chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical histories, concomitant medications and drug histories are all unknown. On an unknown dates in 2016, an unknown number of patients received PNEUMOVAX 23 (lot: L038522, expiry: 11-AUG-2017) after a temperature excursion that occurred on 21-NOV-2016. The reporting nurse stated that none of the patients involved had reported adverse events or symptoms after receiving their vaccination. The patients' laboratory data was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Administered 2 vaccines that were not necessary for recommended dosing schedule. Hep B vaccine administered as well as IPV. MCIR listed recommended dosing that was not correct and pt. had 2 imm. records in MCIR that have since been merged, or in process of being merged.
Flushing across chest area, loss of appetite, lethargic, rapid heart beat, jittery. Would seem to feel better then symptoms started again.  Went to Urgent care test showed  no Covid, no flu. Diagnosed hyponatremia and dehydration Stopped farxiga, hydrochlorathorazide and fossinapril Next day 11/23 went to ER still having flushing across chest.  Tested for more viruses showed none EKG and chest X-ray normal Diagnosed hyponatremia and reaction to influenza immunization Next day still had flushing lack of appetite 11/24 after eating  better increased sodium rich foods Feel much better . No flushing across chest Told to follow up with nephrologist
This spontaneous report was received from a medical assistant regarding a 75 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 08-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose: 0.5 ml, lot # K007824, expiration date 05-NOV-2015, via intramuscular route in deltoid on an unspecified arm). On an unspecified day in 2015, the patient experienced excess swelling and redness at injection site and it was very bad. The patient sought medical attention via coming to the office and received treatment with unspecified topical cream. The patient's outcome was recovered (in 2015). The relatedness between the events and the vaccination with PNEUMOVAX 23 was not provided. This is one of several reports received from the same source. Additional information has been requested.
Confirmed breakthrough case  COVID-19 (Moderna) 1 81 Years 10 Months 03/16/2021 Hospital Moderna 011A21A   COVID-19 (Moderna) 2 81 Years 11 Months 04/13/2021 Hospital Moderna 025B21A
pt rheumatoid arthritis was acting up & pt having trouble moving legs;29OCT97 weakness in proximal muscle grows & diff walking;1NOV intubated d/t resp failure & diff controlling secretions;quadriplegic 10% movement of one eye;
Sore left deltoid, brief general achiness.  All side effects gone by injection-time-plus-36 hours.
This spontaneous report was received from a nurse refers to a 14 year old patient of unknown gender. On 14-JUL-2014 the patient was vaccinated with (Oka-Merck) PROQUAD injection. No concomitant medication was reported. On 14-JUL-2014 it was reported that a 14 year old patient received (Oka-Merck) PROQUAD and no adverse symptoms reported. The outcome of 14 year old patient received (Oka-Merck) PROQUAD and no adverse symptoms reported is unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
The child is a under care. The child immediately had a vasovagal reaction after injection of HPV vaccine. She did not loss consciousness . The FNP was called into the room and had the child lie down and drink Gatorade and eat a popsicle. Less than 5 minutes after she started to eat the popsicle, color had returned to the child's face. Within 10 minutes she stated she felt better. She was able to walk normally and move all 4 extremities well. The child denied pain. No swelling or redness noted at the injection site.  No respiratory distress noted. After the 15 minute observation period, the child left the office. The child and staff who had accompanied child were instructed to call the clinic as needed,
c/o pain 8-8-07 2 hrs after inj. mom rubbed clear alcohol on shoulder x 2
27OCT93 140PM pt noted urticarial rash & warmth on rt forearm & lt upper arm; rt forearm had burning sensation p/being scratched by pt; ice applied by p/school care staff on lt arm for 10 mins;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with first dose of RECOMBIVAX HB (dose 1 ml, lot #, expiry date, vaccination site, route not provided). On an unknown date in July 2016, the patient was vaccinated with second dose of RECOMBIVAX HB (dose 1 ml, lot # expiry date, vaccination site, route not provided). It was reported that, on 20-OCT-2016, the patient was vaccinated with third dose of RECOMBIVAX HB (dose 1 ml, lot # expiry date, vaccination site, route not provided) (Inappropriate schedule of vaccine administered). No adverse effects were reported. Product quality complaint was not involved. No further information was available. Additional information has been requested.
Pt developed immediate pain in the right shoulder. He has had persistent pain since then and appears to have had SIRVA and now frozen shoulder; he received a steroid injection and is seeing PT and now having some improvement.
Admit for COVID. Vaccine completed Jan 2021. Treated with O2, LMWH, steroids, lasix, zinc. Discharged home.
Initial report received from a healthcare professional on 02 December 2013. Patients received FLUZONE and the doses were drawn up the day before and used. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient endorses a feeling of numbness in her throat, swelling of the tongue, and tingling of the lips. It was apparent she was also experiencing increased anxiety with evidence by arm tremors. Patient received 50mg IM diphenhydramine and 4mg of IM Dexamethasone.
Warmth fling rush from shoulders up through neck to top of head Muffled hearing Felt faint  Blood pressure drop
POSSIBLE ADVERSE REACTION; 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced possible adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible adverse reaction was not reported. This report was non-serious.
Back pain; Sore arm; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Shoulder pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer and Surgery since an unknown date. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced BACK PAIN (Back pain), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Shoulder pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  also applied ice to help with the symptoms.
1st dose vaccination of Moderna was administered to patient who was 16 years of age, but vaccine indicated for 18 years and older. Patient didn't show any adverse reactions when vaccination given
patient received expired FLUZONE QIV with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a nurse practitioner via non health care professional/ consumer via physician via regulatory authority (under reference number 00814573).  This case is linked to cases 2021SA345624, 2021SA344107, 2021SA345249, 2021SA345067, 2021SA345086, 2021SA344898, 2021SA345823, 2021SA345617 , 2021SA345419, 2021SA345587 and 2021SA345099 (same reporter).  This case involves a 62 years old female patient who received an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication and additional medications was given to patient.  On 15-Oct-2021, the patient received a 0.5 ml first dose of 2021 of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, lot UT7108MA and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event (non-clinical).   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.
There was swelling over eyelid 15 min. after listed vaccines were given. Face was flushed. BENADRYL & prednisolone PO given as per doctors order mother was asked to go to emergency department if condition worsens 1/2 hour after child was feeling better. Follow up on 11/3/10 done. Child was stable.
Redness/extreme swelling to injection site per mom. Witnessed by Dr. at home visit.
Patient seated in waiting area for 15 minute observation. Notified per staff that patient was not feeling well. Patient reported that he "passed out" while seated. Pt diaphretic and pale. VS obtained and blood pressure 98/60. No baseline blood pressure to compare. Pt given Orange Juice x 2 with improvement. Blood pressure retaken and 110/72. Pt with complaint of tingling in fingers , but stated that that was not new. RN sat with patient until patient felt better. Offered to call Paramedic to evaluate patient, but patient declined. Patient reported that he felt better and was going to sit for a few minutes longer and drive home. Patient did admit to fear of shots prior to receiving vaccine.
Nose bleed followed by fatigue, muscle aches, headache, and fever.  Symptoms started 5 hours after injection and lasted approximately 15 hours.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with no drug reactions and allergies. On 28-SEP-2013 the patient was vaccinated with ZOSTAVAAX, lot # J003723, expiration date 28-JUN-2014, 1 dose 0.65 ml, subcutaneous for vaccination. No concomitant medication was reported. On 28-SEP-2013, the patient developed pain and "welt" at the ZOSTAVAX injection site. No lab diagnostics and studies were performed. The patient sought medical attention and saw the pharmacist. Ibuprofen and tramadol treatments were given for the events. Action taken with therapy was unknown. The patient was not recovered from the events at the time of reporting. Additional information has been requested.
COVID myelopathy; felt that her walking was off; feeling numbness of her right leg going up to her upper abdomen/ decreased sensation on her right side up to a mid-thoracic sensory level; COVID myelopathy/ leftsided cervical myelopathy; left arm pain and discomfort; left arm pain and discomfort; tingling sensation in her third, fourth, and fifth digits on her left hand; This is a spontaneous report from a non-contactable Pharmacist. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via unspecified route of administration on 21Jan2021 at unspecified age at single dose for COVID-19 immunisation. Patient was not pregnant at the time of events onset and at time of vaccination. Medical history included mitral valve atresia (MVA) and back pain. Patient has known allergies penicillin. The patient presented to office on 25Feb2021 with left arm pain and discomfort that started three weeks ago on 21Jan2021 and had resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago in Feb2021 she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that had stabilized in the past several days. She also felt that her walking was off but cannot quite describe how or when it started. Exam notable for leftsided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. COVID-19 biofire came back positive. In light of this, COVID myelopathy was (missing information). Adverse event COVID myelopathy start date was reported as 21Jan2021. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, hospitalization. It was unknown if there was COVID prior vaccination. COVID was tested post vaccination. Outcome of event left arm pain and discomfort was recovered with sequel, of the other events was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on a temporal association, the causal association between the reported events and the suspect drug cannot be totally excluded. Patient's risk factor (family history of multiple sclerosis) can also be assessed as possibly contributory to the events. Case to be reassessed if follow-up information is received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
The vaccine was given subcutaneously. Patient does not report any adverse effects except arm soreness.
Dizziness; Headaches; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   This case was linked to MOD-2021-190455.   Reporter did not allow further contact
Patient describes sharp pain; tingling in (L) arm. 5 mins after receiving FLUZONE c/o weakness in left arm as compared to (R) arm. Symptoms are persistent, not worsening. Seen in office- Dx: Myalgia
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with 2018SA315975, 2018SA315981 and 2018SA315982 (same reporter). This case involves a 13-years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UJ000AB, expiry date: 28-Mar-2019) the left deltoid on 18-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. No adverse effects reported at this time. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Redness, swelling, "hot", discomfort, very tender - hardness at injection site - Left lateral thigh 4" x 4".
Received 2nd Pfizer vaccine on 4/22/21.  No immediate reaction or side effects.  On May 30, 2021 in the late afternoon, early evening began noticing my scalp itching.  Itching continued all thru the  night to where it would wake me up.  Next day itching spread to behind ears, behind my neck, right shoulder,  and a few spots down my body.  Small bumps surrounded with a red itchy area.  Also, had a cough and tightness in my upper chest area; lungs hurt.  Itching has continued thru day 3.  Tried taking Benadryl but did not have any effect to remedy the itching.
headache, fever (presumed), extreme chills, extreme dizziness,  extreme body aches. Worst of this was over by mid-day the following day. Chills, dizziness, and body aches continued mildly through Sunday.   I also passed out/blacked out the night of getting the vaccine while using the bathroom. Unclear if this was simply due to standing too quickly while experiencing the above mentioned symptoms and blood rushing to my head or a true side effect of the vaccine.
Swollen tongue , difficulty breathing. We gave 1 Epipen and called EMT, she got better and then was fine
Rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Rash on arm). At the time of the report, RASH (Rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.; 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.
got a rash on bottom of right arm for a couple hours got very tired and liturgic.  My bones and muscles are aching and weak. I am very weak and it is day 6. I can barely function at work. I was walking down the stairs and my leg gave out. Almost like my muscle atrophy.
Seconds after the first vaccine was administered, I felt weak and was unable to walk or stand unsupported. After 30 minutes of observation, I existed the clinic in a wheelchair and received a ride to my home. This weakness lasted a total of 1 hour, after which I was able to stand and walk normally.  The same sequence of events followed my second vaccine, but the weakness was worse and lasted for 3 hours. During the second hour, there was a 15 minute period when I was unable to speak (except to whisper) and unable to lift my arms to reach for a glass of water.
Patient is a 50 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: sensation of throat swelling or throat closure, tingling in the tip of the tongue, itching in the throat. Janssen/J&J COVID-19 vaccine #2 in series administered.   Patient received moderna as first dose on 1/7/21 at a satellite clinic per patient. Patient had numbness on left side of face and arm after getting moderna but did not go to emergency. Numbness went away per pateint. Msg was sent to doctor and was advised to take J&J to complete vaccination.  Patient here for j and J vaccine Upon examination, no swelling of lips noted, no tongue swelling, throat is clear. Voice is clear, speaking in full sentences. No audible wheezing noted. No rash, no hives. Vital signs as follows Vitals:  12/10/21 1407 12/10/21 1412 12/10/21 1420 12/10/21 1430 BP: (!) 143/90  122/84 124/78 Pulse: 77 72 71 71 Resp: 20 18 20 18 SpO2: 100% 100% 100% 100%     Action(s) taken: Another drug administered - Benadryl 25 mg PO x1 Allergy to COVID-19 vaccine documented in Allergies activity: No, advised to see doctor for advise.  Patient advised to discuss second dose considerations with a clinician Sent home at 230pm. Feeling better.
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.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient received a vaccine and did not received other medication in 2 weeks. He had no known allergies. Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 25Jul2022, Treatment stop date: 29Jul2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had COVID December 19, 2020. Had 1st dose Pfizer on 1/6 and 3 hrs after had heart palpitations, dizzy, HR 110-115. Lasted for 48 hours intermittently. 1/29 15 minutes after 2nd dose was dizzy. @ 1120 B/P 110/79 sats 100%, HR 67, @1126 B/P 107/80, HR 72. Stayed for 40 minutes and left feeling fine. Takes no meds, In 2002 had GI Ulcers and was treated and Allergic to Proton Pump  Inhibitors- hives, heart palpitations, generalized swelling, dyspnea