chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness in left injection site arm after second Moderna Covid-19 injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in left injection site arm after second Moderna Covid-19 injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in left injection site arm after second Moderna Covid-19 injection). At the time of the report, VACCINATION SITE PAIN (soreness in left injection site arm after second Moderna Covid-19 injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.   This case was linked to MOD-2021-390866 (Patient Link).
CLINICAL IMPRESSION 1. Cough 2. COVID-19 virus infection 3. Hypoxemia 4. Elevated troponin 5. Generalized weakness 6. Nonintractable epilepsy without status epilepticus, unspecified epilepsy type 7. Essential hypertension, benign
11/05/2003: Phone call to office.  Stated she had fever and chills.  All over shaking.  Complained of severe headache; shot arm swollen, nausea.  Advised to take Benadryl 50mg every 4-6 hours, Tylenol every 4-6 hours.  Drink plenty of liquids and rest.  Symptoms started night of injection better by 18:00 next day.  11/06/2006: PC to patient almost totally recovered.
Developed a fever of 101.4 F, pain and some swelling at injection site, chills, full body pain, dizziness, hive/rash around site and fatigue started during evening of vaccine. Slept throughout weekend. The rash continued to spread on extremities in a scattered pattern and became extremely itchy. Used Benadryl oral and cream. Knew some adverse effects occur, thought they'd go away. Rash & itching continued. Went to Urgent Care on 8/5/2021, by then just looked like a scattered rash over extremities and trunk (esp. buttocks, midsection). Given Methylprednisolone 4mg Dose Pak 21S & Triamcinolone Acetonide Cream 0.5%. Rash improved but not gone and still very itchy but not as bad. Following up with primary doctor on 8/20/2021.
getting jittery; tense; antsy; keyed up; blood pressure:  154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself.  A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010),  allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up".  She took her blood pressure and it was 154/85. One hour later it was 148/89.  Two hours later it was 158/88.  The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86.  At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings.  On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal.  Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure:  154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Ears filled with fluid 11/24/21 - 11/29/21 with no other symptoms, went to 1st choice urgent care on 11/28, did not start medication 11/29/21 as directed as ears clears.   Tinnitus in started 12/13/2021.   Have been given numerous medications in an attempt to reverse, MRI was performed, no health issues found, no ear infection, Tinnitus still present as of 2/22/22, since all medical reasons have been eliminated and due to the short time between vaccination and inner ear fluid, I am believing the vaccination started a domino effect of events ending in Tinnitus which seems to be permanent.
Enlarged red area under the arm, tingling, burning, itching.  Patient self medicated with Benadryl tablets, Aloe Vera Gel for 3-4 days and reddened area decreased in size.  Patient did not contact MD because she felt like there was nothing more they can do.
Arm still feel tender after two months; Arm still sore after two months; 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 TENDERNESS (Arm still feel tender after two months) and PAIN IN EXTREMITY (Arm still sore after two months) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Arm still feel tender after two months) and PAIN IN EXTREMITY (Arm still sore after two months). At the time of the report, TENDERNESS (Arm still feel tender after two months) and PAIN IN EXTREMITY (Arm still sore after two months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Chills, fatigue and 101 fever 24 hours after vac. Symptoms gone in 6 hours. Redness, swelling and subcutaneous hardness with blistering  on skin 3 days after injection. Still currently with symptoms.
Next day, body aches, headache,  joint pain, high fever up to 103.
Information has been received from a physician concerning female patients who were vaccinated with a dose of Gardasil. Subsequently all patients are complaining of burning at the injection site. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 14-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperatures 32. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
She got her vaccine, about 12 hours later initially started with soreness in the left arm, heavy feeling.  Throbbing headache, fatigue and then throughout the night she could not sleep at all, shaking from not being at all.  Her DKA blood sugars around 411, checked every 45 minutes, checked her ketones every couple of hours and they were large, and was drained from energy.  Had highest blood sugar was 411.  Kept monitoring this and if she cannot resolve the issue on her own then she has to seek medical help.  She kept increasing  her doses of insulin until it started to decrease.  On Friday around 7:00 PM is when she got it down to normal parameters, and checked it every 45 minutes to make sure that it did not go up.  The ketones were at the highest level that they could go.    Her blood sugars were under good control prior to the vaccine with normal being 90-130.
10/25/2002 Pt received flu shot and pheumonia shot . Arm received pheumonia shot in QT red and warm to touch. Started on 10/26/2002
Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on 15Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 vaccine. On an unknown date in Apr2021, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Additional Details: Patient seemed to have a panic attack. daughter gave her ativan and it immediately resolved
This spontaneous report as received from a registered nurse refers to a 4 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Multiple small red raised non itchy non painful bumps located over the left upper arm and left shoulder. Afebrile. No other reported symptoms.
Ten days post vax, the pt experienced a mild rash that was smooth on her stomach and bumpy on her legs. The bumps were small. She also experienced a red bump on her face. The pt was also fussy since she developed the rash. No further information is available.
Information has been received from a registered nurse concerning a 6-year-old white male with an allergy amoxicillin and strawberries who on 06-AUG-2002 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck) (lot # 640488/0267M). There were no illness at the time of vaccination. On 24-SEP-2007 the patient developed 15 papular lesions on his lower abdomen and buttock as well as an earache. No diagnostic labs were performed. On 02-OCT-2007 (also reported as 02-OCT-2006), the patient recovered. It was reported the patient's sibling had an adverse experience WAES #0712USA01634. Additional information is not expected.
Pt c/o burning sensation and pain in LUE. Pt has medium sized raised area on LUE. On 06/03- blue, warm to touch with mild swelling and red streaking posterorly above elbow to shoulder.
Palpitations, fatigue, mental fogginess within 72 hours of second vaccine.
The patient came in today, and said that her arm swelled up drastically, and turned bright red after receiving the immunization.  She said she spoke to another pharmacist, and they told her it was a typical reaction.  She said that she had a similar reaction to the flu shot last year.  As of today (11/18/19), she said the swelling has reduced significantly, but the arm is still red.  I didn't see her arm, but I encouraged her to speak to her doctor.  She had an appointment scheduled already, but it got pushed back.  I told her that if it isn't better in a few days, or it starts getting worse, she needs to go see her doctor.
Information has been received from an RN concerning a child who was vaccinated with varicella virus vaccine live in 10/01 (exact date and lot # not provided). Subsequently, the child was hospitalized and dx'd with juvenile diabetes. The RN reported that this was a case of hearsay and she was hesitant to release information. A visiting nurse indicated that the pt's mother was grasping for causes of the diabetes and informed the visiting nurse that she has been told that diabetes can be caused by a virus that attacks the pancreas. The mother has identified the virus as the varicella virus. The RN noted that this association of the virus and the diabetes has not been reported by any medical professional, only the mother of the child. Additional info has been requested.
Smallpox vax. Had contact w/husband's vax site. Husband received vax thru the military. Exposure occurred 3 wks ago. Facial lesions and a lesion on right arm.
No adverse event; 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 NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant drugs included no treatment drugs included
Muscle spasms in right arm, not the arm where injection was made.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not have allergy to any medications, food, or other products. The patients past drug was reported as no. Concomitant medications taken within two weeks prior to the vaccination included ibuprofen (MANUFACTURER UNKNOWN) from unknown date for unknown indication. 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 26Apr2021 at 16:30, the patient experienced muscle spasms in right arm, not the arm where injection was made. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event.  The clinical outcome of the event muscle spasms in right arm, not the arm where injection was made was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Syncopal episode about 13 hours after injection and extreme thirst, severe fatigue that continues-unable to work added due to covid long haul symptoms chest pain, stomach pain, brain fog, just do not feel like self.
periorbital edema 1-2hr p/vax; rx cold compresses & DPH;
died from the 2x flu vaccines and ventilator; Initial information was received on 25-Nov-2020 regarding an unsolicited valid serious case received from a consumer (patient's relative) via social media.  This case involves a male patient (unknown age) who was died from the 2x flu vaccines and ventilator (death), while he received INFLUENZA VACCINE.  Medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who was on ventilator was died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented social media case received from social media involves a male patient (unknown age) who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. The patient was on ventilator. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Information has been received from a registered nurse concerning a 25 month old white male with no known drug allergies who on 23 May 2000 was vaccinated at 16:30 with a first dose of varicella virus vaccine live, SC in the left thigh (lot #634837/1862J). Concomitant therapy on 23 MAY 2000 at 16:30 included a third dose IM in the right thigh of hib conj-hepatitis b vaccine (lot #634236/0290K), a first dose, SQ in the right thigh of MMR vaccine (lot #630385/0049K) and a first dose, IM in the right thigh of streptococcus pneumoniae vaccine (PREVNAR) (lot #471204). On 15 JUN 2001 at 16:00 the patient experienced a chicken pox breakthrough with minimal lesions of trunk and limbs. The patient was not distressed at the time of vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
This is a spontaneous report received from a contactable Nurse via Pfizer sales representative. This female Nurse (reporting for herself) reported that a female patient of unspecified age received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she experienced hurt arm, swelled up and it was red and it hurt her for almost a week and she had to stay home from work because of it. Outcome of the events was unknown.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-SEP-2013, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
trembling in his toes; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (trembling in his toes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetic. Concomitant products included METFORMIN for Diabetes mellitus.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (trembling in his toes). At the time of the report, TREMOR (trembling in his toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included blood pressure medication  No treatment details reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received contained non significant information. The reporter's contact information updated.
pain, itching & redness @ site of inject-spreading; inflamed swollen area 10x15cm rt deltoid
Patient reports numbness & tingling with a heavy arm 10 minutes post vaccination. V/S taken WNL. BP-126/92, HR 80, SPO2 98%, RR-18. Patient given electrolytes for rehydration. Patient reports suffering from medical PTSD of 15 years ago. Pt observed for additional 15 minutes. Pt discharged at 1705. BP 126/92 HR 80 O2 Sat -98% Pt reports tingling & numb in (R) fingertips, arms heavy 5lb.
Chills, body aches,  headache, BP increased, pulse increased, lightheadedness, sweats the day after the vaccine.  (The evening and the whole night.)