chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; nausea; vertigo; This is a spontaneous report from a contactable other-HCP (Patient). This 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in left arm on 16Feb2021 at 15:45 (at the age of 53-years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 19Feb2021, at 12:00 AM, patient had headache, nausea and vertigo. On 21Jan2021, the patient had received other unspecified vaccine within four weeks into the left arm and other unspecified supplement medications in two weeks. No treatment was received for the adverse events.  Patient not had COVID prior vaccination and was not tested for COVID post vaccination. The outcome of all the events was not recovered.  Information on the lot/batch number has been requested.
Developed rt sided parotid swelling secondary to administration of MMR vaccine 1st MMR - 8/25/14 2nd MMR - 9/23/14.
Pt given Zostavax inadvertently in place of Varicella. Pt. parents notified immediately. No reaction founded
L upper arm swelling (deltoid region) hours after injection. Patient reports it became worse day after immunization. She reports it swelled bigger, became red & itchy. Today, injection site is warm, red, tender. Localized swelling comparable to golf ball sized.
Redness swelling, & left arm where vaccine was given warm to touch, pain, warm compresses.
13July96 pt recv 1 dose vax. Feb98 pt exp chickenpox w/"approx 8 lesions".It was reported that "several of the kids in the pt class have chickenpox".
24hrs p/vax painful swelling @ inj site w/myalgias, arthralgia, fever to 101, sore throat w/swelling, fingers feel tight
c/o local rxn redness, swelling & pain @ lt shoulder where vaccine was given;
Information has been received from a healthcare worker concerning unspecified number of patients of unknown age. In July 2014, the patients were vaccinated with GARDASIL (dose, route and lot # not provided), that had been exposed to 1 degree Centigrade for 84 hours (temperature excursion was reported as "supported"). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Onset swelling and redness of Left thigh, day after vaccinees.  Worse on next day.  Diagnosis: Left thigh cellulitis.  Prescribed: Augmentin ES, Benadryl/Motrin, Elevation of Leg - 16 packs.
This spontaneous report was received from a healthcare worker concerning a 67 year old female patient. On 20-FEB-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as H01574 and 08-JUN-2014 respectively, route unspecified). No concomitant medications were reported. On an unknown date in February 2013, the patient experienced swelling, redness and tenderness at the injection site. On an unknown date, the patient sought medical attention (called the physician office). The physician did not see the patient. The physician prescribed ice and BENADRYL over the phone to alleviate the symptoms of the patient. It was unspecified if any lab tests were performed. The outcome of swelling, redness and tenderness at the injection site was unknown. The relatedness for swelling, redness and tenderness at the injection site was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
cough went down about 50% right away; after second injection cough is completely gone; This spontaneous case was reported by a consumer and describes the occurrence of COUGH DECREASED (cough went down about 50% right away) and THERAPEUTIC RESPONSE UNEXPECTED (after second injection cough is completely gone) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic cough.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH DECREASED (cough went down about 50% right away) and THERAPEUTIC RESPONSE UNEXPECTED (after second injection cough is completely gone). At the time of the report, COUGH DECREASED (cough went down about 50% right away) and THERAPEUTIC RESPONSE UNEXPECTED (after second injection cough is completely gone) had resolved.            No concomitant medication use was provided by the reporter. No treatment of events was reported.
7/9/05-Awoke with diffuse rash on trunk, back, thighs, arms; low grade fever; left thigh "hard" and swollen; non-pruritic; No appetite changes. 7/10/05-Rash continues, small red diffuse rash; non-raised. 7/11/05-Both legs, upper arms, chest and lower back.
Over the 2 months after the vaccine, I got chest pain that got worst to the point I could not stand, I could not take a deep breath, I went to the ER, and they admitted me to the hospital and diagnosed with Pericarditis. I am in medication for the next three months and if not, successful I will need steroids.
shingles outbreak; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age of the patient about 60 years old. The age at vaccination was not reported. The medical assistant reported that, 2 weeks ago from the date of reporting, the patient received 2nd dose of Shingrix and developed shingles outbreaks. The reporter consented to follow up.
Syncope 3/3/09-records received-brief syncopal episode after immunizations, resolved without treatment. Seen on 1/19/09 for PPD reading.
Having a bad reaction; worst headache; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Having a bad reaction) and HEADACHE (worst headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Having a bad reaction) and HEADACHE (worst headache). At the time of the report, IMMUNISATION REACTION (Having a bad reaction) outcome was unknown and HEADACHE (worst headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient has received 2 Vaccines and 3 boosters. She received a Moderna vaccine yesterday and was having the worst headache. Having a bad reaction. was this usual.   No treatment information was reported.
After H1N1 mist patient left office and was pale, dark circles under eyes, weak and lethargic. fell asleep and woke 1.5 hours later with a fever of 102. patient came back to office and looked fine except for cold and temp was 99
Vaccine was received at 4:55pm. 8:30pm, I started to feel fatigued and disoriented. By 9am I started to feel muscle aches and sharp joint pain, as expected. By 1200 noon, the pain intensity was increasing, coming in waves, lasting 10-15 minutes. The pain waves were 10/10, very severe, and was causing me to shake, cry, and be unable to function or sleep. I was also very disoriented, but I think due to the pain. It was mildly relieved with ibuprofen/Tylenol alternating every 3hrs, but continued until 6pm. It began to subside at 6pm.  I am an RN, and sought the advice of my employee health nurse, who advised me to seek medical care if it continued through the night. The pain began to subside, so I did not. However, if a  non-healthcare person experiences that, they will think they are dying.
Second Immunization given at 21 days; or fewer than the 24 day interval and the ideal 28 day interval.  No ill effects. Patient notified   R,BSN recommended this form be completed.   RN, BSN  Health Consultant Nurse
Patient left in private car and started itching and came back to health unit. RN instructed patient to go to ER. Entered ER with heaviness in chest and shortness of breath.
Within 2 seconds of administration, pt had a syncopal episode. Facial flushing was present, +LOC occurred, pt was heavily snoring for approximately 20 seconds, then regained consciousness without medical intervention. Vital Signs were stable, BP 112/74, HR 85, O2 99%; no treatment performed other than continuous visual monitoring for 15 minutes after vaccine administration.
Speaking gibberish; Diagnosed with AFIB (new condition); TIA; Blood clot in brain shown by CT/MRI.; This is a spontaneous report from a contactable consumer (patient).  A 94-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 at 15:00 as single dose for Covid-19 immunisation at the age of 94-year-old. Lot number was EL965. Medical history included bladder cancer, Pulmonary hypertension, Hypothyroidism. Concomitant medications included levothyroxine, timolol maleate (TIMOPTIC), cholecalciferol. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2020 at 15:00 for covid-19 immunisation at the age of 93-year-old. On 12Feb2021 at 05:00, the patient was speaking gibberish, the patient went to ER. The patient was diagnosed with atrial fibrillation (AFIB) (new condition) and transient ischemic attack (TIA). Spent night. On 12Feb2021, Computerised tomogram and Magnetic resonance imaging showed blood clot in brain. The patient visited Emergency room/ department or urgent care, and he was hospitalized for one day. The patient was treated for the events (XARELTO). The patient recovered with sequel from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Information has been received from a medical assistant who reported a 2 month old patient received the first dose of 2 mL oral ROTATEQ approximately 4 months ago. The mother of the patient developed unspecified rotavirus symptoms a week later, and went to the emergency room. The emergency room confirmed that she had rotavirus. The patient sought medical attention at the emergency room. These was no product quality complaint. Additional information has been requested. 03/05/09 This is in follow-up to report(s) previously submitted on 11/14/2008; 12/3/2008. Initial information has been received from a medical assistant and follow-up information was received from a registered nurse. It was reported that on 04-AUG-2008 at 10:30 AM the 27 year old patient's child received the third dose (also reported as the first dose) of 2 mL oral ROTATEQ (lot # 660882/0642X). Concomitant therapy on the same time included the third dose of RECOMBIVAX HB (MSD) (lot # 659670/0475X) given IM into the left leg, DAPTACEL (lot # C2953BA) given IM into the left leg, ACTHIB (UP218AB) given IM into the left arm, IPOL (lot # A0491) given SC into the right leg and PREVNAR (C45721K) given IM into the right leg. Concomitantly, the patient had rheumatoid arthritis and took "Flacwhynol" for arthritis. On 08-AUG-2008, the patient got rotavirus from the child after vaccination. The mother developed diarrhea, vomiting, extreme stomach cramps, chills and sweats and went to the emergency room. In the emergency room, the mother was given 2 bottles of dextrose drip, antispasm medication and pain medication for stomach spasms. Blood work was done in the ER and no results provided. No stool studies done. The emergency room confirmed that she had rotavirus. The mother was sent home with medications for pain and antispasms. On 11-AUG-2008, the mother attempted juice and vomited. On 12-AUG-2008 the mother tried clear liquid and then followed by bananas, rice, applesauce and toast (BRAT) diet. On the same day, the mother recovered. Additional information is not expected.
Breast pain; Neck pain; Swelling in armpit; Shoulder pain; Pain in armpit; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number: UNKNOWN), via unspecified route of administration on 02Mar2021 at 09:30 (at the age of 57-years-old) as unknown single for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included other medication used in 2 weeks. The patient did not have any allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced armpit pain, shoulder pain, swelling arm, pain neck and breast pain on 02Mar2021 at 15:00. No therapeutic measures were taken for armpit pain, shoulder pain, swelling arm, pain neck and breast pain. Outcome of event of armpit pain, shoulder pain, swelling arm, pain neck and breast pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This employee received the Influenza vaccine on Friday, 14 Oct at approximately 1230. Specific vaccine was FLUARIX by GSK, lot number CS979. She has never experienced adverse events from the Influenza vaccine before. She last received the injectable flu shot in 2005 and has received FLUMIST each year since that time. She reports that approximately 1445 she developed a headache on the day of vaccination. She describes it as "all over", non throbbing, mild but unrelenting. Took TYLENOL at home with no relief. Early the next morning she began having loose stools. On Saturday, day 1 post vaccine, she was very fatigued and slept most of the day, having to cancel all planned activities. At the injection site her upper arm was exquisitely painful with erythematous swelling. She took a 400mg dose of over-the-counter MOTRIN with no improvement in headache or arm pain. Bowel and headache symptoms but resolved on day 5 post vaccine.
Presented to the ED with weakness,cough, and nausea/vomitting. Patient had fever at home but was afebrile at ED. O2 sat dropped down to 61% on room air so was given oxygen Was given decadron, albuterol, pulmicort, vitamin D, zinc, and melatonin. Remdesevir was not given due to renal function Was discharged home with oxygen tank, steroids, and anticoagulation.
I had fever between 101-103 F; severe muscle and joint pain for 36 hours; severe muscle and joint pain for 36 hours; I had a migraine-like severe headache; couldn't stop vomitting; had a rash on my upper left arm; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection,Lot Number: Er2613), on 25Mar2021 10:30 at a single dose and first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: En6199)on 03Mar2021 03:30 both via an unspecified route of administration, administered in left arm for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included Vitamin c and vitamin d. No allergies to medications, food, or other products were reported. No covid was diagnosed prior to vaccination. On 25Mar2021, 09:30 PM the patient experienced fever between 101-103 f, severe muscle and joint pain for 36 hours. The next 2 days she had a migraine-like severe headache, couldn't stop vomitting, also had a rash on her upper left arm. The patient underwent lab tests and procedures which included pyrexia: 101-103 f. No covid test was done since the vaccination. She was treated with 1000 mg tylenol for 2 days and 2 pills of excedrine. The outcome of events was unknown.
Information has been received from a physician and licensed practical nurse concerning a 5 year old female patient who on 25-MAR-2004 was vaccinated with first dose of VARIVAX (Oka/Merck) (Lot # not provided). There was no concomitant medication. In March 2008 (also reported as May 2008), the patient experienced chickenpox. Subsequently, the patient recovered. On 07-JAN-2009, the patient experienced chickenpox again. There were no Laboratory Diagnostics Studies performed. At the time on the report on 07-JAN-2009 patient was not recovered. The patient sought medical attention was seen by the physician. Follow up information has been received from a licensed practical nurse concerning a 5 year old female patient with no pre-existing allergies no birth defects and no medical conditions who on 25-MAR-2009 was vaccinated with first dose of VARIVAX (Oka/Merck) (Lot # not provided) in left thigh. Also on 25-MAR-2004 she received MMR II. Concomitant therapy included HIB (unspecified carrier). On 31-MAY-2008 the patient experienced breakthrough varicella. On 06-JAN-2009 she experienced breakthrough varicella, she developed itch "tear - drop" papules and vesicles on torso, some on face and extremities. On unspecified date the patient was recovered. Additional information is not expected.
Dizziness, Headache, NauseaVomiting & HYPERtension Narrative:  Seen in ED at hospital for ha fatigue muscle soreness dizziness and hypertension. CT head found incindental cyst on brain, eval by neurologist findings sx not related to finding.
Patient received Menveo and Bexsero vaccine at 16:40. This author asked patient to wait for 30 minutes to monitor for reaction. Pt and pt mother verbalized understanding and waited in exam room. After 15 minutes, pt approached this author and asked to wait in waiting area. 5 minutes later, patient mother informed staff that patient was having difficulty breathing.  Rapid response was activated at 1700.  MD and ED personal showed up at 1700. Pt threw up continuously. Vital signs were captured from patient with 98 pulse and 96 O2 Sat on room air. Epinephrine was administered to patient to right thigh at 1702. 22 gauge IV started in right AC at 1700. Pt alert and oriented throughout the rapid response. Pt stayed conscious throughout rapid response. Pt transferred to ED with ED personal.
Monday last week 4/25, patient began experiencing cold symptoms and had a positive COVID test on 04/26.  His symptoms improved initially however for the past 3 days he has experienced worsening generalized weakness, productive cough with yellow-colored sputum, and rhinorrhea
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, frequency, route of administration and indication were not reported, lot # K022445 expiration date: 17-OCT-2016, L013545 expiration date: 17-OCT-2016, L030585 expiration date: 10-FEB-2017). No adverse events reported. This is one of the several reports received from the same reporter. Additional information has been requested.
redness; itching; incorrect route of drug; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 2nd dose of Shingrix (subcutaneous). In December 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The patient did not know the batch number or expiration date. In mid December 2018, the patient received Shingrix. The patient who reported that the pharmacist that injected her with Shingrix was inept and his technique was hideous. The patient explained he used a subcutaneous diabetic syringe and needle to inject Shingrix into her right deltoid. She reported while he was injecting, he pinched the skin.  The patient was concerned he gave her a subcutaneous injection and was concerned about absorption and efficacy, which led to inappropriate route of vaccination. The reporter consented to follow up. The reporter declined physician information as she had not discussed with him yet.  The reporter gave her permission to contact her back if necessary.   Follow up received from consumer on 19th February 2019: There was no physician involved in vaccination with Shingrix. Consumer was a Registered nurse and she know a good injection when she seen it. And the reporter concern was whether the vaccine took. It was the second of the series and it was done in December at the pharmacy. The pharmacist who given the injection was not trained properly. She understand that this was an intramuscular injection but he used an insulin needle. He laid against my deltoid and pushed it in. Then, in the middle of the procedure, he pinched the skin. He was not very sure of himself and she think that's why he pinched the skin. Nevertheless, he did it all wrong. This was why the reporter concerned. Did she get enough of the vaccine if it was given in the fatty area of my deltoid? She did get a bad itch. She had almost no reaction the 1st time a different pharmacist. She had some edema that time. This time it caused redness and the itching continued for a number of weeks. This was my complaint. In addition, my question was did she get enough of my 2nd injection Also, who was training the pharmacists to give injections? (Hire me and the reporter would teach them the proper way to do an injection.) This case has been linked with case US2019GSK037085, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019GSK037085:same patient