chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10:15 - patient complained she was feeling dizzy, had the chills, and blurry vision. 10:16 - vital signs taken BP 158/104, P 108, T 98.0, O2 98% R 16. Charge nurse informed. Patient was advised to sit in the front of observation for monitoring. 10:30 - Patient complained her vision was getting worse. Vital signs taken BP 149/100, P 104, T 98.0, O2 99%, R 16. Patient was given 50mg Benadryl orally as advised by the charge nurse. Monitoring continued 10:38 -Nurse asked the patient if she had eaten anything, patient was given gatorade. 11:15 - Vital signs retaken BP 138/80, P 80, T 98.0, R 16,, O2 98%. Patient without any signs of distress. States she feels better and ready to go. Patient educated about the side effects of the vaccine and what to do. Patient checked out and left in stable condition.
Pt experiencing high fevers around 102 degrees and extreme fatigue. Did not get of bed the entire day after receiving vaccination pt was told to continue TYLENOL for fever and follow up w/Dr Monday if still have symptoms.
pt recvd vax 8SEP94 & devel hives around Tetramune inj site; rx w/DPH; MD visit next day;hives had progressed, to buttock, elbow & cheek; pt recovered;
Pt's mother called me 10/24/02 and reported pt had pink blotches on trunk-spreading to legs and some on face. He was in no respiratory distress-eating and nursing well, but fussy. I told her he needed to be assessed by a doctor. Given she was away from home, she took him to hosp. on 10/24. The doctor there said it was not vaccine related-rash minimal-she was sent home. On 10/25 the infant had extensive hives. Mother took him to hospital where the attending believed he was reaction related posisbly to vaccines given 10/23. She will have him tested by his doctor when she returns home. He will make determination concerning further vaccines. Benadryl given. Rash resolved.
27 y/o 2 min developed non virulent pustules 9 days after immunization with smallpox.
Vaccine administered 3/17/15, on 3/18/15 patient had area of erythema/wheal about size of a quarter. On 3/20/15 patient had extension of erythema to about 5 cm x 5.5 cm, pruritic, generalized achiness.
This spontaneous report as received from a medical assistant refers to a 56 year old female patient with diabetes and hypertension. The patient had no drug reactions/allergies. On 20-AUG-2013, the patient was vaccinated with a single dose of ZOSTAVAX vial (lot # J002241, expiry date 21-MAY-2014) subcutaneous in the left arm. Concomitant therapies included GLUCOPHAGE. On 27-AUG-2013, the patient was diagnosed with shingles. The rash extended from the left external ear to the second branch of the left 5th nerve. The patient was prescribed VALTREX and KEFLEX. Approximately on an unknown date in August 2013, isolates from the lesions were positive for VZV (Varicella zoster virus) DNA. Approximately on an unknown date in 2013, the patient experienced hearing loss, bloody discharge and left ear pain. The patient sought medical attention (office visit). The patient was in the office on 10-SEP-2013, continued to have left ear pain, bloody discharge, and hearing loss. The outcome of hearing loss, bloody discharge, left ear pain and shingles was reported as not recovered. Upon internal review the event hearing loss was considered as medically significant. Additional information has been requested.
no adverse event; lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022) and NO ADVERSE EVENT (no adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022).    The ID was reported as 80777027399. Patient's age was reported as 18 Year 4 Month. No concomitant medications were reported. completion date was reported as 26-Jul-2022. No treatment medications were reported.
Patient developed swelling of previously injected dermal filler in her upper lip. Swelling developed  the morning of 1/29. It was almost completely resolved by 1/30. Patient was treated with  oral antihistamines (Benadryl and Xyzal).  She had Vobella injected into her upper lip in Februrary 2020 and Restylane Kysse injected into both upper and lower lip in September 2020. Since swelling was only noted on the upper lip, I suspect reaction to the Vobella product.
Information has been received from a health professional concerning a 45 month old female with amoxicillin allergy who on 12/07/1998 was vaccinated with varicella vaccine SC in the left arm. On 05/17/2001 the pt experienced bumps on the head, back, and neck, and presented with chicken pox. Subsequently, the pt recovered. Unspecified medical attention was sought. No further info is available.
Had usual reaction the next day, however, reaction lasted for 9 days. Feeling "crappy" fatigued, brain fog. Did not leave the house for 9 days. Canceled everything.  I work out everyday for 45 minutes on an Elliptical and lift weights. Today the 10th day I could do 25 minutes on the Ellitical
Information has been received from a healthcare worker concerning a 12 year old male with no relevant medical history or allergies, who on 22-APR-1997 was vaccinated with a first dose of VARIVAX (Merck) (lot number, injection site and route not reported). On 28-JUN-2008 the patient was vaccinated subcutaneously with a second dose of VARIVAX (Merck) (lot number 653306/0674U) (injection site not reported). There was no concomitant medication. On 28-OCT-2008 the patient experienced chickenpox. The patient had about 25-30 lesions on his face, back and trunk. The patient went to see the physician's at the office. At time of this report, the patient was recovering from the event. Follow-up information was received from the healthcare worker who reported that the patient received the second dose of VARIVAX (Merck) in the left arm. On 28-OCT-2008 the patient developed 25 to 30 spots on his face, back and trunk. The healthcare worker also reported that the patient had one pustule in the right leg which was cultured and sent out. The patient was given clindamycin. Laboratory test included culture results showed light growth staphylococcus. The healthcare worker also reported that the patient had recovered from the events. Additional information is not expected.
This spontaneous report was received from a pharmacist refers to a 71-year-old male patient with concurrent conditions of unspecified heart issues and unspecified prostate issue. On 07-DEC-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection, lot # N025656 with expiration date on 19-APR-2019 (dose was not reported). Concomitant drugs included unspecified blood pressure and prostate medications. On 08-DEC-2017, the patient experienced swelling below the injection site on his elbow and forearm area. The patient was prescribed cephalexin, prednisone (manufacturer unknown) and erythromycin and began the therapy on 08-DEC-2017. On 10-DEC-2017, the patient reported to the pharmacist that the swelling had travelled down to an unspecified area of his body (reported as "travelled down to his"). The patient did not recover from the events at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not reported (it was also reported that the pharmacist was unaware of the patient's status at the time of the report).
Fever, chills, headache, nausea, tiredness, sleepiness, poor appetite
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 51-year-old female patient who received FLUARIX (batch number 329TN, expiry date June 2016). On 17th November 2015, the patient received FLUARIX (intramuscular) .5 ml. On 19th November 2015, 2 days after receiving FLUARIX, the patient experienced injection site rash, tingling of extremity, feeling of warmth facial, facial flushing, injection site warmth, injection site erythema and eruption facial. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the injection site rash, tingling of extremity, feeling of warmth facial, facial flushing, injection site warmth, injection site erythema and eruption facial were recovering/resolving. The reporter considered the injection site rash, tingling of extremity, feeling of warmth facial, facial flushing, injection site warmth, injection site erythema and eruption facial to be probably related to FLUARIX. Additional details were received as follows: The patient experienced the events last night from date of reporting. The events were improved 1/6th as bad as they were previously. The patient experienced the rash on left arm as a prickly feeling like she brushed up against a Christmas tree. The patient also had cyst-like lumps under the skin on face. The patient's face and left arm were feeling hot and flushed.
This spontaneous report was received from an employee at pharmaceutical company who came across an article on a social media news feed and refers to a female patient of unknown age. The article from News Network and was posted 29-MAY-2017. On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (MMR) vaccine (manufacturer not specified). The article indicated that the governments conceded or the court ruled that vaccines had caused brain injury. In turn, this injury led to an autism spectrum disorder (ASD) diagnosis and MMR vaccine was the common denominator in this case. The outcome of the event was unknown. Causality was assessed as related. Upon internal review, autism spectrum disorder was considered medically significant. This is one of several reports from the same source. Additional information is not expected. Sender's Comments: US-009507513-1708USA012166.
Flu vax given on 11OCT91, pt c/o stiffness all over body 6-7 days p/shot;
RSV, recombinant subunit. AREXVY VIAL  SUSPENSION FOR RECONSTITUTION. extreme (uncontrollable) chills about 10.5 hours after receiving the vaccine. Lasted for about 40 min.  Moderate flue like symptoms for the next 8-10 hours.
Patient is pharmacy employee and he called in with complaint of "flu with back pain and stiffness.  This is the worst my back has ever been."
Shingles. Noticed bumps irritation on scalp 3/30/21. Progressively larger, red, painful. Steroids and antiviral. Lasted 4/9/21 crusts.
This was a Johnson & Johnson vaccine. No option was given on the website for this.  Nausea no vomiting for about 10 hours Fever of about 102 20 hours post shot. She experienced a long bout of a fibrillation along with this fever. She?s experienced an abnormal level of confusion with her Alzheimer?s. This morning about 32 hours post shot her temperature is 95°. At 48 hours there were still redness and swelling at the injection site. However all the other symptoms had abated.
Swelling and redness at injection site. Swelling of deltoid muscle on L arm. Sent to ER for evaluation.
like having the flu; feel horrible; This case was reported by a consumer via call center representative and described the occurrence of influenza in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza and feeling bad. On an unknown date, the outcome of the influenza and feeling bad were unknown.   It was unknown if the reporter considered the influenza and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and it made him feel horrible, like having the flu. The caller declined to provide more information for safety report. Limited details were provided.
Headache, NauseaVomiting, VERTIGO, MIGRAINE Narrative:
pt recvd vax 25MAR95 devel 5cm red, hot, indurated site;
administered dose 1 and then they got Covid; administered dose 1 and then they got Covid; This is a spontaneous report from a contactable Other HCP. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)  via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  A patient in a nursing home was administered dose 1 and then they got Covid and was admitted to the hospital. They were administered convalescent plasma and monoclonal antibodies. Outcome of the events, administered dose 1 and then they got Covid was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity between the first vaccine dose and the event onset. The case will be reevaluated should additional information become available.
Patient diagnosed with COVID on 6/21/2021 Headache, Cough, Sore Throat, Runny Nose, Fever
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
After taking the third shot of the vaccine and during my routine lab work, my Platelets count was down to ten. A second lab test was requested by my primary care doctor and it was the same. I was then admitted at the hospital for treatment. I was in the hospital the first time for two days and was released with some steroids hoping it will take care of the problem. I had another lab test and the platelets were down to six. I was admitted in the hospital again, treated and released with more medications. A few weeks later the platelets numbers dropped again. I am now taking PROMACTA on an daily basis. I also have check my platelets on a weekly basis. I hope this present medication will help stabilize my platelets
Tachycardia body was on fire high bp shaking Nausea feeling of impending doom headache
6 hrs p/fluzone pt reported heart palpitation, chest pain; chest & back ache; denied SOB; went to ER 3NOV92 in the evening for heart palpitations again; pt states EKG & CXR ok; was referred to cardiologist;
weakness; difficulty breathing; unable to move his legs; Lung problem; neuromyletis optica; This spontaneous case was reported by a consumer and describes the occurrence of NEUROMYELITIS OPTICA SPECTRUM DISORDER (neuromyletis optica), ASTHENIA (weakness), DYSPNOEA (difficulty breathing), HYPOKINESIA (unable to move his legs) and LUNG DISORDER (Lung problem) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROMYELITIS OPTICA SPECTRUM DISORDER (neuromyletis optica) (seriousness criteria death, hospitalization and medically significant), ASTHENIA (weakness) (seriousness criteria death and hospitalization), DYSPNOEA (difficulty breathing) (seriousness criteria death and hospitalization), HYPOKINESIA (unable to move his legs) (seriousness criteria death and hospitalization) and LUNG DISORDER (Lung problem) (seriousness criteria death and hospitalization). The patient was hospitalized on 09-Jun-2021 due to ASTHENIA, DYSPNOEA, HYPOKINESIA, LUNG DISORDER and NEUROMYELITIS OPTICA SPECTRUM DISORDER. The patient died on 08-Jul-2021. The reported cause of death was Neuromyelitis optica. It is unknown if an autopsy was performed.            No concomitant medication was reported.  The patient was placed on ventilator and had a tracheotomy tube.  No treatment information was provided.   No laboratory data was provided.  Very limited information regarding the events has been provided at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time.; Reported Cause(s) of Death: Neuromyelitis optica
Swollen throat, tounge, dizziness, difficult breathing, increased blood pressure, nauseau, difficulty swollowing, headache. This were the immediate adverse effect withi in 5 to 10 minutes of receiving the shot. Followed by aches, chills, loss of appetite and days of swollend tongue and sore throat and difficulty swolling. My breathing was not affected as I did not experience a full anaphylaxis reaction but I continue with the discomfort a week and a half later. I have been taking benedryl, claritin, and fatmotidine which is what my doctor suguested I take to calm down the allergic reaction and it has helped a bit with the nauseau and the feeling of having a lump in my throat.
Slept for 24 hours after with severe arm pain, (could not lift arm past waist) low grade fever, aches and pains, and a ring around the injection site after 2 weeks.
After 15 minute observation states, feels hot, dizzy "off", B/p135/90, HR 74, 02Sat 98%, monitored for additional 15 minutes symptoms resolved, b/p 124/62, HR 69 and 02 Sat 98%.EE was able to return to work
Received flu vaccine on 12/4/00. On 12/5/00, began experiencing swelling and pain in hands, feet, ankles and knees. Took Prednisone from 12/12/00 to 12/18/00 with relief, but symptoms returned on 12/21/00. Further follow-up pending.
This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On 30th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that the dose of SHINGRIX hurt like a bugger.
Itchy and rash in my body; Itchy and rash in my body; This is a spontaneous report from a contactable Other HCP (patient herself). A 45-years-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via unspecified route of administration, administered in left arm, on 27Jan2021 12:00 (age at vaccination: 45) as dose number unknown, single for Covid-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility. The patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. She had no known allergies. The patient took no other vaccines in four weeks of vaccination and no other medications in two weeks of vaccination. The patient was not tested for COVID prior to post vaccination. The patient experienced itchy and rash in my body, still with the rash on 29Jan2021 08:00 PM. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prednisone was given was treatment. The outcome of the events was not recovered.   Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
I got the vaccine sometime in the afternoon and felt fine for the 15 minutes after the time of injection. I returned to work afterwards, and later that evening I started to feel chills, but it wasn't severe to the point where I went home. When I returned home from work, the chills remained but I also felt extremely exhausted which was unusual for me. I also had a bit of a headache/felt lightheaded. I took Tylenol which somewhat helped the symptoms. I felt fine after going to bed.
diarrhea; little tiredness; mild fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (little tiredness), FATIGUE (mild fatigue) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040P21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (little tiredness) and FATIGUE (mild fatigue). 02-Apr-2021, the patient experienced CHILLS (chills). On 04-Apr-2021, DIARRHOEA (diarrhea), FATIGUE (mild fatigue) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (little tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-067364 (E2B Linked Report).; Sender's Comments:  MOD-2021-067364:family member case
received injection and approximately 10 minutes later, she felt queasy and light headed. She vomited x 1 Moved into triage area,  given juice.  Felt better within minutes.  BP 112/78, p-68, O2sat- 96%, BP- 108/71 at 5:30 pm - BP 115/71, p-62,  no further symptoms.  Discharged home with friend. ER precautions given