chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm to the touch; can feel the lump of the swollen tissue; very hot to touch; swelling on her arm at the injection site; some redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE MASS (can feel the lump of the swollen tissue), FEELING HOT (very hot to touch), VACCINATION SITE SWELLING (swelling on her arm at the injection site) and VACCINATION SITE ERYTHEMA (some redness at the injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included ETONOGESTREL (NEXPLANON) for Birth control.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE MASS (can feel the lump of the swollen tissue), FEELING HOT (very hot to touch), VACCINATION SITE SWELLING (swelling on her arm at the injection site) and VACCINATION SITE ERYTHEMA (some redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE MASS (can feel the lump of the swollen tissue), FEELING HOT (very hot to touch), VACCINATION SITE SWELLING (swelling on her arm at the injection site) and VACCINATION SITE ERYTHEMA (some redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medications were given.
1st dose: got vaccine in left arm, got lightheaded and dizzy with a migraine and felt warm 30 minutes after my vaccine. Got sore arm at injection site 1 hour after vaccine. Got pain on my two fingers on my right hand, felt like I burned myself and it hurt more when you touched it and had to take my ring off. Next day burning pain went up to my arm?feels like nerve pain or inflammation. Cramping in chest and ovaries randomly and still feel dizzy with migraine. Day 3: still have burning pain on right arm but it?s going away, still have migraine and feel dizzy, still getting random chest and ovary cramps. At night got really bad back muscle pain and ovary pain, feels like contractions and hurts when I walk or bend?it is extremely painful.
Big rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Big rash at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 09-Feb-2012, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE RASH (Big rash at the injection site). At the time of the report, VACCINATION SITE RASH (Big rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
injection site soreness; Fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness"; FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown".  Additional information: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Approx 25 minutes after receiving flu vaccine c/o feeling "shaky", hands shaking; no hives, itching or SOB at that time.  Approx 5 minutes later developed several red spots on face, but still no SOB or wheezing.  Figen Benadryl 50 mgm IM in same arm as shot.  Transported via 911 to ER.  Pt. stated she felt worse after the Benadryl.  BS 122/72, HR 120, Resp 16 as Benadryl given; EMS personnel reported systolic BP at 150 when they arrived.  Follow-up with ER - received solumedrol IV, discharged at 2:00 PM.
Rash at or around injection site area and traveled up around neck. Patient's daughter notified us on 11-16-17.
VR stated burning sensation through neck and up into head. VR noted fatigue within 5 min of vaccination. Observed for an extra 15 min. vitals stable. symptoms subsided within 5 min of onset
Nausea; Body ache; Loss of feeling in the left arm; I have numbness and loss of feeling in left arm; Tightening in my fingers.; This is a spontaneous report received from a contactable male consumer (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0176, Expiration date: unknown), via unspecified route, on 27may2021 over left arm (at the age of 33-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Her second is scheduled on 17jun2021. No other vaccines were taken prior 4 weeks. Family medical history was reported as blood pressure. On 30may2021 at 10:00, 3 days 10 hours after the vaccination, the patient experienced Nausea, Body ache, Loss of feeling in the left arm, numbness in left arm, Tightening in my fingers. The reporter assessed all events as non-serious. She wanted to know if the presented reactions are normal or not. She also asked about the need of meeting a doctor. The outcome of all the events was unknown.  No follow-up attempts possible. No further information expected.
DIARRHEA; SEVERE FATIGUE; FEVER 103 F AND 100 F; MUSCLE ACHES; WORSE HEADACHE; BAD CHILLS; This spontaneous report received from a consumer concerned a 58 year old male. The patient's weight was 210 pounds, and height was 68 inches. The patient's past medical history included: neck pain, and concurrent conditions included: blood pressure, alcohol use, smoker, and cholesterol, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042821A, expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced bad chills. On 04-AUG-2021, the patient experienced severe fatigue. On 04-AUG-2021, the patient experienced fever 103 f and 100 f. On 04-AUG-2021, the patient experienced muscle aches. On 04-AUG-2021, the patient experienced worse headache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 05-AUG-2021, the patient experienced diarrhea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 103 f and 100 f, had not recovered from severe fatigue, and muscle aches, and the outcome of bad chills, worse headache and diarrhea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815409.
Mother reported to PHN on 11/19/2001 that pt developed pain in scrotal-testicle area approximately 2 weeks after MMR given. Was seen by private MD and diagnosis made of "epididymitis". Mother reported MD did not fell this episode of epididymitis and MMR was related. Approximately 1 week later, pt developed "severe" joint pain and has been seen by several physicians. Presently being treated by MD at Hospital. Mother reported that pt has had blood work done, multiple appointments and presently receiving therapy and treatment due to continued joint pain. Was encouraged to complete adverse event report or call the 1-800 number.
Fever; arm pain and myalgia/Muscle ache; Body chills; Nausea; Fatigue; Joint pain; Headache; red local rash developed at the site of injection; A red local rash developed at the site of injection; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), MYALGIA (arm pain and myalgia/Muscle ache), CHILLS (Body chills), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L208 and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (Painful and itchy rash on bilateral upper and lower extremities) since June 2007 and Endometriosis since 20-Dec-2018. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) from 25-Jan-2019 to an unknown date for Endometriosis.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), MYALGIA (arm pain and myalgia/Muscle ache), CHILLS (Body chills), NAUSEA (Nausea), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (red local rash developed at the site of injection) and VACCINATION SITE RASH (A red local rash developed at the site of injection). The patient was treated with HYDROCORTISONE (topical) 06-Jan-2021 at a dose of 1 dosage form as required and LORATADINE 06-Jan-2021 at a dose of 1 dosage form as required. At the time of the report, PYREXIA (Fever), MYALGIA (arm pain and myalgia/Muscle ache), CHILLS (Body chills), NAUSEA (Nausea), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (red local rash developed at the site of injection) and VACCINATION SITE RASH (A red local rash developed at the site of injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Blood pressure measurement: 146/84 mmHg (High) 146/84 mmHg. On 05-Jan-2021, Body temperature: 97.4 (normal) 97.4°F. On 05-Jan-2021, Heart rate: 105 (High) 105 Beats per minute. On an unknown date, Body temperature:.         Other concomitant medication Benadryl is used for unknown indication   This case was linked to MOD-2021-002982 (Patient Link).
UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse events was not reported. This report was non-serious.
Information has been received from a nurse, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In 2016 (reported as on unspecified dates in September 2016 and October 2016), the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L018503, expiration date 16-MAR-2017; lot # M029680, expiration date 17-JAN-2017 and lot # M036161, expiration date 06-MAY-2018 (dose, strength, anatomical location and administration route were not provided). No symptoms were reported. The vaccine had a previous temperature excursions of 30 minutes at 57 Fahrenheit (F). Temperature: 54 F. Time frame: 1 hour. With a data logger involved. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
It's been, kind a like, somebody sitting on my chest.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. No medical history and concomitant medications were not reported. On an unspecified date, the patient reported it was been, kind a like, somebody sitting on my chest. The patient reported he had got the vaccine yesterday (Jul2021) and today (Jul2021), it was been, kind a like, somebody sitting on his chest. Patient said, he was just wondering, if he should just go back to where, he got the shot from. He enquired if this was a sign of some kind of a serious allergic reaction to it or was normal. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Period came earlier by 1-2 weeks after first vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01May2021, the patient reported period came earlier by 1-2 weeks after first vaccination. 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 event period came earlier was resolved on an unknown date in May2021  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Severe chest pain onset during PT. Rated # 8 on scale 1-10. Radiation to rt arm. Center of chest described as a squeezing, hard to breath. No palpitations, diaphoresis or dizziness. Would have intermittent pain in past during PT but nothing like this.   Symptoms: CHEST PAIN, UNSPECIFIED(R079).
p/vax pt felt hot noc of 6/8/99 & felt weak 6/9/99;devel bumps & blisters on back 6/11/99 2 inches below lt scapula 20mm size & pain under lt axilla & lt shoulder;took DPH;
This is an initial report of an AE, received on 06Oct2015, a 57-year-old female received FLUBLOK intramuscular on 05Oct2015. On 05Oct2015, the evening after receiving FLUBLOK, the subject developed a red, raised, 8 mm x 8 mm, rash that was itchy and sore. She applied hydrocortisone cream and took oral ibuprofen. On 06Oct2015, the rash remained. At the time of the report, the events of rash and itchy at injection site were not resolved. Medical/surgical history for the subject included egg and latex allergies. Concomitant medications were not reported. The company's assessment of the causal relationship between rash and FLUBLOK is a possible relationship in light o the safety profile information that injection site reaction is an expected event, and between itchy at the injection site and FLUBLOK is also a possible relationship in light of the safety profile information that injection site reaction is an expected event. In summary, this case report does not change the known safety profile of FLUBLOK.
green stools; foggy headed; left arm sore; thick speech; gassy; left arm hurt swollen; shaking; headache; Tiredness in afternoon/ tired; fingers, toes hurt; fingers, toes hurt; itching; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Left Arm (at the age of: 60-year-old) on 02Apr2021 09:00 as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypertension, intervertebral disc degeneration, drug hypersensitivity, weight fluctuation, arthritis. Concomitant medication(s) included lisinopril (LISINOPRIL); ibuprofen (IBUPROFEN); colecalciferol (VITAMIN D [COLECALCIFEROL]); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). The patient previously took morphine and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination and post vaccination, patient had tested with covid 19. On 02Apr2021 13:00, the patient experienced tiredness in afternoon/ tired, fingers, toes hurt, itching, On 03Apr2021 the patient experienced shaking, headache. On 04Apr2021 the patient experienced gassy, left arm hurt swollen. On 05Apr2021 the patient experienced foggy headed, left arm sore, thick speech, green stools. On 08Apr2021 the patient experienced green stools. Therapeutic measures were taken as a result of itching. The outcome of all events was not recovered.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with a doses of RECOMBIVAX HB lot # J000722, expiration date 17-SEP-2015 (dose, route of administration and anatomical location were not reported), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Taken to ER for febrile seizure. Had cough and congestion for a few days. Seizure lasted 4-5 minutes and received albuterol en route to ER. Dx'd with ear infection and treated with amoxicillin.
Moderna COVID-19 Vaccine EUA  1/11/2021: Received vaccine at around 1400 1/15/2021: 0830-0930 exposed to covid positive patient within 6 feet, both wearing masks in anatomy lab with HEPA filters present  1/17/2021: Completed PCR test. Received negative results.  1/18/2021: Rash at site of injection that migrated to chest 1/19/2021: Rash resolved by 5 cm local erythema at site of injection, warm to touch 1/19/2021: Took motrin 400 mg and Benadryl 25mg and will monitor
Information has been received from a pharmacist concerning a currently 69 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU, lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014127.
Information has been received from a female consumer with a history of shingles twice, who on 24-JUL-2007 was vaccinated with a dose of ZOSTAVAX.  On approximately 24-OCT-2007, the patient developed shingles.  The consumer reported that "I had the disease twice, so I contacted two doctors to get their advise as to whether I should or should not get the vaccine.  The answers from both were a definite yes, no question.  Just three months later, I developed the disease, and now 11 weeks later, I am still suffering".  It was unspecified if medical attention was sought.  Follow-up information has been received in which the consumer provided the address of her physician.  Additional information has been requested.
Information has been received from a medical assistant concerning a female patient of unknown age. The patient's concurrent condition and medical history were not reported. Concomitant therapy included sterile diluent. On 23-FEB-2018, the patient was inadvertently vaccinated with VARIVAX (lot # N012132, expiration date 17-APR-2019) and PROQUAD (lot # N023966, expiration date 28-FEB-2019, therapy type rHA), as prophylaxis (route not reported). No adverse effects were reported.
Headache, Myalgia, Fever, fatigue Narrative:   Other Relevant History:
Information has been received from a physician referring to patients of unknown age and gender. Concurrent or historical condition was not provided. On an unknown date the unspecified number of unspecified patients were administered improperly stored doses of GARDASIL (lot # K016966 with expired date of 10-MAY-2017, strength, dose, frequency and route unknown). Concomitant therapy was not provided. The vaccine was stored under 33.4F for 41 minutes. Previous temperature excursion included 73F for 1 hour 29 minutes, 34.1F for 2 hours 3 minutes and 34.3F for 1 hour and 29 minutes. Data logger was involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
After vaccination patient appeared pale and weak. He was instructed to sit down. His head fell to the side and his eyes closed. He opened his eyes seconds later and took sips of water he was instructed to wait 15 more minutes to monitor.
Initial swelling, redness, itching of left arm.  Pain in left arm that traveled to the right upper arm, across the back and neck.  I have reduced strength in both arms, have reduced energy and tire easily.
Pt. stated he felt light headed while sitting in observation area. He stated it happens after injections. Pt A &0X3, water given and pt. tolerated well. EMT's observed. Left in stable condition at 2:48 p.m.
pt recv vax 27OCT97 & returned to clinic 29OCT97 for swelling of lt upper arm;area was about 2cm wide extending about 10cms in a crest from anterior to posterior upper arm;swelling greater yesterday;applied ice reduced the swelling;
Rash on both arms and legs, tops of feet up to inner thigh. Patient saw dermatologist and due to the symmetry of the rash the physician believed it was from the injection. Patient was given a steriod cream and also a steroid injection.
Event - AM of next day after shot work up feeling weak, chills, no appetite. Excessive tiredness set in. Slept 16 hours. Lasted all day. Sat. 11/4/23, too, drank buttermint tea by Twinings. Rx - slept, took vitamin C500mg chewable. Drank herbal tea, soup broth. Call my doctor. Outcome - felt better on Sun. 11/5/23.