chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with shingles; Hospitalized due to sickness; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer sponsored program. A female patient of an unknown age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration on 24Apr2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient was not able to get her second dose and missed her second dose because she was hospitalized due to sickness and diagnosed with shingles, was wondering to get her second dose. This term was highlighted by the reporter. The reporter seriousness for the adverse events was reported as hospitalization. The patient was hospitalized from an unspecified date to unspecified date (as reported). She received her first dose of Pfizer Covid-19 vaccine on last Month 24Apr2021 and she was scheduled for the second dose last 15May2021, but she missed. She was not able to get her second dose because she was hospitalized due to sickness and she had shingles until now. She took it on 24Apr2021 and was trying to get back her second dose vaccine but was sick and finally diagnosed with shingles and still had them. She was wondering that she should go ahead and get my second dose. The outcome of the events was not recovered.
36 hours after HAVRIX vaccine became very fatigued - 48 hours after vaccine developed 102.8 fever with chest congestion and occasional moist cough productive of moderate amount yellow sputum - low grade fever 72 hours after immunization - presently afebrile - fever resolved approximately 84 hours after immunization.
PT was vaccinated before the 5 month window for booster dose and was not immune comprised.
Information has been received from a registered nurse via a company representative referring to a 67 year old female patient. The patient had no drug reactions/allergies. On 20-NOV-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L011531 with expired date 07-JAN-2017, dose and route were unknown). No concomitant medication was reported. On the same date, the patient experienced chills, possibly a fever, soreness, inflammation, and red "wales" that localized at the injection site and then streaked down the patient's arm. The patient emailed a physician's office for medical attention. No treatment was given and no lab test was performed. The events lasted 3 days and the patient was fully recovered on 23-NOV-2015. Additional information has been requested.
Metallic taste in mouth for 4 days. Odd taste sensation. Early onset of mensural cycle.
LESS THAN FULL DOSE GIVEN BUT CONSIDERABLY MORE THAN 1/2 DOSE GIVEN. ESTIMATED 90-95% GIVEN. NO HARM TO PATIENT
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 072477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 23-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA, expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
On 5/22/2014 at the childs visit - redness and mild swelling (L) upper arm below the deltoid area - region where the shot was given subcutaneously. No tenderness, no itching - local reaction only. Diphenhydramine was given 1 1/2 teaspoonful.
Client presented to the vaccination site on 12/02/2021 accompanied by his parent for his second dose Pfizer COVID vaccine. Today, the client received the second dose Pfizer COVID vaccine for 5 through 11 years of age (Lot #: FK5127 exp: 01/24/22) at 1040. LVN noted the client was 12 years old after administration of the second dose Pfizer COVID vaccine for 5 through 11 years of age. PHN provided education to client?s parent stating the client received the incorrect formulation of the Pfizer COVID vaccine after LVN notified PHN. PHN educated client?s parent and client on possible adverse reactions and when to seek medical care. The client denied any chronic conditions, current medications, or known allergies. PHN submitted a medical consult via text message to Clinical Project Coordinator requesting for guidance on how to proceed. PHN received recommendation from the doctor was received via text message from Clinical Project Coordinator. The doctor recommended against repeat vaccination today but stated in 21 days the client may receive a dose of Pfizer COVID vaccine for 12 years of age and older at the parent's request. PHN talked to the client's parent at the EMT station. PHN provided education regarding administration of the incorrect formulation of the Pfizer COVID vaccine and the recommendation from the doctor stating the client may receive a third dose of Pfizer COVID vaccine for 12 years of age and older in 21 days, and that client?s appointment is scheduled for 12/27/21. PHN provided education to the client's parent again regarding possible adverse reactions, and when to seek medical care. The client did not report any symptoms during the 30-minute observation period. The client left the vaccination site with his parent at 1110 ambulating unassisted with a steady gait.
Pharmacy believes that Shingrix was reconstituted, patient was given the vaccine and upon peeling the label off to document the vaccine on the patient consent form noticed that the white tablet of powder was still in the vial. Patient was notified that she only received diluent and was re-vaccinated.
Swelling around injection site - redness, itching and pain.  Fever - 101 degrees F. - Worst symptoms so far, about 36-48 hours after the injection was administered.  Only one injection was administered.  The form will not let me make corrections on line 13.
error diluting the medication with 0.8ml rather than 1.8 ml resulting in more concentrated form
He developed mild tenderness, pain and fatigue. He then developed pain in the left side of his back which then transferred to the right side of his upper back.
Progress Notes PA-C (Physician Assistant) ? ? General Surgery/Trauma Cosign Needed Expand All Collapse All      COVID VACCINE CLINIC  12/22/2020    Patient:                                                                                                         DOB:    Date:  12/22/2020                                                                                         MRN:  5380787     Subjective Patient is a 23 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination.    He denied any history of previous adverse reactions to vaccines.  He does report recent hx of GI symptoms that he is currently being worked up for.  He reports onset of similar sx around time of vaccine injection.   He was given the Pfizer vaccination in the deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience dizziness, throat dryness, and nausea.  He denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, vomiting, abdominal pain and hypotension.       Review of Systems Otherwise negative, except for above    Objective    Vitals Vitals:   12/22/20 1131 BP: 118/66 Pulse: 88 SpO2: 96%       Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat.     Palpations: Abdomen is soft.  Neurological:     Mental Status: He is alert.        Assessment/Plan    Treatment included no therapy. Follow up response to treatment:no side effects. Patient discharge:  Stable to go home and follow up with PCP.   Patient was monitored in the emergency bay without worsening or evolving sx.  Orthostatic vitals signs were negative for hypotension or tachycardia.  He was able to ambulate well without assistance and reported improvement of sx prior to discharge.  Signs and symptoms of systemic hypersensitivity were reviewed and discussed with instructions to call 911 or report to the ED if SOB, throat/lip/tongue swelling, chest tightness, n/v, abdominal pain, or pruritic rash develop.     PA-C Electronically Signed 12/22/2020 12:08 PM
3 days after vaccination Patient developed and chest pain, dyspnea, and elevated inflammatory markers, Normal D-dimer
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.)   pain; It started in her neck; upper nerves in her head; now radiates down to her lower back; muscle weakness; nauseated; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included levothyroxine, ascorbic acid (VITAMIN C), and cholecalciferol (VITAMIN D); all taken for unspecified indications, start and stop dates were not reported. The patient received the first dose of the Pfizer covid vaccine on 16Mar2021. The patient reported that she had a lot of side effects from the vaccine. She reported that on Mar2021, she was still experiencing pain after the vaccine. It started in her neck and upper nerves in her head and now radiates down to her lower back. She has been using heat and ice. She also had muscle weakness on Mar2021 but that was improving. She also was nauseated on Mar2021 but was keeping hydrated and was still able to eat. She didn't like to take over the counter medications because anytime she does that it might cause her liver enzymes to be up. The patient asked when this will go away. The patient reported that she was supposed to get her second dose on 08Apr2021 and asked if the side effects will be worse. The patient reported that she had been hearing a lot of rumors that it was not wise to get like an MRI or CAT scan after the vaccine and the patient asked if this was correct. The outcome of the event muscle weakness was recovering. The outcome of event nauseated was unknown. The outcome of the remaining events was not recovered.
pt recvd flu vax & exp soreness in the arm of inject most of the day; approx 10PM, arm became extremely sore, w/o swelling or discoloration; approx 1AM pt exp chills & spastic shakes; pt was unable to get warm despite layers of blankets;
Patient exhibited shooting pain/tingling in hands and legs 5-7 days after vaccination. On March 29, 2021, the patient noticed an itchy rash on the left side of her lower back.  She received the vaccine in her left arm. She was diagnosed with shingles on March 30, 2021, two weeks after receiving the vaccine.
Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 09-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JUN-2016 the patient was treated for a painful rash which was diagnosed as shingles. On or about 17-JUN-2016 the patient was treated for a new outbreak of shingles vesicles. On or about 06-JUL-2016 the patient was treated for ongoing and worsening symptoms which were diagnosed as severe shingles. Although shingles is an incurable viral condition, the patient was prescribed Lidocaine for management of her pain and symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Initially typical red, swollen, tender, indurated area at vaccine site, but then 4 days after developed red papular pruitic rash at site of vaccines and today was noted to have confluent area of papules at site but also many other lesions on extremities. Now no pain, but still felt warm.
0.5ml Polio administered in error along with DTAP-HEP B-IVP combination vaccine. No reactions noted.
COVID 19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 16Dec2021 at 16:00 as dose number unknown, (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication in 2 weeks. : Paxlovid treatment started on 19Jul2022 to 23Jul2022. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
R arm swelling, rash, pain, fatigue, dyspepsia. Sx started 1 day after vaccine administered.
Her arm still hurts; she just started to recover from it.; Unlike the first dose where her pain was concentrated in her hip and tooth, the second dose caused pain in every part of her body including fingers, arms, head, and neck.; Chills; Fever; Swollen arm; Both her doses caused her side effects to be so terrible she felt as if she may have to be admitted into the nursing home; "It was horrible!"; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), FEELING ABNORMAL (Both her doses caused her side effects to be so terrible she felt as if she may have to be admitted into the nursing home), FEELING ABNORMAL ("It was horrible!"), PAIN IN EXTREMITY (Her arm still hurts) and FEELING OF RELAXATION (she just started to recover from it.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING ABNORMAL (Both her doses caused her side effects to be so terrible she felt as if she may have to be admitted into the nursing home), FEELING ABNORMAL ("It was horrible!"), PAIN (Unlike the first dose where her pain was concentrated in her hip and tooth, the second dose caused pain in every part of her body including fingers, arms, head, and neck.), CHILLS (Chills) and PYREXIA (Fever). On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Her arm still hurts) and FEELING OF RELAXATION (she just started to recover from it.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen arm), FEELING ABNORMAL (Both her doses caused her side effects to be so terrible she felt as if she may have to be admitted into the nursing home), FEELING ABNORMAL ("It was horrible!"), PAIN IN EXTREMITY (Her arm still hurts), FEELING OF RELAXATION (she just started to recover from it.), PAIN (Unlike the first dose where her pain was concentrated in her hip and tooth, the second dose caused pain in every part of her body including fingers, arms, head, and neck.), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided          No relevant concomitant medication was reported.   This case was linked to MOD-2021-083557 (Patient Link).
On 4/13/00, the pt was found to have a positive hepatitis B antigen. A doctor visit was required.
Pt recvd vax 5NOV92 & 3 hrs following the vax devel nausea, vomiting, aching all over, joint pain in shoulder & hips, sharp pain in muscles & t99; No further details were provided;
Abdomen pain from booster; Digestive issues from booster; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdomen pain from booster) and DYSPEPSIA (Digestive issues from booster) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091021A and 013M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL).   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ABDOMINAL PAIN (Abdomen pain from booster) and DYSPEPSIA (Digestive issues from booster). At the time of the report, ABDOMINAL PAIN (Abdomen pain from booster) and DYSPEPSIA (Digestive issues from booster) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided. After patient's booster dose on 02 Nov 2021, 4 to 5 days later she had a lot of abdomen pain, digestive issues, amylase was not elevated though.   This case was linked to MOD-2021-407131 (Patient Link).
Inflammation sign (redness/warmth) on upper R arm. Took Ibuprofen . All sx gone in couple days. Also numbness on L nose and surrounding area. Sx gone in couple days.
Pt had a fever and then barky cough and had croup. We saw the doctor and they gave a steroid so he could breath better.
Arthralgia, Fever, R axillary pain, bruising, tenderness Narrative: referred to PCP and tested neg covid  Other Relevant History:
Severe headache, jaw pain, neck,  back, buttocks, thighs, calf, right ankle and right big toe.  Severe pain in all muscles. Partly debilitating, not able to climb in bed, tie shoes, bath legs in shower, climb in and out of his vehicle.
Upper right arm at injection site, developed elongated red, hot welt in diameter 6" x 3 inches". Showed for 3 to 4 weeks. Now at 6 weeks, size reduced to 2" x 1".  Still visible. No itching, or illness.
her arm started swelling; her arm became red/arm is very red; her arm is very red, and has red dots, like a rash; the patient has pain, and her arm is still very sore today; the patient has itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-OCT-2023, the patient received Arexvy (left arm). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: the patient has pain, and her arm is still very sore today), itchy upper limbs (Verbatim: the patient has itching) and red rash (Verbatim: her arm is very red, and has red dots, like a rash). On 25-OCT-2023, the patient experienced swelling arm (Verbatim: her arm started swelling) and erythema of extremities (Verbatim: her arm became red/arm is very red). The outcome of the pain in arm, itchy upper limbs, swelling arm, erythema of extremities and red rash were not resolved.   It was unknown if the reporter considered the pain in arm, itchy upper limbs, swelling arm, erythema of extremities and red rash to be related to Arexvy.     It was unknown if the company considered the pain in arm, itchy upper limbs, swelling arm, erythema of extremities and red rash to be related to Arexvy.  Additional Information: GSK Receipt Date: 31-OCT-2023 The reporter was the husband calling on behalf of his wife who was a patient, and was also on the phone, and reported that she received her Arexvy vaccine and her arm started swelling and became red. The reporter stated that the patient's arm was bright, bright, red about 6 to 8 inches, the patient had itching and pain, and her arm was still very sore today (till the time of reporting). The patient reports that her arm was very red, and has red dots, like a rash, still today (till the time of reporting). The patient did not have any lot/expiry information or route of administration. The patient reports her arm was feeling better yesterday, 30-OCT-2023, but it came back today on 31-OCT-2023. Consent to follow up with HCP was not obtained.  The reporter did not consent to follow-up.
My arm started swelling at the injection site this afternoon. It feels warm and hurts when I try to lift my arm.  I think I am filling out the wrong part of this form. It keeps timing out so I'm in a hurry to finish. I just wanted to report my arm was swelling and hurt a week after the vaccination.
Approximately 3 days later after being vaccinated,  I experienced post-menopausal bleeding . It has now been going on for 18 days. I saw my OB/GYN on 01/21/2021 and she performed a biopsy, a pap smear, and also had a vaginal, and abdominal ultrasound, done on me the same day. All tests came back normal. No cervical polyps were seen; endometrial lining was appropriate for my age , being 2 years post menopausal. There is no other explanation for the bleeding that persists.
Arm is swollen, red, and warm to touch on the inside of the vaccinated arm from bicep to middle of forearm. Patient reports no pain or itching. Suggested that the patient take BENADRYL and we will follow up with her tomorrow to see if symptoms are improving.
his wife has Lupus; This is a spontaneous report received from a contactable consumer (patient husband) via medical information team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unknown route of administration on an unknown date in 2021, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that he and his wife received the first dose of the Pfizer COVID vaccine three weeks ago. Reporter stated they are scheduled for the second dose tomorrow. Reporter stated that his wife has Lupus and she was prescribed a Medrol steroid dose pack three days ago. Reporter would like to know if it would be okay for his wife to receive the second dose of the vaccine after taking the Medrol steroid dose pack. The outcome of the event was unknown.  Follow-up needed. Further information was requested.
Within 2 hours of injection, slight itching, upper body only.  Each day, itching has become worse, all over body itching, no rash. I?ve been taking Benadryl daily, but itching doesn?t completely subside. I do have just slight bump at injection site.
11 pts who recvd a series of 3 doses of Engerix-B reported to have not responded;