chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fainting in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles and cardiac syncope (narrow cardiogenic syncope). On 10th April 2019, the patient received the 1st dose of SHINGRIX. On 10th April 2019, 1 sec after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), injection site pain, pain in arm, nausea, chills, weakness, low blood pressure, feeling unwell and looked pale. On 11th April 2019, the patient experienced local swelling and enlargement of lymph nodes. On an unknown date, the outcome of the fainting, injection site pain, pain in arm, chills, weakness and low blood pressure were recovered/resolved and the outcome of the nausea and local swelling were not recovered/not resolved and the outcome of the enlargement of lymph nodes, feeling unwell and looked pale were unknown. It was unknown if the reporter considered the fainting, injection site pain, pain in arm, nausea, chills, weakness, low blood pressure, local swelling, enlargement of lymph nodes, feeling unwell and looked pale to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. It was reported that right away(1 second) after receiving SHINGRIX the patient fainted, experienced injection site pain and a few minutes after receiving SHINGRIX the patient felt sick and looked pale. The pharmacist monitored the patient for about 20 minutes after receiving SHINGRIX. The patient experienced nausea. The evening, 2 minutes after receiving SHINGRIX, the patient reported experienced chills, that lasted for 7 hours and 7 hours after receiving SHINGRIX the patient felt weak and experienced low blood pressure. One day after receiving SHINGRIX, the patient's armpit was also swollen. She suspected that she experienced swollen lymph nodes under her left arm, which was the side where she received SHINGRIX. The reporter did not consent to follow up.
Patient developed sudden onset of chest pain which was diagnosed as myocarditis.  Feeling a little bad on 6/2/2021 with some mild chest pain on that date.  Took ibuprofen.  Woke up suddenly on 6/3/2021 with severe chest pain.  Called pediatrician and was going to wait for them to open; however, it was so severe that they took him to the Emergency Department.
This study case was received from the investigator in a trial on 24 May 2013. A 43-year-old female subject was found to have angina decubitis 1 day after receiving the following vaccination on 11 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM (lot number, route and site of administration not reported), Tdap (manufacturer, lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included a normal ECG and normal troponin I on 11 February 2013. Treatments were not reported. Past medical history included eczema. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Did not feel well over the weekend; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well over the weekend), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 MALAISE (Did not feel well over the weekend), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, MALAISE (Did not feel well over the weekend), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
After vaccines were given, patient was still in chair and her head went down-syncope episode. Pt was transported by rolling stool to a pt bed.
Headache, Arthralgia, Fever, Diarrhea,  injection arm pain Narrative:  Other Relevant History:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022; No adverse event; Administered the vaccine after the 30 day by use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by use date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by use date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by use date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022).    No concomitant medications were reported.   The patient received half dose. The vial did not undergo any temperature excursions.  No treatment details were reported.
Patient described a sharp intense pain that occurred in the middle of the night following vaccination in the left arm where she received the fluzone HD vaccine. Patient denies having this feeling before and felt the need to call. Patient reported that it did not continue to feel that intense and got better, but was still more tender in the left arm compared to the right. Upon follow up, patient denied any further pain. It was thought that the pain might have likely been from sleeping on the affected arm during the night time.
05/04/2021 I started having pain on my collar bone lost mobility in my shoulder for a day. I had an injection and they hit the bursa instead of the correct point. I had swollen lymph notes the size of a marble. It developed in over a week and lasted for 3 weeks. They were very painful. It has fully recovered.
The day before thanksgiving I started having a sore throat and I usually get a sore throat if I don't cover my throat. I usually wear a coat or a jacket, but I didn't think I had the virus. I thought it was because I didn't wear a jacket. I took a COVID-19 test just on a whim and the results came back that I was positive for COVID-19. and a sore throat was the only symptom I had. The test was expired so I also went to my local drug store and took another COVID-19 test and the results were the same, positive. I reached out to the doctor, and I think I was given Paxlovid, but I don't recall exactly
Information has been received from a hospital pharmacy technician via a pulmonogist concerning a 67 year old female patient who was vaccinated with a dose of PNEUMOVAX 23 (Lot #658175/0856U). Subsequently the patient "got sick" and required bed rest. She had body aches and a low grade fever. Treatment was specified. At the time of the report the patient's outcomes was unknown. Additional information has been requested.
Sore arm, Redness and swelling in upper arm, Migraine,  Body aches, Joint pain, Fatigue, Decreased Appetite, Dry mouth/increased thirst, Nausea/Vomiting, Diarrhea, Nasal drainage, Sore throat, swollen lymph nodes & Fever. Took Ibuprofen, Tylenol, Excedrin, and Benadryl. Lots of rest and cold compress applied to upper arm. Symptoms lasted approximately 48 hours.
Our arm was sore; Running a little low temperature.; My daughter started to feel a little yucky that evening about midnight; This is a spontaneous report from a non-contactable consumer (patient's mother) via medical information team. A 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on 29Jan2021 at 17:30 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jan2021, the patient started to feel a little yucky that evening about midnight, reporter thought that her daughter may be running a low-grade fever, but her temperature was 97.1 degrees Fahrenheit. The only other reaction was arm was sore for maybe an hour or 2. On 30Jan2021, the patient was feeling fine today and was feeling okay just running a little low temperature. On 30Jan2021, the patient's body temperature was running 97.5 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature: 97.1 degrees Fahrenheit on 29Jan2021 and 97.5 degrees Fahrenheit on 30Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.
general malaise; All experienced similar symptoms, primarily the next day, including injection site soreness; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (general malaise), INJECTION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) in a 13-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 04-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 05-Nov-2023, the patient experienced MALAISE (general malaise), INJECTION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue). At the time of the report, MALAISE (general malaise), INJECTION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) had resolved.      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient was vaccinated COVID booster 2023 on 04-Nov-2023 and received a flu vaccine at the same time. Primarily the next day experienced injection site soreness, fatigue and general malaise. All symptoms resolved within the following 24-48 hours.  It was reported that administered at a pharmacy without a treating physician.   This case was linked to US-MODERNATX, INC.-MOD-2023-749068, US-MODERNATX, INC.-MOD-2023-749069, US-MODERNATX, INC.-MOD-2023-749070 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749068:Same Reporter  US-MODERNATX, INC.-MOD-2023-749069:Same reporter  US-MODERNATX, INC.-MOD-2023-749070:Same reporter
After the second dose, 2 days after receiving it, the lymph nodes in my neck and clavicle region had swollen and were painful to touch on my left side.; After the second dose, 2 days after receiving it, the lymph nodes in my neck and clavicle region had swollen and were painful to touch on my left side.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took penicillin for unknown indication on unknown date and experienced penicillin allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After the second dose, two days after receiving it, the patients lymph nodes in her neck and clavicle region had swollen and were painful to touch on her left side on 25Apr2021. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events after the second dose, two days after receiving it, the patients lymph nodes in her neck and clavicle region had swollen and were painful to touch on her left side was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received DTaP #4 the afternoon of 02/07/2022. Pt. presented on 02/09/2022 reporting that pt developed erythema at injection site the morning of 2/9.  Pt had previously received DTaP #4 on 02/07/2022.  Per FOC, pt went to school that morning.  FOC was contacted a couple of hours later due to increased swelling and redness on pt's upper R arm.  FOC attempted to contact pt's PCP for further direction; reports he was unable to reach provider, as she is currently out of town.  Per FOC, provider did not provide contact information or instructions to reach an on-call provider.  FOC and pt came to inquire about reaction.  Two RNs met with FOC and pt.  RNs observed injection site erythema and swelling.  Pt endorsed itchiness but denied pain.  FOC denied any behavioral changes.  RNs counseled FOC to apply ice to R arm 20 minutes at a time, avoiding direct contact with skin.  RNs also provided FOC with website. After the Shots handout, including weight-appropriate dosing of Ibuprofen.  RNs counseled FOC on s/sx of allergic rxns and advised FOC to have pt seen at urgent care or ED if sx worsen and/or new sx develop.  FOC notified that does not have any providers on site to see pt and was provided a list of local urgent cares and hospitals.
After 1st dose he tested positive for COVID; After 1st dose he tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ENG190; Expiration date was not reported) on 26Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first dose of vaccination, the patient had tested positive for COVID-19. The outcome of the event was unknown. The patient was scheduled to get the second dose of vaccination on 19Mar2021, and was asking if he could have it.
I received my first Moderna Covid 19 vaccination on February 2, 2021. I felt a little fatigue for a couple of day, but no other reaction.  About a week after the vaccination, my arm started to itch.  I have a large, red, "hive"-type area on my arm, about one inch below my vaccination site. The area is warm to the touch and appears to be getting bigger.
Immunization  12/22/2020 COVID Vaccine Clinic Need for vaccination Dx Referred by MD Reason for Visit Progress Notes MD (Physician) ? ? Endocrinology   COVID VACCINE CLINIC 12/22/2020    Patient:  Date:  12/22/2020                                                                                           Subjective Patient is a 63 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    Arrived at 5:50pm   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, 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, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse.   Vitals were normal Glucose was 100    Felt better right away Normal BP is 110s per pt     Objective    Vitals:   12/22/20 1759 BP: (!) 164/83 Pulse: 82 Temp: 98 °F (36.7 °C) SpO2: 95%     Physical Exam Vitals signs reviewed.  Constitutional:      Appearance: Normal appearance. She is normal weight.  HENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat. Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time. Mental status is at baseline.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.       MD Electronically Signed 12/22/2020 6:01 PM
no adverse event; Administration of expired M-M-R II to a patient; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies and concomitant medications were provided.  On 03-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin) (M-M-R II) 0.5 milliliter (ml) (lot # S039312 has been verified to be a valid lot number, expiration date was reported and established as 04-DEC-2021), subcutaneously for prophylaxis (expired product administered).   No product quality complaint (PQC) and no additional adverse event (AEs) were reported.
Extreme pain at the injection site and upper arm.  The injection site has hard knot and is a little swollen.
On August 26th, 2005,  given the Meningococcal vaccination which is required for college admission.  On September 5th, 2005 (10 days later) he complained that he did not feel well and he collapsed to the floor.  I rushed him to the ER.  Blood work & an EKG were done.  Nothing was found, and it was diagnosed as a VasoVegal Episode and we were advised to follow-up with our Primary Care physician.  He still complains of being light headed ("top of his head feels numb") and "fuzziness" in his vision.  We have also been to see a Neurologist (EEG, MRI of the brain all normal), Cardiologist (Echo Cardiogram normal), Eye Exam (normal), and an ENT (Inner ear problem ruled out).  They have been unable to diagnose what is causing his condition.  He was perfectly healthy until this episode occured and it appears a possible link to the timing of this vaccination.  His Neurologist agreed that it is possible that his condition may be an adverse event related to this vaccination.
5-10 minutes after I administered the vaccine the patient felt light headed and dizzy.  She lost color in her face and her mom helped her go down to the floor.   She recovered completely within minutes and walked out to the rescue to have her BP checked.
3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Could not lift my arm and the pain was like an 8 of 10.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Also my left arm hurt so bad for 3 days; with lumps under her skin; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO179) via an unspecified route of administration on left arm on 03May2021 11:30 as 2nd dose, single for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO158) via an unspecified route of administration on left arm on 12Apr2021 at 10:30 as 1ST DOSE, SINGLE for COVID-19 immunisation. Known allergies were none. Medical history and concomitant medications were not reported. She did not take any other vaccine in four weeks and no other medications within two weeks. On 06May2021 at 20:30 3 days & 9 hours after 2nd vaccine patient reported that she broke out in a rash on her chest neck and behind her ears, with lumps under her skin and felt hot. Took Benadryl at 21:00, in morning rash moved to stomach and left side. Event resulted in Doctor or other healthcare professional office/clinic visit. Then took Claritin and it disappeared. Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non-stop until 18:00 that evening. Also, her left arm hurted so bad for 3 days that she took Tylenol on day 2 after vaccine. Could not lift her arm and the pain assessment was like an 8 of 10 on 06MAY2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The clinical outcome of all events was resolved on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.