chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Dry mouth; Slight fever; Clamminess; Pain in upper right arm; Joints became stiff; Itchy on right arm/hand; Headache; Dizziness; Nauseated; Could not sleep; Feeling tingling throughout right side; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 16Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome with diarrhea (IBS-D), high blood pressure, sciatica (Sciatic Nerve Lower Back Pain), scoliosis, laryngopharyngeal reflux (silent reflux), gastroesophageal reflux disease (GERD), gastroparesis and food allergy (gelatin). The patient previously took vibramycin, doxycycline, tetracycline and flagyl and experienced allergy to these medications. Prior to the vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol succinate ER (MANUFACTURER UNKNOWN), pantoprazole sodium sesquihydrate (pantoprazole sodium) (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date. On 16Apr2021, 15 minutes after the shot she felt fine. 30 minutes after the shot she started feeling tingling throughout her right side, along with pain in her upper right arm. 45 minutes after the shot her joints became stiff and she started becoming itchy on her right arm/hand. 60 minutes after the shot she started getting a headache and dizziness. 90 minutes after the shot she got nauseated. She could not sleep that night because of the dizziness. On 17Apr2021, next day all of the same symptoms plus fatigue, dry mouth and a slight fever with clamminess. Two days after the shot no more tingling, less pain in the arm, joints were a little looser, still had a headache, some dizziness, and still had a dry mouth. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events feeling tingling throughout right side was resolved on 18Apr2021. The clinical outcome of the events joints became stiff, dizziness, could not sleep, pain in upper right arm was resolving and that of itchy on right arm/hand, headache, nauseated, fatigue, dry mouth, slight fever and clamminess was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 06-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # M023169, 13-JUN-2018 intramuscular. On an unknown date the patient experienced tingling from injection site radiating up the arm to the neck immediately after the injection while still in the office. The medical assistant requested as lot check. The outcome of the event was unknown. Additional information has been requested.
Breakthrough COVID-19 case: I thought I was getting allergies. I had ear pressure and feeling fatigue. I also started to experience sinus congestion. The symptoms were not going away. After about a week I went to an urgent care and was tested for COVID-19 and it came back positive. I took over the counter medication to help the symptoms. My symptoms subsided after about 10 days.
Fever was up to 103. Aches. Diarrhea. Cold sweats 3 days after. Strange pain in different areas in my legs.
This spontaneous report was received from a Physician refers to a 15 month old female patient. The patient had no pertinent medical history and known allergies. On 23-JUL-2014 the patient was vaccinated with her first dose of (Oka/Merck) VARIVAX lot#J012378, expiry date: 03-OCT-2015, 0.5ml, subcutaneously in the right thigh. No concomitant therapy was reported. On 29-JUL-2014, 7 days after onset of therapy the patient experienced chicken pox rash. No treatment was given. The patient's caretaker sought medical attention by office visit on 30-JUL-2014. However, no intervention initiated to prevent serious criteria as there was none. No product quality complaint was filed. The action taken was assessed as not applicable. No lab tests were performed. The outcome of chicken pox rash was reported as not recovered/not resolved. The causality was unspecified in the report. Additional information has been requested.
Second dose of Hepatitis A given by error too early from first dose.CDC called and verified that this dose would not be valid and should be repeated in 6 months from today's dose. Adverse reactions would be the same as any other dose of Hepatitis A.
Itchy, painful raised welt near injection site started the morning after the injection. It has slowly become more painful and itchy. The welt is 1.5-2 inches in diameter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer stage 3" (unspecified if ongoing), notes: Previous breast cancer stage 3, in 2016-2017, with double mastectomy and radiation treatments; "double mastectomy" (not ongoing); "radiation treatments" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 10Nov2023 to 14Nov2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384621 same patient, different product/event;
Sinking sensation in the middle of my chest right below the center of my ribcage (there is a rolling sensation whenever I laid down, sat down, or stood up) Nerve issues (tingling sensation & numbness in my feet and fingers) Dizziness  Fatigue
PT visited office on 11/14/02 at 14:30. Presented with c/o itching and rash to lower extremities. He received the influenza vax on 11/12/02. His daughter called a health department on 11/13 and talked to the OD. He presents today and feels that the itching and rash are related to the influenza vax. He has not taken any Benadryl as recommended by the OD. The rash is restricted to the lower extremities. He states when the areas of rash first break out white raise pustules are visible. Reporter did not see any during this visit. PT has prickly red raised patches ranging in size from 1 cm round to 6 cm round on his lower extremities, more so on his ankle areas than upper leg areas. There is no visible reaction near inject site of flu vax. PT denies any difficulty w/breathing. PT also denies having contact w/any plant, animal, new soap, etc, that may have caused a rash to lower extremities. PT was seen by an MD who could not rule out the potential of a reaction to the flu vax. PT was instructed to take Benadryl for the itching and should his condition worsen return for evaluation. He does admit that the rash he is experiencing does seem better than the previous day.
Severe pain in my right arm that moves from my arm to my neck, swelling and redness of area, causing my nerves to twitch.
ON 6/6 WAS ADMINISTERED INFARIX DTAP LOT AC14B006AA IM IN L DELTOID. IN 1 D DEVELOPED REDNESS, WARMTH AND SWELLING WITH SPREADING DOWN THE ARM.
Patient report feeling nauseous, no other symptoms. Patient was seen and cleared by EMS. Patient reports feeling better.  BP;120/59, pulse 64, BS 166
Swelling and red blotches spreading across left deltoid area. Increasing in size and discomfort day 1 and 2 post administration of vaccine.  Severe pain and limited mobility of affected arm. Body aches.
Bad sore throat, yellow mucus, slight fever, trouble breathing, loss of appetite, restless sleep, slept sitting up in a recliner so I could breathe.
My whole left side went numb and I was in bed for the rest of the day. It got better because I started researching (I'm an RN). The numbness cleared up in a week. But the pain in my left knee was unbearable so I went to see my Pain Doctor. I also went to see my orthopedic doctor on March 30th and he ordered a bone scan on Monday to see if my knee implant was affected. He told me to get the nerve block from my pain doctor.
Went to facility to vaccinate residents in rooms. The nurse assured us that she had checked everyone's vaccination status and that they were eligible for a bivalent booster.  Nurse had a consent form signed by the patient's daughter to receive the vaccine.  Patient is unable to make decisions on her own and her primary language is different. Patient had no adverse effects from the vaccine. When we returned to our office to enter patient info I got an alert that this patient has already had her bivalent booster in January, thus was not eligible to receive the vaccine today.
Headache, Myalgia, NauseaVomiting, FATIGUE/CHILLS Narrative:
After about a week and one half I started to get a very red rash that grew from injection site and then started to grow larger every day and move down my arm. It was hot to touch, not painful but itchy
24 hr sp/vax devel red, swollen, hot 40 cm area on rt arm where MMR given;
showed an alk phos of 2199 (41-133) from bone which fell to 1100 last week; rash on her legs in early Oct2021; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A 77-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY, solution for injection), on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Comirnaty (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset 01Oct2021, outcome "recovered" (Feb2022), described as "rash on her legs in early Oct2021"; BLOOD ALKALINE PHOSPHATASE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "showed an alk phos of 2199 (41-133) from bone which fell to 1100 last week". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. It was unknown if therapeutic measures were taken as a result of blood alkaline phosphatase increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 day later knot, heat , redness and itchy occurred at the injection site.   Side Effects went away about in 5 days, now it has  returned smaller red area, itchy, small lump around the site.
Muscular, bone, joint achiness:  from 10pm 5/10/21 - 10am 5/13/21  chills: 11pm 5/10/21 - 11pm 5/11/21 generalized slowing of movement and cognitive function: 8am 5/11/21 - 2pm 5/11/21 Never felt like I was fevering so never checked temperature.
Fever up to 101.8 with some LUE discomfort. ID consulted - imaging, lab, cultures, antibiotics ordered.
Information has been received from an unspecified reporter referring to an 18 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 15-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Tested NAAT positive for COVID 9/1/21 after being fully vaccinated.
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. Medical history and current conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose, strength, route, lot number, expiration date and anatomical locations were unspecified). No concomitant therapies were reported. On an unknown date the patient developed shingles after received ZOSTAVX. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected.
Hep A #1 and Prevnar #4 given to pt in left arm. Developed redness, swelling and pain left arm and was seen next day 9/24/03. Treated with Benadryl PO and Keflex PO. Pt then developed worsening urticaria on left arm with F/U. Pt was seen again 9/26/03 for F/U and had generalized urticaria and decreased of left arm. Tx with Prelone 2mg/kg for 5 days, Benadryl and Keflex.
1May91-pale early this (430)AM,awoke to be fed @ 7am 1May, back to sleep @ 730am, mom took T @ 115pm-did not wake up. 9pm awake & eating well. 2May91 930am-eating well.Awake for 2 hrs.
Started with extreme headache on evening of 3/3/21. During the night I developed fever, chills, and nausea. These symptoms continued through 3/5/21. I could drink fluids on 3/4, but remained sluggish on 3/5. Feeling better today, 3/6.
Covid vaccine received, was instructed to go to ?observation area? for 15 minutes. While walking, started to feel faint, sat down and started to feel okay. After 5 minutes, I started to feel faint again and felt my heart rate go up. My Apple Watch showed my heart rate at 144. I asked staff to check my vitals and I was instructed to go to the nurse area. Vitals showed heart rate of 140s-150 (Apple Watch registered my highest heart rate during that period was 160). Blood pressure about 135/90 (my normal is 115/80), SPO2 of 99%. After 5 minutes, heart rate down to 90, BP 120s/90s. Every 5-10 minutes I would feel faint, a sense of ?impending doom,? mild nausea, and my heart rate would go up to 140s, it would last about 2 minutes then go down to 90s. This cycle of heart rate going up and down kept repeating for 30 minutes. No chest pain, no shortness of breath. Prior to going home, heart rate was 90, blood pressure was 125/98. Total time being observed was 40 minutes from time of vaccine to leaving observation.
Pt has a history of anxiety about receiving vaccines. She informed us she would faint "I usually feel a bit light-headed after taking shots". While giving the shots, I spoke with her to keep her engaged but after the second shot, she fainted. No speaking, eyes wide open, unresponsive, and her breathing was steady. I monitored her for breathing and tried waking her up. She returned to normal after 10 seconds
pt started crying 8PM & wouldn't stop;pt changed color;911 called paramedics worked on pt for 30mins & then went to hosp;pt was reported dying, then dead;autopsy requested;
FIBROMYALGIA ATTACK; HANDS SHAKING; COULD NOT STAND; COLD FEELING; FINGERS HURT; BOTH LEGS VERY WEAK; CHILLS; FEVER FEELING; HOT FEELING; TOOTH ACHE; FELT  A WAVE OF PAIN OVER THE ENTIRE BODY; This spontaneous report received from a patient concerned a 74-year-old white not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included: polymyalgia rheumatica, and concurrent conditions included: fibromyalgia  The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, 1 total administered on 30-Apr-2021 for prophylactic vaccination (dose number series 1).  On 17-May-2021 to 19-May-2021, the patient stated that she had a fibromyalgia attack but did not correlate this to the administration of the Janssen vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, 1 total, administered on left arm on 16-NOV-2021 at 13:30 for prophylactic vaccination (dose number series  2).  No concomitant medications were reported.  On 16-NOV-2021  at 23:00, the patient experienced hot, fever feeling which lasted about 15 minutes. She did not take her temperature. The patient then experienced a very cold feeling, hands shaking, and after 15 minutes it was resolved. Then the patient felt a wave of pain throughout her entire body that was very weird, unusual, not a muscle ache/pain. She tried to stand but both legs were very weak, and she could not stand. She then laid back down. The patient stated that the pain lasted 10 hours solid and would rate it as a 10 on the pain scale. She did not take any medications because she could not get up. Patient stated that every tooth in her mouth had a tooth ache, the fingertips hurt, and entire body hurt (dose series 2). After 10 hours it disappeared, and patient went into her normal attack of Fibromyalgia. For about 2-3 days she took it easy. Patient reported she was now experiencing her normal fibromyalgia pain and has not experienced anything else.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot feeling, hands shaking, cold feeling, chills, and fever feeling on 16-NOV-2021, and tooth ache, felt a wave of pain over the entire body, could not stand, fingers hurt, and both legs very weak on 17-NOV-2021, and the outcome of fibromyalgia attack was not reported. This report was non-serious.
This is a spontaneous report from a contactable pharmacist via a sales representative, who reported similar events for four patients. This is the fourth of four reports. An adult patient of an unspecified gender who was over 60 years, received a single dose of PREVNAR 13, in Dec2016 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced localized allergic reactions in Dec2016 with outcome of unknown. Patient was taken to Urgent care center and it was unknown if was hospitalized or received treatments. Sender's Comments: Linked Report(s): US-PFIZER INC-2016595828 same reporter/drug/event, different patient.
Despite getting the COVID shot, I still got COVID/ cold like symptoms; Despite getting the COVID shot, I still got COVID/ cold like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (COMIRNATY), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 08Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Despite getting the COVID shot, I still got COVID/ cold like symptoms". Clinical course: Despite getting the covid shot, the patient still got covid. She only had cold like symptoms and it wasn't as bad as her friends that got it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pulmonary embolism; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 6 days due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: All tests came back unprovoked..         No relevant concomitant medications were reported. It was reported that patient had received the vaccine and two boosters. He developed pulmonary embolism that practically shut down his right lung and was lucky to catch it as it could have been lethal. He consulted with blood doctor specialist. So he needs to be on blood thinners for the rest of his life.  Company comment:  This spontaneous case concerns a 49  year  old male patient, with no medical history reported, who received one dose and two booster doses with Moderna COVID  19 vaccine (mRNA  1273) and experienced the unexpected, serious (medically significant and hospitalization) AESI pulmonary embolism. The event occurred approximately 13 months after the first dose of vaccine. Latency between last booster dose and the event cannot be properly assessed since exact vaccination date was not provided. The report stated that the patient experienced pulmonary embolism that "practically shut down his right lung". He was hospitalized for 6 days, and it was reported that he should be under blood thinners treatment for the rest of his life. The outcome was reported as recovering. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Moderna COVID-19 Vaccine (mRNA - 1273) is not affected by this report.