chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had trouble swallowing within 2-3min. of getting shot. Pt was told about protocol of giving EPIPEN and calling 911. She didn't want it, called daughter and then changed mind and said she wanted EPIPEN. RPh administered EPIPEN and called 911. Ambulance arrived and took her to hospital.
Can not sleep; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can not sleep), CHILLS (Chills) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INSOMNIA (Can not sleep), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, INSOMNIA (Can not sleep), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient was given ZOSTAVAX and had a reaction with "redness, swelling, pain and warmth at the injection site and the reaction was about 3" in diameter". It took about 2-3 weeks for the reactions to go away. The patient was recovered at the time of report. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Three hours after vaccine, extreme tiredness - took nap - woke up with extreme vertigo. Never had it in my life. Chiropractic adjustments have helped dizziness and nausea. Another bout of vertigo on 11/30/12 - more chiropractic.
COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 4), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer.    On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-655151 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655151:Husband's case.
Unexpected vaginal bleeding. EBL less than 200mls. Sustained for 1 hour or less; This is a spontaneous report from a contactable nurse (patient). A 30-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: Evrc180), via an unspecified route of administration, administered in arm left on 10Aug2021 at 15:00 (03:00 PM) (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 10Aug2021 at 21:30 (09:30 PM), the patient experienced unexpected vaginal bleeding. EBL less than 200mls. Sustained for 1 hour or less. The patient did not receive treatment for the event. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Had 1st injection 12/19 Didn't get 2nd due to Covid shutdown; This case was reported by a consumer and described the occurrence of social problem in an elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the 1st dose and never get the 2nd dose due to COVID-19 shut down. The reporter asked did he or she need to start over.
Fever 100.3, local swelling and redness on left deltoid with 2 injection given (DTap #5 and IPV #4).
Fatigue, body aches, chills, very sore site extremity all last about 24 hours, rigid neck, headache
This case was reported by a healthcare professional and described the occurrence of nausea in a 25-year-old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent vaccination included tuberculin PPD given on 5 June 2007. There were no concurrent medications. On 5 June 2007 at 11:30 the subject received 1st dose of Twinrix at 1.0 ml in the right arm. Two weeks after vaccination with Twinrix, the subject experienced nausea and fatigue. One week later, she experienced diarrhea followed days later by high fever (103 F), chills and severe headache. On 01 July 2007, the subject experienced vomiting, urine discoloration (rust colored) and her eyes and skin were jaundiced. The subject was hospitalized on 02 July 2007. Her platelet count was 20, her bilirubin 7.9, she was anemic and her liver function tests were elevated. The subject remained hospitalised at the time of reporting and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Twinrix.
Heart/pulse racing; This is a spontaneous report from a Contactable consumer. This 58-years-old female consumer (patient) reported for herself that who received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 05Apr2021 (Batch/Lot Number: ER8734) as SINGLE for covid-19 immunization and was administered in Pharmacy/Drug Store. Medical history included obesity from an unknown date and unknown if ongoing and ongoing anxiety has been taking it off and on for years. Concomitant medication included acetylsalicylic acid (ASPIRIN) 81 mg, as needed taken for anxiety from an unspecified start date and ongoing. She has had an EKG (electrocardiogram) years ago for anxiety. Prior Vaccinations (within 4 weeks) was reported as none. Family medical history relevant to AE(s) was reported as none. Relevant tests as none. Caller has received the first dose of the Covid-19 vaccine. 12 hours later after receiving the vaccine and the next day on 06Apr2021, her heart/pulse was racing on and off. She was due to get the second dose today. She was a little nervous about getting it. She understood the side effects that may happen. She does not know if this was a normal side effect. The patient underwent lab tests and procedures which included electrocardiogram anxiety. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Patient developed symptoms within 2 hours of receipt of IIV. Recalls severe HA, nausea, diarrhea, wheezing, and globus sensation. Also developed urticarial rash on one arm. She self-treated with Benadryl and Albuterol and felt better within an hour. She did not seek urgent care evaluation, but did follow up with her PCM 2 days later to report AEFI.
Dose #1 Moderna 03/17/2021 Lot # 003B21A  Pt currently has Covid 19
Headache, Myalgia,  Headache, chills, myalgias. Chills and myalgias now resolved. Headache continues rates pain 5/10 to temples and top of head. Pain Positional. Missed work today 1/11/2021 Narrative:
Rash on chest and breast area; 80 mm red spot at injection site that is raised and hot to the touch; sore injection spot; cold sore in corner of mouth (Never had a cold sore before); sore on tip of tongue.
Influenza vaccine administered on 1/3/06 at 11 AM. At 3 AM on 1/4/06, patient went to hospital ER, with complaints of circumoral cyanosis, oral temperature of 103.3, generalized muscle aches particularly across shoulder blades and lower back, lethargy, and chills. Stated that she was given oral ibuprofen in ER. Today, 1/5/06, she is still complaining of generalized muscle aches. She stated that this was the first time she had ever received the influenza vaccine. Also reported today, 1/5/06, that she later recalled that she often gets headaches when she eats eggs.
Patient developed flat, red rash and bruising at site of injection. No complaints of pain, itching, or other symptoms.
auxiliary fever of 104 @ home, shallow breathing, rapid heartbeat, pale color, no crying, sore arm sx started around 8PM on 23APR94; went to ER @ hosp rectal fever of 104.8-330AM on 24APR94;
swollen red upper arm  ER visit given Benadryl and Keflex  was itchy, tigh and painful mon
May 5 - vaccine received May 8 - period began and lasted 11 days. Heavier than usual but not considered abnormal March 26- vaccine dose 2 April 6 - period began. Much heavier. At times more than 1oz/hr , measures by menstrual cup.  April 15 - heavy period continues. In the evening started Junel birth control and it stopped by morning. Continued the pack of Junel.  May 8 - another period began, also much heavier than normal. Changing tampons and pads every two hours.   No history of heavy or long periods with the exception of one or two heavy periods after childbirth. I have two children, youngest is age 5. Most periods lasted 3-5 days with only 1-1.5 days of moderately heavy flow.
pt recvd vax; elev T 2mar-7mar; ear infect on 3mar95; septra given for 10-15 days;
not feeling too good the last few days; lots of coughing; Lotsof drainage; arm was sore; left breast was swollen right after the second dose and it is still a bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (left breast was swollen right after the second dose and it is still a bit swollen), MALAISE (not feeling too good the last few days), COUGH (lots of coughing), RHINORRHOEA (Lots of drainage) and VACCINATION SITE PAIN (arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 072B21A) for COVID-19 vaccination.     Concurrent medical conditions included Stroke. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced BREAST SWELLING (left breast was swollen right after the second dose and it is still a bit swollen) and VACCINATION SITE PAIN (arm was sore). On an unknown date, the patient experienced MALAISE (not feeling too good the last few days). an unknown date, the patient experienced COUGH (lots of coughing) and RHINORRHOEA (Lotsof drainage). At the time of the report, BREAST SWELLING (left breast was swollen right after the second dose and it is still a bit swollen), MALAISE (not feeling too good the last few days), COUGH (lots of coughing) and RHINORRHOEA (Lotsof drainage) outcome was unknown and VACCINATION SITE PAIN (arm was sore) had not resolved.            Patient took unspecified medications for stroke. Other concomitant medicines include 4 Allergy medications  No treatment information was provided.; Sender's Comments: Based on the 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.
Pt presented to ER with swelling and redness to upper left arm at immunization site. Diagnosed with cellulitis. Blood drawn, Ceftriaxone 950 mg given IV.
Vaccine given at 33 days after refrigerated. Use by date: 9/25/21
Patient stated that she felt dizzy and was about to pass out--called out to emergency personnel monitoring area who was able to control the patient's fall by easing her to the floor and then positioning her in a supine position with her knees up.  Blood pressure, pulse and orientation assessed for the next ten minutes, all remained normal.  Patient then assisted to sit in a chair for 5 more minutes, then assisted to stand and reassessed for dizziness (which patient denied).  After ten more minutes sitting in a chair, patient released to significant other who escorted patient to a private vehicle.  Patient denies any dizziness or any other adverse symptoms at this time.
Patient was given 2nd booster 4 months from  1st booster. patient is not due for a 2nd booster because he is not immunocompromised. patient has no allergic reaction.
received a Bexsero second dose early/ First dose: Jun 22nd 2021/Second dose: Jul 7th 2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA70BA, expiry date 31st October 2021) 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.   Concomitant products included Men B NVS (Bexsero).   On 9th July 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 9th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: Nurse reported that, the patient received a Bexsero second dose early than the minimum recommended interval, which led to shortening of vaccination schedule. Nurse was looking for information about Bexsero accelerated schedule. No further information reported. The reporter consented to follow up.
Pericardial effusion. Extreme chest pain, shortness of breathing, fatigue. Two months so far. Taking medicine until March 17th, then another follow up with doctors.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19 year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and 3 months after vaccination developed meningococcal meningitis and sepsis, year reported as 2010 (Q 3). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08253, -08254, -08255, and -08256. Documents held by sender: None.
My father felt sick the day after taking his 1st shot, called the nurse and was told to "give it a few days. Drink electrolytes and water". He did that and did not get any better.
Vertigo; diarrhea; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (age at vaccination: unspecified), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was experiencing vertigo and diarrhoea after the first injection but debilitating after the second injection. The patient formally requested the document for the product. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Child received GARDASIL - that night developed abdominal pain, dizziness, diarrhea, and fainted - Seen next day - better - No Temperature - No sore arm.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 74-year-old of unspecified sex of unknown race and ethnicity. Initial information was processed along with the additional information received on 18-JAN-2022. The patient's height and weight were not reported. The patient's concurrent conditions included heart disease. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number:1808980, expiry: unknown)1 total, dose, start therapy date were not reported for prophylactic vaccination. The patient received non-company suspect vaccine included: mrna 1273(Dose number in series 2) (form of admin, route of admin, and batch number: unknown, expiry: unknown)1 total, dose was not reported, administered on DEC-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 29-DEC-2021, the patient had covid symptoms and started feeling better. By 01-JAN-2022 was not feeling so great but not terrible, so the patient took the rapid test twice which both resulted positive (experienced suspected covid-19 infection, and suspected clinical vaccination failure) (Dose number in series 2)(Dose number in series 1), and the doctor started giving paxlovid (antiviral) which the reporter took for three days had some side effects that were not extreme like nausea. Overall was not feeling good. The patient also experienced suspected covid-19 infection, and suspected clinical vaccination failure. (Dose number in series 2)(Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s 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 is related with product quality complaint: 90000211927.; Sender's Comments: V0: 20220123706-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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
May 3 - exhausting, sweats/chills while sleeping; May 4 - exhaustion, full body ache (similar to body ache from flu), headache, and again sweats/chills while sleeping at night
At 1:30 PM on 1/25 patient noticed and itchy red rash that developed while out for a run, which quickly spread to her entire body. C/O face feeling warm and swollen. Denies any shortness of breath.
Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.  It was reported that dose was administered after 30-day Use By date or after manufacturer date of expiry Vial was initially stored in the refrigerator on 03 Jan 2022. That was kept in freezer since arrival until today before use. Vial did not undergo any temperature excursions.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676 (Patient Link).
Large reddened area noticed around inject site of DTP & 4-4 1/2" below inject site;
Day 0- L arm pain, joint pain, body aches, vertigo, headache, exhaustion Day 1- fever, thirst, vertigo, chills, just didn't feel good Day 2- fever, thirst, exhaustion, sun sensitive vertigo (seeing black with in the sun), nausea, chills Day 3- fever, exhaustion, thirst, vertigo, headache, nausea Day 4- fever, exhaustion, thirst, vertigo, headache, nausea Day 5- thirst, exhaustion, vertigo, headache, nausea, large migraine Day 6- extremely exhausted, L arm pain all over again, joint pain, vertigo, headache, just felt off Day 7- exhaustion, thirst, face rash with swelling and warmth and itching, vertigo, headache Day 8- exhaustion, thirst, face rash continues...
bad headache by 5:00 pm Could not sleep due to headache Coughing started in the middle of the night - very sore throat (strep like) Aching and still coughing next day - headache continued some relief with advil and tylenol coughing, aching, headache lasted from Monday night until late Thursday
Chills, fever, body aches, and headache for approximately 24 hours. Site of injection had a hard knot and inflamed for days
Approx. 1 3/4 hours, post vax, the pt called the Pharmacy complaining of severe headache and chest tightness. The pt was counseled to take a dose of oral Benadryl if available and seek immediate medical attention at a medical facility. She was treated and released at the ER by a physician.
Migraine, all over body ache, exhaustion, eyes burn, shivering, nausea, extreme pain at injection site
Pt recvd vax & devel a high fever of 102 following vax on 26JAN93; No further details were provided;