chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest congestion; chest heaviness; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant) and CHEST DISCOMFORT (chest heaviness). At the time of the report, PULMONARY CONGESTION (chest congestion) and CHEST DISCOMFORT (chest heaviness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment details were provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is expected.
2/12/08 given MMR as part of physical. Pt reports symptoms of malaise, fever, chills, joint pain on 2/21 and 2/22. On 2/23 rash developed on torso. States feeling better today (2/26) but still has joint ache.
vaccine was administered outside of the clinic - reported by patient   PULMONARY EMBOLISM, UNSPECIFIED. 6/19/2021 CANCER METASTATIC TO INTRATHORACIC LN  ACUTE RESPIRATORY FAILURE 6/19/2021 CANCER METASTATIC TO INTRATHORACIC LN  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/19/2021 CANCER METASTATIC TO INTRATHORACIC LN  HYPOXIA 5/29/2021 CANCER METASTATIC TO INTRATHORACIC LN  PULMONARY EMBOLISM, UNSPECIFIED. 6/19/2021 CANCER METASTATIC TO INTRATHORACIC LN  ACUTE RESPIRATORY FAILURE 6/19/2021 CANCER METASTATIC TO INTRATHORACIC LN  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/19/2021 CANCER METASTATIC TO INTRATHORACIC LN  HYPOXIA 5/29/2021 CANCER METASTATIC TO INTRATHORACIC LN
still has pain at the injection site; continues pain in the arm, not as intense as initially, but still quite painful; This is a spontaneous report received from a contactable consumer (patient).  A 55-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 02Mar2021 (age at vaccination 55-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at an age of 55 years as single dose for COVID-19 immunisation and had no reaction on previous exposure to drug. The patient had still pain in the injection site, continues pain in the arm, not as intense as initially, but still quite painful, it had been 4 months. The outcome of the event was not recovered.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Uncontrollable crying anger, headaches, frustration, confusion, hard to remember things, loss of focus, depression, weight gain, period lasting 13 days.
red swollen area that itched a lot/it was speckled; red swollen area that itched a lot/it was speckled; red swollen area that itched a lot/it was speckled; tiredness; feeling bad/felt like a bad flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement; LEVOTHYROXIN taken for thyroid disorder; ECOTRIN. Vaccination history included: BNT162b2, administration date: 30Jan2021, for COVID-19 immunization, reaction(s): "she had red swollen area that itched a lot. It was speckled", "she had red swollen area that itched a lot. It was speckled", "she had red swollen area that itched a lot. It was speckled", "Tiredness", "feeling bad/felt like bad flu"; flu shot, administration date: 01Oct2021, for Immunization; Pneumonia shot, for Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "red swollen area that itched a lot/it was speckled"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling bad/felt like a bad flu".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dizziness; BPs 93/55 (pulse 58), 92/54 (pulse 62). O2 sat 100%.
Pain in my neck; Joint pain in my knee; Where I recieved the shot is still sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in my neck), ARTHRALGIA (Joint pain in my knee) and INJECTION SITE PAIN (Where I recieved the shot is still sore) 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 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Pain in my neck), ARTHRALGIA (Joint pain in my knee) and INJECTION SITE PAIN (Where I recieved the shot is still sore). The patient was treated with Physical therapy for Neck pain; Physical therapy for Arthralgia and Physical therapy for Injection site pain. At the time of the report, NECK PAIN (Pain in my neck), ARTHRALGIA (Joint pain in my knee) and INJECTION SITE PAIN (Where I recieved the shot is still sore) outcome was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: no significant information was provided by the reporter
This spontaneous report was received from a physician via company representative refers to two patients of unknown age. On an unknown date in 2012 (reported as a year ago), the patient was vaccinated with 0.65 ml ZOSTAVAX (lot number, expiry date was unknown), subcutaneous. On an unknown date, the patients presented with unspecified rash that could have been shingles of HSB. The outcome of rash that could have been shingles or HSB was reported as recovered. Additional information has been requested.
COVID-19 Vaccine EUA Fever, chills, headache starting about 1100 on 2-6-21 and lasting approximately 6 hours.   Headache and low grade fever on 2-7-21 for which Tylenol was taken.
Pt states he felt fine when leaving HD.  States he went to grocery store and did some errands then went home.  Pt states he was cooking something in kitchen and sat down because he felt a little funny.  Pt states this was at about 12:15 PM - he was tired and " passed out until about 5 PM."  Pt states he woke up because he was smelling smoke because he had put something in oven before  "passing out".  Pt states he was still groggy when he woke up.  Pt reported information to HD next and stated he was ok at that time.
PATIENT IS 12 YEARS OLD. WAS SUPPOSED TO RECEIVE A Tdap SHOT. INSTEAD SHE RECEIVED A BEXSERO.
Ache all over, stuffy head, cough with heavy phlegm, trouble sleeping at onset day zero; gradually felt better until day 5 when felt tired all over; started paxlovid on day 5; positive at home tests on day 2 and day five; negative test on day 8 and feeling fine (day 8 equals day 4 of paxlovid which I will finish on its 5 day course).
This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an adult dose of VAQTA, 50 U/1.0 ml, 1.0 ml (route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information had been requested.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
Shot on Thursday (1/7/21h at 1PM) Immediate:  Experienced some light headiness right after shot. 2-3 hours later - Some chest tightness, even up to throat. Resolved evening that day.     Usual soreness in arm, expected resolved after about 48 hours. Around 2 pm 1/14, felt chest tightness return up to throat, looked at arm, hot red and swollen, like a bug bite, itchy.  Did not take antihistamine.   1/15/21 redness and itchiness still at injection site.  Mild itching. Lingering mild chest tightness.  Upon big inhalation, feels like someone squeezing ? numb pain ? in chest and up to throat with a big breath.
Child received a 6 month - 4 year old dose when she actually 5 years old
Patient was administered the above vaccine after the "Use By" date assigned when removed from the freezer.
Blood clot in calf which began 2 days after my Moderna booster. It was officially found to be DVT with Doppler ultrasound on 11/9/21. I fractured my tibial plateau on 9/29/21 and have been non weight bearing on the affected leg since the accident. No illness, but I fractured my tibial plateau on 09/29/2021. I have had limited mobility (crutches and non weight bearing). I was on a dose of Xarelto, 10mg, one time daily for 30 days which ended on 11/2/21. On 11/6/21 I began experiencing pain in my calf and swelling. On 11/9/21 an ultrasound was completed showing DVT in my calf. I was put back on Xarelto 15mg, twice daily. I have no idea if this is even related to the vaccine booster but I was told to report it.
Initial unsolicited report received from a physician on 14-May-2018. This case involves a 60 years old male patient who was vaccinated with a dose of ADACEL (batch number: U5656AA, expiration date, dose, dose in series, route and site of administration was not reported) on 13-Nov-2017. The patient's premedication, concomitant medication and previous therapy was not provided. On 13-Nov-2017 (reported as since then'), following the vaccination, the patient developed intermittent left deltoid muscle pain from the injection site. No rash or swelling was observed. The patient's laboratory investigations and corrective treatment were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Vaccine injection site bleeding at time of vaccine,  followed by a sever bruise that has lasted well beyond 3 weeks.  About 7-10 after vaccine, tinnitus in left ear began.  Has not subsided.
The patient received his Shingrix vaccine on -1/30/23.  There was no initial reaction.  However, the patient said that 3 weeks after getting his vaccine he began to have ankle weakness/pain in ligaments.  It peaked 1-1.5 months later with general muscle weakness.  It spread to his shoulders, hips, knees tendons locking up/snapping.  He felt arthritis pain and general muscle weakness.  He went to his PCP in April 2023.  They told him not to get the booster of Shingrix.  He stated that he did have a prior reaction to the flu vaccine with ligament/muscle weakness many years ago.  The Dr is taking blood and testing him for inflammatory markers.
Severe cold from 2:30am till 8am. Used over the counter advil medication to suppress it. Felt pain in my left arm throughout the day after the vacination
Shoulder pain. Mid bicep pain. Pain in elbow and forearm, from time to time. Mostly daily shoulder pain. I have trouble sleeping because the left arm has on one comfortable position, and when I sleep, I move it and the pain wakes me up all night. It's been about 10 weeks and is still very painful. I wear a sling on the days that it hurts the most. The shoulder is the worst area of pain. It hurts sometimes front to back, and sometimes on the top of the shoulder. It hurts most days, but sometimes the pain goes away completely for a few hours. It always hurts when I get up in the morning, but calms down after awhile.
Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (name of the drug is not reported).    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication of the patient was not reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 vaccine.  Company Comment:  This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred approximately 6 months after receiving a dose of mRNA-1273 as the third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, three days after the completion of Paxlovid treatment, patient reported recurrence of COVID-19 and its symptoms. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred approximately 6 months after receiving a dose of mRNA-1273 as the third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection. However, three days after the completion of Paxlovid treatment, patient reported recurrence of COVID-19 and its symptoms. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Child (14mos) received 1st dose H1N1 Hx was negative for allergies to eggs. Was due to receive 2nd dose. Family visiting. Mother called nurse at 10:34AM to report child had rash on chest, no respiratory problems, advised BENADRYL and none on hand, planned ER visit.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 014C21A) for COVID-19 immunization. No medical history reported. On Aug 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Aug 30, 2021, patient experienced administered expired product (received expired dose). On Aug 30, 2021, administered expired product (received expired dose): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The nurse called to report 7 different patients received expired doses on Aug 30, 2021. The second patient received the dose as the first Moderna COVID-19 vaccine on Aug 30, 2021.
Sore throat, lymph node in armpit on the same side as injection site is still swollen and very tender.
Shortly after injection, had flu like symptoms - chills, aching, fever 103 later that evening.  This morning, feels well - temperature 99.7 - area of redness at injection site 7cm x 5cm - tender to the touch.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
I experienced an elevated and irregular resting heartrate ranging from 67 beats per minute to 180 beats per minute on the nights of March 5, 6, and 7, 2021, the three nights following the vaccine . My normal resting heartrate is in the 70s.
Patient experienced vasovagal syncope at approximately 4:38PM on 7/20/21. Soon after receiving the Janssen COVID-19 vaccine, the patient experienced syncope. Within the first few minutes of the reaction, patient fainted two to three times. Patient was seated at the time of the reaction, and was further supported by spouse and myself.   After approximately 5-10 minutes, patient was able to walk while supported to a quiet area of the store where she was able to comfortably lay down.  Patient was also provided water and an ice pack.  Around 30 minutes from the initial reaction, patient was able to stand and walk on her own.  Patient was monitored for 35 minutes at the pharmacy by two staff members and her spouse.   All the color had returned to her face and she reported feeling much better.  No medication was administered to the patient.   Patient and spouse were instructed to seek emergency care if symptoms returned.
Broke out with large red lesion on stomach. Itching. Took several doses of antihistamine. Put med. powder to stop clothes from chafing.
Information has been received from a pharmacist concerning a patient who was vaccinated with a second and third dose of GARDASIL (lot # not reported) in Oct 2007 and on 08-APR-2009, respectively. It was reported that the patient was in the office for the third dose late. The patient did not experience any known symptoms. Additional information has been requested.
02-10-16 area of injection pink, reddened, swollen and raised; warm to touch. Suggested Ibuprofen taken with food; and intermittent cool pack to area. Will phone 2/11/16 with condition update. Patient did not call back - presumed to be OK.
other zoster-related conditions; shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 26-JAN-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) by a healthcare provider at clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by health care providers for shingles and other zoster-related conditions. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.
chills; aches; headache; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, pain and headache. On an unknown date, the outcome of the chills, pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group selected as Adult as per vaccine indication. The patient experienced chilling, aches, headache. The reporter inquired how long does the side effects last. The patient had denied permission to contact their physician, and told that he would contact him.