chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted on 09/29/2021 with complaints of not feeling well. During hospitalization course, patient was treated for COVID-19 pneumonia.  Treatment consisted of dexamethasone and baricitinib.  Patient's respiratory status improved nicely throughout his hospitalization course.  Overall, patient improved nicely and significantly back to baseline state.  On day of discharge, patient had no complaints of headaches, dizziness, nausea, vomiting, fevers, chills, shortness of breath, chest pain, or abdominal pain.   All risks and benefits of discharge were outlined and patient was agreeable and eager to be discharged.
Around 2:30-3:00 am on March 6, 2021, I woke up to my lips being Swollen and a  headache, and High Blood Pressure.  I have been keeping my lips moist and applying a hot towel to my lips
according to mom child came down w/chicken pox-4 days p/vax;pt had a pretty bad case of it -spread all over w/fever;
Felt well until later that night of the vaccination, Saturday.  About 11 pm I began to have chills, fever, shoulder and back muscle pain and vomited.   Slept through the night and felt relatively well the next day.  Sunday, felt extremely fatigued but slept well.  Monday felt better, less fatigued but at 4pm came down with the chills for 2 hours and then fever up to 102.7 and muscle pain in my hip muscles.  Have been drinking electrolytes and water dur to vomiting.   Tuesday awoke with minimal muscle pain and only 99.2 fever.   Currently feel better had light breakfast and lunch and temperature is 98.9.
I had fever, confusion, stomach pain, and unable to walk. Went to ER and diagnosed with Colitis. Administered to intensive care for three days. IV antibiotics and followed up with oral antibiotics when released. The symptoms have resolved about 2 weeks later.
hives began 5PM 6NOV97 (>24hr p/vax) & by 9:30 had spread to arms, chest, legs & neck;went to ER given adrenalin & IV;later was able to breath better;seen by MD 7NOV97;sl itching;
rheumatoid arthritis; inflammation; pain in joints; allergic reaction to flu vaacine; Initial information was received on 12-Jan-2021 regarding an unsolicited valid serious case from consumer/ non-health care professional.  This case involves a patient of unknown age who experienced rheumatoid arthritis, allergic reaction to flu vaccine (hypersensitivity), inflammation and pain in joints (arthralgia), while the patient received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date were not reported)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced rheumatoid arthritis with inflammation and pain in joints (arthralgia) and allergic reaction to flu vaccine (hypersensitivity) (latency: unknown) following administration of INFLUENZA VACCINE.  The events rheumatoid arthritis, inflammation and arthralgia were assessed as medically significant.  No laboratory data was reported.  The patient was taking XELJANZ XR (TOFACITINIB CITRATE) 11 mg once daily via oral route for rheumatoid arthritis since AUG-2020.  It was not reported if the patient received any corrective treatment for hypersensitivity.  On an unknown date, the patient recovered from inflammation and arthralgia (reported as symptoms of rheumatoid arthritis, inflammation and arthralgia finally resolved).  At the time of report, outcome of rheumatoid arthritis and hypersensitivity were unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown age who had rheumatoid arthritis, allergic reaction, inflammation and pain in joints after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset was unknown. However, patient's laboratory data, concomitant medications ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.
The client had the 2nd dose of Pfizer BioNtech COVID vaccine on 2/19/2021.  On Sunday following the injection she started to experience joint and muscle weakness from her waist all the way down her legs.  She is still having symptoms which has affected her daily living and caused difficulty with tasks such as getting dressed and putting on shoes.
Provider came out of patient room and asked nurse to give patient her COVID booster. Patient only had her 1st and 2nd dose charted in her chart. Nurse did give patient her booster and provider went in room to finish up with patient. When provider came out of room, she stated that patient did find her COVID vaccine card and she had her booster in December 2021. Nurse wrote the vaccine she administered on 3/3/22 on patient card and then charted the one she had in December 2021 in her chart.
7-10-18  Tdap immunization; 7-12-18  Both ears plugged; 7-13-18  Pressure on head from one ear to other ear; 7-14-18  Woke up dizzy, hard to walk; 7-15-18  Still dizzy, ringing of ears; 7-16-18  Dizzy, ringing of ears, minor headache; 7-17-18  Dizziness gone, equilibrium challenged; 7-20-18  Ringing of right ear changed to constant static, left ear unplugged & no static on left side; 7-21-18  Hearing loss in right ear more & more evident; 8-23-18  Clicking in right ear began along with constant static; 9-06-18  More clicking occurring with constant static & substantial hearing loss in right ear.
Fever <100  Body Aches / Chills  Headache  Stiff neck x4 days Underarm pain / armpit pain x2 days
03/2021 in my left arm a dull ache pain, with some sharp pains depending on what position its in. My PCP said it was likely granylorication after the vaccine.
only reaction from her first dose was sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (only reaction from her first dose was sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0391L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder (She called to inform us at Moderna that she had auto immune disorder and she is taking biological medication agent) and Rheumatoid arthritis. Previously administered products included for an unreported indication: KEVZARA since an unknown date. Concomitant products included SARILUMAB for Autoimmune disorder.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (only reaction from her first dose was sore arm). At the time of the report, PAIN IN EXTREMITY (only reaction from her first dose was sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information provided.    This case was linked to MOD-2021-041497 (Patient Link).
Pt had area 6cm in diameter swollen on left arm. Treated with Keflex BID x 7 days.
Woke up from a nap hearing loud ringing in my ears. It did go away, but began again in January. By late January, I had it constantly. I have learned that I have some mid range hearing loss in my right ear as well.
Began feeling fuzziness/discomfort in my head on 9/5/21. This was not a headache or a migraine. This feeling lasted 5 days on and off and caused me to have trouble sleeping for fear of not waking up. On 9/9/21 the feeling in my head worsened as I tried to fall asleep. I got out of bed and told my girlfriend I needed to go to the ER. Almost immediately the feeling in my head became so severe that I thought I was going to die at any moment and went into a full-blown panic attack. At the ER I had 3 more panic attacks. I had a CT scan and bloodwork completed and they showed nothing was wrong. It is now 9/23/21 and for the past 2 weeks, I have continued to have the same feeling in my head followed by panic attacks ranging in severity from mild to quite severe. I have been prescribed Atarax and Xanax to help with anxiety and panic attacks. My entire life I have never had any mental health issues and am a very relaxed person. There has been no major life events or stressors in my life to cause the anxiety and panic attacks. The only thing that has changed in my life is receiving the Pfizer vaccine leading me to believe it is the cause of the head discomfort leading to panic attacks.
This spontaneous report has been received from a medical assistant referring to a patient of an unknown age and gender. The patient's medical history, drug and allergy history and current conditions were not provided. It was reported that on 15-MAY-2017, the patient received an improperly stored dose of GARDASIL 9 lot # M036059 and expiration date of 03-JUN-2019 (dose, route and anatomical location were not reported) for prophylaxis. The patient's concomitant therapies were not provided. The vaccine was stored at a temperature ranges between 32° Fahrenheit (F) to 36°F, during a time frame of 100 hours with no previous temperature excursions. No adverse events were reported.  Additional information has been requested.
headache; shortness of breath; body pain; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) via unspecified route on left arm single dose for COVID-19 immunization on 10Mar2021, 02:00 PM, at 58-year-old. Medical history included: high blood pressure, asthma, diabetes; allergies: ranitidine, metformin. Concomitant medication was not reported. The patient had headache, shortness of breath, body pain; doctor or other healthcare professional office/clinic visited and was reported as life threatening illness (immediate risk of death from the event). Treatment received as: betamethasone 6mg/ml 3ml, prednisone 40 mg x 4. Outcome of the event was resolving.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of the events headache, shortness of breath, body pain cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021445163 Same patient, different shot/event
felt like a freezing / dog; felt like a / soaking, whipped dog; felt like a freezing, soaking, whipped dog; This case was reported by a consumer and described the occurrence of feeling cold 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 feeling cold, feeling unwell and chills. On an unknown date, the outcome of the feeling cold, feeling unwell and chills were recovered/resolved.   The reporter considered the feeling cold, feeling unwell and chills to be possibly related to Shingrix.   Additional details were provided as follows: Age at vaccination was not reported. The patient felt like a freezing, soaking, whipped dog for a day or two after each shot. For tolerability of 2nd dose refer the case US2021AMR053984. No further information reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR053984:2nd dose
This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 01-AUG-2018, the patient was vaccinated with GARDASIL 9 lot # N032956, expiration date 13-JUL-2020, intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported.
Diarrhea; Lightheadedness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Lightheadedness) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included OMEPRAZOLE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Lightheadedness) and NAUSEA (Nausea). On 03-Feb-2021, DIARRHOEA (Diarrhea), DIZZINESS (Lightheadedness) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment details reported.
Postherpetic neuralgia stopped, after 17 years of constant itching, and pain in two area on my back, the PhN is gone. Have had no PhN since 02/012011. Less than 30 days after receiving the Zostavax Vaccine. Significantly positive for me, after 3 serious outbreaks of Shingles, first on November 1, 1994, second December 10, 1995 and third on March 3, 2000. Have had constant Phn since first attack. Have none now.
Both doses of the vaccine raised my blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Both doses of the vaccine raised my blood pressure) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL and FINASTERIDE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERTENSION (Both doses of the vaccine raised my blood pressure). At the time of the report, HYPERTENSION (Both doses of the vaccine raised my blood pressure) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 158/93 mmHg (High) 158/93. On 19-Mar-2021, Blood pressure measurement: 148/91 mmHg (High) 148/91. On an unknown date, Blood pressure measurement: 153/96 mmHg (High) 153/96.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Lisinopril.   This case was linked to US-MODERNATX, INC.-MOD-2021-079319 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079319:First Dose
She did not receive the second shot per her doctors orders; tip of nose swollen; nausea-doesn't get sick it just passes; legs became weak and can hardly walk; lips swollen and purple; swollen under lower lip; arm itch; arm swollen with bumps; Both sides of tongue have big bumps and all red; Lower lip is completely raw; arm red/hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (arm red/hot), PRURITUS (arm itch), PERIPHERAL SWELLING (arm swollen with bumps), CYANOSIS (lips swollen and purple) and LIP SWELLING (swollen under lower lip) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) and SOTALOL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ERYTHEMA (arm red/hot), TONGUE DISORDER (Both sides of tongue have big bumps and all red) and CHEILITIS (Lower lip is completely raw). On 21-Mar-2021, the patient experienced PRURITUS (arm itch) and PERIPHERAL SWELLING (arm swollen with bumps). On 27-Mar-2021, the patient experienced CYANOSIS (lips swollen and purple) and LIP SWELLING (swollen under lower lip). On 28-Mar-2021, the patient experienced MUSCULAR WEAKNESS (legs became weak and can hardly walk). On 29-Mar-2021, the patient experienced SWELLING (tip of nose swollen) and NAUSEA (nausea-doesn't get sick it just passes). On 08-Apr-2021, the patient experienced INTENTIONAL DOSE OMISSION (She did not receive the second shot per her doctors orders). On 08-Apr-2021, INTENTIONAL DOSE OMISSION (She did not receive the second shot per her doctors orders) had resolved. At the time of the report, ERYTHEMA (arm red/hot), PERIPHERAL SWELLING (arm swollen with bumps), CYANOSIS (lips swollen and purple), TONGUE DISORDER (Both sides of tongue have big bumps and all red) and CHEILITIS (Lower lip is completely raw) had not resolved and PRURITUS (arm itch), LIP SWELLING (swollen under lower lip), SWELLING (tip of nose swollen), MUSCULAR WEAKNESS (legs became weak and can hardly walk) and NAUSEA (nausea-doesn't get sick it just passes) outcome was unknown.            Treatment medication included Steroid shot and Diphenhydramine. The patient also cold compressed her arm. Patient's doctor suggested her to not get the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: event added, SD and Email added
patient complained about dizziness and rapid heart rate 15 minutes after vaccine administration. BP was 145/88, 143/95, 131/87- pulse 72,71,69 every 10 minutes.  felt better after 1/2 hour and left home. called her 5 hours later, she was doing fine
Headache, Sedation, Myalgia, Arthralgia, Pain/selling/redness/itching at injestion site Narrative:
Four adverse events:  1.)  Menstrual cycle started (11/1/21) one week early after first shot and then ceased after the second shot.  My menstrual cycle was normal up until I had my first covid vaccination shot.  2.)  Heart feels abnormal, labored on daily basis since covid vaccine, more so after second shot.  Annual Breast Thermascan on 11/12/21 showed inflammation near heart.  With abnormal breast thermascan, referred by gynecologist for diagnostic mammogram and breast ultrasound which was performed on 12/14/21 and indicated no breast cancer.  Appointment made with Cardiologist which is delayed due to doctor availability until 1/20/22.  3.)  Right upper eyelid spasms/twitches periodically.   4.)  Small mass in right groin/upper inner thigh area that may be a blood clot just under skin.  Need to schedule dermatologist appointment.
partial paralysis from the chest down; parasthesia; Diminished quality of life; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (partial paralysis from the chest down), PARAESTHESIA (parasthesia) and IMPAIRED QUALITY OF LIFE (Diminished quality of life) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PARALYSIS (partial paralysis from the chest down) (seriousness criteria hospitalization and medically significant), PARAESTHESIA (parasthesia) (seriousness criterion hospitalization) and IMPAIRED QUALITY OF LIFE (Diminished quality of life) (seriousness criterion disability). The patient was treated with Physical therapy for Paralysis and Physical therapy for Paraesthesia. At the time of the report, PARALYSIS (partial paralysis from the chest down), PARAESTHESIA (parasthesia) and IMPAIRED QUALITY OF LIFE (Diminished quality of life) outcome was unknown.            No concomitant medications were reported. No laboratory data were reported. Treatment medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-244077 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. MOD-2021-244077:cross link - Patient 1 in article
This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L040415, expiration date: 13-APR-2017) (dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient received her covid vaccine and 10 minutes following the vaccine she stated she was feeling light headed. She was already sitting down so the nurse took a set of vital signs at 6:14pm: oxygen saturation 98%, heart rate 104, respiration?s 18. She attempted to get a BLood Pressure on the patient?s forearm due to patient?s upper arm being too large to fit the Blood pressure cuff.  The patient stated her heard was racing like it did when her asthma starts t act up. Nurse called the paramedics at 6:18pm. The paramedics arrived at 6:22pm and took vital signs and placed an EKG pads on the patient to monitor her heart. The patient continued to feel light headed. She stated that she has not had much water in the past days and often forgets to eat. She had a sandwich with morning and a muffin at 4:00pm.  The paramedic did not feel like the patient needed to be taken to the ER unless the patient wanted to go. Shy patient attempted to stand up with the help of 2 paramedics and she started to sway. The patient decided to go the the ER vis ambulance. Her husband mark was waiting in his car and was altered to the news that patient would be going to the ER.
Patient fainted when he got up to walk down the hall. Hit side of cheek on wall when he went down. Got him sitting up and in a chair. Given water and cool towel, assessed by physician.
Pt recv vax on 11/30/98; on 12/4/98 pt exp queasy stomach, malaise, pain/red/indurated vax site; tx=Benadryl
pt recv vax 1PM; 730-8PM pt got fussy total body rash-fine red blotches head to toe, no change in stools, no emesis, no fever, no joint or face puffiness, rash started to resolved 10PM;
Significantly bruised armpit down to chest wall.; This case was reported by a physician via sales rep and described the occurrence of bruise in a 66-year-old female 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 bruise. Shingrix was discontinued. On an unknown date, the outcome of the bruise was unknown.   It was unknown if the reporter considered the bruise to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: The patient was significantly bruised from the armpit down the chest wall.  It was significant enough that doctor would not give second dose. The reporter consented to follow up.