2007 was vaccinated in her upper arm with the first dose of ZOSTAVAX (Merck). On 15-OCT-2007, the patient was vaccinated with a dose of influenza virus vaccine (unspecified) (manufacturer unknown). There was no illness at time of vaccination. On 21-APR-2009 the patient developed a herpes zoster outbreak on the left lower thoracic dermatome. Subsequently, on 06-JUN-2008 the patient recovered from herpes zoster outbreak. A doctor visit was required. Additional information is not expected.
Extreme joint pain in shoulders, wrists, fingers, hips, buttocks, legs. (Polymyalgia Rheumatica) that began about a week after the second Moderna injection and became worse and worse in intensity over several months, for which I ultimately sought a consultation with a Rheumatologist.
Approx 2 minutes after receiving 2 vaccinations, patient was standing next to exam table and began to complain of feeling nauseated then became limp and her body began to lower to the floor. RN and patient's mother assisted patient to the floor before any injury could occur, patient's head came into contact with the wall and a metal stand up weight scale but without causing injury to patient. Patient awoke within less than 15 seconds from intially staring to slump and was alert but was asking what happened and complained of a headache on the right side and dizziness. Pt was assisted to a supine position, a pillow placed underneath her head and her feet raised upon a stool and allowed to rest for a period of time, BP taken throughout the remainder of the time the patient was monitored. Pt recovered without further events. Sips of water given.
Information has been received from a registered nurse concerning a 19 year old female who on 04-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (0.5 ml) (lot # 654510/0962F). Subsequently, on 04-JAN-2007, the patient was rushed to the emergency room with symptoms of body aches, breathing problems and a temperature of 103. The patient was released from the emergency room within 12 hours. The nurse reported that the emergency room physician believed that the above reaction was due to influenza. The patient recovered. The reporter considered the patient's experience to be disabling. Additional information has been requested.
This  64 year old female received the Covid shot on 3/16/21    and went to the ED on  3/28/21     and was admitted  on /21 with the following diagnoses listed below. U07.1 - COVID-19
Vomiting; Trouble walking; Chills; Vertigo; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), VERTIGO (Vertigo), VOMITING (Vomiting), GAIT INABILITY (Trouble walking) and CHILLS (Chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PAIN (Soreness). On 01-May-2021, the patient experienced VERTIGO (Vertigo). On 02-May-2021, the patient experienced VOMITING (Vomiting), GAIT INABILITY (Trouble walking) and CHILLS (Chills). At the time of the report, PAIN (Soreness), VERTIGO (Vertigo), VOMITING (Vomiting), GAIT INABILITY (Trouble walking) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol for the pain Advil for the soreness.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Approximately on an unknown date in 2012 (reported as last summer), the patient was vaccinated with dose 1 of GARDASIL (lot number, expiry date, dose and route unspecified). Approximately on an unknown date in 2013 (reported as this summer), the patient was vaccinated with dose 2 of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. There were no known adverse effects. Additional information has been requested.
Client developed swelling, redness, itchiness at injection site 9 days after receiving vaccine.  Client states she had only mild soreness at the injection site the day after receiving the vaccine but it went away in a day
have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2020, the patient received the 1st dose of Shingrix. On 28th September 2020, 14 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles 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 selected as adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix 2 weeks ago and experinced Shingles. The reporter did not consent to follow up.
Patient said their eyes were burning for about 30 minutes then it went away after they received the vaccination.
I was having difficulty in breathing and short of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EL9267) via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that "the patient had the first Pfizer shot (clarified as Covid 19 vaccine) on 09Feb2021 and the next day on 10Feb2021 was having difficulty breathing and short of breath and went to urgent care and they gave patient a shot of he/she think (statement incomplete) and they put patient on a breathing machine and patient was wondering if he/she should go get the second shot on 02Mar2021". The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
very painful / area under the injection site; red / area under the injection site; hot / area under the injection site; hard / area under the injection site; This case was reported by a consumer via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 2nd dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth and injection site induration to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient had very painful, red, hot, hard area under the injection site after Shingrix dose number 2. It was day 3 and the edge of the reaction was still advancing, the reporter also asked what to do. No contact details were reported.
Primarily nocturnal intense leg cramping for 9-10 minutes in the front of her lower leg from foot to mid-leg. Her muscles seize up to the point where she can't put weight on the leg or walk. Symptoms don't seem to happen during the day but it happens almost every single night, sometimes up to 3 or 4 times a night.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (REACTION TO COVID VACCINE), COUGH (Cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered beyond 35 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered beyond 35 days). In June 2022, the patient experienced COUGH (Cough). On an unknown date, the patient experienced VACCINATION COMPLICATION (REACTION TO COVID VACCINE). At the time of the report, VACCINATION COMPLICATION (REACTION TO COVID VACCINE) and COUGH (Cough) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered beyond 35 days) outcome was unknown. No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was sick in Jun 2022 with a terrible cough. The patient had a terrible reaction to the Covid vaccine. No treatment medication was reported. The reporter's causality for the event(s) of REACTION TO COVID VACCINE and COUGH with SKYRIZI (RISANKIZUMAB) was no reasonable possibility.
This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. On an unknown date, doses of GARDASIL 9 (Lot #: L013429, exp date 14-FEB-2017 (also reported as 21-JUL-2017); L025737, exp date: 28-JUL-2017; L023230, exp date: 28-JUL-2017) (dose and route were not reported) which were exposed to temperatures outside of the recommended range were administered to the unspecified number of patients. It was unknown if the patients sought medical attention. No adverse effects have been reported. The reporter refers that there was not product quality complaints involved. This is one of several reports from the same reporter. Lot number L025737 has been verified to be a valid lot number for GARDASIL. Additional information has been requested.
This spontaneous report as received from a Nurse refers to unknown amount of patients with unknown demography. The Nurse reported that on 07-APR-2014 (also reported as yesterday morning), unknown amount of patients were vaccinated with LIQUID PEDVAXHIB (dose, route and frequency were not reported) which was exposed to 19C for 1.5 hours. No adverse effect reported. No further information was provided. This case is linked to the case 1404USA005550 and 1404USA008612 (same reporter link). Additional information has been requested.
(I'm a physician, so I'm reporting for myself) About 60 seconds after the J&J vaccine was administered, I experienced a wave of a very odd sensation of "impeding doom," reminiscent of that experienced after my prior vaccination with the Moderna vaccine. As this wave settled, I felt a very strange sensation in my mouth, tongue, and throat which was entirely foreign to me--as though they were stimulated somehow, and I was concerned they would swell. On examination, there was no observed swelling in the oropharynx; and around 5 min after the vaccination was given, I was administered IM diphenhydramine into my right arm. The sensation eventually abated abotu 5-8 minutes later, and I was observed for an additional 25 minutes with repeat examinations of the oropharynx without apparent issue. I did develop two reddish marks on my left neck with were not pruritic; and those eventually resolved as well. My father is an allergist, so I went home under his supervision and with an EpiPen available at all times; but my symptoms resolved without further flare or concern.
Patient post vaccine administration approx 20 minutes. Reported feelinging tightness in chest, spreading to throat. Patient was taken to observation portion of clinic. Patient was hypoxic in 70's. Supplemental oxygen applied. Oxygen saturation increased to 88. Epipen administered and albuterol nebulizer treatment started while waiting for ED/Rapid response team to arrive. Patient transferred to ED for further observation.  From the physician that treated the patient: "It was a bit of a bizarre presentation. She reported throat tightness after the vaccine. She had a completely normal exam and no other complaints. no signs of airway/oral/pharyngeal abnormality. no respiratory abnormality. Unfortunately she was significantly hypoxic when I took her vitals. as low as 76%. Good waveform. I even checked the pulse ox on myself because I didn't believe it. In addition, with supplemental oxygen, her sats went up. I had to pull the trigger and treat her even though she looked well and I had no objective exam findings to explain her profound hypoxia. She received IM Epinepherine and Albuterol neb. By the time she was in ED she was satting 100% and her throat tightness resolved. So, not sure how to answer your question. Clinically I pulled the trigger and treated her for anaphylaxis following a vaccine administration. I wish it was a problem with my sat monitor but I don't believe it was. I was using a life-pack with wave form and verified with two other people that the O2 saturation function was working properly. Intuitively, it doesn't make sense but I think we should probably consider it a reaction to the vaccine. "
Patient was found unconscious after receiving the Moderna vaccine. Patient was sitting on chair. I called for staff assistance. Patient was placed on the ground. Patient lost consciousness for about 30 seconds. Charge nurse was notified. Patient was placed onto wheelchair and transferred to urgent care.
moderna covid-19 vaccineEUA  Lost sight twice 1 second ea . all facial nerve pain & burning mouth  has been much more severe
Patient came in today and wanted a booster dose. She did report to us that she had severe reaction with the Janssen (JJ) covid vaccine. She said she was hospitalized in the ICU for 3 days. She had severe Fatigue and sedation  amongst other side effects  with the JJ, vaccine that is why she wanted the Moderna Vaccine instead today.
1st Shot on 2/22/21, no adverse reaction aside from injection side muscle pain. 2nd Shot on 3/15/21, vaccine administered at 15:15EST, after going home, became very tired around 17:30, took nap, woke up at 21:30 with pounding headache and the "chills." Went to bed at that time, took ibuprofen for headache,  Slept through morning alarm on TUE 3/16 at 05:15, woke up at 08:45, in to work by 10:30. Left work at 13:30 due to continued headache & body aches, chills, (had to turn a space heart on in my office), hands were cold. Took nap from 16:00 - 19:00. Still had headache, body aches, and chills. Went to bed around 21:15. Woke up on WED 3/17 at 01:30, had the chills, and was shivering, still had head ache. Turned up the thermostat from 70 to 75. Put an extra blanket on the bed. Woke up at 03:30, t-shirt and blanket soaked in sweat. Woke up for day at 05:45. Right underarm swollen, (lymph gland/nodes). Experiencing runny nose, body aches, headache continues.
Was getting a booster dose of Moderna after receiving first Janssen dose. Pt received 0.5ml in place of the 0.25ml booster dose. As of 12:12pm on 10/27/2021 only a message could be left for the patient. Unsure of any reactions.
Raised hive and warm to the touch where shot was given on the upper left arm. Muscle soreness in left arm.
While driving home after receiving the vaccine, she started seeing colorful dots out of the eye where she'd had a cataracts surgery and implant. At the time of the call (20 minutes after the administration), she reported via phone that symptoms were improving.
Irregular/abnormal heartbeat which was not present prior to vaccination. (Unresolved) Extremely enlarge lymph node under arm that lasted more than one month. (Mostly resolved)
Received flu vaccine; within 20-30 minutes developed shortness of breath and resp wheezing. Self treated with Benadryl and daughter's inhaler, then saw private physician on 10-18-04, where she was given steroids and inhaler.
immunocompromised patient given 2 doses for primary and a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given 2 doses for primary and a booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 11-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given 2 doses for primary and a booster dose). On 11-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient given 2 doses for primary and a booster dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
stomach discomfort / upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of stomach discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th August 2021, the patient received Shingles vaccine. In August 2021, 4 days after receiving Shingles vaccine, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was not recovered/not resolved.   It was unknown if the reporter considered the stomach discomfort to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the vaccine for shingles on Monday and four days after getting shingles vaccine, the patient had stomach upset. The patient enquired what he/she could do about this.
pt recv 2 doses of vax & lab eval JAN98 revealed a lack of seroconversion;
He got his vaccine, he got one of the vaccines, inserted the needle more painful than usual and she explained that it did not take.  He could feel something inserted and something happened and there was no raised dot.  She then called a NP and they repeated the entire process.  He asked if there was any problem getting 2 doses and they assured him that there was not.  He was light headed and some chest pain which he felt was nerves.  It was not affecting his mobility.  It was red, itching as normal as described.  When he woke up today both insertion points are very red, his entire forearm begging about 2" from his wrist to his elbow is red, swollen, hurts to touch, and not affecting mobility.  His arm is sore to use, light touch sensation causes discomfort.  He does have an appointment to be seen by a doctor today.   He got his first vaccine with the first one other than a slight bump where it was inserted into his left arm on 8/7/22.  He did get 4 COVID vaccines,  2nd and 3rd vaccines he got some reactions, was in bed with those for a few days.
pt suddenly became pale, went limp, eyes rolled back in head, arms began jerking & became unconscious-mom feels pt was trying to have a sz;
Walking to observation and felt dizzy and lightheadead.  Sat down in chair and WC obtained and taken to med evaluation area for further evaluation.  Fluids offered and lying supine.  Denies any further dizziness.  Did not eat or drink this morning prior to vaccination and worked out the day before.  History obtained and discussed next vaccine to be given in med eval area lying down.  Ambulated without any furhter dizziness, 32 oz water and has designated driver in car, instructed not to drive home.  pt verbalized understanding discharge ambulatory at 1333.
"moderna COVID-19 vaccine          "  7 days acute right kidney pain for 24 hrs