chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 34 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 29 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Messed up Afib; Not feeling good; It has been one thing after the another; Shingles; Strep throat; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2, second single dose via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: EW0162) for covid-19 immunisation. The patient previously received first dose of bnt162b2 on an unspecified date (LOT number: EW0150). The patient's medical history and concomitant medications were not reported. The patient got second vaccination and still not feeling good and it had been one thing after the another and started off hours after the second vaccination. The patient got the shingles and then had strep throat and then there was congestion and it also messed up Afib. The patient mentioned it was almost like the symptoms from COVID. Outcome of the events was unknown.   Follow up attempts are possible. Further information is expected.
Has not received the second dose > 4 months after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose) had resolved.        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.   No relevant concomitant medications were reported.  Patient decided not to get the second shot. On 11 Aug 2021, she walked in to this pharmacy and presented her vaccination card and she is requesting to get the second shot.  No treatment information was provided.
Muscular pain in left shoulder and arm became very painful 24-36 hours after injection. It was difficult to sleep due to pain. This pain dissipated 48 hours after injection. Pain returned 6 days after injection, on Monday the 8th. Pain was in the lower portion of the left arm and in the calf muscle of left leg. In my opinion, this cannot be explained by any other physical activities.
Mouth was drooping; Swollen lymph nodes; Liver enzymes were abnormally elevated; Cold sores; Arms were numbing when sleeping; Eyes were burning; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196) via an unspecified route of administration in left arm on 27Jun2021 at 13:00 (at the age of 45-years-old) as first dose, single for COVID-19 immunization. Medical history included anemic and iron deficiency. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jun2021, the patient experienced eyes were burning at night while sleeping they started burning a few days after the vaccine. On 05Jul2021, the patient experienced liver enzymes were abnormally elevated and cold sores. On 07Jul2021, the patient experienced swollen lymph nodes. On 08Jul2021, the patient experienced mouth was drooping. On an unspecified date in Jul2021, the patient experienced arms were numbing when she was sleeping started three or four days ago and last night did not feel the numbing in her arms, she thought it has recovered completely. Patient reported that when she saw her face she thought she had a stroke and rushed to ER. She confirmed that she was not admitted. Therapeutic measures were taken as a result of mouth was drooping (bell's palsy), treatment was received as steroid and an antiviral medication. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date in 2021, computerized tomogram: do not have stroke on an unspecified date 2021, hepatic enzyme: liver enzymes were still elevated on 05Jul2021, magnetic resonance imaging: do not have stroke on an unspecified date in 2021. Patient was told at ER that she did not have a stoke and probably had Bells Palsy. The outcome of events of eyes were burning was recovered on an unspecified date in 2021, arms were numbing when sleeping was recovered on an unspecified date in Jul2021 and the outcome of events mouth was drooping, cold sores was recovering while the outcome of events swollen lymph nodes, liver enzymes were abnormally elevated was not recovered.
P/receiving a dose of Td, pt exp tenderness & swelling @ inject site; p/2 wks, a large knot that is red & hot to the touch, still remains;
Child received H1N1 LAIV on 10/23/09. Fever and cough began on 10/24/09. He has continued with fever until today; cough has gotten progressively worse. On exam: lungs are clear, afebrile in office, no wheezing.
no antigen, adjuvant-only used; no antigen, adjuvant-only used; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The HCP (health care professional) reports that administering adjuvant only (no antigen) to the patient.  The reporter consent to follow up. Additional Supportive Information: The patient received Shingrix vaccine without antigen which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR194824:Same reporter US-GSK-US2022AMR194823:Same reporter US-GSK-US2022193687:Same reporter US-GSK-US2022193689:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193690:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193687:Same reporter
Stroke with fine motor skills not working; Severe shaking chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke with fine motor skills not working) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included NINTEDANIB ESILATE (OFEV), EZETIMIBE, SIMVASTATIN (VYTORIN) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (Severe shaking chills). On 05-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke with fine motor skills not working) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke with fine motor skills not working) and CHILLS (Severe shaking chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is taking clopidogrel (Plavix) 75mg and aspirin 81mg as advised by health care professional to try to alleviate the symptoms.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
After shots 2, 3, & 4 (booster), I broke out in hives on my face, chest, belly & back.  Used Benadryl to calm the itching.  Each event started approximately 2 days after the  shot.  Also had fever over 102 for 2-3 days.
unknown details of event as pt was in LTC facility where medical records would be located. Pt is reported to have expired at the facility.
pt recv vax 21MAR94 & 10 days later devel a rash on trunk & face; No further details were provided;
low energy; bones ached; was very bloated; Difficulty  breathing; pain in the middle of her chest once; weight gain; insomnia; urine colouring yellow; really tired; temperature of 100.1; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing) and CHEST PAIN (pain in the middle of her chest once) in a 49-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing), CHEST PAIN (pain in the middle of her chest once), WEIGHT INCREASED (weight gain), INSOMNIA (insomnia), CHROMATURIA (urine colouring yellow), FATIGUE (really tired) and PYREXIA (temperature of 100.1). At the time of the report, ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing), CHEST PAIN (pain in the middle of her chest once), WEIGHT INCREASED (weight gain), INSOMNIA (insomnia), CHROMATURIA (urine colouring yellow), FATIGUE (really tired) and PYREXIA (temperature of 100.1) outcome was unknown.            Details regarding concomitant and treatment medications not provided. The patient reported that her white blood count was low (details regarding test not provided). She reported that she was in the second week of the fourth cycle of Ibrance and was to start back on Ibrance on a Friday, but waited until the following Tuesday per her doctor's orders. She reported of having difficulty going up the stairs. She drank more water since she noted her urine was more yellowish. The patient also reported that she was adjusting her eating patterns to help with her sleep but still sometimes she was not able to sleep.
Information has been received from a physician who reported that her daughter was vaccinated with her second dose of HPV and experienced pain during the injection. The patient stated there was no pain when she received the first dose of HPV. Unspecified medical attention was sought by the patient. The patient's outcome was unknown. No further information is available.
The patient complains of feeling unexpectedly poorly for 5 to 10 days.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (The patient complains of feeling unexpectedly poorly for 5 to 10 days.) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 002A21M) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (two years ago).    On 27-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (The patient complains of feeling unexpectedly poorly for 5 to 10 days.). At the time of the report, FEELING ABNORMAL (The patient complains of feeling unexpectedly poorly for 5 to 10 days.) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient complains of feeling unexpectedly poorly for 5 to 10 days. No other side effects. The patient received her second Moderna Covid-19 on 27Mar2021 lot number 002B21A expiration date is not known. The patient received in her right arm. The patient did not complain of any adverse reactions. The patient received her first Moderna Covid-19 vaccine booster dose on 26Oct2021 lot number 026D21A expiration date is not known. Patient received in her right arm. The patient not had adverse reactions. The patient received her next booster dose as a Pfizer vaccine on 04Apr2022. The patient received her next booster on 02Sep2022 as a Moderna vaccine lot number AS7143C expiration date not known, and the patient received in right arm no side effects for this vaccine. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742771, US-MODERNATX, INC.-MOD-2023-743475 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742771:Spikevax 2023-2024 (same patient) US-MODERNATX, INC.-MOD-2023-743475:
Immediately experienced heart palpitations. EMS called and I was hooked up to electrocardiogram and EMT found multiple episodes of back to back PVCs and a bundle branch block. Was taken to hospital ER for examination. Was examined by electrocardiogram, blood panels. Electrolytes good, only slightly elevated glucose levels, cbc good, no troponin. In ER roughly 2.5 hours then released. Dr. was ER physician. Said heart looked good and had stopped beating abnormally. Was told to come back to ER if developed sustained heart palpitations or any further concerns.
No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot.  At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine.  As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup.  As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held.  As of June 25th max athletic output at 80% of capabilities prior to the vaccine.
Menveo was administered before reconstitution with only the diluent portion; Menveo was administered before reconstitution with only the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 1st August 2022, the patient received Menveo. On 1st August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment:  The patient received the menveo vaccine before reconstitution with only the diluent portion. The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up. Additional Supportive information: Till the time of reporting,the patient received the menveo vaccine before reconstitution with only the diluent portion which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This case has been linked to the cases US2022168204,US2022168209, US2022168203, US2022168210 reported by the same reporter.; Sender's Comments:  US-GSK-US2022168204:Same reporter US-GSK-US2022168209:Same reporter US-GSK-US2022168203:Same reporter US-GSK-US2022168210:Same reporter
Sx's of redness, discomfort, induration and warmth and c/o headache began 3/25/03 at about 14:00. Feeling less discomfort today (3/26). No redness. Tx ibuprofen
Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced side effects. The caller did not want to provide demographics and did not want to provide any adverse event information. For tolerances of 2nd dose, refer case US2020008243, reported by same reporter for the same patient.
sore arm; nose bleeds; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced nose bleeds (non-serious) on 04Feb2021 with outcome of recovered and sore arm (non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are possible, information about batch number cannot be obtained
This spontaneous report as received via company representative from a registered nurse refers to herself. An drug reactions/allergies and pertinent medical history were not specified by reporter. In January 2013 (date unspecified) the patient nurse was vaccinated with ZOSTAVAX (dose, lot number were not provided), subcutaneously. In January 2013 the patient experienced shingles. On an unspecified date, approximately in January 2013, shortly after the vaccination the patient developed a rash. The rash consisted of 10 painful blisters that were located on an unspecified area of her leg. The outcome of shingles was reported as recovering/resolving. Additional information is not expected.
Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-366918, MOD-2021-366925 (Patient Link).
Pain at injection site; headache; MUSCLE ACHES; diarrhea; FATIGUE; SHIVERING; body aches; slept; could not move; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On 12th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased. On an unknown date, the outcome of the injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, muscle pain, diarrhea, fatigue, shivering, general body pain, sleepiness and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reported that all the symptoms presented the same day as the vaccination.  The pain was at the injection site and lasted a day or two. The diarrhea lasted about 12 hours.  All other symptoms lasted about 24 hours.  She said she could not move due to the body aches and slept for 24 hours. The reporter did not consent to follow up.
no adverse events this was a 3rd dose administered to a 12 yr old in error per protocol. pharmacist was not aware of patient age and conversation with patient did not alert to problem.
-Nausea, Vomiting, Memory loss, headache, seizure - 4/12/2021 at 4 am -Seen in ED on 4/12/2021 and had a negative non-contrast brain CT -MRI 4/15/2021 showed a Nonpygenic thrombosis of intracranial venous system
Patient described a rash today - 3/10/23 - that occurred on 2/25/23, the day after her injection - measles like in appearance.