chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe bronchitis, viral/x-ray: spots on the lower right lung; made her woozy; feels fatigued all the time; fell extremely ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time) 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 Antibiotic resistant Staphylococcus aureus infection. Concurrent medical conditions included Bronchitis and Bronchial scarring.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced MALAISE (fell extremely ill). On an unknown date, the patient experienced BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time). The patient was treated with HYDROCODONE for Cough, at an unspecified dose and frequency and LEVOFLOXACIN at a dose of 500 mg. At the time of the report, MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2021, Chest X-ray: abnormal (abnormal) reveled spots on the lower right lung. On 20-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (made her woozy) to be not related. No further causality assessments were provided for MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung) and FATIGUE (feels fatigued all the time).    treatment products were Z pack and cough pearls. no concomitsnt products were reported.
Macular degeneration; reaction to COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (Macular degeneration) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced MACULAR DEGENERATION (Macular degeneration) (seriousness criteria hospitalization and medically significant) and IMMUNISATION REACTION (reaction to COVID-19 vaccine). At the time of the report, MACULAR DEGENERATION (Macular degeneration) and IMMUNISATION REACTION (reaction to COVID-19 vaccine) outcome was unknown.            No concomitant medication information was reported.  The patient was missed a dose of humira therapy due to being hospitalized. She had Macular degeneration and reaction to COVID-19 vaccine.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Company Comment: This is a spontaneous case concerning an elderly patient of unknown gender with no relevant medical history, who was hospitalized due to the unexpected, serious (medically significant) event of Macular degeneration, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an elderly patient of unknown gender with no relevant medical history, who was hospitalized due to the unexpected, serious (medically significant) event of Macular degeneration, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Red, raised, sore lumps from the flu shot location to under arm down toward side of breast. This was her first flu shot ever.
This is an initial spontaneous report from a contactable Nurse. A Pfizer vaccine sales representative reported on behalf of a nurse who reported for her daughter. This 3 year old, female consumer received a single shot of PREVNAR 13 on an unknown date in Mar2011 at a dose of 0.5ml once intramuscularly. Previously the consumer included PREVNAR 7 since an unknown date at an unknown dose and frequency. The relevant medical history and concomitant medication included was unknown. The patient experienced pneumonia on an unknown date in Mar2011 after receiving PREVNAR 13 at 0.5ml once. The relevant laboratory tests included was unknown. In response to the reported event PREVNAR 13 was stopped on an unknown date in Mar2011. Therapeutic measures taken for the reported event included unspecified antibiotics. The consumer had recovered from the reported event on an unknown date at the time of report.
This person was given the incorrect COVID-19 vaccination for his second dose. He received his 1st dose of Moderna on 01/07/2021.
local reaction vs cellulitis at site of Varicella vaccine placed on Keflex x 10 days
sore; tired; getting this stabbing shock pain on the left side of my head; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) via an unspecified route of administration on 22Jan2021 07:45 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Patient age at vaccination was 24 years. The patient has no known allergies. Medical history was none. The patient's concomitant medications were not reported. The patient reported first days she was just sore, tired then by the 3rd day began getting this stabbing shock pain on the left side of her head that last about 3-5 seconds each time through out the whole day. It is not like a regular headache pain it is a sudden stabbing shocking pain only on the left side of the head. Over the counter migrane medicine does not take that pain away when it does come. Onset date of the events was reported as 25Jan2021 01:00 PM. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Painful swollen lymph nodes under left arm and close to breast. I keep my left arm in sling like position held close to my body to help alleviate pain.  Left back shoulder aches. Sometimes painful when I breathe and feel pain under rib cage on left No fever
T+0:00, second COVID shot received. T+2:00, My arm is starting to inflame and firm up. It?s painful, but bearable. T+5:00,  Mild headache, but again bearable T+6:00, Chills and fever set in, headache intensifies, it was around this time I took 400 miligrams of ibuprofen to combat the now throbbing headache.  I spent eight hours in bed and I felt fine, but standing up and moving about made my headache come back.  T+14:00,  I took 400mg of Ibuprofen, drank some water, and decided to try to go to sleep. T+16:30, I woke up with chills, but I managed to go back to sleep. T+20:45, I woke up again, same symptoms, went back to sleep. T+25:15, I woke up and took another 400mg dose of Ibuprofen.  T+36:00, This is when I noticed I stopped feeling chills T+48:00, headache symptoms are almost gone.
Pt vaccinated with DTP experienced high pitched cry x several hrs, fever 104 with tylenol.
Local reaction to shot, altered mental state, irritability, involuntary movements, concentrating & focus difficulties, personality changes, extreme hyperactivity, very oppositional, mouth noises.  All of the above was witnessed by both parents and independently confirmed by special needs teacher.
pt recvd vax 24NOV03 & exp chills, fever, muscle aches, bronchitis; sx persisted as of today 20DEC93 but less severe; however now has laryngitis;
Patient passed out briefly after receiving Typhoid and "Anthrax vaccinations.  Transported via wheelchair to Acute Care for evaluation and treatment.
About a week after the first dose I woke up with a terrible headache and nausea. The symptoms persisted for about 3 days, although the headache wasn't so bad anymore, BP was elevated on the 4th day. After the 5th day I started to feel a little better but head still hurts a little.
About 15 minutes after getting the Pfizer Covid-19 vaccine, patient informs pharmacist of itchiness in her abdomen, back and arms. She also notices swelling on upper lip.  No complaints of difficulty breathing or wheezing. Pharmacist gives patient an injection of diphenhydramine 50mg IM and provides an ice pack for patient to put on injection site area.  After about 15 minutes, patient feels the swelling in lip begin to subside, as well as lessened itchiness on her body.  Patient counseled to seek further medical attention if symptoms worsen.
Patient started to faint right away after Tdap and HepB vaccine given, both eyes roll up for 10 seconds, muscle stiffening and loss of consciousness for 20 seconds, skin pale, sweating, patient returned consciousness and asked, "what happened? feeling weird".  Three minutes later patient started to have low abdominal pain and had a feeling of bowel movement. Then patient went to bathroom with assistant had a huge bowel movement. Patient returned to exam room and lay down to exam bed, still have skin pale and sweating.  After 15 minutes observation of patient lying down on exam bed, she recovered.
severe dizziness; fog fines; This is a spontaneous report from a contactable consumer (patient) via sponsored program. A 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203 and expiration date: not reported) via an unspecified route of administration, administered in arm right on 27Feb2021 12:30 as second dose, single for COVID-19 immunization at Public Health Clinic (at the age of 43years). The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and BIRTH CONTROL (both as other medications in two weeks). Previously, received PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot Number: EL9264 and expiration date: not reported) via an unspecified route of administration, administered in arm right on 06-FEB-2021 13:45 as first dose, single dose for COVID-19 immunization at Public Health Clinic (at the age of 43years). No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. On 28Feb2021 02:15, the patient experienced severe dizziness and fog fines. The patient was on day 3 post second covid vaccine and continued to have severe dizziness and fog fines. Both adverse events resulted in Doctor or other healthcare professional office/clinic visit and no treatment was given for these. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
swelling & puffiness--hands & feet on dorsal surfaces; not pitting; mild erythema of palms & soles; no blisters, no mucous membrane involvement; no hx of fever, irritability; pt feeding well, no edema elsewhere, no change in urinary pattern
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Got positive after about 2 weeks of getting a negative result; (23May2022) Positive, notes: Got positive after about 2 weeks of getting a negative result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccination site was red, warm to touch, sore and swollen for 5 days. Site returned to normal for 7 days then began itching. The next day the vaccination site was once again red, warm to touch, raised rash and large welt. It continues to have welt and large red spot.
Sore at the site of injection; Redness at the injection site; Warm touch at the injection site; A spontaneous report (United States) was received from consumer concerning a 41-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore at the injection site/Pain, Redness at the injection site/Redness and warm touch at the injection site/ Warmth. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.   On 10 Jan  2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:025L20A)  via  unknown route  at unknown location  for prophylaxis of COVID-19 infection.  Patient experienced soreness, redness, and warm to ouch at the injection site on 11 Jan 2021 after taking the first dose of vaccine. Tylenol and Advil were used as treatment medication by the patient. Consent was given for the follow up by the patient. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events injection site pain, Redness at the injection site and injection site warmth was considered unknown.
Was diagnosed with Shingles. I had a Stiff Neck, Extremely Swollen Lymph Nodes, Rash forming on Right side of forehead and right eyelid, very sluggish, and a lot of pain. Each say the rash was getting larger and causing more swelling.
This spontaneous prospective pregnancy report as received from a 27 year old female patient with none pertinent medical history drug reactions or allergies. On 23-SEP-2014 the patient was vaccinated with GARDASIL (in the gluteus maximus, dose, units, route of administration, lot number were not reported) instead of RHOGAM (anti-Rh gamma globulin). None concomitant medications was reported. Then, the patient was administered a second injection which was the correct dose of RHOGAM (anti-Rh gamma globulin) without incident. The patient became pregnant with LMP (last menstrual period) of February 2014 (reported as 7 months). Initial exposure to GARDASIL was at 28 weeks. The pregnancy outcome was not reported. The patient also stated that in 2009 (reported as when she was about 22 years old) the received one dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) but the series of three was not completed. The patient did not experience any adverse reactions GARDASIL. There was no treatment given for the event. None lab diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------  HYPOTENSION 7/17/2021 CANCER METASTATIC TO UNSPECIFIED LN  HYPOTENSION 7/17/2021 COMPLETE SMALL BOWEL OBSTRUCTION  HYPOTENSION 7/17/2021 ABDOMINAL PAIN  HYPOTENSION 7/17/2021 CANCER METASTATIC TO UNSPECIFIED LN
called to observation area 1120 for report of mottled skin.  bp 150/80, p 90.  noticed 5 min after vaccine new, firm, raised area right wrist  1/2 x 1/4 x 1/4.  skin arms, chest, face flushed.  by 1130 skin redness of chest decreased, by 1135 color at baseline - raised area 1/4x 1/4x/1/8.  1140 return to work.  had talked w/ provider prior to vaccine and ok to give.
Information has been received from an unspecified reporter via a company representative referring to a 1 day old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 18-AUG-2016, the newborn was vaccinated with a dose of expired ROTATEQ (dose unknown, lot#: K022990, expiration date unknown) orally (product use issue). Additional information is not expected as there was no consent to request follow up.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A physician reported that a male patient, his grandson, received the first of PREVNAR 7, on an unspecified date via unknown route of administration. Additional suspect medication, HIB vaccine, was received via unknown route of administration on the same unknown date. Relevant medical history and concomitant medications were not reported. The patient experienced mild fever. The seriousness criterion for this event was none. The outcome of the event at the time of the report was unknown. Follow-up (27FEB2011): Follow-up attempts completed. No further information expected.
Parent of client receiving vaccines said client became nauseous on 5/13/10 (no vomiting) and extremely fatigued on 5/13/10 ("enough to miss school on 5/13/10"). Parent said s/s subsided by 5/14/10 morning ("he felt good enough to go to work").
-Red line on left arm -Lump at injection site -Developed hives all over body and inside mouth which lasted 3 days -Patient took Aleve   and reported no symptoms on 11/19/2020
Clt. was given 0.5 dose of Novartis H1N1 vaccine instead of 0.5 dose of Sanofi H1N1 vaccine. Correct dose, but Novartis not licensed for his age.
His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; This is a spontaneous report from a contactable consumer (patient's wife).  A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261 with Expiration Date 31May2021), via intramuscular, on 22Jan2021 (at 09:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included ongoing restless legs syndrome and ongoing acid reflux. Relevant concomitant medications included omeprazole ongoing from an unknown date for acid reflux and gabapentin ongoing from an unknown date for restless legs syndrome. Her husband had the injection on Friday 22Jan2021. The next morning his left foot was swollen up really bad, red and tender and he could not walk on it. He has had problems like that before and he had it checked and was told it is not gout. It did not go away and she called the nurse on Sunday morning, and the nurse did not think it was a reaction and told her that a lot of times it is swelling in the lymph nodes. He was advised to go and see a podiatrist on Monday. He saw the podiatrist yesterday morning and the podiatrist gave him a one injection that contained Lidocaine, dexamethasone, and depomederol. After injection, the swelling right down and his foot was ok. The patient went to go get the Moderna injection and she asked those giving the injection if it was ok for her husband to get that injection from the podiatrist. She was told that people are not supposed to take paracetamol (TYLENOL) or ibuprofen. She was told that they did not think it was a good idea for her husband to get that injection from the podiatrist and it may have wiped out the benefit of the Pfizer COVID VACCINE. His foot was 95% recovered, he could walk on it and the swelling was down. The patient was recovering from the events.
Patient was administered Fluzone Quadrivalent Instead Of Fluzone High Dose Quadrivalent/no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via agency (Reference number- 00315344) and transmitted to Sanofi on 14-Oct-2020.  This case involves a 68 year old male patient was administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [lot number and expiry date not reported] via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] [lot number, expiry date and other dosing details were not applicable] (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due wrong product administered. (latency: on the same day of vaccination).  It was reported that, reporter wanted to known if the patient can be revaccinated with another dose of the FLUZONE QUADRIVALENT or given the full dose of FLUZONE HIGH-DOSE QUADRIVALENT.   At the time of report, 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 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.  There will be no information available on the batch number for this case.
after administrating second shot customer customer become extremely sweaty and start to shake . it last about 1 minute. he wake up from this right away and start asking whats happend to him. he said he was really anxious about shots and was very nervous. he described it as anxiety attact. i call 911 and emt came in 5 minutes. customer was siting in immunization room and i provide him with bottle of cold water. emt service checked the patient. all his vitals were normal bp, heart rate, they ask him if he wanted to go to hospital and patient said no. he moved to sit my pharmacy department another 20 minutes then he went home