chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 09-JAN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R005865 with expiration date in 22-OCT-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001823: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
I Woke Up & I Had Wet My Bed & When My Son In Law Picked Me Up & Took Me To Their House I Spent The Night There & The Next Day They Took Me To ER & I Was Admitted, I Had A Fever & Was Very Confused.
Since completing the vaccine shots (Moderna), I have experienced amenorrhea (missed menstrual cycles). Also, I have experienced irregular menstrual cycles.
On the same day of the vaccination (2nd dose) at night I started to feel a lot of chills, severe back pain, very mild fever of 98.8. The next morning I got up and my pressure dropped, I fell to the ground, I was sweating a lot, my skin was cold, I was breathing with difficulty, I felt that I was lacking oxygen, my arms were numb (tingling) my hands were locked , that numbness lasted for many minutes, I had intense stomach aches, leg pain and I still feel a little dizzy and weak.
Information has been received from a health professional concerning a 69 year old female who on 14-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck) ( Lot # 658863/1414U), and subsequently developed a localized rash. No treatment was required. There was no concomitant medication. At the time of reporting the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Headache; extreme fatigue to the point that she could not walk; extreme fatigue to the point that she could not walk; A spontaneous report was received from a Consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Headache, Fatigue and Gait inability.  The patient's medical history was not provided. Relevant concomitant medication was not reported.  On 07 Jan 2021, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.  After first dose the patient did not experience any adverse event. On 04 Feb 2021, prior to the onset of event, the patient received their second dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced Headache then extreme Fatigue and Gait inability. Due to these events the patient was hospitalized.  Laboratory details was provided as the physician did some laboratory test, but result was normal.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the events, Headache, Fatigue and Gait inability, was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning an 11-12 year old female who on an unspecified date was vaccinated with her first dose of Gardasil (lot number, route and site not reported).  Concomitant suspect therapy on the same day included an unspecified Hep B vaccine (manufacturer, lot number, route and site not reported).  The patient received the Gardasil 20-25 minutes after the hepatitis vaccine and subsequently the patient developed an anaphylactic reaction.  The patient was administered epinephrine at the office because her throat closed up.  The patient will not finish the Gardasil series.  The patient recovered on an unspecified date.  The event was reported as requiring intervention (other important medical event).  Additional information has been requested.
arm soreness, very fatigued, dry throat, coughing wheezing, viral pneumonia
Date of symptom onset - ?1/13/21 midday  Symptoms - ?EE reports she felt pretty tired of the day after receiving her 2nd dose of the vaccine.  EE reports when she woke up this am she started feeling generalized body aches, chills, ?clammy? and HA.  EE reports + congestion and runny nose.  EE denies fever but has been taking Tylenol round the clock since yesterday per EE.  Last dose of Tylenol taken at 18:30 (1/13) 1000 mg.  At time of call temperature 99.6.  EE reports her husband called while at work this am and 7- month old son with cough and fever at home.   Last day of work and shift - ?currently at work  Home remedies? -   see ?symptoms? Any improvement? - mild Recommendation? After completing algorithm with EE, EE meets criteria to be taken off of work and to be scheduled for testing.  EE educated to notify manager of need to leave work at this time and to contact EH command center for assistance with testing.  EE provided with phone number of EH command center.  EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns.  EE verbalized back understanding and denied further questions at this time.
No additional adverse effects reported; Received 4 doses of GARDASIL9.; fisrt dose on 04-MAY-2018, the second dose on 09-NOV-2018, the third dose on 07-AUG-2019 and the fourth dose on 05-MAY-2020; This spontaneous report was received from a registered nurse (also reported as a nurse) referring to an approximately 16 years old male patient. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 04-MAY-2018, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# N026812 with expiration date 22-JUN-2020, dose detail and route were not reported) for prophylaxis.  On 09-NOV-2018 the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N035955 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 09-OCT-2020, dose detail and route were not reported) for prophylaxis.  On 07-AUG-2019, the patient received his third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602284 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 26-SEP-2021, dose detail and route were not reported) for prophylaxis (inappropriate schedule of product administration, onset date was on 04-MAY-2019).   On 05-MAY-2020, the patient received his fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S004578 with expiration date 29-SEP-2021, dose detail and route were not reported) for prophylaxis (extra dose administered). No additional adverse effects were reported.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
ADULT OBSTRUCTIVE SLEEP APNEA 4/26/2021 ADULT OBSTRUCTIVE SLEEP APNEA NEUROPATHY 3/22/2021 ADULT OBSTRUCTIVE SLEEP APNEA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2021 ADULT OBSTRUCTIVE SLEEP APNEA ADULT OBSTRUCTIVE SLEEP APNEA 4/26/2021 ADULT OBSTRUCTIVE SLEEP APNEA NEUROPATHY 3/22/2021 ADULT OBSTRUCTIVE SLEEP APNEA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2021 ADULT OBSTRUCTIVE SLEEP APNEA ADULT OBSTRUCTIVE SLEEP APNEA 4/26/2021 NONTRAUMATIC ACUTE KIDNEY INJURY NEUROPATHY 3/22/2021 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2021 NONTRAUMATIC ACUTE KIDNEY INJURY
arm pain at the injection site; fatigue; Joint ache; Muscle ache; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache) in a 41-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included Allergy to wool and Allergic skin reaction. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ESCITALOPRAM for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pregnancy test: positive (Positive) Positive.     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.
At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108/68, 97.6, RR 16, o2 98% on RA, and HR 45. Pt AOx4. Pulses thready. Patient?s skin is moist and clammy.  Called for a WC and took pt to exam room where she sat in a reclining chair. VS taken every 5 minutes. She kept mentation through her stay. She states she felt slightly nauseated but was able to hold down water. VS started to improve once she was reclined in exam room. Education provided about f/u with PCP as HR fluctuated between 57-85. Educated about monitoring for symptoms the rest of the day and when to go in for evaluation is symptoms reappear. Pt verbalizes understanding. At 1400, pt states she is feeling better and feels well enough to leave facility. She has no one in town to come get her. VS= 02 98% HR 60, T97.8, BP 120/74, RR 16. Time of leaving, pulses were strong and equal, cap refill WNL. Will call at 1700 for F/U call.
pt recv vax got sick had to leave work early;sweating, burning up, h/a, body aches, felt faint, dizzy, got up from desk-had to grab desk felt like going to pass out;sick to stomach;pain sharp on rt side lower abd;pain moving up
Myalgia, Fever, NauseaVomiting, CHIKLLS, SEWATS, HEAVY ARMS Narrative: STAYED HOME FROM WORK
Patient states the next morning after the injection date of 01/05/2018, she states she was having extreme difficulty lifting or rotating left arm with tolerable soreness. Pt had just informed me on Thursday 03/15/2018 and that she had reported to her doctor and the doctor indicated that may be related to vaccine which could cause shoulder injury. Since 03/15/18, she is currently undergoing physical therapy with the shoulder and deltoid strapped down. Pt's states that there has been improvements since she started the physical therapy.
04/15/2022 vaccination. 06/16/2022 That evening I had a sore throat. 06/17/2022 the following morning, I started having cold symptoms to include raspy voice and feeling yucky. COVID-19 negative. 06/18/2022 this is when I felt really bad. I was using DAYQUIL/NYQUIL. I had headache, fatigue, diarrhea, loss of appetite, possible temperature. I slept for about 15 hours. 06/20/2022 Telehealth appointment. COVID-19 positive. I started to feel a little better.
extreme fatigue (began about 24 hours post-injection, resolved within 12 hours), chills (began about 28 hours post-injection, resolved within 8 hours)
Patient is very muscular w/ bulging deltoid, but weighs 180 lb only. A 25 G 1 inch needle was used for second dose, and some vaccine dribbled out of patient's arm (given in right arm). Company rep, stated, "...if more than 1/2 of the dose was administered, do not repeat the dose; if less than 1/2 of the dose was administered, or the proportion cannot be estimated, administer another dose in the opposite arm." Therefore, the dose was repeated in the left arm  with the patient's approval, using a 23 G 1 & 1/2 inch needle. No vaccine fluid leaked with the repeat dose. We will follow up with the patient post-vaccination.
Information has been received from an office manager concerning a female who was vaccinated with GARDASIL. The patient experienced syncope, hypotension and agitation. The patient received unspecified medical attention. At the time of the reporting, the patient's status was unknown. No further information is available.
Patient called 06/06/2018 340 pm stating pain at injection site and an indent where the shot was administered. Patient stated they are going to make an appointment with doctor to get x-ray.
She went limp and slumped in my arms at 9:30 am the day after her 2nd injection, so almost 24 hours later.  Blood pressure, pulse and respiration were absolutely normal. But she was unable to speak for the rest of the day, she would open her mouth but could not get any words out. She also was extremely fatigued and slept most of the day, had no grip in her hands and was very stiff when she was able to get up. Had a slight fever, which went down after taking 1/4 of a Tylenol.  No pain in the arm at the injection site and also no redness or swelling.  So the know side effects of fatigue and muscle/joint pain hit her very hard.   She is much better today, 24 hours after experiencing the side effects.
extreme fatigue and muscle soreness slept most of 24 hours ibupropfen helped with soreness but could not stay awake more than 2 hours.
Patient received a flu vaccine clinic at her workplace.  The next day (10/7), the employee HR representative called the pharmacy and talked to me {RN) who administered the vaccine.  The HR person said that after patient received the vaccine, she left and went  to the store.  When at the store shopping, she felt that her throat was closing and itchy.  Per report, also felt as though her arms were tingling itchy.  Took Benadryl while at the store and symptoms went away.  HR person said that patient did not go to see a medical provider because symptoms went away after Benadryl dose.  Patient says she will follow up with her Doctor at a scheduled appointment at the end of the month.
About 5-6 hours after my shot, i started to get a fever. It eventually reached about 103 (the highest I recorded). I had severe chills (it felt like my muscles were all contracting as I lay in the fetal position trying to stay warm). Over the course of about 12 hours (starting with the onset of the fever) I experienced nausea, vomiting, headache, cough and elevated heart rate. According to my apple watch my heart rate hit 140 at points. It was over a 100 for quite some time. My resting heart rate is usually in the 70s. The worst of my symptoms were experienced for 12-14 hours from the onset of the fever (5:30 PM 4/10/21 - 7:00AM 4/11/21.  4/11/21 7:00am - the rest of 4/11/21 i experienced fatigue, headache (though less severe) and had no appetite. I vomiting a couple more times early in the day, and had trouble keeping water down unless it was a sip at a time. Mild body aches. Fever hovered at 99-100 most of the day.  elevated resting heart rate  4/12/21 mostly symptom free but for fatigue and elevated heart rate  As of today, 4/13/21, I am still experiencing  a slightly elevated resting heart, mid 80's.
patient received both pentacel and pediarix on same day; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included PENTACEL VACCINE (DTAP-HIB-IPV), ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).   On 01-AUG-2023, the patient received Pediarix. On 01-AUG-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: patient received both pentacel and pediarix on same day).  The outcome of the overdose 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 Information: GSK receipt date: 7-Sept-2023 The patient's past medical history, medical treatments, vaccinations and family history were not provided. Information on the batch number was requested. The nurse reported that the patient had not required any treatment for the event, reports that the patient had not required any emergency room or physician visits. The patient received Pediarix and Pentacel on the same day, which led to overdose.
1 wk p/vax pt having infantile spasms 1-2x & became progressively worse; 4-5 days w/crying & irritability hospitalized 7JUN - 9JUN93; seen by MD; also crying;
Itching, swelling and redness at injection site. Tx BENADRYL, Ice, Topical steroid.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that unknown number of patients were vaccinated with ROTATEQ route oral (dose strength not reported) that had been improperly stored. Approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
FATIGUE; MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on MAR-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 MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and mild headache was not reported. This report was non-serious.
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Bell's Palsy within two days following first dose of vaccine. The patient stated that she was hospitalized, and a neurologist told her to get it (as reported). The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Low grade fever to begin.  By 11:00 pm I had chills, literally shaking, for over 3 hours.  Finally fell asleep after 2:30 a.m.  Not feeling well 23 hours later, but getting better.
Swelling, redness, pain, puffiness along inside of left bicep down to arm fold at elbow. First noticed upon awakening less than 24 hours after vaccination. Primary Care Physician prescribed steroids and antibiotics. Followup PCP visit scheduled for 12/20/18.
I got my first shot on August 10th, 4 days later my neck swelled up like a cobra and on August 29th I woke up unable to move my left hand, wrist and fingers. I can feel everything but my brain can not get them to move.  I suspect Guillian barre syndrome
I noticed I was experiencing tinnitus / ringing / buzzing in my ears about 3-4 days after receiving the first Pfizer dose. It was rather pronounced, particularly at night. I have also seemed to have increased level of insomnia as I try to get to sleep. It hasn?t been terrible but both symptoms can be annoying at times. The buzzing in my ears can sometimes be hardly noticeable but at other times it seems a bit loud, particular when I am trying to get to sleep. It sounds like what they call pink noise. It does not seem to be affecting my hearing acuity.