chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 29-DEC-2008 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later on or about 12-SEP-2009, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Celullitis in the left arm. Patient goes to the doctors office and he prescribes Septra D/S (one tablet once a day) and Hibiclens (to wash the area daily).
(L) upper arm, redness, swelling pain, baseball size lump redness down to elbow, fever.
No additional AE; HCP called to report a possible temperature excursion on GARDASIL 9 that was then administered to a patient on 07/11/2023; This spontaneous report was received from a licensed practical nurse, referring to a 12-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W002614, expiration date reported and validated as 15-SEP-2024) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse event.
Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient received the 2nd dose of Shingrix and experienced fever. The patient inquired that how long fever would last. The information regarding consent to follow up was not reported. No further information was available.
Patient had syncope from a sitting position, history of vasovagal syncope, occurred 10 minutes after receiving vaccine. Patient recovered in the recovery area, advised to follow up with MD
Golf ball size knots at all injection sites, rash, fever of 102 degrees for 3 days, trouble walking for 2 weeks (falling constantly and lots of pain) rash at injection sites.
The customer reported they had a 2 month old patient who received a dose of ROTATEQ (date unknown) and had difficulty swallowing the oral dose.; No other AE.; This spontaneous report was received from a medical assistant via a company representative, referring to a 2-months-old female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered by oral route, as prophylaxis (formulation, strength, vaccination scheme, lot number and expiration date were not reported), at this time; the patient had difficulty swallowing the oral dose (product use complaint). No additional adverse events were reported.
38 Years old   Male status post COVID-19 booster vaccine 2 days ago presenting to ED with 2 days of generalized myalgia and abdominal pain.  All bodily pain is described as dull/aching and is worse with nothing, better with nothing.  The patient believes that his acute symptoms are directly related to his recent vaccine.  The patient states that he would not have come into the emergency department today, but he was sent to the emergency department by his boss to make sure he was okay to work.  Overall, symptoms appear mild in nature.
Numbness of Left side of face around pre-molar area; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness of Left side of face around pre-molar area) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 030M20N) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Cholesterol (Slight cholesterol) and Salmonella since November 2008. Concomitant products included ROSUVASTATIN from 2008 to an unknown date for Cholesterol, DICYCLOMINE [DICYCLOVERINE] from 2012 to an unknown date for Salmonella, MAGNESIUM from 1976 to an unknown date and VITIS VINIFERA SEED (GRAPE SEED EXTRACT [VITIS VINIFERA SEED]) from 1976 to an unknown date for Supplementation therapy.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness of Left side of face around pre-molar area). At the time of the report, HYPOAESTHESIA (Numbness of Left side of face around pre-molar area) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   other concomitant included fish oil 1000 mg for an unknown indication. Treatment medications were not provided by reporter. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The reporter's contact information was updated (e-mail Address was added). On 08-Jun-2021: Added Patient's demographics, medical history, concomitant medications.
Information has been received from a consumer concerning her 16 year old daughter with no medical history or drug allergies who on 06-DEC-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Within 24 hours after vaccination the patient started experiencing pain and within 2 days she started vomiting. She was admitted to a hospital on 12-DEC-2008 (enzyme levels were over 800) and released on the 16th. The hospital determined it was pancreatitis. Multiple tests were performed in the hospital including CAT scan and ultrasound but the results were not provided. The patient was not fully recovered yet, however her mother stated that she was better and her enzyme levels were coming back to normal. Additional information has been requested.  3/16/09 Received PCP medical records of 7/31/08-2/13/2009. FINAL DX: acute on chronic pancreatitis w/strictures & pancreatic stones s/p stent placement; pancreas divisum; asymptomatic until 12/10/08. Records reveal patient experienced good health on 12/6/08 when received HPV #1 & flu shot.  RTC 12/10/08 w/cough, cold s/s & chest/upper abdomen pain near diaphragm.  Dx w/muscle strain & URI.  RTC 12/12 w/continued upper abdominal pain w/vomiting, watery diarrhea, pale w/decreased bowel sounds, guarding & rebound.  Sent to hospital for acute abdomen.  RTC 12/17 s/p hospitalization w/resolving pancreatitis.    4/16/09 Received hospital medical records of 12/12-12/15/2008. FINAL DX: pancreatitis, etiology unknown Records reveal patient experienced progressively worsening epigastric pain x 5 days, N/V x 1 day.  Seen by PCP & dx w/musculoskeletal pain.  Continued to worsen &unable to walk or attend school.  ALso had cold s/s during the week & multiple sick contacts. Surgery & GI consult done. Labs & PE improved & able to tolerate diet.  D/C to home W/PCP & GI f/u.
very sore arm within hours of vaccination; extremely sore the following morning.  the pain subsided considerably by midday;   the second dose was received monday afternoon, it is now thursday afternoon and there is only mild soreness/tightness in my arm.  after the first dose i experienced only mild itchiness at the vaccine site (left arm).
administered only liquid component of Menveo; administered only liquid component of Menveo; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 8-Aug-2022 Reporter's comment: The physician reported that a medical assistant inadvertently administered only the liquid component of Menveo to two unknown patients out of a group of a possible six patients. It was unknown which two of the group of six patients received only the liquid component.  It was confirmed that no patients only had the powder component. The reporter declined follow-up from Safety.  Additional supportive information: The patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is for 1 of 6 linked patients reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR116728:Same reporter US-GSK-US2022AMR116730:Same reporter US-GSK-US2022AMR116731:Same reporter US-GSK-US2022AMR116737:Same reporter US-GSK-US2022AMR116736:Same reporter
3 WEEKS AFTER 2ND MODERNA VACCINE I DEVELOPED ITCHY BLISTERS UNDER THE 3RD AND 4TH TOES ON MY LEFT FOOT.  THEY KEEP COMING BACK EVERY FEW WEEKS.
Two days post vax pt experienced redness and tenderness at injection site. ER physician diagnosed reaction to DT booster. Pt was treated with Vicodan and Keflex.
The dose was moved from the freezer to the refrigerator on 18SEP2022 and administered on 22OCT2022; sore arm; body aches; A patient received a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), EXPIRED PRODUCT ADMINISTERED (A patient received a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The dose was moved from the freezer to the refrigerator on 18SEP2022 and administered on 22OCT2022) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Oct-2022, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and EXPIRED PRODUCT ADMINISTERED (A patient received a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The dose was moved from the freezer to the refrigerator on 18SEP2022 and administered on 22OCT2022). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), EXPIRED PRODUCT ADMINISTERED (A patient received a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The dose was moved from the freezer to the refrigerator on 18SEP2022 and administered on 22OCT2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that vaccine was administered from individual vials and size of vial  was reported as 5.5mL. No temperature excursions occurred. The patient experienced sore arm and body aches since this dose. No treatments, medications, or additional doses had been administered at the time of report.
Patient returned to clinic on 12/14/2018 for c/o redness, pain and subjective fever X 3 days.  Patient was diagnosed with cellulitis and was prescribed cephalexin 500 mg BID X 10 days and ibuprofen 600 mg TID prn fever/pain. Patient's condition worsened overnight and was advised to go to nearest emergency department.
vaccine vial stored longer than recommended time period, potentially up to 28 days, no adverse reactions
Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and clammy. Felt like heart racing. Dizzy. Radial pulse 88 and regular. BP 116/72.  Patient declined going to the Emergency Department and was observed for approximately another 30 min,  Chest discomfort subsided. Her husband ( an MD) came in and took her to his office for further observation.
She has pain at the injection site; low grade fever; She's been feeling fatigued; His wife has not been feeling well; This is a spontaneous report received from a contactable consumer (patient husband). A female patient [reporter wife] of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 08Apr2021, as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in Apr2021, after receiving vaccination, patient experienced pain at the injection site, low grade fever, feeling fatigued and not feeling well. Reporter asked what to do about those side effects. Outcome of the events were unknown.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Pain at the site of the shot; chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 30Mar2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to 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 31Mar2021 at 11:30, the patient had pain at the site of the shot, chills and headache. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events pain at the site of the shot, chills and headache which included treatment with paracetamol (TYLENOL). The clinical outcomes of the events pain at the site of the shot, chills and headache were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an eight years old female patient who was accidently vaccinated with a 0.5 ml dose of vaccine ADACEL (lot U6069BA and Exp. Date not reported) via intramuscular route in the left thigh on 14-Nov-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
2 days after receiving immunizations developed chicken pox like rash arms and legs.  Red area at site.
Pain in arm including upper arm and joint.  Patient complains of extreme pain continuing for 4 days at injection site and throughout arm, with inability to lift arm.
LEG PAIN; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. The patient was previously treated with prednisone for arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included mycophenolate mofetil for arthritis. On an unspecified date, the subject experienced leg pain, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and muscle ache. This report was non-serious.
pt recvd vax & p/2nd vax pt exp deltoid muscle contraction; contractions ceased shortly p/inject;
Lethargic, not eating, crying (3 hours straight or longer), dull eyes, hard lump in thigh, very high fever, drooling.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 16-DEC-2013, the patient was vaccinated with ZOSTAVAX at a hospital as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-NOV-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. She was prescribed  acyclovir, gabapentin (NEURONTIN), prednisone and oxycodone/paracetamol (PERCOCET) management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of shingles was not recovered. Additional information has been requested.
about 1 hour after receiving vaccine had swelling in throat resolved on own in 15 minutes. then 7 hours later returned with difficulty swallowing and breathing. started wheezing, felt light headed and dizzy, took epi injection.
Fever (39.7 rectal) and tonic clonic seizure 7/19/06, 8 days after vaccines given. Seen in ER, normal exam. Still fever at recheck 7/21/06, faint macular rash on trunk. Had 1 other febrile seizure 6/26/06.
Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster).    Concomitant product use was not provided by the reporter.  It was reported that the nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster.  Treatment information was not provided.
Myalgia, Fever, fatigue, lymphadenopathy Narrative: employee reports low grade fever, bodyaches, lymphadenopathy, fatigue-these have resolved. Reports was difficult to move her arm/touch axillary area.
Extremely fatigue,  nauseA, headace, right eye blood shot, right side jaw pain, swelling right side face , right side ear pqin
Patient was conversing normally, then word faded out in mid-speech and patient leaned left until head came to rest on padded exam table. Bilateral pupils noted to be dilated with fixed stare straight ahead, mild tremors noted to all 4 extremities lasting 20 to 30 seconds.  Then all tremors ceased, pupils returned to normal, patient sat self up and asked "what happened?".  Student alert and oriented x person, place, and time. Respirations remained even and unlabored before, during, and after event.  Patient denies any previous seizure history of any type at this time.