chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema (during childhood any closeness to allergy items would trigger immediate breakout). Previously administered products included TUSSIONEX ER (Caused itching in the past) and Aspirin (Too many pills would cause stomach burning). Concurrent medical conditions included vaginal dryness (Controlled with medication), multiple allergies (Chlorine, dust, wool, pollen, soap, cats, dogs and formaldehyde, Tree pollen, Hay fever, dust and perfume) and drug allergy (INDOCIN, DIMETAPP, FELDENE, SYNALGOS -DC). Concomitant products included RESTASIS, Calcium With Vitamin D, Fluocinonide Cream and lovastatin. On 21st May 2018, the patient received the 1st dose of SHINGRIX. On 23rd May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site warmth and erythromacular rash. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, injection site warmth and erythromacular rash were recovered/resolved. The reporter considered the injection site erythema, injection site pain, injection site swelling, injection site warmth and erythromacular rash to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, but it could be either 73 or 74 year of age. The patient received SHINGRIX on left deltoid. The patient noticed two days after the injection, at the site, her skin was red, puffy, warm to the touch and sore. The patient said that she was unsure as when the reaction occurred because she was packing to move out of state. It was not until she removed a bandage over the injection site two days later, that she noticed the reaction to the vaccine. In addition to the actual site, she said that there were two red and puffy spots just below where she got the shot. Before she left for the move, she went by another pharmacy to ask the pharmacist to look at her arm. The pharmacist described what he saw to her as being if it was a live vaccine. He had given other customers injections of the same vaccine, but had not seen anything like this. The pharmacist did recommend to the patient to contact her pharmacy where she received the injection and to report the incident to them. She said that all the side effects had resolved in about two weeks after being given the vaccine.
After receiving shot in R arm, I immediately became short of breath and notified pharmacist I did not feel well. I then sat back down and took a few breaths and recovered within 1 minute from this. Then I started to feel dizzy and sat back down. The pharmacist was with me the entire time and then I waited until I felt comfortable to leave (within 5 minutes). I did let him know I had eaten breakfast (eggs, pumpkin bread and a pear around 9:30am with coffee and well hydrated). I was at work and the rest of the day experienced nausea, lack of appetite. Around 30 minutes after the injection, I felt intense neck and shoulder pain mostly on the left side and this persisted as if I had a "stiff neck" it was hard to move mhead from side to side. I left work around 4:20pm, lack of appetite, nausea continued as well a a headache, shivering and all over body aches, increased heart rate noted 1 hr after injection using smart watch. Mild arm soreness at injection site which seems appropriate. I took 1 Aleve and  500gm Tylenol, 1 Pepcid, 12.5mg Denedryl.  I had 1 incidence of diarrhea at home. I'm unable to keep my head up due to fatigue and neck pain. I had a hot shower and feel overall malaise and cold feeling. I went to the doctors the next day and was dx with allergic reaction, rx prednisone, zofran, used sick time and back to work today 10/28/23.
Bad reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 60 or 61 years. The reporter stated that her friend had the first Shingrix injection, sometime between July 2019 and August 2019 and experienced a bad reaction.   The reporter stated that the patient could not remember what the bad reaction was and had no further information. The patient consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
About 3PM, onset of sever chills/shaking, needed third blanket to sleep, abated by morning
Dizziness,  lathergy/no energy, spacy feeling,  sleeping a lot.
Swelling and red blotchy area around injection site. Very hard knot about 1in in diameter around injection site. Significant pain going from arm to neck.
Sore muscle with hours, fever of 101 at 3 AM that kept patient down for most of the day, itchy hot rash of about 2.5 inch radius around injection site that lasted for almost a week after.
Some get Guilaine Barr Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Some get Guilaine Barr Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: Gsk Receipt Date: 01-APR-2023 This case was reported by the reporter via interactive digital media. The reporter reported that some patients got Guillain Barre syndrome after taking Shingles vaccine. This case has been linked to the case US2023AMR049581 and US2023AMR049605 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR049581:Same reporter. US-GSK-US2023AMR049605:Same reporter.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 05-JAN-2017 at 13:28, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457
DAPTACEL was inadvertently given instead of Adacel with no reported adverse event; DAPTACEL was inadvertently given instead of Adacel with no reported adverse event; Initial information was received on 28-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] inadvertently instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and Product administered to patient of inappropriate age)  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (0.5mL, lot 65829BA, expiry date 01-Mar-2022) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual case of medication error due to wrong vaccine administered and Inappropriate age at vaccine administration  (latency: same day).  It was reported "Medical office assistant reporting that DAPTACEL was inadvertently given instead of Adacel."  At time of reporting, 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 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.  There will be no information available on the lot number for ADACEL in this case.
tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 4th of 4 patient.   A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was tested positive for Covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient
Dizzy, run down two hours after injection. Woke up 4 am then off and on with extreme body pain, sore neck , lower back, right hand and arm. Headache and fatigue at 6:45 am got up with two children (2 yrs and 10 months) ate small breakfast by 9 am I couldn?t get off the couch or stay awake. My head started aching and my eyes hurt, I felt extreme chills two thick blankets weren?t enough to warm me. Extreme fatigue, stomach pain and loss of appetite. I fell asleep and didnt have the energy to walk to my bed until 2:30 pm.  It set off my stomach and I was vomiting off and on until around 9 pm. By then I could keep little bits of fluid and food down. Then I was hot. I felt flushed but had no fever. My usual heart rate is 52-54 bpm via Watch while laying down. My heart rate during this hot period laying in bed was 102 -101 bpm. Which is consistent for my workout heart rate. I went to sleep and woke up 7 am with my kids and was well enough to take care of them but not do all my usual chores. I couldn?t bend down or put my head lower than chest or the extreme throbbing headache was back. Still had body aches and fatigue but nowhere near yesterday. It is 11:22 pm Sunday and I feel spent.
It was a really bad cold that came out of no where. I had a fever. Never had a loss of smell and taste. I took a at home COVID-19 test and it all came back negative. It lasted about a week and a half.
Shaky and cold. Stable vitals 120/80. Numbness in her hands and shivering. Ambulance called at 11:35 am for evaluation. Vitals taken by emergency team. Patient released in her own private vehicle with husband as the driver.
missed his second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his second dose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed his second dose) outcome was unknown. Not Provided          Concomitant medications taken by the patient were not provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-068589 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068589:Wife case
Vaccines given Tues. 8/7/12. PENTACEL, PREVNAR 13, Hep B, ROTATEQ. By that evening baby has fever 101.4 degrees & fussy, stuffy nose, listless. Call to office 8/9/12 at 0815. Well by the evening of Aug 9th. Fever broke, Sx. left.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Repaired atrial septal defect", start date: 2001 (unspecified if ongoing); "Birth control pills" (unspecified if ongoing), notes: Birth control pills. The patient took concomitant medications. Past drug history included: Demerol, reaction(s): "known allergies: Demerol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Covid test date=28Dec2021, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2021) Positive, notes: Nasal Swab.  Additional information: No other vaccine in four weeks. Other medications in two weeks included birth control pills.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): PFIZER INC-202201313468 Same reporter/patient/vaccine, different dose/event.
Donor returned to center on 5/23/2021 and reported that 2 hours after receiving the tetanus vaccine on 5/7/21 she began to feel nauseous and fatigued donor reported symptoms lasted for approximately 3 days. Donor reported that symptoms resolved on their own without medical treatment.
the third dose of ROTATEQ was delayed due to the patient experiencing a fever with the administration of the second dose of ROTATEQ; patient is currently experiencing diarrhea; patient experiencing a fever with the administration of the second dose of ROTATEQ at 4 months of age; This spontaneous report was received from a nurse referring to a 4 month old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On approximately March 2019, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), for prophylaxis, along with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and diphtheria toxoid, hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL). With this administration, the patient experienced fever. Then, on 19-SEP-2019 (conflicting information also reported as "09/19/219"), the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # and expiration date reported as S010564 on 17-JAN-2021, at 12 months of age. This third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was delayed due to the previous fever experienced.  Approximately in September 2019, also reported as "currently", the patient was experiencing diarrhea and was not recovered from it.  No treatment was given for the adverse experiences neither laboratory studies were performed and they called to the office for medical attention.   At the reporting time, the outcome of pyrexia was unknown. The causality assessment was not provided.
pt recv vax & exp rash consisting of about 12 small red pustules, on scalp & face;no further details were provided;
pt recv vax & devel again devel urticaria; f/u from the MD in NOV94 indicated that the urticaria had resolved; No further info was provided;
Extreme Muscle Aches in both lower legs.  Felt like my legs were breaking.
No additional AE. No PQC.; Patient was administered improperly stored PROQUAD on 03/11/2021.; This spontaneous report has been received from a nurse, referring about a patient of unknown gender who was 4 years old. Information about the patient's pertinent medical history, concomitant medications and previous drug reactions and allergies was not provided.   On 11-MAR-2021, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Therapy type: rHA), lot number T025221, with expiration date on 19-JAN-2021, for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  The vaccine was stored at a temperature of -12 degree Celsius (°C), for a time frame of 6 hours and 30 minutes, with no previous temperature excursion. The call was due to a digital data logger.  No adverse events were reported.  This is one case, of several from the same reporter.; Sender's Comments:  US-009507513-2103USA004415: US-009507513-2103USA004233:
DAy 3 -5 after the covid vaccine: severe chills, headaches,  severe vertigo- can't get out of bed
I had extensive surgery on my left hand  in fall of 2019. The adverse reaction was after I received my 1st shot in my left upper arm.  The vaccine seems to have settled in the nerves, transplanted tendons and ligaments involved in the surgery. The pain in my operation area has been very bad, and continues to this day, 04/19/2021. It has been like a decovery set back.
15 without Preexisting Conditions, conveys feeling Nausea, hot, shakiness. Noted to be pale.  Laid down to cot, cold pack to forehead. VS taken within acceptable limits but for temperature  starting at 91.5F from the neck. Monitored without ALOC, self resolved symptoms. Temp improved to 93.5F. Able to ambulate out without assistance with mother.
Pt woke up at 3 am with vomiting and diarrhea for about an hour. Woke up and is now experiencing loss of appetite.
extreme BP, fever, vomiting, pain in abdomen, headache, hot/cold with uncontrollable shaking, brain fog went to ER where they only took BP, drip, Tylenol--there for 2 hours. Dr. said it was an antibody overload
Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; This is a spontaneous report from a contactable nurse.  A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, in left arm, on 30Dec2020 at 07:30 (at the age of 58 years-old) as a single dose for COVID-19 immunization.  The vaccination was administered at a hospital. There was no medical history.  Concomitant medication included bupropion hydrochloride (WELLBUTRIN), celecoxib (CELEXA [CELECOXIB]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), rosuvastatin calcium (CRESTOR). The patient did not receive any other vaccines in the 4 weeks prior to this vaccination and other medications (concomitant medications) were taken in the past 2 weeks. Prior to the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 0745, the patient experienced dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the events of dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site, was recovered on an unspecified date. After receiving the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt. received 0.25ml of Moderna from a vial that was opened beyond the recommended time. No adverse effects noted. Dr and pt. notified. Per Moderna no additional booster recommended.