chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pharmacist administered MENACTRA to a 73 yrs old female patient per the pts request with no reported adverse event; Menactra was administered the syringe needle was not secure and there was leakage between the needle and the syringe; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist and consumer non health care professional via Medical Information number: 00807265.  . This case involves a 73 years old female patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (product administered to patient of inappropriate age) (syringe issue).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number and expiry number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration and syringe leak (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Post vax, the pt developed a slight fever, itching, no appetite, and big bumps.
Treatment of COVID-19; Treatment of COVID-19; 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 19Mar2021 as dose 1, single (Lot number: EL9264), on 11Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 16Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) in 2 weeks included: TRIAMTERENE; LOSARTAN. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID; UNKNOWN RESULTS. Therapeutic measures were taken as a result of covid-19. It was reported that, the patient completed her 5 day series of Paxlovid on 01Jul and was feeling much better. Stated that, on 6Jul, she woke up feeling sick again - fever, sore throat, congested, coughing, dizzy and tested positive for COVID. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 27Jun2022 and stopped on 01Jul2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Dizziness, racing heart, headache, trouble concentrating, fatigue, vomiting, tingly feeling in fingers and toes, pressure in chest.
Swollen and painful axillary lymph nodes beginning 24 hrs after and remaining 48 hours later Bloody nose Extreme headache Excessive fatigue affecting daily activities
Several days after vaccine patient developed itching of ankle. A day or so later developed swelling, itching and redness in several areas of his body. On 5/9 he came to PF with swelling of upper lip and left hand. He had been having chest tightness the day before.
Patient came to the office for flu shot and shingrix #2. I administered both vaccines, Flu in LT, shingrix in LT. When I went to enter the shingrix in the mmunization registry the patient had already had 2 shingrix vaccines. We only had record of one in our database, I had given patient Shingrix in 02/2020 and that's all I had listed in our database. It showed in the vaccine registry that this patient also recevied a dose of shingrix in 2018 so this one I gave her today 10/19/2021 would be a third (extra ) dose of shingrix vaccine.
Diagnosed Two Pulmonary Embolism; DVT on left leg; Coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism), DEEP VEIN THROMBOSIS (DVT on left leg) and COUGH (Coughing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (DVT on left leg) (seriousness criterion medically significant) and COUGH (Coughing) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism), DEEP VEIN THROMBOSIS (DVT on left leg) and COUGH (Coughing) outcome was unknown.  After his 2nd dose of Moderna vaccine on 01-Apr-2021, the patient's coughing become worst again. His pulmonologist prescribed prednisone and his family physician prescribed him Azithromycin.  No concomitant medications were not provided.  Treatment included as Eliquis, Azithromycin, cough medicine, prednisone.  Company comment: 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.   This case was linked to  (Patient Link).
A few minutes after receiving vaccine per the guardian the patient experienced loss of consciousness, light shaking, and urinated. Patient regained consciousness quickly and the paramedics were called and she received medical attention. Paramedics assisted patient to hospital for further assessments.
One day after vaccine. Pt developed itchy and swelling injection site. No fever PE indurated with Erythema about 5 cm around injection site.
BP 136/78 in the morning; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (BP 136/78 in the morning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 15M20A and 040A219) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HYPERTENSION (BP 136/78 in the morning). The patient was treated with AMLODIPINE for Hypertension, at a dose of 7.5 mg and BENAZEPRIL for Blood pressure high, at a dose of 20 mg. At the time of the report, HYPERTENSION (BP 136/78 in the morning) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood pressure measurement: 136/78 (High) Increased. On 16-Mar-2021, Blood pressure measurement: 144/? (Inconclusive) Inconclusive. On 18-Apr-2021, Blood pressure measurement: 145/85 (High) increased. On 19-Apr-2021, Blood pressure measurement: 123/77 Inconclusive and 128/69 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she was previously on 5mg strength amlodipine in first follow up.   This case was linked to MOD-2021-080512 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up (TCR) received on 18-May-2021 does not contain any new information. On 19-May-2021: Treatment medications for the event added. On 25-May-2021: Outcome of event changed to recovering/resolving.
pt recv vax 1APR96 & MAy96 pain & swelling lt front  & thumbs both hands;
notice a redness at injection site and measured size (5cm x 6cm) on morning of 1-21-21.   slight warmness to touch. measured again on morning of  1-22-21 (6cm x 10cm).  Called pharmacist who suggested I take benedryl and call doctor.  I did both. Saw doctor at 2:30 on 1-22-21.
felt constantly dizzy, the dizziness gets bad; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt constantly dizzy, the dizziness gets bad".  Additional information: Caller reported that a friend of hers, 2 weeks after the second vaccine felt constantly dizzy, the dizziness got bad, she had all kinds of test runs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
urticaria began <1 hr p/given persisting intermittently for >6 wks;
Hart rate drop to 30 beats per minute from  62; Blood pressure drop; Nausea; Sweating; Could feel a change and felt very strange starting in my head and neck; The feeling got worse as the minutes ticked by; This is a spontaneous report from a contactable consumer.   A 61-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm, on 09Apr2021 14:15 (Batch/Lot Number: ew0158) as a single dose, for covid-19 immunisation. Medical history included an allergy to sulfa drugs. There were no concomitant medications.  On 09Aug2021, at 14:30,  the patient experienced "Nausea, sweating, blood pressure drop, hart rate drop to 30 beats per minute from 62 which is normal for me, within twelve minutes of getting the shot. After the shot within 3 or 4 minutes I could feel a change and felt very strange starting in my head and neck.. The feeling got worse as the minutes ticked by. Motioned for one of the girls to send the paramedics over. They hooked me to the blood and hart monitor. The reaction eventually faded and my heart rate and blood pressure went back to normal after about 15 minutes." There was no treatment nor hospitalization for the event. The outcome of the event was recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. And since the vaccination, the patient has not been tested for COVID-19.
Blood Pressure Rise followed by waves of extreme fatigue, lasting (ongoing) 5+ months.
Rash - 8-13-09 - Groups of raised red areas with white edges. Fever - 100 on 8-12-09 - Fever resolved 8-12-09. Fatigue/malaise on 8-12-09. Resolved/improved 8-13-09. Sx's developed on 8-12-09.
My left foot started to hurt in the early evening and continued to hurt all night long until around 5 AM.  Sometime in the middle of the night, my right toes started to hurt, too, but not as severe as my left foot.  I walked on it and massaged it, but the pain didn't go away all night.  My foot and toes were not red, white or purple, but the top of my foot felt a bit swollen and warmer to touch than the right.  I did not take any Tylenol because I did not want to camouflage the pain, but let it ride and see what happened.
tends to have low blood pressure; Dizziness; she lies down and then gets up she is dizzy; tired; she might have almost fainted as the room was spinning; This is a spontaneous report from a contactable consumer, the patient.  A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284, expiration date 0Apr2021), via an unspecified route of administration in the left arm on 18Jan2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included Reflux esophagitis, COPD and a root canal on 14Jan2021. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020. Past drug history includes sore arm after COVID-19 vaccination on 28Dec2020.  It was unknown if the patient has any allergies to medications, food, or other products. The patient's concomitant medications included oral famotidine (FAMOTIDINE) 20mg twice daily for reflux, (tiotropium bromide) SPIRIVA 2.5mcg, two puffs once daily by mouth for COPD, latanaprost (LATANAPROST)125mcg; one drop each eye at night for Glaucoma, (TIMOLOL)  5% one drop twice daily to each eye and (LORATADINE) 10mg; take once daily by mouth as needed for allergy. The patient did not receive any other vaccine within four (4) weeks prior to the vaccine. The vaccine was administered to the patient at the hospital. On 19Jan2021 the patient experienced dizziness and feeling tired. The patient further described that she had the vaccine on Monday and since yesterday, when she woke up, she has a lot of dizziness; and again this morning when she woke up. Also, when she lies down and then gets up she is dizzy. Mentions she didn't see dizziness on the list of side effects. She knows that is a side effect of COVID. She is asking is dizziness is a side effect of the vaccine wants to know if she should call her doctor. She continued and mentioned that she noticed when she was waking up on 19Jan2021 she was so dizzy that she couldn't get out of bed. Adds she thinks she might have almost fainted as the room was spinning. Mentions she tends to have low blood pressure but this is not typical. As far as side effects from the vaccine she mentions she is tired. The tiredness started after the second dose and has continued through today but not as bad. The clinical outcome of dizziness was reported as not recovered, the outcome of fatigue was recovering and the outcome of almost fainted and low blood pressure was unknown.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Seasonal influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Seasonal Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. In prior years from vaccines (unknown manufacturers) the reporter experiencing sickness. The reporter was unable to provide complete details of events.
Has swelling & erythema 3cm at injection site. Has difficulty raising arm due to pain. Rx. BENADRYL & Ibuprofen.
About two or three days after the vaccine I felt a lump under my chin almost to my neck. So I made a appointment to see my primary care doctor and he advised that it could be a reaction from the vaccine. The doctor said that we would keep a eye on it for now and come back in May for a follow up. If I come back and the bump is still there he will then send me out to have biopsy. I've notice that it will feel big at times like it has increased in size and other times it will feel like smaller in size. There are some days when I feel slight pain more of a discomfort feeling.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 48 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Pulmonary Sarcoidosis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "previous breast cancer" (unspecified if ongoing), notes: previous breast cancer; "previous spinal cord tumor" (unspecified if ongoing), notes: previous spinal cord tumor; "Sulfa allergy" (unspecified if ongoing), notes: Sulfa allergy; "penicillin allergy" (unspecified if ongoing), notes: penicillin allergy. Concomitant medication(s) included: METHOTREXATE, start date: 26Dec2021, stop date: 20May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. It was reported that patient also received Paxlovid from 10May2022 to 14May2022 for the indication of treatment of Covid-19.
3 weeks after vaccine, developed bilateral lower extremity pain with right lower extremity swelling. Seen by PCP. No new treatment. Symptoms lasted 3 weeks.
Caller reported that his son had the two doses of the Moderna covid19 vaccine and had covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller reported that his son had the two doses of the Moderna covid19 vaccine and had covid) in a male 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller reported that his son had the two doses of the Moderna covid19 vaccine and had covid). At the time of the report, COVID-19 (Caller reported that his son had the two doses of the Moderna covid19 vaccine and had covid) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Redness and a nodule on left thigh at site of DTAP. A large wheal, 1/2 dollar-sized appeared later the same day and continued X 3 days.
This case was reported by a physician and described the occurrence of transverse myelitis in a male pt who received Engerix-B. On an unspecified date, the pt received Engerix-B. Three days later, the pt experienced transverse myelitis. As of 2/10/04, the event remained unresolved. This case was assessed as medically serious by mfr.
THERE WAS NO ADVERSE EFFECT UNTIL YESTERDAY (01/12/21). I NOTICED MY LEFT ARM SPECIFICALLY ON THE INJECTION SITE WAS GETTING SWOLLEN, HOT AND ITCHY. THE AREA FELT THICK, BULDGED AND SORE. IT HAS GOTTEN WORSE THIS MORNING (01/13/21).
Was administered the PREVNAR 13 vaccine at pharmacy. During the night awakened by severe pain in body wide muscle and joints, and had extreme difficulty in walking. Eased in the following days, but as of 08/20/2018 continues intermittent pain in cal., gluteus, and shoulder muscles and hip, hand and knee joints.
Patient presents to clinic complaint of left sided soreness under arm and left breast and nipple soreness and swelling since 1/3/08. Observed left nipple soreness. Patient guarding during palpation of breast and under arm. Denies nipple discharge.
lower eye area has been swollen; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202, expiry date: unknown), via an unspecified route of administration in the right arm, on 23Feb2021 15:30, as single dose, for covid-19 immunization, at a hospital. The patient's medical history and concomitant medications were not reported.  The patient had no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, expiry date: unknown) received at 33 years of age, via an unspecified route of administration in the left arm, on 01Feb2021 13:00, as single dose, for COVID-19 immunization. It was reported that the patient's lower eye has been swollen since 27Feb2021. This event resulted to physician office and emergency room visits. Treatment included warm compress twice a day. The outcome of the event was not recovered.
headache, nasal congestion, otalgia, sore throat, productive cough, shortness of breath with exertion, body aches, nausea vomiting diarrhea, went to outside ER, diagnosed with bronchitis and prescribed antibiotics, steroids, inhaler, CT with "abnormal nodule in her lungs"
Had minor diarrhea the next morning; Throughout 4/6 I felt better, but lightheaded and weak.; Throughout 4/6 I felt better, but lightheaded and weak.; By 5:30pm, I started to have stomach cramps, chills, and more severe body aches (to the point it was painful to move).; By 5:30pm, I started to have stomach cramps, chills, and more severe body aches (to the point it was painful to move).; By 5:30pm, I started to have stomach cramps, chills, and more severe body aches (to the point it was painful to move).; On 4/5 in the morning, I noticed a pain in my back and chalked it up to sleeping wrong.; I was severely nauseous in the middle of thenight; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the arm right on 01Apr2021 at 14:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included vitamins (MANUFACTURER UNKNOWN)  from an unknown date and for unknown indication. The patient had no known allergies. 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 COVID-19 vaccination. On 05Apr2021 at 08:00 in the morning, the patient noticed pain in back and chalked it up to sleeping wrong. On 05Apr2021 at 17:30, the patient started to have stomach cramps, chills and more severe body aches (to the point it was painful to move). The patient was severely nauseous in the middle of the night. On 06Apr2021 in the morning, the patient had minor diarrhea and throughout 06Apr2021, she felt better, but was lightheaded and weak. By 07Apr2021, the patient was able to go back to work, but stomach cramping flared up occasionally and was able to eat. The patient found it odd that she would have a reaction after the first shot and 4 days after the injection. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event pain in back, chills, diarrhea, severe body aches and nauseous were recovered on 06Apr2021, while that of lightheaded and weak were recovered on 07Apr2021and that of the event stomach cramps was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
AN ERROR WAS MADE, THE PATIENT WAS 3 MONTHS AWAY FROM TURNING 6 AND WAS GIVEN A MODERNA 6-11 YEARS DOSE. NO ADVERSE EFFECTS, NO TREATMENT GIVEN