chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 18 or 19 year old female with sulfonamide allergy who on an unspecified date recently was vaccinated with a first dose of Gardasil (lot # 657868/0523U) deltoid. On an unspecified date 3 to 4 weeks post first dose the patient developed a quarter-size raised and tender area in the vicinity of the injection site after vaccination. Medical attention was sought. At the time of reporting the patient had not recovered.   Follow-up information was received.  On an unspecified date the patients adverse events have resolved.  On an unspecified date the patient had received the second and third dose of HPV 6 11 16 18 VLP vaccine (yeast) without an incident. Additional information is not expected.  This is in follow-up to report(s) previously submitted on 8/14/2007; 1/7/2008. Follow-up information was received. On an unspecified date the patients adverse events have resolved. On an unspecified date the patient had received the second and third dose of GARDASIL without an incident. Additional information is not expected.
Tinnitus began within a couples of days; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 13:30 (at the age of 59-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Feb2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. 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 COVID-19 vaccine. Concomitant medications of the patient were not reported. On 06Feb2021 at 23:00, the patient experienced "tinnitus began within a couples of days, continued to this day". Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 24Feb2021, the patient underwent vault (SARS-COV-2) test and the result was negative. The clinical outcome of the event "tinnitus began within a couples of days, continued to this day" was not recovered at the time of this report.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
End up having a stroke; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-May-2021 and was forwarded to Moderna on 08-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (End up having a stroke) 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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (End up having a stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (End up having a stroke) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  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.   Reporter did not allow further contact; 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.
Pt was vaccinated at 0845 - she was in observation x30 min .  After 30 minutes she started complaining of itching and was observed scratching her forearms and chest.  She self medicated with benadryl 50mg caps - she was observed for an additional 40 minutes - all symptoms had resolved.  Pt was instructed to follow fact sheet and take action on any additional allergic symptoms.
This spontaneous report was received from a Registered Nurse refers to an unknown number of male patients (out of the 4 clients) of unknown age. The nurse reported that on an unknown date, the patients got their doses of GARDASIL a bit early. The patients received the second dose of GARDASIL (lot#, route, dose not reported) 4 weeks after the first dose and the third dose was received 12 weeks later. No adverse effects reported. This is 1 of 2 reports received from the same reporter. Additional information is not expected.
Pt. states that after receiving the 1st dose of Moderna 09/01/2021, started experiencing symptoms 09/02/2021 of uncomfortably shakey, extreme fatigue, and weakness (slight headache). 09/03/2021 symptoms subsided. No noted Primary visit.
both Shingles vaccinations but got shingles/suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Jun-2022 Reporter's comments: This case was reported by patient via interactive digital media and described occurrence of suspected vaccination failure. The patient got 2 doses of Shingrix and still experienced shingles and wanted to know if could receive booster dose. Additional Supportive Information:  This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
PT reported to the Clinic around 1500. PT stated she received the second dose of the Moderna Vaccine around 1330. PT stated she started to break out in pin point hives on both arms around 1450. PT stated she has had hives after a flu vaccine before. PT states it was  over a decade ago. PT denies any difficulty breathing or any other symptoms. I called the on call provider and the PT was seen in clinic at 1536.
Severe shakes and chills in middle of the night, body aches, headache, fever, malaise. Last approximately 48 hours.
Initial report was received from a consumer, who was also the patient's wife, on 08 October 2012. A male patient had received an intramuscular injection of ADACEL, lot number C4149AA (site and date of administration not reported). Fifteen days post-vaccination, the patient had a severe outbreak of erythema multiforme. A biopsy was done but the results were not available at the time of the report. No additional information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006743: US-009507513-1706USA010999: US-009507513-1706USA011000: US-009507513-1706USA011001: US-009507513-1706USA011003.
a hard time to breath/shortness of breath like an asthma attack; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (a hard time to breath/shortness of breath like an asthma attack) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044a21a and 002a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient has asthma since she was 6 years old). Concomitant products included VITAMIN D [VITAMIN D NOS], OMEPRAZOLE, ATORVASTATIN, AMLODIPINE, ALENDRONATE SODIUM (ALENDRONATE) and ASCORBIC ACID, ZINC (VITAMIN C + ZINC) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, 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 experienced DYSPNOEA (a hard time to breath/shortness of breath like an asthma attack) and PYREXIA (fever). At the time of the report, DYSPNOEA (a hard time to breath/shortness of breath like an asthma attack) and PYREXIA (fever) outcome was unknown.            Treatment information was not provided
pt slept 19hr up 1/2hr -slept several hours-again-eyes, above eyes, nose dark red blotchy;
After the first dose in Feb2021, she stopped coughing; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After the first dose in Feb2021, she stopped coughing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Ceclor and Penicillin. Past adverse reactions to the above products included Hives with Ceclor and Penicillin. Concurrent medical conditions included Non-cystic fibrosis bronchiectasis (Coughing stopped for three months after vaccination, then resumed.) since 07-Jan-2017, AFib since 01-Jan-2020 and Sulfonamide allergy (Sulfa drugs (hives)). Concomitant products included ALBUTEROL [SALBUTAMOL] for Bronchiectasis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After the first dose in Feb2021, she stopped coughing). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After the first dose in Feb2021, she stopped coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.   This case was linked to MOD-2021-214763 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received. Updated patient demographics, and history. The vaccine administration date, and lot number was added.
Swelling, redness, pain in upper arm. As of 11/7/2013 pt redness and swelling was going down.
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 09-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
mom took pt to ER because was burning up & vomiting; was told t104; tx w/APAP-rubbed down & kept for 3 hrs;
Rash all over body and fever of 102.9 start Wed evening. TYLENOL was given for fever.
14 MONTH old with cough, congestion for 4 days; had fever for the first 2 days of illness, but none since.  Developed grouped blisters on medial aspect of right foot 3 days ago. Not sure if they are painful or not.
By 6 pm on the 4th of November I had pain at the injection site, I couldn't lift my arm.  I had generalized aches, fever and shakes.  By the next morning I called in at work, I couldn't get out of bed I had a rash from under my arms to the top of my legs. Wednesday I relaxed all day drinking plenty of fluids.   I tried to work on Thursday but left early with a fever.  I'm still in bed, I missed 2 days of work and I work per diem as an RN.
Pt received vaccine, while walking to recovery became dazed, confused, unsteady on feet. Staff  held her and  guided her to floor to lie down put feet up.  MD assessed summized vagal vasal response. No LOC, No SOB. pt did not hit her head.  Applied ice to back of neck,  gave water for hydration. VS146/84, HR 60 reg, resp 12, SpO2 97% Pt's . Left Deltoid site benign - reddness - swelling -bleeding.  Mother was at her side.  stated "she has a problem with needles this happens to her".  Provided reassurance.  Monitored  30 minutes. kept reassessing condition.  Pt stated she felt better.  Ok'd to exit with family after 30 minutes.   4/10/21 next day tried to contact  x 2 to check on condition , no answer left message, no return call back
About a week after vaccinations she demonstrated a fever of 101 at 10:00pm. She continued to have a low grade fever for 3-4 days following. Behavior was much worse, difficulty sleeping, jerking and twitching, difficulty walking, very irritable. Symptoms faded over a 2 week period.
He reports that she had been having a fever ranging from 100.4F to 101.2F or 101.4F.; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Caller states his wife also has a headache, body aches, and has been "sleeping alot".; Fever is accompanied by chills that present how they'll just affect just one arm or leg at a time; This is a spontaneous report from a contactable consumer (patient's husband). A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. It was not reported if the patient was pregnant at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced that she had been having a fever ranging from 100.4f to 101.2f or 101.4f, fever is accompanied by chills that present how they'll just affect just one arm or leg at a time (chills), caller states his wife also has a headache, body aches, and has been "sleeping alot" on an unspecified date with outcome of unknown. It was also reported that the fever is accompanied by chills that present how they'll just affect just one arm or leg at a time. The patient underwent lab tests and procedures which included body temperature: 100.4f to 101.2f or 101.4f fahrenheit on an unknown date. The action taken in response to the events for bnt162b2 were not applicable. Therapeutic measures Tylenol and stuff were taken as a result of events. The clinical course of the outcome of the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
The Pfizer vial used to administer was mixed with less than 1.8ml (but equal or greater than 1.5ml) diluent. The patient received the 0.3ml dose from this vial
None,  Too young to receive vaccine. She requested Moderna and I did not recheck her age. I was giving LTCF staff vaccines at the facility.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-SEP-2017, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with expired sterile diluent (lot# was not reported), expiration date: 06-SEP-2017. No adverse effect was reported.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    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 MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-296287 (Patient Link).
pt recv vax 26MAR98 * for 3-4 days pt had fever to >102.5 & irritability;dx on 1APR98 w/conjunctivitis, sx starting in past 48hr;
pt recv vax & exp impotence & rotator cuff tendinitis w/rt arm & back pain;pt impotence responded to sildenafil citrate (viagra) & now has nl sexual function;
Local reaction involving erythema 7x13cm & tenderness and induration 3x4cm of (L) upper arm, Fever 103
Day of Injection 25Sep21: Dizziness, seizure and loss of consciousness within minutes of the injection.  Immediate feelings of tightness at the injection site, followed by tightness and pain in the left arm, shoulder and neck. These issues continued for a week following the injection. 26Sep21: Woke up feeling tired, fatigued with full body aches. laid down for a nap around 2pm, woke up around 2:45pm experiencing extreme body shakes, similar to a seizure. Face was pale, lips were white (no color in face) with extreme chills. Laid down and continued extreme shaking for about an hour and a half. Fever was 104.5. After that 1.5 hours, fever reduced to 103, he slept for a while, checked temp again at 5:30, reduced to 101.5 and color had returned to his face. Fatigue continued that evening. The next day he woke up feeling better, but still had the stiffness in his left arm, shoulder and especially in the neck.  as of today, the extreme shaking/seizures have not returned but the future is of course unknown.
Covid monitoring documentation. PT admitted 1/17/22 documented to have positive covid. PT received Pfizer 4/23/21 Lot EW0158 for dose 1. Dose 2 was Pfizer given on 05/14/21 Lot ER8736.
This case was reported by a consumer and described the occurrence of jerky movements in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) for prophylaxis. The reporter is the father of the subject. A physician or other health care professional has not verified this report. The subject's medical history included birth "six weeks premature." The subject weight 2.5 pounds at birth. Concurrent medications included unspecified "medications typical for a premature baby." On 25 June 2003 the subject received the 1st dose of Pediarix. On 25 June 2003 the subject was also vaccinated with Haemophilus influenzae type B conjugate vaccine (ActHib). Approximately one month following the administration of the vaccinations on an unspecified date in August 2003, the subject experienced "jerking movements in her limbs and head."  The subject was examined by a neurologist and "no problems were found". The jerking movements resolved on an unspecified date on or before 08 August 2005. On an unspecified date after August 2003 and on or before 08 August 2005, the consumer reported that the subject, "exhibited a flapping motion in her arms when she is excited and experienced delayed speech development - a few months behind what it should be, ear infection, rash and rosacea." The ear infection, rash and rosacea resolved on an unspecified date on or before 08 August 2005. The flapping motion and delayed speech development were ongoing at the time of initial reporting, 08 August 2005. No further information will be available.
13-14 days after 9/8 (2nd) COVID vaccine, abrupt saddle embolus to lungs, acute LLE DVT. Hx of remote DVT to LLE decades ago.
A non-serious spontaneous report of inadvertent administration of two doses of the H1N1 Intranasal vaccine has been received from a physician concerning a seven-year-old female subsequent to the administration of H1N1. Relevant medical history and concomitant medications were not reported. On 04-Oct-2009, the patient received H1N1. On 09-Oct-2009, she received a second dose of H1N1. According to the clinic, the patient's mother had checked "no" on the item for "received vaccine within the last 30 days". The patient's nose was irrigated by the clinic physician after the second dose. There was no adverse event associated with this vaccination error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, fatigue, chills Narrative:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient claims she did not eat or drink before coming in for the vaccine.She was given water and recovered after a few minutes after which she was helped to her car where she was taken home by her husband.