chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Moderna Covid-19 vaccine that underwent a temperature excursion; patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR5186C, 018B21A and 047A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient weight was reported as unknown. It was reported that, the nurse had discovered temperature excursions of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. Further nurse stated that, none of the vaccine in the refrigerator underwent two different temperature excursions. It was reported that the patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses. Side effects after the doses was reported as unknown. No treatment medications were reported.
Started swelling with mild swelling, by 6/22 am some rash had started on my arm and by 6-23 PM it had spread all of the way down to my wrist and had started on my other arm.  I had started having some mild wheezing and coughing issues.  I took Benadryl and applied Ice packs and went to the icc on 6-24 they gave me steroid shots and antibiotics and told me to continue with and inhaler and Benadryl and ice packs and follow up with a doctor on Monday. By Sunday night I could barely breathe and was un able to get out of bed. I went to the hospital on 6-27 with acute asthma and acute bronchitis.  Had 3 breathing treatments, steroid iv, Percocet for the pain in my chest and ribs from coughing so hard, cough meds, and they sent me home with prednisone, cough meds and doxycycline. I saw my doctor today 6-28-16 for a follow up and she said it was an anaphylactic reaction to the shot. I still have bruising all around my arm from the extreme swelling, itching, and am having trouble breathing.
Breakthrough case admission after 3 vaccines Moderna 3/10/21 Lot# 024M20A;  Moderna 4/7/21 Lot# 017B21A;  Pfizer 1/7/22 Lot# FG3527
Patient received pediatric dose of Pfizer booster (0.2 ml) instead of adult booster of 0.5 ml.  No symptoms or adverse effects.
9 days post vax pt developed 102F; Seen by MD 24MAY91 was told virus; CBC done showing 10-20% viral appearing lymphocytes; On 25MAY91 developed few fine bumps on body; Bumps gone by 27MAY91;
Information has been received from a physician concerning a male who on 25-JUL-2007 was vaccinated with the first oral dose of Rotateq. On 25-JUL-2007 about 4 hours after vaccination, the patient was extremely irritable and experienced diarrhea. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Received the first dose on  Monday 03/22/2021 symptoms of itching, tenderness  and swelling appeared approximately 3-4 hours later. The side affects resolved on Friday 03/26/2021. On Tuesday 03/30/2021 I awoke to a swollen deltoid/ bicep at the point of injection. My arm was immoveable, heavy, hot to touch,hard and swelling protruding outward the size of a baseball
Overnight the patient developed multiple adverse reactions described in the VIS, including muscle aches, chills, and headache.  She states she has never had previous reactions to the flu vaccine and was feeling better by the morning.
Arm pain, swelling, welt from elbow to shoulder x 3 days. Pain persisted x1 wk. Pain did not limit activity. General malaise. No measured fever.
AT AROUND 2100 (1/18/21) I STARTED HAVING CHILLS, FEVER OF 100.5, BODY MALAISE. I TOOK TYLENOL 1000MG AROUND 0100 (01/19/2021). PO FLUIDS. I WAS ABLE TO SLEEP FOR ABOUT 5 HOURS AND WOKE UP WITH THE SAME SYMPTOMS. TOOK ANOTHER 1000MG OF TYLENOL AROUND 7:30AM.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 06-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent an unknown number of excursion hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2020, the patient received Shingrix. On 15th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient had received a dose of Shingrix day before reporting date and had soreness at the injection site.  The patient declined to provide any additional information other than that the soreness was already better. The reporter did not consent to follow-up. This case has been linked to US2020AMR208235, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR208235:same reporter
autoimmune disease; Hypertrophic Lichen Planus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 16:00 as dose 2, single (Lot number: Ff8841), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulpha" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; IBUPROFEN. Vaccination history included: BNT162b2 (Dose number 1, lot number Ff8841 Administration time 16:00, vaccine location-Right arm), administration date: 26Oct2021, when the patient was 58-year-old, for COVID-19 Immunization. The following information was reported: LICHEN PLANUS (disability, medically significant) with onset 01Dec2021 at 12:00, outcome "not recovered", described as "Hypertrophic Lichen Planus"; AUTOIMMUNE DISORDER (disability, medically significant) with onset 01Dec2021 at 12:00, outcome "not recovered", described as "autoimmune disease". The events "autoimmune disease" and "hypertrophic lichen planus" required emergency room visit. Therapeutic measures were taken as a result of autoimmune disorder, lichen planus. Clinical information: Ae treatment: Clobestasol propionate cream usp 0.05%, Prednisone. No covid prior vaccination and post vaccination.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 02-MAY-2018, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot number M038744, expiry date 26-APR-2018) (exact dose was not reported) for prophylaxis. No adverse effects were reported.
No adverse effect reported.; patient was inadvertently administered a dose of GARDASIL 9, on 9/9/2019, that had been improperly stored.; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent history, concomitant therapies and drug allergy or reactions were not reported.       On 09-SEP-2019, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1581027, expiration date: 03-JUN-2021; dose and route were not reported) for prophylaxis, that had been improperly stored (improper storage of product in use). No adverse effect was reported.   The administrated vaccine experienced the following temperature excursion: temperature: 60 Fahrenheit (F) for 8 hours 25 minutes. Previous temperature excursions: above 47 degree Fahrenheit/9 degree Celsius (46.6 F) for 2 hours 45 minutes. The call was due to a data logger.
Approximately 1 hr following vaccine/mist broke out in small (pintop) hives an bilateral arms then also large (50 cent piece) hives on shoulders, neck, back, and chest. Lasted approx. 8hrs-very itchy then slowly disappeared.
no adverse event; expired MMR vaccine was administered to a patient; This spontaneous report was received from a registered nurse, referring to a 40 year old patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 10-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S013539, 0.5 milliliter for prophylaxis (route and site of administration were not reported) which had expired on 02--MAY-2021.  The vaccine had not had any temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Son had seizure the evening after the day of vaccine. He then had another seizure the morning after the first seizure. He also had a terrible sore throat starting three days after vaccine.
This case was reported by a consumer and described the occurrence of shivering in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 26th May 2018, the patient received the 1st dose of SHINGRIX. On 27th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering. On 27th May 2018, the outcome of the shivering was recovered/resolved. The reporter considered the shivering to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. This event was reported as a general adverse event which was listed in the GlaxoSmithKline product literature. The patient's shivering was not serious nor was a physician involved.
Patient received vaccine on 06/01/18 around 3pm. She started to experience a sore arm and later in the day some flu like symptoms but she did not report this to the pharmacy until 06/04/18 around 11am. On 06/04, patient also started to experience tremor of the thumb on the left hand. Sent patient to urgent care clinic and patient will contact primary care doctor as well.
*******************COVID BREAKTHROUGH CASE********************************* Severe body aches; Chills; I think I had a temperature but never took it. Dr prescribed Paxlovid.
It was reported that a patient (1 of 2) received a Fluzone vaccination. Sometime after the vaccination the patient developed leg cramps. No specifics were provided. Further information is requested. From additional information received on 12/7/2000, it was reported that the patient received the Fluzone SV vaccination on 11/30/2000 at 10:00 am. Reportedly at 12:01 pm that same day the patient developed pain and cramping of the right calf. The patient was seen in the ER. The patient's recovery status is unknown. Additional patient, vaccine, vaccine administrator and responsible physician information was also provided. From additional correspondence received on 03/20/2001 it was reported that the patient recovered from this experience.
Patient reports throat tightening/swelling, red itchy eyes, fever of 101. Reports symptoms are improved.
PATIENT'S MOTHER REPORTED TO PHARMACY THAT PATIENT DIED 6 DAYS AFTER RECEIVING THE JANSSEN COVID 19 VACCINE.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with GARDASIL 9, lot no. M020103/ expiration date-15-FEB-2018 (Incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of the vent was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Dizzy spell lasting about 40 minutes -- debilitating enough so I had to sit/lie down immediately. Second event 02/12/2013 lasted approx 5 minutes and also required me to sit down until it passed.
Fever of 101.7, chills, pain in every joint, shooting pain down the front of my right high & into my ankles, which lasted approx. 12 hours.
bleeding; Clot blood; Menstrual cycle abnormal; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in arm left on 22Oct2021 10:15 at 42-year-old (Lot Number: FD8448) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Patient was not pregnant and was not pregnant at time of vaccination. Patient did not have COVID-19 prior to vaccination. Patient did not have known allergies. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient experienced bleeding (medically significant) on 02Nov2021 10:00 with outcome of recovering, clot blood (medically significant) on 02Nov2021 10:00 with outcome of recovering, menstrual cycle abnormal (medically significant) on 02Nov2021 10:00 with outcome of recovering. No therapeutic measures were taken as a result of the events. Patient did not tested for COVID-19 post vaccination. It was reported that the patient experienced very profuse bleeding with presence of large amount of blood clots for two days in the subsequent menstrual period after vaccination. This was completely abnormal to her regular menstrual periods.  No follow-up attempts are possible. No further information is expected.
Chest pain immediately after vaccination; Confused immediately after vaccination; Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination; Very Emotional after vaccination; Anxiety after vaccination; Can not sleep after vaccination; Agitated all the time after vaccination; Body Pain after vaccination; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination) and ANXIETY (Anxiety after vaccination) in a 28-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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination), ANXIETY (Anxiety after vaccination), SLEEP DISORDER (Can not sleep after vaccination), AGITATION (Agitated all the time after vaccination) and MYALGIA (Body Pain after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination), ANXIETY (Anxiety after vaccination), SLEEP DISORDER (Can not sleep after vaccination), AGITATION (Agitated all the time after vaccination) and MYALGIA (Body Pain after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided Patients cardio echo and enzymes were normal.
pt had redness and swelling below the injection site and complained of pain in arm radiating to neck and back
Erythema and swelling noted left arm where Dtap was given day after shot given. No fever.
pt recv vax; did not cry;was staring before fell back;all 4 limbs shaking; was blue; tremors lasted about 3-5 mins;seen in er; T 103.8;blood work  & U/A done, both neg;dx as virus;
Blood shed during menstrual cycle has increased VERY significantly both flow rate and overall amount; This is a spontaneous report from a contactable consumer.  A 30-year-old female consumer (Patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0173) in the Left arm on 30Apr2021 at 02:00 PM (at the age of 30-year-old ) as single dose and the second dose (lot EW0187) on 24May2021 at 02:00 PM in the Left arm at single dose for COVID-19 immunization. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had known allergies to Sulfa drugs. No concomitant drugs. The patient reported that blood shed during menstrual cycle has increased very significantly since first round of vaccination (both flow rate and overall amount). Onset date reported as 15May2021. The patient was not COVID tested post vaccination. No treatment was received. The outcome was not recovered.  Follow-up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Patient started getting "splotchy" around her neck. BP 168/100, HR 92, SpO2 96% RA. She was shaky. About 10 min later started complaining of itching and felt a little SOB. Give Benadryl 25 mg IM. Pt states she was feeling "hot and cold". Mild itching and dizziness. SOB resolved. Pt discharged after 1 hr 40 minutes home with friend. VS stable.
This report was received from Pfizer Inc and was assigned a manufacturer report number (2016118776) for  PREVNAR 13. It was reported by a physician referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 17-AUG-2015, the patient was vaccinated with PREVNAR 13 and developed low grade fever that escalated to 104 degrees, extreme redness and swelling at the injection site. (1604USA006010). On 07-FEB-2016, the patient was vaccinated with PNEUMOVAX23 (anatomical location, dose number, lot number and expiration date were not reported). The patient's concomitant medications were not reported. On an unknown date, the patient experienced and unspecified reaction. At the time of the report, the outcome of the unspecified reaction was unknown and relationship between the event and vaccination with PNEUMOVAX23 was not provided. Additional information has been requested.
It hit the bone. She hollered because it hurt so bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), administered in arm left, administration date 25Mar2021 (Lot number: ER8733) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE] taken for diabetes mellitus (ongoing); GLIPIZIDE taken for diabetes mellitus; LOSARTAN taken for blood pressure measurement (ongoing); METHIMAZOLE taken for thyroid disorder (ongoing). Vaccination history included: Bnt162b2 (dose 1), administration date: 03Mar2021, when the patient was 73 years old, for COVID-19 immunisation, reaction(s): "pain in the right shoulder where she got the shot", "pain over her heart area", "toothache", "pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm", "pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm". The following information was reported: BONE PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (25Mar2021), described as "It hit the bone. She hollered because it hurt so bad".  Additional information: He said the shot had to be in the other shoulder and he put it in the left shoulder in the bone. It hit the bone. She hollered because it hurt so bad. He said no one ever jumped like that before. She jumped because it hurt. She still has the pain in the right shoulder, but she doesn't feel anything in the left where she got it today. Caller clarified Pfizer shot as COVID19 Vaccine. The pain in the right shoulder travels down the right arm. It goes down the shoulder  and down the arm.   No follow-up attempts are possible. No further information is expected.