chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ended up in the hospital for 9 days; She mentions coughing and being winded recently; She mentions coughing and being winded recently; This case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 70-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for product used for unknown indication and fluticasone fur+umeclidinium+vilanterol ellipta dry powder inhaler device (Trelegy Ellipta Dry Powder Inhaler Device) inhaler (batch number Unk, expiry date unknown) for product used for unknown indication.   Concurrent medical conditions included asthma (patient was a long time user of inhaler and had a history of asthma). Concomitant products included montelukast sodium (Singulair) and levosalbutamol hydrochloride (Xopenex).   On an unknown date, the patient received Flu vaccine, Trelegy Ellipta (inhaled) 1 puff(s) once daily (1 puff(s) daily) and Trelegy Ellipta Dry Powder Inhaler Device. On an unknown date, unknown after receiving Flu vaccine, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device, the patient experienced hospitalization (serious criteria hospitalization), cough and breathlessness. Trelegy Ellipta was continued with no change. On an unknown date, the outcome of the hospitalization, cough and breathlessness were unknown.   It was unknown if the reporter considered the hospitalization, cough and breathlessness to be related to Flu vaccine, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's comments: The reporter reported that she was a long-time user of inhaler. She stated that she was on singulair and xopenex as well and has a history of asthma. She stated that she had received a flu shot over 5 years ago from reporting and ended up in the hospital for 9 days after getting vaccine.  She did not remember if she was on TRELEGY at that time.  She mentioned of having coughing and being winded recently.  The reporter had consented to follow-up. Additional supportive information: The time taken to onset for event - cough and breathlessness was conservatively captured as more than 2 years.
Mom states on 8/7/02 pt developed swelling around site of injection L  area. Pt received DTaP/IPV.
Patient received vaccine on 4/13/21 and started to feel COVID19-like symptoms on 4/15. Patient experienced chills, aches, "tickle in the throat," etc. Patient had been exposed to someone that tested positive. Went to urgent care, was not tested for COVID19- urgent care stated it was allergies and prescribed a Z-pak. Patient took an at home rapid test on 4/16 and tested positive for COVID19. Patient quarantined for 2 weeks and received second vaccine dose on 5/10/21.
This spontaneous report was received from a medical assistant, referring to a 12 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 07-JUN-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1806USA012318: US-009507513-1806USA005053: US-009507513-1806USA012319: US-009507513-1806USA012316.
A nurse reported that on 13-NOV-2002, a 55-year-old female received injections of Flu-Shield (2002-2003 Formula) and PneumoVax 23 (MSD) vaccines.  On 14-NOV-2002, she developed a fever of 103 deg. F.  She experienced fever following receipt of Flu-Shield (2002-2002 Formula) lot 4020024.
Diarrhea - lasting c. 8 hours No unusual foods were eaten, the effect cleared up completely within 24 hrs. I?m attributing it to the vaccine (without complaint), but it is a guess. So grateful for the opportunity to receive the vaccine.
headache it aches very pain; headache it aches very pain; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 08Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache it aches very pain. It was reported by the patient that "The patient had the second vaccine on the 8th of February and now the (inaudible) was ok but headache it aches very pain. Explained how took 3 pills of Tylenol a day but still had headache". Therapeutic measures were taken as a result of headache it aches very pain, treatment received with 3 pills of Tylenol a day. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
at 1640 patient stated he felt tachycardic, VS were 120 hr bp 155/96, O2 was 100%. Patient stated he felt light headed and dizzy, patient was given water, feet elevated. at 1500 VS were 155/97, hr 76, and oxygen saturation was 100%. Patient stated he was feeling a bit better and wanted to walk around and left the room.
15 minutes after shot, rash on torso (front and back) and neck, red flush on face.  Seen at County site by EMT for 1 hour.  No SOB, alert.  Rash lessened after 1 hour, dissipated entirely after 3 hours.  Patient advised to contact PCP and not to have second dose.  PCP notified 2/24/2021,  reiterated not to take second dose.
Information has been received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. No relevant medical history was provided. Since 12-MAR-2015 these patients were vaccinated with 12 doses of VARIVAX (Merck) (dose and route not reported) which were improperly stored. No adverse events were reported. This is one of two cases received from the same reporter. Additional information has been requested.
Patient adverse events and reactions the following: Breakout in rashes, hives and wheals all of his body. He had to be injected with two epipens and other meds to avoid anaphylaxis shock. Patient has an abnormal heart rate and gets monitored weekly on the effects of the shot. Breakout in rashes, hives, wheals, and have fast/pounding heartbeat daily.
Temp 103 deep hip joint, back joint, neck pain, couldn't mpve legs without pain, bend  in hip or get comfortable all night. Tender skin, pain wash head to foot. Extreme weakness, couldn't sit up; exhaustive trying to, could not walk without stagger, needed help. Heavy hydro sweat when fever broke 3 am Oct. 3rd. Felt better, left side occipital neuralgia pain began strikes to every 4-5 seconds for hours on a pain level to 10 Oct. 4 Gabapentin 1200mg a day breakthrough. Oct.6 relief. Still tender inflammation Reduce to 300 mg. gabapentin. Aleve, naproxen and ibuprofen. Exhaustive.
This case was reported by a consumer via call center representative and described the occurrence of red blotches in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 1st dose of SHINGRIX. On 6th August 2018, 3 days after receiving SHINGRIX, the patient experienced red blotches and itchy rash. On an unknown date, the outcome of the red blotches and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the red blotches and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced red, itchy blotches covering her upper left arm. At the time of this report, the red, itchy blotches were better but not completely gone. The patient had denied permission to contact their physician. The reporter did not agree to be followed up.
Patient states when she got home she took off the band-aid and noticed a small red spot that she was not concerned about. Then on 12/26/18 at 7pm she noticed the spot was larger. Patient went to doctor on 12/28/18 in the AM. Patient presented to clinic to find out what vaccine she received in that arm. The site is warm to touch(right arm) has a darker red area that gets lighter as the area spreads creating a bulls eye effect. No visible blisters or rash notes. Patient denies blisters or rash. Patient was given a prescription for triamcinolone cream from the doctor. Patient denies SOB. Patient instructed to be aware of the site and monitor for blisters, if blisters were to occur she would be contagious and need to stay away from anyone immunocompromised, pregnant or anyone who has not had vaccine. Patient states she was only around a 5 month old on day of vaccine.
PRESSURE HEADACHE (POTENTIALLY SINUS HEADACHE); BODY ACHES; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 14-APR-2021, the subject experienced sinus headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and had not recovered from sinus headache. This report was non-serious.
PATIENT RECEIVED THE ADMINISTRATION ON 9-11-18 AT 11AM. ON THE MORNING OF 9/13/18 THE PATIENT CAME INTO THE PHARMACY AND REPORTED THAT THE INJECTION SITE AREA WAS RED AND WARM TO THE TOUCH. PHARMACIST VERIFIED THE REPORT OF THE PATIENT AND THE AREA WAS RED AND WARM TO THE TOUCH. THE AREA OF INVOLVEMENT WAS ROUGHLY 4-5 INCHES IN LENGTH AND WIDTH
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergy. Concomitant medication(s) included: SYNTHROID, start date: 15Sep2012, stop date: 06Aug2023; OMEPRAZOLE, start date: 12Feb2022, stop date: 06Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included paxlovid from 22Jul2023-26Jul2023, and had bitter taste rebound after testing negative.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Pt experienced swelling to the right thigh to knee, fever of 102. Dx with allergic reaction.
At the site of injection red streaks appeared on Sunday following a Friday night injection.  By Monday they streaks had combined into one round area that is approximately 3.5-4 inches in diameter. They area is extremely painful like a bruise, red, hot and itchy.
The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022; No Adverse Event; expired Moderna Covid-19 Vaccine was given to 5; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine was given to 5), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine was given to 5). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine was given to 5), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine was given to 5) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022).    No concomitant medications was reported.  It was reported that reporter called in to report that an expired Moderna Covid-19 Vaccine was given to 5 Pediatric patients ages 6 months and older. Vaccine was given on 05 Nov 2022 around morning time. No adverse event reported from any of the patients . Affected vials were individual ones with size of 2.5 ml.  Vial was initially stored in the refrigerator on 29 Sept 2022 and did not undergo temperature excursions.  No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669845, US-MODERNATX, INC.-MOD-2022-669841, US-MODERNATX, INC.-MOD-2022-669846, US-MODERNATX, INC.-MOD-2022-669847 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669845:Same reporter US-MODERNATX, INC.-MOD-2022-669841:Same reporter US-MODERNATX, INC.-MOD-2022-669846:Same reporter US-MODERNATX, INC.-MOD-2022-669847:Same reporter
My daughter was given the vaccine prior to being 6 months which is against the CDC dosing.
A day after vaccination, my daughter started experiencing random mild involuntary jerking.  Mainly her left arm.  It lasted about 2 weeks.
This case was received on 01 May 2009, via another manufacturer (document number 956545). The event occurred to a subject enrolled in a study. A child received a diphtheria/tetanus toxoids/acellular pertussis vaccine (manufacturer and lot not reported), and experienced severe edema/swelling/induration during study week 4. The reporter assessed the event as definitely related to the vaccine. The subject also experienced another serious adverse event while enrolled in this study, which is captured in case number 2009-01941.
Hives within 5 hours. No respiratory distress. Prescribed Benadryl.
ATIENT RECEIVER HER IMMUNIZATION ON 9-28-20 AND HER ARM BEGAN TO HURT THAT SAME DAY. SHE SAID IT WAS GIVEN HIGH ON THE ARM BUT A KNOT FORMED APPROXIMATELY 4 OR 5 INCHES FROM SHOULDER. IT ALSO WAS HOT TO THE TOUCH. I WAS INFORMED TODAY THAT SHE CAN NOT RAISE HER ARM. WE TOLD HER TO GO TO HER PCP IF SHE HAS ONE OTHERWISE GO TO AN URGENT CARE CENTER.
Rash- confluent red rash on face and flat macular rash on rest of body.
This case was reported by a consumer and described the occurrence of injection site erythema in a 3-month-old female patient who received PEDIARIX. Concomitant products included Hib vaccine and rotavirus vaccine. On 2nd November 2014 12:00, the patient received the 1st dose of PEDIARIX. On 2nd November 2014 12:00, an unknown time after receiving PEDIARIX, the patient experienced injection site erythema. On 3rd November 2014, the patient experienced blotchy rash. On an unknown date, the patient experienced skin texture abnormal and fever. The patient was treated with TYLENOL. On 2nd November 2014, the outcome of the injection site erythema was recovered/resolved. On 5th November 2014, the outcome of the blotchy rash was recovered/resolved. On an unknown date, the outcome of the skin texture abnormal was not recovered/not resolved and the outcome of the event was recovered/resolved. It was unknown if the reporter considered the injection site erythema, blotchy rash,  skin texture abnormal and fever to be related to PEDIARIX. Additional information received: Mother reported daughter experienced an injection site reaction. Mother does not wish to be contacted. Information provided at time of report has been documented.
Patient felt mucous/lump in throat about 25 minutes post vaccination. Patient reported history of anxiety and felt very anxious about vaccine. Icepack was given and placed upon chest. Patient was observed for 15 additional minutes, upon which she felt improved. Released at that time from observation.
mom states pt was seen in ER 2wk p/vax, inc fever & febrile sz-taken to ER
Moderna Arm Shingles Called pharmacy where received vaccine was told my  swollen  read rash on arm was Moderna Arm, then was a few days latter wasn't better my Allergists informed me to call my primary physician or go to Urgent care for service since I was noticing itching on right shoulder back
Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine. Concomitant products included RIZATRIPTAN for Migraine.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; 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. Further information has been requested
developed a dull pain in his left deltoid; Initial information received on 17-Feb-2021 regarding an unsolicited valid non-serious case from a patient.  This case involves a 30 years old male patient who experienced a dull pain in his left deltoid (Pain in extremity), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 06-Jan-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7115NA and expiration date :30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  On 07-Jan-2021, the patient developed a non-serious a dull pain in his left deltoid (Pain in extremity), 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient did not recover from the event Pain in extremity. As the patient stated that he does not feel like the pain has resolved at all since.
Severe ?Strep Throat?  diagnosed at ED, all tests came back negative for strep, tonsils were severely inflamed and bleeding, worse case of strep throat, followed by 3 weeks of coughing after antibiotics were completed.
11/27/21 pt had a positive COVID test; 12/1/21 pt admitted to hosp with worsening dyspnea; brought to ED via EMS; hypotensive, tachycardic, hypoxemic; CXR showed worsening bilateral opacities; given IV fluids and ABX; started on O2 supplementation - Vapotherm; given dexamethasone, Remdesivir; pt worsened clinically; went into cardiac arrest; ACLS protocol and pt intubated; given vasopressors; family decided to change status to DNR; pt passed away in the hospital.
Youth had pain and small bruise on L arm, Had fever to 101.5 a few hours after vaccine given.
p/vax pt devel fever of 101 to 103;pt seen by MD;lab results revealed a decreased hgb & hct & elevated BUN & serum creatinine;exp weakness, dizziness & appeared pale;hosp given blood;dx hemolytic anemia of unk etiology & renal failure;
Red and swollen around injection site quarter size & sore. Advised to take BENADRYL as directed and apply cold compress.
2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.
Fever of 103 deg F, 24 hrs after injection. Body aches, redness, swelling, warm to touch, three days following injections.
After Menactra & Tdap to deltoid pt had pain & some numbness symmetrically arms, hands.  Trouble lifting arms/arthralgias.  Still with symptoms.
5 days after the shot, the lymph nodes located under the arm pit on the same side of the shot were very sore, even to the touch. The pain was low to moderate and lasted for 2-3 days before going away.