chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician's office concerning a patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction and a swollen arm. No further information was provided. There was no product quality complaint involved. No further information is available.
Meningococcal MCV4 Lot# U3433AA - Exp. 08/02/11 vaccine administered 08/10/11, 8 days after expiration date. Dose not readministered.
Patient was "feeling flush" with no other symptoms after second dose of vaccine. Vital signs obtained.Blood pressure 106/61, pulse 83, temperature 98.0F, oxygen saturation 99%. Patient encouraged to drink some water and to stay in observation for another 15 minutes and to alert nursing to any worsening or new symptoms. After 15 minutes, this nurse reassessed patient to which he stated he was having chest pain and has extensive cardiac issues. Nursing obtained another set of vitals, blood pressure 107/60, pulse 79, oxygen saturation 100%. Patient then was encouraged by this nurse to be assessed and evaluated in the ER. Patient agreed and was wheeled down to the ER and checked in at 1514. This nurse then gave report to the ER charge nurse.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. Since 17-FEB-2015, the patients were vaccinated with VAQTA (strength, dose, lot# were not reported) intramuscular which were improperly. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Vomiting; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0187 and expiration date was not reported), via an unspecified route of administration in left arm, on 17May2021 at 16:45 (at the age of 13 years old) as 1st dose, single for COVID-19 immunization in a pharmacy/drug store. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced vomiting on 19May2021. This event resulted in doctor or other healthcare professional office/clinic visit. The event was non-serious. It was reported that the patient received an unspecified treatment for this event. The outcome of the event was recovering at the time of report.
injection site reaction of tenderness, soreness/tender to the touch; she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down; myalgia/muscle achiness "on and off; significant fatigue; swelling at the injection site swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down/large, a little puffy like an enormous welt; very itchy; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA287385(cluster).  This case involves a 69 year old female patient who experienced injection site reaction of tenderness, soreness/tender to the touch, she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down, myalgia/muscle achiness "on and off, significant fatigue, a little puffy like an enormous welt and very itchy after receiving vaccine Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Penicillin allergy.  On 12-Sep-2023, the patient received a dose of 0.7 ml suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, formulation, expiry date and lot number not reported) via intramuscular route in unknown administration site as immunization.  On 12-Sep-2023 the patient developed injection site reaction of tenderness, soreness/tender to the touch (vaccination site pain)she developed redness and swelling at the injection site: "about 3 or 4 inches across and 2 or 3 inches down/large, a little puffy like an enormous welt (vaccination site swelling), (vaccination site erythema), soreness/tender to the touch (vaccination site pain), myalgia/muscle achiness "on and off (myalgia), significant fatigue (fatigue) and very itchy (vaccination site pruritus) (latency: same day).  Reportedly: also have felt itchiness on the injection site. In addition I have had myalgia and fatigue for the last five days from that shot. No fever was experienced. She states that the achiness has resolved, that was only for "a couple of days". The fatigue lasted "a number of days" but is also better. Her arm remains "red and itchy and not a happy camper.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for the event  vaccination site pain, vaccination site swelling;  was Not Recovered / Not Resolved for the event  vaccination site erythema, vaccination site pruritus and was Recovered / Resolved on an unknown date in 2023 for the event myalgia,  was Recovering / Resolving for the event fatigue; Sender's Comments:  US-SA-2023SA287395:01770285
The injection was administered too high into the rotator cuff area.  Extreme pain ensued.  Feels like a serious injury and taking anti-inflammatory drugs to try to prevent tendon injury.
On left up arm, bicep, and red patch.  No itching, no bumpiness, no pain, and comes and goes.
INJECTION SITE SORENESS AFTER SECOND COVID SHOT; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (INJECTION SITE SORENESS AFTER SECOND COVID SHOT) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown. On an unknown date, the patient experienced INJECTION SITE PAIN (INJECTION SITE SORENESS AFTER SECOND COVID SHOT). At the time of the report, INJECTION SITE PAIN (INJECTION SITE SORENESS AFTER SECOND COVID SHOT) had resolved.            It was reported that, there was no known allergies.  No concomitant medications were reported.  On an unknown date, laboratory test of biopsy and colonoscopy was reported as unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event injection site pain was not provided with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-642637 (Patient Link).
0830 - ache in arm, warmth in chest, couldn't catch breath, anxiety Pt given juice and water ( no cp no sob, palpitations) 0856 BP 164/100 HR 61, chest CTA, CV RRR  0927 BP 149/91 HR 54 feeling better
got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt recvd vax in 1988 & recvd 4th dose of vax 11SEP92 & exp h/a, neck stiffness & vertigo; presented to MD on 17SEP92 w/nausea, blurred vision, h/a;
Pt experienced severe vomiting & cold sx approx 1 wk /p receiving vax on 9NOV90; Developed severe speaking difficulties 4mo later & was hospitalized; MRI revealed a lesion on the lt side of brain; dx w/demyelinating encephalopathy;
This spontaneous report as received from a nurse refers to a 68-year-old male patient. The patient had no pertinent medical history and no drug reactions or allergies. On 27-JUN-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23. The patient experienced redness, pain, and swelling in the entire arm that began "within 24 hours" of receiving PNEUMOVAX 23. The pain radiated to the patient's shoulder. The patient was instructed to take an unspecified over the counter pain reliever and to apply warm compresses to the arm. The patient's symptoms lasted "at least 3 days," but at the time of reporting were resolved. The causality was not reported. The nurse reported that multiple vaccines resulted in a similar adverse event, but was unsure which patient received which vaccine. The vaccines involved were PNEUMOVAX 23 lot N001007, expiration date: 19-SEP-2018, lot #N011491, expiration date 04-NOV-22018 and lot #M047519, expiration date 04-AUG-2018. The nurse requested a lot check for PNEUMOVAX 23 lot M047519, expiration date 04-AUG-2018 and lot N011491, expiration date 04-NOV-2018. This report is one of four "Multiple Patient Reports".; Sender's Comments:  US-009507513-1707USA008579: US-009507513-1707USA008989: US-009507513-1707USA008391:
2AUG95 notice soreness to touch x 1-2 days;4AUG95 soreness gone;7AUG95 woke w/sore arm feeling sl feverish & malaise;early PM noticing redness & swelling & some swelling & discomfort going up arm into neck;area of redness-cant raise arm;
4 minutes- severe dizziness 6 minutes throat and tongue swelling 8 minutes - asthma attack
client was siting in the monitoring section and stated he felt fine and then as monitor walked away he fell taking the chair with him. He came around and asked in a strong regular voice what happen. BP 120/72. Placed on back with legs raised. EMS came assess felt his head and gave in instructions for a headache and if had blurred vision and other signs to go to the urgent or ED for evaluation for concussion. Client had decline going to the hospital.
Sore left arm; injection site was warm with firm/tight skin; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sore left arm) and VACCINATION SITE WARMTH (injection site was warm with firm/tight skin) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Autistic disorder.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced LIMB DISCOMFORT (Sore left arm) and VACCINATION SITE WARMTH (injection site was warm with firm/tight skin). On 04-May-2021, LIMB DISCOMFORT (Sore left arm) had resolved. On 08-May-2021, VACCINATION SITE WARMTH (injection site was warm with firm/tight skin) had resolved.            Concomitant medications were not given. Treatment information were not provided.   This case was linked to MOD-2021-269192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Additional events added, medical history updated
Extreme immobilizing pain in arm. Could not lift arm for two days. Pain in arm radiated when I walked. Up my neck and down my back
RED RAISED ITCHY RASH ON STOMACH AND UPPER ABDOMEN; This spontaneous report received from a patient concerned a female of unspecified age. 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, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced red raised itchy rash on stomach and upper abdomen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red raised itchy rash on stomach and upper abdomen. This report was non-serious.
Itchy and rash. I got my vaccine in Jan and Feb, 2021. I only had sore arm after my first shot and around one day fever after 2nd shot. I took 1 pill of Advil and slept a lot after 2nd shot and everything seemed OK.  Around 1 month later, I don't know for why I have very itchy skin problem I never experienced before. But I didn't see many rash. The scalp was very very itchy. I even can felt lots of pimples or acnes on my scalp. More over, there was eczema about 2 quarter size showed up around my left elbow. I applied hydrocortisone many times per day.   Around 2 weeks later, the itchy problem seemed OK.  From about April 5, 2021, there started to have rashes on my right jaw. And itchy problem came back. This time it is worse. There are so many rashes all over my body, and scalp got itchy again. the eczema around elbow changed to another area but close to the old one.  I cannot sleep well even with the help of anti-allergy  medicine.  I didn't have any life style change, and I suspect this is my adverse effect to the Vaccine. Thank you very much!
Patient called 7/14/17 to report that his left arm was swollen and red from just above the elbow all the way to his wrist. He wanted to know which vaccinations he had received in his left arm and was going to see his provider. He was given amoxicillin and diflucan by his provider.
Administered FLUVIRIN vaccine around 12:30pm. Patient experienced numbness on the palm of her hand and top of forearm, pain at injection site. Verified injection site not too high. Amount of bleeding was not abnormal. Patient was not dizzy nor light-headed. Gave patient ice pack to apply to injection site. Observed full 20 minutes. Gave my business card and asked that if numbness persists to follow up with physician and notify pharmacy. Phoned patient at 3pm to inquire if numbness continued. Per patient, numbness has gone away, the arm is still sore. I advised that if the patient would like to take some Tylenol to help with the pain, that would be ok. If the numbness returns (not expected) to please be sure to follow up with doctor.
This case involves a 20 months old male patient who experienced administered pentacel to a patient without reconstituting it with no reported adverse event. while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); HEPATITIS A VACCINE (HEPATITIS A VACCINE); and INFLUENZA VACCINE (INFLUENZA VACCINE). On 28-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U7013AA via intramuscular route in unknown administration site for prophylactic vaccination. On 28-DEC-2021 the patient developed a non-serious administered pentacel to a patient without reconstituting it with no reported adverse event. (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (administered PENTACEL to a patient without reconstituting it with no reported adverse event.). At time of reporting, the outcome was Unknown for the event administered pentacel to a patient without reconstituting it with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance. 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.
One week after vaccine experienced extreme fatigue for approximately 3 days.  Approximately 2-3 days after that began experiencing severe intermittent muscle pain in legs, arms, hands and sometimes feet.  Continues currently (March 23,2021).
No other AE's reported; Varivax administered to a patient during a temperature excursion.; This spontaneous report as received from a nurse, who refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 22-FEB-2021, the patient received a dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, for prophylaxis, lot # T017681, expiry date 21-MAY-2022 (formulation, concentration, dose number, route of administration, frequency were not reported). Digital data logger was involved. The vaccine underwent the temperature excursion at -7.4 degrees of Celsius (C) for 3 hours and 54 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2102USA008793: US-009507513-2102USA008721:
FATIGUE, FELL X 2 Narrative: Patient's neighbor/CG who reports that patient experienced fatigue next morning following the second vaccine and found in the floor on 3/5 and 3/6.  on 3/6 started having hallucinations "seeing animals on the blanket". Patient is back to normal today. Pt is to be evaluated with his PCP for an evaluation after two falls. Per caregiver patient didn't his head bit bruise are present on the face.
pt recv vax 20NOV95 & 13MAY97 pt devel chickenpox;
Pt recv vax on 10/30/98; on same day pt exp edema & erythema of vax site to left hand x several day; tx=elevation of arm, ice, Ibuprofen, Benadryl
My period was so much heavier than normal and so much more painful. I was unable to go to school or do any work. This is NOT how I usually experience my period. Many people I've spoken to have said that after receiving the Pfizer shot, their period was heavier and earlier than normal. This information should have been included in the warnings, as this seems to be an EXTREMELY common side effect to people who mensurate. Please start including female-specific health outcomes in your research.
Between 45minutes to 1 hour following injection of the vaccine, I experienced a tightness in the jaw and an extremely fast heartbeat lasting roughly 10-15minutes. As I had left the vaccination facility and was on my way home I was prepared to inject an epipen sensing an anaphylaxis  reaction, however my heartbeat went back to normal at around the 15 minute mark. During these 10-15minutes, I felt that there were a couple of times where I might lose consciousness, but did not.   Prior to leaving the vaccination center, I placed an ice pack on the injection site for roughly 45 minutes, only removing for my drive home. There was no redness or apparent swelling at the injection site.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 (BNT162B2), on 15Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 08Nov2023 to 12Nov2023. Known allergies: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381312 Same patient, different drug;US-PFIZER INC-202300381474 Same patient, different events;
My left arm where I got the injection started to go numb at night. It happened really gradually. At first I would just have to wake up and have to shake my arm. In August I would wake up with intense nerve pain in my arm. I passed out because of the pain. We had to call an ambulance. They did an X-ray and EKG and both came back normal. They prescribed gabapentin. I had to do physical therapy. I might have to have an MRI because they cannot find a problem with my tests. I also have to do more physical therapy.
This non valid spontaneous report as received from a consumer via Pfizer as a social media review refers to a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date the brother's patient was vaccinated with ROTATEQ oral (dose, frequency, route of administration, lot# and expiration date were not provided). On an unspecified date, it was reported that the ROTATEQ the brother's patient received gave the patient pneumonia. As she kissed her brother's neck she experienced secondary transmission. She also developed rash, bad pains and high fever for two weeks. The outcome of rash, bad pains, high fever and pneumonia was unknown. Additional information is not expected as no contact information was available.
Patient received FLUAD and PNEUMOVAX 23 vaccine on 10/10/18 with no signs and symptoms of allergic reaction upon administration. However, on Wednesday 10/17 a adverse event was reported to pharmacist during her shift at 4830. Both husband and wife state that right arm in which they received FLUAD vaccine caused substantial swelling that took a week to subside. Patient informed pharmacist that arm was sore, throbbing and red like a sunburn and took a week to subside.
This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with first dose of with unidentified Merck HPV vaccine. The physician stated the consumer fainted shortly after receiving the injection. It is unclear as to whether the consumer was still in the physician's office at the time of fainting. No hospitalization or treatment information was reported. The physician stated that due to the incident with the first injection that the consumer has refused to complete the series. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with unidentified Merck HPV vaccine. Additional information has been requested.
Received flu vaccine on Sept. 5 at 12:00 noon. Became ill by 1:00 PM Sept. 5, fever, cough, nose congestion, chest congestion, diarrhea, fatigue, sore body joints. Some symptoms lasted 12 days.