chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 18Mar2021 at 15:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included liver transplantation, hypothyroidism, allergy nos, allergy to molds, flagyl allergy and sulfonamide allergy. Concomitant medications included tacrolimus (MANUFACTURER UNKNOWN) from , bupropion hydrochloride (WELLBUTRIN) , calcium levomefolate (DEPLIN) and levothyroxine sodium (SYNTHROID) and more. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 25Feb2021 at 15:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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. On 21Mar2021 at 05:30 AM, after 2.5days of the vaccination, the patient experienced fever, chills, headaches and fatigue which lasted 4-5 days and took very long to get over. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures and treatments were taken as a result of the adverse events included with non steroidal anti inflammatory drugs, tylenol and heat. The clinical outcome of the events fever, chills headache and fatigue was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Red, warm, lump on left leg. Pt's mother will monitor and come to clinic if no improvement or enlargement in 24-48 hours.
Pink spot on arm close to injection site about 2 inches wide; Pink spot on arm close to injection site about 2 inches wide only slightly tender; Received 3rd dose of BNT162B2 Pfizer vaccine; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 26Nov2021 at 11:15 (Batch/Lot number: 33030BD) at the age of 42 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VENLAFAXINE and ADDERALL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: ER8730, Anatomical location: Left arm, Route of administration: Unspecified), administration date: 31Mar2021, when the patient was 41 year(s) old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot Number: EW0153, Anatomical location: Left arm, Route of administration: Unspecified), administration date: 21Apr2021, when the patient was 41 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 at 11:15, outcome "unknown", described as "Received 3rd dose of BNT162B2 Pfizer vaccine"; VACCINATION SITE ERYTHEMA (non-serious) and VACCINATION SITE PAIN (non-serious), both described as "Pink spot on arm close to injection site about 2 inches wide only slightly tender", with onset 28Nov2021, outcome "not recovered". Therapeutic measures were not taken as a result of the events vaccination site erythema and vaccination site pain.   Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that the pink spot on arm which was slightly tender might have been there earlier, but the patient didn't look; had been wearing long sleeves. The patient reported that this wasn't a problem but figured it was worth reporting just for the information; the patient realized it wasn't dangerous or harmful (as reported). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Soreness in my left arm at the injection site area. I treated with ibuprofen. It was fine the next day - used a lot of motion to help. I rubbed it and I guess I wasn't suppose to. I had no other issues until my typical seasonal allergies but a week an a half later - Saturday, I noticed I was having symptoms and was notified by a family member, that family member on Tuesday after I started having symptoms that they had a positive test. So I got tested at a Rapid Test site. I had productive cough and sinus congestion and some chest pain and shortness of breath. That went on for about a week and a half. I contacted my physician after the positive COVID test and because I have asthma related to the Hiatal hernia - and I increased to maximum dosage on Advair. That worked. Mucinex with Sudafed to dry that out. And started to use Cool Mist Humidifier and had that in my room constantly and I did self isolate to my bedroom during that time.  Vicks vapor rub on my chest. I wasn't running a fever - it varied slightly but it never went over 99. My highest temperature I think was 98. I monitored my O2 with finger monitor - as I had shortness of breath doing stairs. Lowest around 88 but then it would return to 96 or 97 in about 15 minutes.  Follow up with doctor (primary care doctor) - telemed appt.
Woke up around 3:00 am with 'flu like' symptoms.  Basically body aches. Not Major. Tylenol has seemed to help and I was able to come to work.  No fever
lower back felt like it was breaking; severe nausea [after second dose]; fever; chills; aches and pains all over my body; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back felt like it was breaking), NAUSEA (severe nausea [after second dose]), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 BACK PAIN (lower back felt like it was breaking), NAUSEA (severe nausea [after second dose]), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body). At the time of the report, BACK PAIN (lower back felt like it was breaking), NAUSEA (severe nausea [after second dose]), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body) outcome was unknown.            Patient reported that her all vaccination doses were given in her deltoid.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-390522, MOD-2021-390664 (Patient Link).
Information has been received from the nurse, reported that PROQUAD (lot # J004321, Expiration date 17-OCT-2014) and VARIVAX (Merck) (captured in MARRS# 1311USA002616) went through unsupported temperature excursion on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 28-AUG-2013 one patient (age and gender not reported) was administered the unsupported PROQUAD (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MAARS# 1311USA012185, 1312USA003400, 1312USA003401, 1312USA003306, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information has been requested.
dizzy and visual changes loss of consciousness, came to after 2 min BP 80/40 HR 70 ETOH abuse stayed in recliner for 10 min and felt better, a friend came to pick him up
I  received my 2nd booster shot on 04/15/2022 and my adverse event started on 05/16/2022 . Almost a month after my booster shot i  had sore throat , body ache, headache, and very fatigue, so i took a home COVID test on 05/17/2022 which was positive. I called my  doctor   on the same day  through tele health. she prescribed me PAXLOVID for 5 days.  I just finished it. today 05/23/2022 i feel good but i still have slight fatigue not like before. Am getting better.
Felt like she had the vaccine again, she is very confused; Left arm warmer than her right arm; Sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Felt like she had the vaccine again, she is very confused), SKIN WARM (Left arm warmer than her right arm) and VACCINATION SITE PAIN (Sore at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041?(A)20A - not sure) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). On 09-Mar-2021, the patient experienced CONFUSIONAL STATE (Felt like she had the vaccine again, she is very confused) and SKIN WARM (Left arm warmer than her right arm). At the time of the report, CONFUSIONAL STATE (Felt like she had the vaccine again, she is very confused) and SKIN WARM (Left arm warmer than her right arm) outcome was unknown and VACCINATION SITE PAIN (Sore at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
some sort of hive. i believe right below the injection site. it is not itchy. it is not raised on skin.  im saying its right below the inj site based on the bandage the pharmacist had placed on my arm. its about a 4cm circle.  i noticed it the morning after getting the injection. the area is tender when palpated.  the area is stiff when you palpate.  as if the muscle i guess were stiff in just that area or maybe its only the skin that feels stiff. slightly reddish.   its almost like the rash/hive that has been reported when people get the covid vaccine. a coworker who is a clinician thinks it could be the vaccine medication travelled a little bit to that area and cuased a reddish spot. . i have applied warm moist compress for few minutes each morning.
This spontaneous report as received from a pharmacist refers to a 52 year old female patient. Pertinent medical history was unspecified by reporter. The patient had none known drug reactions or allergies. On 10-APR-2015 the patient was vaccinated with 1 dose of ZOSTAVAX, 0.65 ml, subcutaneous (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies included gemfibrozil, metformin (manufacturer unknown), NEXIUM, gabapentin and clonazepam (duration and schedule were not reported). On an unspecified date in April 2015, after receiving the vaccine, the patient experienced erythema, swelling and pain at the injection site. Then, on an unspecified date in April 2015, the injection site pain spread to the patient's shoulder, axilla and chest. The pharmacist also reported that the patient had a difficulty moving her shoulder (hypokinesia). The patient sought medical attention by calling the pharmacist on 23-APR-2015. No treatment was given for the adverse events. The outcome of the injection site erythema and injection site swelling was reported as recovered on an unspecified date in April 2015. The outcome of injection site pain, shoulder pain, hypokinesia, chest pain and axillary pain was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Chest pain  Symptoms: DIZZINESS AND GIDDINESS, PALPITATIONS.
Next day post vax, the pt presented with cellulitis from injection site on down, a red swollen arm, and a slightly elevated temperature. The pt was treated with Keflex, warm compresses, and told to keep the affected area elevated.
On 03/15, the pt developed low-grade fever "flu" type feeling and on 03/17, she developed red bumps on arm pits, groin area; white spots in mouth, temp 101 deg. F., joint pains, weakness and itching.
Swelling in lips, hands, back & arms & feet; was itching; had raised red bloches w/center white dots; lip swelling was dramatic; took Decadron, Hydroxyvine;
hot spots on finger joints; red rash/red rash; itchy rash/itchy rash; Chills; did not feel good; huge hives at the injection site; arm was warm to the touch; arm was lumpy; a terrific headache/headache; arm was hard; arm was swollen; Arm was sore/arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (a terrific headache/headache), VACCINATION SITE INDURATION (arm was hard), VACCINATION SITE URTICARIA (huge hives at the injection site) and VACCINATION SITE WARMTH (arm was warm to the touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore/arm was sore). On 29-Jan-2021, the patient experienced VACCINATION SITE INDURATION (arm was hard) and PERIPHERAL SWELLING (arm was swollen). On 01-Feb-2021, the patient experienced HEADACHE (a terrific headache/headache). On 03-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (huge hives at the injection site), VACCINATION SITE WARMTH (arm was warm to the touch), VACCINATION SITE MASS (arm was lumpy) and FEELING ABNORMAL (did not feel good). On 04-Feb-2021, the patient experienced CHILLS (Chills), RASH ERYTHEMATOUS (red rash/red rash) and RASH PRURITIC (itchy rash/itchy rash). On 06-Feb-2021, the patient experienced RASH PAPULAR (hot spots on finger joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Feb-2021, VACCINATION SITE URTICARIA (huge hives at the injection site) had resolved. On 05-Feb-2021, VACCINATION SITE MASS (arm was lumpy) had resolved. On 06-Feb-2021, CHILLS (Chills) had resolved. On 07-Feb-2021, HEADACHE (a terrific headache/headache), VACCINATION SITE WARMTH (arm was warm to the touch) and FEELING ABNORMAL (did not feel good) had resolved. On 08-Feb-2021, VACCINATION SITE INDURATION (arm was hard), PAIN IN EXTREMITY (Arm was sore/arm was sore) and PERIPHERAL SWELLING (arm was swollen) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash/red rash), RASH PRURITIC (itchy rash/itchy rash) and RASH PAPULAR (hot spots on finger joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sore/ache arm at injection site since 9-16-11 requiring doctor visit/medication.
nausea/vomiting, lack of apetite, sweats at night for more than 10 days post vaccination
I was perfectly fine before receiving this flu vaccine, but immediately following the vaccine I experienced a lot of pain in my left arm and within hours it was difficult for me to move my arm as usual. My mobility has decreased and I have constant pain in my left arm. Daily tasks such as washing my hair, putting on my coat, and changing my children are challenging due to the pain. I have trouble sleeping at night because I cannot get comfortable due to the pain. I have sought chiropractic treatment since October 8, 2018, and am presently going to him, which slightly helps. I have seen my primary medical doctor on October 29, 2018 and according to her, the strength in my left arm is weaker than my right. She gave me the antibiotic Moxiflaxicin to treat for infection in my arm and a six day supply of steroids. The steroids helped with the pain, but as soon as those were finished the pain returned. I have taken ibuprofen daily. I also saw another doctor on November 8, 2018 who prescribed me Gabapentin. I have not taken these because I found out that afternoon that I am pregnant.
patient experience palpitations after receiving Moderna #2.; Patient  has underlying palpitations and getting work up by cardiology. 1:25 162/73 pulse 121 1:35 151/70 pulse 93 1:48 150/82 pulse 76 1:42 136/75 pulse 77 Patient improved after rest and drinking some water. Denied dizziness, chest pain and shortness of breath.General: calm, no acute distress. - possible adverse reaction vs his underlying palpitations.  He is under care of cardiology and is getting work up for palpitations. Patient discharged at 2:05pm
Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine; Left arm soreness; Entire body swelling \ water weight\ arthritis feeling; Gained 5-10lbs.; Hands looked black/blue; Palms looked red; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), SWELLING (Entire body swelling \ water weight\ arthritis feeling), WEIGHT INCREASED (Gained 5-10lbs.), CYANOSIS (Hands looked black/blue) and ERYTHEMA (Palms looked red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness), SWELLING (Entire body swelling \ water weight\ arthritis feeling), WEIGHT INCREASED (Gained 5-10lbs.), CYANOSIS (Hands looked black/blue), ERYTHEMA (Palms looked red) and PRURITUS (Itching). On an unknown date, the patient experienced OFF LABEL USE (Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. On 23-Apr-2021, CYANOSIS (Hands looked black/blue), ERYTHEMA (Palms looked red) and PRURITUS (Itching) had resolved. On 24-Apr-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved. On 05-May-2021, SWELLING (Entire body swelling \ water weight\ arthritis feeling) and WEIGHT INCREASED (Gained 5-10lbs.) had resolved. At the time of the report, OFF LABEL USE (Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.
Muscle fatigue, pain, and spasms. General malaise and fatigue. Urethral spasms and burning. Symptoms lasted about 48 hrs and got better. I took IBU 600 mg x 2 doses
Pt presented for seasonal flu vaccination clinic. Received flu vaccine about 0845. At 10:00 am noticed redden rash covering both arms. Presented to ED. Given BENADRYL PO with relief of rash.
Pt developed 2-3 inch localized reaction. Hx of (L) mastectomy/lymphedema, pt had both PCV 13 & flu in (R) deltoid. Denies fever. Ice compress el/ibuprofen-issue is resolving.
?COVID arm?  I developed an itchy, hot, round red rash at the injection site 7 days after the vaccine.
COVID 19 Treatment; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing); "asthma as cold" (unspecified if ongoing), notes: asthma as cold; "bronchitis when Sick" (unspecified if ongoing), notes: bronchitis when sick,; "migraines" (unspecified if ongoing); "low TSH" (unspecified if ongoing); "bronchitis when Sick" (unspecified if ongoing), notes: bronchitis when sick,; "asthma as cold" (unspecified if ongoing), notes: asthma as cold. Concomitant medication(s) included: METFORMIN taken for polycystic ovaries. Past drug history included: Davocet, reaction(s): "Known allergies: Davocet". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Aug2022 to 02Sep2022. Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Body aches, headache, nausea.  Tylenol, ibuprofen and Benadryl.  Lasted 24 hours
11sep89 pt vax developed GBS w/ flu like symp, weakness and numbness in legs, tingling hands, bilateral weakness in the deltoid and pharyngeal, tongue and left facial nerve weakness.  pt recovered.
Headache; Nausea; Chills; Overall feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, at 07:00 the patient experienced headache, nausea, chills and overall feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, chills and overall feeling unwell were recovered on an unspecified date in Apr2021.    No follow-up attempts are possible. No further information is expected.