chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We both received the first dose of the Recombinant Zoster (Shingles) Vaccine on June 20, 2018, at Dr. office. We received the Vaccine Information Statement when we left the office, but were not advised about any possible severe side effects prior to receiving the vaccine. That night neither of us slept well because of severe soreness in our arms, where the shot was administered. Spouse had fever, chills, and nausea. Because patient was driving, we went forward with our plans for the following day, to leave to visit our daughter and her family, a distance of about 540 miles. That afternoon patient developed severe chills and nausea, severe enough that he did not want to continue to drive. We stopped about half way to our destination, both took a four hour nap, had a small supper, and went back to sleep for twelve hours. During that time patient continued to have severe chills. The following day (June 21) we both continued to have extremely sore arms but felt somewhat better, so we completed our trip. We drive home on June 25 and 26. On Saturday, June 30, patient continued to experience flu-like symptoms, which he described saying, "I feel the same way I felt the day after getting the Shingles shot." He also had a deep, hard cough, and complained of having a swollen right leg and pain in his left side. On the following day, Sunday, July 1, he was so uncomfortable with those symptoms that we went to a walk-in clinic near our home. The physician at the walk-in clinic advised patient to go the ER. There he was diagnosed with blood clots in his right leg and both lungs, Pulmonary Embolism, and was hospitalized until the afternoon of July 5th. Did the Pulmonary Embolism occur because patient, as a result of the vaccine, slept for so long at the motel on June 21? Perhaps became dehydrated and didn't move around much? Or was it because we had embarked on a long road trip, as we had done many times before? Patient feels strongly that the PE was, at least in part, a result of side effects of the Shingles vaccine. When we arrived at the E.R., the first thing the attending physician asked was, "Have you taken a long trip? Have you been inactive for any reason?" The inactivity occurred when we slept for sixteen hours at the motel. That was directly a result of us receiving the Shingles vaccine. Now we are questioning, should we get the follow-up vaccine when we are due to have it, or should we choose not to have it? Thank you for your attention to our concern.
Elevated heart rate, shortness of breath, fever (101.3), body aches, nausea, fatigue, impaired sleep - lasted 2 days
Patient has experienced nausea & vomiting, fever & chills that have lasted for 10 days.
mild disease / cold-like symptoms / none hospitalized; all 5 were vaccinated with the same lot # of Moderna; This spontaneous case was reported by a health care professional and describes the occurrence of NASOPHARYNGITIS (mild disease / cold-like symptoms / none hospitalized) and PRODUCT QUALITY ISSUE (all 5 were vaccinated with the same lot # of Moderna) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     Medical history was not provided.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PRODUCT QUALITY ISSUE (all 5 were vaccinated with the same lot # of Moderna). On an unknown date, the patient experienced NASOPHARYNGITIS (mild disease / cold-like symptoms / none hospitalized). On 05-Feb-2021, PRODUCT QUALITY ISSUE (all 5 were vaccinated with the same lot # of Moderna) had resolved. At the time of the report, NASOPHARYNGITIS (mild disease / cold-like symptoms / none hospitalized) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given. 5 of our employees tested positive with breakthrough infections
04/16/2021 PM: Light fatigue as well as light soreness in shoulder around injection point 04/17/2021 AM: Moderate soreness in upper body and back as well as moderate fatigue 04/18/2021 AM: Heavier fatigue and moderate soreness 04/18)2021 PM: Mild fever, moderate fatigue
She took a COVID-19 test and tested positive; fever; coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PYREXIA (fever) and COVID-19 (She took a COVID-19 test and tested positive) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COUGH (coughing). On 12-Feb-2021, the patient experienced PYREXIA (fever). On 13-Feb-2021, the patient experienced COVID-19 (She took a COVID-19 test and tested positive). At the time of the report, COUGH (coughing), PYREXIA (fever) and COVID-19 (She took a COVID-19 test and tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Pyrexia: 12-feb-21 (High) 100.4. On 13-Feb-2021, SARS-CoV-1 test positive: positive positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided. Schedule for 2 dose 18-feb-2021, she tested positive and pharmacist has said to finish her quarantine before she gets 2 dose.
extra dose administered; felt sick to his stomach half an hour ago; experiencing vomiting; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of neoplasm malignant (the patient had a full course of Shingrix and got cancer in 2021, He also had a breakout of shingles earlier this year, for the tolerance of previous dose refer case - US2023105254 ).   On 01-AUG-2023, the patient received the 3rd dose of Shingrix. On 02-AUG-2023, 1 days after receiving Shingrix, the patient experienced upset stomach (Verbatim: felt sick to his stomach half an hour ago). In AUG-2023, the patient experienced vomiting (Verbatim: experiencing vomiting). On an unknown date, the patient experienced extra dose administered (Verbatim: extra dose administered). The outcome of the vomiting and extra dose administered were unknown and the outcome of the upset stomach was not reported.   It was unknown if the reporter considered the vomiting and upset stomach to be related to Shingrix.     It was unknown if the company considered the vomiting and upset stomach to be related to Shingrix.   Linked case(s) involving the same patient:  US2023105254   Additional Information: GSK Receipt Date: 02-AUG-2023 The patient self-reported this case. The patient received one dose of Shingrix yesterday. The reporter stated that he experiencing vomiting in the middle of the night and felt sick to his stomach half an hour ago. The reporter consented to follow up. The patient was given 3rd dose of Shingrix, which led to extra dose administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023105254:Same reporter (original case)
Case died of Covid 8 months after completing the Covid vaccine series.  She died in a LTCF, and details of her symptoms or supportive care are not available.
PATIENT BECAME DIZZY, SWEATING PERFUSELY, CONFUSED WITH A BP OF 154/144 AND A PULSE OF 48.  LIED PATIENT ON THE GROUND AND RAISE HIS FEET ABOVE HIS HEAD. PLACED A COLD COMPRESS ON HIS FORHEAD AND GAVE HIM SOME WATER, CALLED 911. AFTER 5 MINS THE PARAMETICS WERE ON SCENE AND HIS VITALS BECAME NORMAL AND HE WAS TRANSPORTED TO THE HOSPITAL FOR OBSERVATION.
No reaction other than left arm pain with the first 4 shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Past drug history included: Penicillin (augmentin), reaction(s): "known allergies: Penicillin (Augmentin)". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "No reaction other than left arm pain with the first 4 shots"; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "No reaction other than left arm pain with the first 4 shots"; BNT162b2 (Dose Number: 3, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 25Aug2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "No reaction other than left arm pain with the first 4 shots". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "No reaction other than left arm pain with the first 4 shots".  Additional information: It was reported that facility where the most recent COVID-19 vaccine was administered was  health clinic, administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not tested COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201167373 same patient, vaccine, event, different dose;
Soreness and body aches set in after going to bed later that night. By 3am, was very weak, thirsty and had increasing pain throughout body, and armpit. Managing pain with tylenol and pain is worse at night when laying down. As of 4/18, armpit is still sore and may be due to enlarged lymph node from vaccine. Cannot lay on it and affects range of motion due to ongoing soreness.
My Fluarix was lot # 7AJ5J.  Right Shoulder pain and movement limitations.  Shot give in right arm and I required assist of left arm to lift right arm past shoulder height and across body.  Pain and movement limitations continue three weeks post.
Clavicular Lymph node Swelling and discomfort ongoing not resolved to date.
Patient  brought in to ED via EMS status post fall, due to weakness and full body chills. History of ESRD on dialysis, MWF, missed last 2 sessions.
Patient began to feel "jittery" and cold all over as soon as she received the shot. There was no intervention patient was observed for the full 15 min wait time and stated they felt fine and wanted to leave.
Woke up with chills, entire body began to shake violently and uncontrollably for about an hour; Woke up with chills, entire body began to shake violently and uncontrollably for about an hour.; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO176) via an unspecified route of administration in the left arm on 11May2021 at 12:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, chronic pain and COVID-19 on an unknown date and unknown if ongoing. The patient had no known allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included mirtazapine (MANUFACTURER UNKNOWN), beclometasone dipropionate (QVAR), salbutamol (VENTOLIN), paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN) and Adv; all for unknown indication from unknown date and unknown if ongoing. On 12May2021 at 03:30, the patient woke up with chills, entire body began to shake violently and uncontrollably for about an hour. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events woke up with chills, entire body began to shake violently and uncontrollably for about an hour was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient was given a second dose of her primary series of Moderna one week earlier than the minimum interval of 28 days. No adverse effects were noted. Patient will be notified to come back in 28 days to receive a valid second dose.
neutropenic/low neutrophil count; bone marrow problem; UTI; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 13Mar2021 (Lot number was not reported) as 1st dose, single and on 16Apr2021 (Lot number was not reported) as 2nd dose, single for COVID-19 immunization in a pharmacy/drugstore. Medical history included myasthenia gravis from 2015 and lupus from 1995. Concomitant medications included pyridostigmine bromide (MESTINON) taken for myasthenia gravis and calcium (CALCIUM ACTIVATED) taken for an unspecified indication, with start and stop date for both medications were not reported. On 25Mar2021, 12 days after the first dose, the patient was hospitalized for neutropenic/low neutrophil count. The patient was admitted and was determined to also have UTI. Then on Apr2021, after the second shot, the patient was again hospitalized due to low neutrophil count and got UTI. The patient was given IV antibiotics for the UTI. The patient had a bone marrow exam on 07Apr2021 and showed bone marrow problem which started on an unspecified date. Other lab tests were neutrophil count: low on 25Mar2021 and neutrophil count: low  on Apr2021, SARS-CoV-2 test (COVID-19 antigen test): unknown result on 07Apr2021, thyroid function test (T3 and T4): unknown result on 07Apr2021. The outcome of the events neutropenic/low neutrophil count and UTI was not recovered while for the event bone marrow problem was unknown.  Information on the lot/batch number has been requested.
Her lung infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Her lung infection) 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 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Her lung infection) (seriousness criterion medically significant). The patient was treated with DOXYCYCLINE for Lung infection, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Her lung infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. It was reported that, patient took Moderna COVID 19 vaccine on 28-Jan-2021 and couple of days back her doctor prescribed doxycycline for her lung infection and she is taking it since few days. She wanted to know that whether doxycycline effects immune response of vaccine. Company comment This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of PNEUMONIA. The event occurred approximately two days after the administration of a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of PNEUMONIA. The event occurred approximately two days after the administration of a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historiical condition was reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of VAQTA 25/0.5 lot # L009445, expiration date: 01-JUN-2017, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA003819, 1508USA005117, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). Additional information has been requested.
20 days post Varicella vaccine at local doctor's office - woke with red raised spots on face 4-5, 1 on back of neck, 2 on stomach, 1 under arm- itchy. afebrile. Family called doctor's office then local health department phone call with interview to PHN with comfort measures. 15 spots in 24 hours from onset.
Patient reports injection site being pink, warm, very sore, and 1/2 size of a golfball.
Hives; Blotches around the neck; Round circles under both armpits; Body aches; Headaches; Chills; Fever; Pain in the arm; Sweating profusely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 06-Jan-2019 to an unknown date and LISINOPRIL from 06-Jan-2019 to an unknown date for an unknown indication.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Fever) had resolved. On 17-Mar-2021, URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits) had resolved.            Steroid cream was provided to treat the rash from  17-FEB-2021 to 17-MAR-2021.   This case was linked to MOD-2021-248017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Non-significant FU: updated contact details. On 06-Jul-2021: Significant FU: patient characteristics, concomitant medications, reaction start/end date, causality, and treatment for the event.
Stomach ache, upper back ache, nausea, headache, muscle pain, weakness
Swelling under left arm, acute genital ulceration (lipschutz ulcer)
Headache, chills, fever, body aches, nausea - Duration about 2 days. Headache fatigue 4+ days.
Site: Pain at Injection Site-Medium, Additional Details: Patient had pain in the arm from shot. She went to see MD who took an X-ray and no sign of fracture or broken bone. They did note inflammation in the area. Patient stated that there was no bruise on the outside but there was internal brusing per patient.
couldn't raise her left arm above her waist; the bones in her shoulder cuff hurt really bad down to the elbow; This spontaneous report was received from a 76 years old female consumer referring to herself. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown/ was not reported. The patient did not have any pertinent medical history and concomitant medication. The patient was sensitive to anesthetics, particularly sensitive to procaine hydrochloride (NOVOCAINE).  On an unknown date (reported as a few years ago), the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, route, lot # and expiration date were not reported) for prophylaxis and without any problems or issues. However, on 26-MAR-2019, the patient was vaccinated with the second dose (reported as a follow-up booster shot) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5ml, intramuscularly in the left deltoid (reported as directly into the top muscle of her left shoulder) (lot # and expiration date were not reported) for prophylaxis (reported as pneumonia prevention).  On the same date within one hour of received the follow-up dose, the patient could not raise her left arm above her waist (injected limb mobility decreased). On an unknown date in March 2019, the patient experienced the bones in her shoulder cuff hurt really bad down to the elbow. On an unknown date in March 2019, the patient experienced more difficult to drive her car due to events, she could not drive without lifted her arm and put it on the steering well. The patient had sought medical attention. She contacted her nurse practitioner's office since get the follow up dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), and spoken to staff members but she had been unable to speak directly with her nurse practitioner yet since her nurse practitioner had not been available for the last couple of days. The patient received treatment for the events and drawn her blood work. The outcome of events was reported as recovering. The causality assessment between events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
headache, severe Vertigo, vomiting, chills. bouts of dizziness has continued.
After 12 hours, I threw-up & felt very weak. Also, sensitive to motion. I felt normal after a nights rest, but my sense of smell & taste were gone. Plus, increased congestion. After a month, the senses are only slight. I had visited my PCP & received a negative Covid test. I can't understand why my senses have not returned.
TOOK FIRST THREE DOSES WITH FOOD; This spontaneous case report was received from a consumer (PVX2019-390) on 12-Feb-2019. The report describes a 20-year-old female consumer who "took first three doses with food". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer ate food 10 minutes after taking the first three doses. The doses were taken on 06-Feb-2019, 08-Feb-2019, and 10-Feb-2019 respectively. She took the fourth dose properly.   The action taken with Vivotif with respect to the event "took first three doses with food" was not applicable.  The clinical outcome of the event "took first three doses with food" was unknown.  Company's Comment: The causality of the event "took first three doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first three doses with food" was considered as not applicable.