chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 days of mild fever, general weakness, overall ache, sore arm.  3 hrs of sore throat.
Patient is a 75 year old female who has completed a 2 hours observation period with the following signs and symptoms of an adverse reaction; hypotension and loss of consciousness. Moderna COVID-19 vaccine #1 in series administered. 1318- pt. reported blurred vision to RN. Pt immediately assessed, during assessment pt. temporarily lost consciousness. Vitals- O2 sat-96%, HR-55, B/P-55/27, resp-16; 1320-DOD called, recommendation was to send to the ER via 911; 1324- Paramedics arrived and assessed pts. blood sugar (167), vitals O2 sat-98%, HR-71, resp 16, BP-91/40. Paramedics stated transfer to hospital was not necessary, but offered, Pt. declined ambulance transfer to ER. 1330- Continued to monitor pt. while giving oral fluids. Pt. reports she has fully regained consciousness, and blurry vision has resolved. Vitals, BP-102/42, HR-73, O2sat-96%, resp-16; 1335- Vitals, BP-110/50, HR-82, O2sat-96%, resp-16; 1400- Vitals, BP-121/45, HR-66, O2sat-97%, resp-18; 1420- Vitals, BP-125/31, HR-66, O2sat-96%, resp-16, DOD advised pt. should be assessed by MD. Pt. continues to refuse transfer via ambulance, no family members present. 1440- Pt discharged.     o Action(s) taken: Recommended transfer to higher level of care, risk and benefits explained to patient, patient declined ride from ambulance to ER and was discharged.   o Patient advised to discuss second dose considerations with a clinician
VACCINATION SITE NODULE; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a 7 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccination site nodule, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination site pain and vaccination site nodule was not reported. This report was non-serious.
I was sick last week; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I was sick last week) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick last week). At the time of the report, ILLNESS (I was sick last week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. patient Reported Just got booster and Had shots 2&2 in March 2021. Patient reported that was sick last week. Home test done and tested negative.   Reporter did not allow further contact
This spontaneous report as received from a 64 year old male patient with pertinent medial history of hernia surgery. Patient's drug reactions and allergies included: patient had received an unspecified Flu vaccine: influenza virus vaccine (manufacturer unknown) in 1993 and 2 days after receiving this unspecified flue vaccine he then developed the flu (MARRS#1310USA012808); patient received an unspecified pneumonia shot: pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) as well as an unspecified tetanus shot: Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown) on 03-SEP-2013 and then developed pain which he recovered from 2 days later (MARRS#1310USA012809); Patient had liquid MORPHINE (unspecified manufacturer/dose/frequency) and made his "arm completely red" and raised his blood pressure (date unspecified). On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial, "one-shot", route as "under the skin", lot #,  strength, formulation were unknown). After receiving ZOSTAVAX, on 18-OCT-2013, patient developed an injection site reaction which included redness, swelling, itching, warmth, pain, and the reaction site is the size of a silver dollar that was red and raised. The patient had sought medical attention via speaking to the pharmacist. No lab diagnostics studies were performed. Treatment of BENADRYL (unspecified manufacturer) was given for the event. The outcome was reported as not recovered. Additional information is not expected.
One day post vax, pt complained of redness approximately 1 3/4", swelling, itching and pain at site of injection. On 11/9/00, the swelling decreased but the redness increased approximately .5". The pt complained of headache, increase of itching and pain. Further info is requested.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen) and MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen), MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) and HEADACHE (Back part of the head hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt bad/felt lousy), PAIN IN EXTREMITY (Arm was killing me/Whole arm hurt), CONTUSION (Blue and bright red bruises on left arm), PERIPHERAL SWELLING (Really swollen), MUSCULOSKELETAL STIFFNESS (Unable to turn neck on left side) and HEADACHE (Back part of the head hurt) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache is consistent with the product safety profile.
SWELLING UNDERNEATH THE EYE; SKIN UNDER EYE IS LITTLE SENSITIVE; SKIN UNDER EYE IS IRRITATED; This spontaneous report received from a consumer concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: dermal filler in cheeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced swelling underneath the eye. On 12-SEP-2021, the patient experienced skin under eye is little sensitive. On 12-SEP-2021, the patient experienced skin under eye is irritated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling underneath the eye, skin under eye is irritated, and skin under eye is little sensitive. This report was non-serious.
Reports she got Pfizer (1st dose) on Friday (4/30) at 12pm.  Sore at first. Calmed down by Saturday. Sunday was fine. Woke up Sunday night/monday morning with tingling sensation in left arm to finger tips. Also feels this sensation in her cheeks. Started having tingling in her toes (left side). No tingling on the right side. No weakness. Sensation is the same. No pain/itchiness.
Breakthrough case. Felt a sore throat, nauseas, shaky and tired with sinus pressure and a cough. Took home COVID-19 test and it was Negative. Two days later I took another Home Test and it was positive. I had a telehealth appointment with my Dr, and was prescribed Paxlovid. Still testing positive but feel better
Patient came to the ED and was admitted to the hospital with Covid.  Patient also documented to have acute metabolic encephalopathy due to Covid, hypoxemia, and thrombocytopenia due to Covid.
pt recv vax 12DEC97 & about 12hr p/vax pt exp itching other exp included muscle pain, vesiculation, joint pain, severe sweating, weakness, anorexia & h/a;pt had a measles-like rash w/little red bumps;severe itching;
inconsolable crying;trembling/shaking;fever, felt warm-didn't check;arching of back was using APAP for pain & fever;to MD 18FEB & dx w/sinus infect;1wk later dx w/bilat OM;
No additional AEs were reported.; Nurse reported that a patient received an expired ROTATEQ.; This spontaneous report was received from a licensed practical nurse concerning a 7-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not provided.   On 14-JUL-2022, the patient received an expired first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # 1742079, expiration date 08-JUL-2022 for prophylaxis (Expired product administered) (Dose, route of administration, and anatomical location was not provided). No additional adverse events were reported (No adverse event).
"Hospitalized (11.16.21 -discharged 11/22/21; COVID-19 positive (11.16.21); Fully vaccinated  COVID infection Acute on chronic respiratory failure Hx COPD Patient vaccinated, with Moderna X2 Last vaccine was in March 2021 Currently on 3 L of oxygen, She is at baseline 3 to 3.5L at home  -- s/p Decadron 6 mg daily for 10 day --s/p Remdesivir course  --continue home inhalers-Trelegy  DETAILS OF HOSPITAL STAY:   Septic shock  [A41.9, R65.21] COVID-19 [U07.1] Hypoglycemic shock  [E15]   ADMISSION AND DISCHARGE DIAGNOSES:  HOSPITAL COURSE:   Shock-Resolved  - suspected hypovolemic    History of fast bacilli in BAL 10/29/2021, Aspergillus fumigatus in BAL 10/29/2021 Enterobacter cloacae complex in BAL 10/29/2021 History of Right sided Empyema 2/2 to Strep Intermedius s/p right thoracotomy and washout 10/2 Hydropneumothorax/Pneumomediastinum s/p Chest tube which was removed H/O  Right Bronchopleural fistula s.p 5.5 Zephyr valve placement per pulmonary - CT thorax:  Improved loculated hydropneumothorax, chronic consolidation/atelectasis, extensive subcu emphysema in the chest wall has improved - blood cultures NGTD - ID evaluated , home on Augmentin and Cipro x 12 additional days  --ultrasound bilateral lower extremity no evidence of a DVT - ID followup, repeat Fungitell as outpatient    COVID infection Acute on chronic respiratory failure Hx COPD Patient vaccinated, with Moderna X2 Last vaccine was in March 2021 Currently on 3 L of oxygen, She is at baseline 3 to 3.5L at home  -- s/p Decadron 6 mg daily for 10 day --s/p Remdesivir course  --continue home inhalers-Trelegy   DM2            Lab Results Component Value Date   HGBA1C 5.7 (H) 10/23/2021             Lab Results Component Value Date   GLUCOSE 126 (H) 11/21/2021  HTN     BP Readings from Last 1 Encounters: 11/21/21 121/70   Depression  Restart home medications
Facial hives - requiring ED visit -> IV steroids, IV BENADRYL and IV PEPCID. Was monitored for 2 hours in ED.
Felt lethargic and not up to par for one week. On 4-22-15 - big red spot appeared on arm on shot site. Itched. Got from doctor flucinonide 0.5% ointment. Didn't help. Took prednisone 10mg for six days. Took away rash.
This case was reported by a healthcare professional (medical assistant) and described the occurrence of hive in an 18-month-old male subject who was vaccinated with Dtap (manufacturer unspecified). On an unspecified date the subject received 4th dose of Dtap (details unknown). At an unspecified time after vaccination with Dtap vaccine, the subject experienced hive. At the time of the report, the subject was 14 years old, but the healthcare professional reported that at 18 months old when the subject received the 4th dose of Dtap vaccine, he experienced hives. The manufacturer of the Dtap was unknown. At the time of reporting the outcome of the event was unspecified.
Immediately after I received injection I felt dizzy and nauseous.  I started sweating heavily and was unable to stand. I felt very faint and thought I might pass out. I could not see or hear properly. It felt like I was on psychedelic drugs. My ability to process information and communicate was severely impaired. I had trouble finding words to explain what was happening to me. I heard ringing in my ears and felt very hot and like there was pain all over my body and I couldn't sit still. This lasted for about 10 minutes. The pharmacist gave me a pill. I don't know what he gave me, but this even was super scary and I don't know if it was an allergic reaction.
Missed the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) outcome was unknown. Not Provided      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 drugs were not provided concomitant drugs were not provided
small skin lesions on right hand which started 3 hours after vaccine administration and appeared white/dry at first then became dark gray/brown and faded several days later
area on her left arm that was the size of a quarter, red / area was 6 inches across and was a big, red hard area.; area on her left arm that was the size of a quarter, red and hard / the area grew larger and harder/ area was 6 inches across and was a big, red hard area.; area on her left arm that was the size of a quarter, red and hard and warm/ area became warmer.; bad headache/nagging headache; nausea; her stomach wasn't feeling well; and she just didn't feel right; pain and soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). In June 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the injection site pain, erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad were recovered/resolved.   It was unknown if the reporter considered the injection site pain, erythema, induration, localized feeling of warmth, headache, nausea, gastric disorder and feeling bad to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix in June 2020. She had pain and soreness at the injection site which was her left arm. The next day she had an area on her left arm that was the size of a quarter, red and hard and warm that lasted for 3 days and then after the third day the area grew larger and harder and became warmer. She had a bad headache the day after the initial injection. The patient had a nagging headache for a week to a week and a half after that. The diameter of the area was 6 inches across and was a big, red hard area. After about 7 to 8 days, she contacted her physician and they put her on steroids. During that time, patient's stomach was not feeling well and she was not felt right with nausea.  Everything had resolved at time of reporting.  The reporter consented to follow up.
Information regarding Prevnar was received from a healthcare professional regarding a 5 month old male patient who experienced pneumococcal meningitis and pneumococcal bacteremia. At 4 months of age the patient received the second dose on 8/26/04. The patient's concurrent illness includes gastroesophageal reflux disease with a past history of coxsackie viral infection. Indication for Prevnar was immunization. Product was administered on 8/26/04. Dose regimen was 1 dose 1 time per day (IM). Concomitant therapy included Zantac. The patient experienced pneumococcal meningitis and pneumococcal bacteremia on 10/11/04. He was treated with Motrin for fever on 10/11/04. The infant expired that same day. No additional information was available at the time of this report. 11/7/04 Received PCP progress notes. Autopsy Report received on 11/22/2004 states COD is Sepsis due to streptococcus pneumoniae w/associated injury in multiple organs.
Received injection 11:40 A.M. At 5:00 P.M started  to experience malaise, chills 7:00 P.M. low grade fever spiking at 99.9 degree F By 10:00 P.M. next  morning general weakness & malaise. Event lasted about 36 hours.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A,expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Patient received her 2nd dose of the COVID-19 Moderna vaccine on 10/19/21. She visited the pharmacy on 10/21/21 presenting with a large swollen bump at the injection site that covered from the shoulder down to mid-arm. There was swelling and redness/discoloration. The patient did not attempt any treatments yet but plans to take an antihistamine when she arrived home. She stated she had the same reaction after her first dose and presented photos of her arm.
Returned to work after shot did not feel well, hot, red, sweaty, difficulty breathing, swelling at inject site. Taken to walk in clinic at her work site, for anaphylactic reaction. Treated with IV/meds. Now on prednisone. DOS 10/11/06 Assessment: allergic rhinitis to hepatitis B vaccine. Chief Complaint: chest tightness due to reaction to hepatitis B vaccine. PE: WNL except for slight erythema across face and rash above the breast bilaterally with mild erythema, slight erythema across the shoulders posteriorly. RX with sol-medrol IV and 50mg Benadryl IV. Rash resolved no more episodes of chest tightness. DC with RX for Zyrtec and Prednisone.
Extreme dizziness for over two weeks with debilitating dizziness and fatigue. Also nausea and digestive issues.
rashes; facial swelling; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (Father) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Mar2021 as 1st dose, single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On an unknown date the patient experienced rashes and facial swelling. The outcome of both the events was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Patient was given immunization and then stayed to be observed per office policy.  Five minutes later patient was pale and vomiting.  Doctor came in to exam room and observed patient. Water was given to patient and ice pack placed on back of neck.  Patient vomited one more time. Other nurse stayed with patient until the doctor and the patient and mother of patient felt it was ok for patient to leave office.  Left office by her own ability and color had returned to her face.
Patient developed leg swelling and rash 10 days after vaccine administration. She was diagnosed with urticarial vasculitis.
FEELING LIKE HAD 2 HEART ATTACKS; BOTTOM OF MY HEART IS NOT RECOVERING; SERIOUS HEALTH ISSUES; CONSTANTLY OUT OF BREATH/STRUGGLE TO BREATH; RUN DOWN AND TIRED; NEVER HAVING ENERGY; EARS ARE SCREAMING CONSTANTLY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: genetic high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after having the Johnson & Johnson vaccine the patient experienced serious health issues. The patient reported that, the bottom of heart is not recovering from a tread mill test which was done due to the patient feeling like had 2 heart attacks. The patient had performed with scan to see if there was any blockage to arteries, since patient had genetic high cholesterol, results shows zero build up in main arteries. But patient experienced constantly out of breath with no excursion and struggle to breath. The patient also experienced ears are screaming constantly, run down and tired, and never having energy. Laboratory data (dates unspecified) included: Scan (NR: not provided) Zero build up (blockage), and Treadmill test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bottom of my heart is not recovering, and the outcome of serious health issues, feeling like had 2 heart attacks, constantly out of breath/struggle to breathe, ears are screaming constantly, run down and tired and never having energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211112604-COVID-19 VACCINE AD26.COV2.S-feeling like had 2 heart attacks. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recvd vax & returned in 40 mins c/o dizziness; administered 02 via nasal cannula, & 50mg inject of DPH & Epi; taken to hosp; pt adm & discharged;
Headache for first 24 hrs. with low grade temp. Hardness at injection site, large wide area of rash/redness and irritation down upper arm almost to elbow. Duration of more than 2 weeks until finally rash/redness faded to lowest area.