chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 65-year-old female patient. The patient had no pertinent medical history but she had allergies to "sulfas". Historical drug included Pneumococcal Conjugate Vaccine (PCV13). Concomitant therapies included numerous unspecified medications. On 24-MAY-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R000579, expiry date 09-SEP-2019; strength, dose and route of administration were not reported) as "second follow up to PCV13". On 24-MAY-2018, the patient experienced severe reaction, which included "swelling under the arm, up to the shoulder and across the chest" and the reaction "affected her breathing". On 25-MAY-2018, the patient was hospitalized due to these events. Upon the patient's office visit on 31-MAY-2018 for her follow-up hospital visit, the patient stated that she, the patient, was admitted to the hospital due to an "infection at blood draw site", which was performed also on 24-MAY-2018 but prior to vaccination with PNEUMOVAX 23. The infection started the same day as blood was drawn. It was clarified by a nurse that the patient's reaction was located "a foot away from the injection site" for PNEUMOVAX 23. The nurse stated the patient was treated for the infection at a blood draw site, not an allergic reaction to PNEUMOVAX 23. The nurse stated no antihistamines and no breathing treatments were administered to the patient. On 27-MAY-2018, the patient was discharged from the hospital. On an unspecified date, approximately in May 2018, the patient recovered from the events. The reporter did not provide causality assessment between the events and PNEUMOVAX 23. However the patient's opinion that the reaction was not related to PNEUMOVAX 23 was mentioned. Furthermore, in nurse's opinion the reaction was not due to the suspected vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-JUL-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-FEB-2016, the patient was treated by a physician for shingles and post herpetic neuralgia. The patient was diagnosed with shingles, post herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
w/in 6-8hrs the area around inj had become hot, red & swollen; in the next 24 hrs; swelling became large & was about 2 1/2" in diameter; area was very hot & hard; swelling began to dec in 72 hrs;
Patient received 4th dose when not approved for patient age, patient contacted and made aware. patient is currently ok.
pt recvd vax 1AUG95 & 22SEP95 pt devel a papular vesicular rash consistent w/varicella in the buttock area, & lower legs;streptococcal culture of anus was neg;lesions culture on 27SEP95 @ the time they were drying
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-AUG-2009 the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a health care facility (by an unspecified health care professional), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 05-AUG-2014, the patient was treated by a physician at a health care facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 25-AUG-2014, the patient sought subsequent treatment from a physician at a health care facility for ongoing and worsening symptoms of shingles and persistent pain which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damages secondary to zoster infections.  On or about 08-OCT-2015, the patient sought additional treatments at the health care facility for uncontrolled symptoms of post-herpetic neuralgia. The patient has been prescribed gabapentin and acyclovir for management of her painful and persistent symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
suffered Shigella; This case was reported by a consumer via interactive digital media and described the occurrence of shigella infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID19 VACCINE. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced shigella infection (serious criteria GSK medically significant). On an unknown date, the outcome of the shigella infection was unknown.   It was unknown if the reporter considered the shigella infection to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient took the vaccine and suffered Shigella 6 months later. The patient also took the Covid-19 Vaccine this year and so far so good. he patient requested to be careful. The follow up was not required. It was unknown if the reporter considered the shigella infection to be related to COVID19 VACCINE.
Patient received vaccine on 10/7/10. Patient called pharmacy on 10/15/10 to report a reaction - a 5 inch red, swollen area; also described as dry, hot, and scabby. The physician put the patient on AVELOX for infection. On 10/18/10, the patient said she was calling the doctor because AVELOX making her sick. We left messages for patient to call us back, but haven't heard from her. MD office said on 10/27/10 that issue is resolved.
Giant hives on legs, left arm, and neck. Benadryl was given along with calamine lotion topically.
Itchy patch on arm after first dose; Big patch on arm after first dose; Red patch on arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy patch on arm after first dose), VACCINATION SITE RASH (Big patch on arm after first dose) and VACCINATION SITE ERYTHEMA (Red patch on arm after first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy patch on arm after first dose), VACCINATION SITE RASH (Big patch on arm after first dose) and VACCINATION SITE ERYTHEMA (Red patch on arm after first dose). At the time of the report, VACCINATION SITE PRURITUS (Itchy patch on arm after first dose), VACCINATION SITE RASH (Big patch on arm after first dose) and VACCINATION SITE ERYTHEMA (Red patch on arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided Treatment information was not provided.
had shot still have it/suspected vaccination failure; suffering with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot still have it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: suffering with shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient interactive digital media. The patient was suffering right now with shingles.  The patient had a Shingles shot and still had it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Starting the day after the vaccine she noticed a huge mass in her armpit and swelling under her clavicle.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Patient reports having chest pain developing 1 day post-vaccination. It improved 7 days after onset. The patient states he has a lingering dry cough that he believes is unrelated to the vaccine. Contacted patient's PCP at patient request to have a possible appointment at the office/  PCP recommendation for 2nd dose.
Pt reported that exactly 10 days and about same time received shot experienced what she calls "spinal shock" after talking with a physician friend. She was in bathroom + experienced tingling numbness in arms/legs, sweating + uncontrollable pain where she had to fall to floor +  . After immediately ran to toilet + lost her bowels. She had no focus + laid on floor for about 30 min, then was fine + back to normal. Looked on line + found the similar symptoms linking to H1N1 component.
When evaluating the patient's vaccination card, the nurse understands that the last dose was administered on 10/24/21, so she proceeds to administer a second booster. When making a duplicate of the vaccination card, since the original was slightly mutilated, the nurse realized the patient's last dose was 12/24/22, so the booster was brought forward 10 days
swollen arm when she received the Shingrix shot; headache; felt sick; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of peripheral swelling (received flu vaccine on an unknown date and experienced swollen arm refer case US2022096941).   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced swelling arm, headache and sickness. On an unknown date, the outcome of the swelling arm, headache and sickness were recovered/resolved.   It was unknown if the reporter considered the swelling arm, headache and sickness to be related to Shingrix.     Linked case(s) involving the same patient: US2016018882, US2022096941, US2022AMR097788, US2022AMR097795   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received first dose of Shingrix into unknown arm and had swollen arm, headache and felt sick. The side effects lasted one day. The reporter did not consent to follow up. This was one of four cases, reported by the same reporter. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR097795.; Sender's Comments:  US-GSKCCFUS-Case-01417054_AE-81514: US-GLAXOSMITHKLINE-US2022096943:Same reporter US-GLAXOSMITHKLINE-US2022AMR097632:Same reporter US-GLAXOSMITHKLINE-US2016018882:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097788:Same patient, same reporter US-GLAXOSMITHKLINE-US2022096943:Same reporter US-GLAXOSMITHKLINE-US2022096941:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097632:Same reporter US-GLAXOSMITHKLINE-US2022AMR097795:Same patient, same reporter
A pharmacist reported that a child received a dose of Prevnar and subsequently developed hoarseness. The child recovered. No further information was available at the date of the report.
I felt like I had anxiety with "flutter" sensation in my chest. I checked my blood glucose and it was normal. I checked my blood pressure and it was above the normal range for me. Went to see my primary care physician to check by blood pressure and they prescribed a blood pressure medicine, metoprolol. Also drew blood for analysis.
mom described onset of fever & fussiness 1APR99;faint rash began 12APR99 on arms & hands;seen in office 15APR99 for a generalized petechial rash & rt OM;labs ordered-no tx;rash almost resolved;
Delayed receiving second dose because of COVID-19 pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient was delayed receiving second dose because of COVID-19 pandemic and pharmacy delays in receiving Shingrix vaccines and had not yet been administered. The pharmacist was not able to provide lot number and expiration date of first Shingrix vaccine. The VAERS details were reported for 1st dose of Shingrix. The reporter consented to follow up.
-headache starting evening of the injection (1/28/21) -fatigue and headache throughout the following 2 days so through 1/30/21 -chills briefly the morning of 1/29/21 -sweats the evening of 1/29/21 -no fever measured
Around 2AM the following day, pt reports waking up w/ drenching sweat, shallow breathing, low blood pressure (self test approximately 90/60), and states "fought passing out for one hour."
I was having chest pain 03/02/2023. I had a fever and chills. Cough and body aches and my throat was sore can diarrhea and congestion.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (other healthcare professional). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: Unknown), in left arm for Covid-19 immunisation, coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: Unknown), as dose 2, single (Batch/Lot number: Unknown) and as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "Breast cancer", start date: 2018 (unspecified if ongoing), notes: in remission/groundglass lesion in lung. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (01Aug2022) Negative; (10Aug2022) Positive, notes: with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication in 2weeks. Patient received Paxlovid treatment, start date: 27Jul2022, treatment stop date: 01Aug2022, lot number: 2815213. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
URTICARIA; blisters Narrative:  follow up: 1/10/2020 patient in clinic with c/o rash, blistering, and  pain at flu injection site from flu shot given on 12/01/2020. Patient called and  states that he has a rash with red bumps and some blisters about as large as a dollar bill. Not having a hard time lifting arm, declares the pain is 7/10 achy pain. Flu shot given on 12/1/20 and he states this started o 12/3/20 with itching and has progressed to this. Has been putting Hydro-cortisone cream on and it has not been helping him. Patient states that about 2 days after he received the flu shot he started getting blisters and open skin areas on the area where he was given the  flu shot. States arm is painful. Was using neosporin but states that did not help.  Also states that he was using the eclobetasol cream on his rash on his legs and  states it has not helped. Patient feels like he needs an abx for this to heel. States the rash and blisters on his left deltoid only showed up after he got the flue shot.  follow up: 1/7/2021 a 73 y/o MALE walked-in this morning with c/o persistant rash. Chart reviewed; Patient last seen face-to-face at PCP appt 12/1/20, rash discussed and evaluated at that time. Per PCP Note, "rash to both lower legs x 2-3 weeks. papular, pruritis above ankle, scaly patch ant L ankle rash on both LE ., L>R . no known bites/stings or exposure," Rash appears very similar at today's visit. Patient states rash is present to BLE. Patient recently finished a Prednisone dose Pack for c/o rash/redness to swelling to arm after receiving the Flu Vaccine. Patient states this did help his BLE rash as well. ASSESSMENT: No redness, swelling or warmth noted to the legs. No drainage or bleeding noted.  No blisters noted. Skin blanches, and pedal pluses present and equal bilaterally.  Patient has scaly, dry skin noted to lower extremities, and small (pin-point) area of open skin. It appears as if patient has been scratching at his legs. Patient  admits to rubbing his legs. Patient states his legs itch, and burn. Patient c/o pain in the legs. Patient ambulated in a clinic today without assistive devices. Gait is normal and steady. No limping, guarding or grimicing noted. RN CONSULT with PCP. Topical Ketoconazole Cream ordered, and Miconazole RX renewal  requested. Patient advised to use topical cream BID for comfort/relief. Patient advised he may also get Aveeno Oatmeal Based Lotion, or Eucerin Lotion OTC for relief of Dry Skin and Itching. Patient advised to apply topical RX cream to clean dry legs, and use OTC lotion intermittently for additional comfort/relief.  Provider: Reason for contact : Recalcitrant LE rash He reports frustration with rash, persists despite PC measures. Discussed Dermatology recomendations with him in detail. chronicity,incurable but treatable Strategies to avoid dry skin Educated on use of Moisturizers - issue Hydrocerin Clobetasol oint x2wks then Tacrolimus 0.1% oint prn if rash persists or recurs keep using for up to one week after rash is resolve Avoid chemical irritatns.
Localized itch after 2nd dose of vaccine. Treated w/Bendryl. Has environmental allergies. No drug allergies.
Diarrhea all day, body aches, fever of 100.4 degrees, couldn't maintain body temperature (was sweating one minute and freezing the next), overall grogginess, body pain
Information has been received from a certified medical assistant concerning a 4 year old white female, also reported as an adolescent, with no past medical history and no known drug allergies who on 11/1/99 was vaccinated in the leg with a first dose of varicella virus vaccine live (lot C7165). There was no illness at the time of vaccination. On 4/10/03 the patient presented to the doctor's office with a moderate case of chicken pox. Unspecified medical attention was sought. Follow up information that on 4/10/03 the patient was seen in the office with complaints of itching on her arms, legs, and stomach with small pustules. The child was recently exposed to another child with varicella. The child was diagnosed with varicella. The outcome was reported as recovered. The reporter indicated that the patient's sister was vaccinated with a dose of varicella virus vaccine live and developed a moderate case of chickenpox. No further information is expected.
Pt. states that after receiving the 2nd dose of Moderna 05/2021, started experiencing symptoms of difficulty lifting (Left) arm, extreme pain throughout arm, swollen lymphnoids, Chest pain, flu-like symptoms, shortness of breath, and heart palpations. Primary visit 10/2021 recommended Physical Therapy.
pt exp elevated BP 160/80 & HR 100, shaky, lightheadedness w/in 20 minutes p/vax, tx Epi & w/in 25 minutes BP dec to 136/78, pulse 80; next 5 days had h/a, weakness, lethargy & soft stools;
red rashes right arm, rash on my right breast on April 21, 2021  light headedness briefly one day after April 10 Light headedness on April 18
3 days p/vax pt devel a scratchy throat, watery eyes & sinus & nasal congestion;