chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Notes APRN (Nurse Practitioner) ? ? Pediatrics Cosigned by: MD at 12/20/2020 11:30 AM Expand All Collapse All      COVID VACCINE CLINIC 12/18/2020    Patient:   Date:  12/18/2020                                                                                          Subjective  Patient is a 36 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat tightness.  She denied rash, hives, difficulty breathing, hoarseness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including rapid progression of symptoms.   Patient has PMH of mild anxiety   Review of Systems  Constitutional: Negative for activity change, appetite change and fever.  HENT: Negative for congestion, facial swelling, rhinorrhea and trouble swallowing.        Initially with some throat tightness.  Resolved within 10 min  Respiratory: Negative for cough and shortness of breath.   Neurological: Negative for dizziness, weakness, light-headedness and headaches.         Objective    Vitals Vitals:   12/18/20 1251 BP: 130/82 BP Location: Left arm Pulse: 98 SpO2: 100%       Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: She is not ill-appearing.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: No posterior oropharyngeal erythema.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert.        Assessment/Plan    Treatment included no therapy. Follow up response to treatment:excellent. Patient discharge:  Stable to go home and follow up with PCP.   Monitored patient for 15 min in the emergency bay Within 10 min of arrival the throat tightness resolved Patient felt comfortable to be discharged home - feels that she was anxious about the vaccination. Strict orders to go to the ED if shortness of breath, throat tightness, or other allergic symptoms develop or worsen. Patient verbalized understanding.    Orders Placed This Encounter Procedures ? COVID-19      APRN Electronically Signed 12/18/2020 2:17
Patient came in for second dose. Patient was scheduled in 21 days instead of 28 days for 2nd dose. This was not cough until after patient already received the vaccine. Patient was confused about what vaccine he got and timing. Patient did not bring card with him. Frist dose was Moderna. Patient received 2nd dose Moderna as well, but a received a week early.
FEELING AWFUL; CAN'T WORK; EXTREME HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced feeling awful. On JUN-2021, the subject experienced can't work. On JUN-2021, the subject experienced extreme headache. On JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling awful, extreme headache, nausea, and can't work. This report was non-serious.  .
Information has been received from a healthcare worker, certificated medical assistant (CMA) who reported that multiple unspecified patients received doses of improperly stored GARDASIL injection (lot # J003727 expiration date 07-NOV-2015 and lot # K009482 expiration date 06-MAR-2017, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Break through Covid positive on August 28 2021 On August 31 2021 received monoclonal antibody infusion Recovered well no complications
this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long.  Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen,  still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff.  experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.
Papular rash on face and arms started 5 days after booster dose some facial swelling  Some intermittent shortness of breath on and off for 3 days after
Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient reports that has head to toe rash. refused to take benadryl as says give vertigo.  recommended to take an anithistamine asap and if no improvement seek the attention of a doctor
Beginning at 2:15 pm I experienced injection site soreness. At 10 pm I experienced a mild headache and muscle aches. Between the hours of 12-1 am I experienced chills, vomiting, and muscle aches. At 2 am I experienced insomnia, a fever of 102, continued muscle aches, and my oxygen saturation was between 92-95%. At 2:25 am I took 1000 mg of Tylenol to reduce the fever and muscle ache discomfort.
As part of a vaccination schedule for patients with Sickle Cell Disease patient was administered Pneumococcal 23 valent in her right arm and Meningicoccal Conjugate vaccines in her left arm on 3/26 @1130am.  At 1600, her mother reported that her right arm started to hurt.  She was then given ibuprofen.  At 3/27 0200, she started crying and said her right arm was swollen.  Mother called and gave her another dose of ibuprofen at 0545 per physician advise for fever of 102.9°F.  At 1347, mother called reporting patient's fever had gone down but returned to 101.3°F.  She was told to bring the child to outpatient hematology clinic.  In clinic, a urinalysis was performed due to elevated WBC and ANC (13.8 and 10,200).  The urinalysis was positive for UTI (gamma hemolytic streptococci, lactose fermenter gram negative bacilli, and gram positive bacilli suggestive of Diptheroids).  Ceftriaxone was given in clinic, and Augmentin was prescribed for UTI. She was given ondansetron for nausea and ketorolac for pain in clinic.  She was discharged from clinic that afternoon after pain was controlled.
Concurrent with fever 102.6 developed burning/ tingling sensation in feet. Numbness and occ shooting pains have continued in both feet, worse after the booster shot, and continuing to this day with worsening of numbness slowly ascending/ loss of vibratory perception in gt toes (diminished at ankles) and no motor weakness detected.
Sore throat, fever (up to 103 deg F), coughing, stuffy nose, tiredness.  Used Tylenol and Motrin.  Visited doctor on 11/10/2009 and was suggested H1N1 nasal spray reaction and give decongestion medicine.
No other adverse events; a 12 year old received an adult dose of VAQTA in error on 28Feb2023.; a 12 year old received an adult dose of VAQTA in error on 28Feb2023.; This spontaneous report was received from a registered nurse concerning a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-FEB-2023, the patient was vaccinated in error with and adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, adult dose/formulation, lot# NZ7GR, expiration date: 17-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate age at vaccine administration) (Incorrect dose administered). No additional adverse events were reported.   The reporter inquired whether the dose of hepatitis a vaccine, inactivated (VAQTA) could be considered a valid dose.   This is one of two reports received from the same reporter.  Lot Number NZ7GR was confirmed to be not valid for hepatitis a vaccine, inactivated (VAQTA) by the lot validation team.; Sender's Comments:  US-009507513-2303USA001716:
Excruciating pain in the neck muscles. Lasted five days. I was in tears from the pain on 5 separate occasions. Needed two muscle relaxant and anelgesic for 5 days
Patient presented to the ED with cough, nausea, vomitting, weakness, confusion, with fever. She tested positive for COVID a few days before.  Started on decadron, oxygen, and inhalers. Developed pancytopenia. Started on vancomycin for suspected blood infection Developed atrial fibrillation with rapid ventricular response.  Was given lopressor, amiodarone, magnesium, lasix, and atrovent.  Patient started to vomit and was given zofran. Remdesivir was given as renal function improved.  Patient is still hospitalized as of this moment. Barticinib is being considered.
Massive headache Nausea Diarrhea Body ache Fatigue For 3 days Extreme lightheadedness/dizzy
9 -year-old Client was given an adult dose of Pfizer upon arrival for 1st dose.  Administration error was detected during the visit for the 2nd dose of Pfizer on 12/10/2021.  No adverse reaction occurred.
Chest pressure with palpitations and rapid heart beats. Skips beats when laying down or standing up suddenly.
Collapsed,pale ,sweating hypotension,bradycardia,feable pulse Epipen jr 0.15mg given,benedryl 2tsp given EMS called assessed, father didnt want to go to ER.Patient was observed in the office for 90 mins.His condition came back to normal and sent home
pt recv vax 02FEV94 & pt exp chills, sweats, fatigue, fever & a mild sore throat; 3FEB94 presented to MD & was dx w/bronchitis; tx w/ATB for 3 wk & subsequently recovered; No further details were provided;
Swollen arm at injection site, size of tennis ball; Pain at the injection site; felt very sick; chills/ shivering; felt freezing cold; felt hot; Fever; Pain under eyes; Eyes swollen; Swollen face: lips, tongue, eyes, cheeks; couldn't see well with peripheral vision; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. In October 2021, 2 days after receiving Shingrix, the patient experienced eye pain, eye swelling, facial swelling and peripheral vision defective. On 21st October 2021, the patient experienced injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot and fever. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site swelling, injection site pain, sickness, chills, eye pain, eye swelling, facial swelling and peripheral vision defective were not recovered/not resolved and the outcome of the feeling cold, feeling hot and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, sickness, chills, feeling cold, feeling hot, fever, eye pain, eye swelling, facial swelling and peripheral vision defective to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient reported that 1 day after after receiving the first dose of Shingrix experienced serval adverse reactions such as  felt very sick, shivering, felt freezing cold and hot, fever, pain under eyes, huge injection site reaction the size of a tennis ball. The patient 2 days after receiving the dose had pain under eyes, right eye swollen and could not see well with peripheral vision, lips, cheeks and whole face are swollen and had shills, The reporter consented to follow up.
Menstruation (period) cycle initially delayed by appx. 20 days in January after the shot. Period started on January 31st and ended on February 7th. I then suddenly started to see spot bleeding on February 21st, which continued for a week. As of February 26th, I am fully bleeding as my regular period with the increased amount of blood. I have been on a very regular period cycle (28-35 days) and not had this kind of experience for at least the past two decades.
Patient stated she had diarrhea several hours after vaccination (around 10:00 am). Donor asked to leave work due to not feeling well. On 8/18/17 at 0600, patient was at work and told me that she had been up in the night with diarrhea, chills, and a sore left arm (states she can't move it without pain).  Patient also states she has a "hive" on her left foot which she showed me. It is about the size of a nickel with a raised area and redness. Patient's left arm is slightly red but not swollen. Patient stated she put ice on her arm on 8/17/17.
Tongue warm, tingling, and numb-ish.; Injection site 5 inch swollen; fevered; injection site red; Under same arm, lymph gland swollen about same size and tender; Under same arm, lymph gland swollen about same size and tender; Tongue warm, tingling, and numb-ish.; Tongue warm, tingling, and numb-ish.; Glands in throat itchy and random sharp pain.; Glands in throat itchy and random sharp pain.; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 13Aug2021 at 12:00 (Lot Number: FC3180) at the age of 56-year-old as single dose for COVID-19 immunization. Medical history included multiple environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.  Known allergies included demerol. Since the vaccination, the patient had not been test for COVID-19. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included Spring Valley 10. The patient previously received Demerol and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23Jul2021 at 10:00 AM (Lot Number: FA6780) at the age of 56-year-old as single dose for COVID-19 immunization. On 13Aug2021 at 14:00, the patient experienced injection site 5 inch swollen, fevered, and red. Under same arm, lymph gland swollen about same size and tender. Glands in throat itchy and random sharp pain. Tongue warm, tingling, and numb-ish. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible;  No further information is expected.
Hives started 1 to 2 hours after receiving vaccines.  Client went to her doctor one day later and was advised to take Benedryl and ice the area.
Sudden itchy bumpy rash that is located always in both palms, but also comes and goes in random places all over body. Scratching makes the itching and rash worse. Prescribed steroid pills and lotion from my primary care doctor does not help.
This case was reported by a healthcare professional and described the occurrence of convulsion in a 7-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included tracheo-oesophageal fistula post surgery. Concurrent medical conditions included craniosynostosis. Concurrent medications included ZYRTEC. On 7 July 2011 at 16:45 the subject received 1st dose of HAVRIX (.5 ml, unknown route, right arm). On 7 July 2011, 3 minutes after vaccination with HAVRIX, the subject experienced convulsion. This case was assessed as medically serious by GSK. On 7 July 2011, the event was resolved. The healthcare professional considered the event was probably related to vaccination with HAVRIX.
Swelling all over body [Swelling NOS]. Neurological Changes [Neurological Symptoms NOS].
Received an Expired Dose of Heplisav-B; Initial Report Received on 13-Jul-2022  A pharmacy intern reported that a 23-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported. The patient had no known allergies.  No concomitant medications at the time of vaccination were reported.  On 11-Jul-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC # 43528-003-05) route and injection site not provided by the pharmacy intern reporter.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Had Ims = noon 12/6/10 (L) deltoid about 10 pm noted red, warm arm to touch, next day 12/7 swollen. Fever 12/7 only low grade <100. Treatment BENADRYL, ice, warm pk KEFLEX.
Patient had pain in left leg right after shot.  This a.m. (3/6/08) developed redness, 9cm x 6.5cm.  Treated with Keflex.
Fever and chills the same day. Had dizziness. Passed out later that day and headaches. Claims still has headaches.
UNDERAGED CHILD. 11 YEARS OLD.  DOB LISTED ON CONSENT. IMMUNIZATION REGISTRY LISTS AS DIFFERENT.
Persistent mild fever (99.5+) Ache (bone-ache, almost like arthritis) Fatigue Sleep trouble
Two days post vax the pt developed vomiting, diarrhea and a small amount of blood in the stool. The gastroenteritis resolved within nine days. The most recent information received reports the outcome of the event as resolved.
had discomfort on her right arm; could not go to work due to the pain; could not move it and had it elevated for the pain; strong pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (strong pain in the arm of the injection ), LIMB DISCOMFORT (had discomfort on her right arm), IMPAIRED WORK ABILITY (could not go to work due to the pain) and PAIN (could not move it and had it elevated for the pain ) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (strong pain in the arm of the injection ), IMPAIRED WORK ABILITY (could not go to work due to the pain) and PAIN (could not move it and had it elevated for the pain ). On an unknown date, the patient experienced LIMB DISCOMFORT (had discomfort on her right arm). At the time of the report, PAIN IN EXTREMITY (strong pain in the arm of the injection ), LIMB DISCOMFORT (had discomfort on her right arm), IMPAIRED WORK ABILITY (could not go to work due to the pain) and PAIN (could not move it and had it elevated for the pain ) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol(paracetamol).  Concomitant medication included unspecified allergy medication.   This case was linked to MOD-2021-083718 (E2B Linked Report).; Sender's Comments:  MOD-2021-083718:Same reporter, Husband's case
Four months after I was very tired, body ache, could smell or test anything, had fever and it lasted over a week. I went to the doctor and I wasn't test for COVID. They tested the thyroid and test was fine.
Arexvy on 18Oct2023 (lot number 4HY3A, expiration date 23Jan2025), and then afterward the patient stated he had already received a dose on 30Sep2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4HY3A, expiry date 23-JAN-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 18-OCT-2023, the patient received the 2nd dose of Arexvy. On 18-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Arexvy on 18Oct2023 (lot number 4HY3A, expiration date 23Jan2025), and then afterward the patient stated he had already received a dose on 30Sep2023). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 18-Oct-2023 The pharmacist stated that the first dose was not showing up in the state database, so he did not had the lot number or expiration date. The Vaccine Administration Facility was the same as Primary Reporter. Reporter gave permission for follow-up. The patient received second dose of Arexvy, which led to extra dose administered.
asymptomatic 24 hours after receiving the shot. Woke up at 0400 sweating slightly, and a temperature of 100.7. Took one tylenol (200 mg) to start, after 4 hours the fever reduced to a 100.1. Arm was sore this morning but over the course of the day it has gotten better. Have been pushing fluids the whole day.
Patient was vaccinated with IPV, typhoid vaccine, and TdAP all in the left deltoid on 9/23/09 by RN at nursing clinic. On the following day (9/24/09) she developed left shoulder redness, swelling & blisters and was seen in the ER. She received steroids & underwent bullae drainage, with improvement in the ER, and she was discharged to home with a steroid taper, and recommendations to take Benadryl.
Complex febrile seizure 14 days after administration. MMR and VZV administered separately. Also with viral URI so picture is more complicated.
exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhausted) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (exhausted). At the time of the report, FATIGUE (exhausted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information in response to events was not provided.
Weakness, soreness, and pain in upper arm/shoulder. Trouble doing medial tasks like changing clothes, putting on car seat belt, raising arms above head, moving things with only right arm.  Some movements hurt more than others. Weakness and pain still persist currently. Have had a Tetanus booster roughly 10-11 years ago without issue. Possible that vaccine was injected too high?
Pt has COPD and is oxygen dependent.  He has a  BMI of 39.  He was admitted due to PE and is COVID positive.
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a adult male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The caller was the patient who received SHINGRIX approximately 2 months ago on left arm. The caller reported that he was still experiencing sore arm muscle at injection site since that dose was given. This case has been linked with US2018154149, reported by same reporter.