chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:34 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.94.  Concomitant products were not provided.  On 28-Feb-2021, for excursion time was 09 AM, temperature was 27, and for excursion time 01PM, temperature was 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: not provided, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 27, 2 PM: 37, 3 PM: 43, 4 PM: 45 and 5 PM: not provided.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt recvd 3 doses of Engerix-B 6MAY91, 3JUN91 & 14NOV91; 14NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
Dizziness, Headache, NauseaVomiting, EXHAUSTION Narrative:
Severe Anxiety approx. 1.5 hrs. after vaccination which lasted approx. 2 minutes
12/18/2020 1st Covid Vaccine Pfizer EH9899 Left Arm 9am 1/08/2021 2nd Covid Vaccine Pfizer EL3246 Left Arm 9am 4/10/2021 mass covid testing, LTC  Antigen Covid +, Asymptomatic 4/11/2021 Covid PCR test - confirmed positive 4/21/2021 returned to work
A painful nodule appeared below site of injection. Pain persists after 2 months. Arm feels like it drops when picking moderately heavy items (not consistent). Flu shot received at pharmacy. Date of vaccination is an estimate. Pain symptoms emerging is an estimate. I was unclear whether this could be related to vaccine given the delay of symptom manifestation after vaccination. Contacted Health Department who indicated I submit a VAERS report. Recent reports by health officials indicate other patients have developed painful nodules at location of vaccination which made me question whether this nodule is vaccine related. I am looking for guidance.
This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 02-JAN-2018. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:Original Case : 1801USA006569.
This spontaneous report as received from a nurse refers to a 14 month old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 22-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine: VARIVAX lot # R018780 and expiration date 01-JUL-202 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored sterile diluent used was reported. The vaccines were exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases. Sender's Comments: US-009507513-1903USA011480: US-009507513-1903USA011573: US-009507513-1903USA011572: US-009507513-1903USA011571: US-009507513-1903USA011574.
38 year old female has a history of Thalassemia and no previous history of severe allergic reaction.  She complained of shortness of breath 15 minutes after receiving her first doe of the Moderna COVID-19 vaccine. She had no respiratory distress, no nasal flaring, no tachypnea, no increase work of breathing.  She spoke in clear/complete sentences and had clear bilateral breath sounds.  Her vital signs remained stable (BP 117/78, HR 67, RR 18, SaO2 100% on room air).
This spontaneous report as received from a registered nurse refers to several unspecified patients of unknown age. The patients may have been vaccinated with VAQTA (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced vaccine was improperly stored. No adverse effect reported. Same reporter link for case 1212USA005070 RECOMBIVAX HB and case 1212USA004414 GARDASIL. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received 1.5 years ago before the reporting date). Concomitant products included CRESTOR, amlodipine and trazodone. On 27th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th January 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, fatigue and injection site erythema. On 29th January 2018, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving and the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site swelling, injection site pain, fatigue and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. On the reporting date, the patient and swelling had gone down a lot, though there was still redness.
fever; chills; just the arm sore; headache that has been since she had her booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (just the arm sore), HEADACHE (headache that has been since she had her booster dose), PYREXIA (fever) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O11F21A, O18B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced HEADACHE (headache that has been since she had her booster dose). On 26-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (just the arm sore). On 27-Nov-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (just the arm sore) outcome was unknown, HEADACHE (headache that has been since she had her booster dose) had not resolved and PYREXIA (fever) and CHILLS (chills) had resolved.            No relevant concomitant medications were reported. Treatment medication included Painkiller for fever.  On 27-Nov-2021, the patient couldn't tell if she had a headache or not because all the pain went away with the painkiller she took for fever, but on Sunday she had a headache.Sunday, Monday and Tuesday had passed and she still had a headache, and it felt like it was increasing in intensity.
Teeth chattering chills, fever, body aches, joint pain, nausea, congestion, head ache neck ache
Had (?), bone ache in left arm after shot. Began Friday. Then Sunday noted episodes of slurred speech. (?) Improved since then. No noticeable problem now.
LIGHT HEADED DIZZY THROAT SWELLING LIP NUMBNESS INC HEART RATE SHORTNESS OF BREATH AND WHEEZE.  GAVE 1 25MG BENADRYL AND COLD WATER.  WAITED ANOTHER 15 MINUTES.  PATIENT GOOD TO LEAVE.  CALLED THIS AM STATED HE TOOK ANOTHER BENADRYL AS HE HAD SYMPTOMS,
Patient stated that  her face swelled up about 2 hours post vaccine. Client notified me at her appointment of her second dose. Dose was not administered and she was referred to clinic for that dose due to our rural location and lack of emergency services. I called the client to find out how she did with the second dose,  she stated they did not administer it. She informed me at that time that she thinks she also had shortness of breath following the first dose while she was driving to work 1 hour away. All symptoms resolved on their own with no treatment.
sleep paralysis; Tiredness; sleepiness; soreness at injection site; This is a spontaneous report from a contactable healthcare professional. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 09:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as not available. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included fluconazole (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 11:00, the patient experienced tiredness, sleepiness, sleep paralysis, soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tiredness, sleepiness, sleep paralysis, soreness at injection site was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a 60 year old female patient. The patient did not have concurrent conditions, medical history, historical drugs or concomitant therapies. On 10-OCT-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously, once, lot # N016185 expiration date 31-JUL-2018 (anatomical application was not reported) for prophylaxis, reconstituted with sterile diluent (MERCK) lot number M005906, expiration date 14-AUG-2018. On 11-OCT-2017, the patient experienced itching at the injection site. On 12-OCT-2017, she had the injection site tender and hard. On the same date (might have started earlier), she had a blister "like rash" at the injection site. The patient was in a clinic at the time of reporting, but not treatment was given for the events. The outcome of the events was not reported. The causal relationship between the events and ZOSTAVAX and sterile diluent (MERCK) was not reported.
PATIENT FELT LIGHT HEADED AFTER GETTING THE VACCINE DUE TO  ANTICIPATION. WE CHECKED THEIR BLOOD PRESSURE WHICH WAS NORMAL.
This spontaneous report as received from a medical assistant refers to a unspecified patients of unknown age and genders who on an unknown dates were vaccinated with one improperly stored dose of PROQUAD (Merck) (dose, lot #, expiration date and route were not reported). NO adverse events were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Severe traveling pain from low deltoid to elbow. Pain remained constant and increased causing sleeplessness. Sought medical attention 11/17/2011.  MD diagnosed and treated it as "musculoskeletal pain".  Pain continuses today and is relieved only by contiunued use of pain medications.
This spontaneous report as received from a nurse refers to an unspecified number of patients. In 2015 (reported as since 13-MAY-2015), the patients were vaccinated with doses of PNEUMOVAX23 batch/lot # K008410, expiration date 25-FEB-2016 (also reported as 26-FEB-2016), batch/lot # K020214, expiration date 25-MAR-2016, batch/lot # K019561, expiration date 20-APR-2016 that had been exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Localized reaction, improvement noted in pain, redness and swelling with ice and tylenol
patient presented to emergency department on 2/1/22 with shortness of breath patient was admitted for further management of hospital-acquired pneumonia patient was found to be covid-19 positive on 2/1/22 patient di require treatment for symptoms associated with covid-19 infection. treatment included remdesivir patient was discharged to home on 2/7/22
chest pain and pressure; flu like symptoms and fatigue; metal taste in mouth; chest pain and pressure; flu like symptoms and fatigue; chills; nausea; taste disruption; This is a spontaneous report from a contactable consumer(patient). A 36-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (at the age of 36years) as dose 1, single for COVID-19 immunization. Medical history included allergies to penicillin and also penicillin related drugs, childhood asthma she had sort of severe childhood asthma. Concomitant medications were not reported. The patient experienced chest pain and pressure, flu like symptoms and fatigue, metal taste in mouth, chest pain and pressure, flu like symptoms and fatigue, chills, nausea, taste disruption. It was reported Caller states she was a little bit concerned because she was experiencing chest pain and chest pressure because she had sort of severe childhood asthma. Caller states another hot line she talked to today said that was not a usual side effect. Caller states she did experience a lot of the other symptoms she saw on the website like flu like symptoms, fatigue, chills, nausea, metal taste in mouth, taste disruption were common. Caller states she has an allergy to penicillin and penicillin related drugs and that is in the mix she guesses. Caller wants to know was she a good candidate for the second vaccine. Caller states she was a little bit she has to go pick up her son in a few minutes. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Cough, runny nose, nasal congestion, febrile x8 days. Temp max in ER = 105.2 degrees F. Tx/Rx = MOTRIN, TYLENOL, antibiotics for pneumonia.  12/3/09 Hospital recs received for date 11/19/09 to 11/24/09. DX: pneumonia LUL and LLL. Presented to ER w/ c/o fever x8 days, dx by PCP w/ bronchitis given abx. Pt. parent states has not improved and on this day observed pt. breathing fast, decreased PO intake, since abx started, has had some diarrhea, cough, runny nose, nasal congestion. H1N1 vax x1wk ago. Assessment: tympanic membrane red bilat, (+)nasal congestion, (+)decreased breath sounds on left. Pt admitted, tx, upon dc pt. stable with some mild diarrhea noted poss. Due to abx tx. Pt to f/u with PCP.
Sore to firm touch under left arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En615906121) via an unspecified route of administration in the left arm on 26Feb2021 at 18:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) and herbs (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 27Feb2021 at 09:00, the patient experienced sore to firm touch under left arm pit. 17 days after the first dose the patient had sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore to firm touch under left arm pit. was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received only one immunization at well-child visit:  Infanrix.  (Most recent previous immunization for these diseases had been 9 months prior, via Pediarix.)  Immunization on left thigh.  Patient developed a large red swollen area on left thigh, offset from immunization site.  Zone was hot to the touch for 3 days.  Indurations were worst at 24 hours post-immunization.  Swollen zone continued to spread for 3 days post-immunization.  Maximum size of swollen zone was greater than 5 inches long and about 2.5 inches wide.  No fever observed.  Swelling gradually faded after 3 days, leaving purple zone and eventually returning to normal skin coloration.
Patient states that evening of vaccination she started to have pain and swelling radiating from injection site to shoulder, up neck to under eye area and then across left clavicle.  Patient states that jaw was sore.  Following morning, the patient experienced joint and muscle pain and a headache (similar to when she had COVID in Oct 2020).  Patient also had a cold sore occur 24 to 48 hours post vaccine.  Patient called pharmacy on 12/21/20 to report ADR and pharmacist recommended contacting PCP as well.
Bladder pain; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER PAIN (Bladder pain) and PAIN IN EXTREMITY (arm pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer in June 2020. Concomitant products included OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced BLADDER PAIN (Bladder pain) and PAIN IN EXTREMITY (arm pain). On 15-Mar-2021, BLADDER PAIN (Bladder pain) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: No significant information was received. On 08-May-2021: Outcome of bladder pain updated.
I have had four nose bleed.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route on an unspecified date (Lot Number: ER8736) as a single dose at the age of 60-year-old  for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for blood pressure, start and stop date were not reported; estradiol taken for an unspecified indication, start and stop date were not reported. The patient was on different medication along with blood pressure medication. The patient takes the first dose two weeks before and have had four nose bleed. The patient never had any nose bleed since before the vaccination. The patient wanted to know if the nosebleed would be part of the symptom and should she got the second one. The outcome of the event was unknown.