chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Because of the leakage, the patient did not receive a full dose of the vaccination; Syringe leak; vaccine was leaking between the Leur Lock and the syringe; This case was reported by a nurse via sales rep and described the occurrence of accidental underdose in a 55-year-old female patient who received FluLaval Tetra 2020-2021 season (batch number 55R79, expiry date 30th June 2021). This case was associated with a product complaint.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced accidental underdose, syringe leak and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The FluLaval vaccine was leaking between the Leur lock and the syringe, which led to syringe leak and pharmaceutical product complaint. Because of the leakage, the patient did not receive a full dose of the vaccination and the employee would need to be re-vaccinated, which led to accidental underdose. This occurred right before administration. The nurse confirmed that the office was using a 25-gauge needle and there was no damage to the carton evident. The needle was still attached to the syringe and was available for return to GSK. There was no damage or breakage to the syringe barrel. The syringe was pre-assembled with the needle right before administration. GSK to credit their wholesaler account for one dose of the FluLaval Quadrivalent vaccine. The reporter consented to follow up.   Follow up information was received from QA department on 30th November 2020: Conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.  A customer reported a complaint which falls within the following product technical complaint category: PRTC syringe/needle connectivity issue based on the defect description. An investigation has been conducted, including review of the reported defect trends, the returned sample, the retained samples and our production records, which has demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. Additionally, no deviation which could be related to the reported complaint has been identified and all of applicable verifications confirmed the conformity of the batch to specifications. Given the outcome of its investigation, GSK Biologicals considers the complaint that is the object of this report as unsubstantiated.
Information has been received from a registered nurse referring to a 17 month old patient of unknown gender. In November 2014, the patient was vaccinated with the first dose of MMR II and (Oka/Merck) VARIVAX (lot#, dose and route for both products were not reported). On 23-MAR-2015, the patient was vaccinated with MMR II and (Oka/Merck) VARIVAX again. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a physician via a field representative refers to a male patient of unknown age. On 10-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX, refrigerated vial 19400PFU, injection (lot# and route not reported). The physician reports that the patient received ZOSTAVAX at the wrong place on his arm. The patient received the ZOSTAVAX underneath his arm and close to his armpit. The ZOSTAVAX was not administered at the physician's office, it was administered at a pharmacy (location unspecified). On 10-APR-2014, the patient experienced a red welt and itching at the injection site. No product quality complaint (PQC) was reported. The patient was recovering and the welt was much smaller now. Additional information has been requested.
very itchy; her arm their was lump which oval shape; warm to touch; covid arm; red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (covid arm), RASH ERYTHEMATOUS (red rash on arm), PERIPHERAL SWELLING (her arm their was lump which oval shape), FEELING HOT (warm to touch) and PRURITUS (very itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced ADVERSE REACTION (covid arm) and RASH ERYTHEMATOUS (red rash on arm). On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (her arm their was lump which oval shape) and FEELING HOT (warm to touch). On an unknown date, the patient experienced PRURITUS (very itchy). On 10-Feb-2021, RASH ERYTHEMATOUS (red rash on arm) outcome was unknown. On 17-Feb-2021, PERIPHERAL SWELLING (her arm their was lump which oval shape) outcome was unknown. At the time of the report, ADVERSE REACTION (covid arm) and FEELING HOT (warm to touch) outcome was unknown.
Patient states that after a few  days after receiving the shot she had the area swollen. That it became red ,hot and very inflamed as days went by. She states that she has had MRI studies, Doppler studies as well as been on morphine and steroid shots and the pain is still severe and getting worse. They are thinking that she had an allergic reaction to the fluzone hd shot.
Red, swollen area 6x6cm, Left thigh measures 30.5cm. No discharge, pt ambulatory, warm to touch.
Gastritis, severe abdominal pain, depression, bloating, gas, belching, not able to eat normal foods, weight loss.
discs have deteriorated; Difficulty in standing; Eye hemorrhage; arm pain; flu-like symptoms; feeling hot and cold; could not lift arm; whole body shut down/ could barely move/ cannot stand for long periods/ feeling paralyzed; fever; leg problems/ legs feel brittle; burning knee caps; hurts to walk; aches and pain in legs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number YE53N, expiry date 7th November 2021) for prophylaxis.   The patient's past medical history included muscle strain (just finished therapy for a hip strain and she was feeling no pain.), eye disorder and pain. Concurrent medical conditions included joint inflammation. Concomitant products included prednisone.   On 28th August 2019, the patient received Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder, mobility decreased, fever, limb discomfort, burning sensation in joints, pain upon movement and leg pain. On an unknown date, the patient experienced intervertebral disc degeneration, difficulty in standing and eye hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder and fever were recovered/resolved and the outcome of the mobility decreased, limb discomfort, burning sensation in joints, pain upon movement and leg pain were not recovered/not resolved and the outcome of the intervertebral disc degeneration, difficulty in standing and eye hemorrhage were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, feeling hot and cold, movement disorder, mobility decreased, fever, limb discomfort, burning sensation in joints, pain upon movement, leg pain, intervertebral disc degeneration and difficulty in standing to be related to Shingrix. The reporter considered the eye hemorrhage to be unrelated to Shingrix.  Additional details were provided as follows: The patient had visited her internist 3 times and has had her back scanned.  The patient's discs had deteriorated and her blood work showed that her inflammation levels were now normal. The patient had a hemorrhage in her right eye in late November, it was not related to her Shingrix vaccine. The reporter consented to follow up.      Lab Comments: On an unspecified day the patient underwent laboratory tests.
Mild fatigue; Pain at injection site; Pain in nearby muscles of neck; Dull headache; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on unknown date in Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included gestational diabetes and hyperthyroidism from unknown dates. Concomitant medications included methimazole (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. Prior to 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 12Mar2021 at 15:00, the patient experienced mild fatigue, pain at injection site and in nearby muscles of neck and dull headache. The patient reports persisting dull headache into the next week. The patient did not received treatment for reported adverse events. The clinical outcomes of the events fatigue, pain at injection site, pain in nearby muscles of neck and dull headache were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
On 9/16/2021 at 4:07pm patient and parents arrived to drive thru vaccination site requesting Moderna Covid-19 vaccines. After completion of consent forms, the nurse administered Moderna 0.5ml vaccine to patient's left deltoid. Shortly after documenting, the nurse noticed the patient was 17yrs old and had received the Moderna vaccine. The nurse monitored the patient for 20 minutes without any signs of distress, hives, itching, redness or swelling noted. Patient denied pain or discomfort. Parents and patient were made aware that patient received Moderna instead of Pfizer vaccine for her age. Patient was seen by medical provider via telehealth visit on 9/16/21.
SYMPTOMS OF COVID; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and batch number: 211A21A expiry: 14/DEC/2021) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-DEC-2021, the patient experienced expired vaccine administered. On 07-FEB-2022, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On an unspecified date, the patient experienced symptoms of covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the symptoms of covid and expired vaccine administered was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Pt received vaccine and within minutes of receiving the vaccine, pt stated that he had dizziness and felt light headed.  Neuro assessment was performed by reporting nurse and neuro assessment WNL.  Pt started hyper ventilating and pt was advised to slow down his breathing.  Pt continued to complain of feeling dizzy and lightheaded.  Pt had bilateral feet elevated on a chair and bilateral arms raised.  Site was called to the patient and they assessed the patient.  Pt was laid down on the floor and bilateral feet elevated. Pt had a 12 lead ECG performed showed 60 with a run of SVT with rate of 182.  Pt had VS taken initally 80/40, 62, 24. continued treating patient, FSBS was 79.  Pt was advised to go to the ER for further assessment and treatment.   provided O2 2L via , 12 lead ECG monitoring, IV access to right AC, 20g secured with opsite, 0.9% NS bolus of 200ml.  Pt was transported.  Ship staff aware of incident and will f/u with patient status.
Patient describes a feeling of a racing pounding heart. The symptoms started approximately 2 days after receiving the booster dose and have not resolved. Symptoms are worse when patient is laying down at night. Patient is following up with her family doctor in the coming weeks.
PATIENT RECEIVED FIRST COVID VACCINE AND WANTED TO GET HIS SECOND DOSE DURING VACCINE CLINIC OFFERED. PATIENT DID NOT HAVE HIS VACCINE CARD WITH HIM, BUT WAS CERTAIN HE HAD RECEIVED THE PFIZER VACCINE FOR THE FIRST DOSE. HE WAS GIVEN A DOSE OF THE PFIZER VACCINE TODAY AND WHEN WE GOT BACK TO THE CLINIC TO ENTER THE INFORMATION INTO THE EMR, IT WAS DISCOVERED THAT HE HAD THE MODERNA VACCINE FOR THE FIRST DOSE.
Seen in office 1 week after I given with cellulitis left thigh. Upper injection 2cm erythematous, firm, tender. Lower injection erythema, warmth, tender diffuse 5.5x 3 cm. TX'd with Amoxicillin 250 mg BID x 10D. Zyrtec 2.5 mg PHS.
Pt returned for second shot with a raised, light red rash on left arm.  Pt reported that she had developed the rash 2 days after receiving first rabies shot.  Pt denied allergies to any components of the vaccine or bandaids.  Pt was given second shot in the other arm, band aid was removed after 5 mins and the site was sprayed with benedryl.  Pt was advised to take oral benedryl if rash occured.  Rash reappeared at injection site 2 days after shot and was treated with oral benedryl.  It was felt that patient should not receive last rabies shot and will get a titer drawn Oct 13th.
day after shot: syncope, fever, chills, running high BP and has a cold. Following up with PCP.
Stayed in bed all day long; Appetite /no appetite; Headache; Nausea; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Stayed in bed all day long), DECREASED APPETITE (Appetite /no appetite), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Slight fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Stayed in bed all day long), DECREASED APPETITE (Appetite /no appetite), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Slight fever). At the time of the report, FEELING ABNORMAL (Stayed in bed all day long), DECREASED APPETITE (Appetite /no appetite), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Slight fever) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Dizziness, extreme fatigue ,  headache , runny nose.    Dizziness subsided after laying down for an hour. Still having extreme fatigue, stuffy nose, and headache
Chest Palpitations started around 5-7-21.  I saw both my doctor and a cardiologist.  I wore a heart monitor for a week.  The palpitations went away after a few weeks.  My left leg went dead on me on 6-8-21.  It was constantly numb.  I went to the ER on 6-11-21.  They did a CT scan of my spine and said maybe it was my lower back but everything checked out.  I saw my doctor on 6-17-21.  He gave me prednisone and recommended physical therapy.  I saw my chiropractor who had me obtain an xray on 6-18-21.  My left arm and left face went numb.  Both of my legs were really weak and I could barely walk for a few days.  I went to the ER on 6-24-21.  My right leg swelled up, possibly a post blood clot issue.  They completed an MRI on my head and neck that came back normal.  They referred me to a neurologist.  My right leg went numb.  My gluteus went numb on both sides.  All were numb at the same time.  My right hand went number for just a few minutes.  Then, the numbness went away and came back in various areas moving around.  I had an EMG done on 8-3-21 and the results came back normal.  I saw a neurologist on 8-10-21 and they couldn?t find anything wrong.  Currently, my left arm, hand and face are always numb.  I also have visible twitching in muscles all over my body now that I didn?t have before the vaccine.  I don?t know if this is a life threatening or permanent problem.
itchy; sore; swollen; Red pancake circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red pancake circle), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE SWELLING (swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red pancake circle). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE SWELLING (swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red pancake circle) had not resolved and VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator Patient used Allergy cream and Benadryl used as Treatment medication
Day after I experienced fever, chills,  fatigue.  The next day, I got my period.  Then, 6 days after the 2nd shot I experienced severe dizziness, vertigo, almost fainting several times,  tingling in hands and arms, tingling on both sides of face and ears,  some tingling in legs (shin area). Followed by cramping in hands,  inability to move hands or feel with hands for about 15 minutes (I have never experienced this before).  I went to the hospital to get an IV and felt better 30 minutes later.
I have a Nexplanon Birth Control implant. Usually, I only receive my period 3-4 times a year and it is very light. Since getting my second dose of the covid vaccine, my periods have been frequent and heavy. At first, I didn't think much of it. Then, I saw a news segment about other women who were having abnormal period symptoms since getting the vaccine. Then, I began asking my friends and family and most had similar stories. Some had heavier than normal, some more frequent, some more or worse symptoms. I have not experienced any worse or unusual symptoms, but the other two I have. In the news segment, it asked women who may be experiencing similar issues to VAERS. I am happy to do it, and happy to help any further questions. I have also encouraged my family and friends to report their symptoms as well.
The child was vaccinated with the Pfizer-Child Covid-19 vaccine, everything was mixed correctly.  Unfortunately, we missed calculated the 10-week BUD window and gave the vaccine outside the BUD by two days.  Spoke to the child parent.
Friday PM 4/23 flu like all evening, Sat 4/24 woke up as if beaten up severely, weak, could not go down stairs.  Then became to this day one week later at times stabbing pain in back, Confusion, Agitation, Eating Less, Choking, Higher Anxiety and Depression levels, metal fogginess and feeling out of it the entire time.  I was out of work two days (Monday and Wednesday) this week sought Primary help on Wed video visit.
Swollen lips for 24 hours, then hives, fatigue, and esophageal reflux with pain
Pt. received Varicella vaccine 9/28/12 at 830 AM. On 9/29/12 at 1 PM her (R) upper arm developed large (30 mm) hive with heat, swelling and tenderness that lasted approximately 24 hours and resolved w/ BENADRYL and ice pack. H/O varicella as child but no documented proof from MD.
PAIN IN BOTH FOREARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain in both forearm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in both forearm. This report was non-serious.
knot at right neck; Pain at injection, right arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (knot at right neck) and VACCINATION SITE PAIN (Pain at injection, right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection, right arm). On 20-Jan-2021, the patient experienced NECK MASS (knot at right neck). The patient was treated with Physical therapy (heating pad) for Neck mass and Physical therapy (heating pad) for Vaccination site pain. At the time of the report, NECK MASS (knot at right neck) and VACCINATION SITE PAIN (Pain at injection, right arm) outcome was unknown.            Treatment included physical therapy-heating pad   This case was linked to MOD-2021-120543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: patient contact details has been updated. a new event and outcome of the event has been updated based on initial source document.
4/25/05 Imm given, 4/27. Rec call from mom states 3" hour glass shape on RA is red and hot, started yesterday. Child feels find, no fever. 4/28 area not as red. 4/29 area pink. 5/2 area normal, no redness.
Deltoid sore for 6 weeks. Pain with movement. No swelling, redness or warmth.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, Lot # K016314 and expiry date on 05-JUN-2017 (one dose administered), and Lot # L010126, expiry date on 22-JAN-2017 (three doses administered), (dose and route of administration were not provided). No adverse events were reported.
After patient received the flu vaccine she went to the checkout window at our office and after approx. 2 minutes she reported to the receptionist that she didn't feel well. We immediately sat her down in a chair on the spot and attempted to speak to her. She was unresponsive for 1 minute and then started slowly to respond to us. We wheeled her to an exam room and did vital signs and blood sugar as she stated that she hadn't eaten breakfast and it was about 9:30am. Blood sugar was 101. VS wnl. Pt was cold and clammy. It took her about 10 minutes before she was able to say she was feeling better. Was seen by her Provider and cleared to leave. Advised to return to clinic PRN.