chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 102; chills; headache; joint pain; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 11:00 at a single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 21Dec2020 for COVID-19 immunization. On 11Jan2021 at 09:00 PM, the patient experienced fever 102, chills, headache, joint pain, and fatigue for 2 days. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovered in Jan2021.
Moderna VOID-19 Vaccine EUA - She is having fever of 100.02, chills and shaking, body aching , joint pains, bone pains, headaches and eye pain. Will visit the doctor if symptoms continue to persist.
No adverse effects reported; patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse (also reported as office manger) regarding a patient of unknown age and gender. Information on patient's medical history, concurrent conditions and concomitant therapies was not reported. On 28-MAY-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S009945, expiration date: 10-AUG-2020, strength, dose, frequency were not reported) via unknown route for prophylaxis. On 28-MAY-2019 the patient was administered an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)(product storage error). No adverse effects were reported (no adverse event). There was no involvement of product quality complaint (PQC). Temperature Lowest temperature below 36 degree Fahrenheit (32 degree Fahrenheit) Time frame 72 hours There was no involvement of previous temperature excursion. Digital data logger was involved.
Very rapid heart beat and shortness of breath.  Also I received my 1st dose on 3/10/21 and on 3/31/21 I noticed blood in the toilet when I had a bowel movement.  I received my 2nd dose on 4/7/21 and on 4/17/21 and I noticed blood in the toilet again.  I did not strain and my stomach was not hard.
No adverse effects were reported; 8 year old patient was inadvertently administered a dose of GARDASIL 9; This spontaneous report was received from a physician via a company representative and refers to an 8 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUN-2019 (also reported as 17-JUL-2019), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R021636, expiration date 12-MAY-2021, intramuscularly in the patient's upper left arm (dose and frequency were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Varivax given 11/17. Then about 11/27 site was red, bumpy and raised for 3-5 days and is not bruised. febrile Dec 2,3, and 4. today 12/07/06 she had a rash on body and fact (not on palms/soles). Probable viral exanthem.
Patient called this morning. He said he had raised red, itchy blotches all over.  He said he had some benadryl at home and was going to take some. I followed up with him just now at 3pm. he said the welts have gone down and he's not as itchy.
Patient complained of numbness and tingling after receiving injection in left arm. Also decreased function and support of arm. Pain to lateral deltoid with radiating numbness and tingling to the fingers. Difficulty with lateral raising.
On may 16th she got sick and went to er, bp spiked pt had to have an emergency heart cath. She has a leaking valve now is still having this issue. When she had the heart cath she was told she had myocarditis
Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) POA: Yes Active Problems:   Uncontrolled type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (CMS/HCC) (5/6/2016) POA: Not Applicable   Lactic acidosis (2/15/2021) POA: Yes   Vaccination reaction - suspected (2/15/2021) POA: Yes   Hyponatremia (2/15/2021) POA: Yes Was admitted to the ICU for further treatment
Myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported having myalgias from 1st dose of Shingrix. The reporter did not consent to follow up.
Patient received her first dose Pfizer vaccine (LOT#: EW0185 EXP: 8/2021) at 0925 on 5/19/21. Patient alerted  EMT at 0940. Patient stated that she felt a strange sensation in her mouth/ throat region. Patient then stated that her tongue was numb and tingly. Patient also stated that she felt hot in body temperature. EMT took patients vital signs at 0940. BP: 108/78, pulse: 69, O2: 99%. Patient received water. Patient was offered diphenhydramine at 0946. Patient refused diphenhydramine at 0946. EMT retook vital signs and reassessed patient at 0950. BP: 98/68, pulse: 69, O2: 99%. Patient stated that she felt slightly better. EMT retook vital signs and reassessed patient at 0957 BP: 110/78, pulse: 67, O2: 98%. Patient stated that she felt no symptoms. EMT retook vital signs and reassessed patient at 1010. BP: 108/70, pulse: 62, 02: 98%. Patient stated she felt no symptoms and felt good to leave vaccination site. Patient stated that she had not eaten breakfast. PHN educated patient on worsening signs and symptoms and when to call EMS or go to emergency room/urgent care. Patient verbalized understanding of education. Patient completed observation time. Patient left vaccination site unassisted and with a steady gait at 1015.
Swollen, hot and tender area on both deltoids, 8cm X 8cm left, 7cm X 6cm right. The dose was split, due to swelling elbow to shoulder with flu vaccine last year.
Shortly after vaccination.  Patient complained of dizziness and nauseous. Patient was evaluated by EMS and BP was measured at 200s/130s.  Patient was placed in supine position.  BP continued to stay elevated.   Patient reported that she experienced HTN post birth but resolved.  Patient was transported by EMS to Emergency Room for further assessment.
Woke up with extreme pain by my shoulder blade, down my arm on March 13th. Used NSAIDS for a couple of days with no relief. Went to ED Triage nurse to ask for guidance on next steps. Went to urgent care on 3/15/21 and was prescribed muscle relaxers for muscle pain with no relief in my shoulder and arm. Appointment with orthopedic doc, on 3/17/21. He ordered an MRI of C-spine and diagnosed nerve pain. Pain traveled from arm to hand and back to shoulder then repeated 24/7. Used ice-packs, and alternated with heat.  Second appointment with Dr. on 3/23/21. Discussed nerve pain and Parsonage Turner Syndrome.
she not applied vaccine to patient till 20 mint and the enjection in her hand; out side temperature that time 38 centi grade; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade). At the time of the report, PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade) had resolved.            It was reported that the patients went to hospital for moderna vaccine 2nd dose. There was one nurse, she took moderna vaccine to fill the injection. After filling injection she not applied vaccine to patient till 20 minutes and the injection in her hand ,outside temperature that time 38 centi grade.  Concomitant medications were not reported. Treatment information was not provided.
Nausea, headache, severe joint pain, chills - cold and hot, and fatigue
Allergic Reaction post-vaccination, including shaking, paleness, lightheadedness, dizziness. More symptoms, such as nausea, vertigo, facial numbness, "buzzing" feeling, chills/sweats, brain fog from second day to day 14, coming in waves.
103 degree fever, chills, nausea, high heart rate and high blood pressure. High heart rate continued and I went to ER on 4/3/2019, and again on 4/4/2019 when I was admitted to the hospital and diagnosed with A-fib. High heart rate continued and I was readmitted to the hospital on 4/12/19. Dr., who was the doctor in the hospital, indicated that after further research he felt that the A-fib had been caused by the shingles shot I received on 3/21/2019. Dr. recommended that I report my case to the CDC.
Dose Pfizer-PEDI  COVID given to child too young to receive. Intended immunization was influenza.
went all the way across, halfway to her chest; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and CHEST PAIN (went all the way across, halfway to her chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On an unknown date, the patient experienced CHEST PAIN (went all the way across, halfway to her chest). At the time of the report, PAIN IN EXTREMITY (arm pain) and CHEST PAIN (went all the way across, halfway to her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was not provided. Patient treatment information was not provided.
Soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) via an unspecified route of administration on the left arm in Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported (received within 2 weeks of vaccination). On 22Jan2021 17:00 the patient experienced soreness at injection site. No treatment was received for the event. The facility where the vaccine was administered was in a workplace clinic. Patient was not pregnant. 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. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered on an unspecified date.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was captured adult as per vaccine indication. The healthcare provider reported that a customer stated their neighbor had a golf ball size swelling on their arm after receipt of SHINGRIX. The healthcare provider was calling to ask how to handle symptom management questions. This patient was not hers. She had no information about the patient or vaccine. It was a customer's neighbor who had the complaint.
Breakthrough case of Covid 06/06/2022 Sx began in the mid-afternoon of 06/06/2022. I was fine in the morning and in the afternoon I was sick. My sx included general feeling of not feeling well with body aches, sinus drainage, coughing, headache and chills. No fever right away.  It was not until 06/07/2022 that I was truly sick, the sx got worse. I developed a fever later in the day that may have hit 100 once, it lasted for a few days, but it never got higher than 100. I test positive on a home test and the results were positive. On Wednesday 06/08/2022 I saw the doctor through a virtual appointment. I was prescribed Paxlovid and my medications were adjusted. I started Paxlovid that evening. The Paxlovid dosage was reduced to 2 in the morning and 2 in the evening. Currently I am feeling fine. On reflection I feel that I got it because my daughter is a schoolteacher and she brought it home. We traveled from the house. We drove for an hour and half to two hours in the same car and spent a lot of time together.  She was ill with allergy sx so not aware of the Illness until a co-worker posted on social media that she was ill and that is when she decided to test.
PROQUAD and MMR-II were administered together to a one year old patient; Adverse Event filed with limited information reported, no additional information provided; This spontaneous report as received from a pharmacist on behalf of the nurse refers to a 1 year old patient. The patient's medical history, concurrent condition and concomitant medication were not reported.  On an unknown date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (route, strength, dose, batch/lot # and expiration date were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route, strength, dose, batch/lot # and expiration date were not reported) were administered together to the patient for prophylaxis (Inappropriate schedule of vaccine administered). Per pharmacist, the parents of the patient called the nurse to report and inquired what should be done who in turn called the pharmacist to see what to do. Per caller/pharmacist, it was not given by the nurse that inquired nor was it given at their office but the parents called the nurse to see what to do. No additional information was provided.
Significant injection site soreness, felt bad, aching all over, low grade fever, facial swelling, red splotches around injection site and axilla, headache, dizziness-onset evening of injection.
pt recv vax & exp tonic-clonic sz & was hosp;@ the date of this report, pt cont to exp sz;the reporter does not believe this event was vaccine-related;
Symptoms of diarrhea and growth in abdomen following vaccination in otherwise healthy person. Diagnosed with Diffuse Large B-cell Non-Hodgkins lymphoma and 3b follicular lymphoma, >20 cm lymphoma mass in abdomen
HYPOXIA 4/5/2023 DM 2 W HYPERGLYCEMIA HYPOXIA 4/5/2023 DM 2 W HYPERGLYCEMIA
No additional adverse events were reported; Nurse called because GARDASIL dosing has been interrupted.   She reported that 35 year old patient received one GARDASIL quadrivalent when she was a teenager and now she received one dose of GARDASIL 9 on 6/16/2022.; Nurse called because GARDASIL dosing has been interrupted. She reported that 35 year old patient received one GARDASIL quadrivalent when she was a teenager and now she received one dose of GARDASIL 9 on 6/16/2022; This spontaneous report has been from a licensed practical nurse (L.P.N.) concerning to a 35-year-old female patient.     The patient's medical history, concurrent and previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, while the patient was teenager, she was vaccinated with one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (dose, vaccine scheme, route and anatomical site of administration, lot number and expiration datewere not provided).  Then, on 16-JUN-2022 (reported as now) the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, vaccine scheme, route and anatomical site of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and interchange of vaccine products). No additional adverse events were reported.
Initial report received on 22/Feb/2006 from a health care professional.  A 73-year-old female patient who no reported past medical history, had received an administration (route not reported) of DECAVAC, lot number U1703CA, in the left deltoid on 24/Jan/2006.  Two day later, the patient developed increased local edema at the injection site and was diagnosed with cellulitis.  Per the reporter, the patient was treated with antibiotics and no further office visits were completed.  At the time of this report, it is unknown if the patient recovered from these events.
Swollen face; Swollen mouth; Diarrhea; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA, SWELLING FACE, and MOUTH SWELLING in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced DIARRHOEA. On 14-Jan-2021, the patient experienced SWELLING FACE and MOUTH SWELLING. On 15-Jan-2021, SWELLING FACE and MOUTH SWELLING had resolved. At the time of the report, DIARRHOEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 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.
Received Tdap in ED on 8/22/15 - c/o redness, swelling and heat to (L) arm where vaccine was given since 8/24/15.
hot to touch; swollen; a red mark the size of a quarter was visible; arm hurt really bad and it itched; arm hurt really bad and it itched; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (a red mark the size of a quarter was visible), FEELING HOT (hot to touch), PERIPHERAL SWELLING (swollen), PRURITUS (arm hurt really bad and it itched) and PAIN (arm hurt really bad and it itched) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L02A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LEVOTHYROXINE, PEPSIN, LOSARTAN, UBIDECARENONE (COQ) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (arm hurt really bad and it itched) and PAIN (arm hurt really bad and it itched). On 23-Jan-2021, the patient experienced RASH MACULAR (a red mark the size of a quarter was visible). On 02-Feb-2021, the patient experienced FEELING HOT (hot to touch) and PERIPHERAL SWELLING (swollen). At the time of the report, RASH MACULAR (a red mark the size of a quarter was visible), FEELING HOT (hot to touch), PERIPHERAL SWELLING (swollen), PRURITUS (arm hurt really bad and it itched) and PAIN (arm hurt really bad and it itched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.
Reaction around her small pox vaccine site / redness; Reaction around her small pox vaccine site / swelling; Reaction around her small pox vaccine site /raised, Inflamed skin; Reaction around her small pox vaccine site / and discolored skin / (not resolved); Reaction around her small pox vaccine site / tenderness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th December 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site inflammation, injection site discoloration and injection site tenderness. On 22nd December 2020, the outcome of the injection site erythema, injection site swelling, injection site inflammation and injection site tenderness were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site inflammation, injection site discoloration and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received 1st dose of Shingrix vaccine and by the evening of 10th December 2020, she began to had a reaction around her small pox vaccine site which included redness, swelling, inflamed skin, raised and discolored skin and tenderness. All of these symptoms lasted about 2 weeks and then resolved except for skin discoloration which still not resolved. The reporter consented to follow up.
Random headaches; Loss of energy; Stomach pains; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0181) via an unspecified route of administration in the left arm on 24Jun2021 at 11:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 27Jun2021 at 00:30, the patient experienced random headaches, loss of energy and stomach pains. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as the result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events random headaches, loss of energy and stomach pains were unknown at the time of reporting.