chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 21 February 2007 from a health care professional. A 65-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Adacel, lot number C2689AA, and a left deltoid injection of Pneumovax, lot number 1005F; on 22 January 2007 during a routine physical. The next day, the patient experienced fever, chills, sore arm, and "upset stomach." These symptoms resolved the following day. The patient also reported a sore, red left deltoid and skin "sloughed at the injection site." At the time of this report, the patient had not recovered. Follow up information received on 22 Marcy 2007. The patient visited a doctor on 20 February 2007 with complaint of lower abdominal bloating. After receiving the vaccines on 22 January 2007, she had swelling and erythema of the left arm that took over a week to improve. It was so erythematous that the skin actually peeled after the inflammation remitted. During that time she noted some metallic taste in her mouth, some nausea, which gradually improved over the following two weeks, slightly loose stools. The arm is completely resolved, but she still had a slightly queasy stomach and lower abdominal bloating. She had belching. She has tried some Pepcid Complete with partial relief of symptoms. Her bowel movements are generally quite regular. No melena. She does take Metamucil and that has not changes. The physician's impression was abdominal bloating and belching. Certainly consistent with acide reflux, but may also have some lower gastrointestinal symptoms as well. A trial of Prilosec 20 mg b.i.d. was prescribed.
Cold sweats and unsteadiness 10/9  about 5:15 PM, with mild nausea and abdominal pain Night sweats 10/9 and 10/10 Malaise 10/10 and 10/11 7/10  pain at injection site 10/10 and 10/11, with stiffness
fluzone QIV multi-dose vials, split the .5ml dose into 2 or 3 doses with no AE; Initial information received on 04-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult patient who administered fluzone QIV multi-dose vials, split the 0.5ml dose into 2 or 3 doses (off label use), while he/she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fluzone QIV multi-dose vials, split the .5ml dose into 2 or 3 doses (off label use) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.   No laboratory data was provided.  It was also a case of off label dosing frequency (latency on same day).  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Red, itchy, painful began 8 hrs after vaccination. Today red, itchy but not painful. Temp taken at dr's office (on 2/8/10 was 99.1 degrees F oral). Mom did not report until today.
Some of it leaked out and was enough to get her shirt wet, maybe she got 1/3 of the dose; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced incomplete dose administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, the patient received her first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  Enough product leaked out to get her shirt wet. The pharmacist reported that the patient received maybe one-third of the dose.   Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, incomplete dose administered, was considered resolved.   Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
Tight chest, cold tight in throat and chest, swollen lips, headache, flared trigeminal neuralgia symptoms
Projectile vomiting 20 mins after vaccine.  Then again 30 mins after.that.  Patient stable after second episode.  Able to take fluids PO,   Patient sent home to rest, with instructions to call 911 if any Shortness of breath,or his symptoms get worse he can go to the Emergency room.
Red rash 2x3 in size; itchy rash looked like a rectangle; Red rash at the injection site of the left arm; Red rash at the injection site of the left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Red rash 2x3 in size), VACCINATION SITE PRURITUS (itchy rash looked like a rectangle), VACCINATION SITE ERYTHEMA (Red rash at the injection site of the left arm) and VACCINATION SITE RASH (Red rash at the injection site of the left arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Nose congestion.   On 25-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Red rash 2x3 in size), VACCINATION SITE PRURITUS (itchy rash looked like a rectangle), VACCINATION SITE ERYTHEMA (Red rash at the injection site of the left arm) and VACCINATION SITE RASH (Red rash at the injection site of the left arm). On 07-Mar-2021, VACCINATION SITE INDURATION (Red rash 2x3 in size), VACCINATION SITE PRURITUS (itchy rash looked like a rectangle), VACCINATION SITE ERYTHEMA (Red rash at the injection site of the left arm) and VACCINATION SITE RASH (Red rash at the injection site of the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications was provided   This case was linked to MOD-2021-117037, MOD-2021-036644 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient details updated
Breastfeeding; This spontaneous case was reported by a nurse and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): No medical history was provided by the reporter.  The mother's past medical history included No adverse event (No reported medical history).    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Jan-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). On 14-Jan-2021, EXPOSURE VIA BREAST MILK (Breastfeeding) had resolved. Not Provided      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 concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pain, redness, swelling at injection site. Headache, fever, body aches, fatigue. Lasted 24 hours.
This case was reported by a physician via call center representative and described the occurrence of macula lutea hemorrhage in a 61-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 30 min after receiving SHINGRIX, the patient experienced macula lutea hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the macula lutea hemorrhage was unknown. It was unknown if the reporter considered the macula lutea hemorrhage to be related to SHINGRIX. Additional details were reported as follows: The patient presented with macular hemorrhage 30 to 40 minutes after receiving a dose of SHINGRIX. The health care professional (HCP) did not have SHINGRIX information, as the vaccine was given at a primary care office. The reporter was not willing to provide patient details. The reporter did not consent to follow up.
patient requested covid booster  and  after receiving covid booster asked "when she would come back for 2nd dose". Upon further questioning patient had already received covid booster on 10/30/2021 and had meant to request a shingrix vaccine
Mom phoned PHN 03/08/04 to report reaction to DTAP: onset the afternoon of 03/04/04 of swelling, redness and warmth at left deltoid site with pain. Onset 03/05/04 of generalized rash "whelps" and mom took pt to ER, also temp 101.  Pt given IM Decadron and prescribed Hydroxycine and pt improved rapidly
I was very tired, weak, fever 101, aches all over, nauseated. It lasted 24hrs.
Patient had a vasovagal response in father's truck.  He was diaphoretic and had low blood pressure 93/46.  Father informed me that son had not eaten all day.  Ambulance was called to have him checked out.  He was fine. Blood pressure went up to normal and he refused to go to the hospital.
This spontaneous report was received from a physician refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB lot # L025738, 14-AUG-2017, M008551 02-SEP-2018, M023718 09-AUG-2018. No adverse effects were reported. Temperature excursion 29.4F for 132.75 hours, 31.5 F for 40.25 hours, 46.3 F for 15 mins, 29.6 F for 58.5 hours. There was no previous temperature excursion. Additional information has been requested.
She had pneumonia for several weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "severe eczema" (unspecified if ongoing), notes: she took Dupixent for severe eczema, which she has had before vaccinated. Concomitant medication(s) included: DUPIXENT taken for eczema. Vaccination history included: Bnt162b2 (Dose:1,single), administration date: Dec2020, for COVID-19 Immunization. The following information was reported: PNEUMONIA (medically significant) with onset 2021, outcome "recovered", described as "She had pneumonia for several weeks". She took Dupixent for severe eczema, which she has had before vaccinated. She received both doses more than 6 months ago and delayed the booster shot because she had pneumonia for several weeks. She had no problems after receiving the first two doses. The patient took Dupixent, a monoclonal antibody for eczema, and she took it every two weeks for severe eczema. Pneumonia, after second vaccine, delayed booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L039638, expiry rate: 23-AUG-2017 or lot # M007124, expiry date: 05-OCT-2017). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Rash and urticaria pruritus PREDNISON 5 MD UD, hydroxyzine 25 MG QID
Fever of 100 F; on and off headache; Tired that night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100 F), FATIGUE (Tired that night) and HEADACHE (on and off headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (Tired that night). On 24-Mar-2021, the patient experienced PYREXIA (Fever of 100 F) and HEADACHE (on and off headache). On 24-Mar-2021, PYREXIA (Fever of 100 F) and FATIGUE (Tired that night) had resolved. At the time of the report, HEADACHE (on and off headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  Treatment information include paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Followup email received on 11-May-2021 contains no new information
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA 6/3/2022 &  12/20/2022  --  RECURRENCE OF SAME SYMPTOMS
w/in 2-3 days of vax pt unable to run & very weak;1wk p/vax dx w/mono--5 days p/mono dx high fever & back pain-night sweats;another blood test shows hepatitis positive;
pt had varivax vax 4MAR96 & on 3DEC97 pt came down w/chickenpox confirmed by MD clinically-being reported in relationship to vax efficacy;
Initial Pfizer injection: resulted in no symptoms except slight fatigue and soreness at injection site. Day 1 after second dose: Two brief periods of chest pain. Day 2 after second dose: Upon waking up the next day from receiving my second dose, I had extreme chest pain, but no difficulty breathing. This was exacerbated when bending down (producing an almost nauseating feeling) and/or lifting my arms. Sitting up without support increased discomfort while laying down made things more tolerable. After home testing: my blood pressure, it ranged from 103/70 to 108/70; temperature never reached over 98; and oxygen levels were 96-98. I felt as though I could feel my heart beating against my chest and generalized pain as though there was a heavy weight directly under my sternum. After napping, the pain subsided, but would always return. After activity as small as making lunch, the pain returned in full. Pa Day 3 after second dose: Woke up to chest feeling tired, as though strained and the pain could return at any moment. Still a constant dull ache. Blood pressure came in at 111/65 and resting heart rate at a range of 73-83 thus far. Trying to take it easy today so as not to cause the pain to return. General notes: I've been taking Ibuprofen and later Naproxen Sodium (ran out of the former) for pain up until day 3 (testing to see if the pain returns in full) and Zyrtec for general/pet allergies. Have taken Olly Goodbye Stress gummies up until day 3 in case of anxiety/stress worsening my condition.
Myalgia rhinorrhea, hot/cold flushes, injection site pain Narrative: Per nursing report: "2nd dose of Moderna on last Wednesday [actually Thursday], 1-21-21. On 1-22-21 c/o runny nose, muscle pain cross  shoulders, pain at site of injection and cold and hot flashes. States took off Friday  [1/22] due to feeling bad. States feels better"
Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Sep-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose). On 10-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Nurse inadvertently injected a Moderna Covid-19 vaccine to a patient as a second dose who had received the Pfizer Vaccine as their first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. Patient did not report any adverse events with both Pfizer and Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up added- Pfizer start date was added.; Sender's Comments: This case concerns a 23 year-old male patient with no reported medical history, who experienced the unexpected event of Interchange of vaccine products. The event occurred on the same day as the first dose of Moderna COVID-19 vaccine, which followed a previous dose of Pfizer COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
rash w/severe itching & low grade fever began approx 4 days p/shot persisted til 12th day 5MAR93; had shot of cortisone w/immediate relief; took DPH several more days; sx resolved completed, 2-3 days later;
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 120 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Body aches, "felt like flu" x 2 wks; intermittent h/a, fine papular red rash;
experiencing vivid and detailed nightmares /dreams daily; This is a spontaneous report from a contactable physician (patient) via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2 reported as COVID Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID Vaccine; unknown lot number and expiration date) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient reported that after the second Pfizer dose patient was experiencing vivid and detailed nightmares /dreams daily. These dreams have persisted for 3 weeks. The outcome of the event was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Patient developed fever, vomiting and diarrhea approximately 42 hours after receiving vaccines. Became pale w/cyanotic lips approximately 48 hours after vaccines. Evaluated at health center on 8/20/16, tachycardic, tachypneic, and lethargic so transferred to medical center then another hospital. Dx - Meningococcal meningitis, remains inpatient.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date of 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had two temperature excursions; one of 24 hours and other one of 32 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was 48 F (8.888888889 Celsius).  The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "overweight" (unspecified if ongoing), notes: other medical history: overweight. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 21Dec2022 to26Dec2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.