chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. Since an unknown date, the patient received a series of "small doses" of PNEUMOVAX23 (anatomical site, route of administration, exact dose, lot number and expiration date were not provided) every week as a desensitization regimen, also reported as "getting it as an allergy s hot". No adverse effects reported. The pharmacist was wondering the accuracy of this information. Furthermore, no product quality issue was involved.  Additional information is not expected as no consent to contact the pharmacist was provided.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/29/2022 HX OF LARYNGEAL CANCER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/29/2022 DYSPHAGIA
PT'S LEFT ARM IS SWOLLEN AND RED AROUND THE AREA WHERE VACCINATION WAS ADMIISTERED.
Narrative:  Limited information provided on adverse reaction - patient received vaccine outside of hospital at the clinic. No  records to review, self reported to nurse during an appointment.
LOSS OF TASTE; SWEATING; CHILLS; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced sweating. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced tiredness. On 10-MAR-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and chills on 10-MAR-2021, and had not recovered from loss of taste, and tiredness. This report was non-serious.
This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUL-2016, the patient was vaccinated with an improperly stored VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Raised, red area, hot to touch and itching, the size is 3 inches X 5 inches
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 62-year-old male patient who received SHINGRIX. Concomitant products included FLOMAX. In April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovering/resolving. The reporter considered the pruritus to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX vaccine approximately a week before the reporting date. The patient experienced medium amount of itching. Medical disclaimer was provided and patient was counseled to follow up with health care physician. The patient had denied permission to contact their physician. The patient provided limited information due to time constraint.
This spontaneous report was received from a nurse refers to a 2 year old male patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 12-AUG-2014, the patient was vaccinated with the first dose of VAQTA, intramuscular, lot number K007791, expiration date 22-AUG-2016, (dose and anatomical location were not reported). On 10-AUG-2015, the patient was vaccinated with the second dose of VAQTA, intramuscular, lot number L009445, expiration date 01-JUN-2017, (dose and anatomical location were not reported). There was no concomitant medication reported. On 13-AUG-2015, the patient experienced seizure (unspecified type). As a result, the patient was admitted to a hospital and was discharged on 15-AUG-2015. The patient was prescribed diazepam (manufacturer unknown) 10mg, rectal suppositories to be administered in the event of another seizure. On 22-AUG-2015, in a follow-up office visit it was reported that the patient had not had another seizure. On an unspecified date in August 2015, the patient recovered from seizure (unspecified type). No product quality issue was involved. Upon internal review, seizure was determined to be medically significant. Additional information has been requested.
12 mo female given MMR, VZV, Hep A #1 7/2. Mom noticed rash few days later on thigh. CC rash starting on thigh and abdomen a few days after varicella and MMR vaccine. It seemed to resolve for 1 day then came back with much more diffuse distribution. Now present on face, torso, back, legs and arms. She is not itching except when she sees her belly, then she'll grab at it. Mom reports that she's felt hot, but she hasn't had a thermometer to take temp.
A little over a week after the vaccine my throat got sore which progressed to a cough.  My jaw and throat area was painful.  I was tested for COVID but it was negative.  My body would get really warm at times and I would get winded and had heart palpitations.  I went to see my PCP who ran various test and diagnosed me with having an overactive thyroid.  I was treated with meds and further test and over a month later I began feeling a little better
Within 24 hrs after pneumococcal vaccine, there was serious pain in right shoulder could not have full arm movement. Also pain in the forearm bicep area and numbness in the right hand and fingers. Treatment pending.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no medical history or drug reactions/allergies reported. On 22-SEP-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (lot# K004487 with expired date 21-AUG-2015, dose, frequency and route were unknown). No concomitant therapy was reported. No adverse event was reported. Additional information has been requested.
Contracted COVID-19; Dizziness; Chest tightness; Chest pains; Soreness in her chest and back; Headache; Tiredness; Muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains) and BACK PAIN (Soreness in her chest and back) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains), BACK PAIN (Soreness in her chest and back), HEADACHE (Headache), FATIGUE (Tiredness) and MYALGIA (Muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains) and HEADACHE (Headache) had not resolved and BACK PAIN (Soreness in her chest and back), FATIGUE (Tiredness) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Received HPV9 on 6/13/16. States it hurts to move left arm. Indicates area at deltoid. Mom has been using ice packs daily.
Hallucinations; He started to have trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant) and INSOMNIA (He started to have trouble sleeping). At the time of the report, HALLUCINATION (Hallucinations) and INSOMNIA (He started to have trouble sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.  The events trouble sleeping and hallucinations started approximately one week after the first shot.  Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-308135 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Pfizer COVID-19 vaccine EUA on 04/23/2021 and tested positive via nasal swab PCR on 05/27/2021
patient was relaxed, aware and talkative immediately following administration of HPV vaccine, while documenting location given patient slow experienced vasovagal syncope, slowly falling forward while in a sitting position. This writer assisted patient to supine position and requested assistance. within 45 seconds patient was regaining consciousness, asking what happened, and stated he was "just chilling" on the floor. Patient was helped into a seating position and given an icepack placed on the back of the neck. patient stated he felt weird, woozy and opted to lie down.  patient remained for about 20 minutes prior to feeling he could leave without concern.
This spontaneous report was received from a 79 year old female consumer concerning herself. No pertinent medical history was reported. The patient's drug reaction or allergies included allergy to Sulfa drugs and "Vythroman". On 26-MAR-2008 the patient was vaccinated with ZOSTAVAX (dose, route and frequency: unknown). Other concomitant therapies included valacyclovir hydrochloride (1 gm, three times a day) and gabapentin. On 21-DEC-2015, 2827 days after onset of therapy the patient experienced shingles on her left arm and back, she also had bumps and a breaking out rash. The patient had sought medical attention and treatment was received for the adverse events. The action taken was not applicable. The outcome of the adverse events was reported as recovering/resolving. The causality of the adverse events was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Case number PHEH2015US026969, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 51 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 14 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature before she left for the day and when she arrived the next day and the temperature was fine. It was new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
7 days after injection, onset of maculopapular rash at vaccine site. At day 14, has continued to spread and upper arm w/ generalized erythema. No itching or pain.
17JUL97 4PM awoke from sleep, felt warm, ate one bite of pizza-fell over-both arms & legs jerking, eyes rolled back, foaming @ mough, lips blue;picked up by mom still jerking-called 911;taken to ER-02 was applied;t104 @ hosp;pt recovered;
pt recv vax & 1 days p/vax pt devel fever, nausea, retching & a rash on neck & chest;felt miserable;went to hosp ER recv pain pills & antihistamine pills, went home p/1 1/2;both shoulders still sore;
Starting 7/26/02, Increased temp on 7/27/02- left arm, red swollen, warm, awoke with swelling. 7/28/02-Arm still swollen, red, warm also rash spreading across back. On 7/29/02 appt with Dr-rash on back better. Decrease swelling, Still red and warm. Now itchy, Been treating with Benadryl.
On day 8 post injection, I woke up and had a very red rash about 3/4 inches in radius around the injection site. My arm was also slightly sore at the specific point spot where I was injected 8 days before. The rash disappeared slowly after 3 days. Now at day 15 post dose 1, it?s barely there but still slight itching.
Pt received vaccines at another clinic 12/04/06. On 12/05/06 she started with fever and later developed rash on arm which spread to all extremities and face. We saw her on 12/06/06, rash appeared like erythema much for me. She also was given Tylenol on 12/04.
Coolness and tingling  in right hand (non-shot arm) in the 15 minutes after receiving the shot. Lymph node swelling in neck and armpits, both sides, starting day following injection. Swelling and pain in pointer finger of right hand (opposite side from injection) 10 days out from injection. Pain increased and spread to other hand on day 11, and couldn?t use/bend fingers without shock of pain - sudden onset, no history of hand swelling or pain. Better with Prednozone. Three days left of rx.
Site: Pain at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Additional Details: Pt indicated that had such severe pain for several days after the Moderna vaccine that was unable to get up to use restroom. 2 days later when symptoms did not ease, pt went to ER and was given benedryl and steroids.
On March 26, 2017 my husband was taken to the ER complaining of extreme fatigue and dizziness. At that time he was totally cognizant of his condition. He did not have dementia, he was appropriately forgetful (as I) for an 88 yr. old. After tested for lung x-rays and CT of his brain he was diagnosed with aspiration pneumonia or malignancy in one lung. He was admitted that evening and after being taken to his hospital room, a nurse administered PNEUMOVAX 23 to him. The next morning, I noticed he was confused and somewhat disoriented. After seeing the small card regarding the vaccine I was appalled and complained.
Dizziness on standing; Muscle pain; Fatigue; Nausea; Headache; Fever; Blacked out; Hives; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACRIVASTINE (BENADRYL ALLERGY RELIEF), PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 16-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizziness on standing), MYALGIA (Muscle pain), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out), URTICARIA (Hives), DIZZINESS POSTURAL (Dizziness on standing), MYALGIA (Muscle pain), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: 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.; Sender'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.
Patient indicates arm red and swollen from elbow to shoulder and stomach upset and had been vomiting.
CHIEF COMPLAINT:   patient with dementia fell out of bed, found between bed and nightstand 1am, placed back in bed. This am patient was unable to stand for wife. On anticoags.   HISTORY OF PRESENT ILLNESS:     This is an 84 Years old male with PMH of HTN, HLD, insulin-dependent DM II, CAD on DAPT, COPD not on home oxygen, and CVA w/ speech impairment who presents to the ED by ambulance after generalized weakness and inability to get out of bed this morning.  Patient's wife reportedly found him wedged between the bed and the wall last night, assisted him in getting back into bed but this morning patient was unable to ambulate.  Patient is on Plavix.  No reported vomiting, recent fever or chills, complains of chest pain or shortness of breath.  History is limited by the patient's expressive aphasia and dysarthria.  Patient is reportedly able to ambulate at baseline and this was unusual for him.  He denies any complaints of headache, neck pain, chest pain, shortness of breath, nausea or vomiting, focal paresthesias or weakness, abdominal pain, hip pain.  Again, history is limited at this time now.  Awaiting the patient's wife.
Positive Ag test; Positive Ag test; mild cough; scratchy throat; fatigue; HA congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), on 15Mar2021 as dose 2, single (Lot number: EL3247) and on 03Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 20May2022, outcome "unknown", described as "HA congestion"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "Positive Ag test"; FATIGUE (non-serious) with onset 20May2022, outcome "unknown"; COUGH (non-serious) with onset 20May2022, outcome "unknown", described as "mild cough"; THROAT IRRITATION (non-serious) with onset 20May2022, outcome "unknown", described as "scratchy throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, cough, throat irritation, fatigue, upper respiratory tract congestion. If other vaccine in four weeks was unknown. Adverse event: Travel from (place withheld) wedding back 18May, sx on 20May mild cough and scratchy throat and fatigue and HA congestion and Positive Ag test.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Extreme headache Nausea Vomiting (couldn't hold down water) Muscle aches/back pain diarrhea Fatigue Pain and rash at injection site Face swelling
Had phone on speaker because holding the phone is hard on caller's neck; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Had phone on speaker because holding the phone is hard on caller's neck) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Had phone on speaker because holding the phone is hard on caller's neck). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Had phone on speaker because holding the phone is hard on caller's neck) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
My first shot in 1/22/2019, I had zero side affects. My 2nd shot on 3/27/2019, the next day I felt like I was saturating to get flu symptoms - fever, tired, nausea, stuffed nose. Then I noticed that night, the area where the shot was administered was very sore, red and warm. It?' been that way for 3 days now.
Skin sensitivity, crying excessively, could not move. 12/30/2008 MR received for DOS 11/20/08. Pt in for 12 yr WCC and vax. Dx with B OM. Returned to office that pm with c/o irritability, body pain and crying. Referred to ER. 1/5/09 ER records received for 11/20/08 visit with dx:  Immunization reaction. Pt presented with lightheadedness, body aches, sensitive skin, malaise and chills. Tx with Solumedrol and Benadryl.
she did have arm pain with the first shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Mmr (she was given the second MMR shot in the hospital the day of or the day after she had given birth). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "she did have arm pain with the first shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed sore throat, muscle aches and weakness starting the day after vaccination. He was seen in the ED on day 5 following vaccine with fever and myalgia. He was hospitalized on day 13-15 following vaccine with myosistis and weight loss with CPK elevated to 583 at it's peak. He was again hospitalized with progressive unintentional weight loss and continued muscle pain on day 23-28 following vaccine (15-20 pound unintentional loss). Following his first admission, he was treated with 10 days of Doxycylcine (as recommended by pediatric ID consultant) which did not seem to alter his course. He was also seen by Rheumatology consultant on his second admission.