chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reaction/faint grey dot; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 1-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR149551   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. Additional Supportive Information: For tolerance to the 2nd dose US2022AMR149551. This case is linked to the case US2022AMR148961, US2022AMR148919, US2022AMR149560 and US2022AMR149561 reported by the same reporter. It was unknown if the reporter considered the depigmentation spot to be related to Prevnar and Acthib.; Sender's Comments:  GSK-US2022AMR148961:same reporter GSK-US2022AMR148919:same reporter GSK-US2022AMR149551:same reporter GSK-US2022AMR149560:same reporter GSK-US2022AMR149561:same reporter
Left arm pain with redness, swelling and warmth, 9x7" induration. Areas of erythema outlined, suggest Benadryl 12.5mg, monitor, follow up if not improving. Pt was c/o left arm pain after getting his 5 yr shots. Mom states that the site is red, swollen and warm to touch today. Went to school today but not as active as usual. More tired than usual. the pt has been afebrile.
Had Dtap on 3/13/07 with in 24 hrs developed redness and swelling, resembling cellulitis.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported; batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection, and suspected clinical vaccination failure. On an unknown date, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191088.; Sender's Comments: V0:  20210855314-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt rcvd vax; 4 hrs later pt had a high pitched cry; pt leg was pale almost unresponsive state & irregular breathing then normal;
Client passed out 5" after receiving vaccine when he stood up to leave.  No obvious abrasions or areas of redness or swelling.    Awoke quickly.  Ate 2 granola bars and a juice box and was feeling better.  Stayed in the clinic for 30".  C/O headache on an off.  Referred to PCP Dr. and mom stated she will talk with her husband who is a police officer and first responder.  Client walked out and was alert and oriented.
allergic reaction; rash that looks like small bumps from my side around to the middle of my front trunk; This case was reported by a other health professional via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced allergic reaction and raised rash. On an unknown date, the outcome of the allergic reaction and raised rash were unknown.   It was unknown if the reporter considered the allergic reaction and raised rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had an allergic reaction. The patient had a rash that looks like small bumps going from my side around to the middle of my front trunk.  The reporter asked what could did to help get over this.
Child was seen for initial medical exam on 1/7/2021 and reported last menstrual period 11/10/2021 with a history of irregular menses. Our provider ordered an HCG to confirm  initial urine pregnancy test that resulted negative. HCG result was positive and child was referred to OB for further evaluation.
On 1/13/2022, I took a nap in the early afternoon. When I awoke, I had body aches that were so severe that I could barely move. I also had headache, nausea, sore throat, cough, congestion, and fatigue. The body aches were so severe that my husband had to help me go up and down steps. The respiratory symptoms were so severe that I had to do albuterol nebulizer treatments every few hours. The fatigue was so severe that I would fall asleep sitting up, even when I was at the urgent care clinic. On 1/15/2022, I went to local Urgent Care where I was diagnosed with COVID-19. I had a breakthrough case.
Fever; fatigue; achy joints; headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), FATIGUE (fatigue), ARTHRALGIA (achy joints) and HEADACHE (headache) 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-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (fatigue), ARTHRALGIA (achy joints) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), FATIGUE (fatigue), ARTHRALGIA (achy joints) and HEADACHE (headache) had resolved.            Patient has stated that he has seen his HCP for his adverse reactions and he was prescribed Steroids after that his issues has resolved immediately.  Concomitant product information was not provided.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up document contains significant information- Updated medically confirmation by HCP , Provided treatment information and Updated Events outcome as Recovered
Patient states did not experience any symptoms until 2 weeks after receiving vaccine. States has been having stiff neck since and is ongoing. Denies, fever, headache, nausea, vomiting. States pain occurs when moving head side to side but not when bending neck forward. States pain level varies throughout the day. Has taken ADVIL, gotten a massage, used heating pad and icy hot while temporarily alleviate the pain but eventually returns. Patient was not concerned about it at first but states had other family members that experienced the same thing and realized it was after receiving Yellow Fever vaccine (STAMARIL). Informed Dr., advised to see PCP and to inquire about vaccine related viral meningitis. Since patient states neck stiffness has happened to two of her relatives, also patient's son and husband received vaccine 1 month after but deny symptoms at this time, Dr. suggest we report. Patient states she will keep us updated with any further treatment and outcome.
Following the first covid shot, my child got fevers and croup/ sore throat/ loss of voice three days later-that got progressively worse until one week post vaccine when she was having difficulty breathing.  It was able to be treated with inhaled steroids and a dose of oral steroids.  The croup mostly resolved and was treated with two doses of steroids.  Following the second dose she again began with a sore throat and loss of voice and croup the next day and was again treated with steroids.  She has had croup before and was hospitalized for it for severe respiratory distress five years ago but has not had significant breathing difficulties since.
Pt had a scratchy itchy throat and eyes mattering. She also states a hoarseness in her throat.
MOUTH SORES; SORES ON THE FACE; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced mouth sores. On 15-MAR-2021, the subject experienced sores on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 15-MAR-2021, and the outcome of headache, mouth sores and sores on the face was not reported. This report was non-serious.
Cough; Pain in her body; She couldn't close her hand; Diarrhea; Vomit; She had a fever for 3 days; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration on 07Apr2021 in left arm as dose 1 single (at the age of 53-year-old) for COVID-19 immunization. Medical history included Covid-19, issue with immunology. Concomitant medications were not reported. Confirmed the immunology condition was prior to vaccine. Patient clarified she had Covid twice prior to vaccine, had symptoms for 5 months, off and on, reason she went to immunology doctor, studied why she had Covid so many times. Patient stated that after first dose of the vaccine she had a fever for 3 days, cough, pain in her body, states she had no pain in her arm, states she couldn't close her hand, she had diarrhea and vomit for 3-4 days, exact dates unknown, states this lasted a few days. Patient was scheduled to receive the second dose on 28Apr2021, stated she was unable to take it due to immunology problem, wanted to know if it is it okay to get 2nd dose even though it has been 90 days since taking first dose. Patient had been advised by HCP to receive the second dose >90 days from first dose of Pfizer Covid-19 vaccine Patient was asking if that is okay to receive the second dose within that time frame.  Patient was asking if she can restart the vaccination series. Stated she does have antibodies for Covid, stated her doctor told her she had great antibodies right now. The outcome of the events was recovered on an unspecified date.
Vaccine number one administered on 2/11/21 Pfizer product Vaccine number two administered on 2/26/21 Pfizer product Number of days between 2 doses is 15.
Itchy skin since the first vaccine, worse after the second one and got almost out of control after booster shot.
Redness, swelling across entire bicep/upper arm, vancomycin given at hospital.
On Sept. 10, 2022 I received a bivalent covid booster shot at a pop-up clinic at High School to my left arm. The shot was immediately painful in my arm -- and much more painful than previous shots or boosters. The pain intensified in the days following the booster and spread to my shoulder. The pain has persisted ever since. I did not have any pain in my arm or shoulder prior to receiving the shot. I'm concerned that this is SIRVA. I went to my primary care physician today. She diagnosed frozen shoulder and prescribed a course of physical therapy.
This literature marketed report has been received from the authors of a published article, and refers to a 76 year-old male patient. His past medical history was significant for a recent episode of allergic contact dermatitis due to poison ivy, which was managed by his primary care physician with a short seven-day taper of oral methylprednisolone. On an unknown date, within a couple of days of completing the methylprednisolone taper, the patient received (manufacturer unknown) VZV vaccine, which was administered subcutaneously into the left upper extremity (dose, lot # and expiration date were not provided). On an unknown date, the patient presented with a three day history of a vesicular rash localized to the left lateral neck, shoulder, and proximal upper extremity. The rash was not accompanied by pruritus, burning, or pain. Additionally, the patient denied experiencing prodrome symptoms, such as paresthesia, pain, burning, and/or pruritus, prior to developing the cutaneous eruption. Review of systems was unremarkable. On an unknown date, physical exam findings were significant for a confluent, erythematous, vesicular eruption in a dermatomal distribution on the left inferior/lateral neck, left clavicle, left shoulder and proximal upper extremity. These findings were consistent with herpes zoster (aka, shingles). The patient was immediately started on a seven-day course of oral valacyclovir. Since the rash was asymptomatic, no topical anti-inflammatory medications were prescribed. The patient reported improvement in the eruption within 2-3 days of starting oral valacyclovir. The rash remained asymptomatic. Of note, after starting valacyclovir, the patient indicated he experienced mild, intermittent left-sided headaches, which resolved with over-the-counter ibuprofen. Otherwise, his review of systems remained unremarkable. Of note, no samples were collected from the rash to determine if the varicella zoster virus was derived from the vaccine versus a wild-type strain. The outcome of the event was considered to be recovering/resolving. The authors considered the event of herpes zoster to be related to the therapy with Zoster Vaccine Live (manufacturer unknown) as the herpes zoster developed shortly after vaccination. Additional information has been requested.
sore arm; malaise; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
chills, myalgia, low grade temp 99.5, loose  stool, premature vent beats, fatigue
injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 2, single and administration date 17Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "injection site pain".  Additional information: The reporter was the Pfizer employee and had worked on development of COVID vaccine. His wife (patient) received two doses of vaccine as noted below and experiencing intermittent pain at site of injection even after 2 months of last administration. The pain was not constant but appears randomly and lasts for few minutes to hour before subsiding. It bothers her routine activities sometimes, but not always. The reporter stated that she informed him only on Monday 07Jun2021 that the pain sure to be related to vaccine injection site.  No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after two vaccines Moderna 7/13/21 Lot# 051C21A;  Moderna 8/15/21 Lot#091D21A
rapid resting heartrate / Normally heartrate is around 62 but in this instance it was around 80; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (rapid resting heartrate / Normally heartrate is around 62 but in this instance it was around 80) in a 60-year-old female 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) at an unspecified dose. On an unknown date, the patient experienced HEART RATE INCREASED (rapid resting heartrate / Normally heartrate is around 62 but in this instance it was around 80). At the time of the report, HEART RATE INCREASED (rapid resting heartrate / Normally heartrate is around 62 but in this instance it was around 80) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up upended
Pt symptoms started on wednesday following vaccination on monday. Initially she had abdominal pain, nausea, vomiting and diarrhea. On thursday symptoms worsened with and pt febrile to 105 (per husband at bedside). EMS was called as patient developed alerted mental status.  Pt initially presented to (Community Medical Center) with hypotension concern for sepsis. While her initial LFTs on presentation showed a mild elevation in AST (60) and normal ALT on 11/11/21. Following her episode hypotension AST/ALT increased dramatically to 3690/1938. She also had rapidly worsening thrombocytopenia from 48,00 on presentation to 8000 . INR was elevated, fibrinogen was low rasing concern for DIC. At the hospital pt with renal failure requiring HD on 11/15. Labs were also notable for elevated CK of > 5000 noted to be 244 on 11/12/21. CT with perinephric standing, fecal retention concern for ileus/ suscepted colitis, and possible PNA with multifocal infiltrate. Additionally she developed painful purpura fulminans involving her hands, forearms, legs and feet during her hospitalization. Patient was transferred to shands for evaluation for liver transplant. At shands patient stablized with downtrending LFT. Now patient is recovering in hospital, no plans for liver transplant.
Patient with metastatic lung adenocarcinoma, received 3rd dose of COVID vaccine, was on holter monitor with PSVCs and PVCs, requested to come to emergency center, with nonsustained VTs,  cardiology consulted for possible ischemia,  prior history of ibrutinib, CARTOX. Patient discharged in stable condition
arm was slightly tender; arm was slightly tender, red, with a rash and itching at the injection site with no pain; arm was slightly tender, red, with a rash and itching at the injection site with no pain; arm was slightly tender, red, with a rash and itching at the injection site with no pain; lymph nodes under her armpit are sore; Slightly swollen; Left arm-red; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via intramuscularly administered in arm left on 11Feb2021 13:30 (at the age of 74-years-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 in Oct2020 and heart issues. The patient's concomitant medications were not reported. On 11-FEB-2021 19:00 patient experienced left arm-red, slightly swollen, itchy- then went into Lymph nodes under arm & side of left breast, red with a rash and itching at the injection site with no pain. On 12Feb2021 (the next day), the patient experienced arm was slightly tender. On the day of reporting, these lymph nodes really hurt. She would like to know how long these symptoms should last. The patient did not have nausea, dizziness or rash all over her body. All events were reported as non-serious by the reporter. No therapeutic measures were taken as a result of events. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on 05Oct2020 and second sars-cov-2 test result was negative on 19Oct2021. The outcome of all the events was reported as recovered.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Follow-up (25Mar2021): This is a follow up spontaneous report from a contactable consumer in response to Non-HCP letter sent which included, age of the patient during vaccination, suspect product details (start date, lot number, route of administration, anatomical location), new events (arm swollen and redness) onset time for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hives on face.  Lasted about 5 hours.  No ill feeling.  Did not seek medical attention.
Information has been received from a nurse practitioner concerning a male with no pertinent medical history and no drug reactions/allergies who on 30-AUG-2006 was vaccinated SC with a first 0.5 mL dose of MMR (Lot # 651110/1048R). There was no concomitant medication or illness at the time of vaccination. On approximately 01-SEP-2006 (also reported as 14-SEP-2006) the patient experienced fatigue, malaise and fever. On 13-SEP-2006 (also reported as 14-SEP-2006) the patient developed a rash on his face, back, and chest. The reporter indicated that the patient "wasn't sure whether he was feeling tired since he has been surfing". Subsequently the patient recovered. It was also noted that the patient has never had any other vaccinations. There were no lab diagnostic studies performed. Unspecified medical attention was sought. No further information was available. There was no product quality complaint. Additional information is not expected.
4MAR98 brought to clinic by parents listless, vomiting, clear phlegm (started this AM) rt arm swollen size of silver dollar;no erythema, stated no fever (parents checked @ home);not hot to touch;seen by MD who states had flu;