chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient experienced Asthma Attack; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (patient experienced Asthma Attack) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Arrhythmia, COVID-19, Gastroesophageal reflux disease, Iron deficiency anemia and Supraventricular tachycardia. Concurrent medical conditions included Anxiety, Arthritis, Asthma (uncomplicated), Hyperlipidemia, Hypertension and Hepatocellular carcinoma. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), ALPRAZOLAM, AMIODARONE, AMITRIPTYLINE, AMLODIPINE, APIXABAN, BUDESONIDE;FORMOTEROL, CALCIUM CARBONATE, CELECOXIB, CHOLECALCIFEROL, CYANOCOBALAMIN, CYANOCOBALAMIN (VITAMIN B-12), DICLOFENAC SODIUM, EPINEPHRINE, ERGOCALCIFEROL, ESTRADIOL, EZETIMIBE, BENRALIZUMAB (FASENRA PEN), FLUTICASONE PROPIONATE, FUROSEMIDE, GABAPENTIN, IPRATROPIUM, MELATONIN, METOPROLOL TARTRATE, MONTELUKAST, DRONEDARONE HYDROCHLORIDE (MULTAQ), MUPIROCIN, INOSITOL NIACINATE, NIACIN, OMEGA-3-ACID ETHYL ESTER (OMEGA 3 ACID ETHYL ESTERS), OMEPRAZOLE, POTASSIUM CHLORIDE, TELMISARTAN, VITAMIN C [ASCORBIC ACID] and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHMA (patient experienced Asthma Attack). The patient was treated with OMALIZUMAB (XOLAIR) for Asthma, at an unspecified dose and frequency. At the time of the report, ASTHMA (patient experienced Asthma Attack) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication included as gluc sulchondro, Hydrocodone acetaminophen.
I still need my second shot; A little tired; headache; Possible partial dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Possible partial dose of vaccination), PRODUCT DOSE OMISSION IN ERROR (I still need my second shot), FATIGUE (A little tired) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Possible partial dose of vaccination), FATIGUE (A little tired) and HEADACHE (headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (I still need my second shot). At the time of the report, INCORRECT DOSE ADMINISTERED (Possible partial dose of vaccination) and PRODUCT DOSE OMISSION IN ERROR (I still need my second shot) had resolved and FATIGUE (A little tired) and HEADACHE (headache) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Added Reporter contact information On 12-Aug-2021: Added New Reporter information and Patient demographic and narrative was update accordingly
Patient was given the monovalent Pfizer vaccine rather than the intended bivalent Pfizer vaccine booster.  Tender muscle, visible lymph node is swollen under armpit.
1421: 57 yo female approximately 20 minutes after vaccine experienced SOB. PMHx: Asthma Medication: Albuterol Inhaler Patient took two puffs of Albuterol inhaler felt immediate relief.  No SOB, No Cough, No chest tightness SaO2 Sat: 99% on RA Patient cleared by Physician on duty after a 45 minute observation and return to baseline
Patient has a localized light purple area-about the size of a quarter at site of injection. Patient stated she had a headache on 12/12/14. Shot was administered (ZOSTAVAX) on 12/12/14.
Heavy period off schedule from pill pack since first vaccine (19Apr).; This is a spontaneous report from a contactable consumer (patient herself).  A 19-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0162, Expiry date was not reported), via an unspecified route, administered in left arm on 19Apr2021 at 14:00 (Age at vaccination 19-yearsold) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility type vaccine was hospital. Medical history was none. The patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cefalexin monohydrate (LEXIPRON), ethinylestradiol, levonorgestrel (VIENVA) taken for an unspecified indication, start and stop date were not reported. The patient experienced heavy period off schedule from pill pack since first vaccine on 19Apr2021. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received vyvanse, lexipro and vineva other medications within 2 weeks of vaccination. 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 received pain medication, saline hydration drip treatment for the events. Therapeutic measures were taken for the results. The clinical outcome for the events was recovering.   Follow-up attempts are completed. No further information is expected.
PATIENT PRESENTS RED ARM AT THE SITE OF INJECTION, PAINFUL WHEN TOUCHING. PATIENT HAS BEEN TAKING TYLENOL FOR PAIN.
went to bed early; woke up with severe diarrhea; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (went to bed early), DIARRHOEA (woke up with severe diarrhea) and NAUSEA (nauseous) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20a and 023L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-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(s). On 02-Jan-2021, the patient experienced NAUSEA (nauseous). On an unknown date, the patient experienced SLEEP DISORDER (went to bed early) and DIARRHOEA (woke up with severe diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Diarrhea, at a dose of UNK dosage form. At the time of the report, SLEEP DISORDER (went to bed early), DIARRHOEA (woke up with severe diarrhea) and NAUSEA (nauseous) outcome was unknown.            No concomitant medications were reported.  Treatment medication included 2 doses of Immodium.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
The only thing I have done differently is taken 3 Covid vaccines from Pfizer. I think the vaccine stopped the itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "I have suffered severe itching with every bite" (unspecified if ongoing), notes: I live in (State withheld) where mosquitoes are terrible and I have suffered severe itching with every bite; "I have suffered severe itching with every bite" (unspecified if ongoing), notes: I live in (State withheld) where mosquitoes are terrible and I have suffered severe itching with every bite. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The only thing I have done differently is taken 3 Covid vaccines from Pfizer. I think the vaccine stopped the itching".  Additional information: It was reported that the patient has something strange that has happened to me for the first time in my life! My mosquito bites do not itch anymore. I live in (State withheld) where mosquitoes are terrible and I have suffered severe itching with every bite. I! am 65 years old and my bites do not itch The only thing I have done differently is taken 3 Covid vaccines from Pfizer. I think the vaccine stopped the itching!  No Follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
severe headache/Slamming headache; tinnitus/Tinnitus has gotten louder; Pressure in her head when patient bend over; Head throbbing; States her head is throbbing and she's had tinnitus before in the background, but now it got louder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 09:20 (Lot number: EN6202) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "stage 2 kidney disease", start date: 2018 (ongoing), notes: stage 2 kidney disease; "interstitial cystitis" (ongoing), notes: Caller states she has a urologist and nephrologist. Diagnosed 3-4 years ago; "Blood pressure high" (ongoing), notes: Diagnosed at least 10 years ago.; "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 06Mar2021, when the patient was 62 years old, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 28Mar2021, outcome "not recovered", described as "severe headache/Slamming headache"; TINNITUS (non-serious) with onset 28Mar2021, outcome "not recovered", described as "tinnitus/Tinnitus has gotten louder"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Pressure in her head when patient bend over"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Head throbbing"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "States her head is throbbing and she's had tinnitus before in the background, but now it got louder". Therapeutic measures were not taken as a result of headache.  Calling about Pfizer vaccine. The patient wakes up every day with a slamming headache and tinnitus from hell. Caller is asking if this is normal and are other people experiencing this, When she bends over she feels pressure in her head. States her head is throbbing and she has had tinnitus before in the background, but now it got louder. Caller states she has interstitial cystitis with an inner stem implant that zaps contractions for frequency. She checked the battery on the implant because she thought it was out of battery. She states she has never had anything effect it. The contractions were every 30 minutes, she was up going to the bathroom every 30 minutes. The implant that she has to stop that was useless against that. It has subsided. Started right after the vaccine, she had a long drive home and that's how she noticed it. Resolved after five days. Last night was her first normal night again. When she got vaccine she was told to alternate between Ibuprofen and Aspirin. She states she cannot do anything about the tinnitus. She also states she does not take anything for the headache.   No follow-up attempts are possible. No further information is expected.
tested positive for Covid virus; tested positive for Covid virus; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in the left arm in Mar2021 (at 09:15AM) (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunization. Medical history included asthma, and allergies to grass, mold, pollen, and cat. Concomitant medications included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; clobetasol (CLOBETASOL) taken for an unspecified indication, start and stop date were not reported; ketoconazole (KETOCONAZOLE) taken for an unspecified indication, start and stop date were not reported; aloe vera, malus domestica (VINEGAR APPLE CIDER PLUS) taken for an unspecified indication, start and stop date were not reported. The patient tested positive for COVID virus on 19Apr2021 at 17:00. Treatment for the event included OTC medication. The patient had no Covid prior vaccination and had tested post vaccination. The patient underwent lab tests and procedures which included nasal swab (PCR): negative on 13Apr2021 and positive on 19Apr2021. The outcome of the events resolving.
Patient had right arm pain immediately after vaccine was given on 4/6/18 (i.e. pain in left shoulder deltoid region later the same day). The pain resolved on 4/12/18, but he developed tonsillar pain that same day. He developed joint pains in his hands, fatigue, generalized muscle weakness, and elevated temperature to 100° F. He was seen in the Family Medicine Clinic on 4/16/18, was diagnosed with acute pharyngitis, and started on a 10-day course of AUGMENTIN. Over the next few days, he developed right-sided pleuritic chest pain and chest congestion for which he went to the Clinic emergency room on 4/22/18. He was diagnosed with acute bronchitis and pleuritic chest pain, and was admitted to the hospital service. He was given IV ceftriaxone and discharged home on 4/23/18. He presented back to the same ER that evening with worsening right-sided pleuritic chest pain, but did not require readmission. He was discharge on cefuroxime and doxycycline. Over the next couple of days, he developed an erythematous maculopapular rash over his chest, abdomen, back, and extremities. He held cefuroxime, but continued doxycycline. I saw him on 4/26/18 for hospital/ER follow-up where he noted that the pleuritic chest pain on the right had resolved, but was now on the left in his mid-chest with deep inspiration. Also, I visualized the diffuse rash which had been stable. We continued doxycycline and added azithromycin. His chest x-ray revealed slight bilateral pleural effusions, greater on the right and right-sided bronchial cuffing suggestive of acute bronchitis. Plan is to continue doxycycline and azithromycin for now with close follow-up.
Crying w/out stop x 3 days. Non-consolable. Used acetaminophen.
headache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration (at the age of 37-years-old) on 16Jun2021 as second dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she received the second dose of the Pfizer COVID 19 vaccine yesterday and she was having a headache today (17Jun2021). She would like to know if it is okay to take headache medications in this case. Response: Spoke from attached document regarding the use of OTC NSAIDs or Antipyretic medication use after receiving the vaccine and having side effects. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
My arm became red, itchy, hot to the touch, and was very swollen.  The swelling made my arm at least 25% larger.  My elbow also was painful, which has not gone away since the swelling went away.  My elbow pain continues.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-JUL-2013 the patient was vaccinated with the first dose of GARDASIL, injection (route, dose, lot number and expiration date). On 03-JAN-2014 the patient was vaccinated with the second dose of GARDASIL, injection (route, dose, lot number and expiration date). No adverse effects was reported. The outcome of event was not reported. Additional information has been requested.
Called and spoke with patient concerning vaccine on 10/15/2021. Per conversation with patient she stated i dont know what you are talking about and hung up. She did tell this nurse her name.
No additional adverse events reported; Administration of expired dose of ROTATEQ.; This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were unknown.      On 07-SEP-2021, the patient received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1684166, expiration date 27-JUN-2021, dose, 2 ml/one time; strength was unknown) orally for prophylaxis (expired product administered). No additional adverse events reported. No product quality complaints reported.
Patient experienced a vasovagal reaction after vaccination. The patient reported feeling hot, sweaty, dizzy, and nauseous about 5 minutes after vaccination. The patient was brought to the floor and provided with water and ice packs to use as cold compresses. The patient never fully lost consciousness and recovered from the event fully after about 10 minutes. He was able to leave the clinic after observation and there was no need for emergency medical services.  Afterward, the patient reported a history of vasovagal reactions post vaccination.
Report 20000302771 describes hives in a male of unspecified age who received Engerix-B. Allergies, medical history, and concomitant medications are unspecified. On an unspecified date, the vaccinee received his first dose of Engerix-B. Subsequently, he experienced hives. As of 10/03/2000, the outcome of event is resolved.
Immediatly following shot, the injection site hurt and increased in pain. Left arm verry sore. Went to bed around 9pm and woke up at 2am sicker than I have been in years (than when I had COVID Jan of 2020). I suffered  debilitating migraine, horrible left arm pain (barely able to move my left arm), feever, ache (all over body), nausia and heartburn (I NEVER get heatburn). Went through the entire next day sick and night sick. I woke up the 2nd morning feeling much better.  I had lingering symptoms - left arm pain until morning of September 15th.  I had daily heartburn for an entire week (again - I never have heartburn).  I am still experiencing boughts of nausia. My migraines have been much worse since the vaccine - I am suffereing from one now. The Botox knocked my migraines down to a couple a week - I'm having them almost every other day since the vacccine.
Administered half dose (0.25ml red cap vial)  for the 2nd primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered half dose (0.25ml red cap vial)  for the 2nd primary dose) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On 05-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced ACCIDENTAL UNDERDOSE (Administered half dose (0.25ml red cap vial)  for the 2nd primary dose). At the time of the report, ACCIDENTAL UNDERDOSE (Administered half dose (0.25ml red cap vial)  for the 2nd primary dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Patient administered half dose (0.25ml red cap vial) instead of full dose by mistake.  Treatment information was not provided.
Cellulitis of both thighs in annular pattern at injection site. Presented on 8-6-07 and treated with antibiotic
When I got the vaccine at 9am in the morning. At 2 o'clock in the afternoon my body was shaking. dizziness, and vomiting even through the nose. They didn't give me any information about why I was like that. Just a year I'm doing my papers they want me to get the second dose. And I don't want to because the first one almost killed me.
Patient stated her arm "was not the same since flu shot was given". Patient was diagnosed with cellulitis on 11/12/18. Patient's arm was red, swollen, and complained of itchiness.
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/25/2021 ADJUSTMENT DISORDER W MIXED ANXIETY AND DEPRESSED MOOD I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 9/12/2021 ADJUSTMENT DISORDER W MIXED ANXIETY AND DEPRESSED MOOD J96.00 ACUTE RESPIRATORY FAILURE 9/12/2021 ADJUSTMENT DISORDER W MIXED ANXIETY AND DEPRESSED MOOD J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/2/2021 ADJUSTMENT DISORDER W MIXED ANXIETY AND DEPRESSED MOOD J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/28/2021 ADJUSTMENT DISORDER W MIXED ANXIETY AND DEPRESSED MOOD I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/25/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 9/12/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 9/12/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/2/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/28/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE
I woke up with pain in the neck/throat on the morning of the 30th after receiving the Moderna vaccine. It felt like my throat was closing and it was extremely difficult to swallow.  It felt like I had been punched in the throat. This pain and difficulty swallowing lasted throughout that day on the 30th and was completely gone when I woke up on the 31st. No other symptoms.