chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to five patients of unknown age and gender. On unspecified dates five doses of improperly stored VARIVAX (Merck) (0.5 ml 1 dose, subcutaneously: lot# was not reported) were inadvertently administered to unspecified patients. No adverse effects were reported. Additional information has been requested.
"covid arm"? itchiness, sore to the touch -- started last night or Sunday, 8 days after the shot
2/17/2021 Vaccination 2/28/2021 I started to experience symptoms of Shingles and I went to the Dr. to get treated. This Dr. has since retired. I started on medication and it took a couple of weeks for the Shingles to run its course.
A non-serious, spontaneous report of my son got three doses of H1N1 LAIV and positive for strep throat has been received from a physician concerning a seven-year-old male, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications were provided. The patient received H1N1, Intranasal on 21-Oct-2009, 18-Nov-2009 and 01-Dec-2009. On 01-Dec-2009 the patient mistakenly received a third dose of H1N1, Intranasal. On the evening of 01-Dec-2009 the patient experienced a fever and the next day on 02-Dec-2009 the patient tested positive for strep throat. The outcome of the events are unknown.
I felt like I had the flu and nausea. Muscle soreness and headache. I became dizzy and had to catch myself before I fell. Doctor gave me shot.
Hospitalized with low oxygenation/high pulse; Hospitalized with low oxygenation/high pulse; Interstitial lung disease; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 71-year-old non-pregnant female patient received BNT162B2 (BNT162B2 Formulation: Solution for Injection Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) via an unspecified route of administration on 25Feb2021 (at the age of 71-year-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine includes BNT162B2 (Pfizer Batch/Lot number: EL 9269. Expiration date: 31May2021) via unspecified route of administration on 06Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient medical history included type 2 diabetes mellitus, arthritis, Gastroparesis, hypertension, hyperlipidaemia, chronic kidney disease. Concomitant medication(s) included nabumetone; colecalciferol (VIT D); fexofenadine hydrochloride (ALLEGRA); dexlansoprazole (DEXILANT); allopurinol taken for an unspecified indication. The patient experienced interstitial lung disease (medically significant) on 26May2021 and hospitalized with low oxygenation/high pulse (hospitalization) on an unknown date in 2021. Patient was First diagnosed with pneumonia 23Feb2021 (subsequent multiple times); hospitalized with low oxygenation/high pulse 12Apr-14Apr2021, started 24/7 oxygen; 04May2021 anesthesiologist asked what was wrong with lungs when awaiting transport to surgery for back operation; 26May2021 Pulmonologist diagnosed interstitial lung disease - stating likely never had pneumonia - started Prednisone 40 mg, one month on 21Jul2021, 20 mg, one month, dropped to 10 mg for one week. Restarted 20 mg and Micophenolate. So weak pulmonologist restarted 20 mg along with Micophenolate. Around 31Aug2021 declined in energy and stamina till barely can get to bathroom by self. Continuing through current. The patient underwent lab tests and procedures which included heart rate: high on an unknown date in 2021, oxygenation index: low unknown date in 2021, sars-cov-2 test: negative on 24May2021, sars-cov-2 test: negative on 18Jun2021, sars-cov-2 test: negative on 16Aug2021. Patient took BNT162B2 (Pfizer Batch/Lot No. FC3182) on 16Aug2021 as DOSE 3, SINGLE for covid 19 immunization. Therapeutic measures were taken as a result of events includes Antibiotic. Outcome of events was not recovered.
Rash over trunk of my body; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 06Jan2021 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the left arm on 16Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 08Jan2021, the patient experienced rash over trunk of her body. Therapeutic measures were taken as a result of rash over trunk of her body and included treatment with diphenhydramine (BENADRYL). Outcome of the event was recovering. The event was considered non-serious by the reporter.
A report was received from a health care professional on 10/21/03 concerning a 41 year old female vaccinee who experience nausea 6.5 hours after, and vomiting on day after receiving Fluvirin on 10/20/03. On 10/20/2003 the vaccinee experienced nausea 6.5 hours after vaccination. The nausea lasted until the following morning, during which time the vaccinee vomited every half hour up to a total of 6 to 8 times. The vaccinee claims to have an allergy to eggs and the last time she was exposed to eggs she experienced diarrhea, blotchy red rash, nausea and vomiting. The vaccinee was still nauseated at the time of the report and was to see her physician for treatment. There was insufficient information to determine the reporter's causality assessment.  Update 1, 11/27/2003: Follow up information received from a health care professional indicated that following treatment with diphenhydramine hydrochloride the nausea and vomiting resolved.
right-sided parotitis clinically, and on Ultrasound confirmation  Impression: Findings suggestive of right parotitis with reactive right lymphadenopathy. No necrosis or abscess.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Spikevax COVID19 vaccine bivalent, the dosage given in ml was unknown to the HCP. HCP requested the list of information necessary for an assessment to be sent to her email since she did not have the info available at the time of the call and she would contact us again with that information. This case is for patient 30 out of 100 patients. Concomitant medications were not reported.  No treatment information was provided   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
Patient incorrectly received his third COVID vaccine a week too early. It was given on 8/22/22 but not due till after 8/30/22. This caused a delay in administering the Monkeypox Jynneos vaccine in this high risk patient.
Patient reported that the arm was "infected". Within 24 hours of the vaccine, a "boil" appeared and was leaking fluid and pus for 2 weeks. Upon examination, there are no signs of infection. The area of the injection site is slightly pink  as expected with a healing lesion. There is no swelling, pain, or significant redness.  No increased temperature/fever. The patient and his caregiver stated that the appearance today is greatly improved.
Both times I felt like I had COVID all over again. My whole body hurt so bad. I missed work both times. I had COVID in November. I experienced fever, chills, body aches.
Received 100mcg Moderna COVID-19 booster rather than 50mcg approved dose.
Fatigue; body aches; joint pain; severe chills (painful); low grade fever; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 39-year-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) intramuscular, administered in left arm on 12Jan2021 at 18:30 pm (age at vaccination was 39 years) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. Medical history included cavernous hemangioma and dermatographia. The patient had known allergy to Sulfa. Concomitant medications were not reported. On 13Jan2021 at 11:00 am, the patient experienced fatigue, body aches, joint pain, severe chills (painful) and low grade fever. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was resolved on an unknown date in 2021.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Red, raised area R thigh, tender to palpation 7-10cm diameter, itchy
Rash onset after flu shot ON 10/5/2018. Initially on body, neck area then now on other parts of arms, legs, trunk. Rash will get worse and then better according to patient.
Patient had FLUZONE HD, PNEUMOVAX 23 on 12/23. Came home and had fever on 12/23 - and her arm was swollen/redness by 12/24 - no more fever, and redness/swolleness was subsided. She was much better on 12/26.
Vaccine given on 5/6/03 at another doctor's office. By next evening redness and swelling (large local reaction). Right upper arm at site of DTaP.
Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 1/6/21 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Pt had televisit consult with psychiatry and neurology. She is subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. She is noted to have a history of shellfish allergy. She experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time.
Patient received Pfizer vaccine on 12/17/2020. The patient developed COVID shortly after and was unable to receive the second dose. Due to the limited supply of Pfizer vaccine, our facility was unable to acquire any more. After consulting with our infection control officer, it was decided the patient should receive one dose of Janssen, which was given on 3/19/2021. Patient has been vaccinated with two different manufacturers. There was no adverse reactions present with either shot.
I got fever the next day and I could not drive back home. The following day I woke up to this pain and lump on my neck, where my neck and my shoulder are. It was feeling kind of sore but it was a soft lump. On Saturday I called a nurse and she told me to go to care. They did not do any medical tests or prescribed any medications because I did not get seen because they were taking too long and I had to go take care of my mom.
Patient presented to the ED and was subsequently hospitalized with closed displaced fracture of shaft of left femur. He died on 06/27/2021
patient fainted after receiving a dose of GARDASIL 9; This spontaneous report as received from a physician via company representative, refers to a 11-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot number, expiration date were not reported) for prophylaxis.     On an unknown date, the patient experienced fainted (syncope) after receiving a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). It was unknown if laboratory/studies were performed. The patient did not receive any treatment for the event. The outcome of syncope was unknown.   The causality was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
Breakthrough case admission after 3 vaccines Pfizer 1/11/21 Lot# EK9231;  Pfizer 2/1/21 Lot# EL9265;  Pfizer 8/19/21 lot# FC3181
pt was adm to hosp for immune thrombocytopenia secondary to vax or viral infect;had worsening petechiae, purpura & t103 on admit;initial platelet count 1;given IgG infusion;inc to 29;
Flu Vaccine was not administered correctly. The dose was not injected into the muscle of the arm as recommended.
Narrative: COVID infection following COVID vaccine series 01/06, Pfizer, dose #1 (NON-Facility) 01/22, Pfizer, dose #2 (NON-Facility) 06/01 CRP 0.952 06/01 ESR 18 08/04 pt cc: chills, cough, fever, myalgias, sore throat exposure: daughter COVID+ 08/07 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE result: B.1.617.2 08/12 SARS-COV-2 CLADE results: 21A Delta 08/24 COVID swab, result: detected
Woke up in AM of March 29 with injections sites with minimal Redness, Warm, induration, Swelling and pain.  Mother was given Home comfort measures and to return March 30 for follow up.  Child returned and injection sites symptoms have gotton worse throughout the night.  Dr. examined child and treated her for infected injection sites and child is to return to Clinic in one week for follow up.
10/22 3am - Woke up with 103.1 fever. Managed with Ibuprofen and was able to keep fever at around 101. 10/23 Afternoon - Started experiencing tightness in chest with cough and wheezing. Used Albuterol rescue inhaler. Fever still present. 10/24 Morning - Fever broke, breathing issue still present. 10/24 Late afternoon - Chest tightness and wheezing still present and worsening. Decision made to go to ER. 10/24 Evening - Attending physician acknowledged wheezing and initiated nebulizer treatment. Discharged same evening. 10/25 - Breathing improved but still needed to use nebulizer. Rattling felt in chest from coughs but nothing productive. Lots of post-nasal drip. 10/26 - Virtual consultation with primary care provider. Treatment currently consists of Flonase, Mucinex, prescribed prednisone, and nebulizer.
On January 7th (8 days after my vaccination) I noticed heat and redness about the size of my fist at the injection site. It had a well defined border and was slightly swollen but not painful. Yesterday, January 8th, the site was less red but larger and with a less well-defined border. Today, The site looks less red but is slightly larger in size. It looks as if the center of the site is returning to the normal skin color and the redness is remaining in the border.  There is still no pain at the site.
pt recvd vax 24JUL95 & 4AUG95 pt devel five to six blisters;The distribution of the blisters was unk;No further details were provided;
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days 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 reporter reported this case for her daughter-in-law's father. The age at vaccination was not reported. In March or April 2018, the patient received SHINGRIX. The patient denied permission to contact their physician. The reporter did not want to provide any additional information.
Information has been received from a health professional a 38 year old female who on 14-FEB-2006 was vaccinated with a first dose of varicella virus vaccine live. On 12-MAR-2006 the patient developed 11 varicella lesions and a fever of 101.2 F. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
suffered violent shakes, chills & severe h/a;began v x 5 & d;also thick tongue;tx @ ER;gen body aches & pain in rt back, rt shoulder area;also weakness & SOB;fever blister & upper & lower lip & nose swelling;unable to sleep d/t pain
This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 14 year old patient (gender not provided) who on 26-DEC-2017, was vaccinated with improperly stored dose of GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020), (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Patient initially experienced muscle aches, fever, and headache for 3 days starting 1 day after vaccine -- within 3 days the muscle aches resolved, but then she continued to have severe headaches. The headaches became migraine like in quality with photosensitivity and a one-sided pounding that was debilitating and associated with nausea. The headaches respond to migraine treatment (Sumatriptan) started after the vaccine, but she has never had migraines before. The migraines continue almost every day until today, 4/27/2021. Due to the onset of new migraine-like headaches with no prior history, a workup and neurologic exam was done twice which was normal both times (see below). However, it seems significant that someone has new daily migraine headaches for longer than 3 weeks after the vaccine was given so we are reporting it.
Patient came to clinic for first dose of Monkeypox vaccine.  The patient moved her arm during the intradermal dose administration, the wheel was not achieved.   The patient requested a subcutaneous dose.  Subcutaneous dose administered without incident.
Patient received vaccine on 6/11/15. On 6/14/15, came back to report severe redness/bumps/swelling and severe pain at injection site and extending to elbow.
Immense pain in right leg. Significant Limping and hopping around, crying and complaining about severe pain. Irritable. Lasted multiple days.  Emailed with pediatrician and waited it out at home.
On Dec 28th I received the shot & initially didn't feel anything. When I woke up on the morning of Dec 29th I had a really bad headache, felt burning up & cold at the same time. My right arm (shot arm) and my left hip were super soar. I couldn't keep liquids down. I passed out the first time between 6:55 A.M. & 7:05 A.M.  Later that morning I passed out a second time for 2 mins. I still plan to get the second dose on Jan 25th 2021. Since I'm a contact tracer I texted my supervisor. I was advised to take the day off & report it just in case  it was related to the vaccine.
ten days before receiving the vaccine I had been diagnosed with strep and was treated for that, On May 18, 2023, I started having a rapid heart. I thought it would go down. Upon trying to stand I felt faint, my husband called the ambulance. On the way to the emergency room, they gave me adenosine to get my heart rate down. Upon arriving at the emergency room, they took my bloodwork, all came back normal. I was sent home with the advice to contact my primary care and cardiologist.