chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Pharmacist concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. It was reported that Pharmacist's colleague accidentally administered both doses into a single nostril in 4 children approximately 2 weeks ago. The outcome of the event of ACCIDENTALLY ADMINISTERED BOTH DOSES INTO A SINGLE NOSTRIL IN 4 CHILDREN is unknown. The report was considered to be non-serious.
no redness, c/o weakness, pain lt arm up to shoulder;weak grip strength lt hand;c/o knot on arm-no erythema or lesions;
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
Blood sugars were elevated. Average blood sugar readings are 130 and lower. They were running 200-302 for most of the 4 days following the injection.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes (controlled) from an unspecified date. Concomitant medications included metformin (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:00 the patient experienced blood sugars were elevated. Average blood sugar readings were 130 and lower. They were running 200-302 (UNITS UNSPECIFIED) for most of the 4 days following the injection. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Blood sugar increased was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Lymph notes all over my body are inflamed and tiredness (started  3/20/21 - the day after I received injection), and now COVID-arm (bruise at injection site, rash, pain) this started 3/22/21.
fatigue; joint pain; muscle pain; Unable to sleep; Sore left arm/ injection ste pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. In September 2019, the patient experienced fatigue, joint pain, muscle pain and sleeplessness. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the fatigue, joint pain, muscle pain and sleeplessness were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, joint pain, muscle pain and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient same day after receiving vaccine experienced pain at the injection site with sore left arm which resolved in three days. The patient also experienced fatigue, muscle pain and joint pain. For the muscle pain and join pain, the patient was taking ibuprofen which was not helping her much and she was unable to sleep because of that. On the day of reporting the joint pain was localized to both her hips and both the knees. The patient consented to follow up.
Eight days following vaccine, large localized cellulitis type reaction. Gradually increased in size of 2 in diameter to 6.5 in diameter over 72 hours. Painful, red, hot to touch, and hard. Keflex and steroids given which subsided pain and hardness. Still red and warm to touch on day 15.
migraine; This is a spontaneous report received by Pfizer from the company (Case ID: GI-2021-2655). A contactable consumer reported for a female patient (wife) who received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation; eletriptan hbr (RELPAX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced migraine (non-serious) on an unspecified date with outcome of unknown.  The action taken in response to the event( for eletriptan hbr was unknown.   No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
No ADR noted.  RN noticed after the administration that the High-dose Fluzone was given instead of the standard Fluzone vaccine.  Per phone conversation with parent after this was discovered "Patient's mother stated that the her son is doing well and has had no reaction to the flu shot. " on 1/24/2020
severe numbness in his right arm; tingling sensation that runs down his arm; feels debilitating; a cyst became inflamed; a cyst became inflamed; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (severe numbness in his right arm), PARAESTHESIA (tingling sensation that runs down his arm), FEELING ABNORMAL (feels debilitating), INFLAMMATION (a cyst became inflamed) and CHEST WALL CYST (a cyst became inflamed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Chest wall cyst.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (severe numbness in his right arm), PARAESTHESIA (tingling sensation that runs down his arm), FEELING ABNORMAL (feels debilitating), INFLAMMATION (a cyst became inflamed) and CHEST WALL CYST (a cyst became inflamed). At the time of the report, HYPOAESTHESIA (severe numbness in his right arm), PARAESTHESIA (tingling sensation that runs down his arm) and FEELING ABNORMAL (feels debilitating) outcome was unknown and INFLAMMATION (a cyst became inflamed) and CHEST WALL CYST (a cyst became inflamed) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication use was reported. The second thing is he has a cyst on his chest that he's had for 4 years, but it became inflamed after the vaccination. It was acting up pretty severely that he went to his doctor who said it was from the vaccine. His doctor had to cut and drain the cyst and it seems fine now.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 76 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Jun2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Poly chondritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Drug allergy: Codine".The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.
** 31 weeks. Due date- April 6,2021, first child** I got the shot in the afternoon . The next day I was standing at my standing desk and started to feel light headed, and sat down and became ore light headed. My vison started to gray out,  my arms were tingling and my ears were ringing.  That lasted for a few minutes, it slowly got worse to the point where I thought I was going to faint, then slowly got better.  I spoke to my midwife about this, I was unsure if it was the vaccine or the pregnancy.  I've never had this happen before. My midwife thought it was a Blood drop from eating then standing up right away.
pt states that shortly p/shot began to ache all over & felt bad; tingling sensation in arm immed p/shot was given; had flu-like sx; felt very weak;
This spontaneous report as received from a pharmacist refers to a 88 year old female patient. The patient had no pertinent medical history, no drug reactions or allergies. In 2006 (reported as about eight years ago), the patient was vaccinated with the dose of PNEUMOVAX23 (dose and lot number were not reported)(indication reported as vaccination). The patient did not use any concomitant medications. On an unknown date in July 2014 (reported as recently) the patient experienced unspecified respiratory issues. No treatment was given for the event. Lab diagnostics studies were not preformed. The outcome of unspecified respiratory issues was reported as not recovered/not resolved. The relatedness between the event between the event and the PNEUMOVAX23 was not reported. Additional information has been requested.
swelling in feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in feet".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness at the injection site; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix. On 2nd December 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of the Shingrix vaccine and experienced pain at the injection site. The patient still had redness at the injection site which was over 4 inches in length. Did not consent to follow-up.
HPV vaccine administered in error to patient who is too young by contract nurse.  No adverse symptoms noted, but vaccine is contraindicated due to age.   Merck had no advice as no studies have been done on this age group.  Poison control also said they could not help and recommended contacting a pharmacist.  Presumably a pharmacist is not going to have any further insight since they do not typically administer these vaccines.  Patient seen by PCP in office today. Mom informed and educated on signs/symptoms to monitor for.
pt recv vax;devel n, lightheadedness & dizziness; 4jan94 recv vax & devel n, lightheadedness & dizziness;
About 3 days after the 2nd dose vaccine, I started to notice pain when moving my right shoulder.   I ignored it for a few months and have notice the pain has increased.   I did go see my doctor.   They did order an MRI.  The doctor says the muscles around the tendon is inflammed and causing my pain.  The doctor did give me epidural shots directly to my neck to help with my pain.   I am also in physical therapy which has helped.  I was also prescribed Diclofenac for the pain.   I am still having pain and weakness in my right arm  and the pain is 7/10.   There are times where I can not hold or carry heavy items.
Loss of sensation & motor function of arms & legs; pt fell occurred on 2 occasions 11APR91 & 7JAN91; also had ptosis of lt eyelid;
8/14/07 Received DTaP, IPV left arm, Varicella right arm. 8/15 Redness, swelling upper left arm, by evening scant blisters. 8/16 > blisters, > redness, swelling and tenderness. No fever. A early cellulitis. Rx Cephalexin.
This spontaneous report as received from a pharmacist regarding to a 60 year old female patient. Patient's current condition included high blood pressure. On 23-FEB-2015, the patient was vaccinated with ZOSTAVAX (lot # K011002, Expiry: 07-NOV-2015) (dose and route was unknown). Concomitant medication included unspecified flu vaccine on 20-JAN-2015. On 25-FEB-2015 (also reported as today) the patient experienced a raised, red, 2 inch by 2 inch, rash around the injection site. No treatment was received. Patient sought medical attention, called to the pharmacy. No product quality complaint was involved. The outcome of the events was reported as not recovered. The reporter causality was not provided. No further information was provided. Additional information has been requested.
Information has been received from a physician concerning a 19 female patient who on 12-JUN-2009 was vaccinated with the second 0.5ml dose of GARDASIL (lot number, route and site not reported). Subsequently, the patient experienced seizure after getting second dose of GARDASIL. The patient had sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. The patient did not have any adverse event from the first dose of GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Covid breakthrough case. May 6 was the dinner rehearsal. May 10, the people at the wedding started showing symptoms and they contacted us in May 11. Base off the information from everyone around on May 12 my husband tested and it was positive so I did and I was negative. The 13th we decided to go to urgent care because I had itchy throat and headache. The did a rapid test and PCR on the 13 both came back negative. The Dr. instructed me to follow the same isolation instructions as my husbands because I was around him. Sunday May 15 I started taking Nyquil, dry cough, fatigue, congestion. May 16 I tested positive home test. Overnight I wasn't getting any better they wanted me to see someone within 24 hours. May 17, fever 98.4 took Tylenol which broke my fever came with chills. I felt stuffy and I feel like the symptoms are getting worse. Virtual appointment, Sudafed and benzonatate.
Information has been received from a nurse, via a mother of a consumer, concerning a 6 year old male, with unknown medical history and no known drug reactions/allergies reported, who on 16-NOV-2000 was vaccinated (route unknown) with a dose of Varivax (Lot # unknown). The patient was treated with acetaminophen (TYLENOL) and calamine lotion. The nurse reported that she received a call from the patient's mother. The mother stated that her son has "breakthrough chicken pox". The patient received varicella virus vaccine at another institution on 16-NOV-2000. It was reported that on 26-MAY-2006 the patient started with a fever and spots appearing on Saturday (27-MAY-2006). The spots appeared in scalp and generalized rash on body. The patient's mother would not bring the patient to the office for an examination. The amount and extent of spots were not reported. No product quality complaint was involved. Additional information is not expected.
Initial information has been received from a medical assistant and follow-up information was received from the patient's mother concerning a 11 year old white female who on 14-JUL-2008 at 3:30 PM was inadvertently vaccinated subcutaneously with a dose of ZOSTAVAX into the left deltoid instead of VARIVAX because of a medication error. No adverse symptoms were reported. It was unknown if the patient sought medical attention or not. Follow-up information was received from the office manager stating this was a case of human error. Both vaccines were on the same shelf and the nurse accidentally picked up the wrong vial. The office has since started a practice where 2 people will verify the vaccine that is being drawn up and given. There were no suggestions for labeling, storage conditions, etc. She felt it was human error not a problem with the vials themselves. Additional information is not expected.
HCP reported RECOMBIVAX HB was administered to a patient on 09DEC2022 after the expiry date of 21NOV2022. No additional AE or PQC reported. No additional information provided.; HCP reported RECOMBIVAX HB was administered to a patient on 09DEC2022 after the expiry date of 21NOV2022. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 09-DEC-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number U005271, with an expiration date of 21-NOV-2022) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Received 3rd shot instead of booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received 3rd shot instead of booster) in a patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Received 3rd shot instead of booster). At the time of the report, OFF LABEL USE (Received 3rd shot instead of booster) had resolved.            No concomitant medication were reported. No treatment information was provided by the reporter.  The patient was not immunocompromised and received third full dose.
Pericarditis; Chest pain; This case was received via FDA VAERS (Reference number: 1391592) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM GENERIC), SILDENAFIL, VARENICLINE TARTRATE (CHANTIX), ZOLPIDEM TARTRATE (ZOLPIDEM TARTATE) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant) and CHEST PAIN (Chest pain). The patient was treated with IBUPROFEN on 10-May-2021 at a dose of 600 mg three times a day and COLCHICINE (MITIGARE) at a dose of .6 mg twice a day. At the time of the report, PERICARDITIS (Pericarditis) and CHEST PAIN (Chest pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; 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.
This spontaneous report was received from a healthcare worker refers to unspecified number of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L030872, expiry date: 11-JUN-2018). Healthcare worker reported that the vaccine underwent temperature excursion at 34 degree Fahrenheit for 72 hours. There were no previous excursions. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
In the evening post vaccination, my arm became sore and then at about 8P.M. I began to have chills. The next day the chills got worse, my arm became very red and the injection site became inflamed and very hard. The chills went away after the second day however, the arm continued with being sore, and after a week it tapered off. The swelling also reduced. I am no longer experiencing anymore symptoms.
Pt states arm of injection site is sore next day and still sore today, she also has a headache. Counsel on placing cold compress to area and take TYLENOL for pain and headache. Soreness has subsided.