chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt transferred from a local Hospital due to fatigue and increased heart rate and shortness of breath. Pt tested positive for COVID and was found to have pneumonia and was transferred. He has a PMH of CAD s/p multiple cardiovascular stents, CHF, and liver cirrhosis.
11 year old female patient inadvertently given DAPTACEL instead of a TDAP vaccine with no reported adverse event; 11 year old female patient inadvertently given DAPTACEL vaccine with no reported adverse event; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 year old female patient who was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 13-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5774AA and expiry date: 18-Sep-2022) (Frequency: once) via an intramuscular route in the right arm instead of TDAP not produced by Sanofi Pasteur (lot number and expiry date: not reported) via an unknown route at an unknown administration site (Wrong product administered and Product administered to patient of inappropriate age) for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered and inappropriate age at vaccine administration (latency on same day).  It was reported that "Patient age greater than one year enter as two month, four month, etc. Many pediatric vaccines need month for age. Pregnancy: not applicable, Last menstrual period, Due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement. Reporter relationship: HCP (health care professional) Product used: Used First time product used: Yes".  At the time of reporting, no adverse event was reported.   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 the 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.
MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On 08-SEP-2021, the patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious.
44 y/o female, past medical history of Hashimoto and Regurgitation of the Mitral Valve, who presents with a choking feeling to her throat, shortly after vaccination was done. Vaccination site was the Left arm. Patient, on her own, without consult of the NP took her own Claritin 10mg. All vitals within normal limits. Patient states that she can not take Benadryl. Patient observed for length of time with minimal improvement. Patient states that her throat felt less restrictive, less tight but states that she has a weird feeling to the lower part of her throat. Patient lungs are clear. Case consulted with Doctor and it was agreed to provide patient with dose of EPI and transport to the ER. EPI 0.3mg administered to the right deltoid by Paramedics. Shortly after patient states that she felt a lot better. Patient transported to hospital.
Maybe a little tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 76 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Maybe a little tired the next day".  Additional information: The patient stated that how wanted to continue using Premarin and looking for assistance. Stated that the patient was retired. The patient recently broke leg and have medical expenses as a result. It was clarified that patient was taking the Premarin .625mg tablets before broke leg. patient stated the patient have never had a problem with that and the patient have been Pfizer vaccinated. No problem, maybe a little tired the next day but sometimes that comes with 76 years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RN administered incorrect vaccine to patient; patient received flu vaccine instead of Tdap vaccine. He had previously received annual flu vaccine on 11/29/22. Patient is aware incorrect vaccine was administered. At this time, patient is not experiencing any adverse side effects.
On 1/8/03, small blister appeared at injection site. Parent reports that another "chickenpox" blister also on one ankle. On 1/17/03, injection site appeared red, hot to the touch and hard with a blister at the injection site that appeared to have a "head" on it. On 1/17/03, RN suggested comfort measures and to contact MD. On 1/24/03, per call to mother, MD gave ABT and site is "almost healed". No further concerns expressed by parent.
1st day was fine 2nd day I had headaches like I never had before in my life 3rd day still the same headaches and spitting blood from my lungs 4th - 7th day am still congested like I have never been before in my life. Have been congested from day 2 - 7th, heavy congestion (very thick mucus and a constant nasal drip).
This spontaneous report was received from a 68 year old female consumer reporting on herself. Pertinent medical history and concurrent conditions were unspecified by reporter. On 17-NOV-2015, the patient was vaccinated with PNEUMOVAX23 injection, intramuscular for prevention of pneumococcal disease (dose, lot number and expiration date were not reported). Concomitant medications were unspecified by reporter. On 18-NOV-2015, while the patient visiting her physician, the physician, the physician noticed a (softball) sized red mark at the injection site that was also so warm to the touch. The patient stated that she also was suffering stomach aches since receiving the injection. Patient sought medical attention as she saw the provider. Treatment with PREDNISONE was received as physician stated that it should help with redness. The patient stated that after the first dose she noticed decrease in the size of the redness in her arm. At the time of report, it was reported that the patient status was recovering. Additional information is not expected as there was no contact details provided.
warm, painful to touch tightness of the skin, and itching ibuprofen and tylenol have been used, and ice packs to the area called employee health to notify January 1, 2021 at 3:40 pm. and left a message spoke with Staff in employee health on January 4th, informed of symptoms and was advised to fill out the RL and if symptoms persists call my primary physician
Papular rash on trunk, legs face given BENADRYL. Provider spoke with mother on 12/23/16. Pt much better per mother.
On febuary 4th started getting itch on arm, big swollen area the size of 3 inches diameter.
5:30 Chills, fever to 102, Tx with Tylenol.  GI Upset, diarrhea. 11PM Difficulty sleeping; GI upset, LOC x2. Pallor. Transport to ER via ambulance. Treated with IVs, Zofran, toradol
Left shoulder pain (same arm as flu shot) began within 2-3 hours of injection, and continued to get increasingly worse. Limited motion resulted. Physician consulted 2/21/2017 and diagnosed with frozen shoulder (adhesive capsulitis). Left shoulder steroid injection received 3/3/2017 and physical therapy begun 3/13/2017.
Diverticulitis; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis (15-20 years ago. It was silent for about 20 years).   On 01-Jan-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 15-Nov-2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (Diverticulitis) outcome was unknown.            No concomitant medication was reported.  It was reported that she was diagnosed with Diverticulitis and started antibiotics. She stated that she has a medical history of Diverticulitis 15-20 years ago. It was silent for about 20 years. She did not think it was related to the vaccine.  This case concerns a  84-year-old, female patient with relevant medical history of diverticulitis,  who experienced the unexpected event of Diverticulitis. The event occurred approximately 9 months after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The patient's past medical history remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  84-year-old, female patient with relevant medical history of diverticulitis,  who experienced the unexpected event of Diverticulitis. The event occurred approximately 9 months after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The patient's past medical history remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Multivitamins (Multi Vitamin) and Birth control. On 20 October 1997, 20 May 1997 and 18 April 1997 the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B to complete the three dose series. Recently (date not specified) hepatitis B titers were drawn and showed 9 mIU/ml. The subject did not have protective titers and was considered to be a non-responder. No additional information was known.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 80-year-old male patient who received SHINGRIX for prophylaxis.  On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 22nd January 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 24th January 2019, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The reporter was the wife of the patient. On Monday evening from the reporting date,  the patient received his SHINGRIX. The next day following the injection, the patient experienced flu like symptoms. On 24th January 2019, the reporter indicated that the symptom had all resolved. The reporter did not consent to follow-up.
Pt states 1 day after vaccine experienced a flare-up of a herniated L-5 disc (pt says it is a chronic condition) and that it was resolved the next day. Believes it was related to the vaccine because his chiropractor stated that he has seen several patients present with this problem post covid-vaccine.
Patient inadvertently received Proquad and Varivax at appointment. No side effects noted at this time.
At 4:15 pm, While under observation for 30 minutes, pt c/o heaviness  in the eyes., and slight chest pain.  pt. also c/o  nausea and vomiting symptoms.  pt.  c/o numbness in the left arm.  Pt. was encouraged to take deep breaths. Pt. was helped to the ground in a supine position. BP=140/90, HR=88, RR=18  . Pt was alert and oriented X4.  2 minutes after deep breaths, patient  reported that all symptoms had subsided except numbness in the left arm.
Client reported to RN that she developed "sensitivity in my bones" about one week after the vaccine that has not resolved. The client states she feels the sensitivity about every other day. The client states that laying down, getting up, or kneeling exacerbates her symptoms. She states that it feels similar to "when you workout after you haven't worked out in a long time." The client states that she is 11 months postpartum and is currently breastfeeding. The client stopped taking her prenatal vitamins about 3 months ago. The client has not followed up with any medical providers regarding her symptoms. The client has no chronic conditions or medications. No known allergies.
Back of left arm swollen 1 1/2" x 2", red, warm to touch.  Advised cool pack 20 min QID.  Advil every 6 hours.
Arm pain shortly after, then woke up in the middle of the night with HA and emesis x 3.
The pt experienced a red sore arm. The pt sought unspecified medical attention. Additional information has been requested.
ARM SWELLING; extreme pain; exteme pain (unable to sleep); fever of 100.9; headache; This case was reported by a consumer via sales rep and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received the 2nd dose of Shingrix. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, pain, sleeplessness, fever and headache. On 6th December 2020, the outcome of the swelling arm, pain, sleeplessness, fever and headache were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain, sleeplessness, fever and headache to be related to Shingrix.  Additional details were provided as follows: On 5th December 2020, the patient had undergone body temperature test which results 100.9 degree F. After receiving 2nd dose of Shingrix, the patient experienced arm swelling, extreme pain, unable to slee, fever and headache. This continued till Sunday but has since subsided. The reporter consent to follow up.
Left thigh had large, red, hot indurated area 16cm x 9.5cm. Small, narrow ring of pallor around redness.
Patient developed Nausea, Vomiting, Abdominal Pain, Headache 11/4.
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted in store and hit her head...she was advised to go to ER by family member for follow up
on 7/25, when I woke up at 3 am, my arm at the injection site was swollen and warm. As the day went on the swelling got worse. The swelling was about 4 inches in diameter.. I felt like I had the flu and it hurt to raise my arm above my shoulder. Today, 7/26, the swelling is worse, About 6 inches in diameter. The site is very hot. It itches and is uncomfortable to raise my arm above my head. I feel very sick. Have diarrhea, Stomach cramps, feel run down like i have a bad flu. My neck and hip joints ache. (I don't usually have any pain). I feel fuzzy in my head and my throat hurts. I contacted the medical office yesterday and will again today. ,
Information has been received from a physician, via a company representative, concerning an approximately 9 week old (" 2 months old") female infant, who on 30-OCT-2007 was vaccinated with the first dose, "7.5mcg," of COMVAX. On 31-OCT-2007 the infant developed redness and swelling at the injection site that lasted for a month, and continued to have a bump at the injection site. The physician indicated that the infant was recovering from the events. Unspecified medical attention was sought for the infant. Additional information has been requested.
Violent shaking chills/rigors alternating with feeling feverish, muscle aches in all large muscle groups, headache, dizziness (mild compared to headache), anorexia, fatigue.
Left leg redness, hot to touch 13cmx10.5cm, tender. A doctor prescribed Keflex 250/5  3.4 tsp twice a day for 10 days and cool compresses.
Vaccine administered 6/3/04. 6/12/04 Macular papular rash over most of body, fever 104, seizure, lethargy, pale post symptoms. 911. Hospital.  Nurse follow up on 07/16/04 states: "Per review of hosp. d/c summary: final diagnoses were febrile seizure, and viremia vs MMR reaction. (no conclusion was reached)  Additional symptoms reported are vomiting and dehydration."
This spontaneous report as received from a consumer (reported as patient's husband) refers to a 60 year old female patient with no pertinent medical history and drug reactions or allergies. On 08-MAY-2014 the patient was vaccinated with ZOSTAVAX, vial (lot# and expiration date not provided) (dose not reported), route reported as "injection". Concomitant therapies included unspecified vitamins (manufacturer unknown). On 12-MAY-2014, the patient noticed an unspecified amount of red circles on her skin on her right inner thigh. The circles had a darker red core. There were 4 additional red spots in the same area. They were searched what that could be and had diagnosed it as shingles. The red circles did not itch or hurt. No diagnostic tests were reported. The patient did not seek medical attention. The outcome of the event of shingles was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
I had a fever of 103  after the 2nd dose that lasted for 2 days. Two days after the fever,  my face was slightly  numb with a teary eye and runny nostril( I do not have allergies).  2-3 days after the numbness wore off, I felt tingling sensations in various parts of my body, particularly,   my arms, legs, and face.  The symptoms did not improve and I went to the emergency room because half my face was numb.(I did not receive treatment).The symptoms are still present almost two months later, however, not as severe.
My mother was in a facility that had a COVID outbreak. I was with her during the week before she went into the hospital. I wore a mask and took precautions. Late on 27th, I started experiencing a 100.4 fever, sore throat, and sinus drainage. My sinuses hurt. November 28, 2022, my brother took me to the clinic. They took my vitals and gave me a COVID-19 test. I tested positive for COVID-19. They prescribed LAGEVRIO capsules. I took 4 capsules twice a day for 5 days.
Retinal detachment; Retinal detachment; This serious case was reported by a lawyer and described the occurrence of retinal detachment in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13-NOV-2020, the patient received the 2nd dose of Shingrix. On 05-AUG-2020, the patient received the 1st dose of Shingrix. On 09-AUG-2020, not applicable after receiving Shingrix and 4 days after receiving Shingrix, the patient experienced retinal detachment (Verbatim: Retinal detachment) (serious criteria GSK medically significant). On 15-NOV-2020, the patient experienced retinal detachment (Verbatim: Retinal detachment) (serious criteria GSK medically significant). Rechallenge with Shingrix was positive. The outcome of the retinal detachment and retinal detachment were not reported.   It was unknown if the reporter considered the retinal detachment to be related to Shingrix. It was unknown if the reporter considered the retinal detachment to be related to Shingrix.     It was unknown if the company considered the retinal detachment to be related to Shingrix. It was unknown if the company considered the retinal detachment to be related to Shingrix.   Additional Information: GSK receipt date: 30-Oct-2023 As per legal complaint, The plaintiff consumed Shingrix vaccines on 05 Aug 2020 and on 13 Nov 2020. As a result of use of above Shingrix vaccine the plaintiff was diagnosed with retinal detachment.  On or about 15 November 2020 two days after her second Shingrix vaccine, Patient experienced a recurrence of her retinal detachment.
After the second dose they felt beat up for a day; Develop covid arm; Red rush in the injection side and  burning sensation; Red rush in the injection side and burning sensation; Red rush in the injection side and burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (After the second dose they felt beat up for a day), VACCINATION SITE REACTION (Develop covid arm), VACCINATION SITE RASH (Red rush in the injection side and  burning sensation), VACCINATION SITE PAIN (Red rush in the injection side and burning sensation) and VACCINATION SITE ERYTHEMA (Red rush in the injection side and burning sensation) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PALPITATIONS (After the second dose they felt beat up for a day), VACCINATION SITE REACTION (Develop covid arm), VACCINATION SITE RASH (Red rush in the injection side and  burning sensation), VACCINATION SITE PAIN (Red rush in the injection side and burning sensation) and VACCINATION SITE ERYTHEMA (Red rush in the injection side and burning sensation). At the time of the report, PALPITATIONS (After the second dose they felt beat up for a day), VACCINATION SITE REACTION (Develop covid arm), VACCINATION SITE RASH (Red rush in the injection side and  burning sensation), VACCINATION SITE PAIN (Red rush in the injection side and burning sensation) and VACCINATION SITE ERYTHEMA (Red rush in the injection side and burning sensation) outcome was unknown.            No treatment information were reported. Patient took 1st dose on 1-MAR-2021 to left non dominant arm.   This case was linked to MOD-2021-300593 (Patient Link).
no adverse event from Vaccine. this person was in an accident while riding his motorized scooter and was hospitalized. He was found to be (+) when admitted after the accident.