chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness all over body began the evening of injection (between 7:30-9:00pm on 1/3/22.  Treated with Benadryl on 1/4/22 and 1/5/22.  Symptoms were resolved by 1/6/22. Some milk redness on the skin near neck, torso, and back: morning of 1/4/22, resolved by afternoon the same day.  This is not the reason for our reporting but he did experienced normal Covid-shot symptoms as well including: sore muscle near injection sight and warm skin near the injection sight, both lasting for a few days.
The concern is that the injection was administered subcutaneous and not intermuscular. The injection site is approximately 10 inches below acromion, far lower than deltoid muscle. The injection site appears anterior even missing the triceps. I have been evaluated by a doctor who is unable to confirm accurate placement of vaccine and could not speak to efficacy if in fact vaccine has been administered subcutaneously. Does series need to be restarted? It should also be noted that I did not experience a reaction at site of injection until post day 8 - which is concerning for slower absorption (subcutaneous administration).
Child developed a blistering rash on her right hand; with additional coin shaped areas of erythema on her arms and legs, as well.
Pt recvd Pneumovax 23 on 29AUG89, & again on 23OCT89; exp sl soreness of arm, & later recovered;
Patient developed fever of 102-103 degrees 9 days after vaccine administered. She was noted to have a generalized pinpoint rash for 2 days with the fever.
Pt c/o heavy tongue, this RN immediately took the pt for further evaluation.  BP 140/90, O2 92%, HR 100, Lung field diminished, HX COPD, pt states she was "joking" pt walked out the building and stated she was feeling better.  Supervisor present during the assessment.  pt stated getting dry mouth with  meds.  Pt refused to stay.  Instructed to call PCP or go to ER if symptoms worsen.  Pt denies SOB or any other symptoms.  Stated she was feelin well and walked out as I watched her
Pt states he had excessive sleepiness, real bad aches and pains all over, and flu symptoms.   Lasted more than 5 days  pt reportedly took advil and Tylenol.
At 11:55 am Pt began to feel dizziness. Pt was unsure if it was due to her not eating so she did not notify provider. At 1:30 pm Pt contacted clinic with c/o worsening dizziness and difficulty catching her breath. I spoke to Dr. and he recommended for Pt to come in to be evaluated. Upon arrive at around 1:45pm Pt began to complain of blurry vision. Pt then evaluated by Dr.
Information has been received from a physician and a practice manager via two company representatives referring  to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 29-DEC-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). This specified lot number vaccine was exposed to temperature excursion fourteen times. The total cumulative excursion time (hour) and lowest recorded temperature (Fahrenheit degree) for each time were as below: (216, 29.3); (144, 34.2); (24, 33.6); (24, 33.4); (52, 33.1); (72, 32.9); (144, 32.4); (100, 34.5); (28, 30); (24, 34.3); (104, 29.1); (38, 34.9); (36, 1.1); (24, 34.8). The storage criteria and type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of ROTATEQ administered orally (lot number M004508 with an expiration date of 29-JUN-2017 and lot number M019708 with an expiration date of 25-OCT-2017) (strength, dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 Celsius (C) for 48 hours. The aforementioned temperature was identified due to a data logger. There were no pervious excursions reported. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
SIDE EFFECTS TOOK QUITE A WHILE  TO GET OVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported 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 an unspecified date, the subject experienced side effects took quite a while to get over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects took quite a while to get over was not reported. This report was non-serious.
Hives/itching at 3:30pm. Prednisone 30mg and Cetirizine 10mg orally by PA-C with additional tablets of both to be taken for the next 3 days.
Patient had initial redness at injection site which disappeared then on 1/1/21, the area became red, swollen, and hot all over. The area continues to be red and patient describes significant itching at the injection sight.
Patient Recived Immunizations Below approximately 510pm. Returned to clinic approximately 610pm complained of swelling around both eyes and diff breathing through nose no shortness of breath no swelling of lips
can't sleep; I have a headache; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (can't sleep) and HEADACHE (I have a headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (can't sleep) and HEADACHE (I have a headache). At the time of the report, INSOMNIA (can't sleep) and HEADACHE (I have a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   Reporter did not allow further contact
Then ended up passed out; She was dizzy so she sat on the floor; She came out of that and started vomiting for 10-15 minutes.; Fever the rest of the day; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Then ended up passed out), DIZZINESS (She was dizzy so she sat on the floor), VOMITING (She came out of that and started vomiting for 10-15 minutes.) and PYREXIA (Fever the rest of the day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Then ended up passed out), DIZZINESS (She was dizzy so she sat on the floor), VOMITING (She came out of that and started vomiting for 10-15 minutes.) and PYREXIA (Fever the rest of the day). On 21-Nov-2021, LOSS OF CONSCIOUSNESS (Then ended up passed out), DIZZINESS (She was dizzy so she sat on the floor) and VOMITING (She came out of that and started vomiting for 10-15 minutes.) had resolved. On 22-Nov-2021, PYREXIA (Fever the rest of the day) had resolved.        The day after the booster shot, patient felt dizzy so she sat on the floor and then ended up passing out. Patient came out of that and started vomiting for 10 to 15 minutes. Patient had a fever the rest of the day. The next day Patient was back to herself. It was baffling to her, Patient never has fainted before. This shocked her.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of loss of consciousness and other associated expected, non-serious events. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events had resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419387 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of loss of consciousness and other associated expected, non-serious events. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events had resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21st December 2022, the patient received Menveo. On 21st December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: A Certified Medical Assistant (CMA) informed that only the diluent of Menveo had been administered to a patient earlier on the same month. The health care professional (HCP) did not had information on lot number, also not gave consent for follow-up since no adverse reactions had been observed. The reporter did not consent to follow-up. Additional supportive information: A Certified Medical Assistant (CMA) informed that only the diluent of Menveo had been administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
1/27/2021 around 8:00pm noticed left side of nose was stuffed up 1/28/2021 around 3:30pm started having pressure in sinus area of face 1/29/2021 continued with pain and pressure at sinus area as well as clear runny nose - took Sudafed PE beginning at 2:00pm and had relief.  Took another dose of Sudafed PE at 6:00pm and again at 10:00pm 1/30/2021 felt fine all day until around 7:00pm and felt pressure again in sinuses, took Sudafed PE 1/31/2021 felt fine most of the day and did not take any Sudafed PE 2/1/2021 woke up to a runny nose and frequent sneezing but no sinus pain or pressure
no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 29 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on an unspecified date. On 03-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the right arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the left arm (lot T027914, expiration date 18-AUG-2022) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.
COVID hit me pretty hard with the usual respiratory distress. I am a doctor so I did not go see one. I did not take any medications.
Client complained of tingling on left arm after receiving 1st dose Pfizer Covid vaccine (lot# ER8732, exp 3/28/21). Client was sitting in post vaccine waiting area 30 mins when she alerted EMT of tingling of arm. EMT performed first assessment. Vitals 1445: blood pressure 128/92, pulse 81, oxygen 99. PHN  joined EMT shortly after. Client stated tingling on left arm that began 5 minutes after receiving vaccine; did not alert EMT until later. Per client no shortness of breath, chest pain, numbness, palpitations, headache, or blurry vision. Client stated this was a new onset that she did not have prior to receiving vaccine. No history of reaction to vaccines in the past. Current medication include daily vitamin and nasal spray. Allergy to antibiotic, but unsure of name. PHN assessed bilateral strength, facial droop, and arm weakness. Per client feeling fine besides the tingling sensation. PHN asked client to stay additional 15 mins for observation. Vitals 1452: blood pressure 132/92, pulse 78, oxygen 100. Alert and oriented. Tingling sensation the same, no changes. Per client history of anxiety and also had caffeine this morning, which she usually does not take. Last vitals at 1515: blood pressure 128/90, pulse 80, oxygen 100. Per client no change in tingling sensation. Was not radiating or worsening. Client advised to follow up with provider prior to receiving second dose. Client instructed to seek medical care if symptom did not improve or worsened. ER precautions given. Client left facility with steady gait at 1517.
Palpitations Narrative:  PARAMETICS CALLED FOR TACHYCARDIA 154  Other Relevant History:
Patient given a TB vaccine while he had a fever of 104 and a case of Strep throat. He began to have neurological problems about 24 hours later. (Trouble swallowing, weakness and a pain in limbs, inability to sleep + heart rate issues). There was no treatment other than IV iron for the restless leg syndrome he developed. He missed 7 weeks of school. His problems resolved over a period of 6 months.
chills; cough; Short of breath; sore throat; fatigue; loss of taste/smell & appetite; Loss of taste/smell & appetite; Loss of taste/smell & appetite; muscle & joint aches; muscle & joint aches; swollen lymph nodes; hoarseness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-year-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200) via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:00 as DOSE 2, SINGLE (at the age of 71-years-old) for covid-19 immunisation. The patient's medical history included diabetes, hypothyroidism, fibromyalgia, neuropathy, and known allergies: penicillin all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not tested to COVID prior and post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3246) via an unspecified route of administration, administered in Arm Left on 10Feb2021 02:00 PM as DOSE 1 SIINGLE for covid-19 immunisation. The patient was not tested to COVID prior and post vaccination. The patient experienced chills, cough, short of breath, sore throat, fatigue, loss of taste/smell & appetite, muscle & joint aches, swollen lymph nodes, hoarseness all on 12Mar2021 10:30. Patient had not taken any other vaccines in four weeks. Patient had not received any treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Pharmacist gave the shot after 15 hours that the vial was opened; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave the shot after 15 hours that the vial was opened) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave the shot after 15 hours that the vial was opened). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave the shot after 15 hours that the vial was opened) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided  No treatment medications were provided.
Pt developed urticaria and wheezing. She was given IM epinephrine and and Benadryl with improvement of symptoms. She was transferred  to  ER via ambulance
Intermittent fever 101.9 1/23 @0717PM --  Tachycardia 130hr 1/23 @0717PM -- 138hr 1/23 @0921PM --- 113hr 1/24 @0422AM -- 117hr 1/24 @0704PM Body aches/Chills -- 1/23 @0722PM Right arm pain, hard nodule palpated, and warmth to touch  at injection site  -- reported 1/24 @0149PM Reported bloody nares. (dried blood witnessed on wash cloth) -- reported 1/24 @0149PM Mild Headache 1/23 @0722PM Painful lump at right axillary that was not near prior to injection -- reported 1/24 @0149PM
MOTHER REPORTS IMMUNIZATION GIVEN APROX. 1:30PM ON 5/16/05 AND MOTHER NOTICED AT 5:00PM THAT CHILD HAD 100.0 TEMP. CHILD WAS GIVEN MOTRIN 1/2 TSP.  AND HAD BEEN ROTATING TYLENOL AND MOTRIN EVERY 4 HRS.  5/19/05 AT 1:00AM TEMP WAS 103.0.  MOTHER TOOK CHILD TO NP ON 5/20/05.  NO TREATMENT PROVIDED.   5/20/05  PHONE CALL TO MOTHER AND REPORTS CHILD IS DOING BETTER WITH NO FEVER REPORTED.
On 01Jan2021 received the dose of the Moderna vaccine, and today 12Jan2021 took the second dose; A spontaneous report was received from a consumer who was also a 70-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 1st Jan 2021 and 12th Jan 2021, resulting in the event inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1st Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (Lot Number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12th Jan 2021, the patient received the second dose of two planned doses of mRNA-1273 (Lot Number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. The four weeks dosing schedule was not observed. The patient did not present any side effects.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, inappropriate schedule of product administration, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot Number: 025L20A) reporting Inappropriate schedule of product administration without any associated adverse events.
I felt extremely fatigued around 6pm the night of my booster shot. I tried going to be around 11pm, however I was no longer tired. Instead, I found it very very difficult to fall asleep. I drifted in an out of sleep for a few hours when I was jolted suddenly awake at around 3am. My body was shaking uncontrollably, it was like I had severe chills but I couldn't control my movements. I thought I was cold so I put on a jacket and sweat pants and bundled up under my coveres, but I was still convulsing. This lasted for about an hour. During this time, I had numbness in my fingers and toes. I also felt like if I stood up I would pass out. I was extremely nauseous. I also experienced chest pain and felt unable to breathe properly. The convulsions stopped after about an hour, maybe an hour and a half but my body is extremely weak still and my chest pain is still persistent. I still feel like my hands and feet are numb. And I'm still extremely nauseous.
Patient, received the 2nd dose of the Pfizer COVID vaccine Lot # EW0167, Expiring 05/04/21 at 1105. EMTs noticed a client on the floor at about 1110 and rushed over to see what was going on. EMT went to tell lead nurse of the incident. The client was on the floor lying down when the EMTs and lead nurse went over to respond. Per report from one of the patients sitting next to patient in the observation area, Patient started leaning forward in her chair, started falling over, and the patient caught her before she could hit her head and slowly helped her to a lying position on the floor. Patient woke up on the floor at about 1111 and did not remember fainting. Vitals were taken at that time, P: 88, SpO2: 100, and BP: 138/96. The client upon waking up was A/O x 4 and stated that she "felt fine." She takes no medications, has no allergies, and has no medical history. The client ate some food in her car right before the appointment and explained that she had 4 shots of espresso in the morning. At about 1115 the client was slowly assisted to a chair in the observation area and was given some water to drink. The client stated that she has fainted before while donating blood about 4 years ago but that this has never happened after a vaccine. Vitals were taken again at 1121, P: 85, SpO2: 99, and BP: 120/78. Vital signs were within normal limits and the client felt "like normal". At 1135 the client verbalized feeling good and ambulated out of the facility and was able to safely drive herself home.
this 57yo Male ret. He received his first Pfizer covid vaccine on Jan 7th to left arm at hospital (not where he works). He went home and reported was fine, but tired.  Stated his fatigue and onset of shortness of breath began day 1 post vaccine kept him from working.  As his symptoms worsened, on day 4  (1/11/2021) he obtained a pulse ox and O2 sats were in the "80's" with normal heart rate. He went to ER on 1/11 1507 with body aches, fatigue, chest discomfort and SOB where he was ultimately admitted with diagnosis of COVID-19 pneumonia.  Is on O2 support via NC.