chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports rash/hives left arm and left posterior thigh within hours of receiving vaccine. Also reports intermittent dizziness moderate to severe headache, blurry vision, shortness of breath, palpitations.
pt recv vax & exp a gen rash;the nurse reported a total of 6 patients w/the same exp;
Headache, Sedation, Myalgia, Arthralgia, Swollen lymph nodes, Pain/Redness/Swelling/Itching @ injection site Narrative:  Other Relevant History:
Diffuse hives, approximately 6 hours, post vax. Prescription written for Atarax; had improved already on Benadryl.
1. Mild right deltoid area muscle pain started about 1 hour after injection (12-JAN-2021) and worsened to severe, treated with warm bath, was resolved the next morning at 5:30 a.m., there was no erythema or swelling at injection site   2. Had chills starting around 6 p.m. and were resolved next morning at 5:30 a.m. , unknown if there had been a fever as no thermometer was available   3.  Had severe headache beginning around 11:p.m. on 12-JAN-2021 and eyes were very sensitive to light. Since headache and light sensitivity did not resolve on their own, 200 mg of ibuprofen gel capsule was taken at 6:00 a.m. on 13-JAN-2021 and both events resolved by 6:30 a.m.   4.  Upon waking at 5:15 a.m. my entire face was bright red and there was slight swelling in the area below the eyes and upper cheek bones which resolved by 6:30 a.m. None of these symptoms warranted contacting my physician.
101 to 102 F fever for 36 hours, resting heart rate consistently over 100 bpm for 36 hours, body aches and chills for 48 hours, SpO2% 93% for 12 hours
Nausea, dizzy, vomited. She was pale and diaphoretic. No loss of consciousness. We had her lay down and applied a cool towel to her forehead. After 5 minutes, she seemed back to her baseline.
Right arm Influenza vaccine- erythema and warm to touch area 1 1/4" x 1 1/2". Left arm Pneumococcal vaccine-erythema and warm to the touch area 4"x 2 1/2".
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 19-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
A report was received from a health care professional on 21 October 2003 concerning a vaccinee of unknown demography who received expired Fluvirin on 20 October 2003. On 20 October 2003 the vaccinee received expired Fluvirin. No adverse symptoms were reported at the time of the event. There was insufficient information to determine the report's causality assessment. Update 1, 24 November 2003: Follow up information received from a health care professional indicated that the 87 year old female vaccinee did not experience any adverse reaction. The reporter stated that the vaccinee will receive the 2003-2004 vaccine in January 2004.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient reported sweating, chills, feeling lightheaded/dizzy with visual disturbance (blurry, narrowed vission) for about 20 minutes post vaccination.  Blood pressure taken 15 minutes after vaccination 105/68.  Monitored patient for 30 minutes post.  Symtpoms resolved significantly after drinking some fluids and patient left with Father.  Followed up with patient next day and patient reported feeling feverish/chills not taking any medication to manage.
Large local cutaneous reaction to vaccinations on left thigh. No evidence of infection currently. Prescription for Keflex sent. Discussed heat and massage per Dr.
feels dizzy,; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS POSTURAL feels dizzy,) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS POSTURAL feels dizzy,). At the time of the report, DIZZINESS POSTURAL (feels dizzy,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient takes medication for pre-diabetes.   This case was linked to MOD21-065775 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: ADR Form received on 17-MAY-2021 Contains No new information; Sender's Comments:  MOD21-065775:1st patient
Morning after received shot 10-22-21 with terrible body aches all over plus chest pains. I primary doctor & was told to take.
Ache in her injection site arm; Slight fever; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-302693 (Patient Link).
Numbness in jaw, back and neck; patient felt paralyzed. Extreme stiffness in jaw, back and neck after 1st dose for 72 hours.
This spontaneous report was received from a currently 61 year old patient referring to herself. The patient didn't have medical history or drug reactions/allergies to be reported. On 17-NOV-2015, the patient was vaccinated with ZOSTAVAX for prophylaxis (route, lot number, and expiration date were not provided). Concomitant medications included thyroid medicine, one tablet, daily (details unspecified). On an unknown date (reported as "a few months ago") the patient got shingles  even though she had the ZOSTAVAX vaccine 2 years ago. She further stated that her face was itching and hurting due to the swelling. The patient also had horrible headaches so she could not hold her head up or even talk. Also, on an unknown date, the patient had discomfort in her eyes and went to see an eye doctor where he told her that her nerves were swollen which was the reason why she was experiencing headaches. She also stated that she was more affected on the right side of her face and also had some on her back and leg, but they eventually went away. She then further stated that it hurt so bad that she could not sit or even brush her hair. Her doctor did prescribe: Gabapentin (100mg, 3 times a day), Famciclovir (3 times, a day), and also Calamine (which was "helping and clearing them up a little") (details unspecified). The patient's outcome for the aforementioned events was not recovered. The causality assessment between suspect therapy and reported adverse events was unknown.
5 days post vaccination severe onset of dull lower rib cage anteriorly and posteriorly with gradual onset of papulo-vesicular rash starting a week later and peaking at following 7 days with classical H. Zoster rash along the lower ribs cage course both posteriorly (max rash) and anteriorly and gradual resolution but neuralgia persisting. Treatment with gabapentin and Valtrex initiated and continued until complete vesicular eruption resolution.
At 1640 patient reported generalized itchiness to upper and lower extremities. Patient is AOX4 and denies any SOB and chest pain at the time. No redness and rashes noted at the extremities. Vitals are stable. Offered patient with fluid and patient tolerated well. Patient refused to take the medication as stated that she feels better and requested to let her go home.  At 1722 while patient getting ready to go home., patient started complaining of dizziness, nausea and slight chest tightness. Patient vitals are stable , legs elevated. At 1748 IM Benadryl given as patient requested. At 1802 patient stated that her symptoms are resolved . Patient stated feeling better and vitals are stable prior to leave the site. Patient left the site with stable condition accompanied by mother . Educated patient to go emergency room in case of SOB and chest pain.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): Regulatory Authority. A 41-year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 PNEUMONIA (medically significant) with onset Dec2021, outcome "recovered", described as "COVID Pneumonia"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "recovered" and all described as "COVID"; TINNITUS (non-serious) with onset Dec2021, outcome "recovered", described as "Tinnitus". The clinical course reported as on 04Mar2021, patient started therapy with Covid-19 vaccination (UNK INGREDIENTS) for vaccine COVID-19. On Dec2021, it was reported that patient experienced with tinnitus, COVID, COVID Pneumonia. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (22Mar2022): This is a follow-up spontaneous report received from the same contactable consumer. This consumer (patient) reported for himself that: Updated Information: Added case became valid, product start/stop date added, new events (Covid-19, drug ineffective, Covid-19 pneumonia, tinnitus added), event outcome updated, clinical information. The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt recvd  vax 16MAR92 & that evening devel a red papular rash on face & neck, & it was mildly itchy; pt recovered w/in 24 hrs; No further details were provided;
pt's wife dx'd with COVID 2 wks prior to pt coming to ED; 11/1/21 pt admitted to hosp with worsened altered mental state; cough; 11/5/21 pt found to be positive for COVID; given remdesivir, Decadron, O2 supplementation; able to be weaned to RA; pt refused to eat or drink; family refused NG tube or PEG tube; given IV fluids to stay hydrated; transitioned to comfort measures and pt expired in the hospital
received 1100 pruritis all over body 1110.  pt took benadryl 15-20 minutes prior to arrival due to similar symptoms with first vaccine pt reports improved symptoms at 1140. no sob, throat swelling, lip swelling or visible hives.
Experienced itching and hives all over body 15 minutes after injection. Administered BENADRYL 50mg and symptoms dissipated. She notified her family doctor and no further action required.
Patients mother reported to doctor that pt developed shingles (2 weeks)after Gardasil injection
My eyes and face swelled up and my left eye has been red, itchy, and sore since then.
2nd shot worse with coughing/mucus buildup; inability to eat; Went from very active to very inactive and rapid decline; COPD; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in a 93-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 PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). At the time of the report, PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 99 (Inconclusive) 99. On an unknown date, Weight decreased: decreased (Low) lost lot of weight.         Concomitant products were not provided/unknown.  Treatment medication were not reported/unknown.  Patient have been in Hospice care. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-236373 (Patient Link).
Vaccine was administered at approximately 6:15PM and patient was instructed to sit in waiting room for 10 to 15 minutes to make sure he was OK. He looked fine and sat looking at his phone for approximately 5 minutes. He then  stood and walked to pick up window and asked if it was normal to have stomach pains. I said no and asked if he felt dizzy. He said "no" then turned to go back to his chair. As soon as he turned he said "now I feel dizzy". I told him to return to his chair and he suddenly crumbled to the floor. I had my technician call 911. After 1 to 2 seconds of being unresponsive he suddenly came to. I had him continue laying on floor for a couple minutes and then he got up on his own and went to the chair. We gave him a cool towel for his neck and had him lean his head forward and down onto a chair placed in front on him.  The paramedics came within minutes and found him to be OK.  After they left he continued sitting in the chair for approximately 10 more minutes while talking on the phone (to his parents, I think). He then left stating that he was now OK and that it probably happened because he was nervous
This spontaneous report as received from a other refers to a 9 month old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 20-NOV-2017, the patient was inadvertly vaccinated with a dose of GARDASIL 9 (lot# reported as C5263AA expiration date 12-SEP-2019) for prophylaxis. No adverse effects were reported. Lot Number C5263AA is NOT valid for GARDASIL 9.
pt recvd vax 13MAR93 w/in 24 hrs pt had fever of 105; pt was listless, projectile vomiting, fever started that evening-cried all noc;
pt recv vax & exp h/a, aches, pains;sx resolved w/o tx p/both doses;
States that 24 hours after being immunized at approx 2pm 10/28/2005 starts with chills, temp 100 also c/o massive headache. Arm red and swollen. Cold packs to arm. States today 10/31 she feels better except for the local reaction. States welp was approx 5 inches long with welp at left arm.
When I first got the injection I had a slight sensation through my left neck gland to my ear. Felt fine as the days have progressed my neck gland has become very swollen especially as of today 1/2/2020 and a fullness in that ear, tonight had a sharp pain from that area  Otherwise feel fine.  The neck gland has become very tender.  Please advise
Large (2-10cm diam) erythemous blotches-no distress-approx 15% of total surface area; pt recvd DPH;
Diplopia started on 10/9/2020, unsteady gait on 10/10/2020.  Diagnosed with. Miller Fisher variant of Guillain Barre by neurology on 10/13/2020.  Hospitalized 10/13-22, treated with 5 day course of IVIG and PT/OT.  At discharge, still with paresthesias to feet, diplopia.  Able to walk independently, but with unsteady gait and decreased fine motor coordination, ongoing outpatient PT?OT and on short term disability.
I'm feeling fatigued, cold/slight chills, lost of apatite, slight nausea, and body aches.
Sore arm - day of vaccine followed by general malaise - day after fatigue - day after chills - about 24 hours after fever with 101.6 max - from 24-32 hours after lymph node swelling in left armpit - noted 48 hours after
Patient has recent diagnosis of Covid and presents hypoxic in the 70s noting shortness of breath.  Patient has received monoclonal antibodies.  Patient denies any fevers or chills.  Patient denies any new symptoms.  Patient denies any nausea or vomiting.  Patient denies any other modifying, alleviating or precipitating factors. Associated Symptoms: shortness of breath
swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, on an unknow date for covid-19 immunisation. On an unspecified date, the patient experienced swollen lymph nodes, which was generally resolved within 10 days, and likely to have resulted from a robust vaccine-elicited immune response. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
I in bump immediately after injection 10:30 AM: 3-5 days later itching, warmth then pain at injection site: 02/03/2015 "so painful it interrupted sleep/" bump was smaller in size. 02-05-2015 not so painful and can sleep, but bump still present but smaller.
More frequent loose stools for the past 2 weeks since receiving this vaccine, and also cough that may or may not be associated.
16 weeks pregnant; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing). Date of last menstrual period: 08May2023. The patient was 16 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12Feb2024. The patient's concomitant medications were not reported. Past drug history included: Known allergies: clindamycin, reaction(s): "Known allergies: clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "16 weeks pregnant". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was given as treatment. It was reported that the treatment start date was 01Sep2023 and the treatment stop date was Sep2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient developed a temperature of 103 that lasted 24 hours. He recovered without sequelae.
Patient presented for an appt with his sister.  Patient had already completed his series of HPV vaccine and was due for his #2 Menveo and #1 Bexsero  Staff accidentally administered his sister's HPV vaccine to him and vice versa.  No adverse reactions noted.  Patient will need to return for correct vaccinations.
arm swollen at injection site about 10 inches wide,redness, the area is hot; the area at injection site is hard; arm swollen at injection site about 10 inches wide,redness, the area is hot; arm swollen at injection site about 10 inches wide,redness, the area is hot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (arm swollen at injection site about 10 inches wide,redness, the area is hot), INJECTION SITE INDURATION (the area at injection site is hard), INJECTION SITE SWELLING (arm swollen at injection site about 10 inches wide,redness, the area is hot) and INJECTION SITE ERYTHEMA (arm swollen at injection site about 10 inches wide,redness, the area is hot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (arm swollen at injection site about 10 inches wide,redness, the area is hot), INJECTION SITE INDURATION (the area at injection site is hard), INJECTION SITE SWELLING (arm swollen at injection site about 10 inches wide,redness, the area is hot) and INJECTION SITE ERYTHEMA (arm swollen at injection site about 10 inches wide,redness, the area is hot). At the time of the report, INJECTION SITE WARMTH (arm swollen at injection site about 10 inches wide,redness, the area is hot), INJECTION SITE INDURATION (the area at injection site is hard), INJECTION SITE SWELLING (arm swollen at injection site about 10 inches wide,redness, the area is hot) and INJECTION SITE ERYTHEMA (arm swollen at injection site about 10 inches wide,redness, the area is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs and treatment medications were reported.