chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness, headache, nausea, exhausted, wanting to sleep constantly, trouble breathing when sleeping(wife noticed this).  These symptoms although getting better have lasted six days.
Chemotherapy; This spontaneous case was reported by a consumer and describes the occurrence of CHEMOTHERAPY (Chemotherapy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEMOTHERAPY (Chemotherapy). On 15-Apr-2021, CHEMOTHERAPY (Chemotherapy) outcome was unknown. Not Provided      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.   The patient will start radiation soon.   This case was linked to MOD-2021-091916 (Patient Link).
Pain, swelling and heat at injection site, severe runny nose, sneezing, coughing, sore throat
Fever 102.7, heavy fast breathing, lethargy, chills, extreme fussiness, crying in pain for extended time, swollen painful injection site.
14DEC93 father of child called about 10AM states that lump on lt leg is larger & sore; suggested that take pt to MD;
Red spot (erythema) about size of baseball at injection site. Decreased in size to about a silver dollar by 12/31/16 when she came in and told me about.
LOSS OF SLEEP; STRANGE DISORIENTATION IN HEAD; PAIN IN ARM; HEADACHES; CLOUDY HEAD; UNUSUAL LOSS OF ARM USE AND NUMBNESS IN  ARM; RECURRENCE  OF HOT FLASHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received from patient on 16-JUN-2021 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2031421A) 1 total, dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches, cloudy head, a recurrence of hot flashes, unusual loss of arm use and numbness, loss of sleep because of the pain in arm. The patient was also making unacceptable and unusual mistakes at work because of the strange disorientation in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, cloudy head, recurrence of hot flashes, unusual loss of arm use and numbness in arm, loss of sleep, pain in arm, and strange disorientation in head. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210633003-Covid-19 vaccine ad26.cov2.s- Cloudy head, Unusual loss of arm use. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recvd flu vax & exp severe depression, manifested as sobbing; also exp pain & heat @ the inject site; pt was taken to ER where was treated w/Pred for 5 days & Ativan for 7 days; still depressed;
Covid arm 3inch x 3inch red swollen hot tender around injection site   Had same reaction with 1st dose just one week later.
This spontaneous report as received from a nurse practitioner refers to a 1 day old female patient who was born from a 23 years old female patient with gastrooesophageal reflux disease. The mother's history of previous pregnancies and live births was not known. The patient's mother was vaccinated with the first, second and third dose of GARDASIL (Lot # unspecified) intramuscularly on 12-NOV-2007, 21-JAN-2011 and 05-SEP-2012, respectively. No other co-suspects were reported. Concomitant medications included: ZANTAC. The patient's mother was exposed to GARDASIL during first trimester of pregnancy. The patient was born in May 2013 and was doing fine. The patient had an unspecified birthmark on her leg. The patient was healthy and happy and had no problems at all. Upon internal review, birth mark on the leg was considered congenital anomaly. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose: 1, 2, 3 / Moderna, Dose: 4, 5; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 07Jan2021 as dose 2, single (Lot number: EL3246), in right arm and on 20Oct2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 64 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 16Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24May2022 as dose 4 (booster), single (Lot number: 03BA22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prior asthma" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing); "treated with radiation", start date: May2021 (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jan2021; FLUOXETINE, start date: 01Jan2020; ELDERBERRY BLACK FLOWERS, start date: 01Jan2021; ZINC, start date: 01Jan2021; VITAMIN D3, start date: 01Jan2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24May2022, outcome "unknown", described as "Pfizer, Dose: 1, 2, 3 / Moderna, Dose: 4, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive home Covid antigen test; negative, notes: repeat antigen test day after completing meds was negative; Positive, notes: Covid antigen test the next day was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: Positive home Covid antigen test. Took the prescribed Paxlovid 3 capsules twice daily for 5 days. Also, symptoms resolved and repeat antigen test day after completing meds was negative. Three days later, mild upper respiratory symptoms returned and repeat Covid antigen test the next day was positive. Respiratory symptoms still present now, yet not as severe as the initial episode of Covid which was treated with Paxlovid. That was first infection during the three years since Covid first appeared. The patient received Paxlovid treatment from 29Apr2023 to 03May2023 for covid-19 with brand Pfizer. Patient had no known allergies. Sender's Comments: Based on the information in the case report, a possible causal relationship between the events vaccination failure, covid-19, interchange of vaccine products and suspect drug BNT162B2 cannot be excluded.
With the first dose 4/22/2021 I felt dizziness the next day around 2pm. I received the second dose 5/13/2021. Since the day after, 5/14/2021 I have felt consistent dizziness, vertigo, nausea.  It's been over a month and my condition has not improved. I have finally decided to submit this report and visit my doctor.
Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator and administered on 29-Apr-2022; dose of expired Moderna Covid-19 vaccine was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of expired Moderna Covid-19 vaccine was administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator and administered on 29-Apr-2022) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of expired Moderna Covid-19 vaccine was administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator and administered on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of expired Moderna Covid-19 vaccine was administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator and administered on 29-Apr-2022) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The vial was initially stored in refrigerator on 29-Apr-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Vaccine was given in upper left arm around 12:00 on Feb 26, 2021, by 3:00 pm- 4:00 pm the site of the vax was painful and had begun to swell.  The swelling eventually encompassed my left arm above the elbow and over the shoulder to around and under the arm pit area.  My temperature was 100.5, the arm had turned slightly red and was entirely painful to touch.  The next day most of the swelling was gone, arm remained painful  to touch for 4-5 days.  Temp was back to normal range the on morning of  feb 27th.
07/07/22 presents to ED for "shortness of breath". PMHx of "asthma, pulmonary hypertension, obesity"
101.2 fever for four days with weakness for two weeks - 14 days. Since then, I have had virus symptoms every four or five days, such as aching joints, lethargy, muscle pain, and nausea that lasts about 48 hours each time. Then it clears up and I feel better for a  few days, then it comes back. I haven't felt well since the shot.
After two days I noticed I had a large bulge in my right armpit. Warm to the touch. Tenderness and painful.
Other: patient felt like she has her throat tightening and felt itching to the rear of her throat.   Patient felt the itching start behind her ears and move to the back of her throat with some throat tightening. EMS called at 1448, patient signed ama
Left arm extremely sore at injection site. Cannot lift it over my head. Extremely stiff and painful neck. Hurts to turn my head. Muscles in such a knot that I i have a level 9 migraine that started about 6:00 last evening. No medical treatment required. Nothing I can take for it. Sipping one cup of coffee and resting. Hoping it will ease off by tomorrow.
Face paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of facial paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial paralysis (Verbatim: Face paralyzed) (serious criteria GSK medically significant). The outcome of the facial paralysis was not reported.   It was unknown if the reporter considered the facial paralysis to be related to Shingles vaccine.     It was unknown if the company considered the facial paralysis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by patient's cousin via interactive digital media. The reporter stated that it was very common, so be careful of vaccine. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR049000 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR049000:Same reporter
Extreme fatigue and muscle aches almost 24 hours after vaccine. At 29 hours after vaccine I started having chills and headache along with the fatigue, muscle aches . Went to bed and woke up next morning- 36 hours after vaccine, all side effects were gone except tiredness. I noticed my right under arm was sore. I looked in the mirror and it was swollen. Had swollen lymph nodes in right under arm for 2 days after vaccine. Currently 4 days after vaccine and side effects are gone except tired arm on right side which I had the injection.
Lft. arm erythema with swelling; warm to touch extending 5-6 cm along back of arm.
ON 03/14/2022 AT APPROXIMATELY 1730HRS,  MEDICATION ERROR: .2ML OF UNDILUTED ORANGE CAP PFIZER VACCINE WAS ADMINISTERED TO CLIENTS LEFT DELTOID. CLIENT WAS ASSESSED AND PRESENTS NO SIGNS NOR SYMPTOMS OF ANY ADVERSE REACTIONS AT THIS TIME.  INCIDENT WAS REPORTED TO CLIENTS PARENTS AND EDUCATION WAS PROVIDED. MEDICAL DIRECTOR NOTIFIED.
The patient has been scheduled to receive the first primary  dose of Moderna was mistakenly administered the Bivalent booster shot. No adverse reactions upon observation
Swollen lymph notes; lump in right breast Started day following vaccination, on 1/21/22
Cough; Feeling hot/ FEELING HOT VACUUMING; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and FEELING HOT (Feeling hot/ FEELING HOT VACUUMING) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease. Concomitant products included METHOTREXATE for an unknown indication.   On 02-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough) and FEELING HOT (Feeling hot/ FEELING HOT VACUUMING). At the time of the report, COUGH (Cough) and FEELING HOT (Feeling hot/ FEELING HOT VACUUMING) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  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
I woke up in the middle of the night around 01:30AM on the morning of 10/04/2022, with chest pain. It didn't feel like a stabbing or sharp pain but like a band around my rib cage. It didn't seem to get worse when I was breathing, and I wasn't short of breath, but it was constant. As time went on, I started to feel a little off and a little nauseous, so I took an aspirin and headed to the emergency room. It started to get a little better on my way there, but I decided to follow through and be checked. At the hospital, they did an EKG and blood work and did not find anything but did recommend that I follow up with a primary care doctor. I have followed up with them and will be seeing a cardiologist in the near future. I also have experienced a site reaction after every vaccine and this time it was a bit worse. I didn't seek medical care for it, but I did develop a big knot in my arm at the injection site.
pt recvd vax; felt light headed; 10 min after vax, pt fainted; to clinic, EPI given; P 62, BP 140/110;
Vary swollen lymph node in neck; Hard lump at vaccination site; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA vaccine; Lot number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 11:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. Concomitant medications included high blood pressure medicines (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), me (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced very swollen lymph nodes in the neck and hard lump at shot site and it was still same 3 days later. The 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 events swollen lymph nodes in the neck and hard lump at shot site (vaccination site lump) were unknown.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician assistant concerning a 37 year old male patient with concurrent condition of cerebral palsy with mental retardation who in approximately 2009 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# unknown). On unspecified date the patient was vaccinated intradermally with 0.1 ml a second dose of 0.1ml of PNEUMOVAX 23 (Lot# 665925/0932Z). The physician's assistant stated that the patient was vaccinated with PNEUMOVAX 23 instead of a PPD, tuberculin injection test because of product confusion. He stated that the box of PNEUMOVAX 23 2.5 ml looked like the box of PPD, tuberculin test and he had been asking the patient to return to the office to examine the injection site. No adverse reaction noted. Physician assistant had been asking the patient to return to the office to examine the injection site. The patient sought unspecified medical attention. Additional information has been requested.
The liquid MenCWY component was inadvertently administered alone without the lyophilized MenA component.
VAXELIS was administered after a temperature excursion; This non-serious spontaneous safety report was received by the partner on 04-Apr-2022 and forwarded on 05-Apr-2022 from another health care professional.  Due to the nature of the event, the causality assessment between the event "VAXELIS was administered after a temperature excursion" and the product is not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by a health care professional on 22-APR-2022. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality assessment between the event "VAXELIS was administered after a temperature excursion" and the product remains not applicable.  No further information is expected.
Patient denied history of fainting. Patient received Janssen vaccine at 11:49. Immediately after receiving vaccination patient was complaining of arm pain. Patient was asked  by charge RN to stay seated at table instead of moving to observation area. Patient started complaining of feeling dizzy at 11:53 am. RN asked patient to lie down. Patient wanted to remain seated. Patient asked if he was diabetic. Patient confirmed he had type 2 diabetes and was unsure of last time he ate and blood sugar. Snack and cold water was obtained for patient. Patient became diaphoretic and was breathing fast. Blood presssure obtained and read 195/177. Blood glucose was obtained and read 132. RN asked for assistance lowering patient to ground. Patient's eyes rolled back while lowering patient. Patient was unconscious for approximately 60 seconds. EMS was called by bystander. Patient came back to consciousness and was alert and oriented. Patient's Blood pressure was obtained adnd read 156/80. HR was 58. EMS arrived and obtained vitals. Patient refused further treatment by EMS. Patient had ride pick him up at 12: 40. Patient was alert and oriented and no other symptoms upon leaving vaccination site.
On 4/20/21 Pt taken to ED by EMS about 10 minutes after vaccination with c/o palpitations, unsteady gait, weakness, dizziness, and right shoulder pain.  Today, 5/17/21 with c/o of ongoing right shpulder pain.
1st shot  headache 2nd shot  5 days later about 6" hive on injected arm,  swollen , hot
Pt had emesis x 3 and was later found unresponsive in bed with questionable post-ictal period after regaining consciousness. CT head normal; CSF WNL; Electrolytes WNL; CBC WNL; Admitted to PICU for continued lethargy.
The patient called at 3:05pm on 09-12-2019 saying that since her flu shot on 09-10-2019 she has had some arm soreness and swelling that has occured. I also double checked with the patient to make sure she had no shoulder pain or tingling and she does not. She said she did not feel any pain while giving her flu shot or in the immediate time after but her arm began to swell later. I also discussed with her the location of the shot and how she and I both remember that it was not given high up in the arm, but in the muscle. I reassured the patient that this is something that can happen occasionally when you get a flu shot. We will notify her MD.
Left arm swelling, redness with  8/10 pain  Fever tmax 102.5  Extreme fatigue, drowsiness Poor appetite Nausea  Diarrhea Muscle and body aches  Chills  Headache I am on day 2 following vaccine and feel slightly better but still low grade fever.
Indurated swollen area to the left upper thigh. 9cm area of erythema with redness and a ring of about the distal 1.5 to 2cm. In the central section, it's a type of pale indurated discoloration. She is walking on it without much difficulty. WBC was done and was 12,400. No significant shift. As reported by doctor.
Diarrhea mixed with blood; Almost passed out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Diarrhea mixed with blood) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020 and Diverticulitis since an unknown date. Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Diarrhea mixed with blood) (seriousness criterion medically significant) and PRESYNCOPE (Almost passed out). On 02-Mar-2021, PRESYNCOPE (Almost passed out) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Diarrhea mixed with blood) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood test: normal (normal) Blood test-Normal. On 02-Mar-2021, Haemoglobin: normal (normal) Hemoglobin-Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to the ER for observation and blood tests which came back normal (including hemoglobin). For several days it cleared up, then it has come back sporadically but not to the same degree.   This case was linked to (Patient Link).; Sender's Comments: 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.  However, Further information is requested.