chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-APR-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles 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 was considered to be not recovered. Additional information has been requested.
Immediately at administration, pt had a knot develop under skin. There was a small amount of bleeding, but that ended quickly. Pt denied pain or other negative sensation at time of injection. Pt advised to use cold compresses, tylenol and benadryl cream to help with symptom management.
Information was received from a medical assistant referring to an unknown number of unspecified patients of unknown demographics. The patients' medical history was not reported. On unspecified dates, the patients were administered improperly stored GARDASIL 9 of lot # M036059 with an expiry date of 03-JUN-2019 (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. There were no concomitant therapies reported. The vaccines were exposed to 27.3 Fahrenheit degree (F) for 16 minutes and 32 to 35 (31.6) Fahrenheit degree (F) for 15 minutes. There was previous temperature excursion involved which was at 32 to 35 (34.4) Fahrenheit degree (F) for 15 minutes. Digital data logger was involved. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001749:
Same as the 2nd dose...rash, feverish, swollen, itchy...lasted one week...still itches every once in a while.
(L) deltoid area, warm to touch. 2 1/2" x 2 1/2" erythema, edema, painful to touch.
Fever; headache; Fatigue; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (headache), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
This spontaneous report as received from a nurse refers to a 8 months 3 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
10/27 prevnar 20 injection 10/28 next morning fever 102 and chills, increasing swelling and redness around injection site. 10/29 fever and swelling continue. urgent care diagnosis of cellulitis in left arm, prescribe Cephalexin 500mg 4xdaily 10/30 intermittent fever, swelling and redness expands down through elbow into forearm 10/31 diagnosed with allergic reaction or infection,  Aleve twice per day, Doxycycline twice per day for 7 days, Can take benadryl as needed, STOP taking Keflex. Giving antibiotics (ceftriaxone) in clinic. Cold compresses at home.
Headache; Fatigued; possible fever: 99.9 highest temp; Covid 19 virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid 19 virus), HEADACHE (Headache), FATIGUE (Fatigued) and PYREXIA (possible fever: 99.9 highest temp) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2020, the patient experienced COVID-19 (Covid 19 virus). On 25-Jan-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigued) and PYREXIA (possible fever: 99.9 highest temp). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid 19 virus), HEADACHE (Headache), FATIGUE (Fatigued) and PYREXIA (possible fever: 99.9 highest temp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
This is a spontaneous report from a contactable pharmacist received via a Pfizer representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date. This event lasted one day and resolved on an unspecified date. The reporting pharmacist said he thought maybe the plunger or tip of the cap was made with latex and the patient was allergic.
Entire body extremely, nonstop itchy. Head to toe. Everywhere. Started one week post second pfizer vaccine. Red bump/dots/scabs on chest and stomach. Antihistamines did not alleviate the extreme itching. Started steroid Prednisone on Sunday, April 25th in the afternoon. Symptoms are better overall, but still itchy all over.  On April 25th, I was due to get my period within a few days. I got my period and on April 26th had the worst period of my life. Heaviest amount of blood I've ever seen.
After receiving his first Pfizer COVID19 shot and waiting 15 minutes at the pharmacy, the patient and his parents left the store.  They came back shortly thereafter and said he was having a seizure in the parking lot.  The pharmacist went out to investigate, and found the patient alert and responsive in the back of their vehicle.  He said he was okay several times and his father also said he was okay.  Later in the afternoon, his doctor sent in a prescription for Lorazepam for breakthrough seizures.  The pharmacist called the next day and his father repeated that he was okay.
A 16-years-old female patient inadvertently received a dose of Flublok vaccine rather than Fluzone/no AE; A 16-years-old female patient inadvertently received a dose of Flublok vaccine rather than Fluzone/no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a health care professional.  This case is linked to case 2020SA262658 (same reporter).  This case involves a 16-year-old female patient who inadvertently received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  The patient had not received any other concomitant vaccination.   On 22-Sep-2020, the patient inadvertently received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [prefilled syringe, lot number: QFA2029 and expiry date was reported as 30-Jun-2021, reporter was not sure about the expiration date] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] via an intramuscular route at the deltoid for prophylactic vaccination. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: at the time of vaccination). Reporter wanted to know about revaccination with Fluzone and efficacy. At the time of report, no adverse event was reported.  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.
Sensitivity after injection, 2in Red irritated area, warm to touch, hard lump.
This case was reported by a nurse via sales rep and described the occurrence of pericarditis in a 58-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant) and chest pain. On an unknown date, the outcome of the pericarditis and chest pain were unknown. It was unknown if the reporter considered the pericarditis and chest pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the medical assistant (MA). The patient did not have a history of heart trouble. The age at vaccination was not reported. In 2018, the patient received the SHINGRIX vaccine and experienced chest pain and went to the emergency room (ER). The treating physician did not see anything and released the patient. The patient went back to the ER later the same day and was seen by another physician, who diagnosed him with pericarditis and was 100 percent certain that it was caused by the SHINGRIX vaccine. The vaccination responsible physician did not believe that the event was caused by the SHINGRIX vaccine.
Mild headache, scratchy throat, dry cough. BP 140's/80's, pulse 82, 100% O2 sat. Given Benadryl 50 mg.
Extreme Chills and severe body aches developed while sleeping. Nauseous and fainted and hit head on way to puke.  Now on concussion monitoring.
POTS MCAS Neuropathy  Dysautonomia  Muscle Pain Insomnia GI Distress Phantosmia  Blood Clotting Shortness of breath Body temp disregulation  Headaches  Rosacea  Chest pain  Back pain Light headed  Fatigue  Brain fog and cognitive impairment  Eye dryness Rashes  Joint pain Anxiety
Starting Wednesday morning I felt gas pains in lower colon area. It progressed and by Thursday morning the 20th of October I knew I was having an episode of diverticulitis. My doctor was unavailable. An urgent care doctor called me. My abdomen was hard to the touch. I went to ER that afternoon. I didn't have a fever, just pain. I had some tests. I had a high blood cell count and diverticulitis event but no ruptures. I was prescribed AUGMENTIN. I was discharged was Friday at 7:00AM. I began to get better but on Saturday the 22nd the ER called me back in because my cultures showed an abnormality. They did two more cultures and monitored me to ensure I did not have signs of a blood infection.
Pediarix to 7 year old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J9593N, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: A dose of Pediarix was administered to 7 year old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case has been linked to US2021223568, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223568:same reporter
According to all the paperwork that we have received, this patient has received 3 doses of the Moderna vaccine. 1st on 12/20/20, 2nd on 1/20/21, and 3rd on 2/23/21
Erythema, swelling, sore to touch left leg. Keflex given for cellulitis. Tylenol and war compress for comfort.
Initial information received on 27 August 2014 from a healthcare provider. It represents one of a group of three patients who experienced similar adverse events after vaccination with ADACEL; the other two patients are captured in case number 2014SA118214. A patient (age and gender not reported) was vaccinated intramuscularly in August 2014 (date not specified) with ADACEL lot # U4902BA. The dose and site of administration was not reported. On an unspecified date in August 2014, the patient experienced a low grade temperature, erythema at the injection site was seen and treated for cellulitis. The patient's medical history and concomitant medications were not reported. Laboratory tests were not reported. It was reported that the patient recovered on an unreported date. Documents held by sender: None.
Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Chest pain. Numbness tingling. Fever. Muscle pain headache swollen lymph node nerve pain in face. Chills. Fatigue; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp.   A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 18Apr2021 13:00 (Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (at the age of 42 years). Medical history included migraine from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing, Sulfa allergy. The patient did not receive other vaccine in four weeks. COVID prior vaccination was unknown. Concomitant medication included desogestrel, ethinylestradiol (RECLIPSEN) taken for an unspecified indication, start and stop date were not reported; rimegepant sulfate (NURTEC ODT) taken for an unspecified indication, start and stop date were not reported. The patient experienced chest pain, numbness, tingling, fever. muscle pain headache swollen lymph node nerve pain in face. chills. Fatigue on 18Apr2021 22:00. COVID tested post vaccination was no. The outcome of events was Resolved with Sequel.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within a 1/2 hour of injection he started convulsing. Episode lasted approx. 1 minutes. Pt was taken to ER by car.
starting to feel sick; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (starting to feel sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (starting to feel sick). At the time of the report, MALAISE (starting to feel sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
hand has been going numb even when the arm is straight; Injection arm obviously has pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWOK3) via an unspecified route of administration in the arm right on 13Apr2021 at 18:00(at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EPTJ34) via an unspecified route of administration in the  right arm on 10Mar2021 at 13:00(at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient had no allergies to her knowledge. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 21:00, the patient's injection arm had pain, no redness/swelling and that hand went numb even when the arm was straight. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events injection arm pain and hand went numb was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
No additional AE; TE with PROQUAD.; This spontaneous report as received from an other health professional and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.   On an unknown date the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: rHA) (PROQUAD) lot # W012728 and expiration date 16-OCT-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not reported) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2305USA003072:
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, these patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L019298, expiry date: 22-JUN-2017). Medical assistant reporter that the vaccines went to 31.8 F for 7 hours and 45 minutes. They were logged by a data logger and there were no prior excursions. The vaccines were back in range. No adverse effects were reported. This is one of five reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 5 year old male with drug reaction to flu shot a year ago who on unspecified date was vaccinated with MMR II "normal shot". Concomitant therapy included VARIVAX. Other concomitant therapy included DTaP (unspecified). In approximately December 2008 ("couple of months ago"), the patient experienced hives over his entire body and severe itching after the vaccination. After a few hours, the patient recovered. The patient sought medical attention from the physician. Additional information has been requested.
Arthritic pain in ankles and wrists Febrile (low grade) Muscle aches Dizziness Sore throat Fatigue
pt recv vax; beginning @ 15-18 months of age pt devel autism " which still persists."