chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer (patient's mother) regarding her 17 year old daughter. There was no information on pertinent medical history and drug reactions or allergies. On 17-OCT-2013, the patient was vaccinated with first dose of GARDASIL injection dose reported as 1 dose, route, product lot#, expiry date not reported to prevent strains of HPV. There was no information on concomitant therapy. The reporter states that on an unknown date in March 2014, her daughter was experiencing inflammation in all of her joints, swelling, pain, and weakness after receiving the first dose of GARDASIL. She also stated that all of these symptoms were escalating to the point where the patient was almost debilitated. The patient sought unspecified medical attention and as per physician's recommendation the patient did not receive the second and third doses of GARDASIL. Treatment was given for the adverse events. The treatment medications included unspecified steroids, Doxycycline, Ibuprofen and unspecified anti-inflammatories. Major unspecified laboratory diagnostics studies were performed. There was no product quality complaint involved. The outcome and causality was unknown.
On left deltoid one day after receipt of second Varicella and Menactra, patient developed redness, swelling and tenderness at the site. Also had warmth at the site - redness about 10cm diameter. Seen in Urgent Care 2 days after vaccination - prescribed 10 day course of Keflex for suspected cellulitis.
devel hives & swelling all over body;seen @ hosp ER 8PM adrenaline given sent home w/instructions given DPH;seen @ clinic 20APR99 11AM again w/welts/hives adrenaline given;
I was awakened early Tuesday morning with my left arm sore. It continued to get worse. Lost the range of motion and was becoming very painful. I made an appointment with my doctor Friday 10/6 pain in my left shoulder joint and arm. I thought I had damaged my rotator cuff or had tendinitis. The doctor suggested that I take anti-inflammatories and make an appointment for physical therapy. Over the weekend I lost all ability to move my arm. I couldn't even lay down to sleep. By Saturday or Sunday (can't remember right now one of the two) night I went to the hospital extremely painful couldn't even hold anything with my left arm. I talk with the emergency doctor about possibly having an adverse reaction to my flu shot. I've had tendinitis before and the pain I was experiencing greatly surpassed anything I felt from tendinitis. I can't take anything other than an acetaminophen and aspirin for pain. When I got home from the hospital I started taking TYLENOL and two BENADRYL every five hours. After one full day of taking BENADRYL and TYLENOL there was some improvement. By Tuesday my ability to move my arm improved markedly. By Wednesday I had full use of my arm. No more pain and full range of motion returned.
cold like symptoms; exposed to covid; This is a spontaneous report from a contactable consumer or other non-HCP communicated to a Regulatory Authority. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 (Lot number was not reported), as DOSE1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cold like symptoms and exposed to covid. Patient received first dose 27Mar2021 and due for second 15Apr2021, had cold like symptoms and has been exposed to covid and currently waiting on results from Covid test. Patient would like to know what the protocol is if she tested positive. No unaddressed medical questions referred or forwarded to Medical Information. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Client described her tongue as feeling swolen 10-15 minutes after receiving vaccine. Epinephrine and Benadryl administered, client transported to ER. Client was observed in ER for one hour, then sent home.
Patient experienced diarrhea with Verzenio 150mg. She states that was able to stay on top of it in the beginning, but after she receive the updated COVID vaccine she spent the majority of the next 2 days resting in bed and was not able to stay on top of it, resulting in severe dehydration for which she was hospitalized 10/1 thru 10/4/23. Situation has completely resolved as of 10/13/2023 an she is planning to restart Verzenio at a lower dose (100mg) ASAP per oncologist recommendation.
Woke up at midnight with severe chills. Took warm bath and noticed entire right arm ached and right hand joints swollen. Began vomiting X 20. At 2:00 AM temp was 101 F. and right neck gland was swollen, right ear ached , and right eye lid was swollen. Chest felt heavy and shooting pains from right side across chest, 3:30 stomach settled . At 6:00 AM all symptoms  still present but very diminished. 11:00 AM some residual knuckle swelling, other signs and symptoms gone. No difficulty breathing. Slight tenderness at injection site at injection site on right deltoid. Called hospital at 3:00 AM-told it was flu shot.
Pt recvd 3 doses of vax p/3rd dose exp a fever of 104;
multiple pulmonary emboli; This is a spontaneous report from a non-contactable consumer (patient's wife) via Medical Information team. A 72-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date were unknown) on 19Jan2021 and experienced gradually being short of breath, which was further described as "he would walk for 50 yards and he would be huffing and puffing." The patient's medical history and concomitant medications were not reported. It was further reported that about 8 days after the first one, the patient started noticing gradually being short of breath. He would walk for 50 yards and he would be huffing and puffing, which was unusual, because he could walk a lot. It gradually got worse and then after the second one, it continued to get worse and he finally ended up in the hospital for 3 days with multiple pulmonary emboli on an unspecified date. The reporter was asking if this had been reported with the vaccine. The patient was hospitalized for the event multiple pulmonary emboli on an unspecified date for 3 days. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her male child, who on an unknown date, was vaccinated with a dose of PEDVAXHIB (Lot #, dose and route not reported). Concomitant therapy might have been PENTACEL and PREVNAR. Consumer reported that, on an unknown date, her son was given five live virus vaccines all at one time and developed screaming for three hours, fever and injection site redness. The mother was not sure what products were given since this was some time ago. At the time of the report, the patient's outcome was unknown. No further information is available.
Pt. states that he became hot and dizzy while experiencing tunnel vision. A friend with the pt. stated that he fell out of the chair he was sitting in but did not hit his head on the floor. EMS and an on-scene Dr. made immediate pt. contact. It was determined that the pt. experienced a syncopal episode. He was already regaining consciousness upon arriving at his side. Vitals were taken and pt. recovered over time. Pt. signed an AMA and was taken home by a friend.
SEVERE MIGRAINE; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a consumer/non healthcare professional (patient's mother) concerned a 22 year old female. 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, batch number: Unknown) dose was not reported, frequency 1 total, administered on 07-APR-2021  Vaccination site was left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced body aches, chills, weakness. fever and severe headache with eye involvement. Patient was taken to the Emergency Room and was told that the vaccine caused a severe migraine. The reporter sought compensation of patient's medical bills. Patient was hospitalized and discharged on 30-APR-2021. Patient was hospitalized for 1 day. Patient was hospitalized on 30-APR-2021. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from body aches, chills, and fever on 2021, and the outcome of severe migraine was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210539285-COVID-19 VACCINE AD26.COV2.S- severe migraine, body aches. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210539285-COVID-19 VACCINE AD26.COV2.S- chills, fever. This event(s) is labeled per RSI and is therefore considered potentially related.
arm pain; This case was reported by a consumer via (Shingrix) call center representative and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine and no problems other than arm pain. The follow up would not be possible as no contact details were available. For tolerance of 2nd dose, refer case US2021AMR191198, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR191198:same patient, different dose
8 cm circle, irregular red border (target like). No redness or swelling, fever localized.
Vesicles 0.3cm on trunK & extremities multi 20-30 pink papules.
This spontaneous report as received from a nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-SEP-2018, the patient was inadvertently vaccinated with a dose of VAQTA, lot # N016805, intramuscular, which expired on 04-SEP-2018 (exact dose, frequency and site of administration were not reported). No adverse effect was reported.
Aching all over, then just in the hip and to the knee. I went to the doctors office and they gave me steriods, cyclobenzaprine 10 mg tablet FLEXERIL, and celecoxib 200 mg capsule CeleBREX. Has not helped with the issue and I am still in great pain today (April 26th). It is so bad that I have fallen at work and home. It makes me very nervous now because I do not need to end up breaking something or getting hurt really badly because I did what was right and took this shot. I also have a full hysterectomy scheduled for May 18th.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 06-SEP-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml, single dose vial of sterile water for injection, for drug diluent use, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
This spontaneous report as received from a consumer who is a male patient of unknown age. The patient's medical history included shingles on his scalp in July 2012. In February 2012, patient had undergone unspecified steroid treatment in a nebulizer for months due to a respiratory infection and no allergies were reported. On 10-DEC-2013 the patient was vaccinated with ZOSTAVAX (strength, dose and frequency unknown). Concomitant therapies included atorvastatin (manufacture unknown) and trazodone hydrochloride (manufacture unknown). On 10-DEC-2013, he first had brief redness or soreness at injection site which quickly disappeared. However, after 24 hours the vaccination patient began to experience extreme sensitivity of the skin and torso. This skin sensitivity flared late over the next days, and has intensified, with a painful sensitivity stretching from back to torso as of 17-DEC-2013. The patient has no rash, redness, lesions or itching. Patient sought medical attention and has not received any treatment. No laboratory tests were performed. The outcome of redness or soreness at injection site was reported as recovered/resolved. The outcome of extreme sensitivity of the skin on torso, skin sensitivity flared over the next days and has intensified with a painful sensitivity stretching from back to torso was unknown. Additional information has been requested.
The patient came on her Day 16 to get second vaccine; The patient missed her Day 7 dosage; Case reference number US-BN-2021-002379 is a spontaneous case report initially received from other health professional via regulatory authority (reference ID: USBAV21-0547) on 28-Oct-2021 and concerns a 23-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 12-Oct-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number: ARBA851C), at a dose reported as 'standard', administered intramuscularly, for pre-exposure.   On an unspecified date in Oct-2021, the patient missed her day seven dose (explicitly coded as 'Missed dose'), and the patient came on day 16 to get second vaccine (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown whether the patient experienced any adverse event.  The reporter assessed the case as non-serious and not related to RabAvert.  No further information was provided.; Reporter's Comments: The 23-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported, on an unspecified date the patient missed her day seven dose, which is considered product dose omission issue, and the patient came on day 16 to get second vaccine, which is considered inappropriate schedule of product administration. No associated adverse events were reported with the reported medication errors. The events of product dose omission issue and inappropriate schedule of product administration are considered listed per convention. The patient's medical history and concomitant medication details were not provided. The causality for the events of product dose omission issue and inappropriate schedule of product administration is assessed as not related to the suspect vaccine, but to a human action. This case is considered non-serious.; Sender's Comments: The 23-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported, on an unspecified date the patient missed her day seven dose, which is considered product dose omission issue, and the patient came on day 16 to get second vaccine, which is considered inappropriate schedule of product administration. No associated adverse events were reported with the reported medication errors. The events of product dose omission issue and inappropriate schedule of product administration are considered listed per convention. The patient's medical history and concomitant medication details were not provided. The causality for the events of product dose omission issue and inappropriate schedule of product administration is assessed as not related to the suspect vaccine, but to a human action. This case is considered non-serious.
w/in 5 min of receiving vax pt broke out in hives around face & neck & trunk; pt was taken to ER & given DPH;
Pt received Varivax on 10/22/1997 at age 16 mos. Confirmed chicken pox after exposure to father with shingles on 04/19/04. Was seen in ER on that date + office on 04/22/04.
patient's first dose was a Pfizer COVID-19 vaccine and their second was a Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient's first dose was a Pfizer COVID-19 vaccine and their second was a Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient's first dose was a Pfizer COVID-19 vaccine and their second was a Moderna COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient's first dose was a Pfizer COVID-19 vaccine and their second was a Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided by the reporter.
scratch marks all over; Keeps me up at night; It got so irritating; itching/initially in his arms, then moved on to his stomach,then his legs/internal itching/gotten progressively worse and sill experiences it/ itching moves to different parts of his body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching/initially in his arms, then moved on to his stomach,then his legs/internal itching/gotten progressively worse and sill experiences it/ itching moves to different parts of his body), SCRATCH, SLEEP DISORDER and SKIN IRRITATION in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010A21A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL, ROSUVASTATIN and LISINOPRIL for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PRURITUS (itching/initially in his arms, then moved on to his stomach,then his legs/internal itching/gotten progressively worse and sill experiences it/ itching moves to different parts of his body). On an unknown date, the patient experienced SCRATCH, SLEEP DISORDER and SKIN IRRITATION. The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Itch, at an unspecified dose and frequency; GABAPENTIN for Wakefulness, at an unspecified dose and frequency and PRAMOCAINE HYDROCHLORIDE (CERAVE ITCH RELIEF) for Itch, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching/initially in his arms, then moved on to his stomach,then his legs/internal itching/gotten progressively worse and sill experiences it/ itching moves to different parts of his body) had not resolved and SCRATCH (scratch marks all over), SLEEP DISORDER (Keeps me up at night) and SKIN IRRITATION outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood test: normal (normal) normal. In September 2021, Computerised tomogram: normal (normal) normal. In September 2021, Magnetic resonance imaging: normal (normal) normal.         The patient stated that he started experiencing itching at the beginning of Apr-2021. It started initially in his arms, then moved on to his stomach, and then his legs. He said that the itching was internal and not on the skin. It had gotten progressively worse and he still experiences it. The itching moves to different parts of his body. It has gotten so bad that it keeps him up at night.  The patient saw his doctor in Sep-2021.  The patient also said that he tried some over the counter creams and other treatments, none of which helped him in subsiding the itching. He tried some OTC Claritin and allergy medicines, which didn't work, Gabapentin - doesn't help itching, helped him sleep, and Cerave itch relieving moisturizing cream - didn't work.
sporadic rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (sporadic rash) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (sporadic rash). At the time of the report, RASH (sporadic rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Drug details were reported.  No Treatment information was provided.  Patient had sporadic rash after 2 weeks of vaccination.
About 48 hrs after vaccine administered, patient complained about a sore arm. She said it felt pain like a tetanus shot. She 2 red rash around the injection site. I checked on her the next day and the pain was better and rash cleared.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 31-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S023499 and expiration date 08-AUG-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes,  with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
2 days p/taking Hep vax, child devel red itchy rash & hives all over; 2 days later hives getting more cranky & had edema & swelling of both feet;
Pt vaccinated with Engerix-B developed diarrhea, fever, nausea, tightness in chest, congestion, cough.