chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 13 minutes post vax, the pt experienced chest pain, a husky voice, throat swelling, sweating and a rapid heartbeat, sweaty and hot. Upon internal review, chest pain and throat swelling were considered to be "Other Medical Events." She went to the ER but was not admitted. On 6/9/00, the pt felt weak and experienced facial flushing. Follow up information reports that the pt required hospitalization for the duration of 1 day. It was reported that the pt subsequently recovered. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 26-AUG-2016 the patient was vaccinated with expired dose of ROTATEQ (dosing details were not reported) (lot # K024700, expiry date: 30-JUL-2016), The vaccine ROTATEQ did not have any previous temperature excursions. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Itchy; Swelling arm; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Fever). At the time of the report, PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Fever) 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 Concomitant drugs and Treatment information was reported.    This case was linked to MOD-2021-213585 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up Received on 01-JUN-2021 contains No New Information On 02-Jun-2021: Follow-up Received on 02-JUN-2021 contains No New Information On 08-Jun-2021: Follow-up Received on 08-JUN-2021 contains No New Information
itchy red area at the injection site and a little round like a quarter size; itchy red area at the injection site; itchy red area at the injection site; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EN6199 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 11Mar2021 10:45 (at the age of 65-year-old), as dose 2, single, for COVID-19 immunisation in hospital. Medical history included breast cancer from May2019 to Dec2019 (Currently in remission). There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EN6201 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 18Feb2021 (at the age of 65-year-old), as dose 1, single, for COVID-19 immunisation in hospital. Patient did not receive any other vaccinations within 4 weeks prior to COVID vaccine. On 18Mar2021 (reported as last night), injection site started itching and she did not look at it because she was in bed and on 19Mar2021 (reported as this morning), when she looked, it was kind of red at the injection site and a little round like a quarter size. Patient wanted to know if it was contraindicated to take Benadryl after receiving the Covid-19 vaccine. The patient did not visit emergency room or physician office due to the events. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Febrile reaction - T max 103.9. Started 6-7 days after MMRV and Hep A; lasted 5 days.
pt recvd vax 25JAN93 & lab eval on 12MAR93 revealed a neg rubeola titer of 0.12; No further details were provided;
G62.9 POLYNEUROPATHY 3/23/2023 CARDIOMYOPATHY, UNSPECIFIED G62.9 POLYNEUROPATHY 3/23/2023 CARDIOMYOPATHY, UNSPECIFIED G62.9 POLYNEUROPATHY 3/23/2023 ALLERGIC RHINITIS G62.9 POLYNEUROPATHY 3/23/2023 CARDIOMYOPATHY, UNSPECIFIED G62.9 POLYNEUROPATHY 3/23/2023 NONTRAUMATIC ACUTE KIDNEY INJURY G62.9 POLYNEUROPATHY 3/23/2023 CARDIOMYOPATHY, UNSPECIFIED G62.9 POLYNEUROPATHY 3/23/2023 ESRD (END STAGE RENAL DISEASE)
Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given  Benadryl P.O.  Discharged home with husband driving, advise to continue Bendaryl every 4-6 hours and to follow up with PCP.
Information has been received from a nurse practitioner concerning an unspecified number of patient's who were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast) and complained of burning during administration.  The patient's outcomes were not reported.  Additional information has been requested.
pt called to report swelling to site of yellow fever vaccination & also c/o fever, chills & nausea;onset of sx 3 days p/vax;sx discussed w/MD on duty MD & was told to return to ER;cellulitis site of inj;
About 1-2 hours after receiving vaccine patient called with description of red spots on right upper arm. No shortness of breath , no palpitations, no tachycardia, no altered mental status. Patient's mom concerned.
Client received Tdap - 2nd dose 4-5-12. No adverse reaction. Follow up on 4-9-12 - no problem.
PT REC'D PPV23 AND HPV IN RT AM IM, 1 DAY AFTER INJECTED PT C/O PAIN AND ITCHINESS IN THAT ARM. CAME TO CLINIC. ARM APPEARED READ AND SPLOTCHY AND WARM TO TOUCH. PT WAS TOLD TO GIVE IBUPROFEN AND BENADRYL.
I passed out from severe gastro pain and was taken to the Emergency room , blood work and a CAT was done . A diagnosis of divurticulitis was given antibiotics due to my allergies could not be prescribed so self care and home was done. Follow up care six months later was done with scope and endoscopy  being performed and diverticulosis was diagnosed. This was not diagnosed or noted in any previous scopes or medical exams prior to dose three of the COVID-19 vaccine.
This spontaneous report was received from a medical assistant and refers to two patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # L048452, expiration date: 01-MAR-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 55 degrees Fahrenheit for 800 hours, which was not detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
I am feeling like I have flu; Rash; Chills; Low fever; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer.  A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose (first dose) for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Consumer stated, "I want to ask of side effect on Covid Vaccination (captured as Covid Vaccine) because I have already got first dose yesterday and like after few hours I got chills, low fever and the chills, it was like muscle pain, joint pain about today morning it was worse and I am feeling like I have flu already. It is like the same symptoms but muscle, joint pain. I got a little rash on my skin. I ask my doctor he said its better to call them and ask like what's going on that I supposed to do or just wait." The outcome of the event rash and Flu like symptoms was unknown, while the outcome of the other events was not resolved.  Information on the lot/batch number has been requested.
Tinnitus, headache, ear infection, pain in kidneys, lower back, lower abdomen,  discomfort under armpits, sensitive to light and sounds, inability to concentrate, top of head feels cold but warn to touch. Note: Approximately 7 days after 2nd dose, sweating profusely at night  while sleeping. This continued most nights for approximately 4 weeks.
Patient stated that her doctor says she has blood clots and believe it could be due to the vaccine.
Patient reported to medical clinic 24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration.  At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He planned to follow-up the next day.   The patient returned to  medical Clinic on 03/22/2021 with no specific symptoms. Previous symptoms from initial encounter resolved according to medical chart. Patient returned on 03/28/2021 with right upper arm DVT proven on U/S. He was seen at Primary Care Clinic beforehand where diagnosis of DVT was made. He was then started on anticoagulation therapy by MD in clinic after specialist phone consult, and will be closely followed. He was sent to Evacuation  to home station due to the complexity of the condition, medications, etc.
Scalp became highly sensitive; Chills down back when hair shifted overnight after vaccination; Arm was in pain overnight and day after; This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 04Mar2021, the patient's scalp became highly sensitive, chills down back when hair shifted overnight after vaccination and her arm was in pain overnight and day after. 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 events scalp became highly sensitive, chills down back when hair shifted overnight after vaccination and arm was in pain overnight and day after was resolved on 05Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lite rash developed 2 weeks after the 1st shot(1/9/21) Day after the 2nd shot the rash became red and in the net couple days has spread over the arm and on my left chest and become bumpy.
1/21/2021, blood glucose levels were fluctuating from very low to high, normally stable and consistent. 1/22/2021 spiked a temp of 101.9  that would come and go, nausea with eating, high anxiety with feeling of fatigue and being in a fog. Feels good when first getting out of bed in the morning but about an hour or two he feels tired with his anxiety level rising. PCP contact with new orders to increase daily dose of Prozac to assist with the anxiety and rest. Patient stated that he has been resting and was feeling a little better today.
Patient presented for follow up. Provided records for immunization indicating 2nd varicella needed. Varicella administered today. After vaccine was given to patient I noticed that a separate vaccine record for our chart had that he had already had his second varicella vaccine 8/15/11.
Fever, chills, headache, joint pain, nausea, vomiting.  Temp to 101.8 and other symptoms started approx  8 hours after vaccination and lasted for 36 hours
she has been itching for hours and the sensation keeps coming and going; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration and unspecified date at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. On an unknown date, the patient stated that she has been itching for hours and the sensation keeps coming and going. It worsens in the morning and not so much in the evening. She said that there was no rash, just itching. The patient was asking any information on itching as a side effect of the vaccine. Outcome of the event was not recovered.   Information about Lot/Batch number is requested
I notice it has an odor; Sinuses start to run occasionally; Post nasal drip; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BREATH ODOUR (I notice it has an odor), SINUS DISORDER (Sinuses start to run occasionally) and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREATH ODOUR (I notice it has an odor), SINUS DISORDER (Sinuses start to run occasionally) and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip). At the time of the report, BREATH ODOUR (I notice it has an odor), SINUS DISORDER (Sinuses start to run occasionally) and UPPER-AIRWAY COUGH SYNDROME (Post nasal drip) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Patient had swelling of (L) leg that started 24-30 hours after the injections were given. Reports "blotchy" in appearance on leg - reports swelling of (L) leg twice the size of (R) leg. "Unable to see knee cap bones." Swelling reported knee to hip. Went to urgent care - evening of 5/22/12.
3 1/2hrs p/vax woke from nap crying very forcefully w/o stop;had been nap 11:30-12:45;pt given APAP;pt refused bottle, afeb
This spontaneous report as received from a physician refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 19-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N000235 with expiration date on 26-OCT-2019 (dose and route of administration were not reported). Since 21-JUN-2017, the administered dose of PEDVAXHIB underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Within 5 minutes of receiving vaccine patient's face, neck, chest, and arms developed a red rash. The Dr. immediately brought her to the back and gave her Benadryl and monitored her breathing because she is an asthma patient. We stayed there an extra two hours for monitoring. She was kept on Benadryl every 6 hours for 48 hours.
Received expired booster vaccine >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication use was reported.
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 4-Jun-2022 and did not undergo temperature excursion. Manufactory code for the lot was MOD. Patient got half dose.  No treatment medication was reported by reporter.
56 year old patient who received one dose of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 56-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 5th April 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received infanrix instead of boostrix at the age of 56 ,which led inappropriate age at vaccine administration. The reporter consented to follow up.
Pt with intermittent stabbing chest pain, and constant chest pressure which onset one week after vaccine and is getting progressively worse.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that an improperly stored dose of GARDASIL inj was administered to a patient (dose, route and lot number were not provided). No adverse effects were reported. Additional information has been requested.
patient with delayed allergic reaction to menveo vaccine -  Left upper arm swelling/redness - rx for prednisolone & cold compress prn will follow up on 8.7.23
C/o strong sense of nausea. Responded, assisted her in removing jacket, elevated feet onto chair. B/P 98/60, HR 65, O2sat 95, provided water to drink and a cool towel to forehead, advised a few slow deep breaths.  Observed her closely,   At 1058 she was feeling a little less nauseated-B/P 108/80, HR 62, O2sat 96.  At 1105 she was feeling much better, B/P 102/72, HR 64, O2sat 98.  Escorted to car where she had portable O2 which she placed on at 3l/nc for the drive home.
PREVNAR 13 arm hurt for 5 days. Ice on spot for 2 days and unable to move elbow those days.
Initial report received 09 September 2011 from a health care professional. A 15 year-old female patient with no concurrent illnesses, no known allergies (NKA), but current medical condition of QT syndrome (type not identified) had received a first intramuscular left deltoid injection of MENACTRA (lot number U2562AA), and a first intramuscular right deltoid injection of GARDASIL (manufacturer Merck [reported as GSK], lot number 1968U) on 28 April 2011 and the following evening she fainted (duration not reported, also reported as syncope). The patient did not require medical evaluation. Circumstances surrounding the episode of fainting were not provided. It was noted the patient did have a recent change in her concomitant medications, which also were not provided. The physician doubted connection with the vaccinations. It was noted that no other vaccinations had been received within 4 weeks prior to 28 April 2011. The patient was reported as recovered. Documents held by sender: None.