chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown.            Relevant concomitant medications were not reported.  Patient received first and second dose of Moderna COVID-19 vaccine and experienced heart palpitations really bad for 6 weeks. After that patient took Pfizer COVID-19 vaccine as booster dose and experienced same event and it kept the patient up for hours at night.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Fine rash started 1/07/15 at 6pm, on face 1st, spread to entire body 1/8/15. 1/9/15 to ER, and ER Dr thought was the vaccines. Low grade fever started 1/7/15, highest fever was 101 degrees. Gave BENADRYL on 1/9/15.
Died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Relevant concomitant medications were not reported. No treatment medication was provided.  Company comment: This case concerns a 17-year-old female patient with no medical history provided, who died due to unspecified reason (serious unexpected event of Death) after receiving the mRNA-1273 vaccine. The dose of the vaccine was not provided. Furthermore, the temporal relationship between vaccination and death remained unknown, since the date of vaccination and date of death were not disclosed. It was also unknown whether the autopsy was performed. Limited information precludes a meaningful medical assessment. The rechallenge is not applicable as the patient died. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-447283, MOD-2022-447300, MOD-2022-447299 (Patient Link).; Sender's Comments: This case concerns a 17-year-old female patient with no medical history provided, who died due to unspecified reason (serious unexpected event of Death) after receiving the mRNA-1273 vaccine. The dose of the vaccine was not provided. Furthermore, the temporal relationship between vaccination and death remained unknown, since the date of vaccination and date of death were not disclosed. It was also unknown whether the autopsy was performed. Limited information precludes a meaningful medical assessment. The rechallenge is not applicable as the patient died. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Pt recv vax on 2/23/99; approx 1 hr post vax pt exp diarrhea, vomiting, eyes rolled back in head, passed out, lethargy
Extreme soreness in left arms, unable to move left arm, fainting spells , dizziness and passing out
muscle in arm was very sore for 2 or 3 days & then sore yet for 4 or 5 days afterwards;It felt hot to touch & a 2" reddish circle was visable for several days p/first 2 days;
Developed diarrhea, vomiting & temp 105(r) approx 7.5 hrs p/receiving vax; Diarrhea was severe x 12-15/24hrs; VOmiting & diarrhea con't for 14 days; tx tylenol q 4 hrs, Pedialyte;
Painful for 24 hrs / Very painful; This case was reported by a consumer via call center representative and described the occurrence of pain in a 71-year-old 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. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's 1st dose was painful for 24 hours.  This case is linked to another case US2019AMR211993 for the same patient (2nd dose).
Janssen COVID-19 Vaccine EUA: patient received vaccine in the morning then later that afternoon developed fever, chill, backache, upper abdominal pain, malaise.  Presents to emergency department (ED) with vital signs within normal ranges. Temperature 37.7 degrees Celsius. Patient received ondansetron and intravenous fluids. Discharged home medically stable with symptom improvement.
little surgery on back; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (little surgery on back) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SPINAL OPERATION (little surgery on back). At the time of the report, SPINAL OPERATION (little surgery on back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient had went to a dermatologist and a little back surgery was performed on the patient. It was also reported that the patient was on antibiotics for seven days and this antibiotics were to prevent infection.
Patient is a 68 year old male who was being seen by his primary care doctor for diabetes and dyslipidemia management. During the visit the patient received a pneumococcal polysaccharide vaccine injection intramuscularly in his right deltoid. Patient called the clinic two days later complaining of generalized right arm swelling, redness and pain and was advised to return to the clinic for examination. The patient was treated with amoxicillin 875/clav K 125mg tab; take 1 tablet by mouth twice a day for 7 days with food, diphenhydramine HCL 25mg cap; take one capsule by mouth three times a day as needed for allergies and prednisone 5mg tab dosepak as prescribed and the swelling and pain resolved within one week. And Generalized right arm swelling, redness and pain. Amoxicillin/Clavulanate tab BID, Diphenhydramine 25 mg TID, Prednisone tab other.
pt recv vax;on 14jul95, visited MD for D&C & found out she was pregnant;subsequently had a spontaneous abortion;
Arm mobility decreased; arm pain; injection site lump; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 2nd dose of Shingrix. In January 2019, less than a month after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm and injection site lump. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm and injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine, the patient was not able to lift arm out to the side without pain and had a lump within the muscle where the vaccine was given. Till the time of reporting, the patient had the issue. The patient asked for advise that what to do.
Extreme pain down arm from injection site (shoulder) down through elbow. Severe stiffness in arm,  can't use arm.
Patient showed up 2 days after PNEUMOVAX was given and complaining that she could barely lift her arm it was so sore. I instructed her to follow up with her primary care doctor to get checked out and make sure everything was ok. She said it was starting to get a little better but still hard to lift her arm and she was concerned.
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 12-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 888 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had the vaccine and within 24-48 hours he began to experience pain on his right side-primarily abdomen area.  He lives alone and is 86 years old.  The pain got worse so he was taken to the hospital.  He reports being told that he had a heart attack.  He is still in the hospital at this time, but felt that he should report it.  He does not know who is doctor is.
This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a 63-year-old female patient who received FLUARIX TETRA QIV. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX TETRA, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to FLUARIX TETRA. Additional details were received as follows: The patient experienced a bad reaction while using FLUARIX quadrivalent (season unspecified). No further information was available.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 6-month-old patient, who on 25-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 428 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012766.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. After the improper storage reported as 04-SEP-2014, on unspecified date(s) of 2014, the patients were vaccinated with 4 doses of improperly stored GARDASIL (lot#, dose, route and frequency were not provided). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
difficulty breathing; skin allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003102 (Novavax).  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "recovered", described as "difficulty breathing"; DERMATITIS ALLERGIC (non-serious), outcome "recovered", described as "skin allergies".  Additional information: It was reported that the symptoms lasted for a week.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-364352, MOD-2021-363245, MOD-2021-363032, MOD-2021-363226 (Patient Link).
patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Dose given at he time of puncture 03-Sep-2021, was obtained on 01-Jun-2021 and kept in the freezer until date of puncture, then stored in refrigerator.   This case was linked to MOD-2021-418964, MOD-2021-423000, MOD-2021-423024, MOD-2021-423025, MOD-2021-423026, MOD-2021-423027, MOD-2021-423028, MOD-2021-423048, MOD-2021-423050, MOD-2021-423052, MOD-2021-423053, MOD-2021-423056, MOD-2021-423058, MOD-2021-423308, MOD-2021-423320, MOD-2021-423321, MOD-2021-423339, MOD-2021-423351, MOD-2021-423357, MOD-2021-423365, MOD-2021-423371, MOD-2021-423372, MOD-2021-423373, MOD-2021-423395, MOD-2021-423396, MOD-2021-423397, MOD-2021-423398, MOD-2021-423431, MOD-2021-423432, MOD-2021-423433, MOD-2021-423434, MOD-2021-423435, MOD-2021-423436, MOD-2021-423437, MOD-2021-423438, MOD-2021-423439, MOD-2021-423440, MOD-2021-423449, MOD-2021-423450, MOD-2021-423451, MOD-2021-423458, MOD-2021-424031, MOD-2021-424075, MOD-2021-424078, MOD-2021-424081, MOD-2021-424082 (Patient Link).
the patient received improperly stored vaccine; This spontaneous report was received from a nurse referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 30-SEP-2019, the patient received 1 dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004251 and expiration date 22-SEP-2020; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). The vaccine underwent temperature of 1.4 Celsius for a duration of 20 minutes. The previous temperature excursion of 10.5 Celsius for a duration of 56 minutes. The call was because of data logger.
She received flu shot in Lt. arm on 10/23/2013; approx 2 hours later her nose started running clear liquid, then Lt. hand and Lt. side of face became numb and her speech was slurred.  She declined to have ambulance called and was taken to local health unit by home health nurse.  B/P was 170/110 other vitals were wnl.  EMS was called approx 20 minutes after symptoms, B/P remained elevated at 182/110 and 180/110.  EMS arrived and transported pt to ER.  MD told her she may have experienced a TIA.  CT scan done at hospital did not reveal any findings and pt was allowed to go home.  Pt reported to work the next day to fill out workman's comp papers and reported symptoms had resolved.
her daughters covid 19 infection lasted about 4-5 days; her daughters covid 19 infection lasted about 4-5 days; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent. A 20-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "recovered" (2021) and all described as "her daughters covid 19 infection lasted about 4-5 days". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative; (2021) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The parent called on behalf of her 20-year-old daughter just received her 'third dose' of the Pfizer covid vaccine today (21Dec2021). She stated that her daughter recovered from covid 19 about 2-3 weeks ago (around thanksgiving [Nov2021]). States her daughters covid 19 infection lasted about 4-5 days (Nov2021), she isolated for 10 days (2021), tested negative twice afterwards (2021). She confirmed that her daughter received primary series of the Pfizer covid vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever, malaise,  diarrhea within 12 hours after Prevnar. Also some scatted papules lower abdomen
Patient called 7/12/22 to report that since having the booster on 7/8/22 until today patient experienced severe pain to Right deltoid site of injection. Also experienced feeling cold, sore throat, headache. States could not work. Is planning to go to work tomorrow as she is feeling better.
received expired dose yesterday.; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd March 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-Mar-2022 Reporter's Comment: The reporter consented to follow up. Additional supportive information: On the day before reporting, the patient received an expired dose of Twinrix, which led to expired vaccine used.
Fluzone Quadrivalent pre-filled 0.5mL syringes were administered that was delayed in transit, no AE; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with 2019SA265062 (18 month old patient administered with another dose).  This case involves a 2 years old female patient who received 0.5 ml dose vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6645LA, expiry date:30-Jun-2020) via intramuscular route in the left thigh), on 13-Sep-2019 which was delayed in transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Patient reported itching, some swelling, and localized pain around injection site and extending to surrounding tissue. Patient reported improvements in symptoms since injection date on 5/9/17 but still experiencing some pain.