chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was given her vaccine in the right deltoid at 8:50am on 07/17/2020. Later that evening around 8pm, the patient noticed soreness in her shoulder. The next day, she noticed tenderness to palpation of the medial, upper arm as well as in the right axillary region. She checked her arm and noticed some swelling at the injection site and some erythema distally to the injection site. Today (07/20/2020) she presented for evaluation in the clinic and states the area of erythema has grown since she first noticed it. Her shoulder is sore and she remains having areas of tenderness to palpation including the injection site, the erythematous area distal and medial to this as well as her anterior axillary region.
After injection my left arm at site was sore, swollen, and red. As the day progressed, I felt tired and just not well. When I got home around 730 or so, I had a temp of 104 and felt horrible! I had a headache, fever, chills, I was violently shaking, and my husband said I kept stiffening my body up every few minutes. I was very lethargic and in and out of consciousness. This happened all throughout the night. The next day I woke up and was very sore like I had been beat up, had a severe headache, and was extremely nauseous and tired. This lasted about 3 days. My arm stayed sore and puffy for about a week. I did not go to the doctor for this but did let my work nurse practitioner know what had happened when I returned to work the next week.
This spontaneous report as received from a medical assistant to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 20-JUL-2017, the patient was vaccinated with a dose of VAQTA injection, intramuscularly, for prophylaxis (exact dose, lot# and expiration date were not reported). On 09-MAR-2018, the patient was vaccinated with a dose of VAQTA injection, intramuscularly, for prophylaxis (exact dose, lot# and expiration date were not reported). On 09-JUL-2018, the patient was vaccinated with a dose of VAQTA injection, intramuscularly, for prophylaxis (exact dose, lot# and expiration date were not reported). No adverse effects were reported.
Terrible pain in her arm/ only a little bit of arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Feb2021 (Lot number: EN5318) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FOLIC ACID. Vaccination history included: Bnt162b2 (Arm, Left - Administered at about 3:30PM on 18Jan2021(first dose), Lot number-EL8982 , Date of start of reaction/event -18Jan2021, Outcome of reaction/event at the time of last observation-Not Recovered/Not Resolved), administration date: 18Jan2021, when the patient was 68 years old, for Covid-19 immunization, reaction(s): "arm (left) has been quite sore", "her left armpit area, for about 10 days, was reddened and developed a black and blue like area", "she had a pins and needles feeling develop in her left hand after her first COVID-19 Vaccine, but the pins and needles feeling had subsided". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Feb2021, outcome "recovered", described as "Terrible pain in her arm/ only a little bit of arm soreness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had been experiencing terrible pain in her arm since she got the dose of the vaccine. There were no other products and patient history. Reported she was quite healthy. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect. There were not any prior vaccinations (within 4 weeks) and not applicable for adverse event following prior vaccinations. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse event was not provided.  No follow-up attempts are possible. No further information is expected.
Narrative: Patient received COVID-19 vaccination on 4/1/2021. Patient presented to the ED with chest pain. Cardiac work up was negative for acute cardiac or pulmonary emergency and patient was discharged.
Pt. returned to walk-in clinic about 20 minutes after receiving Fluzone. C/O Itching on chest and upper back.  Area was reddened.  No hives or raised lesions were noted.  Denied difficulty breathing.  Called MD Consultant.  She ordered Benadryl 25-50mg.  Pt. instructed to take benadryl as soon as possible when returning home and to call personal physician if symptoms worsen.  I called the pt the next morning to see how she was.  She stated that the symptoms were gone about 30 minutes after taking the Benadryl.
Potential side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Potential side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Potential side effects). At the time of the report, ADVERSE REACTION (Potential side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1240 Approx 20 min after immunization pt developed palpitations, Normal vitals. Given benadryl due to hx of reaction to previous covid shot. Developed nausea/vomiting and throat tightness. Epi given at 1245 and 1256. EMS arrived at 1258 to take to ER. pt remained alert and oriented, respiration even and unlabored. Vitals remained stable.
Extreme chills (uncontrollable shaking) fever of 102, dry heaves 3 times over period of only first 30 min., headache & dizziness. Fever (100-102) & intermittent spells of chilled shaking & headache lasted 48 hours. Fever (99-101) another 24 hours with no headache or chills. No intestinal or respiratory symptoms.  Extreme pain in shoulder/arm below injection site within 1 hour with lumps and redness developing 40 hours after injection.  Still some pain and redness, but decreasing.  Treated self with fluids and Tylenol & ibuprofen.
BRUISING OF UPPER LEFT ARM, SEVERE PAIN IN LEFT ARM, AND RANGE OF MOTION OF LEFT ARM GREATLY DECREASED, WITH NUMBNESS.
24 hours after receiving vax. appetite decreased, by noon, started feeling nauseous, then immediately became really nauseous. Then began uncontrollably shivering, having to vomit and covered in blankets, then immediately turn to sweating. Did not check for fever. Does not have symptoms at time of call. Pt used anti nauseous meds to control her nauseous meds. Was too sick to drive to ER.
No adverse effects were reported; The patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 04-NOV-2019 or 05-NOV-2019, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004253 with expiration date: 21-OCT-2020; dose and route of administration were not reported) for prophylaxis.  There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion below 36 degrees Fahrenheit for 2 hours and 18 minutes. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA001917: US-009507513-1911USA001926: US-009507513-1911USA001946: US-009507513-1911USA002043: US-009507513-1911USA002053: US-009507513-1911USA002198: US-009507513-1911USA002263: US-009507513-1911USA002388:
approx 18mos p/ vax pt devel approx 15 lesions on trunk.
Noticed yesterday itching on right arm, woke up today and arm has a red circle around injection site
I experienced a stomach ache first, then feeling of nasuea, dizziness, severe sweating for approximately 15 minutes on Feb 27th.  The  sx then went away except for the stomach aches for a few hours afterwards.  Yesterday and today I have experienced feelings of lethargy, fogginess, stomach ache, sore throat, stomach ache and nasal congestion which have faded in an out throughout the day.
lump on left arm; Itching all over; Light headed; Aching joints; Chills; This is a spontaneous report from a contactable consumer, the patient. A 64-years-old non-pregnant female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1070) via an unspecified route of administration in the left arm on 28Apr2021 at 13:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, sjogren's syndrome and asthma.  Patient had many allergies to food and drugs including flu shots. Concomitant medications included loratadine (CLARITIN), guaifenesin (MUCINEX), insulin human zinc suspension (HUMULIN U-500), empagliflozin (JARDIANCE) and mirtazapine (MIRAP), all from unknown dates for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 64-year-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 28Apr2021 at 14:30, the patient experienced itching all over, lump on left arm, light headed, aching joints and chills. Its reported that patient had lump on left arm lasting 7 days (still detectable), itching all over responded to CLARITIN/antihistamine treatment lasted 3 days, light headed lasted 2 days, aching joints 3 days, and chills lasted for 1 day. Therapeutic measures were taken as a result of the event itching all over and included treatment with CLARITIN/antihistamine treatment on an unknown date. The clinical outcome of the event of itching all over  was recovered on 01May2021. The clinical outcome of the event of lump on left arm was recovering at the time of this report. The clinical outcome of the event of chills was recovered on 29Apr2021. The clinical outcome of the event of light headed was recovered on 30Apr2021. The clinical outcome of the event of  aching joints was recovered on 01May2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated event data (Treatment Received selected as Yes and event onset time updated be 2:30pm; duration and stop date/time updated for events).
Patient received Anthrax vaccine aboard ship on 7/4/99, 7/20/99, and 8/10/99 and found diagnosed with ITP on 9/5/99.  No sure if related to Anthrax vaccine.
Inappropriate schedule; This spontaneous report was received from Other Health Professional and refers to a 4-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications were not reported.  On 02-FEB-2023, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 31-MAR-2023, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration).  This one of several reports received from the same reporter.
patient received only 2 doses of GARDASIL 9 when she was 45 years of age. Patient is now 46 years of age; No additional AE reported.; This spontaneous report was received from a pharmacist referring to a 46 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On unknown dates the patient was vaccinated with only 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product quantity: 1; dose, route, lot# and expiration date were not reported) for prophylaxis when she was 45 years old. The patient was now 46 years of age (inappropriate schedule of product administration). No additional adverse event (AE) reported.
After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy.; After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy.; After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Lot number: FF2587) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Verbatim:menstrual cycle started 4 days early), administration date: 20Aug2021, when the patient was 35 years old, for Covid-19 immunization, reaction(s): "menstrual cycle started 4 days early". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION DELAYED (non-serious), DYSMENORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy.". Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation delayed, dysmenorrhoea.  Additional information: It was reported that after receiving the first vaccine, patient menstrual cycle started 4 days early and was lighter than normal. After receiving the second vaccine, my menstrual cycle was late 5 days. The cramps are excessive and bleeding/clots heavy. I have never had disruptions in my cycle regardless of life changes, stressors, etc. I know my body is reacting to this vaccine based off my cycle history and the symptoms I am experiencing. I am regular with a 28-day cycle. Never early. Never late. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. No Known allergies ware reported Device Date: 30Oct2021.  Follow-up attempts are completed. No further information is expected.
Initial unsolicited report received from a nurse on 06 Apr 2016. This case involves a 44-year-old "45-year-old" female patient who was vaccinated with a dose of ADACEL (batch number U5288BA, expiry date not reported) intramuscularly in the left deltoid on 23 December 2015. Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications was not reported. On an unspecified date, one week following the vaccination "first week after vaccination", the patient had pain and redness at the injection site. The pain sometimes shoots down the arm, and it can limit the patient range of motion (ROM) in the arm at times. It was reported that, symptoms had been ongoing from time of vaccination, four months ago. It was reported that patient required emergency room/doctor visit. Patient's lab data and corrective treatment were not reported. The outcome of the events was reported as not recovered. List of documents held by sender: none.
High fever, chills, muscle aches, night sweats, nausea, vomiting, headache. Persisted for 3 days.
stomach hurt like there is a lot of pressure and she have abdominal pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurt like there is a lot of pressure and she have abdominal pain) and BACK PAIN (Back pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson for her covid19. Past adverse reactions to the above products included No adverse event with Johnson and Johnson for her covid19.    On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurt like there is a lot of pressure and she have abdominal pain) and BACK PAIN (Back pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach hurt like there is a lot of pressure and she have abdominal pain) and BACK PAIN (Back pain) outcome was unknown.            NO Concomitant drug reported.
14APR92 fever 101-102, sore leg (ice & Tempra q 4 hrs) mom to call p/8 hrs if still has sx; lump on lt leg where DTP was given 16 APR92 fever 104-105, seen @ MD p/hrs on 15APR92, sore leg, was also given warm showers;
sick; first vaccine in February and did not get the second; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second). At the time of the report, ILLNESS (sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Patient received the first vaccine in February of 2021 but did not get the second because the first made patient sick. The patient wished to receive the second vaccine.  No treatment information provided.
Cellulitis RUA-pt receiving antibiotics pt c/o NIT at site and rusanto RLA. Pt c/o several px RUA. Very hard, red area RU. Started on Zithromax.
Pt. reports she started feeling itchy after receiving vaccine. Vital signs taken and pt. examined by physician. Pt. given Benadryl IM to right gluteal. Pt. continued to be observed. Pt. stable and Dc' d home with instructions to return to ER if symptoms worsen.
1/17  6pm- Body Aches (flu like, no fever), 8pm- Chills, 10pm- Shivering 1/18 no sleep, 9 am- no chills 1/19  8am-no Body Aches, no shoulder pain
This spontaneous report was received from a certified medical assistant and refers to an unspecified numbr of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (lot # M004116, expiration date on 12-OCT-2017 (strength, dose number, route and anatomical location were not reported). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 31.5 degrees Fahrenheit for 125 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 76 year old female with no known allergies and no past medical history, who on Oct 07, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). Concomitant therapy included influenza virus vaccine (Fluzone). On the night of Oct 07, 2002 the patient developed a "local reaction", reported as "swelling at the site of injection". When the patient was seen in the physician's office the next day (Oct 8, 2002), it was reported "the entire area, from front to back of upper arm, shoulder to elbow" was red. Subsequently, the patient recovered. It was noted the patient called the physician office on Oct 11, 2002 and reported her arm was "fine and the condition resolved". Unspecified medical attention was sought. The health professional also reported another patient who had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES0210USA01291).
This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Flaring up of Sinuses), LACRIMATION INCREASED (Watering of eyes) and RHINORRHOEA (Runny nose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Sinusitis. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced SINUSITIS (Flaring up of Sinuses), LACRIMATION INCREASED (Watering of eyes) and RHINORRHOEA (Runny nose). At the time of the report, SINUSITIS (Flaring up of Sinuses), LACRIMATION INCREASED (Watering of eyes) and RHINORRHOEA (Runny nose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.