chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The most troubling side effect is tinnitus which started about 3 weeks after vaccination suddenly. For the first 3 days it was in both ears, ranging from low to high pitch range. I was very sensitive to any sounds around me. The intensity and sensitivity has gradually decreased, however, a persistently waving LOW pitch in the left ear remains. This is particularly apparent in silent surroundings and when rotating my head or looking left / right. This is very  troubling and has to be studied. Today it is almost 2 months after the third dose of Moderna and I am concerned that this will persist. I can also say that I am not yet myself after 3rd dose of vaccination. I experience also fatigue and more frequent, localized strong headaches than ever before.
Left arm pain for 24 hours; This is a spontaneous report received from a non-contactable physician. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm, on 17Dec2020 09:00, at single dose, for COVID-19 immunization. The patient has no medical history and has no known allergy. Concomitant medication included lansoprazole. The patient experienced left arm pain for 24 hours on 17Dec2020 12:00. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The event was reported as non-serious. The outcome of the event was recovered on 18Dec2020 12:00.  No follow-up attempts are possible. No further information is expected.
Approximately 5 mins after the vaccination the patient asked for water and said she was light headed.  I walked to our cooler and got a bottle of water and when I returned to her (15-20 secs later) she was laying back in her chair, unconscious and twitching.  911 was immediately called.  She was nonresponsive for approx 30 secs.  Then she woke up and was able to talk with me and seemed coherent.  She laid on the floor until paramedics arrived.  She walked out with paramedics.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient's current illnesses, history and prior vaccinations were not reported. On 27-DEC-2016, the patient was vaccinated intramuscularly in the left arm with unknown dose of GARDASIL 9 (lot # M030380, expiry date 01-FEB-2019) and intramuscularly in the right arm with unknown doses of BOOSTRIX (lot # 7RJ9B) and MENVEO (M16004). There were no other medications. On 28-DEC-2016, the patient experienced redness and swelling around injection site on the right arm. There was no lab data. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected as no follow up information could be obtained from the Agency.
About 30 seconds after administering vaccine, GARDASIL, patient fainted, lot consciousness for approximately 5 seconds. Patient states she felt fine after awakening.
Itchy hives and rash,  mostly on trunk (stomach, groin, back)  but some on arms, legs, and kneck.   Itchy palms.  Swollen eyelids and rash on face.  Zyrtec and Benedryl are being taken but is not fully resolving the problem.   Has been 2 days so far, hives and swollen eyelids still not resolved.
pt had generalized swelling of lower lt arm & proximal lt forearm around elbow; swelling was @ 2-3 cm; dec ROM on lt elbow secondary to swelling & pain, erythema @ 5cm around inject site;
Information has been received from a physician concerning a patient who on 11-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (lot#666855/0162Z). Subsequently, the patient developed classic chicken pox lesion within 4 to 7 days after receiving the VARIVAX (Merck). At the time of this report, the patient's outcome was unknown. Follow up information was received from a physician who was requesting a lot check on the above VARIVAX (Merck) (lot#666855/0162Z). This is one of several reports from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
low grade fever; arm was sore; This is a spontaneous report from a Non-contactable consumer (patient herself). This 23-year-old non-pregnant female consumer (patient) reported that: A 23-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 08May2021 (at the age of 23 years) as dose 2, single for COVID-19 immunisation. Medical history included food allergy: Shellfish, glucose tolerance impaired, covid-19 from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, levonorgestrel (DAYSEE) taken for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported. She received metformin, daysee, prozac, hydroxyzine in two weeks. Prior to vaccination she had tested positive for COVID-19. She did not have COVID post vaccination. She did not receive any other vaccine in four weeks. Historical vaccine included first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number was not reported) via an unspecified route of administration, administered in Arm Left on 17Apr2021 as single for COVID-19 immunisation and experienced Pain, sore arm. The patient experienced arm was sore immediately on 08May2021 and passed on day two after the dose, she had a low-grade fever the day after the shot on 09May2021. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
signs and symptoms:  shortness of breath, nausea, vomiting, and diarrhea, afib HR 140 Treatment: remdesivir, rocephin, cardizem, metoprolol, xarelto.
No other res´ponse to first shot except arm pain; This is a follow up-spontaneous report from a contactable consumer. A 34-Year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via intramuscular route of administration administered in Arm Left on 17Apr2021 18:15 (Batch/Lot Number: EW0164) as 1st dose, single dose for covid-19 immunization. Medical history included chronic sinusitis from 2004 and ongoing Adenoidectomy x2 2008+2016, Hydradenitis suppurtiva from 2010 and ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) via oral taken for seasonal allergy from 01Mar2021 and ongoing, fluticasone propionate (FLONASE ALLERGY RELIEF) via nasal taken for seasonal allergy from 01Mar2021 and ongoing, spironolactone via oral from 01Jun2019 and ongoing, famotidine via oral taken for gastrooesophageal reflux disease from 10May2021 to 17May2021. The patient previously took doxycycline and experienced Allergic reaction, sulfa g and experienced Allergic reaction. On Apr2021 the patient experienced no other response to first shot except arm pain. The patient underwent lab tests and procedures which included covid-19: negative on 08Oct2020, covid-19: negative on 15Jan2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Tested Positive on day 19 after the 2nd dose. Case starting having symptoms early Sunday morning with a really bad headache and sinus pressure. Now has cough and fatigue. Headache is starting to get better. Cough and congestion is not.
Severe pain on left arm radiating to the shoulder and neck. Consultation sought with Primary Physician.
Significant warmth, tenderness, and swelling at injection site 10cm in diameter. Time of onset unsure was seen at Urgent Care/clinic.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 55-year-old female patient who received SHINGRIX. Concomitant products included ibuprofen and TYLENOL. On 6th March 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2018, 14 hrs after receiving SHINGRIX, the patient experienced chills, headache, general body pain and itchy rash. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the chills, headache, general body pain and pain in arm were recovering/resolving and the outcome of the itchy rash was unknown. It was unknown if the reporter considered the chills, headache, general body pain, pain in arm and itchy rash to be related to SHINGRIX. Additional information was reported as follows: On 7th March 2018 at 4:00, the patient experienced the events chills, headache, general body pain. In March 2018, 24 hours after vaccination, before noon (in AM) the rash appeared on the patient's chest. The rash blanches with pressure and was not raised. The rash was slightly itchy. In March 2018, less than a week after vaccination, the patient experienced pain in arm. The reporter was not able to collect any additional details on sore arm. The batch number and the expiry date for SHINGRIX was not reported. No other additional details were available.
experienced a breakthrough infection with Covid-19; experienced a breakthrough infection with Covid-19; long haul neurological issues from the Covid-19 infection; unable to work; This is a spontaneous report from a contactable consumer via a representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter informed that a female received the Pfizer Covid-19 vaccine, however she experienced a breakthrough infection with Covid-19. The female was currently experiencing long haul neurological issues from the Covid-19 infection and she was unable to work. The reporter informed that the awareness date was on 11Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from the registered nurse regarding a 18 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 29-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with no drug reactions or allergies and no pertinent medical history who on 24-FEB-2012, was vaccinated with a first dose of GARDASIL 0.5 ml, intramuscular (lot number reported as 1668AA, expiration date 15-AUG-2014). Concomitant therapy included ALLEGRA-D 12 hour. There was no treatment given for receiving the first dose of GARDASIL and being pregnant by the patient. It was reported that the patient was pregnant. On an unknown date, home pregnancy test was performed with positive result. The patient's last menstrual period was on 31-JAN-2012. Estimated delivery date would be 06-NOV-2012. Follow-up information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with a history of one previous pregnancies and one full term deliveries and unknown obstetric history of birth defects or infant complications in previous pregnancies, who on 24-FEB-2012, was vaccinated with a first dose of GARDASIL. Concomitant therapy included ALLEGRA-D 12 hour for the treatment of allergies, and reporter was unsure it was taken afternoon (PM) by the patient. Ultrasound test was scheduled on 09-MAR-2012 to reassurance patient's GARDASIL exposure. It was not completed at the time of the report. A follow-up information has been received from a nurse, who reported that the patient was no longer with the practice. Additional information is not expected.
mom called 20MAY98 & said pt hadn't stopped crying since got vax 19MAY98 & fever was 104;mom was instructed to take child to Er;
PAIN IN LEFT ARM AT AND AROUND INJECTION SITE AND MUSCLE PAIN AT INJECTION SITE EXTENDS INTO SHOULDER AND BACK; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced pain in left arm at and around injection site and muscle pain at injection site extends into shoulder and back. The action taken with covid-19 vaccine was not applicable. The patient was recovering from pain in left arm at and around injection site and muscle pain at injection site extends into shoulder and back. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Nothing occurred that was incapacitating. Repeated or constant symptoms starting the day after the injection, and continuing for two days after that (3 days of symptoms): Soreness at injection site, General malaise, Fatigue, Sensitive scalp, Minor muscle aches, Slightly depressed appetite, Dry cough, Shivering (one time, for 5 minutes; resolved by covering up with a blanket).
Pt developed chronic joint pain since 10 days after first LYMErix injection which was 8/19/99. Pt has had pain starting in lower back (sacroiliac joints) and radiating down throughout entire pelvic area. Pt has seen numerous doctors and taken many meds and had several tests done. Pt had second and third doses of LYMErix on 9/20/99 and 10/20/99. Doc 208124 states that patient has very bad chronic joint pain in entire pelvic area and is constantly uncomfortable especially when sitting. Per 60 day follow up: Pt did not recover. Pt continues to have chronic pain in lower back and entire pelvic area. Pt have seen numerous doctors and taken many medications and nothing has helped th eproblem at all. Pt is positive that this problem is a direct result from the vaccine and have seen physicians who confirm it. Please let me know if you need any further info.
PATIENT WAS GIVEN AN EXTRA HEP A PEDIATRIC DOSE.  NO TREATMENT REQUIRED.
Runny nose, scratchy throat, cough, fever, and slight burning in upper back sinus headache
raised splotchy area throughout the trunk area w/itching & discomfort started 8-10hr p/vax;MD gave pt cortisone inj;now presents w/cont rash & itching;
Mid December I started noticing major hair loss, big clumps by New Years. Continued through January. Went to PCP in January, who thought combo of stress, anemia. Saw Dermatologist in Feb. who said hair was growing back. Hair loss has stopped. By April hair was growing back, but still not as full as it was before vaccination. Did not have Covid.
"inconsolable" 5/18-21. 5/21/08 Bloody tinged mucous in stool, normal exam; was observed
fever, muscle aches, sweating, chills, joint pain, headaches started at 12:15 a.m. (approximately 8 hours after the shot) and still continue
ELEVATED WBCs, brown spots on body, red eyes, WBCs attacked my eyes. continue to see eye doctor for chronic uveitis, WBCs in the eyes, edema in the eyes eye drops combigan, prednisone, atropine, bromsite
redness at injection site; swelling, and itching at the injection site; itching at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number BP3F4, expiry date 3rd September 2022) for prophylaxis.   On 10th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th January 2021, 2 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient experienced redness at the injection site approximately 2 inches in diameter, swelling, and itching at the injection site. All events lasted for two weeks and then resolved. The reporter consented to follow up.  Discrepancy : The patient's age was reported as 61 years old however as per date of birth it should be 60 years. In Argus correct age was captured.
rash or hives on my left arm where I had my shot; rash or hives on my left arm where I had my shot; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot). At the time of the report, INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
crying, fussy, legs swollen, red, hot, tender, 6 days later lump, red, hard;pt was given vax on 27JUN96 & mom called in later in afternoon;pt exp inc crying, fussy, legs swollen, red, hot, instructed on ice & APAP;
Pt recv vax on 10/27/98; on same day pt exp vomiting, swollen eyes & myalgia; tx=rest
The adverse event began as a feeling that there was an air bubble stuck in my throat. It then manifested into feeling like there was swelling in my throat. Eventually, there was external swelling on the left side of my throat. This lasted for a couple weeks, and would happen off and on. I visited the Nurse Practitioner at my doctor's office, and she confirmed that there indeed was some minor swelling in the lymph node on the left side of my throat. She ordered an ultrasound for my head/neck, but because of the cost, I was unable to get the ultrasound. The swelling has since subsided. I made the correlation that the swelling was on the same side as both of my Moderna injections, so I figure the swelling is due to the COVID vaccine.
Vaccine given 1 day out of date beyond use date. Patient does not report any unusual signs and symptoms or local reactions.
Narrative:  Patient with breakthrough covid infection despite 2 doses of moderna vaccine. Confirmed with positive test. Given monoclonal antibody therapy.
This spontaneous report as received from office manager via company representative refers to a 18 year old male patient who on an unknown date was vaccinated with GARDASIL, intramuscular (dose, lot # and expiration date not reported). On an unknown date (reported as within the past few days) the patient started sweating and shaking then fainted immediately after receiving a dose of GARDASIL. When the patient fainted he wounded his forehead and received four stiches in his wound. Blood pressure was measured but result was not provided. The paramedics were called at an unspecified time after the patient fainted. The outcome of the events was recovered/resolved on unknown date. Additional information has been requested.