chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had shortness of breath; swelling on my left foot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I had shortness of breath) and PERIPHERAL SWELLING (swelling on my left foot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I had shortness of breath) and PERIPHERAL SWELLING (swelling on my left foot). At the time of the report, DYSPNOEA (I had shortness of breath) and PERIPHERAL SWELLING (swelling on my left foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Wife and I had shots in arm as precaution. I had no initial Rx - wife had nausea and vomit next day. I (husband) became very weak (100 degree temp) for following week) stayed in bed 5 days. Wife.
Within an hour and a half, when I took the bandage off there was swelling and It was hot to touch. Later that day it was red and hot. The next day I wasn't paying much attention to it other than it was sore, and it didn't restrict my movement in any way. The day after was rather sizable, about the size of an egg. Producing heat, red, and rash looking. Over the next few days, it was 4 inches across my arm. It was growing and itching. I called the doctor and did cold packs and Cortaid a few times a day. It wasn't improving and I went to see the doctor on Friday, and she acknowledged that it was pretty big. She gave me a prescription in case it was a staff infection and another steroid. I already wasn't feeling good when I went to see her and she told me to follow up if anything worsens. Saturday night, I took the antibiotic because I had a tremble episode in the middle of the night. Started the antibiotic and used the steroid cream. It's still on my arm but paler, still an occasional itch, still temporary muscle pain in my arm. Occasional headaches, fatigue, did nothing but sit for several days. Woke up with a headache this morning. Run pretty cool temperature at 96 degrees for my temp but it went up to 98.6 at the highest. That's where I'm currently at. The egg in my arm has gotten flatter and hard. Injection site can be sore and still putting on steroids and taking antibiotics. Had diarrhea one night I'm assuming from the antibiotic but I'm unsure. None of the other COVID shots had bothered me at all.
pt recv vax & devel a blistered rash & upset stomach a couple of day p/inj;
I have breast implants. 2 days after second dose I felt SEVERE  discomfort in left breast. Sensation felt like an electrical pulse. 10 days later I had the same sensation in my right breast and arms. The next day the sensation traveled to my stomach and collar bone. Within 3 weeks the symptoms subsided but still have not gone away . On 5/17/21 I had a mammogram and the result showed ruptured breast implants. The implants were replaced on 7/21/21
pt stated that the day after her vax she had 100 degree fever and was not feeling well.  The second day she did not have a temp.  She was feeling bad about every other day.  About a week later she is still feeling bad, coughing and has lost her taste.  She contacted her infectious disease doctor.  He stopped her taking the Sevixtro medicine. He ordered her to take a sputum sample to have tested which she has not collected yet. Pt talked to her supervisor at work and they asked to get a covid test so she went to an Urgent Care where she tested negative.  Pt has appt w/ her infectious disease doctor on 3/9/2021.
3 weeks after HPV shot pt started having severe headaches and has had them daily for past 2 years. Has seen a neurologist sent to hospital but no dx has been made. Now pt diagnosed with depression due to chronic pain. Also has experienced weight loss.
the customer's daughter has her 1st dose of GARDASIL 9 as a teenager and is now "in her 30´s" and has just received the second dose of GARDASIL 9; No additional AE reported. N o PQC; This spontaneous report was received from a pharmacist via company representative, referring to a currently 30-year-old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the teenager customer's daughter was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported).  On an unknown date (reported as "now in her 30´s"), the patient had just received the second dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). No additional adverse event reported.
i am a longtime runner and was comfortably running 35-40 miles a week. i got the Pfizer covid shot and almost immediately i was unable to run, and sometimes barely even walk. i developed very bad Achilles tendinitis in both of my legs. both were tight and painful. Now, i cannot run at all. if i am on my feet for three hours or more my heels are throbbing and the pain is terrible. i have had tendinitis before and i know how to heal it, but everything i try now does not work and the problem is a bad as it was originally. it has now been about ten weeks and there is no relief in sight. i thought side effects, if any, would last only a few days. is there anything that i can do?
Patient had previously received her first Moderna Covid on 08/20/2021.  This was unknown to staff who gave the patient what was thought of as a first dose.  When the dose was entered we noted that the patient had a first dose at a pharmacy.
spot at injection site; large lump at injection site; itchy at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (spot at injection site), VACCINATION SITE MASS (large lump at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH MACULAR (spot at injection site), VACCINATION SITE MASS (large lump at injection site) and VACCINATION SITE PRURITUS (itchy at injection site). At the time of the report, RASH MACULAR (spot at injection site), VACCINATION SITE MASS (large lump at injection site) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Details regarding concomitant medication and treatment medications were not provided.
COVID-19 vaccine given after BUD date of 4/29/22.  Expiration date: 5/31/2022  Letter being sent to parents for re vaccination.
Information has been received from a nurse practitioner (NP) concerning a female who on 19-SEP-2000 was vaccinated with a dose of Varivax (Lot #635188/0761K). The NP reported that the patient subsequently developed mild breakthrough chickenpox. Unspecified medical attention was sought. At the time of this report, the patient was noted to be recovering from the chickenpox as scabs had formed. Follow-up information from the NP indicated that she was unable to locate the patient's information. Additional information is not expected.
Associate reports on 6/19 she started to experience a cough, congestion, runny nose, sore throat, headache, 102.1 fever, and diarrhea.  Currently, 6/22/21, associate still has a cough and congestion,
I was vacationing, during a day long tour we were in a van full of people that were unmasked. One of the people in the van was coughing throughout the day. Two days later, 02/14/23, I noticed I had symptoms, of a cold. On the morning of 02/15/23 I took a home COVID-19 test that came back positive. I called and spoke to an on call lady who suggested I call back in the morning. I called back on 02/16/23, scheduled a telehealth visit. Spoke to a doctor, I was prescribed PAXLOVID that I started taking around noon, by the day I was to fly out 02/21/23 I was feeling much better. I only felt bad on the first day. I retested once I got home to be sure that I was truly COVID-19 free and I am. I still have remnants of a head cold and a husky voice but I do not feel bad.
Serious shortness of breath and tight, burning chest pain started night of 4/24/21. I thought I was having a heart attack or an asthma attack but tried to put off going to have it checked out. The shortness of breath and chest pain continued until the morning of 4/25, at which point I went to an urgent care where they did a chest x-ray (normal) and an ECG (normal) but they then instructed me to go to the ER (Inova) where they did multiple ECGs (normal) and blood work (normal).  The ER doctor told me to follow up with my primary doctor which I did on 4/28.
I had the vaccine at 3:45 on 10/20. At 10 pm  I woke up and projectile vomited, had very bad diarrheah.  was dizzy and weak. The next day 10/21 I stayed in bed all day, feeling  very dizzy and had no appetite. One 10/22 I got up and showered, but still felt dizzy and had little appetite. Today,  10/23, I am still dizzy  and  have no appetite. I would not trust myself to drive. I have written an email to Dr and talked to the nurse today to get vaccine info for this report. I have not been back to clinic.
Call came in from wife husband having sweats, red rash skin flushed. No temp had chicken rice at restaurant. Told to go to ER. This was 5pm.
pt got nauseated x 8hr;inj site got hard;no redness noted;
Vaccines stored in the refrigerator underwent several temperature excursions; No adverse event; Vaccines stored in the refrigerator underwent several temperature excursions and may have; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 22-Sep-2022 at 3:20 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions and may have). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions and may have), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines stored in the refrigerator underwent several temperature excursions and may have) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines stored in the refrigerator underwent several temperature excursions).    No concomitant medication was provided.  On an unknown date, patient received dose 1, dose 2, dose 3 of Moderna vaccine, intramuscularly in the deltoid muscle. Patient received dose 4 in the deltoid muscle.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The reporter stated that the clinic she was assisting, underwent several temperature excursions with vaccines stored in the refrigerator going back to Aug-2022.   No treatment products reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654537 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654537:same reporter
Pt got vaccine in R arm and began to feel arm and shoulder pain five minutes after. Pt also began to feel lip and facial numbness. NO sob. No rashes noted vitals assessed and patient released. Last VS: T: 1259, P: 76, BP: 136/99, SpO2: 98%.
had nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer vaccine and felt fine however 2h later (on an unspecified date) she had nausea nothing to throw up only nausea. The outcome of the event was unknown.    Information on the lot/ batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: 30155819) at the age of 68 years, in left arm for covid-19 immunisation; 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 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Other medication in 2 weeks. The patient had no known allergies. OTC drugs were administered to address symptom. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (11Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30May2022 to 03Jun2022.  Amendment: This follow-up report is being submitted to amend previous information: Recoded suspect product to BNT162b2 and amend case as per vaccine convention (Events recoded to drug ineffective and covid-19 (medically significant), LOE classification added, first 2 doses are captured under "Covid-19 Vaccine" as manufacturer not provided).
Rebound infection; Rebound infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 3 (booster), single (Lot number: EL9729) for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Patient did not have any known allergies.Concomitant medication(s) included: TRUVADA.  The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "Rebound infection". Therapeutic measures were not taken as a result of suspected covid-19, drug ineffective. Patient received Truvada medication in 2 weeks.
pt c/o dizziness, sweatiness, racing pulse & heaviness in chest;pulse approx 90;BP 150/90;pt went to ER via ambulance;according to pt had wheezing in all 4 lobes;was given 02 for 6hr;next day arm red & hot;
Fatigue, muscle aches, muscle spasms, headache, back pain, abdominal pain, neck pain, flushing, tachycardia.
Swelling of my face; Hand joint swelling; Sever muscles pain; Sever joint pain; Severe arm pain emanating from the injection site; Reduced appetite; Feeling unwell; Headache; Feeling pressured behind eyes; Difficulty sleeping; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), vortioxetine hydrobromide (TRINTELLIX) and nortriptyline (MANUFACTURER UNKNOWN); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient previously took levofloxacin (MANUFACTURER UNKNOWN) and ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 24Apr2021 at 20:00, the patient experienced swelling of her face, hand joint swelling, severe muscles pain, severe joint pain, severe arm pain emanating from the injection site, reduced appetite and feeling unwell including headache, feeling pressured behind eyes and difficulty sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling of her face, hand joint swelling, severe muscles pain, severe joint pain, severe arm pain emanating from the injection site, reduced appetite and feeling unwell including headache, feeling pressured behind eyes and difficulty sleeping were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a licensed practical nurse, refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with ROTATEQ orally (lot #, expiration date and dose were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected, because there was no consent to contact a physician.
None, just a sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Jan2021 13:30 (Batch/Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included Sjogren's, auto immune disease, mixed connective tissue syndrome, osteoporosis, osteoarthritis and Known allergies: Latex and MSG (monosodium glutamate). The patient previously took MSG and experienced allergy. Concomitant medications included misoprostol, omeprazole, rosuvastatin, and cevimeline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Approximately on an unknown date in 2021, the patient experienced "None, just a sore arm" (reported). No treatment was provided for the adverse event. The outcome of the event was recovered approximately on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 05-DEC-2014 the patient was vaccinated with an expired dose of GARDASIL, 0.5 ml, intramuscular. (Dose number, lot# were not reported). Expiration date: 21-NOV-2014. Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
severe pain in every inch of my body; just my arms and legs were weak; light headedness; severe headache just in my forehead only; 101.1 F Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain in every inch of my body), ASTHENIA (just my arms and legs were weak), DIZZINESS (light headedness), HEADACHE (severe headache just in my forehead only) and PYREXIA (101.1 F Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE, MONTELUKAST, DOXEPINE, SERTRALINE, PROPRANOLOL, SUCRALFATE (CARAFATE), SIMVASTATIN, LOSARTAN, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMIN XR), MECLIZINE [MECLOZINE], ONDANSETRON (ZOFRAN [ONDANSETRON]) and OXYCODONE HYDROCHLORIDE;PARACETAMOL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (severe pain in every inch of my body), ASTHENIA (just my arms and legs were weak), DIZZINESS (light headedness), HEADACHE (severe headache just in my forehead only) and PYREXIA (101.1 F Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 16-Mar-2021, PAIN (severe pain in every inch of my body), ASTHENIA (just my arms and legs were weak), DIZZINESS (light headedness), HEADACHE (severe headache just in my forehead only) and PYREXIA (101.1 F Fever) had resolved.            Concomitant medication includes OTC supplements.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up contained no new information. On 17-Jul-2021: Follow-up contained no new information. On 26-Jul-2021: Follow-up contained no new information.
Patient is fully vaccinated and boosted 12/30/2021.  COVID + 1/10/2022 at hospitalization. Acitve problem: Atrial fibrillation with RVR. 38-year-old gentleman with history of end-stage renal disease, on hemodialysis, presenting to emergency room having been sent from dialysis unit with the development of shortness of breath and severe palpitations.The patient was found to be in supraventricular tachycardia with rhythm fluctuating with atrial fibrillation and flutter and subsequently admitted for further management. chest x-ray showed diffuse pulmonary interstitial findings, possibly related to COVID-19 infection and pneumonia. Elevated troponin. Treatment: cardizem. IV dexamethasone. room air.  Discharged to home.