chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 23 year old female with no pertinent medical history, who on 03-APR-2007 was vaccinated IM with a first dose of Gardasil (lot # 655322/0092U).  On 15-JUN-2007 was vaccinated IM with a second dose of Gardasil (lot # 0210U).  Concomitant therapy included hormonal contraceptives (unspecified).  On approximately 15-JUL-2007 the patient experienced migraine headache.  The patient was evaluated by a neurologist.  At the time of the report, the status was unknown.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 23 year old female with migraines, who on 03-APR-2007 was vaccinated IM with a first dose of GARDASIL (lot # 655322/0092U). On 15-JUN-2007 the patient was vaccinated IM with a second dose of GARDASIL (lot # 0210U). Concomitant therapy included YASMIN. On approximately 15-JUL-2007 the patient experienced a migraine headache. It was reported that the patient experienced her first migraine followed by nausea caused by flashing lights for several minutes during her junior year of college every week lasting several hours for one month and sought no medical attention at that time. Since then the patient did not experience a migraine until receiving her first dose of GARDASIL. The patient reported that she experienced migraines in early April 2007 that lasted 4 to 5 hours, then every 1 to 2 weeks until early July 2007. It was noted that the patient was under severe stress at work. The patient was evaluated by a neurologist and no prescription was given. The neurologist advised the patient that she was having migraines. It was reported that the patient was under significant stress at that time. The patient had not experienced a migraine headache since early July 2007 but was concerned that the migraines were caused by the vaccination. At the time of the report, the status was unknown. Additional information is not expected.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 72-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 19-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805514 was crossed linked to original cases 201804863 due to same reporter.
This case was reported by a nurse via sales rep and described the occurrence of generalized pruritus in a 9-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 4DY9K, expiry date 7th June 2019) for prophylaxis. On 18th September 2018, the patient received FLULAVAL QUADRIVALENT. In September 2018, less than a week after receiving FLULAVAL QUADRIVALENT, the patient experienced generalized pruritus, injection site swelling, injection site tenderness, erythema and welts. The patient was treated with MOTRIN. On an unknown date, the outcome of the generalized pruritus, injection site swelling, injection site tenderness, erythema and welts were recovered/resolved. It was unknown if the reporter considered the generalized pruritus, injection site swelling, injection site tenderness, erythema and welts to be related to FLULAVAL QUADRIVALENT. Additional details reported as follows: The patient never had any breathing difficulties. After receiving FLULAVAL QUADRIVALENT, the patient woke up and the site where the vaccine was given swelled up in the morning (further unspecified). The nurse gave her some MOTRIN because it was tender. The patient went to school and was informed by nurse that she was itchy all over. The patient's mother sent a photo and there was a 2-3 inches area of redness with a circle of welts around the outside edge. It was resolved by the next day. The reporter agreed for follow up contact. This case has been linked with case US2018GSK173210 and US2018GSK176895 reported by same reporter.
fatigue; Headache; muscle pain; joint pain; chills; Nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 10-Feb-2021, the patient experienced FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea) and VOMITING (vomiting).   On 11-Feb-2021, FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea) and VOMITING (vomiting) had resolved.      Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non-significant information
This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was administered an improperly stored dose of RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018, intramuscularly (dose not provided). The vaccine underwent a temperature excursion of 48.7 degrees Fahrenheit for 48 hours. It was reported that data logger was used. There were no previous excursions. No adverse effects were reported. Additional information has been requested.
Case number PHEH2015US020454, is an initial spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 161211, expiry date: May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. No adverse events were reported following the maladministration.
Redness, swelling at injection site (posterior aspect of right upper arm).  [Varicella vaccine site].
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 1:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 1:59 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 67.57.  No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. Vial was moved to fridge on 02-Feb-2021 and moved to clinic on 08-Feb-2021. Vial was punctured right before administration. Vial best before use date was 04-Mar-2021. Vial was undergone temperature excursion at 10:00 AM and 11:00 AM with 29 and 35 degree Fahrenheit respectively. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
?Moderna COVID?19 Vaccine EUA?    Sorry, I put my 2 vaccination above.... the second one was on February 11, 2021.... Moderna Vaccination Side Effects Report May 13, 2021  First Vaccination ? February 11, 2021 I did not have any effects the first week.  Then on the very same day of the week, in the following week, my arm, where I got the injection, got red and swelled up nearly from my elbow to my shoulder.  It was hot and hard and ached.  It was sore to the touch.  That was on Thursday.  On Sunday, I woke up OK, but as I dressed and started moving around, things did not feel right.  Soon, I knew that I was not going to be able to do the normal things of the day.  Within about an hour of being up from bed, I had a sever attach of vertigo.   I thought is was actually Vertigo, which I sometimes have, so I tried the ?exercise? that you can do to remove the debris from the ear canal and relieve the Vertigo?. This has worked for me in the past.  But, after trying it three times?. Barely being able to perform the procedure because of the severity of the Vertigo that I was experiencing, my daughter said that it might be from the vaccination.  She helped me to my bed.  I could not stand or move well.  Any time I moved my head or my eyes?even if they were closed? everything would spin more.  No matter what I did, I couldn?t the spinning to stop.  Finally, after I held my head and eyes very still, I fell asleep and slept for 7 hours straight.  When I finally awoke, the dizziness had begun to subside.  I slept for 2 more hours and started to feel more normal the next day.  The swelling and pain in my arm stayed for another 2 weeks.  Second Vaccination ? March 11, 2021 I had the injection in the afternoon and did not notice any real issues that day.  On the second day, when I awoke, I did not feel well?kind of dizzy and nauseous?.but not the Vertigo type of dizziness?just an off balance sort of dizziness.  Then I noticed that I couldn?t move or think very well.  It was like everything was in slow motion.  I tried to do the normal things of the day, but finally just gave up and went back to bed.  It was like my mind was watching everything go on in slow motion.  I slept the whole day again.  The next day I was mostly better, but after a couple of weeks, I started having frequent momentary dizzy spells.  They did not seem to be triggered by anything.  They just came and went.    The dizzy spells went on for several weeks? probably a month and gave way to another reaction that is difficult to explain because I have never had this experience before.  It is like when I move around or turn my head, my eyes do not go with me!  It is not a dizzy spell, although it does cause some dizziness.  And, my eyes do not go out of focus.  It is more like they are out of ?alignment? with each other or something like that.    It is very disconcerting and takes 1 to 3 seconds to come to correction.  It is happening more and more frequently.  That would be probably about 80% of the time that I move my body or my head.  It is now May and it does not seem like the side effects are abating.
Nausea, chills, fever (100), body aches, headache, and fatigue lasting for about 48 hours
Flu; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case received from consumer/ non-health professional via social media.  This case involves a male patient of unknown age who experienced flu (influenza), after the patient received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatments, vaccination and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number and expiration date not reported] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced flu (influenza), (latency: unknown) following the administration of INFLUENZA VACCINE.  It was reported by the patient every darn time.  It is unknown if patient's physician provided consent to be contacted. It is unknown if the patient experienced any additional symptoms/ events. Medication Details and reason for taking the medicine were not provided.  No laboratory data or results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding lot number in this case.
Around 4:20pm patient's husband informed the pharmacy that his wife was feeling lightheaded and said she feels like passing out. The pharmacist and I walked over to the patient to ese how she was doing. The pharmacist checked her blood pressure and it was in the 50s. I called 911 as patient was experiencing concerning symptoms (lightheaded, dizzy, sweating, low blood pressure, pale, losing conscious, cold to touch, and foaming in the mouth). Fire department arrived and assessed the patient. They monitored patient until her blood pressure was elevated to the 100s. During this time they also advised her husband to buy Gatorade so they can replete her fluids. Once patient was able to sit up and stand the fire department and her husband escorted her to their vehicle. She was advised to go home, rest, drink fluids, and contact the emergency department if she isn't feeling well again.
After 1-2 minutes after vaccines, and while putting on his shoes, pt complained of not being able to move his left arm at all, then said he felt sick. He had sudden onset of wet clammy hot skin all over his body, he said he felt dizzy or light headed, nausea and weakness. We went to find nurse for help, nurses came in, and had pt lay down and put wet napkins on his legs and head and arms. Pt tried to sit up but felt nauseas so he laid back down again for few more minutes when he said he felt weak and sleepy. In all the event was about 20 minutes. He was given some juice to sip. Then he felt better and was able to walk. Nurse walked him to our car and we left. He was fine the rest of the day and evening and has no other symptoms since then.
who has received one of the shingles vaccines has gotten shingles / have a friend with it right now/ Suspected Vaccination failure; have a friend with it right now / she is in agony!; she is in agony!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient received Shingles vaccine and at the time of reporting, she had shingles and was in agony. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR127615, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127615:Same reporter
Aching/Sore; Very sick; This is a spontaneous report from a contactable consumer. This consumer (Patient Husband) reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced aching/sore, very sick. Reporter is very sick right now by the aching and sore. So, we are trying to see how long is it supposed to last, whether she needs to go to the emergency room now what she needs to do. Reporter stated, I am calling because me and my wife couldn't get our second round of the vaccine (unspecified vaccine) yesterday (split not made). Reporter was informed that Pfizer Medical Information is the right department to answer this question and informed about the role of Pfizer Drug Safety. Further probing could not be done as the reporter hung up the call abruptly. Hence limited information available over the call. The outcome of the events was unknown.   QR Comment: Split to be made which was not made by the Call handler.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. The Nurse reported for two patients. This is the 2nd of two reports. A 20-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced skin sensitivity, bodyache, nausea and local reaction, assesses as non-serious, on an unspecified date with outcome of unknown. Follow-up (19AUG2016): Follow-up attempts are completed. No further information is expected.
General fatigue; Joint pain (specifically isolated to my bilateral hands, fingers, thumbs) caused difficulty with gripping objects; This is a spontaneous report from a non-contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 07Jan2021 17:15 at a single dose on Left arm for COVID-19 immunization. Medical history included depression, anxiety, chronic sinusitis, and allergy seasonal /pet dander. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), bupropion hydrochloride (WELLBUTRIN), asa (ASA), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA). The patient previously took Ceclor, Sudafed and experienced drug allergies. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 17Dec2020 18:15 at a single dose on Left arm for COVID-19 immunization. The patient experienced general fatigue and joint pain ("specifically isolated to my bilateral hands, fingers, thumbs") caused difficulty with gripping objects on 09Jan2021 13:00 ("01:00 PM"). No treatment received for events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment not received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Swollen lymph nodes (armpit); This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 26Apr2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mango. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hepatitis B vaccine (HEPATITIS B) for unknown indication on 30Mar2021. The patient received other vaccines within four weeks prior to the vaccination. On 27Apr2021 the patient experienced swollen lymph nodes (armpit). The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes (armpit) was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Erythema to entire upper extremity tx=cellulitis. Rx Nafcillin.
Room temperature vaccine administered to patient; Moderna Covid 19 vaccine left out at room temperature over 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna Covid 19 vaccine left out at room temperature over 12 hours) and VACCINATION ERROR (Room temperature vaccine administered to patient) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid 19 vaccine left out at room temperature over 12 hours). On an unknown date, the patient experienced VACCINATION ERROR (Room temperature vaccine administered to patient). On 15-May-2021, PRODUCT STORAGE ERROR (Moderna Covid 19 vaccine left out at room temperature over 12 hours) had resolved. At the time of the report, VACCINATION ERROR (Room temperature vaccine administered to patient) 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 treatment information was provided.  No concomitant medication was provided.