chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child exposed to hepatitis by babysitter from another country.  Babysitter hospitalized for hepatitis workup.  Child given hep A #1 9am.  Returned to clinic c facila edema.  12.5 mg enadryl PO given.  Observed x 1 H.  D/C to home, stable.  RTC 2/10/06 Benadry 12.5 mg PO q 6hr x 5; Zantac 25 mg PO BID; Prelone 25 mg PO x 2 d, 15 mg PO x 2 d, 7.5 mg PO x 2 d.  2/10/06 - NOTE: Parent reports babysitter hospitalized for unknown type hepatitis.  Child exposed by babysitter.  Child seen 2/10/06 stable, refer Peds allergy.
Initially when they gave the injection, I didn't say anything. I immediately felt a warm wave travel down my left arm down to my fingerprint. 2 hours later I started having 10out of 10 pain on my left side, I took ibuprofen and put ice on it. I Have a very high tolerance but I couldn't even strap my bra. I Still I have pain. I went to see my doctor on 12/08/2021 She didn't have nothing helpful, She said It looks like a shoulder pain and to keep an eye on it but the pain is still going. I do have an MRI scheduled which it kinda sucks because my insurance won't pay for it so I don't thing I can cover the cost of it.
severe headache and shoulder suprascapula pain started 4 hours after vaccine and lasted 2 days
Received Moderna vaccines on 1/12/21, 2/9/21, 10/26/21. Tested positive for COVID by PCR on 10/30/21. admitted to Hospital on 10/22/21 d/t hip fracture. Asymptomatic for COVID.
pt recvd vax & 2 wks post inject exp itching on arms & back;
Swelling in legs; Tightness in legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in legs) and MUSCULOSKELETAL STIFFNESS (Tightness in legs) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038AH0) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in legs) and MUSCULOSKELETAL STIFFNESS (Tightness in legs). At the time of the report, PERIPHERAL SWELLING (Swelling in legs) and MUSCULOSKELETAL STIFFNESS (Tightness in legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.
received unnecessary dose; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 3-year-old patient who received Hib (Hiberix) (batch number 5ep38, expiry date unknown) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number J953N, expiry date unknown) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received the primary schedule on an unknown date before 21st September 2021) and hiberix (received the primary schedule on an unknown date before 21st September 2021).   On 21st September 2021, the patient received Hiberix, Infanrix and Infanrix Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Hiberix, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Age at vaccination was not reported. The patient received unnecessary dose of Infanrix and Hiberix which led to extra dose administered.The patient's family was informed. The patient had already received the appropriate doses of these vaccines prior to 21st September 2021. No known adverse events due to error. The reporter consented to follow-up.
Swollen, lymph, note on arm of shot. Cold sore. Soreness on other arm as if shot was given there.
restless leg issues; hard to walk-leg felt heavy; injection site felt feverish; pain in shoulder and neck; Pain in shoulders and neck; Injection site felt sore in the upper arm; palpitations that feel like a panic attack, racing heart; Muscles from the legs down has been "firing off" with no relief; Legs feel exhausted when they are not firing off.Like she has been walking on leveled ground for days; nausea; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site felt feverish), NECK PAIN (pain in shoulder and neck), PALPITATIONS (palpitations that feel like a panic attack, racing heart), RESTLESS LEGS SYNDROME (restless leg issues) and GAIT DISTURBANCE (hard to walk-leg felt heavy) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PALPITATIONS (palpitations that feel like a panic attack, racing heart), LIMB DISCOMFORT (Muscles from the legs down has been "firing off" with no relief), FATIGUE (Legs feel exhausted when they are not firing off.Like she has been walking on leveled ground for days), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site felt feverish), NECK PAIN (pain in shoulder and neck), RESTLESS LEGS SYNDROME (restless leg issues), GAIT DISTURBANCE (hard to walk-leg felt heavy), ARTHRALGIA (Pain in shoulders and neck) and VACCINATION SITE PAIN (Injection site felt sore in the upper arm). At the time of the report, VACCINATION SITE WARMTH (injection site felt feverish), NECK PAIN (pain in shoulder and neck), PALPITATIONS (palpitations that feel like a panic attack, racing heart), RESTLESS LEGS SYNDROME (restless leg issues), GAIT DISTURBANCE (hard to walk-leg felt heavy), LIMB DISCOMFORT (Muscles from the legs down has been "firing off" with no relief), FATIGUE (Legs feel exhausted when they are not firing off.Like she has been walking on leveled ground for days), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), ARTHRALGIA (Pain in shoulders and neck) and VACCINATION SITE PAIN (Injection site felt sore in the upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 and events were updated.
Atrial fibrillation - Successful placement of a 31 mm WATCHMAN FLX device was performed. Hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received on 23-JAN-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 23-JUL-2012, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered widespread rash throughout his body and continues to suffer from this constant and painful rash. The patient also suffered blurry vision, corneal epithelial defects and epithelial keratitis and was ultimately diagnosed with herpes zoster ophthalmicus. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Herpes zoster ophthalmicus and widespread rash throughout his body and continues to suffer from this constant and painful rash were considered to be disabling. Upon internal review, herpes zoster ophthalmicus was considered to be medically significant. Additional information has been requested.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein Narrative was updated.
during the administration of Shingrix to a patient the vaccine leak on the arm; during the administration of Shingrix to a patient the vaccine leak on the arm; during the administration of Shingrix to a patient the vaccine leak on the arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details provided were as follows: The pharmacist reported that during the administration of Shingrix to a patient the vaccine leak on the arm which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. No adverse event was reported. No patient identifiers were reported. No vaccination date was provided. No product complaint was reported. No lot number and expiry date was provided. Reporter consented to follow-up.
Headache, Myalgia, Rash, c/o fatigue,injection site sore Narrative:
Approx. 7cm circular area, with redness, swelling and warmth on left thigh, noted at 17:50 on 11/1/00.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
09/24/22 presents to ED for "syncope". PMHx of "HTN, T2DM, and CKD"
pt recvd vax 15JUN93 t103, nausea & vomiting 17UN93 temp was 104 1/2, cont vomiting; tkaen to ER given pedaprophine; vomiting & temp cont through Sunday, improved 21JUN93;
Patches are itchy; headache; still breaking out in patches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Patches are itchy), RASH (still breaking out in patches) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041220A and 030M204) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced RASH (still breaking out in patches). On 18-Feb-2021, the patient experienced RASH PRURITIC (Patches are itchy) and HEADACHE (headache). On 18-Feb-2021, HEADACHE (headache) outcome was unknown. At the time of the report, RASH PRURITIC (Patches are itchy) and RASH (still breaking out in patches) outcome was unknown.            Reporter did not allow further contact
Initial and follow-up information has been received through the pregnancy registry from a 25 year old female office manager with no pertinent medical history who on 07-DEC-2006 was vaccinated with a 0.5 ml dose of GARDASIL (lot #653938/0954F).  There was no concomitant medication.  On 29-DEC-2006 the patient learned that she was pregnant.  Unspecified medical attention was sought.  On an unspecified date the patient underwent "blood work" and an ultrasound.  There was no adverse experience.  At the time of the initial report, the patient was 9.5 weeks gestation.  It was reported that the patient was induced at 41 weeks estimated gestational age for a low amniotic fluid index.  The patient had a primary cesarean section due to a non-reassuring fetal heart rate and failure to descend with minimal cervical dilation.  She delivered a healthy normal female weighing 7 pounds and 2 ounces on 24-AUG-2007.  It was reported that the mother had some difficulty "mentally" postpartum.  At the time of the report, the mother and baby were "well."  Upon internal review, non-reassuring fetal heart rate and failure to descend with minimal cervical dilation were considered to be other important medical events.  Additional information is not expected.
booster was 0.5 ml; she is pregnant and has a little concern; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of OVERDOSE (booster was 0.5 ml) and MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and has a little concern) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J212A, 009C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 23-Jul-2022. On 21-Jan-2022, the patient experienced OVERDOSE (booster was 0.5 ml) and MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and has a little concern). On 21-Jan-2022, MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and has a little concern) had resolved. At the time of the report, OVERDOSE (booster was 0.5 ml) outcome was unknown.            No concomitant and treatment medications were provided. The patient declined to enroll in pregnancy registry.
No adverse symptoms or effects reported; patient inadvertently received first dose in VARIVAX immunization series that was reconstituted inadvertently with expired DILUENT; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions, concomitant medication, and previous drug reactions or allergies were not reported.     On 23-MAR-2020, the patient received the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number R023504 with an expiration date on 16-AUG-2020 (vaccination scheme, route of administration, and anatomical site of injection were not reported), which was reconstituted inadvertently with an expired sterile diluent (MERCK STERILE DILUENT), lot number N028746 with an expiration date on 17-MAR-2020 (strength, dose, frequency, route of administration were not reported), both as prophylaxis (expired product administered). No adverse symptoms or effects were reported nor product quality complain involved.
This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. On 06-FEB-2015, the patients were vaccinated with M-M-R II (strength, dose and route were not reported) (lot # K001231 and expiration date 27-JAN-2016) which were exposed to an unsupported temperature excursion. No adverse effect was reported. No product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022; No Adverse Event; Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-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. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022).    No concomitant product use was reported. The number of doses/vials -around 50 doses from 5 vials. On 08-Jul-2022 the vials were initially stored in the refrigerator. The vaccines were administered from the 07-Aug-2022 until the 11-Aug-2022 Vial did not undergone any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
body pain; Discomfort; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Temperature: 107" (unspecified if ongoing), notes: reaction to typhoid medication, so bad she had to go to for treatment; was put in buckets of ice. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "body pain"; DISCOMFORT (non-serious) with onset Mar2021, outcome "not recovered", described as "Discomfort"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Fatigue". Additional information: The patient expected to have some discomfort for a couple of days like any shot would give her. She was just confused because she had body pain, discomfort, and fatigue. She has never had a reaction to any product except one. The only reaction she has ever had in her 59 years was from a drug that came from Canada. She had a reaction to a typhoid medication. It was so bad she had to go for treatment. Her temperature was 107, and they put her in buckets of ice. Other than that, she has never had an adverse reaction. She did not really feel like this was shot related because it was lasting so long, the discomfort and fatigue. She just didn't think any of the side effects could be related to this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HEADACHE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Onset of reactive lymphadenopathy and swelling in left anterior cervical chain and supraclavicular areas on 1/15/09 with torso macularpapular rash
Very swollen and red arm, radiating heat. Went to ER and got Benadryl, steroid, and other treatment per patient.
Transient Ischemic Attack on April 14, 2021 and Transient Ischemic Attack on April 18, 2021.
Large red warm bump at injection site. Came to work my charge nurse looked at site, had me fill out incident report with shift manager. Was then sent to ER to have Dr. on duty to look at, the Dr. looked told me to rub the site so the tissue and muscle would absorb vaccine. Since time the bump is still there and are is steadily getting worse.