chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client vaccinated per protocol into left deltoid.  Client immediately complained of pain at site of injection.  Nurse stated that his muscle seemed to tense when vaccine was injected.  About one hour later the client returned to the nurse and reported continued pain in his whole arm as well as burning and numbness in his pinky and ring finger of the left hand.  Nurse recommended that if there was no improvement that he contact his PCP.  Client has no PCP so was recommended to go to Urgent Care.  No redness at site of injection.  It is unknown if client had medical visit.  Attempts to contact resulted in no return call from client.
Moderna vaccine administered at 10:33.Prior to the  end of the mandatory15minute observation time, she developed red blotchy areas from her front chest/neck area. She did not complain of any shortness of breath.  She stated she  was "a little dizzy" and could "feel her heart beating".  Radial Heart rate was 146.  Nurse STAT called at 10:49. ED team arrived and transported to ED for examination.
Rash (small erythematous raised macules around neck and extending to top of the back) and fever to 103.5 followed by diarrhea.
Daughter contacted the clinical location for vaccination to inquire regarding if her mother was confused when at the location to receive her vaccine as she ended up in the ED 2 hours later with a diagnosis of stroke.  completing VAERs due to how closely the vaccine was to the event.
local rxn of hot to touch, redness spreading distally, poss cellulitis;seen on 12APPR96;empiric ATV rx;as of 17APR96 sx in resolution stage;last Td containing vax 27MAY97 w/o incident;
Serious itching on the skin on lower legs after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Serious itching on the skin on lower legs after 2nd dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Serious itching on the skin on lower legs after 2nd dose). On 12-Jul-2021, PRURITUS (Serious itching on the skin on lower legs after 2nd dose) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-512258, MOD-2022-512313 (Patient Link).
Patient received Pediarix, MMR, ActHib, Hepatitis A, and Prevnar vaccines on 10/9/08.  Her mother called the nurse on 10/20/08, stated that child had a low grade temperature on 10/17, but fever climbed to 104 on 10/18, and child developed seizures.  She was evaluated in the emergency department of Rosebud Indian Health Service on 10/18/08.  Mother states that although the ER provider was unable to find any other reason for the child's high fever and seizures, she was prescribed Keflex at that time.  When mother called on 10/20/08, child was well and had had no further seizures since 10/18.
Based on additional information received and internal review on 28-Feb-2019, it was found that the report (previously processed as non-valid) is considered as valid as the patient identifier was available in initial report and observed in follow-up. Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15-months old female patient who was vaccinated with dose of PENTACEL batch number Lyophilized powder (Lot: C5594AA, expiry date: 27-Oct-2019), Liquid vial (Lot: C5444AA, expiry date: 27-Oct-2019) Package: Lot: C5594AA), expiry date: 27-Oct-2019) via unknown route in left leg on an unknown date. The concomitant vaccine included PREVNAR 13. It was an actual medication error due to inappropriate reconstitution technique. PENTACEL was not mixed with the correct diluent. Medical assistant took the Lyophilized powder vial from out of the PENTACEL box and gave a separate Diluent but the liquid portion was not given. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up report received from a nurse on 27-Feb-2019. No new information was updated. Follow-up report received from a nurse on 28-Feb-2019. The patient details and concomitant vaccine was added. Case became valid. Narrative updated accordingly. List of documents held by sender: none.
Patient received her MMR on April 25 from her primary care doctor.  Then on May 5th, she developed flu like symptoms and rash on May 7th.  Tested positive flu today.  Unclear if rash is from MMR.  Seen in urgent care today. Pt will follow up with her primary care doctor tomorrow.
Information has been received from a physician concerning a female patient in her 20's who in November 2006, was vaccinated with a dose of HPV vaccine. Immediately after administration, the patient passed out. Medical attention was sought. Subsequently, the patient recovered. The physician explained that another physician from a different office administered the vaccination to the patient. Additional information has been requested. There was no product quality complaint involved.
Headache, Myalgia, NauseaVomiting, inj site pain Narrative:
No adverse events.  Patient received doses too close together.  1st dose was given one week prior by an alternate provider. Exact date unknown.
Patient received 1st dose of pfizer series on 9/10/2021 after receiving completed series of modern vaccine on 4/21/2021 and 5/19/2021
pt recvd vax on 15JUL93 @ 640PM; pt lying down @ time since mom stated pt faints w/stress & is on Tegretol for sz; pt recvd MMR sat up & immed layed down & both legs shook for 30 seconds;
Induration at injection site.  Onset about a day after vaccine.  This resolved on follow up 5 days later
The initial shot hurt more than I can remember and my arm was very sore for the rest of day and night.  The soreness never really went away and instead became increasingly debilitating.  Without significant pain, I cannot dress myself, put on seat belt, pick up my children, sleep, exercise etc.  I have no strong reflex and am concerned if I fall, I will not be able to save myself.  I have been to the Dr., and tried advil but nothing is helping to ease the pain.  It is AWFUL.
61/2 x 6 1/2 macular papular rash on left deltoid
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # N000237, expiration date 25-OCT-2019 and N001348, expiration date 31-OCT-2019 (strength,dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 32 degree fahrenheit to 35 degree fahrenheit for 480 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Lot number N001348 has been verified to be a valid lot number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate).; Sender's Comments: US-009507513-1708USA004188: US-009507513-1708USA004176: US-009507513-1708USA004187:
2 weeks after vaccine, noted increased essential tremor; "cotton head"  trouble wit balance.  This lasted about 2 weeks.  However, essential tremor continues
developed swelling and itching and redness at the sight of immunization on the right arm. a 5x8cm area of redness and swelling was observed; she could use her arm without difficulty.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 35 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
10/29/07 - Diagnosed with cystitis, started on Bactrim. 10/31/07 symptoms resolved, afebrile, administered HPV and flu vaccine.  11/6/07 presented to ER with 2-3 days progressive back and abdominal pain, vomiting.  Diagnosed with pyelanephtitis.  Given IV fluids and antibiotics (Rocephid) and additional PO antibiotics (Augmentin).  Returned to ER 11/7/07 continued pain, ? constipation as cause.  Prescribed mag citrate.  Office follow up 11/9/07 - abdominal and back pain remained unexplained with normal exam, labs, work-up.  11/12/07 patient reported symptoms resolving.
PT WAS NOT DUE FOR SECOND DOSE. CAME TO VACCINE CLINIC STATING HE WAS DUE. PT WAS ADDED TO SCHEDULE AND VACCINE WAS ADMINISTERED 3 DAYS EARLY.
Engerix B adult administered to 11y/o patient; Engerix B adult instead of pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old male patient who received HBV (Engerix B adult) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     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: 6-Sept-2022 Reporter's comment: The medical assistant reported that the patient received a dose of Engerix-B adult instead of pediatric dose. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received  a dose of Engerix-B adult instead of pediatric dose, which led to overdose and adult product administered to child.
ACUTE DVT OF LEFT POPLITEAL VEIN 3/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Flu vaccine left thigh - red, warm, firm 3-4cm. DTaP upper Rt thigh - red, warm, firm 5-6cm.
2x2 cm erythematous swollen patch, sl indurated area (L) deltoid - faint erythematous circle about 5x5 cm with outside square. ? sl warm to touch. Benadryl 1-2 days to resolve reaction. Monitor for any reaction, increased redness, fever, etc.
Information has been received from a physician concerning a 64 year old male consumer who got the ZOSTERVAX (Merck), unknown dose and frequency, on 03-APR-2009, for an unknown indication. The patient's relevant medical history and relevant past drug history include melanoma treated with chemotherapy over a year ago. The patient relevant concomitant medication are unknown. This physician reports that 2 days after he got the ZOSTAVAX (Merck), on 05-APR-2009, he developed pain in his scalp and left ear. She reports that today, on 08-APR-2009, he has linear lesions along the nerve line and at the angle of his eye, which she reports to be a medical emergency. As of 08-APR-2009, it is unknown if he will continue to get ZOSTAVAX (Merck), it is unknown if he continues to have pain in his scalp and left car, and he continues to have linear lesions along the nerve line and at the angle of his eye.
Fever 42 degrees C, myalgias, cough. Started next day after H1N1 vaccination-continued fever 1 week later up to 40 degrees C.
Cellulitis - Rt deltoid swelling and redness had imm on Wed 4/10/13 gave KEFLEX 250mg/5mL 4mL po tid advised BENADRYL to help with swelling.
Information has been received from a registered pharmacist concerning her 12 year old daughter who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (Lot # and expire date not reported), 0.5 ml, subcutaneously. Registered pharmacist stated that on an unspecified date, her daughter experienced shingles and added that her daughter's shingles cleared up after she was administered acyclovir. The patient sought unspecified medical attention. Follow-up information was received from a physician concerning a female patient with no illness at the time of vaccination who on 03-JUL-2007 was vaccinated with the second dose of VARIVAX (Merck) (Lot # and expire date not reported), 0.5 ml, subcutaneously. Suspect therapy included the second dose of GARDASIL (Lot # and expire date not reported) administered on 27-JUL-2010. Concomitant therapy included the third dose of FLUVIRIN (Lot # and expire date not reported) administered on 22-AUG-2010. The physician stated that on 11-JAN-2011, the patient was diagnosed with shingles/Zoster. In 2011, the patient recovered. There were no laboratory diagnostics studies performed. The patient did not seek medical attention. Additional information is not expected.
fever; cold sweats; body aches; migraine; fatigue; This is a spontaneous report from a contactable consumer (Patient).   A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Right on 03Apr2021 at 11:45 (age at vaccination: 32 year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 13Mar2021 at 00:00 (at the age of 32-year-old) as dose 1, single for COVID-19 immunization and experienced minor chills and body aches. Allergies to medications, food, or other products were reported as none. 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 04Apr2021 at 04:00, the patient experienced fever, cold sweats, body aches, migraine and fatigue the first and third day after vaccination. No treatment received for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Starting about 12 hours after administration, I had a fever of 101F, headache, body aches, nausea, extreme fatigue; this lasted about 36 hours.  Starting on 5/10 (about 72 hours later),  I started developing vesicles on my left upper chest and neck as well as left femoral area; these are painful and very itchy and resemble internet photos of shingles  (I?ve never had shingles before). The vesicles are continuing to spread in these two areas.
Headache, fever (100 F), nausea, chills, muscle & joint pain,  fatigue.  Tylenol 500 mg, twice daily Advil, 200 mg, once daily, at bedtime.  Symptoms resolved within 36 hours.
they both knocked me off; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of malaise (1st dose received on an unknown date, refer case US2022AMR028356).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR028356  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt knocked him/her off his/her butt for a day but well worth the actual shingles. The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR028356:same reporter
Numbness & tingling in both hands and wrists (still a problem in both hands) Significant joint pain in both shoulders, both hands and both hips (still a problem in hands and hips - shoulders not currently an issue)
Hives, generalized occurring a month after 3rd Moderna shot, contorlled with Allegra 180
Vaccine administered after temperature excursion; Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to Frozen Vaccine 47Minutes -13.79 C and Refrigerator 59 Minutes 12 C were noted. No concomitant information were provided by the reporter. Treatment information was not provided.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, LEFT ANTERIOR DESCENDING CORONARY ARTERY ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED 6/20/2022  --  RECURRENCE OF SAME SYMPTOMS
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The pharmacist reported that patients just usually report that their arm hurts after receiving SHINGRIX.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized with fatigue, fevers, and hypotension, and  influenza A. Received oseltamivir and intravenous fluids. Discharged to home medically stable.
Onset of mild swelling of upper eyelids about 15-20 mins after vaccine injection, 2/1/2021, with mild itch sensation around mouth about another 15 mins. later. Next day started to have itch sensation all over face slowly spreading to ears, eyelids still mildly swollen around noon. Took Benadryl 25 mg without change but on progression. Took another Benadryl 25 mg 1/2 hour later with resolution of symptoms. Started slowly having recurrence of same symptoms today, 2/12,2021, with improvement after Benadryl 25 mg. Symptoms reoccurring again about 6 hours later, better again after another dose of Benadryl 25 mg.
Left arm numbness/heaviness 15 minutes post injection, mostly resolved with minimal parasthesia at departure. Patient advised to go to ED for any additional symptoms.
Pt was given both the Influenza and Tdap vaccines in his upper right arm/deltoid area. Mother reported that pt then had red area that was warm to the touch and localized temperature of right arm was 102.0 F per school nurse who called mother to report issue when child reported to school the following day. No systemic fever, no lethargy, child had no other complaints. Mother applied ice pack to area as well as applied topical Benadryl cream during the day and administered one dose of oral Benadryl at bedtime. Pt is reported to have less symptoms today when contacted by this reporter.
Swollen lymph on neck; Dose received:3/ dose number=3; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 52 year-old male patient received bnt162b2 (BNT162b2), administered in left arm, administration date 01Dec2021 at 12:30 (Lot number: FJ8762) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP6955; Anatomical site: Right arm; Administration time: 12:00), administration date: an unknown date in Mar2021, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3247; Anatomical site: Left arm; Administration time: 12:00), administration date: an unknown date in Apr2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 12:30, outcome "unknown", described as "Dose received 3/ dose number=3"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021, outcome "recovering", described as "Swollen lymph on neck". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Patient received vaccine on 1/4/21-started having hard chills, and fever and severe-massive headache. Patient took Tylenol and Motrin with No relief. Only slept for about 2-3 hours.  Fever of 101. On day 2-1/5/21-still having fever as high as 101, finally broke at about 5-6 pm, still having massive headache and body aches.  Very painful left arm all the way down to fingers. On both day 3 and 4, 1/6 and 1/7/21-still having massive headache and body aches no further fever or chills. Patient had doctor visit on 1/7/21 and doctor gave patient out of work note and not to return to work until 1/11/21-off for 2-3 days.  Patient is Not going to get the 2nd vaccine-patient will refuse vaccine.