chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours post-injection Pt C/O red, raised, itchy area where injection site located - warm to touch, tender. No fever.
her arm was red; arm swelling; arm warm; he put her on antibiotics just in case because her arm was warm; allergic reaction; she broke out with a rash a little the next day after the vaccination; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received pneumococcal 13-valent conjugate vacccine (dipht crm197 protein) (PREVNAR 13 Solution for injection in pre-filled syringe, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 28Jul2015 14:00, at single dose, for immunization, at the physician's office. There were no medical history, family history and concomitant medications. The patient did not receive other vaccines within 4 weeks. On 29Jul2015, next day after the vaccination, the patient broke out with rash which faded in a few days. Then the rash came back on 03Aug2015. The patient went to the doctor because her rash came back. The patient reported that she had an allergic reaction, nothing serious only rash and on 03Aug2015, her arm was red, warm and swelling. The patient went to the doctor because her rash came back, and her doctor put her on antibiotics just in case because her arm was warm. The events all went away in a few days. The patient reported there was no hospitalization, she only visited the doctor. The outcome of the events was resolved on an unspecified date in 2015.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Began with a lightheaded feeling followed by dizziness and clouded vision. Within minutes of getting into the car from the office visit, I fell asleep for the rest of the day.
Given after FDA emergency use authorization was removed for boosters. Submitting after instruction on CDC meeting, 9/1/22.
Three cycles after my shot (approximately 90 days), my periods began to last 11-12 days,  the flow was abnormal, and they began being 30+ days apart. For 5+ years they have been 28 days apart on the dot, exactly 7 days with the same flow. Although I have PCOS, nothing in that condition has changed and have had no significant changes in my diet, exercise or stress levels - nothing that would cause my period to change after being the same for years.
Dizziness, Headache, Myalgia, NauseaVomiting,  sore arm, chills, losing her voice, Narrative:
I had general soreness and stiffness. I took a bath before I went to bed because I noticed a fever. I had a fever of 103 F. I also realized I lost my motor skills. I was not able to do normal functions. Around 3:00am I experienced shakiness, and I experienced the worst headache in my life. I also have bumps that have appeared on my face.  My right arm where I did not receive the shot I saw bruises down my arm. April 25,2021 is when I was in the hospital my blood pressure dropped and my pulse because very low. My blood pressure has been very high since I have gotten the vaccine.
Very sore arm. fatigue and fever March 9th ,10th and 11th. Dizziness the morning of the 12th.  No issues after lunchtime on the 12th.
Patient felt light-headed, dizzy, diaphoretic after vaccine administration. Patient placed on cot in supine position. Patient provided orange juice and was released after feeling better.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Facial flushing Narrative:  Other Relevant History:
Information has been received from an office nurse concerning a patient who was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Subsequently the patient experienced injection site tenderness, injection site redness and also fluid collection which progressed down arm. Subsequently. the patient recovered from injection site tenderness, injection site redness and fluid collection which progressed down arm. Injection site tenderness, injection site redness and fluid collection which progressed down arm were considered other important medical events (OMIC). Additional information has been requested.
Beginning a few hours after injection I had left arm pain. Then began a fever of 101.4. Then sever body aches and joint pain to the point of near immobility. Swollen lymph nodes. Extreme fatigue. Was prescribed dexamethasone and Toradol for symptoms the day after as I was incapacitated and in tears.
Information has been received from a physician concerning a 12 month old patient with no pre-existing medical conditions or allergies who on 09/15/2005, at 08:30 was vaccinated subcutaneously (also reported as intramuscular) in the left thigh with a 0.5 ml first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (645522/0780P). There was no concomitant medication. The patient was not ill at the time of vaccination. Within the last week, in the morning on 09/24/05, the patient developed fussiness and a sore throat. In the morning of 09/26/05, he developed a truncal rash beginning at the neck and moving down his trunk onto his legs. On 09/26/05, he visited the physician who confirmed the rash origin. It was reported that he had a systemic measles rash, described as multiple erythematous papules (nonconfluent), there were no vesicles and no fever. The patient also had pharyngitis. The physician reported that at first she though it was hand, foot and mouth disease because it has been going around. The physician reported that she could actually see the rash spreading to the entire body. The rash went away the next day (09/27/05). the patient recovered on 09/27/05. The patient did not have adverse events following prior vaccinations. No other additional information was available regarding the adverse event. There was no product quality complaint reported. No additional information has been requested.
Client presented at vaccination site on 12.05.21. Client reported he received first dose Pfizer COVID vaccine on 04/11/21 without issues & received second dose Pfizer COVID vaccine on 05/02/21. He reported with his second dose Pfizer COVID vaccine, he had fever, tiredness, nausea without vomiting 8-10 hours later. He reported he took Tylenol 500 mg for fever with no help. On the third day on 05/05/21, he called nurse helpline and was instructed to go to ER. He went to ER on 05/05/21 received two ?bags? IV (unknown name of medication), normal CXR and normal EKG. He stated he was discharged home from ER the same day. He reported his fever broke on 05/06/21. Client stated he had PCP followed up in two weeks later and everything was fine. Client stated his PCP approved for him to get his booster dose of Pfizer COVID vaccine in six months. Client reported he has Type 2 DM controlled with Metformin & Glipizide and HTN controlled with Lisinopril. Client stated he took Lisinopril at 10 am today. Client told he has a PCP appointment in one month. At 1703, PHN took his vitals: BP 159/105, HR 78, O2 Sat. 98%. At 1723, PHN retook his BP 152/104. Client is requesting for booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor approval to proceed with the booster dose of Pfizer COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received the booster dose of Pfizer COVID vaccine, LOT#:  FF8841 on 12/05/21 at 1752 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1828 unassisted and with a steady gait
3 sick for 2 weeks after the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 weeks after the Moderna vaccine) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 2 weeks after the Moderna vaccine). At the time of the report, ILLNESS (sick for 2 weeks after the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021:
2 month old perfectly healthy developing right on time and normal. Happy attentive baby, cooing and interacting very well before appointment. Received DtaP-Hib-Polio, Hep B, Prevnar 13 and Rotavirus at visit. Was fussy that day, no fever, slept a little more than normal. Next day seemed a little sleepy and projectile vomited, has never vomited before. 2 days after visit baby had what seemed to be a seizer..arms and legs tensed up on an off about 4 to 5 times in a 20 second episode. Baby cried hysterically after and during the episode seemed to be panicked and hyperventilating. After that baby has been jittery, seems to have regressed, no cooing or talking like before appointment, interaction and eye contact limited and not like before, has rapid eye movements, seems like her nervous system is firing off at random times, sleep patters much different. Looked pale for about 5 days after visit. Seems weaker then before. Also extremely sensitive to noises now and startles much easier than before appointment. Going to be seen by a neurologist in case a seizer did occur to prevent further episodes related to vaccines.
This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of an unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On an unknown date, the patients were vaccinated with PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patients experienced cellulitis. The outcome of cellulitis was unknown. The causality between PNEUMOVAX23 and cellulitis was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009127: US-009507513-1705USA009128:
Per history pt had swollen left shoulder and erythema 4 days later when PA checked the patient erythema and swelling of left shoulder had resolved.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received one year before the reporting date). On 18th May 2018, the patient received the 1st dose of SHINGRIX. On 22nd May 2018, 4 days after receiving SHINGRIX, the patient experience shingles and rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The patient began to develop a rash on her neck. On 25th May 2018, the patient was seen by her primary care provider at which time it was confirmed that the patient had Shingles. As treatment, the patient was prescribed VALTREX. No hospitalization or emergency room visit was required. Vaccine was not administered by the reporter but was administered at a pharmacy.
Information was received from a pharmacist on 14-JUL-2010. An adult patient (initials, gender, and DOB unknown) received the flu vaccine injection in 2008 (manufacturer unspecified). The patient had a history of egg allergy and injection site reaction to tetanus and diphtheria toxoids absorbed vaccine (manufacturer unspecified) at age "44 years" prior to 1997 (resolved). The patient experienced an injection site reaction with the flu vaccine injection in 2008. The case was originally reported to Merck & Co., Inc. (case# 1007USA01350). Additional information is expected. The company considered event as non serious. The company considered event unassessable in relation to FLUVAX given the brand name is unknown and vaccination date is unknown. Information derived from this AE report does not change the current safety profile of the product.
Atrial fibrillation; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 The patient reported that she was diagnosed with atrial fibrillation in emergency department. The patient was observed at the hospital and does not recall the medications she was given. The patient reported that she felt well today. Follow-up would not possible as no contact details were available.
lightheadedness;  , nausea, reported truck exhaust, broke en route 1hr prior to arrival;   h/o Rheumatoid arthritis, hypothyroid, 84-Reg; 154/89 at 1058;  146/89 55 Reg at 1103; last 149/89;  TX mask off - door opened  chair reclined;  distraction & emotional support.   After total of 23 mins. wait time, sat up in chair;  lightheadedness abated - mild nausea persisted;  Driver drove off after 25 mins. total time.
First swelling above upper lip, within a couple hours mild swelling around mouth, cheeks, and eyes. Throat feels tight but still able to breathe and eat just fine.
07/08/2021 patient in the am when patient woke up he had a aching in the joint where the big toe meets the foot, progressively worst but it did not impact the activities. Awoke with severe pain and server swelling on the right foot, went to the doctor on on  early evening , Diagnosis 07/9/2021. No more significate events.
tested positive of COVID-19; very ill; tired; Fever; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive of COVID-19), RHINORRHOEA (Runny nose), ILLNESS (very ill), PYREXIA (Fever) and FATIGUE (tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RHINORRHOEA (Runny nose) and PYREXIA (Fever). On 16-Feb-2021, the patient experienced ILLNESS (very ill) and FATIGUE (tired). On 17-Feb-2021, the patient experienced COVID-19 (tested positive of COVID-19). At the time of the report, COVID-19 (tested positive of COVID-19), RHINORRHOEA (Runny nose), ILLNESS (very ill), PYREXIA (Fever) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Coronavirus test: (Positive) Tested COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medications was reported. No treatment information was provided.
Information has been received from an office manager concerning a pt with no medical history and no allergies who on 03Mar04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Subsequently the pt developed swelling, redness and hot to touch at the injection site. No medical attention was sought and no diagnostic studies were performed. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed swelling, redness and hot to touch at the injection site. Additional information has been requested.
Right after the Moderna  shot, she fell dizzy. The room was spinning for her.  She rested in the chair for 30 minutes.  After that she was able to walk with assistance to the car. Her husband drove her home.  I called to check on her 3 hrs later.  She was better.  The next day , she was able to work as a cashier.
The Patient received the vaccine at 8:33am. She was sitting in the waiting area after her dose and started to have a seizure at or around 8:45am. She fell from her chair. The pharmacist on duty immediately responded and assisted as much as possible. No drug interference was administered. The patient seized for about 3 minutes and then came to. She waited for EMS to arrive but they took longer than she wanted to wait and she left the store at 9:05 am.
Patient called complaining of itch and redness/swelling at injection site. Recommended BENADRYL and hydrocortisone cream.
Information has been received from a nurse concerning an approximately 8 week old female who on approximately 11-MAY-2009, "within the last week", was vaccinated orally with the first 2 ml dose of ROTATEQ.  On approximately 11-MAY-2009, "after receiving her first dose", the patient experienced mild vomiting and diarrhea.  The outcome was not reported.  Unspecified medical attention was sought.  No further information is available.
positive covid test, incidental to admission for anemia Narrative:  incidental positive covid test while admitted for another reason, cough but no hypoxia
The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 18-Apr-2022; Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 18-Apr-2022) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 04-Apr-2022.   The vial did not underwent any temperature excursion.   The pharmacist reported that he thought that the vaccine expired in June 2022 however the vaccine expired on 01-Apr-2022.   No concomitant medication were reported.   No treatment drug were reported.
The same day after the vaccination, my left arm was sore and itchy a little bit. After 4 days, still sore, itchy, the area red and besides the left arm was swelled, hot (like it has fever) The following Sun 05/10, I had a video call with a Nurse Practitioner at Medical Center where I got the vaccine and she prescribed the steroid Prednizol, Benadryl for the itching and Ibuprofen for the pain. Today, 05/13 still sore, red, and itchy.
Very sick for a month; Thumb, index and middle finger on right hand are numb and tingling; Regularly in the morning, right hand cramps; tingling in fingers; Excruciating Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating Pain), ILLNESS (Very sick for a month), HYPOAESTHESIA (Thumb, index and middle finger on right hand are numb and tingling), MUSCLE SPASMS (Regularly in the morning, right hand cramps) and PARAESTHESIA (tingling in fingers) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 04-Mar-2021, the patient experienced PAIN (Excruciating Pain). On an unknown date, the patient experienced ILLNESS (Very sick for a month), HYPOAESTHESIA (Thumb, index and middle finger on right hand are numb and tingling), MUSCLE SPASMS (Regularly in the morning, right hand cramps) and PARAESTHESIA (tingling in fingers). At the time of the report, PAIN (Excruciating Pain), ILLNESS (Very sick for a month), HYPOAESTHESIA (Thumb, index and middle finger on right hand are numb and tingling), MUSCLE SPASMS (Regularly in the morning, right hand cramps) and PARAESTHESIA (tingling in fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Pain killers and other unspecified medications. Patient has visited emergency room thrice, and he was kept there for hours. No concomitant drugs were reported.
Initial health care professional report received on 15 Dec 2009: This child was vaccinated intramuscularly with FLUVIRIN (batch no: 102143P1) 0.5 mL on 12 Dec 2009. No adverse event was reported. No more information was available.
Guillain-Barre syndrome - initially had radiating back/rib pain 11/9 then developed proximal weakness, dysphagia, facial weakness, areflexia over ~5 days
A non-serious spontaneous report of tested positive for Influenza A has been received from a health professional concerning a seven-year-old male child, subsequent to receiving FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 04-Nov-2010, the patient received FLUMIST. On 07-Jan-2011, the patient was tested positive for Influenza A. The outcome of the event was unknown.
extreme bouts of diarrhea; Depression; Stomach Problems; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (extreme bouts of diarrhea), DEPRESSION (Depression), ABDOMINAL DISCOMFORT (Stomach Problems) and FATIGUE (Tiredness) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIARRHOEA (extreme bouts of diarrhea), DEPRESSION (Depression), ABDOMINAL DISCOMFORT (Stomach Problems) and FATIGUE (Tiredness). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (extreme bouts of diarrhea), DEPRESSION (Depression), ABDOMINAL DISCOMFORT (Stomach Problems) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.