chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child C/O itching at site of vaccine. There were 50-100 pin point raised welts at SQ site. Client was given 50mg of Diphenhydramine.
Patient reported that several hours after receiving her flu shot while she was at home in the evening she felt shaky and her BP jumped from about 103/70 to about 170/90. She said she took her as needed bp medication as well as Tylenol and after half an hour to an hour later her bp had lowered to about systolic 150 and she felt well enough to sleep. She also reported redness and swelling on her arm with a diameter of about 4-5 inches.
Was having anxiety about getting vaxinated, calmed down and consented to vaccine, and then proceeded to have a panic attack afterward. She waited it out but was being watched by doctors on site and the paramedics. Was taken by ambulance for observation 1 hour after vaccination.
runny nose; loss of taste; loss of smell; abdominal pain; vomiting; muscle ache; nausea; headache; chills; cough; Positive for Covid-19; diarrhea; nasal congestion; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid-19), COUGH (cough), DIARRHOEA (diarrhea), NASAL CONGESTION (nasal congestion) and RHINORRHOEA (runny nose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concurrent medical conditions included Obesity (most recent BMI:32) since 2019 and Hashimoto's disease (Elevated TPO antibodies).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for Covid-19). On an unknown date, the patient experienced COUGH (cough), DIARRHOEA (diarrhea), NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of smell), ABDOMINAL PAIN (abdominal pain), MYALGIA (muscle ache), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). an unknown date, the patient experienced VOMITING (vomiting). The patient was treated with IVERMECTIN (oral) from 21-Jan-2021 to 23-Jan-2021 at a dose of 3 mg 3 days; VITAMIN D3 (oral) from 21-Jan-2021 to 27-Jan-2021 at a dose of 1500 IU once a day; VITAMIN C [ASCORBIC ACID] (oral) from 21-Jan-2021 to 27-Jan-2021 at a dose of 2000 mg once a day and ACETYLSALICYLIC ACID (ASPIRINE) (oral) from 21-Jan-2021 to 27-Jan-2021 at a dose of 325 mg. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid-19), COUGH (cough), NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of smell), ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting), MYALGIA (muscle ache), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown and DIARRHOEA (diarrhea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SARS-COV-2 TEST POSITIVE (Positive for Covid-19), COUGH (cough), DIARRHOEA (diarrhea), NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), AGEUSIA (loss of taste), ANOSMIA (loss of smell), ABDOMINAL PAIN (abdominal pain), VOMITING (vomiting), MYALGIA (muscle ache), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) to be not applicable.    Concomitant product information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up received contain significant information treatment drugs, medical history, lab tests updated.
flu symptoms; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (female) reported that a female patient of unknown age (reporters sister-in-law) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unknown date at single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient had flu symptoms and it started 8 hrs after vaccination. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
My tongue has bumps on it and it hurts to eat. Some on the inside of mouth has impressions lines from teeth that hurt too.
he lost movement of his arm for 24 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced mobility decreased (Verbatim: he lost movement of his arm for 24 hours).  The outcome of the mobility decreased was resolved (duration 24 hrs).   It was unknown if the reporter considered the mobility decreased to be related to RSV vaccine.     It was unknown if the company considered the mobility decreased to be related to RSV vaccine.   Additional Information: GSK Receipt date: 25-SEP-2023 This case was reported by patient via interactive digital media. The reporter reported that her husband got ours and he lost movement of his arm for 24 hours. Follow up was not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR133372:same reporter, different patient
Patient came in for flu shot. Patient claims shot was given in trapezius muscles instead of deltoid. Patient states that he felt numbness in face requiring a doctor's visit. The nurse at the doctor's office said a nerve may have been irritated.
Patient had onset of severe pain in right shoulder following injection. That evening it worsened and had limited Range of motion. This worsened and continued for three weeks before seeking care at my office for evaluation. She continues to be unable to lift arm over head, with severe pain. MRI done. Steroid dosepack given.
8 days post vax pts right side of lip started swelling and within 2 hours her left side and right side of face were swollen. Pt was seen by a physician and was told that this was an allergic reaction to something. Pt stated that there was nothing different in her life other than vax. Was suspected that this could be the cause for swelling.
Received vac on may 7, symptoms started may 9, headache, body aches, joint pain, fever, no appetite  Redness at injection site with extreme pain sensitivity to touch also axilla lymph nodes extremely swollen and very tender to touch. The sensitivity of the arm and axilla nodes has lasted a week.  Body aches and muscle aches were only for a day or two. But it was more intense than during actual covid
09/18/2021 Vaccination of dose 3, 09/19/2021 began having back pains. Went to get x-ray 09/24/2021, walk in. 9/22/2021 client to see primary very next day. Prescribed a muscle relaxer, cleared up after 8 days then upper back tensing up and never having back problems before. Just taking the muscle relaxer as needed. X-ray and ibuprofen. Diagnosis due to inflammation. Still ongoing discomfort.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache) and FATIGUE (tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache), FATIGUE (tiredness), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (Arm Sore, redness). At the time of the report, DYSPNOEA (difficult to breathing), VACCINATION SITE WARMTH (Arm Sore, redness and hot), VACCINATION SITE PAIN (Arm Sore), HEADACHE (Headache), FATIGUE (tiredness), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (Arm Sore, redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication use was provided by the reporter.  The patient reported treatment of events was with paracetamol (Tylenol).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient denied consent for further follow-up
patient did well during administration of vaccine however 27-28 hours post vaccine she experienced sever headache accompanied by right thigh pain and then developed right and left thigh/muscle pain and weakness with persistent bilateral frontal headache that would come and go but get worse when she was up walking around and better with rest. headache and leg weakness/pain and balance issues are persisting 3 weeks post injection. they are not as severe as when they first appeared.
Complained of 2 days of mild pain, swelling, and redness of the upper left arm.  No other symptoms.  Had mostly resolved by day 3 when I examined her.
11/23/2021 esophageal spasms, with front of chest feeling like it is being squeezed 12/09/2021 check heart rate and noticed it was skipping and saw primary provider on 12/10/2021. Doctor said new condition setting off spasms and PVC continuous and not stopping. Referred to heart clinic based on family history. Participant states that she had evaluation 8 years ago and did not have any issues. No blood work but a resting EKG that showed the PVC, based on family history, vaccination and issues with PVC he is requesting the stress test, through specialist referral. Going issue.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-JAN-2018, the patient was vaccinated with M-M-R II injection via intramuscular route of administration in error (dose, frequency, lot# and expiration date were not reported). There were no known adverse effects. The relatedness between the event and M-M-R II was not reported.
Within firs 15 min of first vaccine: Red hot rash on face cheeks. Given 50mg liquid Benadryl- began to clear up in 20 min. 9 days later: 2' to 3"  hot itchy rash and hard lump under the skin at sit of short on right arm AND hot red rash on face cheeks. 10th day worse and went to urgent care for treatment (needed weekend access). Given 5 day steroid pack. Cleared up within 5 to 6 days.
This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and VISUAL IMPAIRMENT (Eyesight has started to decline) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus) and VISUAL IMPAIRMENT (Eyesight has started to decline). At the time of the report, TINNITUS (Tinnitus) and VISUAL IMPAIRMENT (Eyesight has started to decline) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products information were provided by the reporter. No treatment information provided by the reporter.
My right arm remains painful. The whole arm is painful that goes all the way to my ring finger. I wakes me up when I am sleeping. My right ring finger clicks now, and it is hard to make a fist. I think I have a shoulder injury because of the vaccination.
This spontaneous report was received from a patient of unknown age and gender, reporting on him/herself. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot #, expiration date, dosage and route, were not provided). On an unspecified date, the patient experienced herpes zoster reported as "it was the worst pain that the patient have ever had". The patient reported that she sought medical attention as "the physician instructed her to stay home and avoid contact with others". At the time of the report, the outcome of herpes zoster was unknown. the relationship between the vaccine and the herpes zoster was unknown. Additional information has been requested.
Extremely sore arm in area of vaccination. Not able to move upper arm. Rapid swelling of upper arm.
RECEIVED 3 SHOTS ON SAT IN AM.  NOTED ABOUT 2:30 PM SAME DATE L ARM DELTOID AREA BECOMING RED, SWELLING, HOT.  CAME INTO CLINIC TO SHOW NURSE 4/12/10 8AM.  IS VERY RED, RAISED EDEMA AREA TO UPPER L ARM. VERY WARM TO TOUCH.  SHOWED VIS INFO OF REACTIONS AND INSTRUCTED TO GIVE BENADRYL, TYLENOL OR IBUPROFEN, TRY ICE PACKS OR WARM PACKS, MASSAGE AREA, OR CAN TAKE TO DR.  WILL CHECK BY PHONE TO PARENT.
This spontanoeus report as received from a nurse refers to a 9 week old female patient. According to the patient's mother, the patient's records reflected a GARDASIL vaccine (dose, route, lot # and expired date were not reported) administered to the patient on 11-AUG-2011. Concomitant therapy was not reported. The nurse stated that GARDASIL might have been administered to a 2 month old patient. No adverse effect reported. Additional information has been requested.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Somewhere around April 8th 2021, about 3 weeks after my second dose of the Covid 19 vaccine I began to develop unusual symptoms that lead me to contact my PCP for a medical evaluation: severe throat and sever neck pain, soaking night sweats, racing heart, and overall systemic pain. Upon completion of the examination, my doctor prescribed general flu like remedies and requesting for me to be re-evaluated in a weeks? time. I also had to call my cardiologist because the prescribed dosage of the beta blocker I take for an arrhythmia was suddenly no longer working. Not having any relief by the weeks end with any of my symptoms, my PCP doctor referred me to an ENT and my cardiologist altered the dosage of my medication to a higher dose. On April 15th an ENT performed a laryngoscopy. I was put on a 2 week regiment of clindamycin, to continue with my nasal fluticasone and to include some other throat remedies, since it was nearly impossible to swallow whole foods. At that time I was also advised to have a blood test performed by my PCP to monitor thyroid levels. On May 7, I had a blood test which revealed abnormally high thyroid levels along with multiple other abnormal blood levels, very unusual for my regular routine blood work. So the following week my PCP preformed the blood test again to check for possible error. The 2nd blood work verified the first and I was recommended I get a thyroid sonogram. My PCP with the agreement of the ENT, speculated that I had developed subacute thyroiditis. By July I started feeling better and my blood work had fortunately gone back to normal readings. September blood work as well. I recently had a new blood work and will receive the results soon.  I hope this information is of some value to your collection of data. I am extremely concerned regarding the 3rd booster which I have not received.
Information has been received from a health professional concerning a 12 month old female with no known medical history who on 09-JAN-2006 was vaccinated with a 0.5 mL dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot# 649518/0154R). Concomitant vaccination included a dose of Prevnar. On 12-JAN-2006 the patient experienced a high fever and seizures and was taken to the emergency room, but was not admitted. On 13-JAN-2006 the patient had an office visit and was prescribed ZITHROMAX and ZOTEX drops for nasal congestion and coughing. The patient was diagnosed with bacterial rhinitis. Subsequently the patient recovered. There was no product quality complaint involved. The reporter considered the patient's high fever and seizures to be other important medical events (OMIC). Additional information has been requested.
Pt fell when she was done with her vaccine, pt was getting up from the bed and she fell and hit her head (forehead) so we pick her up and gave pt an ice pack for her forehead. Pt did not know what had happen. We took her blood pressure, we made her lay down and retook her B/P over. Then after 20 minutes she was fine.
11 days after moderna shot , I got muffled hearing / hearing loss in left ear and ringing in both ears. I went to Dr, and he gave me steroid shot in ear plus oral steroids after I did an audiology test . My pressure went down the next morning . I still have some ringing in ears but it has greatly improved.
This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patient's identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 6 month old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of ROTATEQ, orally, lot number: N011648 and expiration date: 01-DEC-2018, (strength, dose and frequency were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 9, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following information was reported: influenza/flu, onset Mar 2021, with outcome of unknown. Additional information: Patient was supposed to receive the second dose of the vaccine today, Mar 30, 2021 but developed a bad case of the flu. Patient asked whether she should push through with the shot or put it on hold for another date. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Syncopal episode following vaccination. Patient assisted to floor and then placed lying down on exam table. No injuries sustained. Vital signs checked twice, and patient allowed to leave under care of parent once symptoms dissipated.
Extreme arm pain--feels like arm is broken.   Also feels like an air pocket in ear on the side of the vaccine.
I received my vaccine this morning at 6:12AM and felt fine after. Around 7:45AM I started to feel slightly short of breathe, but figured it was just from the cold outside and my Asthma. The shortness of breathe feeling goes away. Later in the day sometime after 3 PM, I start to feel as if I am getting stuffy. I take a nap on the buss on my way home, and when I wake up I suddenly feel like I am freezing and have chills all throughout my body. I get home and jump in a hot shower to warm up, but it did not help. I then heat up some food to eat dinner, and I go to drink some soda, and I notice I have no taste. I figured the soda was flat, but even flat soda has some taste to it. I then drink a Cherry Gatorade, and still no taste. Now I check my temperature and it is at 101.4, and I have a slight cough.
This spontaneous report as received from a physician via a company representative refers to a 13 year old female patient of unknown demographics. Patient's current condition and medical history was not reported. On an unknown date, the patient was vaccinated with VAQTA, intramuscular injection (dose, unit, route not reported). No concomitant medication has been reported. ON an unknown date the patient experienced fever and ankle swelling after receiving VAQTA. It was reported that the patient was seen at an unspecified emergency room on an unknown date and had received unspecified treatment and it was not known if the patient was hospitalized. There was no product   quality complaint involved. The outcome of the events fever and ankle swelling was not reported. Causality between the events and VAQTA was not reported. Additional information has been requested.
This spontaneous report was received from a healthcare professional refers to a 14-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was not adverse effect reported. Administrated dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.