chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen armpit back chest and arms about 1 day after vaccine left side worse than right  Unable to move my arms straight due to swelling Continuous fever for 3 days while taking ibuprofen Swelling did not decrease  Itchy arms Took Benadryl no improvement
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date in SEP-2021, the patient tested positive for Covid (suspected covid-19 infection), though had vaccinated 3-4 months ago (suspected clinical vaccination failure). Patient had completed a week and a half period of isolation on 03-OCT-2021. The patient stated feeling like hit by a truck after being asked for symptoms and mentioned no hospitalization. The patient was a teacher and likely picked it up at school. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000195910.; Sender's Comments: V0: 20211006359-COVID-19 VACCINE -suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Local swell, erythema, joint pain.  Localized to area of injection, erythema about 8 inches diameter.
Tested positive for COVID-19; Excruciating back pain from neck down to the buttocks; Mild soreness at the injection site; Headache; Fatigue; Chills; Second dose not administered within 35 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days), PAIN (Excruciating back pain from neck down to the buttocks), VACCINATION SITE PAIN (Mild soreness at the injection site) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days). On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness at the injection site), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). On 05-Apr-2021, the patient experienced PAIN (Excruciating back pain from neck down to the buttocks). On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 31-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days) had resolved. On 04-Apr-2021, VACCINATION SITE PAIN (Mild soreness at the injection site) and HEADACHE (Headache) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19), PAIN (Excruciating back pain from neck down to the buttocks), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: positive (Positive) Patient rushed to Emergency Room and he was tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. On 05Apr2021, patient mentioned that together with the fatigue and chills, Patient had experienced excruciating back pain from the neck down to the buttocks rated as 10/10. On 07Apr2021, Patient's pain has gone down to 2-4/10.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Patient's initials, Patient Route of administration and batch number in product tab added. New event added as COVID-19 positive. On 18-May-2021: New event added as Product dose omission. On 02-Jun-2021: Reporter's email address, Address, City and Postal code updated.
Does not feel well; Headache; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 16-year-old female patient (reporter's daughter) that: A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0198), via an unspecified route of administration on 09Jul2021 (at the age of 16-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated I have a question I got a new information about Pfizer that their vaccine is not as effective now because of the new variant. My daughter is 16, so the Pfizer vaccine is the only one she qualified for right now, yesterday she got her first vaccine. Reporter stated she does not feel well today on 10Jul2021, but she said she doesn't eat any Tylenol or anything, she also had a headache on unknown date in Jul2021 that's the only thing. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.
Employee phoned into office c/o fever 100.5, generalized achiness fatigue. Cough, sore arm, but that was mild. Plans to follow-up with primary care provider if does not get better reported on-set  was Saturday for tx. Encouraged to see doctor.
MISSED TO TAKE LAST DOSE OF VIVOTIF ON TIME; This spontaneous case (PVX2019-2275) was received form a nurse on 05-Sep-2019. It described a female consumer who "missed to take last dose of Vivotif on time" (PT: Product dose omission), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif every other day but missed to take fourth dose on time. She had not taken the fourth dose till the time of the report.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed to take last dose of Vivotif on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take last dose of Vivotif on time" was considered as not applicable.
Received VARIVAX 7/9/12, seen on 7/14/12. Rash x 2 more spots everyday. Initially trunk, now on feet. One spot near injection site (Left arm, SQ). Afebrile. No lesions in mouth. Modified chickenpox x secondary vaccine. CALAMINE lotion - BENADRYL.
have numb or tingling areas on my left arm into my wrist and thumb; have numb or tingling areas on my left arm into my wrist and thumb; Initial information received on 25-Nov-2020 regarding an unsolicited valid non-serious case reported by a consumer (patient).  This case involves patient (unknown demographics) who had numb or tingling areas on left arm into wrist and thumb (Hypoaesthesia and Paraesthesia), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date (reported as since few years), (latency unknown) after the initiation of suspect vaccine, the patient had numb or tingling areas on left arm into wrist and thumb (hypoaesthesia and paraesthesia),    No relevant laboratory data was reported.  Action taken with suspect vaccine was not applicable. It was unknown if the patient received a corrective treatment. The events outcome was unknown.  There will be no information available on the batch number for this case.
Patient called today 4/30/21. Reports after first dose, developed knot to left arm, then 2 weeks after shot developed rash to left arm and to lower left leg. No other symptoms. Reports it comes and goes, seems to be worse at night. Using Benadryl and Hydrocortisone cream as needed. Had second dose Moderna 021B21A on 4/8/21 to right arm, reports no problems with second vaccine.  Reports still has the rash come and go to left arm but is better. Advised to see PMD if worsens.
Ischemic cerebrovascular stroke. Patient woke up morning of 1/19/2022 and went into the kitchen to make coffee and knocked something onto the floor, when she bent over to pick it up, she felt dizzy and weak on the left side and had to sit down and then tried to speak and couldn't get any words out. Patient stated it lasted a couple of minutes. Stroke at the right hemisphere MCA distribution without residual deficit
Day 1 - Dizziness aches and pains; increased sense of pain in all normal chronic ache locations Day 2 - severe aches, fever of 101.0
right facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (right facial swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371-21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING FACE (right facial swelling) (seriousness criterion medically significant). At the time of the report, SWELLING FACE (right facial swelling) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Computerised tomogram: inconclusive (Inconclusive) CAT scan did not say anything.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  This case concerns a 70-year-old female with a serious unexpected event of swelling face. Event onset 2 days after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 70-year-old female with a serious unexpected event of swelling face. Event onset 2 days after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
An initial report was received from a doctor's office on 10.Dec.2012 and concerns a 35-year-old female patient who, on 29.Nov.2012, received the first administration of VIVOTIF (batch no: 3000261). The second administration was taken on 01.Dec.2012. Both the first and second administrations of VIVOTIF had not been refrigerated. The patient returned to the doctor's office and was given an new pack of VIVOTIF and she took the first dose from this pack on 03.Dec.2012. The patient's medical history and concomitant medications were not reported. On 04.Dec.2012, the day following her first administration of VIVOTIF from the new pack, ie the third dose, the patient experienced stomach cramps. No further information was available. At the time of reporting, the patient had not yet recovered. The event was reported as non-serious.
blood sugar numbers spiked about 80 points- went to 120 to over 200; This spontaneous case was reported by a consumer and describes the occurrence of   in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy ("Loratad"), Fibroids, Diabetes, Blood pressure high and Stenosis.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with METFORMIN ongoing since an unknown date for Blood sugar increased, at a dose of UNK, bid.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose: 120 to over 200 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included "several prescribed medications" to treat the conditions of fibroids, diabetes, high blood pressure and stenosis.
Redness, Pain, Hard knot the size of a fist, rash, lasting 2-3 weeks.
This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 54-year-old female patient who received FLULAVAL (batch number unknown, expiry date unknown). Previously administered products included eye drops with an associated reaction of hypersensitivity (to thimerosal because of a reaction she had to some eye drops that contained thimerosal in the past). Concurrent medical conditions included drug allergy (to thimerosal). In 2011, the patient received FLULAVAL (intramuscular). On an unknown date, the dose was an unknown dose. In 2011, an unknown time after receiving FLULAVAL, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved. The reporter considered the generalized rash to be related to FLULAVAL. Additional details provided: Caller reported that she received a flu vaccine 3 years ago, probably the fall of 2011, and she broke out in a full body rash that looked like a sun burn that lasted for 7-10 days. The rash started the evening of receiving the vaccine, or the next evening, and it was all over her body by the morning after the rash started. The flu vaccine she received that year was from a multi-dose vial, so she thought it likely had thimerosal in it. While she had not received any additional flu vaccines since 2011, she has received other vaccines like pneumonia and yellow fever due to the traveling that she did and did not have a reaction to any of those vaccines. She knew that all the vaccines she had received since have been from single dose vials or syringes and do not contain thimerosal.
PT recvd vax 10DEC92 & had seizure w/o prior sx in home; sz x 3 w/cessation of resp & spontaneous respiration reoccuring 20JAN; taken to ER reported fever of 108.1; fever reportedly difficult to control x 3 days w/tx;
Significant muscle aches (myalgia) and joint pain of all joints: lasted 48 hrs. (gradual onset). Peaked during the night 10/25/09 until AM. Called MD, rec NSAIDS-call if worsened.
her arm was just a little sore/ it was a little sore but nothing compared to the first one; This is a spontaneous report from a contactable consumer or other non hcp.   A 73-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 as SINGLE DOSE for covid-19 immunization.  after receiving the 1st dose of the Pfizer COVID vaccine on 20Jan2021 and 2nd dose on 11Feb2021. She reports a lot of pain with the first one however it coincided with an MRI for a fusion surgery on C5 and C6, a pinched nerve from bending her neck. The 2nd dose in her right arm coincided with a treatment of metho-prednisolone. She reports the vaccination was given higher a bit higher on the arm, she believes it may have been in the nerve rather than the muscle. The pain was from her scapula down throughout the elbow to the forearm and to her fingers on that side. With the second shot, it was given on 11Feb2021 and though she wanted to get it on the same side, with all the issues she was experiencing she got it in the right arm so she would know the difference. It was given more in the middle of her arm, like what she is used to, and it was a little sore, but nothing compared to the first one. For the first injection, her arm was very sore for 2 and half days after the shot. With the second shot, her arm was just a little sore, it was like it wasn't anything in comparison. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on 12Feb2021.   No follow-up attempts are possible, and no information is expired.
Developed covid-like symptoms a few days after receiving booster dose of Moderna. Positive test in clinic.  Scheduled as outpatient to receive monoclonal antibody infusion.
pt recv vax 9OCT95 & pt devel redness @ the inj site;no tx necessary;pt recovered;
More than 36 days after the first dose without receiving the second dose/5 months after the first dose, Not received the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose/5 months after the first dose, Not received the 2nd dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Immune thrombocytopenia (He states that he has a preexisting health condition of Immune thrombocytopenia (ITP) due to a flu virus. He states he is in remission so he has gone about the low level (it is 100000 and he is now at 125000 or 150000).).    On 06-Apr-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose/5 months after the first dose, Not received the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose/5 months after the first dose, Not received the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Patient states that he has a preexisting health condition of Immune thrombocytopenia (ITP) due to a flu virus and he is in remission so he has gone about the low level (it is 100000 and he is now at 125000 or 150000).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant Follow up received on 16-SEP-2021 and batch number is updated.
Patient received 2nd dose of Moderna COVID-19 vaccine and is not 18 yo. Also received first dose 28 days prior bu t was not caught at that time.  patinet has not experienced any adverse events from the vaccines.
Hypoaesthesia; Tingling; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (Tingling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, ANASTROZOLE (ARIMIDEX) and HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN + HIDROCLOROTIAZIDA) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (Tingling). At the time of the report, HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (Tingling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: ct scan Negative brain normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included Carbamazepine .
Stuffy head stuffy nose; Aches and pains; Chills; Fever; Sick from first dose; I might be allergic; This case was reported by a consumer via (Shingrix GSK  interactive digital media and described the occurrence of nasal stuffiness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced nasal stuffiness, pain, chills, fever, sickness and allergic reaction. On an unknown date, the outcome of the nasal stuffiness, pain, chills, fever, sickness and allergic reaction were unknown.   It was unknown if the reporter considered the nasal stuffiness, pain, chills, fever, sickness and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix a day before reporting. On an unknown date, in May 2021, the patient had stuffy head-stuffy nose aches, pains, chills, fever, allergic reaction and was sick from the shot. The patient was asked about inactive ingredients of vaccine as the patient might be allergic.
Large local reaction- red, raised, warm and tender to touch per mother's report; she did not measure the size.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 20-APR-2017, the patient may have been vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M025869 with expiration date of 24-MAY-2018, or an improperly stored dose of PROQUAD (dose, frequency and route were not reported) lot # M019233 with expiration date of 17-OCT-2017, for prophylaxis. The medical assistant was not sure which one of the vaccines the patient received. The temperature of the VARIVAX and the PROQUAD was between 15 °F and 46 °F (32.4 °F) for a time frame of 2 hours and 30 minutes. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. There was no product quality complaint (PQC) involved. Additional information has been requested.
Almost immediately after vaccination, patient got very dizzy and had to lay down in vaccination room.  She then passed out while her daughter was sitting with her on the bench.  She regained consciousness very quickly and was alert when the emergency personnel showed up to check her out.  Her blood pressure and blood sugar was normal when taken by emergency personnel and she went home with her daughter ~30 minutes after receiving vaccine..
Narrative:  Pt was a 96 YO male with PMH of CAD, bladder cancer, HTN, and HLD. Per medical record, pt passed away with COD of CHF.