chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 10:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 10:56 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 72.91. Concomitant products were not provided. On 27-Oct-2021, Excursion time was 9 AM, temp was 29 and at 10 AM temp was 32; total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine   was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021. 2 vial was moved to clinic. Vaccine BUD date was 29-Oct-2021. The vaccine was again moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 4 vial was moved to clinic. Vaccine BUD date was 04-Nov-2021. Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At 9 AM: 41, 10 AM: 29, 11 AM: 32, 12 AM: 43, 1PM : 43, 2 PM : 43, 3 PM: 46, 4 PM: 46 and 5 PM : 46. 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 Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
Experienced tenderness in the underarm lymph nodes. Severe pain in left wrist and left hand swelled and had inability to open/close my hand without intense pain and discomfort. After about four days from the onset of the reaction the swelling subsided in my hand and the joint pain in my fingers went away. Still experience discomfort in my left wrist with certain movements. No prior injuries to my left arm, wrist, hand or fingers.
This spontaneous report as received from a pharmacist concerns a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 05-JUL-2017 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (route unknown), lot # M003027, expiration date 21-JUN-2017, for prophylaxis. No adverse event was reported. The outcome of the event was unknown. Additional information is not expected.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:48 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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.   No Concomitant product use was reported.  The age of patient was provided as 48.69.  It was reported that unknown number of patients were 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 time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 13-Feb-2021, Excursion time was 09 AM temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by 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.  No treatment information was provided.
Enlarged heart, hospitalized 4 days, heart catheter found no blockage or heart disease. Treated with entresto and sent home with a heart monitor.
felt worse physically; back tenderness; Nerve pain; starting having problems walking; increased weakness; degenerative disc; nerve being compressed; increased pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt worse physically), MUSCULOSKELETAL DISCOMFORT (back tenderness), NEURALGIA (Nerve pain), GAIT DISTURBANCE (starting having problems walking) and ASTHENIA (increased weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, 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 FEELING ABNORMAL (felt worse physically), MUSCULOSKELETAL DISCOMFORT (back tenderness), NEURALGIA (Nerve pain), GAIT DISTURBANCE (starting having problems walking), ASTHENIA (increased weakness), INTERVERTEBRAL DISC DEGENERATION (degenerative disc), NERVE COMPRESSION (nerve being compressed) and BACK PAIN (increased pain in the back). At the time of the report, FEELING ABNORMAL (felt worse physically), MUSCULOSKELETAL DISCOMFORT (back tenderness), NEURALGIA (Nerve pain), GAIT DISTURBANCE (starting having problems walking), ASTHENIA (increased weakness), INTERVERTEBRAL DISC DEGENERATION (degenerative disc), NERVE COMPRESSION (nerve being compressed) and BACK PAIN (increased pain in the back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Magnetic resonance imaging: abnormal (abnormal) showed significant changes from 12-L1 with significant degenerative changes from L2-L3, L3-L4.         Concomitant product use was not provided by the reporter. Treatment information was not provided.  The test result changes of MRI scan were dramatic from previous MRI scan done on 13-Jan-2020. The patient had never felt pain from disk issues before this, and felt actual pain from being touched.  MRI scan results found between 24-May-2021 to 26-May-2021 showed that the patient's ability to walk was getting worse due to increased pain in back the patient had been losing feeling in legs which increased weakness.  Patient had received spinal injection on 14-Jun-2021 directly into L2/L3 facets with incredible relief for two days (felt like new) and increased pain returned but with increased intense.  Patient has possible surgery of spinal fusion set for 05-Oct-2021.   This case was linked to MOD-2021-335370 (Patient Link).
100 degree temp, chills,  excruciating migraine, nausea (no vomiting), dizzy, blood pressure up and down -all these ended 24 hrs. later. Next day diarrhea, stomach pains
Developed limb paresthesias, tremor and low grade fever approximately 10 d after Tdap vaccination. He had difficulty urinating. Dx cervical transverse myelitis. He recovered with steroid treatment. MRI - ? subtle T2 abnormality.
This non-serious spontaneous case, initially received from consumer on 08-Jan-2018 and concerns a male patient of an unspecified age. The patient had no history of allergies. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient was administered with AFLURIA (TIV) (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after the vaccination, the patient had developed peanut allergy. It was reported that, patient refused to provide any other information. At the time of this report, the outcome of the event was not reported.
On 9JUL91 pt recvd DTP/OPV/HIB @ 4PM began crying much different type cry, would not console, t101, given APAP; Seen in ER, both legs swollen & red 3cm diameter;
Client was 17 years old when she receieved Janssen vaccine. Notes fever and body aches that resolved within 3 days. Denies any other concerns. Guardian and client aware state may contact further
This is a spontaneous report from a contactable consumer reporting for his brother's wife. A 7-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. The patient had a sore arm after the first shot. The event outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433387 same reporter, product and event, different patient.
Soldier started having chest pain approx 1 day after vaccination.  Chest pain has been intermittent since vaccination but increased significantly on 9/27.  SM was in class and started having lightheadedness, heart palpitations, increased chest pain, tunnel vision, shaky, cold clammy hands and increased heart rate and SM was brought to ER for work-up.   SM states that his sx's feel a little better with leaning forward and also laying down at times. ER basically told SM that everything was ok and to follow up at clinic.  EKG done at MISC.  Shows some ST elevation in V3-V6 which is consistent with possible pericarditis.
Skin felt warm/Temperature was 100.1 degrees Fahrenheit; Muscle Aches/Aches in her neck/Aches in her shoulders; Headache like she had never had before in her life; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Skin felt warm/Temperature was 100.1 degrees Fahrenheit), MYALGIA (Muscle Aches/Aches in her neck/Aches in her shoulders) and HEADACHE (Headache like she had never had before in her life) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 012A21A and 004MZ("0" or "O")A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Skin felt warm/Temperature was 100.1 degrees Fahrenheit), MYALGIA (Muscle Aches/Aches in her neck/Aches in her shoulders) and HEADACHE (Headache like she had never had before in her life). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 01-Mar-2021, PYREXIA (Skin felt warm/Temperature was 100.1 degrees Fahrenheit), MYALGIA (Muscle Aches/Aches in her neck/Aches in her shoulders) and HEADACHE (Headache like she had never had before in her life) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: 100.1 (High) 100.1 degrees.         Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2021-368122 (Patient Link).
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 13-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:Original Case : 1906USA011674
This case was reported by a physician to sales representative and described the occurrence of welt injection site in a 4-year-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On unspecified date in 2005 or before 26 April 2006, the subject received a dose of Infanrix in an unspecified arm (dose number and lot number not reported.) On the same day, the subject also received inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and live attenuated measles, mumps (strain not specified), rubella vaccine (MMR II vaccine, Merck). At an unspecified time following receipt of Infanrix, less than one year after vaccination with Infanrix, the subject experienced "a welt at the injection site of Infanrix every time (the subject) has a fever." The outcome of the events was not reported.
chills, pain throughout body that prevented ability to walk, and redness that extended far from injection site.
10-15 minutes after receiving flu vaccine pt felt hot began sweating. Transported to ER had increased blood pressure. Also complained of vomiting.
Missed period. For the first time since my period began, I missed my monthly period for the first time EVER in eleven years.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 18:00 (Lot number: FC3182) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: ACCUTANE. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Missed period. For the first time since my period began, I missed my monthly period for the first time EVER in eleven years.". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: : Missed period. For the first time since my period began, I missed my monthly period for the first time EVER in eleven years. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Patient received medications within 2 weeks of vaccination: Accutane, hormonal birth control.  No follow-up attempts are possible. No further information is expected.
Patient blacked-out (unconscious) in the bathroom (two and half hours after the Moderna booster shot). He fell down and realized he was on the floor. He injured his left leg (ankle), and could not get up on his own. He asked for help. Saw orthopedic doctor. On x-ray, doctor saw hairline fracture in the left ankle. His leg was swollen and could not put weight on it. Doctor recommended wearing boots for 6 months.
I administered Moderna primary covid dose to patient because the vaccination record did not show previous covid doses received. The Covid-19 questionnaire was documented as stating "number of previous covid-19 dose as 0". After the vaccine was given, mom handed the CDC vaccination card with Covid-19 Pfizer doses given last year from another facility. Informed mother of the error and explained that the Bivalent dose can be given after 2 months.
I received the second dose of SHINGRIX on Friday, June 22, 2018. All day on Saturday, I ran a 103 degree temperature. I took TYLENOL and ADVIL during the day on Saturday with no results. The area continues to be very inflamed. I finally put a cool rag over my head and the temperature went down to 101 degrees. When I woke up on Sunday, I was still running a 101 degree temperature. On Sunday afternoon, my temperature went down to 100 degrees, and I felt much better. I woke up this morning (Monday) feeling like my temperature was going back up. It was 101 degrees. It is now 5:15 on 6/25/2018. My arm is still extremely sore. I have no fever.
Information has been received from a health professional concerning herself, a 47 year old female, with a history of eczema who on 15-NOV-2007 was splashed in the face with either  measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 657249/0526U) or varicella virus vaccine live (Oka/Merck) (Lot# 658588/1273U). The nurse was not sure which vaccine she was splashed with because they were both drawn up into a syringe. The vaccine did not splash into her eyes. The nurse also reported that she is developing a cold sore on her lip in the area of contact with the vaccine. The patient's outcome was not reported. Additional information has been requested.
Case number PHEH2013US016749, is an initial spontaneous report received from the nurse on 06 Aug 2013 and a follow up report from the nurse received on 30 Aug 2013. This report refers to an 18 years old male patient. His vaccination history included vaccination with an unspecified vaccine and it was well tolerated. he received only Men C, Y, W-135 liquid conjugate component of MENVEO (Batch number: M12024), intramuscularly in the deltoid at a dose of 0.5 ml without being reconstituted with Men A lyophilized conjugate vaccine component on 02 Aug 2013. No adverse event was reported following this administration error. The patient notified that if they would travel, they would want to get another round of meningitis vaccine. Follow up report from the nurse received on 30 Aug 2013: Vaccination history and the patient's statement regarding meningitis vaccine were added.
Swelling pain at site of vaccine 8/6/09 - Seen 8/11/09 - (L) anterior thorax- diffuse erythema with vesicles.
Blisters on toes; felt swelling in arm and lymph; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on toes) and LYMPHOEDEMA (felt swelling in arm and lymph) in a 53-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 28-Sep-2023, the patient experienced BLISTER (Blisters on toes) and LYMPHOEDEMA (felt swelling in arm and lymph). At the time of the report, BLISTER (Blisters on toes) and LYMPHOEDEMA (felt swelling in arm and lymph) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       Concomitant medication was not reported. Patient had blisters on toes that began around the time she felt swelling in arm and lymph. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
1st dose of the vaccine last 29Dec2020/she is already scheduled to take it next Friday; she felt kind of itchy; saw pink all over her body; broke out in a rash; This is a spontaneous report received from a contactable nurse (who is also the patient). A female patient of an unspecified age received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date not reported), via an unspecified route of administration, on 29Dec2020, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported to have received the 1st dose of the vaccine last 29Dec2020. After a few hours, she felt kind of itchy and saw pink all over her body and broke out in a rash for a few days. She mentioned that it was not anaphylaxis and is looking for recommendations if she can receive the 2nd dose of the vaccine as she is already scheduled to take it next Friday (15Jan2021, pending clarification). The outcome of the events was unknown.  Information about batch/lot number has been requested.
sore arm at vaccination site; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), lot number: EL1283, via an unspecified route of administration Left arm from 23Jan2021 14:15 to 23Jan2021 14:15 at SINGLE DOSE (first dose) for COVID-19 immunisation.  Medical history included asthma and penicillin allergy.  Concomitant medication included montelukast sodium 10 mg tab, fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol [SALBUTAMOL].  The patient experienced sore arm at vaccination site on 23Jan2021 15:00 with outcome of recovering.  The patient is not pregnant at the time of vaccination. No treatment was received for the event.
Guest vaccinated at 1307, reported bilateral hand tingling to post vaccination observation staff at 1326. Guest reported history of anxiety, vital signs taken at tingling onset were as follows: Blood Pressure 120/85, Heart rate 68, Respirations 20, O2 98% on room air. Guest reported not having eaten since 1030 and was given a granola bar. Aid arrived to assess guest per aid call but guest declined additional assessment as they reported improvement of tingling. Vital signs retaken at 1344 were as follows: Blood Pressure 110/80, Heart rate 81, Respirations 18, O2 98% on room air. Guest left post observation to go home at 1345. Was told to seek care if tingling returns or other symptoms of concern develop or worsen.