chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/13/2022:  36-year-old male with a history of COVID presented to the emergency department for epigastric discomfort.  Patient states that he has been having loose stools, nausea, vomiting, epigastric discomfort.  Patient states he is COVID-positive.  Patient was seen here few days ago and evaluated. Patient also has loose stools. No indication for Remdesivir or steroids at this time Remains in hospital
she did not receive a full dose/no AE; vaccine leaked around the needle hub and ran down the patients arm/ no AE; vaccine leaked around the needle hub and ran down the patients arm/ no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  It was reported that 55 years old female patient did not receive a full dose/no ae (Underdose), vaccine leaked around the needle hub and ran down the patients arm/ no ae (accidental exposure to product) (exposure via skin contact) of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Dec-2019, the patient received less than 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (unknown formulation) lot QFAA1962 via unknown route in unknown administration site.  It was of actual medication error case due to vaccine underdose.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever, chills, dark urine, jaundice, headache, body aches, severe fatigue. Took Tylenol and 3 days of prednisone from Urgent Care on 1/29/2019. Was swabbed for flu , negative. Still felt sick, went to Dr.'s office on 2/1/2019. She indicated the gall bladder had to be removed. Was admitted to Hospital. On 2/2/2019 - GI doctor indicated Gall Bladder did not have to be removed as patient not in pain.
31OCT96 PM immed p/vax pt felt wave go down arm to elbow, to back & neck;achy through 4NOV;4NOV PM  10:00 same area became itchy, rash appeared;15NOV96 rash intensified, used topical DPH;
Information has been received from a certified medical assistant (CMA) concerning a 72 year old female with an allergy to penicillin and VISTARIL who on approximately 11-OCT-2007 was vaccinated SC in the left arm with a 0.5 mL dose of PNEUMOVAX 23 (lot #656233/0200U) and a dose of  influenza virus vaccine (site unspecified). It was reported that the patient was previously vaccinated with a dose of PNEUMOVAX 23 in November 1996 and "may have had an earlier prior vaccination." On 11-OCT-2007, the patient developed swelling and redness at the injection site. The patient treated the injection site with cool compresses and took BENADRYL. On 12-OCT-2007, the patient was seen in the physician's office. The injection site reaction was described as an indurated, erythematous swollen reaction at the injection site. The patient was prescribed therapy with MEDROL DOSEPAK and Z-PAK. As of 16-OCT-2007, the injection site swelling and redness were "going down." The patient was reported as recovering. A concern regarding the lot was reported. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released. The medical assistant reported another patient who developed an adverse experience after vaccination with PNEUMOVAX 23 (lot #656233/0200U) (WAES#0710USA03557). Additional information has been requested.
Frequent severe coughing attacks, at one point I damaged my shoulders and experienced excruciating pain walking between May and June Difficulty breathing. I have shortness of breath, overproduction of thick green phlegm, change in voice (likely some form of vocal paresis), regular severe pain in throat, and regular lung congestion.
Infanrix was ordered and a Pediarix was given/ RL6 completed, provider aware, notified, and patient's family called and voicemail left.
Pharmacist reports possible off label use of GARDASIL 9 to a 57 year old patient. No additional AE reported. No PQC reported.  AE follow up letter not sent as consent to contact provider was not provided.; No adverse event; This spontaneous report was received from a pharmacist and referred to a 57-year-old patient of unknown gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with 1 dose (reported as frequency) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (possible off label use). There was no additional adverse event (AE) or product quality complaint (PQC) reported.
pt receive Prevnar 23 on 8/16/23 on 8/17/23 pt had redness, warmth, tenderness, swelling and pain to the injection site, at which time she was instructed to take OTC Benadryl and apply ice to affected area. On 8/18/23 pt was noted to now have redness and swelling under both eyes, pt was prescribed Medrol dose pack and Doxycycline.
administered vaccine after temp excursion NOT supported; This spontaneous report was received from a physician and a nurse referring to a 6 months old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.    On 22-JUN-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(lot # 1660704, expiration date 20-MAR-2021; exact dose and route of administration were not reported) for prophylaxis. No additional AE details are available.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA013130: US-009507513-2008USA013131: US-009507513-2009USA002370: US-009507513-2008USA011564:
patient is 15 and boosters are only indicated for 16 and older.  Patient did not report any side effect while in the store and her father said she was not having any side effects when I spoke to him.
Began with fever/rash 2-3 day after vaccines better then return of sx 9/1 - 9/4 also has URI sx - which began before vaccine.
8-31-16 3:00 AM woke up with "severe pain" to injection site, pain up into shoulder area left arm. Pain to point of numbness. Ice applied. This AM ache to site only. Three 1/4 inch red warm areas at site.
Large red splotch at injection site (just over 4 inches in diameter).  Splotch is painful and hot to the touch.  Developed during sleep the night after the Flublok was administered.  Was examined by employee health and told that they had seen that reaction before.
After 15 min wait period, client states his head feels "wavy".  Gave snack and bottle of water and asked client to wait a few more minutes.  He denied any itching or diff breathing.  Client continued to wait and states he "just feels out of it and doesn't feel right".  BP 106/72, HR 88, Pulse Ox 98-99%.  Client states he feels like his eyes feel strange and he "just wants to stare off, but also look everywhere".  Client continues to deny resp diff or distress.  This RN assisted client to lie on exam room table and turned lights off d/t he c/o HA and still feeling differently.  Client in room with sig other.  Continued to monitor client and pulse ox 98-99%  Client did not drive here; they walked.  Client continued to not feel well and this RN discussed going to walk-in clinic or ER.    They state can have a family member come drive them.  Client decided to have family come get, but not going to ER; states going to see how he feels at home.  Pulse Ox checked again and 99%, HR 103.  Auscultated heart sounds and are regular at this time, but notified client that HR is a little elevated.  Strongly encouraged to be evaluated by a physician.  Verbalized understanding. This RN assisted client to family's vehicle and they left at 3:34pm.
Intermittent headaches; In the beginning 7/10 pain and then 2/10; This is a spontaneous report from a contactable physician. A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 20Mar2021 at 11:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included poststreptococcal uveitis. Concomitant medications were not reported. Family history included penicillin allergy. Allergies to medications, food, or other products: Familial history of penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient refers intermittent headaches 24 hours after the vaccine on 21Mar2021 until 01Apr2021. In the beginning 7/10 pain and then 2/10 on 21Mar2021. The patient was treated with ibuprofen at 600 mg one time. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sleep walking; she wound up on the kitchen floor, curled up in a fetal position; This spontaneous case was reported by a consumer and describes the occurrence of SOMNAMBULISM (Sleep walking) and WOUND (she wound up on the kitchen floor, curled up in a fetal position) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep walking (The patient had one episode of sleep walking 40 years ago).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced SOMNAMBULISM (Sleep walking). 07-Apr-2022, the patient experienced WOUND (she wound up on the kitchen floor, curled up in a fetal position). At the time of the report, SOMNAMBULISM (Sleep walking) and WOUND (she wound up on the kitchen floor, curled up in a fetal position) outcome was unknown.            Concomitant medication details included the patient was on concomitant medication but had not specified the names. No treatment medications were reported.  It was reported that the patient received the first booster dose. It was also reported that the patient had drove the car and opened the sunroof at 3 am. The patient had done all this in sleep and had not recalled it. The next morning, the patient went to the car, and saw the sunroof was open about 6 inches, it triggered the patient memory, that the patient was driving with the sunroof open at 3 am and it was raining. It was further reported that the night after receiving both doses of the booster dose, the patient had experienced episodes of sleep walking. Contact was certain this was because of the vaccine.   This case was linked to MOD-2022-535830, MOD-2022-535838, MOD-2022-535842 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Follow up received included significant information: Event start date and as reported causality were updated.
Fever & sz 2 hrs p/inject #4 given; Has hx of sz; has had slow development & speech lag;
Information has been received from a consumer concerning herself with sensitivity to vaccines who received a dose of rubella virus vaccine live (Wistar RA 27/3) as a child when the patient was about a year old and experienced a high fever after getting the vaccine. She also mentioned that at age 18 she had a booster shot done because she had not developed immunity for rubella by titer test and had high fever as well. The patient did not seek medical attention. After getting the booster she had another titer test done and the 2nd shot did not take either. The patient was recovered on an unspecified date. This is one of several reports from the same source. No further information is available.
pain in left arm same day and  a week later on Feb 11, 2021 during the evening an itchy rash on the left side of her neck . The itchiness last 3 days but the rash  still minimally presents.
Information has been received from a health professional concerning a 7 year old caucasian female child with NKDA who on 14 MAR 1997 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot #621192/1550D). There was no concomitant medication or concurrent conditions. On 01 JUN 2001 the child presented to the physicians office with 10-17 small possibly vesicular lesions located on front of trunk and one on her face near her mouth and one on the middle of her right arm. It was noted that a viral culture was sent to lab after 3 weeks. No other symptoms were noted. Follow up information was received from a health care professional which indicated that the viral culture was negative and that the reaction was not associated with the vaccine. No further information is available.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 03-AUG-2017, a 66 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008715: US-009507513-1710USA008717.
arm after all 3 doses; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm after all 3 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A, 037B21A and 022C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm after all 3 doses). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm after all 3 doses) had resolved.            Concomitant medications details were not reported by the reporter.  Patient had sore arm after all 3 doses which went away.   Reporter did not allow further contact
Initial symptom was chills with the development of tension headache with numbness and radiation down neck. Initially thought reaction to shellfish, ruled out. Symptoms progressed to development of chronic, debilitating POTS. She described episodes of intense fatigue, "adrenaline surges," anxiety, and tachycardia. Her resting HR is 40-60. When standing, it will spike to 110 then go down to 95-100. If she raises her left arm, her HR can go up to 130. She was home/bedbound for about 3-4 months in an attempt to keep her HR stable and had to take leave/dramatically reduce work hours. Her symptoms improved slightly with 12.5mg sertraline, vitamin supplements, and an herbal remedy, but she still has flares.
Information has been received from a physician's assistant concerning a 13 month old male with no known allergies, who on 03/15/2001 was vaccinated with varicella virus vaccine. On 03/22/2001, the pt developed a fever of 102 deg F and vomiting which resolved. On 04/31/2001, the pt developed a fever of 105 deg F and vomiting x1. Unspecified medical attention was sought. Upon internal review fever of 105 deg F was determined to be an other medical event. Additional info has been requested.
Eight days post vax, the pt developed a fever to 101 that lasted for three days. Pt also developed a cough, conjunctivitis maculopapular rash to torso, pharyngitis, decreased appetite and irritability. Illness appeared consistent with measle like illness. Pt still symptomatic 13 days post vax.
Diagnosis idiopathic thrombocytopenia - platelets dropped to 5,000 - rash present and burning. 11/17/09 DC summary and Hospital records received for DOS 11/03/09-11/04/09. DX: Immune thrombocytopenia, anemia secondary to GI bleeding Pt. admitted for low platelet count, bruising, decreased appetite, pallor, cough, blood blisters in mouth and blood in stool. Received platelet transfusion prior to admission.Received IgG. Platelet count improved with treatment; DC with f/u
Patient developed fever, abdominal pain, and fatigue about 4 hours after dose administered.  Fever and abdominal pain continued and diarrhea started 2 days later.  Patient then presented to ED on day 3 post vaccine dose. Full lab workup and testing showed this patient met the criteria for MIS-C and was reported as such to physician. Physician has instructed us to report this case as possible vaccine related event. This patient was diagnosed with COVID-19 about 1 month prior to onset of MIS-C illness.
The patient was scheduled to receive her 2nd primary COVID vaccine of Pfizer 5-11-year-old but received the 6-month-4-year-old vaccine, 0.2ml.  The pediatrician was notified.
INJURED FOR THE REST OF THEIR LIVES; This spontaneous report received from a patient via social media concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injured for the rest of their lives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injured for the rest of their lives was not reported. This report was non-serious. This case is a duplicate of 20211242746.
Tachycardia episodes with heart rate over 200 at times even when resting; severe headache  and episodes of high blood pressure. This lasted for approx. 3 days after shot
1 of 3 pts who exp pain in the arm which persisted past 1 wk following vax;
I started my period on the same day as the vaccine. My period schedule is very normal and has consistently started exactly every 28 days for the past 10 years. After receiving the 2nd dose of Moderna vaccine, my period started on the 23rd day of my cycle.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L045953; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
My symptoms were similar - fever, nausea, diarrhea, arm soreness, headache, tired. All lasted 24 hours except headache started for about a week. The brain fog also started the next morning after the vaccine again. It hasn't resolved yet. I have been out of work since May 10th. That is when I started with it being a significant problem. I lost my job due to it sort of.  I started going to Psychiatrist - and have had lab work - my primary care - Anxiety. My Psychiatrist - COVID vaccine and some of my anxiety as well. I started anew job now but it's been hard. I'm pushing through . We have done around 11 medication changes with my psychiatrist to see if anything will help and nothing has helped the brain fog symptoms to improve. I don't feel like I've had any cognitive side affects. It is almost a disassociation that my mind and body isn't working together. It's almost like I have put on the wrong prescription glasses on. I can function. But I still feel impairment from it and it invokes a lot of anxiety because it's not a normal feeling. I am currently on treatment and  have changed all the meds. 75 mg of Wellbutrin ER. in the AM and I'm doing 0.25 of Xanax ER in the morning. My vitamins are the same. Before bed 0.5 mg of Xanax extended release. As needed 0.5 immediate release of Xanax during the day. Have been seeing a chiropractor as well for treatment.
Some of the dose leaked out, maybe half of dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-MAR-2023, the patient received Shingrix (left deltoid). On 06-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Some of the dose leaked out, maybe half of dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 6-Mar-2023 The pharmacist called in to inquired that how to proceed with Shingrix dose. The reporter was unable to provide any patient or vaccine details. The reporter did not consent to follow-up. The reporter reported that they administered Shingrix to a patient on the day of reporting in left deltoid and the syringe malfunctioned and some of the dose leaked out and the patient  only received might be half of the dose which led to incomplete dose administered.
It started with severe pain in my back, and I went to the doctor, and she told me I should go to physical therapy for 3 weeks which did not do anything. Then I went to the chiropractor for a couple of weeks with no improvement and tomorrow I am going to see a spine specialist. I can hardly walk, and I am still in pain. I had an MRI done and they said some discs are bulging and there is degenerative disc disease. I am taking Ibuprofen, Gabapentin and Tylenol.