chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 28 year old who was IM vaccinated with her second dose of GARDASOL. Subsequently the patient experienced numbness in the arm where the vaccine was administered which lasted about 1 week and severe headaches about 2 weeks post vaccination. No further information is available. Additional information has been requested. This in in follow-up to report(s) previously submitted on 3/14/2008.  Initial and follow up information have been received from a licensed practical nurse concerning a 24 year old female secretary with no preexisting illness, and no drug allergies, who on an unspecified date received her first dose of GARDASIL (lot number, route and site not reported) and 10-OCT-2007 was vaccinated with her second dose of GARDASIL (Lot #557737/0522U) intramuscularly in the left deltoid.  There was no concomitant medication.  No illness was reported at the time of vaccination.  On an unspecified date the patient experienced numbness in the arm where the vaccine was administered which lasted about 1 week, and a severe headache about 2 weeks post vaccination.  On 17-OCT-2007 the patient called the physician's office complaining of left arm ache, arm feeling ded, and weakness after her GARDASIL injection.  The patient was instructed to use ice and IBUPROFEN (800 mg twice a day) or VICODIN if needed.  On approximately 24-OCT-2007, 2 weeks post vaccination, the patient developed severe headaches.  On 10-OCT-2007 the patient visited the physician's office complaining of arm pain and aching in the left arm.  It was reported that the patient stated that the pain had improved but at times continued to bother her.  There was restless annoying feeling in her elbow which was not a true pain.  When the patient moved her shoulder wrong it sent a sharp pain into her shoulder.  The injection site in the deltoid looked good.  There was no tenderness or swelling there.  The patient's rotator cuff muscles were pretty strong except for forward elevation was somewhat painful.  The patient could raise her arms above her head.  There was no crepitation of the shoulder and stretch reflexes in the forearm were normal.  Physical therapy was recommended for one to two weeks.  It was reported that the patient did seem to be having some rotator cuff symptoms which were probably unrelated.  The patient recovered from numbness in her arm.  The outcome for headache, injection site pain, muscular weakness, muskuloskeletal pain, and pain in extremity were unknown at the time of reporting as patient cancelled her follow-up appointment.  No product quality complaint was involved.  No further information is available.
the patient was negative for immunity to varicella; the patient was negative for immunity to measles, mumps, but positive for immunity to rubella; This spontaneous report as received from a nurse referring to his son, a 27-year-old male patient, via a filed employee. The patient's pertinent medical history and concomitant medical history were not reported.   On unknown dates, the patient was administered a serious of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot # and expiration date were not reported) and varicella virus vaccine live (OKA/Merck) (VARIVAX) (strength, dose, frequency, route, lot # and expiration date were not reported) on time, as a child for prophylaxis.   On an unknown date, the patient had bloodwork drawn to check titers for school requirement on an unspecified date which showed he was negative for immunity to measles, mumps and varicella, but positive for immunity to rubella. Present status for the events was unknown.  The causal relationship between the events and suspected vaccines were not provided.
It was noted during injection a tremendous amount of pain/stinging/burning that lasted a few minutes. About 20 minutes post injection, numbness/tingling noted in pinky/5th finger radiating down palm to wrist on same arm as injection as well as dizziness. Notified observation RNs and moved to a separate room. Mildly elevated BP but normal HR noted. No rash/hives/difficulty breathing. Numbness and tingling would migrate - most often to thumb but sometimes up entire arm. Released 1 hour after injection after no life threatening signs noted.  Visited PCP the next day (1/6) at 10:15. Professional opinion that it is due to swelling from injection - now noticeable area of swelling around injection site. Recommended ice and NSAIDs.
The patient came to ED c/o sudden onset constant right anterior chest pain radiating to axilla and lateral neck.  Sudden sharp pain 10/10 at rest and worse when supine with associated Short of Breath.  Troponin was elevated at 0.18, d-dimer <200.  All other lab values were normal. The patient is getting admitted for a cardiac workup and further evaluation.
Still swollen and red with pain at the injection site. Had the shot on March 5 and the pain and swollenness has not subsided of today March 16th.
This spontaneous report as received from a licensed practical nurse refers to a currently 2 year old patient. On 19-APR-2018, the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB from lot N034006 expiry date 01-FEB-2020 for prophylaxis (Product storage error). Temperature was reported as 9°C to 25°C. Time frame was reported as 1 hour and 15 minutes. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1804USA010520: US-009507513-1804USA010426.
Pt had a fever of 100.7 following vaccination for 2 days. The 3rd day she started itching and having a rash. It is in random spots, and goes away after a bit. One morning when she woke up her scalp was itching too and ears were hot. Pt is trying benadryl tabs and cortisone cream.
Itchy hives on Monday, 9 days after 3rd Moderna COVID shot. Next day (Tuesday) fine in the morning, left for vacation, broke out into massive scalp/hands/feet hives, coughing, itchy throat. Took Benadryl, Claritin, Pepcid and Ibuprofen. Next day (Wednesday) slept for 14 hours, woke up with horrible throat/esophagus burning sensation, difficulty swallowing, nausea and facial swelling. Went to ER, they pushed steroid and Benadryl, throat felt better instantly, discussed possibly allergy, but no known allergy. Was prescribed steroid. Still breaking out in hives on the 22nd. ER didn't rule out anaphylaxis and sent me back with an epipen, just in case.
Anaphylactic response; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication.  The patient's medical history and concomitant medications were not reported.  The patient received a dose of the Pfizer COVID-19 vaccine and suffered an anaphylactic response. The patient had to be taken to the nearest hospital via ambulance and spent approximately 8 hours in the emergency room. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Three inch radius in size redness , with itch, and lump eight days after vaccination, dose 1. No symptoms prior to day 8.
Patient took Moderna first dose on 4-MAY-2021 and second dose on 23-Jun-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna first dose on 4-MAY-2021 and second dose on 23-Jun-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna first dose on 4-MAY-2021 and second dose on 23-Jun-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna first dose on 4-MAY-2021 and second dose on 23-Jun-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Side effects after any doses was unknown.  No treatment medications were reported.   This case was linked to MOD-2022-612826 (Patient Link).
Second day after the first dose she had a small amount of itching on her lower back; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient reported for herself). This case is for Dose 1. A 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunization. The patient medical history included lupus (Patient also had lupus and so also some skin problems anyway). Concomitant medications were not reported. Patient previously took two cortisone shots in her ankle one on 12Jan2021 and the second was on 08Feb2021 which was two days before she had her first covid shot. Patient reported that she had her first Pfizer covid 19 vaccines on 10Feb2021. she stated that patient did not have any immediate reactions, sat at the clinic for 20 minutes and then went home. She stated that she was fine until the second day after the first dose and had a small amount of itching on her lower back (12Feb2021) when she went to shower, but it went away. Reporter considered the event as non-serious. Outcome of the event was recovered on an unspecified date in Feb2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare worker refers to a 2 year old patient with unknown gender. On 23-OCT-2013 the patient was vaccinated with the fourth dose of RECOMBIVAX HB (dose, route, lot # and expiration date unknown). The patient received an extra dose (4th dose, dates of the primary series of RECOMBIVAX HB were unspecified) of RECOMBIVAX HB on 23-OCT-2013, due to product confusion. The reporter reported that the plunger of the prefilled RECOMBIVAX HB pediatric and the FLUZONE Quadrivalent 0.25 (unit not provided) were both yellow and almost the same color of yellow, which caused the product confusion. No adverse event was reported, product confusion was sent to the PQC team. Additional information has been requested.
Hospitalized all negative nasopharynx swabs for COVID, bronc lavage is SARS COV2 RNA positive on 4/22. Polyarticular joint pain, weakness and fever, has UTI.
HCP said that 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vials were placed in refrigerator on 04-Nov-2021. No temperature excursion was reported. No adverse events were reported.  No treatment details were reported.
Patient received vaccines. Mom stated within fifteen minutes that patient had redness appear on arms with small circular white patches.
Patient stated that vaccine did not feel "smooth" going in. She reproted having a lump at injection site as well as a large bruise. her arm was much more sore than normal, but id feeling much better as of 10/24/14.
Got vaccine at 6:45 on Tuesday evening. At 12:30 the next day (Wed), my fever started going up and I became lethargic. By 4:14 pm, my fever was 100.3F and I had no strength. I was so tired and achy I could not open my eyes. Took Tylenol and went to bed. Took the next day (Thursday), I took off from work and was better by noon.
SWELLING AT THE LEFT NECK REGION. IT IS LITTLE HARD AND PAINFULL WHEN PRESSED ON THE SWELLING SITE.
No further AE information provided.; administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T002845 which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection were not reported), as prophylaxis. The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (10.56 F), during a time frame of 50 minutes, as recorded by a digital data logger. There was a previous temperature excursion of 6 F to 14 F (8.47 F), during a time frame of 30 minutes. No further adverse event information was provided.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000676: US-009507513-2009USA000710: US-009507513-2009USA000749: US-009507513-2009USA000757: US-009507513-2009USA000762: US-009507513-2009USA000736:
Light headed; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 23Apr2021 at 14:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to NSAIDS (non-steroidal anti-inflammatory drugs). 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 vaccination. Concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) for unknown indication on unknown date and experienced drug allergy. On 23Apr2021 at 16:00, the patient experienced light headed. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event light headed was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had a very heavy tight chest feeling on that Friday. I left work and when I got home was tired and all over achy. One trip to  Medical Center -went to ED on 23rd - for shortness of breath. Albuterol inhaler was prescribed (had already been prescribed by my doctor.) I felt ready to go back to work in about two weeks and I felt back to normal in three weeks or so. My Dr. just left practice recently.
Information has been received from a LPN concerning a pt who in March 1999, was vaccinated with varicella virus vaccine live. In January 2000, the pt experienced breakthrough chickenpox. In February 2000, the pt experienced insulin dependent diabetes mellitis. Unspecified medical attention was sought. The diabetes mellitis was considered an important medical event. The pt's sibling had a similar experience after vaccination with varicella virus vaccine live (WAES 00030733). No further information is available. Follow-up was received that indicated the pt was not vaccinated with varicella virus vaccine. Therefore, this id was voided from the database.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 46-year-old female patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On 12th July 2016, the patient received the 1st dose of ENGERIX B. On 8th August 2016, the patient received the 2nd dose of ENGERIX B. On 23rd January 2017, the patient received the 3rd dose of ENGERIX B. In January 2018, not applicable after receiving ENGERIX B and ENGERIX B, not applicable after receiving ENGERIX B and ENGERIX B and unknown after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On 21st August 2018, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The patient received 3rd dose later than the recommended interval, which led to lengthening of vaccination schedule. On 21st August 2018, the patient underwent for serology test of hepatitis B antibody and came up with non-reactive. The healthcare professional did not have information on lot and expiration dates of the vaccines that were administered.
Developed shortness of breath, wheezing approximately 5 minutes after receiving first dose of vaccine.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose ROTATEQ (dose, route, lot and expiration date were not reported) that were exposed to 52 F for 12 hours in February 2014. No adverse effect reported. It was also reported that the vaccine was supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
felt ill about 12:30 am the night after immunization, felt heart was pounding. In the morning was very worried, noted left upper eyelid ptosis and an unusual feeling around the eye. Presented to Health Services and heart rate and auscultation were normal, but there was ptosis L and unusual sensation but not numbness from left eye to upper cheek. Referred for immediate eye exam, preliminary diagnosis zoster vs bells palsy, empiric prednisone and valacyclovir prescribed.
Information has been received from a physician concerning an approximately 16 year old female with no pertinent medical history, who on 29-JUN-2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot # 658100/0525U). On 07-JAN-2008, the patient received the second dose of GARDASIL vaccine (yeast) (Lot # 659439/1267U), and on 03-JUL-2008 the patient received the third dose of GARDASIL vaccine (yeast) (Lot # 660391/0063X). Concomitant therapy included hepatitis A vaccine (inactive) (HAVRIX) and "acne medicines". The physician reported that he saw the patient who had developed thyroiditis after receiving GARDASIL vaccine (yeast), and complained of weight gain and fatigue. A titer test for thyroid was performed, and the patient was found to have antibodies against thyroid. Additional information has been requested.
had a swollen lymph node in her left arm pit; This is a spontaneous report from a contactable consumer (patient's husband). A 50-years-old female patient (wife of reporter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization. The patient 's medical history and concomitant medications were not reported. It was reported that after receiving the vaccine, the patient had a swollen lymph node in her left arm pit, but it went away after a few days. He does not have lot Number or vaccination dates for his wife. The outcome of the event was recovered.  Information on Lot/Batch number has been requested.
No adverse effects; patients were administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medication and concurrent conditions were unknown. No drug reactions/allergies were reported.  On 05-JUN-2019, the patient was vaccinated with an incorrectly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S002496 and expiration date 23-JUL-2020, for prophylaxis (dose, strength, frequency and route of administration were not reported.  The patient experienced no adverse events. It was reported that the  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) had a temperature excursion of (-9°C to 8°C) -3 C for a time frame of 3 hours 39 minutes. No previous temperature excursions were reported. Digital data logger was involved.; Sender's Comments:  US-009507513-1906USA008662:Case number: 1247169 US-009507513-1906USA008695:Case number: 1247112 US-009507513-1906USA008903:Case number: 1247164 US-009507513-1906USA008643:Case number: 1247165 US-009507513-1906USA008789:Case number: 1247163