chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Had trouble with red swelling of leg), ERYTHEMA (Had trouble with red swelling of leg), INFECTION (Infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 10-Jun-2021 and second on 29-Jun-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication.    The patient's past medical history included COVID-19 in January 2022, Crohn's in March 2022 and Diarrhea (was prescribed antibiotics and had helped with the issues).   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate Free. On 29-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 10-Jun-2021 and second on 29-Jun-2021). In June 2022, the patient experienced INFECTION (Infection). On an unknown date, the patient experienced PERIPHERAL SWELLING (Had trouble with red swelling of leg) and ERYTHEMA (Had trouble with red swelling of leg). At the time of the report, PERIPHERAL SWELLING (Had trouble with red swelling of leg) and ERYTHEMA (Had trouble with red swelling of leg) was resolving and INFECTION (Infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 10-Jun-2021 and second on 29-Jun-2021) outcome was unknown.      The patient had diarrhea and was prescribed antibiotics and had helped with the issues. In Mar 2022, went to hospital in regard to Crohn's after catching covid in beginning of year. Concomitant medication not reported. It was reported that on unknown date the patient experienced Itching after Humira injections and Bleeding after taking Humira injections. The reporter's causality for the event(s) of Bleeding after taking Humira injections, had trouble with red swelling of leg unknown onset, Infection, Itching after Humira injections with Adalimumab Solution for Injection was Not Provided.
presents to the emergency department status post mechanical fall this afternoon with a scalp abrasion.  Patient states he had surgery performed 6 weeks ago to correct spinal stenosis for L3-L5, and had a recent fall with no LOC. Patient found to have a subdural hematoma. Currently admitted.
warmth & redness @ site 1 day later, gradually worsening until 25FEB93 when noted abruptly worse itching of lt upper arm, redness & warmth down to elbow;
Excoriated papular pruritic rash that began in the midline upper chest and then spread to the midline upper back down to the midline lower back. Extremely pruritic. No reaction at vaccination site.
given the adjuvant only; given the adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK receipt date: 11-JAN-2023 Reporter's comment: The reporter was a registered nurse (RN) from the clinic, where the vaccine was administered.  She had reported that an anonymous patient was given the Shingrix adjuvant only in the early December.  The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient was administered only the only the adjuvant portion of the Shingrix which had led to inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Next day, extremely tired, two days later arm extremely sore, 8 days later very itchy rash at injection site, hard golf ball, very hot, ring around injection site
Fever, chills, vomiting lasting for about eight hours.  Fatigue lasting for about 36 hours.
Was in bed for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of bedridden (received 1st dose on an unknown date, refer case US2023AMR043593).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bedridden (Verbatim: Was in bed for 3 days). Rechallenge with Shingles vaccine was positive. The outcome of the bedridden was recovered/resolved (duration 3 days).   The reporter considered the bedridden to be related to Shingles vaccine.     The company considered the bedridden to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR043593   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by the patient via interactive digital media. The patient said after 1st dose 3 months later, the MD said he or she had to take another shingles shot with great caution, he or she hoped it would be okay but wrong.  The patient was in bed 3 more days, thinking it was the end.  The patient said would never encourage anyone to take a shingles shot.  That was how it worked for horrible.; Sender's Comments:  US-GSK-US2023AMR043593:Same reporter
Patient received dose 1 of the Pfizer COVID vaccine (lot EW0183) at approximately 1400. At 1405, patient reported to RN that he felt dizzy and sweaty. Patient walked over to zero-gravity chair, accompanied by father, and placed in supine position. PHN approached to assess and noted no work of breathing. Patient reported eating and drinking sufficient fluids previously in the day. Patient reported fear of blood. Vital signs: blood pressure 112/78, O2 99%, pulse 94, respirations 16. At 1408, patient reported symptoms improving. Patient reported no allergies, medical conditions, nor taking medication. PHN offered patient Benadryl which patient declined. PHN encouraged patient to stay for 30min monitoring from the time of reporting symptoms, to follow up with provider, and when to call 911. At 1430, vital signs: 118/80, respirations 14, O2 98%, pulse 86. Patient reported symptoms had resolved. Patient placed in seated position, continued to report no symptoms. At 1435, patient stood up monitored by PHN patient continued to report no symptoms. At 1439, patient left walking with steady gait, accompanied by father.
RASH ON HER LEGS; HIVES; ITCHING; This spontaneous report received from a patient concerned a 46 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 reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced itching. On 25-MAR-2021, the subject experienced hives. On an unspecified date, the subject experienced rash on her legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives, and itching, and the outcome of rash on her legs was not reported. This report was non-serious.
Information has been received from a county health registered nurse concerning a 6 year old male who on 25-OCT-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 26-MAY-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Increased swelling & redness left upper arm that spread encompessing the entire posterior upper arm & extending to the left elbow.  Treatment included Benadryl, Medrol Dose Pak, Amoxicillin 500 mg q8h for 7 days, ice packs.
CHILLS/SOME SHIVERS; FELT CRAPPY; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills/some shivers, fever, and felt crappy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills/some shivers, fever, and felt crappy. This report was non-serious.
Adverse effects included: light-headiness right after receiving shot. Sore arm - even as of 2/1/2021, have redness below the injection site and feels a little warn. Mild fever and chills, Headache, I slept almost continuously for 24+ hours except to wake up to go to bathroom periodically. Afterwards, I would go right back to sleep.  I haven't called or sought any medical advice (pharmacy suggested I call Vaers phone #).. I am concerned about taking the 2nd shot (2/6/21).
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: face numbness in 1/2 of face felt like a stroke per pt, throat getting tight and felt like it was closing, pt reported this to us on 8/9/21 and at that time she was feeling 100%
Patient complained of feeling dizzy 15 minutes post injection. Denies pain, SOB, blurred vision, headache, allergies, and other serious health concerns.  Assessed patient status and vital signs within normal range. No medical interventions. Gave a juice box and continued to monitor for additional 15 minutes. Observed patient ambulate out of clinic safely with no distress.
Vaccination site reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction). At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
About 11 PM on 2/8/13, had seizure and went to ER at hospital. Transferred to another hospital on 2/9/13 at 1330. Discharged 2/11/13 - records attached.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Armpits are swollen; Today is the first day she is not running fever; Has been having bad side effects for 3 days; 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 VACCINATION COMPLICATION (Has been having bad side effects for 3 days), PERIPHERAL SWELLING (Armpits are swollen) and PYREXIA (Today is the first day she is not running fever) 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 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Has been having bad side effects for 3 days), PERIPHERAL SWELLING (Armpits are swollen) and PYREXIA (Today is the first day she is not running fever). On 15-Nov-2021, PYREXIA (Today is the first day she is not running fever) had resolved. At the time of the report, VACCINATION COMPLICATION (Has been having bad side effects for 3 days) had resolved and PERIPHERAL SWELLING (Armpits are swollen) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Vaccine administered 15 days post expiration date of 11/15/07 on 11/30/07. Discovered by charge nurse on monthly inventory of VFC vaccines. Info reported to the health dept and manufacturer as well as physician.
Headache; Light headedness/dizziness; Body ache; Fatigue; Sore lung muscles on front and back; Tightness in chest; This is a spontaneous report from a contactable consumer.   A 28-years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6168), via an unspecified route of administration in left arm on 26Feb2021 at 14:00 as a single dose for COVID-19 immunization. The patient received vaccination at field house facility. The patient did not receive any other vaccine with in four weeks of COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not undergo COVID test post vaccination. The patient had no known allergies. The patient's medical history and concomitant medications were not reported. On 27Feb2021 at 17:00, the patient experienced headache, dizziness, light headedness, body ache, fatigue, sore lung muscles on front and back, tightness in chest. The patient did not receive any treatment medication for the events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
Information was received from a pharmacist concerning a female patient of unknown age, who received a dose of ZOSTAVAX 0.65 ml, once, subcutaneously in December 2013. On 02-DEC-2014, the patient received a second dose of ZOSTAVAX. No adverse events were reported. No further information was provided. Additional information has been requested.
This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 29Apr2021 at 12:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. 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 30Apr2021, about 10-12 hours after the second shot, the patient was weak, tired and had to stay in bed for the entirety of the day. The patient remained tired the 48 hours after the vaccine but was able to go on with day. On 03May2021, the fourth day after the second shot, the patient developed a severe headache, slight nausea and a dizzy feeling. Therapeutic measures were taken as a result of headache and included treatment with TYLENOL. The clinical outcome of the events had to stay in bed for the entirety of the next day, weak, tired, dizzy feeling, slight nausea and severe headache were recovering. No follow-up attempts are possible. No further information is expected.Amendment: This follow-up report is being submitted to amend previously reported information: Amended narrative data in final sentence to No follow-up attempts are possible. No further information is expected and for events (except headache), treatment received updated to No. Initial information needs to be reviewed:Covid_vaccine_details [{product=COVID 19, brand=Pfizer,lot_number=EW0171, lot_unknown=False,administration_date=29Apr2021,administration_time=12:00 PM, dose_number=2,vaccine_location=Left arm},{product=COVID 19, brand=Pfizer, lot_number=EW0158,lot_unknown=False,administration_date=08Apr2021,administration_time=01:30 PM,dose_number=1,vaccine_location=Left arm}]facility_type_vaccine Other if_other_vaccine_in_fourweeks Noother_medications_in_twoweeks no adverse_event About 10 - 12 hours after the second shot, I was weak and tired, and had to stay in bed for the entirety of the next day. I remained tired the 48 hours after the vaccine but was able to go on with my day. On the 4th day after the second shot, I developed a severe headache, slight nausea, and a dizzy feeling. The headache only slightly subsided after taking Tylenol. adverse_event_start_date 30Apr2021;adverse_event_country; ae_resulted_in [None of the above] if_patient_recovered Recovering;if_treatment_ae; No if_covid_prior_vaccination; No if_covid_tested_post_vaccination; No known_allergies; No other_medical_history None
As per employee felt dizzy and a brief period of shortness of breath for approximately 10 seconds. Employee states symptoms subsided immediately after walking. Employee was directed to sit down by medical staff and stated symptoms had subsided before getting to medical office. No treatment required as employee denies symptoms at time of monitoring by medical staff.
Patient complained developing fever blisters 4 days later that lasted 1 week. He applied some BLISTEX on them. Also complained feeling dizzy 4 days later and lasted 5 days. He did not take any medication for the dizziness but felt better 5 days later.
Mom states she noticed on 12/18/2001 in the evening that child's upper leg from mid thigh to hip was hot and swollen. child has run no fever. She gave Tylenol and took her to ER. ER told her to put ice on it. On 12/19/2001 thigh is still swollen, took child to community health center. Child's right leg had huge erythema and swelling from groin to about knee. Dx was reaction to DTap and the physician ordered no more DTap/DTP to be given.
this event is being reported for the following reason: the patient was inadvertently given the 2nd dose shingrix today when he had 1st Covid vaccine on 1/26/21. this would be 10 days past admin of Covid vaccine and not the required 14 days wait. Patient was observed for 30 minutes post vaccine while remaining in clinic and no adverse reaction was noted while patient still in clinic. Covid-19, mRNA, LNP-S, PF (Pfizer-BioNTech) 0.3ml IM given in Left deltoid on 1/26/21. NDC 59267-1000-1 Lot # 1111-20-EL9262 exp date 5/31/21
2nd dose Moderna patients were given dose one day earlier/outside of the CDC-recommended window due to calculation error when appointments were scheduled on prior system we were using. Number of patients affected unknown due to the fact that we are now using a new appointment system.
Severe sinus headache same day took acetaminophen, diphenhydramine and phenylphrine.  one week later sore left arm and rash around stab area  took 500mg acetaminophene and25mg diphenhydramine
Patient called 1/14/18 to inform that she developed Guillain-Barre Syndrome soon after receiving flu shot on 10/9/17. She is currently still hospitalized.
I smelled and tasted cigarette smoke; I smelled and tasted cigarette smoke; This is a spontaneous report from a contactable consumer, the patient. A 41-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 right arm on 03Apr2021 at 09:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced tasted and smelled cigarette smoke for about 7 full days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events smelled and tasted cigarette smoke was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Brain fog,  unsteadiness, disequilibrium, eyelids feel heavy, numbness in fingertips, left hand
One hour after receiving #2 dose of HPV vaccine into the rt deltoid c/o of pain in right shoulder-arm, right side of neck, down into right hip and leg with N & V and diarrhea. Vomiting lasted 24 hours the remainder of the symptoms lasted for 2 - 3 days.  Patient states she will not receive the #3 dose of HPV vaccine.
I was swimming in a lake when suddenly I couldn't breath and my heart started pounding. I was gasping for air.  My pulse went from a normal working out pulse to above 145 bps. It did not come down when floating on my back or resting when I eventually got back into shore. Then when I got home I had to climb stairs and I lost my breath again.