chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 9 year old female with sore throat on 23-FEB-2009 who was vaccinated with her first dose of GARDASIL (lot #661766/0652X) after the strep throat test on 23-FEB-2009. She performed a strep throat test but it came back negative and she did not have fever before vaccination. Subsequently, soon after receiving GARDASIL, the patient experienced fever, nausea, and had swelling, a rash and a knot at the injection site. In the second week of March 2009, the patient's father called the office and stated that the patient still had swelling and knot at the injection site. At the time of reporting, the nurse did not know if the patient had fully recovered and was not sure if the patient would receive the second dose of GARDASIL. The patient called the physician for medical attention. Additional information has requested.
similar side effects as caller; laying down after 2nd dose; he had more symptoms; had fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (similar side effects as caller), ASTHENIA (laying down after 2nd dose), ADVERSE EVENT (he had more symptoms) and PYREXIA (had fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (similar side effects as caller), ASTHENIA (laying down after 2nd dose), ADVERSE EVENT (he had more symptoms) and PYREXIA (had fever). At the time of the report, ADVERSE EVENT (similar side effects as caller), ASTHENIA (laying down after 2nd dose), ADVERSE EVENT (he had more symptoms) and PYREXIA (had fever) had resolved.            No concomitant medications were reported.
patient requested to have fluarix in right arm and pfizer bivalent in left arm. patient reported "electric pain" shooting down in left lower calf when his foot touches the floor while walking 30 minutes after administration.
From initial info received on 7/28/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 30 year old male pt received a dose of TD ADS ADULT, lot U1278AA, in the right deltoid on 7/26/04. Route of administration was not reported. Approximately 24 hours post/vax, the pt developed generalized itchy urticaria described as red, raised patches. Reportedly, the pt was administered Keflex prescription at the time of immunization. He was seen by a doctor on 7/27/04 and given Benadryl, Zantac and a steroid pack. It was also reported that the pt might have received a booster of the vaccine in 1993. It was not reported whether the pt recovered from the event. From additional info received on 9/30/04 from a health care professional; the name of the county where the pt received the vaccination was provided as well as the amended name of the facility where it was administered. Reportedly, the pt recovered on 7/30/04 from the events. No further info is anticipated, this case is considered closed.
On July, 7,2021 I received my first does of the Pfizer-BioNTech vaccine for COVID-19 on upper left arm intramuscular. And on the same night, I have severe pain on injection site which spread all the way to left shoulder. In addition, I also have body ache,fever,fatigue. I took Tylenol as recommended by the nurse. I recovered from the fever and fatigues within couple of days. However, I had left arm and shoulder pain which continues with daily activities. As recommended by the nurse ,I took my second dose of Pfizer-BioTech Vaccine on July 30,2021. Thereafter, the pain in my left arm and shoulder continues till date, which increases with daily activities,including driving, lifting groceries,etc. During these times as During these times my family,friends, and my colleagues notice that my thinking was sluggish, difficulty in finding the right words ,and often misspoke my words, which lasted on/off for couple of weeks. However, my arm and shoulder pain never recovered and my family notice I have unusual snoring at night during my deep sleep.   On the month of October second week, I felt uneasiness, tiredness,and lethargic. Then, I began to experience slight chest pain and shortness of breath when walking up the hill on Sunday,October 10,2021 which intensify on the afternoon of October, 11,2021. The chest pain become so severe like a burning sensation that I was experiencing heavy breathing and the pain was  spreading on the left arm with occasional no feeling of sense . I eventually went to the Emergency Department where they found I had extremely high troponin levels and declared as heart attack. Later, they put 1 stent in my coronary artery where blockage took place. It's been over a month since I was discharge from the hospital, but I am still experiencing moderate to severe pain on my left arm which spread to the upper left shoulder.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 2nd dose of SHINGRIX. On 6th September 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, upset stomach and pruritus. On 9th September 2018, the patient experienced tiredness. On 9th September 2018, the outcome of the erythema of extremities was recovered/resolved. On an unknown date, the outcome of the upset stomach and pruritus were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, upset stomach, tiredness and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The arm redness resolved a couple of days before the time of reporting and the tiredness developed about that time.
off label use; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (off label use) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, OFF LABEL USE (off label use) had resolved. Unknown      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.   Reporter did not allow further contact
Attack of the appendicitis four weeks after May 2021  2nd dose of MRNA vaccine.  Recurring attack every six weeks or so until eventual appendectomy in December 2021.
After each of these vaccines, my infant gets reflux (curdled milk spit up) that is constant (projectile) for a week. This behavior is only present following a vaccination.
Case number PHEH2013US02279 is an initial spontaneous report received from a pharmacist on 22 Jan 2013: This case refers to a 54-years-old female patient. She was received only MEN C, Y, W-135 liquid conjugate component of MENVEO (batch number: X11064), intramuscularly without being reconstituted with Men A component on 22 Jan 2013. No adverse reaction reported following this administration error.
5cm x 5cm reddened, swollen area to R upper thigh, warm to touch, pt was limping on leg 8/22/06. Dtap given at site on 8/21/06.
Patient experienced severe lightheadedness and nausea, felt like she was going to pass out and throw up.  We offered her a bottle water and then walked with her (with an arm on each side) to another room, where we had her sit down against a wall and put her head between her knees.  She also stated she felt very hot, so we got her a cool compress for the back of her neck.  We had her wait for another 15 mins (total of 30mins) before she started feeling better, her coloring looked better (she was very pale at first) and she felt better enough to drive home.
Information has been received from a healthcare worker (also reported as a wholesaler) who received an email from a doctor's office concerning a female who on 30-JAN-2012 was vaccinated with a dose of PNEUMOVAX 23 (lot# 672074/1502AA). On an unspecified date the patient had a "bad reaction", the patient experienced itching and swelling on 1 arm from hand to elbow and a general ill feeling. The patient was admitted to the hospital (name and location of the hospital is unknown). No information on the treatment given at the hospital was provided. At the time of reporting, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
first dose of gardasil in 2013/ patient was in the office at the time of the phone call for her booster (GARDASIL 9); no adverse effect; This spontaneous report was received from a nurse prescriber refers to a female patient of unknown age. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On an unknown date 2013 (at the age of 16 to 17 years), the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), (strength, dose, frequency, route, lot # and expiration date not reported) for prophylaxis. At the time of the reporting, the patient came to the nurse office for her booster of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No adverse effects were reported. No product quality complaint (PQC) was present.
She got her vaccine and immediately felt it going in the arm, and went up to her neck, and gone within the 15 minutes.  Then she left, came home and around 7:00 she started getting really tired, could not keep her eyes open and fell asleep around 7:30.   A couple of hours later her arm was in so much pain and her neck was in so much pain, pain up the left side of her neck, hot and cold chills, body aches.  She had to put a heating pad on her neck due to pain and stiffness.  Today she is having diarrhea, yesterday she had a cough, congestion, headache, and has flu-like symptoms.  She has no appetite, she cannot taste anything, has not eaten in 2 days, is drinking water and holding that down, nausea as well.  She has never had a vaccine in her life that she has gotten sick over like this.  She has not taken anything for it.
This spontaneous report was received from two medical assistants and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016 (reported as from 15-OCT-2016 through 14-DEC-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M028323, expiration date 26-SEP-2018; site, doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 48.48 Fahrenheit degrees (F) for 36 hours and 32 minutes before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA008782.
Sore throat; Nasal congestion; Runny nose; Feel as if I had the virus, I experience the symptoms of a heavy flu; Shortness of breath; Coughing with great effort; Thorax pain due to coughing; Weakness; Sleepiness; Tiredness; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Weakness), SOMNOLENCE (Sleepiness), DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort) and CHEST PAIN (Thorax pain due to coughing) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 12-Jan-2021, the patient experienced ASTHENIA (Weakness), SOMNOLENCE (Sleepiness) and FATIGUE (Tiredness). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort), CHEST PAIN (Thorax pain due to coughing) and INFLUENZA LIKE ILLNESS (Feel as if I had the virus, I experience the symptoms of a heavy flu). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion) and RHINORRHOEA (Runny nose). On 12-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, ASTHENIA (Weakness), SOMNOLENCE (Sleepiness), DYSPNOEA (Shortness of breath), COUGH (Coughing with great effort), CHEST PAIN (Thorax pain due to coughing), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Nasal congestion), INFLUENZA LIKE ILLNESS (Feel as if I had the virus, I experience the symptoms of a heavy flu), RHINORRHOEA (Runny nose) and FATIGUE (Tiredness) outcome was unknown.        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.   Treatment medication not provided. Concomitant medication not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mild chills and fatigue. Took a couple of Advil.  Same repeated the next day evening
3 days post 1st vaccine: stabbing pain in right foot - 12 hours 30 mins post  2nd vaccine: numbness, tingling of right arm, hand, fingers of right hand - 4 days 12  hours 2nd post vaccine: numbness, tingling of right side of face and forehead that lasted 4 days 5 days post 2nd vaccine: stabbing pain in right foot - 2 weeks 4 weeks post 2nd vaccine: nasal wing sores - peaked 6 months but continues 10 months post vaccine 6 weeks: internal and external vibrations, tremors and jerks - peaked 6 months but continues on a lesser level 10 months post vaccine insomnia from waking up jerking and with tremors and vibrations trouble swallowing - peaked 6 month but continues on a lesser level at 10 months 8 weeks: excessive hair loss weight loss POTS symptoms full body flat, non-itchy, non-oozy spotted rash - 2 weeks 12 weeks: shingles on right side of upper back, under arm and breast area 15 weeks oral thrush
pain in that arm ever since the injection; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in that arm ever since the injection) and ARTHRALGIA (Joint pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced ARTHRALGIA (Joint pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in that arm ever since the injection). At the time of the report, PAIN IN EXTREMITY (pain in that arm ever since the injection) and ARTHRALGIA (Joint pain) outcome was unknown.            Reporter did not allow further contact
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-NOV-2012 13:20, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Covid-19 results came back positive; Lost taste; Lost smell; Fever; Chills; Severe body aches; A spontaneous report was received from a consumer concerning a 27-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a positive for COVID-19 test, fever, generalized aching, loss of taste, loss of smell and chills.  The patient's medical history was not provided. Concomitant product use was not provided.  On 02 Jan 2021, the patient received their first dose of mRNA-1273 (Lot number:  026L20A) in her right deltoid for prophylaxis of COVID-19 infection.   The patient stated that the night of her first dose she went to work and started to feel feverish, chills and body aches.  The next morning, 03 JAN 2021, she woke up with severe body aches, loss of taste and smell and fever that was still ongoing.  She was told to get tested for COVID-19 and the results came back positive.    Treatment medications reported were Tylenol and Advil.    The events, positive COVID-19 test, fever, generalized aching, loss of taste, loss of smell and chills were unknown as of this report.; Reporter's Comments: Based on the information provided, the natural history of COVID-19, a causal association between the event of positive COVID test and mRNA-1273 use is assessed as unlikely as well as the events of generalized aches, loss of taste and loss of smell as the patient was most likely exposed to the disease prior to vaccination. The other events of fever and chills are consistent with the product safety profile, although confounded by the COVID-19 infection.
Soreness in arm; Dizziness; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 66-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included lenvatinib mesilate (Lenvima) for renal cell cancer.   The patient's past medical history included stomach pain, cough and vomiting. Concurrent medical conditions included renal cell cancer.   On 5th October 2022, the patient received Flu vaccine. In April 2022, the patient started Lenvima (oral) 10 mg once daily (10 mg daily). On 5th October 2022, less than a day after receiving Flu vaccine, the patient experienced pain in arm and dizziness. The action taken with Lenvima was unknown. On an unknown date, the outcome of the pain in arm and dizziness were recovering/resolving.   It was unknown if the reporter considered the pain in arm and dizziness to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The reporter reported that the patient received Flu vaccine after received flu vaccine the patient experienced soreness in arm and some dizziness that was getting better. The reporter was unknown if MD was aware. The reporter stated that the patient was also on therapy Lenvima drug and also about 5 days last week he was experienced stomach ache, coughing and vomited this are resolved. It was unknown if the reporter considered the pain in arm and dizziness to be Lenvima  Additional supportive information: Follow-up would not possible as no contact details were available.
Patient reported pain in arm after injection on 10/2/18. Pain continued, went to physician on 10/31/2018. Physician prescribed medications and physical therapy. Patient has been reports receiving treatment since.
Patient is a very pleasant 76y.o. year old  male who presented to the ER after a near syncopal episode while ambulating at home. No loss of consciousness. The patient relates that he was diagnosed with Covid one day prior to presentation. He gone to get tested due to symptomatology including fatigue, generalized weakness, diarrhea, and some body aches. He was tested in urgent care, and does not have a copy of those results. The patient did receive 2 doses of Moderna vaccine in March and April of this year. He has not received a booster. He does not have any known Covid positive contacts. On presentation he was afebrile, with stable vital signs and maintaining an O2 sat of 96% breathing room air. CXR was negative for evidence of infiltrate. CBC revealed a normal WBC and differential. D-dimer was mildly elevated at 673, CRP 36, ferritin 794. At present, he states he is feeling "great" - smiling and in good spirits.
Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen.  Outcome- called 911 and medics took over
congestion; sickness; a cold that travelled through their family; headaches; Sprained/twisted their ankle believed about 6 months ago/retwisted their ankle; hurt/They said it was hurting.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "known allergies: gluten", notes: known allergies: gluten. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; LIGAMENT SPRAIN (non-serious) with onset 2021, outcome "not recovered", described as "Sprained/twisted their ankle believed about 6 months ago/retwisted their ankle"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "hurt/They said it was hurting."; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "a cold that travelled through their family".  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 a pharmacy technician regarding her son, a 8 month old male patient on an online article. Concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in December 2006, the patient's mother was vaccinated with dose 1 of GARDASIL. On an unknown date in January 2007, the patient's mother experienced Postural Orthostatic Tachycardia Syndrome (POTS) (MARRS# 1609USA004199). On an unknown date in February 2007, the patient's mother received the second dose of GARDASIL. On an unknown date the patient's mother became pregnant with her first child (MARRS# 1609USA004199). Subsequently on an unknown date the patient's mother became pregnant with her second child (MARRS# 1609USA005960). EDD and LMP was unknown. On an unknown date the patient delivered a male infant. The child was now facing many health issues. The outcome of the health issues was unknown. Causality was not reported. Additional information is not expected as no contact details were provided.