chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired Daptacel with no reported AE; Initial information regarding an unsolicited valid serious case was received from the other health professional via Medical Information (Reference number- 00694842).  This case involves a two-year-old and unknown gender patient who received an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On 23-Jul-2021, the patient received a 0.5 mL second dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Frequency: once, strength: standard, lot C5643AA, expiry date: 17-Jul-2021] via an intramuscular route at the left thigh for prophylactic vaccination (expired product administered). (Latency: on the same day)  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  It was reported that "caller states she administered expired Daptacel and would like to know if needs to be re-administered and management of adverse events and product technical complaints Pasteur adverse event (AE) reporting refunds/credits will not be issued due to adverse events".  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. 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.
On Monday, March 29, I woke up with the right side of my face frozen and not working.
Local erythema of forearm with in 48 hours vaccine administered inadvertently as if it were PPD, topical treatment.
pt recvd vax & w/in 2hrs post vax exp vomiting,nausea,& fever;these sx lasted 36hrs;
pt recvd vax; w/in 2 wks p/ vax exp rash which persists;
dry coughs; been in bed all week; sore arm; chills; strange headaches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry coughs), BEDRIDDEN (been in bed all week), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and HEADACHE (strange headaches) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B10RTYK) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COUGH (dry coughs), BEDRIDDEN (been in bed all week), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and HEADACHE (strange headaches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, COUGH (dry coughs), BEDRIDDEN (been in bed all week), CHILLS (chills) and HEADACHE (strange headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs include Blood pressure medication.
Patient reported having shoulder pain after injection. Pain goes away after but comes back when he used his shoulder or when exercising. He have consulted with his pcp.
Expired vaccine given from last years vaccines '22-'23 expired 6/30/2023. No ADRS occured.
Pt did not need 3rd dose of Rotarix as it is a 2 dose series. Mom notified of error.
a 9 months old male patient was given with expired diluent of Act-Hib vaccine,no AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse in the.  This case involves a nine months old male patient who was vaccinated with an expired diluent of vaccine HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] dose: 0.5 ml third dose, lot UI912AA and expiry 19-NOV-2019 via intramuscular route on left leg on 19-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLULAVAL).  It was a case of actual medication error due to expired product administered.  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 holders compliance with the requirements set out in Directive and Module VI of the 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.
No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 16-AUG-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (lot number U013969 has been verified to be valid, expiration date reported and established as 06-FEB-2023) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T037642 has been verified to be valid, expiration date reported and established as 06-NOV-2022) as prophylaxis (doses, routes of administration, anatomical sites of vaccination and vaccine schemes were not reported).   The vaccine hepatitis A vaccine inactivated (VAQTA) was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9°F) during a time frame of 90 hours. The vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) was exposed to a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (32.9°F) for 90 hours (product storage error).  There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003185:
After vaccination patient developed blisters/rash on arm, back of neck, and head. He was seen by his primary care MD who verified it was shingles. Patient was treated with VALTREX and gabapentin. Still has rash as of 8/23/15.
Approximately 15 minutes after receiving the Janssen vaccine, the patient complained of numbness and tingling around her mouth and fingertips, felt flush/warmness on her face with noticeable redness, and became hoarse while speaking. The patient was given 25 mg of diphenhydramine at the vaccination event and her hoarseness improved but returned a few minutes later.  She was taken to the Emergency Department for further observation.  In the ED, she was given famotidine, dexamethasone, and 1L of fluids, and her symptoms improved.  She was observed for 2 hours and discharged home with diphenhydramine and cetirizine.
My flu symptoms started on 02/01/2023. I had cough and fever. I went to the urgent care in the morning around 10:00AM. We both were sick, so I was trying to get somewhere. In the urgent care they tested me for COVID-19 and flu. I was positive for Flu B. They only prescribed me with TAMIFLU at that time. After 2 days on 02/03/2023 I tested positive for COVID-19 infection with a home test. I called the urgent care and told them that I tested positive, and they called in a prescription for PAXLOVID for 5 days. After 1 week later on 02/13/2023 I still had the cough which was severe. I was constant coughing, so I called my doctor who then prescribed me with amoxicillin. I tested with a home COVID-19 test on 02/10/2023 which was negative.
Information has been received from a physician concerning a patient who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX.  Subsequently the patient experienced herpes zoster at the thoracic area and followed a dermatome.  Medical attention was sought through a phone call.  The outcome is unknown.  No product quality complaint was involved.  This is one of several reports from the same reporter.  Additional information has been requested.
The patient started with a rash on her torso, abdomen, legs and arms. Her mother will just monitor her symptoms.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 79 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017, the patients received improperly stored doses of sterile diluent lot # M020944, expiration date 24-OCT-2018 (dose and route of administration were not reported) used to reconstitute unknown live vaccines. Administered doses of sterile diluent experienced the temperature excursion of 47.48 degrees Fahrenheit for 45 minutes. There was previous excursion on 11-FEB-2017 reported. As of 28-JUL-2017, it was unknown if patients continued to receive live vaccines reconstituted with diluent that underwent a temperature excursion. Follow-up information was received from the register pharmacist on 22-SEP-017. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # and expiration date unknown) (dose and route were not reported) and sterile diluent (manufacturer unknown) (dose and route were not provided) for prophylaxis which was improperly stored. The PNEUMOVAX 23 were stored at from 47 to 77 degree Fahrenheit for 1 hour 30 minutes. It had no previous temperature excursion. Data logger was involved. The following lot numbers of sterile diluent (manufacturer unknown) underwent temperature excursion of 47 to 77 degree Fahrenheit (48.3 degree Fahrenheit) for 1 hour 30 minutes: lot# M047667, expiration date 25-JUL-2019; lot# N004190, expiration date 04-JUL-2019; lot# M020944, expiration date 24-OCT-2018; lot# M017521, expiration date 12-OCT-2018. It was previous underwent temperature excursion from 47 to 77 degree Fahrenheit for 45 minutes. Data logger was involved. No adverse effects were reported. This case was previously considered valid but per current process it was determined to be non-valid as no patient identifier, therefore it is being sent to distribution for the last time to notify all recipients.
Patient reported to nurse on 25MAR21 - injection site pain, redness and swelling (left deltoid).
Lethargic, small body twitches, 104 degree fever which led to febrile seizure, heart rate of 175+ sustained for over 1 hour.
pt recv vax; pt exp failure to seroconvert; VZ test neg after 3 doses;
Additional information provided test results. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-month-old female patient who received a dose of PREVNAR 13 that had been improperly stored. At 4 months of age, the patient received the first dose on 24-May-2010. The patient received a dose of PREVNAR 13 that had been improperly stored on 24-Mar-2010. Office refrigerator went up to 14 degrees Celsius for an unknown length of time. No adverse event was reported. Outcome: not recovered. No additional information was available at the time of this report. See related case(s): CN-WYE-H15411910 (adverse event, non-expedited).
warmth, edema to injection site, lymphadenopathy, sudden onset cough and shortness of breath
mild flu symptoms; aches; just not feeling well all over; very sore arm that lasted 4 days; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms, pain, pain in arm and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, pain, pain in arm and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, pain in arm and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient had received first Shingrix vaccine and experienced mild flu symptoms which included aches, very sore arm and just not feeling well all over. The reporter consented to follow up. For second dose tolerance case has been link with case US2021AMR151481 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151481:same patient, same reporter
Hives on both arms,  thighs,  abdomen; This is a spontaneous report from a contactable pharmacist (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES).   A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Sep2021 16:30 (lot number: FF8841; expiry date: unknown) at the age of 69-years-old, as dose number unknown, single, for Covid-19 immunization. Medical history included chronic rhinitis. The patient was not pregnant at the time of vaccination. The patient had no relevant past drug history. Concomitant medication included loratadine taken for an unspecified indication, start and stop date were not reported.  The patient previously received single dose of influenza vaccine inact split 3v (FLUZONE HIGH DOSE) on 20Sep2021 (Batch/lot number: LDF/LJX) in left arm, for immunisation. On 24Sep2021 at 19:00, the patient experienced hives on both arms, thighs, abdomen. The reporter assessed the event as non-serious. Therapeutic measures were taken as a result of hives on both arms, thighs, abdomen which included loratadine 10 mg and diphenhydramine 25 mg. The patient recovered from the event on unspecified date in Sep2021. Since vaccination, patient has not been tested for COVID-19.
`A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 40-month-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.  Additional information received on 30-Apr-2009 product complaint investigation results.
pt recvd vax & devel a vesicle @ inject site, localized myalgia in lt biceps w/assoc tender nodule (?SC), painful myositis w/localized swelling of approx 1/2 inch, mild malaise, sensation of fatigue, localized swelling;
Daughter complained of pain in her entire R arm the afternoon of 1/28/09, approx 2 days after vaccination.  No radiating pain-just persistant pain in her entire arm.  Sibling was vaccinated with same vaccines @ same time also has R arm pain.  IBUPROFEN is somewhat helpful.  Mom will call MD by 2 wks post vaccination if pain persists.
5/8/20 Within 5 hours of vaccine administration, shot location was swelling, red, sore, and warm to touch.  Administered ice pack. By bedtime body aches developing. 5/9/10 arm still red, swollen, sore, additional head ache and muscle aches, and development of hives 5/10/20 Hives very pronounced, red, swollen, itching in a shingles pattern from neck around torso, to waist. 5/10/20 went to Urgent care, administered an injection of solumedrol, started Prednisone 20 mg, and Triamcinolone 0.1 % Cream
Patient started feeling her finger tips numb about 3 days after taking her vaccination. Consulted with her PCP that did not do anything at the time. In the beginning of September the symptoms got worse. Her fingers she can not move then or do anything. Then her arms started getting numb, and painful. It is from her fingers up to her neck. Her fingers are mostly numb. After some weeks she started having problems walking. Her daughter had to buy her a wheelchair. She can't move her head very well and she can't take care of her primary daily activities by herself as taking a shower, going to the bathroom, she can't dress herself without help, wash dishes doing nothing. She also got depressed, crying a lot and a family family member told her to talk to her PCP who referred her to a specialist and she does not remember her name. She said the specialist prescribed her some pills that are helping her with depression. Patient said the pain at the injection site is so severe she can't wear long sleeves. A Sleeve touching the site is very painful to her. She also says her fingers are swollen and she said she does not feel them anymore. She states she does not have any mobility in both arms. She was prescribed physical therapy but she does not believe it is helping.
got COVID/ he was fully vaccinated with Pfizer and had the booster dose of Pfizer as well; got COVID/ he was fully vaccinated with Pfizer and had the booster dose of Pfizer as well; This is a spontaneous report received from a non-contactable reporter (Physician) from medical information team. The reporter is the patient.  An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "heart patient" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "had the booster dose of Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID/ he was fully vaccinated with Pfizer and had the booster dose of Pfizer as well". Clinical course details: Patient reported he got COVID so he is resting at home and not going to the office although he was fully vaccinated with Pfizer and had the booster dose of Pfizer as well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Started with cough, then excessive drowsiness, then balance issues and ?zoning out?. Was seen at pediatricians office on 2/8/2023 and they thought it was a virus. When I picked him up from his dad, he was stumbling and i noticed nystagmus. Was admitted to local Hospital on 2/8/2023 and diagnosed with cerebellar ataxia.  He was discharged at 9pm on 2/9/2023. Nystagmus was ongoing up until 2 days ago. Is doing vestibular therapy once per week and scheduled to see the neurologist on 3/16. His symptoms have improved dramatically
Well-child two month check up on 04/08. Healthy except oral thrush. Nystatin given and the vaccines were administered. Next day, T 101.4 deg. F. at home, inconsolable crying, vomiting, poor color. T 99 deg. F. on 04/10. Admitted to the hospital, no antibiotics were given. All tests (labs, x-ray, blood work) were negative. Fever resolved and was sent home the next day.
Pt c/o subjective fever, chills, cold sweats, feeling like her "body felt bludgeoned", generalized pain, weakness.
exp joint aches/muscle discomfort generalized & soreness @ inj site x 2-3 days;lump @ inj site size large egg;
I noticed swelling in my right arm pit the day after I received the shot.  The swelling is still there this morning.
Vomiting and nausea for 8 days post shot number 1, fatigue for several days
Since getting vaccinated almost every night when I lay down to go to sleep I am having clear fluid leaking from both of my ears.  I am assuming that this is CSF but have not gone to get tested anywhere.  I have also had what I assume is gout in both of my wrists and thumbs as well as one foot.  I have never had this before.  They lasted about 2 days then cleared up
Pt came to us asking if normal reaction. She had 3 inch diameter red swollen itchy area around vaccination area. She bought ZYRTEC & hydrocortisone cream 1%.
Approximately 1 hr after injection developed redness and itching from site to elbow. 25mg Benadryl taken by client. An hour later reported "bark like" coughing and was advised to see MD or go to ER. 3hr later, reported to ER for wheezing and "breathing issues" received IV Prednisone and Benadryl and doing fine following Tx.
received dose in the glutes; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter requested information about a patient that probably received a Shingrix dose in the glutes muscles, which led to vaccine administered at inappropriate site.
Minor child was scheduled for 2nd dose Pfizer Covid 19 vaccine and was also given Flulaval Quad at the time of service without parental consent.
Day 1: fever (101), chills; fatigue  Day 2: Rapid heart rate; PACs; dizziness; fatigue Day 3: Dizziness; fatigue Day 4 through Day 6; progressively worsening diarrhea;