chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Headache, Fever, NauseaVomiting, fatigue, achey, Narrative: Pt reported had the following ADRs to 2nd dose of covid vaccine on same day received the vaccine: headache, fever, nausea, fatigue, & achey. Pt took tylenol & ibuprofen for relief.  Other Relevant History:
Mother called on 8/20/18 and stated "she did not approve of the Hepatitis A vaccine it made her son tired, wheezing, dizziness, and shortness of breath. 8/21/18 I talked to mother she stated that on 8/20/18 her son was feeling better he is tired and not short of breath".
pain began rt breast area then moved to other areas most prominent on knees bright red rash which spread to different areas of body; cough treated w/Pred;
This spontaneous report as received from a 63 year old male patient, who was referring to himself. The patient was in good health and did not been bedridden with colds / flu in life in 30 year, immune system pretty good. He got flu vaccine 01-SEP-2017. No other information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 15-NOV-2017, the patient was vaccinated with ZOSTAVAX (dose, route of adminstration, indication, lot #, expiration date were not reported). In approximately November 2017, the patient experienced no side effects except the normal redness and burning sensation. The patient waited 2 and a half months after getting flu vaccine before the ZOSTAVAX and asked how long should he wait to get PREVNAR 13. The patient was advised to go back to his doctor because he/she knows best of his medical conditions and most appropriate to make the recommendation. The outcome of injection normal redness (mostly went away 24 hrs) and burning sensation (for a couple of week then went away) was reported as recovered/resolved. Causality relatedness was not reported.
PT HAS BLACK AND BLUE ARM AND SORE TO MOVE.  STARTED THE DAY OF THE SHOT. HAS APPLIED ICE
Broke out with rash on 9/3/07. Seen in office 9/4/07; diagnosed with Varicella.
The patient came to the pharmacy to fill an antibiotic. Upon questioning what the particular indication was for the medication the patient informed us that it was due to her ZOSTAVAX injection on her right arm. It did not look to be the typical reaction to this particular vaccine. Patient was being treated for cellulitis.
IMOVAX in the same site as the globulin with no adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp. Agency number: 01292287.  This case involves an unknown age male patient who experienced Rabies (HDC) Vaccine [Imovax Rabies] in the same site as the globulin with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect RABIES (HDC) VACCINE at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization. Information regarding batch number requested.  On an unknown date, the patient received imovax in the same site as the globulin with no adverse event (contraindicated product administered) at unknown latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.   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 the 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.
1st Dose of Moderna on 30-Mar-2021 and 2nd Dose on 27-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 30-Mar-2021 and 2nd Dose on 27-May-2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037b21a and 016b21a) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol (Use meds), Blood pressure high (Use meds) and Penicillin allergy.   On 30-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 30-Mar-2021 and 2nd Dose on 27-May-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 30-Mar-2021 and 2nd Dose on 27-May-2021) outcome was unknown. Not Provided          Patient was taking medications for High cholesterol and blood pressure. It was reported that the patient previously received a COVID-19 Vaccine. Treatment information was not provided.   This case was linked to MOD-2022-579897 (Patient Link).
Case number PHEH2014US018214 is an initial spontaneous report from the consumer received on 09 SEP 2014. This report refers to an adult male patient. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145402) at a dose of 0.5 ml intramuscularly on an unknown date. It was reported that the vaccine received by the patient had been stored at 32F for 10 hours before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Patient described a rash that appeared one day after getting the vaccine. She experienced a rash and itching on the arm that she had the vaccine. The rash and itching did not spread to her full body, but it took several days to begin subsiding.
May  22 - 24, 2022  -- had fatigue, headache, sinus pressure, aches, fever, chills, nausea, brain fog May 28, 2022 -- lost control of fine motor skill in right arm and couldn't write with a pen and couldn't stop hand and arm from shaking June 12 - 21, 2022 - extreme sinusitis and massive headache and shooting pain up trigeminal nerve on right side of head into ear, eye and back of head.  had to take acetaminophen and ibuprofen every half hour to get ahead of the pain until doctor put me on gabapentin
This spontaneous report as received from a registered nurse refers to two patients of unknown age. On an unknown date, the two patients were vaccinated with PNEUMOVAX23 (lot # H017759) at different unspecified time. The dose, frequency and route of PNEUMOVAX23 was not specified. At an unspecified time after administered PNEUMOVAX23, one patient experienced cellulitis and fever, and the other patient just started to develop symptoms similar to the patient just mentioned. The outcome of the patient with cellulitis and fever was unknown; the outcome of the other patient was unknown. The primary reporter required a lot check. No PDC reported. Additional information has been requested.
Following 3rd DTP vax pt had a screaming/crying episode that lasted >3 hrs; cry was high-pitched; mom gave APAP during 1st 24 hrs following vax;
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient passed out momentarly after receiving vaccination in her chair, patient quickly awakened and responded that she is ok. Instructed patient to lay down and elevate legs and had gatorafe. Asked if she wants an ambluance, patient indicated that this is normal when she seees needles, happened before when she gave blood. patient fully recovered and felt no symptoms, asked family members to pick her just incase. Pharmacy will follow up with patient before closing, will follow in the morning
Tested positive for COVID-19; Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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 products were  reported. No Treatment information was provided.  The reporter stated that the patient got the first Moderna COVID-19 vaccination and then tested positive for COVID-19. The patient missed their second dose due to quarantine and were now going to get vaccinated past the 42 day window. The reporter did not want to provide the patients concomitant medication list and was unsure of when the patient tested positive for COVID-19. This case concerns a 47 year old male with no reported medical history, who experienced the non-serious, unexpected event of Covid 19 and Product dose omission issue  , which occurred on  an unknown time  after vaccination with the 1st dose of mRNA - 1273 (Moderna). The re-challenge for this case is not applicable. The benefit - risk relationship of mRNA-1273 (Moderna ) is not affected by this report.; Sender's Comments: This case concerns a 47 year old male with no reported medical history, who experienced the non-serious, unexpected event of Covid 19 and Product dose omission issue  , which occurred on  an unknown time  after vaccination with the 1st dose of mRNA - 1273 (Moderna). The re-challenge for this case is not applicable. The benefit - risk relationship of mRNA-1273 (Moderna ) is not affected by this report.
lower leg was swollen and started to get bigger and bigger; blood clot in the right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in the right leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included PANTOPRAZOLE for GERD, TRAZODONE for Sleeplessness, SIMVASTATIN and CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (blood clot in the right leg) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (lower leg was swollen and started to get bigger and bigger). The patient was treated with RIVAROXABAN (XARELTO) for Thrombosis, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot in the right leg) and PERIPHERAL SWELLING (lower leg was swollen and started to get bigger and bigger) outcome was unknown. 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.   Concomitant medication includes Benapraxine for to simmer down.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Pt has swollen arm, warm to touch that spans length of her humerus, clear blister like bumps around the actual injection site, reports it being itchy and painful.  Went to primary care doctor on Friday 3/22, originally told by him to use ice and Benadryl, came in again today 3/23 Saturday for a prescription of Norco and Fluocinonide cream from same doctor stating it was not better.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 16:47, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: not hungry, then very hungry but nauseous-Medium, Systemic: Nausea-Medium, Additional Details: Patient arrived to store to show a blister/rash that appeared to be from the bandaid as it was not directly by the injection site. She had made an appointment for store for Janssen/J&J vaccine. After talking to the patient, she thought she signed up for Pfizer, which my store does not carry.
Pt had a positive COVID test on 8/15/22; wife found pt unconscious on 9/4/22; EMS contacted and brought him to the hospital; pt declined and required intubation due to pneumonia; hospice was elected; pt extubated and passed away a few hours later in the hospital
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 19-Feb-2022; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 19-Feb-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 19-Feb-2022 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Feb-2022 at 12:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 19-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 19-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient belonged to ethnicity withheld.  No concomitant medications information was reported. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of as Moderna COVID-19 Vaccine to the patient.  Patient received the booster dose.  It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the expiry date of 04-Apr-2022.  No treatment medications were provided.
Headache, sweating, nausea, diareha,, vomited.   lasted  about 8 hours
9:20 MMR injection given client felt faint and nauseous no emesis noted. Laid client on floor with feet elevated, cool cloth to forehead. P 96 BP 94/58. 9:35 states I feel better. Up to chair P 88, BP 99/50. Taking sips of juice. 9:45 feels back to normal BP 98/50. Went home with grandmother.
Pfizer use for COVID-19 under Emergency Use Emergency Authorization (EUA): after vaccine administration, patient began shaking violently and passed out, patient became responsive after a few seconds.
This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (cancer) outcome was unknown. No concomitant medications were reported. She had her 4th shot back in May-2022. It was unknown whether the cancer was diagnosed prior to or after getting the vaccine. The patient was advised to get the bivalent booster dose before she starts with chemotherapy. No treatment medications were reported. Company comment: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) event of neoplasm malignant an unknown time after the fourth dose of mRNA-1273. Information regarding event onset (before or after vaccine), specific neoplasm, clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) event of neoplasm malignant an unknown time after the fourth dose of mRNA-1273. Information regarding event onset (before or after vaccine), specific neoplasm, clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Rec'd Tdap and Flu vaccines on 10/29/14 at 7:45 AM. At 3 PM on 10/29/14, had hives on chest and forearms. 10/30/14-symptoms worse. Sent to Emergency Dpt. No redness or swelling at injection sites. Prescribed Prednisone, PEPCID, BENADRYL.
Event - stroke without known precursors Treatment- currently in inpatient rehab Outcome - unknown if I will regain full use of right side  3 days at hospital and now currently in inpatient rehab with unknown discharge date
Diarrhea, Feverish (but no fever), fatigue, headache; stay hydrated, keep food in stomach, lie down, Tylenol for headaches and feverish feels
Vomiting and dark green loose stools w/blood at 2:00 am one week following vaccination. Admitted to hospital. Treatment was two air enemas. Discharged 8/5/16.
Rash on arms, belly, back and neck after 3 hrs patient felt hot but no respiratory problems. Employee went home and took BENADRYL within 4 hours rash resolved.
first dose 13Sep2019, not received second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The nurse reported that the patient received first dose of Shingrix. The patient had not received second dose. The first dose was administered at a different facility and reporter did not have the lot number/expiration date information. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination. This case has been linked with the case US2022064033 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064033:Same reporter
pt recvd 2nd dose of vax & c/o n&v x 2; 2 hrs post vax no local reaction to site; t98.1;
Pt presented with rash on face, scalp, neck and very red eyes. Benadryl 50 mg IM given. Vomited once approximately 2-3 hrs later. Had hives approximately 4 hrs later. Symptoms gone in < 12 hrs. NO residual sequelae.
After the second dose of Moderna vaccine I slept at night for about 2 hours and I was feeling muscle fatigue. When I woke up, my body temperature was 100.4 F. Around 10 am I went to the kitchen to prepare my breakfast. During this time I was feeling that my head was heavy. Then I start to feel that I cannot stay anymore and I sat down on my stool. I don't know what happened after that because I lost my consciousness. After that   I found myself lying on the back of my kitchen floor and I was completely wet. Few minutes later my body temperature was normal 97.88 F and I started to feel much better.