chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLEEDING; HEMATOMA; BUMP AT INJECTION SITE; SWELLING; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm. No concomitant medications were reported. On 13-MAR-2021, the subject experienced bleeding. On 13-MAR-2021, the subject experienced hematoma. On 13-MAR-2021, the subject experienced bump at injection site. On 13-MAR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding on MAR-2021, was recovering from swelling, had not recovered from bump at injection site, and the outcome of hematoma was not reported. This report was non-serious.   Additional information was received on 23-Mar-2021. The following information was updated and incorporated into the case narrative: Patient's sex .; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Severe back, knee and hip pain; Severe back, knee and hip pain; Severe back, knee and hip pain; Muscle stiffness; Slowed mobility; This is a spontaneous report from a contactable pharmacist (patient). A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 07Aug2021 (at the age of 37-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Facility type vaccine was Pharmacy or Drug Store. The patient medical history was not reported. No other vaccine in four weeks. There were no concomitant medications. No covid prior vaccination and covid was not tested post vaccination. The patient experienced severe back, knee and hip pain, muscle stiffness, slowed mobility on 14Aug2021. AE resulted in none of the above (unspecified details). No treatment was received for the events. Clinical outcome of events was not recovered.  Information about lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
2 "flu shots" within a week; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number E9R44, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA SHOT.   On 11th October 2021, the patient received the 2nd dose of FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device and an unknown time after receiving INFLUENZA SHOT, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that, the patient had received 2 flu shots within a week, which led to an extra dose administered. It was reported that 1st dose was given on 4th October 2021 on pharmacy and they were not sure of the brand name of the vaccine The lot number for the 1st dose was 30847 with expiry date 30th June 2022 and 2nd dose was given today at the time of reporting at their facility.  The health care professional reported that, the vaccine administered was Flulaval QIV The reporter consented to follow up.
This spontaneous case, initially received from other health professional (nurse) on 13-Feb-2018, concerning a 21-year-old, adult female pregnant patient. On 13-Feb-2018, the pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195235, expiry date: 31-May-2018). It was reported that, the patient did not experience any adverse effects. The reporter considered the event, vaccine exposure during pregnancy as non-serious. Significant follow up received on 27-Mar-2018: This case was considered as lost to follow up. Hence, no amendment was done in the narrative.
2/19/03 Fever, vomiting, chills, bodyaches. Tx - rest off work x 1 day. Ice daily 10 mins 4 x.
No adverse effect; A patient was administered with improperly stored PROQUAD; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 01-OCT-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection (lot # S003170, expiry date: 30-JUL-2020) (dose, frequency and route were not reported) for prophylaxis.  The vaccine was stored at a temperature of 6 degree Fahrenheit (F) to 14 F (13.8 F) for 9 hours. There was previous temperature excursion reported 6 F to 14 F (5.5 F) for 2 hours. A digital data logger was not involved. No adverse effects were reported. No product quality complaint was involved.
Nausea; Pain at injection site; Swelling at injection site; Fluid build up under the injection site; Fever; lethargic; Unable to bare weight on leg; hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE SWELLING (Swelling at injection site), VACCINATION SITE EXTRAVASATION (Fluid build up under the injection site) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE SWELLING (Swelling at injection site), VACCINATION SITE EXTRAVASATION (Fluid build up under the injection site), PYREXIA (Fever), LETHARGY (lethargic), LIMB DISCOMFORT (Unable to bare weight on leg) and VACCINATION SITE WARMTH (hot to touch). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, NAUSEA (Nausea), INJECTION SITE PAIN (Pain at injection site), INJECTION SITE SWELLING (Swelling at injection site), VACCINATION SITE EXTRAVASATION (Fluid build up under the injection site), PYREXIA (Fever), LETHARGY (lethargic), LIMB DISCOMFORT (Unable to bare weight on leg) and VACCINATION SITE WARMTH (hot to touch) had resolved.            Concomitant medications were not provided by reporter.   This case was linked to MOD-2021-028332 (Patient Link).
Information has been received from a physician concerning a female over the age of 65 who on Sept 20 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). ON Sept 20 2004 the patient developed in injection site reaction. The reaction was described as red swollen arm from elbow to shoulder and a hot feverish arm. The patient also experienced body aches and chills. The patients events persisted. No treatment was given for the reaction. It was reported that this was the patients second pneumococcal 23v polysaccharide vaccine. The patients first vaccination has been at least 5 years previously and there had been no reaction to that vaccination. The physician reported that since this is the fifth reaction the practice has had in the past few months he would like an investigation in the the lot 0371P. The physician also reported that another patient had the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P) (WAES0409USA01988). The physician also reported that 3 other patients had reactions after vaccination with pneumococcal 23v polysaccharide vaccine (lot 648139/0009P) (WAES0409USA00219, WAES0409USA00780). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. the lot complies with the standards of the Center for Biologics Evaluation and Research was released. Additional information is not expected.
pt brought to ED for evaluation of a fall at home; pt found to have a new onset of A Fib; COVID pneumonia; DNR/DNI; pt was dc'd to in-hospital hospice care; pt died in hospice
Had covid in April 2020, which among other symptoms resulted in night sweats for weeks. After this vaccine had body aches, chills and low grade fever that lasted for 2-3 days and then resolved.  I am still having persistent night almost 4 weeks later.
Pt recv vax on 3/25/99; on 3/26/99 pt exp swollen/ red rt leg; tx=Benadryl
fatigue; fever; flu like symptoms; aches; dizziness; shaking; out of balance; swollen both arms; like internal tremors; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms.  The patient's medical history was not provided. Concomitant medications reported were Rosuvastatin, Omeprazole, Vitamin D3, Vitamin C, COQ10, Aspirin for drug use for unknown indication.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A)  unknown route for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events,fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms.  Treatment details  was not included.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, fever, flu like symptoms, aches, fatigue, dizziness, out of balance, shaking, like internal tremors, swollen both arms was unknown.
Rash with itching; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash pruritic (received 1st dose on 14th August 2019).   On 6th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced itchy rash. The patient was treated with dermatologicals nos (Ointment) and prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient is the retired pharmacist. The patient received a dose of Shingrix on his right arm. The patient experienced rash with itching. The patient stated that the physician started the patient on an ointment for the rash which did not help. The patient was prescribed another tapering dose of prednisone for the rash with itching. Additional information not provided. The patient consented to follow up. This case has been linked with case US2019205756, reported by the same reporter.
Bilateral high-pitched tinnitus, beginning shortly after administration of second dose. Persistent for the past 10 months.
COVID arm - a big red area, size of palm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (COVID arm - a big red area, size of palm at injection site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID arm - a big red area, size of palm at injection site). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (COVID arm - a big red area, size of palm at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Pt with erythematous, blanching maculopapular rash to torso, back, and thighs no vesicles.
1213PM pt recv vax & became lightheaded felt vagal rxn placed in superior position;BP 126/68, P88;
Shortly after receiving the vaccine client experienced fever, chills, sore arm, aching joints, backache, blood spotting after blowing nose. 4-5 days after he had redness and itching at injection site and generalized swelling on arm where vaccine was given. Also had decreased arm movement.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, 3 days after receiving SHINGRIX, the patient experienced itchy rash. On 21st December 2018, the patient experienced muscle pain, injection site erythema and injection site pain. On an unknown date, the outcome of the muscle pain, injection site erythema and injection site pain were recovered/resolved and the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the muscle pain, injection site erythema, injection site pain and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The next day after vaccination, the patient experienced redness and soreness at injection site along with muscle ache which lasted for total of 2 to 3 days. After 3 days post vaccination, the patient noticed  a rash which was 2 inches in diameter on his right wrist. The rash then increased to 6 to 8 inch of area on both arms which started oozing and became itchy. The rash had started to decrease but it was not completely gone. The patient contacted his doctor via phone in regards to the rash that he experienced. The reporter consented to follow up.
Around two weeks after getting dose 5 I started to have swelling at the injection area. I contacted my doctor and she stated to continue with ice and massage injection area. It took the swelling about 5 days from the time I contacted my doctor for the swelling to go down.
Redness at and surrounding Rt arm injection site. (Approx 5cm). No increased edema, warmth or itching noted. Cool compress applied to site. Instructed to apply cool compress for the next several days. Instructed to give BENADRYL prn if needed for hives, itching. Seek medical attention immediately if breathing difficult occurs. 11 AM spoke with mother who stated redness was resolving.
At 0945 flushing, nausea with dry heaves, cool cloth and ice applies to back of neck, turn fan on gave sierra mist after nausea past, sat for 10-15 minutes, felt better and left 1245 called location red, flushed again.  145pm contacted by location personnel "client fell bashed head and taken to hospital emergency room".
Mom reports redness and hardness at injection site (Right arm, SQ). Provider seen, suggested BENADRYL ointment and BENADRYL PO, per mother. 8/23/13.
Headache, Myalgia, reported redness at injection site Narrative:  reports redness @ injection site still  present. Other symptoms has resovlved.
A report has been received from a Health Professional concerning a 8 year old, Male subject, who had been received Nasal FLUMIST. FLUMIST started no 30-Jan-2014. The patient received inadvertently expired FLUMIST which started on 30-Jan-2014. The outcome of the event of expired FLUMIST administered is unknown. The report was considered to be non-serious by the reporter.
I received an intramuscular injection of the Pfizer vaccine.  Following vaccination, I developed severe swelling  of my right deltoid, pain in my right shoulder, and neuropathy extending into my right hand.  For 9 months, I was unable to elevate my right arm without extreme pain. Although these symptoms have improved, my right should now has severe damage and requires joint replacement. I am left handed and have no arthritis in my left arm whatsover. As a physician, I am now partially disabled.
I went to the Opera hours after receiving the vaccination (standing room) and after an hour of the show I could barely stand. And all the rough the next two days I suffered from sweats, chills, aches body, cramps in my muscles especially arms and hands, and I had a swollen gland type pain in my left armpit.
Screaming pt up to 36 hrs uncontrollably, on and off. Pt vomited several times in a 24 hour period and some diarrhea.
Flu; fever; chills; diarrhea; headache; major dizziness and nausea inner ear problems, diagnosed as UVH. Can't walk without walker, can't drive; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 24Mar2021 at 18:00 (lot number: EN6199 and expiration date: Jun2021) as single dose for covid-19 immunisation. Medical history included high blood pressure, previous stroke, spinal stenosis, and heartbeat issue. The patient is not pregnant at the time of report and at the time of vaccination. The patient has not had COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications included metoprolol; rosuvastatin; montelukast sodium (MONTELUCAST); and fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient did not receive other vaccine in four weeks. The patient experienced flu with fever, chills, diarrhea, and headache on 06Apr2021 at 19:00. Within 2 weeks (Apr2021), major dizziness and nausea inner ear problems, diagnosed as UVH (Unilateral Vestibular Hypofunction). Can't walk without walker, can't drive. The patient did not receive treatment for the events. Outcome of the events was not recovered. The events resulted in visit at emergency room/department or urgent care, and hospitalization for 2 days.
This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # were not reported). On an unknown date, the patient experienced neuropathy peripheral and a breakout. The pharmacist did not clarify the type of neuropathy or the type of breakout the patient experienced. Patient sought medical attention. Action taken was not applicable. The outcome of neuropathy peripheral and a breakout was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Patient(s) were given dose(s) from vial(s) that were stored in an ultracold freezer which is colder; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and EXPIRED PRODUCT ADMINISTERED (Patient(s) were given dose(s) from vial(s) that were stored in an ultracold freezer which is colder) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:47 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:47 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and EXPIRED PRODUCT ADMINISTERED (Patient(s) were given dose(s) from vial(s) that were stored in an ultracold freezer which is colder). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F), PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and EXPIRED PRODUCT ADMINISTERED (Patient(s) were given dose(s) from vial(s) that were stored in an ultracold freezer which is colder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.
Information has been received from a physician concerning a 19 year old female who on 30-MAY-2007 was vaccinated with Gardasil (lot # unknown). Five minutes after receiving Gardasil the patient got up to go to the bathroom, she became dizzy and passed out. She had full recovery within five minutes. The patient did not require any hospitalization and did not have any complications. Additional information has been requested.
Patient was incorrectly administered the Pfizer Bivalent Booster instead of the first Pfizer (non-bivalent) vaccine
pt recvd vax & aprox 2 1/2 hrs later devel swelling & purple knot under skin @ site of inject; mom also reports crying & taken to ER 830PM;
next day p/vax pt had 1 episode of stiffness, fixed stare, redness of entire body, apnea;episodes lasted about 5mins;p/episode pt remained hypoactive;afterwards pt presented a total of 5 episodes of sz;
1st dose on 11 Oct 2020 not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10 November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 11 Oct 2020 not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-MAY-2023 The reporter enquired could he received the 2nd dose now. Minimal information obtained to file adverse event. Consent not asked. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Severe headache started within 6 hrs. of injection. Had a slight rise in temperature to 99.9. Very sleepy and tired. Muscle aches in legs and buttocks. Slight nausea. Took  extra strength Tylenol. Slept off and on for next 24 hours. Had severe sweats and chills.  All symptoms were just like I had had early December, 2020 when I had COVID, as per verified by a COVID nasal test done at local hospital.