chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick) 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.    In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was sick). At the time of the report, ILLNESS (Was sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported. Due to various circumstances the patient does not received the second dose of the vaccine.   This case was linked to MOD-2021-406188 (Patient Link).   Reporter did not allow further contact
sore throat; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore arm at injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore arm at injection site). The patient was treated with ASCORBIC ACID (VITAMIN C ACID) at a dose of 4000 IU; CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ALKA-SELTZER PLUS COLD [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency; ORIGANUM MINUTIFLORUM OIL (OREGANO OIL) at an unspecified dose and frequency and CURCUMA LONGA ROOT, PIPER NIGRUM FRUIT (TURMERIC SUPREME EXTRA STRENGTH) at an unspecified dose and frequency. On 06-Mar-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
STOMACH PAIN; TOOTH ABSCESS; VERTIGO; DIZZINESS; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's weight was 130 pounds, and height was 66 inches. The patient's concurrent conditions included: alcohol use/seldomly drinks champagne, eggs allergy manifested by upset stomach, dust allergy manifested by watery eyes and sneezing, and no tobacco use. The patient experienced inflammation and skin rash in the injection site when treated with etanercept, and adalimumab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number was not reported) 15 mg, 1 time every 1 day from JAN-2021 to 12-MAR-2021, and 15 mg, 1 time every 1 day from 27-MAR-2021 to JUN-2021 for rheumatoid arthritis. Concomitant medications included sertraline for depression, thyroid for hypothyroidism, celecoxib for rheumatoid arthritis, and tramadol for rheumatoid arthritis, and pain.  On 13-MAR-2021, the patient experienced vertigo, dizziness, and nausea. On unspecified date in MAY-2021, the patient experienced tooth abscess. On 16-JUL-2021, the patient had removal of tooth because of the tooth abscess and had bone graft to replace the tooth. The patient had two rounds of antibiotics before pulling the tooth. On unspecified date in JUL-2021, the patient experienced stomach pain.  On 03-AUG-2021, Laboratory data included: Complete blood count (NR: not provided) No results reported, Comprehensive metabolic panel (NR: not provided) No results reported, and Helicobacter pylori identification test (NR: not provided) No results reported. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, and dizziness on 27-MAR-2021, tooth abscess on JUL-2021 and nausea on 10-AUG-2021, and was recovering from stomach pain. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and event tooth abscess as not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210836107-Covid-19 vaccine ad26.cov2.s-Tooth abscess . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD lot # K007158, expiration date 12-NOV-2015 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
There was an excursion from their freezer/they were administered to 118 patients.; There was temperature excursion from  freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from  freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from  freezer). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from  freezer) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received which included patient details (initials, age, gender) and vaccine information ( date of vaccination, dose number).
No adverse effects reported; Nurse reported that one dose of VARIVAX was inadvertently administered past it's expiry, to the patient on 6/28/2019; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 28-JUN-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # N017699 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 09-JUN-2019 but upon internal validation established as 09-JUN-2019, for prophylaxis (strength, dose and route of administration were not reported).    No adverse effects reported.
Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and had many of the side effects. The patient was asking how long the side effects lasts.
It started with minor stomach pain and within two hours it turned in to major shrills. I had to interrupt dinner, go home with an absolute chilling feeling. I went immediately to bed fully clothed and stayed that way for 4 hours.
Resting heart rate of 120 for over 12 hours. It began immediately.  Laying down heart rate was between 115-120 I got my injection, a few minutes later my heart was fast, but I left anyway. My heart was fast through the day, but manageable. At night I fell asleep, and woke up 1.5 hours later to a heart rate of 123. I got up to use the bathroom and could barely breathe because it jumped to 140 while walking the 10 feet to the bathroom.  My heart stayed that fast until the morning
FEVER AND CHILLS - 102.5 fever - severe chills and feeling hot at the same time.  Large red welt on arm
Arm redness (R) deltoid 2 days after, after removal of bandage, some in shape of bandage. No fever.
Tinnitus and body aches. Tinnitus has lowered but still "hisses"
Red raised bumps, rash on abdomen that started approximately a week after second dose, spread quickly. After biopsy, diagnosed as roseola. Treated with triamcinolone acetonide steroid cream. Went away in a few weeks.
Arm was incredibly painful the same night. It felt stiff and it hurt to move it. This continued for a few days. Thought my bicep was going to explode.
patient reports numbness at the vaccination site. site assessed, no swelling, no rash. patient was able to move arm without any difficulty. i observed patient for 20 minutes, was fine.
I got the second shot at 6:30 PM on Tuesday 9/14. Around 2:30 PM on Wednesday 9/15, severe muscle aches began. The severity of the muscle aches cannot be understated -- it was worse than when I had H1N1 and was the worst illness I have had in eight years. I also got a low-grade fever (I have not had a fever since 2014) and dizziness that evening. The muscle aches, fever, and dizziness were gone by the next day after sleeping for 11 hours. However, the lymph node in my armpit was swollen and painful for a few days after that. The lymph node symptom now appears to be gone. I also was very tired until Monday 9/20 and had trouble getting out of bed and was sleeping more than usual. My hair has also been falling out in clumps since around Thursday 9/16. Also, I have been having recurring problems with my muscles since Thursday 9/16. My muscles now keep getting injured. Since getting the vaccine I have gotten significant muscle strains in my right calf, right foot, left abdominal area, and left back area. I walk every day and today I had to get my husband to drive and pick me up in the middle of my walk due to severe pain in my right foot. Another walk that I did on Saturday 9/18 had to be cut short due to pain in my right calf. This has not happened before getting the vaccine, let alone twice in one week.
It was reported that a pt (3 of 7) received Fluzone 98-99 between 10/3/98 and 10/6/98. Reportedly the pt experienced vomiting and diarrhea.
The first three days after 1st vaccine, my left arm was sore and tender from shot, then it cleared up and the pain left.  About seven days later, my left arm became sore and tender to touch again.  About four days after that, my major muscles and joints started aching as well.  Now, I am experiencing pain and stiffness in upper arms, thigh muscles and both knees, shoulders and left wrist joints. I don't know why this is happening to me.
Lymph node on neck swelled up on the left side; Left side of throat was hurting and then as the days progressed it started to get more sore; made things difficult to swallow bc of the pain.; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: F3181) via an unspecified route of administration in the left arm on 09Aug2021 at 12:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, asthma, post-traumatic stress disorder (C-PTSD), known allergy to environmental and treenuts. 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. Concomitant medications included pregabalin (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN) and lamotrigine (LAMICTAL); all for an unknown indication from an unknown start date and unknown if ongoing. On 12Aug2021 at 17:00, the patient experienced lymph node on neck swelled up on the left side and left side of throat was hurting. As the days progressed it started to get more sore and made things difficult to swallow because of the pain. The patient had fibromyalgia and was not sure if her condition didn't react well to this vaccine. 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 lymph node on neck swelled up on the left side, left side of throat was hurting and difficult to swallow was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
sore arms; Tiredness; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (sore arms) and FATIGUE (Tiredness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arms) and FATIGUE (Tiredness). At the time of the report, PAIN IN EXTREMITY (sore arms) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter.  The treatment information was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-026625.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026625
my face, particularly the right side, started itching; Breaking out in welts on my face; Over the next hour, my throat got itchy; right side of my face swelled; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 03Mar2021 at 13:00 (at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history included allergic reaction to melon. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and tocopherol (VITAMIN E); all for unspecified indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 22Jan2021 at 14:00 (at the age of 43-year-old), as a single dose for COVID-19 immunisation.  On 05Mar2021 at 07:30, the patient was driving home from PT (working out) in the morning, and patient's face particularly the right side started itching and breaking out in welts on face. Over the next hour, throat got itchy and the right side of face was swelled. The patient went to the clinic and they told the patient to take Benadryl. The patient took 2 benadryl, and the swelling went down after several hours. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with diphenhydramine hydrochloride (BENADRYL) from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events face particularly the right side started itching and breaking out in welts on face. Over the next hour throat got itchy and the right side of face was swelled was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 1:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 1:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.89 for dose administered on 03-Mar-2021. No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 to 35 degrees Fahrenheit from 09:00 PM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Information has been received from a registered nurse concerning a 40 year old female who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) "as a child" (Lot number not reported).  On 07/29/2002, laboratory evaluations revealed a titer for rubella was negative.  Unspecified medical attention was sought.  Additional information has been requested.
pt recv vax & devel rash;pt called clinic-no fever by evening rash on neck;31OCT96 no noticeable rash;1NOV96 rash on lower arms & tops of hands;2NOV96 rash again on ankles & lower legs;like mosquito bites;
BODY PAIN; THREW UP; SICK; CHILLS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. 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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced body pain. On 2021, the subject experienced threw up. On 2021, the subject experienced sick. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, threw up, sick, and chills on 2021. This report was non-serious.
GENERALIZED ACHES AND PAINS  Narrative:  73 yo male with PMH: T2DM, vitamin D deficiency, obesity, HLP and HTN reported generalized aches and pains after his first dose of covid19 vaccine on 2/9/2021. Pt said it lasted for 4 days. This was reported when he  received his second dose of vaccine on 3/2/2021/
swelling of lymph nodes; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration on 09Feb2021 (at the age of 80-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that, she had a first shot of Pfizer vaccine this morning which went fine. Stated that, she was told they would receive invitation to line up another shot and she did. Stated that, she had a fact sheet that listed reactions and the last one was swelling of lymph nodes sometimes. Stated that, she has a CT scan on her neck lined up to check lymph nodes and wanted to know whether she needed to cancel. Wanted to know whether she can get some information on this and was it safe for her to get the COVID vaccine. Clarified that, it was for Pfizer COVID vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
My son woke up short of breath, heart rate was 99 BPM, 30 min later was 100, 30 min later 126. Called ER. Was told bring him in immediately, this is not normal. They did blood work, chest x ray, EKG, gave him medication to slow down heart was told he may have myocarditis. After all test he was said to be ok and heart will go back down to normal.