chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; chills; fever; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves female patient unknown age who was sick (malaise), had chills (chills) and fever (pyrexia), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Breast cancer.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious events sick (malaise), chills (chills) and fever (pyrexia), next day (1 day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported.  Final diagnosis was fever, chills and sick.  It was not reported if the patient received a corrective treatment.  The outcome of the events was not reported.  Reporter felt these events were as a result of the vaccine.  Information on the batch number was requested.  List of documents held by sender: none.
Pt. with hx of seizure activity with vaccination displayed seizure like activity approximately twenty minutes after second dose of vaccine. No LOC. Pt. experienced no respiratory distress during incident. Activity lasted 3 minutes. Pt. presented confused and lethargic after activity. EMS involved and initial vitals were stable. Pt. A&Ox4, states this is similar to seizure activity experienced within the last month and chronically. EMS released pt. to home, pt. exited facility in company of family who affirmed they were driving pt. home and would remain with pt. through the rest of the day.
One week after second Pfizer Vaccine my arm felt pain from my hand up to over my shoulder. I thought it may be arthritis or a possible fracture. I waited it got worst. Went to Orthopedic doctor they couldn?t find anything. So I went to Chiropractor thinking it may be a pinched nerve. Showed doctor a rash developing on my hand & arm. He said it was shingles. Went to urgent care & doctor diagnosed as shingles and gave meds. A few days later I was rushed to hospital thinking I was having heart attack.  Hospital tests showed no heart attack. Still dealing with shingles & pain & numbness in arm & hand.
Narrative: COVID infection following COVID vaccine series 01/6, Pfizer, dose #1 02/17, Pfizer, dose #2 08/16 pt cc: loss of taste or smell, exposure: unknown 08/18 COVID swab, result: detected at a private Hospital/Urgent Care Clinic 08/25 COVID swab, result: detected
FLU LIKE BODY ACHES THAT WAS REALLY BAD; CHILLS; MILD FEVER; SORE ARM ON INJECTION SITE FELT LIKE PUNCH IN THE ARM FELT LIKE SORE FOR A WHILE; DID NOT FEEL CLEAR HEADED AND FELT UNCOMFORTABLE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild asthma, and sulfonamide allergy, and other pre-existing medical conditions included: The patient's mother had pre-eclampsia. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the patient experienced did not feel clear headed and felt uncomfortable, mild fever, and sore arm on injection site felt like punch in the arm felt like sore for a while. On 13-APR-2021, the patient experienced flu like body aches that was really bad, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like body aches that was really bad, and chills on 13-APR-2021, did not feel clear headed and felt uncomfortable, and sore arm on injection site felt like punch in the arm felt like sore for a while on 19-APR-2021, and mild fever on 18-APR-2021. This report was non-serious.
Initial report was received on 09 January 2012 from a health care professional. A 68 year-old female patient with a history of elevated blood pressure had received on 30 November 2011 an intramuscular left deltoid injection of FLUZONE HIGH-DOSE, Lot number UH490AA, the next day on 30 November 2011, the patient experienced tingling and weakness in the left arm and sensation of coldness in the left arm. The symptoms still persist "a little over a month later." Concomitant medications included: Losartan and Furosemide. The patient had no illness at time of vaccination. No further information was available at time of the report. The patient's outcome was reported as not recovered. Documents held by sender: None.
Hives on neck, progressive. Pt notified her own MD. Took Benadryl q 4-6. Did for 24 hrs, then fine. Not to get #3 in series, (did not see DR).
Patient's stomach began to hurt and felt like it was in "knots", wanted to lay down ;
The pt experienced a fever, achiness, and body pain. Unspecified medical attention was sought. Additional information has been requested.
Red irritated skin/rash at injection site, warm to the touch.  No issues for the first week after injection other than slight soreness, rash appeared at 7 days post vaccine.
Arm soreness and redness around injection site to the point of not being able to use it often. Hives broke out on my right arm. Waves of exhaustion would hit me. One minute I was awake and alert. The next I could feel the blood rush from my head and I was almost asleep.
A few hours after my booster, I experienced unsteadiness/dizziness/ear popping.   Daily I still have very  feelings of unsteadiness, a high pitch (tinnitis), but just briefly a few times a day.  I tried flonase, took a course of prednisone and while the feelings of unsteadiness have greatly improved, I still have tinnitus  and  Am still not 100%?
I felt dizzy and started to sweat after the vaccine. The next day I didn't feel way. By Monday, I felt the tingle I would get with the onset of my Bells Palsy and by the time I reached the doctor I felt my face drooping. I was prescribed some medication and it went away.
On 6/19/00 at 16:00, the pt received her 1st dose of Lymerix and at 18:00, her left arm felt "like she got hit with a sledge hammer". Subsequently, she had "no energy", and experienced flu-like symptoms, chills and redness at the injection site. She was treated with ice and ibuprofen. The most recent information, received on 6/20/00, reports the chills as having resolved on 6/20/00 and the other events as being unresolved.
Patient / received only the adjuvant; Patient / received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 34SD3, expiry date 15th November 2022) for prophylaxis.   On 18th August 2021, the patient received Shingrix. On 18th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The pharmacist reported a male patient had received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via Email.
This spontaneous report as received from a certified medical assistant refers to a 41 year old female patient. On 20-AUG-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (Lot # reported as J001389, expiration date 07-NOV-2014). The medical assistant reported that on 20-AUG-2013, 45 min after vaccination, the patient experienced raised rash on her neck. The patient was treated with BENADRYL. There were no Lab/diagnosis or studies performed. The outcome of raised rash was reported as recovering/resolving. Additional information has been requested.
Bexsero administered subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Men B NVS (Bexsero) (batch number ABXB60BA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Bexsero subcutaneously into the left arm, which led to intramuscular formulation administered by other route. The reporter did not provide patient information at time of call. The reporter consented to follow-up via mail.
Patient noticed a circular rash (1 1/2 - 2 inches in diameter) at injection site. Redness and slight warm to touch. Patient advised to try BENADRYL, ice to site, and follow up with Dr. next day if no improvement. No swelling.
Headache. Stiffening of U.E. associated with falling asleep. Afebrile, no NIV/D. Advised Motrin, Tylenol.
This spontaneous report as received from a health care worker refers to an 84 year old female patient. The patient was allergic to FLAGYL, BACTRIM, erythromycin, MACROBID and PEN-VEEK. On 04-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23(lot number reported as H0110916, expiry date 14-feb-2015, route and dose were not reported). On 05-DEC-2012, the patient experienced swelling and intense pain. On 06-DEC-2012, the patients family member called and reported that the patient was feeling tired and weak and the swelling had moved down to anterior and posterior area around elbow, well below injection site and also reported a large pocket of fluid behind elbow. The patient had received PNEUMOVAX23(lot#, expiry not reported) back on an unspecified date in 2000. The patient sought medical attention (called office).Patient was treated with prednisone. The outcome of all the reported events was unknown. Additional information has been requested.
Pt described an increasing soreness at injection site which advanced to not being able to move arm by the end of the day 7/11.  By 7/12 pt states the discomfort started moving up her neck to her jaw.  Jaw very sore to touch and when she bent forward the pressure was extremely painful.  All joints began to become painful, difficulty making a fist with her hands, ankles, knees sore.  Persistent dry cough developed.  No fever.  Injection site with large area of induration but no advancing erythema.  Went to see PCP who recommended OTC antihistamine.
Information has been received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with doses of improperly stored (Merck) VARIVAX (dose, dose #, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
2/4/21 - awoke from sleep 11 PM with jaw/teeth pain lasting several hours 2/5/21 - extreme weakness, rapid heartbeat, fatigue. Slept on and off all day. 2/ 6 - 2/8/21 - irregular heartbeat, rapid heartbeat, fatigue 2/8/ 21 - appt with primary car, Physician 3:30PM, EKG showed afib,  BP 178/100, pulse 140 - sent directly to ER for further testing. Physician  in ER: cardiac enzymes normal, chest xray normal, administered metoprolol IV which decreased heartrate from 140 to 84. Prescribed Metoprolol 25MG 2x/day and follow up with cardiologist. 2/8/- 2/12/21 - with metoprolol heart rate remained in 80s, weakness, fatigue 2/12/21 - appt with cardiology; Physician Assistant - EKG showed afib, heartrate 80, BP 142/80 - ordered echocardiogram 2/18/21
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013543: US-009507513-1708USA013544.
Pt took H1N1 shot at 3:29 pm on Jan. 25, 2010. After about 10 mins. pt started feeling dizziness and SOB. Pt sent to ER.
Pt recvd 3 doses of Engerix-B 25APR91, 24MAY91 & 23OCT91 the 1st & 3rd dose in lt deltoid & 2nd dose administered in rt deltoid; 25NOV91 it was determined that pt had no antibodies when tested; recvd booster dose 10DEC91 and Abs present;
A report has been received from a Health Professional concerning a 19 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 16-Dec-2014. It was reported that the patient was administered FLUMIST quadrivalent which started on 16-Dec-2014. The outcome of the event of expired FLUMIST quadrivalent administered is unknown. The report was considered to be non-serious.
pt recv vax 11NOV98 & child cried for approx 2min & then let up;had mild redness in rt leg but soon faded a/child lt office;w/in 24hr mom called stating rt leg swollen, very red & very warm to touch & child extremely cranky;no temp;
Pt. describes swelling in arm with lumps around axilla and mid upper ark States fourth and fifth fingers on left had are numb and weak.
Case number PHEH2014US020985 is an initial spontaneous report received from a nurse on 17 Oct 2014. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 15 Oct 2014, she was vaccinated with FLUCELVAX (batch number: 015031A) intramuscularly at an age of eight years. No adverse events were reported following this medication error.
This case was reported by a pharmacist via call center representative and described the occurrence of induration in a patient who received FLULAVAL. On 7th October 2015, the patient received FLULAVAL. On 7th October 2015, less than a day after receiving FLULAVAL, the patient experienced induration. On an unknown date, the outcome of the induration was unknown. It was unknown if the reporter considered the induration to be relataed to FLULAVAL. Additional details were received as follows: This case was previously reported to doctor. This case has been linked with cases, US2015142209, US2015142212 and US2015142208 reported by the same reporter.
I had an enormous increase in trigeminal neuralgia attacks starting within days after getting the flu vaccine. Before that time I would only get a few attacks per year, but following the vaccine, this increased to daily and then to multiple times per day. They ranged from mild to extremely painful. I've been keeping a daily log of how often and how painful each attack is. Some are excruciating, but only last for a second. It has affected everyday life and for days at a time, I couldn't even touch the side of my head to my pillow at night without it triggering an attack. This lasted over 2 months and then dissipated. For the most part, I am back to normal, but still get mild attacks on occasion. I have the autoimmune disease, Type 1 Diabetes and following the same timeline as the trigeminal neuralgia attacks above, my insulin sensitivity also changed. I fought with this for weeks with multiple pump adjustments before finally ending up doubling my daily insulin amounts. This was an abrupt change following that starting within a couple days of getting the vaccine. Blood sugars are back to normal now, but I'm still using double amounts of insulin to achieve this. I am VERY picky about my blood sugar levels, have had Type 1 Diabetes for over 10 years, and have never had this kind of issue with my levels. Both of the above concerns have exhausted my days at times, have affected me at work, and taken valuable time away from my family.
On 4/29/21 around 9 PM, I started feeling chills, fever, severe headache, muscle aches all over my body.  I felt weak and tired throughout the night of the 29th. By morning most side effects subdued but still felt weak and tired.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information on concomitant medications, medical history and concurrent conditions. On 13-DEC-2016, the patient was inadvertently administered GARDASIL 9 that had been improperly stored (lot # M032650, expiry date: 31-MAR-2019, intramuscular route) for prophylaxis. No adverse effects were reported. The vaccine was stored at -4.2 F for 15 minutes. There was no previous temperature excursion. Data logger was involved. The outcome was unknown. No product quality complaint was involved. Additional information is not expected as the reporter did not wish further contact.
At injection site: red, itchy rash, hot skin, hard knot, about 3 inches in circumference
Phlegm in chest - ongoing; slight cough needed to remove phlegm  Received one Rx of Zythromycin Z pack for 5 days but symptoms continue after 5/25 RX
Chills; headache; fever; Bodyache; soreness of left arm; High pulse rate 105-115 /min; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache) and VACCINATION SITE PAIN (soreness of left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache), VACCINATION SITE PAIN (soreness of left arm) and HEART RATE INCREASED (High pulse rate 105-115 /min). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), HEADACHE (headache), PYREXIA (fever), PAIN (Bodyache), VACCINATION SITE PAIN (soreness of left arm) and HEART RATE INCREASED (High pulse rate 105-115 /min) outcome was unknown.
2.5 INCH RED, ITCHY, RAISED , BURNING AREA NEAR INJECTION SITE
STOMACH ACHE; CHILLS; HEADACHE - PAIN BEHIND EYES; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included severe spinal stenosis, smoker, penicillin allergy, and non-alcoholic, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, intramuscular, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced stomach ache. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache - pain behind eyes. On 16-MAY-2021, the subject experienced fatigue. On 16-MAY-2021 16:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache - pain behind eyes, stomach ache, chills, and fatigue. This report was non-serious.
Felt heat in chest; Felt achiness in chest; Pain in arm; Achiness; chills; Little bit of a fever; This spontaneous case was reported by another health care professional and describes the occurrence of CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness), CHILLS (chills) and PYREXIA (Little bit of a fever). At the time of the report, CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness), CHILLS (chills) and PYREXIA (Little bit of a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-405046, MOD-2021-405428 (Patient Link).