chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; body aches; chills; extreme fatigue; they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; temp high to 102.9; infection; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date Oct2021 (Lot number: 30155BA, Expiration Date: 31Dec2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: THYROID. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset Oct2021, outcome "unknown" and all described as "they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "extreme fatigue"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "temp high to 102.9"; INFECTION (non-serious) with onset Oct2021, outcome "unknown", described as "infection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Vaccination facility type: Doctor's office/Urgent care. Vaccine not administrated at Facility. Prior vaccination within 4Weeks. Concomitant drugs: Unknown. Patient Medical History: Unknown. Relevant tests: None. Specific relevant test: None. Proprietary medicinal product name: thyroid medication. States that they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member for their second Covid shot. Storage of vaccine outside Prescribing Information recommendations DURING and AFTER DILUTION (US) (v9.0) under Internal Data; Vial used appeared to have reconstituted date 25Oct2021 upon further review post admin it was 22Oct2021. Expiration date post reconstitution poorly written. Patient experienced temp high to 102.9 body aches chill and extreme fatigue 24hrs post infection temp low to 99.6 -100.1 27Oct however still fatigue.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported Information: Removed "At Risk" classification. Added events "High Temperature", "Infection" and "Product administration error".
Redness and swelling at injection site in a 2-3 inch band around my arm. It's painful and warm to the touch, comparable to a sunburn. It's lasted almost 4 days at this point and feels like it's getting worse over the last 24 hours.
Reaction to second dose of SHINGRIX 50 mcg. Reaction not one listed as a side effect. Itching, redness, heat from various areas of the body. Itching etc. would appear in new area of the body, but on both sides. Started on the lower back and abdominal area, then the lower arms and palms of the hand, then to the arm pits and breast area, then to the backs of the legs and groin region. It was never itchy in more than one of these areas at the same time, and was not accompanied by any breathing problems, so did not warrant ER. It is day three after the shot and I still have symptoms.
I fainted within a couple of hours from receiving the shot, I have been experiencing chest pains and shortness of breath. My vision gets blurry from time to time and I have mild migraines
received an expired dose of Havrix on 04Oct2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   On 4th October 2022, the patient received the 1st dose of Havrix. On 4th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 04-OCT-2022 Reporters comment:  The patient received patient received an expired dose of Havrix on 04th Oct 2022.  The dose expired on 20th May 2022. No symptoms reported. The reporter consent to follow-up. Additional Supportive information: The patient received an expired dose of Havrix on 04th Oct 2022 which led to Expired vaccine used.
24 hours after red indurated around shot about circumference of baseball on Left arm deltoid. 48 hours-red from shoulder to elbow and entire upper arm swollen-inside of arm is blotchy red. No respiratory distress/no fever-very hot to touch
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 08-OCT-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 5208 hours, with the recorded temperature of 1.66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
At first feeling "hot" inside and then at night total body ache(joint/muscle); feeling "hot" inside; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 47 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 10:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced at first feeling "hot" inside and then at night total body ache joint or muscle on 13Feb2021 23:00 with outcome of recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
"A mother reported that her son received his 1st doses of DTAP, HIB and IPV and his 2nd dose of HEP-B vaccines in early July, 1998. He reportedly, developed injection site reactions characterized by hard lumps, redness and warmth. He later, experienced a "high" fever. His mother notified the physician. The pt became irritable and inconsolable. He experienced high-pitched screaming for several hours and arching of his back. He became chronically constipated, needing help to pass hard, clay-like lumps, which often made him bleed. Shortly following his immunizations, he experienced a series of "vague seizure activity". His entire body would twitch and he would seem unresponsive. The physician was notified. He experienced a few more episodes and recovered. Convulsions are considered "Medically Important"."
High fever 102 degrees, chills, coughing. Referred to PMD.  Per acknowledgement letter, box 8 should be marked none of the above.
body aches; head hurt like hell; swollen lips; lip blisters; face was swollen; eyes were swollen shut; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips), LIP BLISTER (lip blisters), SWELLING FACE (face was swollen), EYE SWELLING (eyes were swollen shut) and MYALGIA (body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction NOS. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and EPINEPHRINE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced LIP SWELLING (swollen lips) and LIP BLISTER (lip blisters). 29-Apr-2021, the patient experienced SWELLING FACE (face was swollen) and EYE SWELLING (eyes were swollen shut). On an unknown date, the patient experienced MYALGIA (body aches) and HEADACHE (head hurt like hell). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Myalgia and Headache, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 30-Apr-2021, LIP SWELLING (swollen lips), LIP BLISTER (lip blisters), SWELLING FACE (face was swollen) and EYE SWELLING (eyes were swollen shut) had resolved. At the time of the report, MYALGIA (body aches) and HEADACHE (head hurt like hell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated that she had allergic reactions in the past so she took Claritin D before receiving the shot.
2/22/23 all I had was the sniffles for a day or two. I took an at home COVID test and it was positive. It did not get worse. I called my doctor who prescribed PAXLOVID which I began taking. After four or five days the symptoms were gone. I have recovered.
Ache; FEVER; PSORIASIS FLARE UPS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), PYREXIA (FEVER) and PSORIASIS (PSORIASIS FLARE UPS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.  No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Ache), PYREXIA (FEVER) and PSORIASIS (PSORIASIS FLARE UPS). At the time of the report, PAIN (Ache), PYREXIA (FEVER) and PSORIASIS (PSORIASIS FLARE UPS) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Severe swelling on right arm, equilibrium problems (fell down stairs at work) and tired feeling in arm (still Persisting).
This spontaneous report as received from a pharmacist via company representative refers to a female patient in her mid 60's (years old). Pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX VIA (dose, lot # and Expiry date were unknown) subcutaneously . On an unknown date, the patient experienced redness, swelling and the skin area being heated at the injection site. The  patient spoke to the pharmacist for medical attention. The patient received treatment for the events. On an unknown date, the outcome of the events were reported as recovered/resolved. The reporter did not assess the causality between the events and the suspect therapy. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
her throat began to feel thick and she felt shaky; Within about 5 minutes after the injection my face started tingling; felt like I had a bad sunburn; The morning after I had the typical vaccine side effects of sore arm; A little body aches; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EN6201) via an unspecified route of administration in Left arm on 19Feb2021 16:30 as single dose for COVID-19 immunisation. Patient medical history included breast cancer in 2014 and chemo. Concomitant medications included colecalciferol (VITAMIN D 3) and exemestane. Patient previously took Docetaxel and experienced with Severe anaphylaxis from chemotherapy. On 19Feb2021 16:45 patient stated that about 15 minutes after the injection her face started tingling and soon after felt like she had a bad sunburn. At the same time her throat began to feel thick and she felt shaky. She wasn't shaking but she felt shaky on the inside. She could talk and breathe ok but her throat felt thick inside. After she went home, the thick throat feeling went away in about 40 minutes and the sunburn feeling was gone by the next morning. The morning after she had the typical vaccine side effects of sore arm and a little body aches. Throat and face felt fine. Treatment was not received for events. Outcome of events was recovered on an unspecified date in 2021.
Hospitalization with COVID-19 following vaccination. Vaccinated with Moderna COVID-19 vaccination on 1/29/2021, 2/26/2021, and 10/23/2021.
This spontaneous report as received from a nurse refers to a 10 months 13 days old male 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) LIQUID 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.
difficulty falling asleep; Lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration on the left arm on 06Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included Hashimoto, seasonal allergies, ripe food, allergies to weed, grass, trees. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), fexofenadine hydrochloride (ALLEGRA) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took erythromycin, Bactrim and experienced allergies. Patient did not have COVID and did not receive other vaccines four weeks prior to vaccination and was not pregnant. The vaccine was received at a workplace clinic. On 06Jan2021 10:45, the patient experienced difficulty falling asleep and was lightheaded. No treatment was received for the events. The patient has not tested for COVID post vaccination. Outcome of the events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Client was vaccinated in the afternoon of 5/15/2018. Mom called midday of 5/16/18, stating her child had a fever of 103 degrees, was nauseous, and had a rash around the throat/neck. She stated that the rash began on the morning of 5/16/18. Encouraged mom to give the child TYLENOL or ibuprofen for the fever and if the fever does not reduce go to their primary care provider. Also, encouraged mom to monitor for any signs of anaphylaxis, which she denies. If child has signs of anaphylaxis go to urgent care immediately. Called mom on 5/17/18 to see how the child was doing. Mom stated that the fever was better and the rash did not spread but the child still did not feel well. Encouraged mom to take her child to their primary care provider if the child did not feel any better the following day, as the symptoms could be a result of something else.
THREW UP THE DOSE 15 TO 20 MIN AFTER INGESTING; This spontaneous case report (PVX2019-1958) was received from a nurse on 29-Jul-2019. It described a 29-year-old adult male consumer who "threw up the dose 15 to 20 min after ingesting" (PT: Vomiting), after the administration of Vaxchora, Hepatitis A, Tetanus and Typhoid VI vaccines for unknown indications.  Case report: The consumer took Vaxchora on 29-Jul-2019 and threw up it 15 to 20 minutes after ingesting it. She stated that after administering Vaxchora, the patient also received Hepatitis A, Tetanus and Typhoid VI vaccines prior to throwing up. She stated they were injectable and not oral.  Action taken with Vaxchora, Hepatitis A, Tetanus and Typhoid VI was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, a male consumer "threw up the dose 15 to 20 min after ingesting", after the administration of Vaxchora, Hepatitis A, Tetanus and Typhoid VI. There seems to be a temporal association between the intake of Vaxchora and the event. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides an alternative explanation for the reported event.; Sender's Comments: Company's Comment: In this case, a male consumer "threw up the dose 15 to 20 min after ingesting", after the administration of Vaxchora, Hepatitis A, Tetanus and Typhoid VI. There seems to be a temporal association between the intake of Vaxchora and the event. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides an alternative explanation for the reported event.
Complaints of site tenderness, redness and warmth. Complaints of soreness in lungs, denies any cough. Received po on 11/17/04 and states symptoms mostly subsided now.
Initial misuse report received from a healthcare professional on 07 March 2014. A patient (No information was provided regarding the patient) had received a dose of YF VAX (Lot number, expiration date, route and site of administration were not reported) and the patient had received half dose due to vaccine spraying out at the needle/syringe connection on an unspecified date. i.e. vaccine underdose. This case is of medication error. No adverse event was reported. List of documents held by sender: none.
Information has been received from a nurse concerning a 12 month old patient who was vaccinated with a dose of PNEUMOVAX 23 instead of PREVNAR. The nurse mentioned it was busy and both products were in the same box. No adverse effect reported. At the report time the outcome was unknown. Additional information is not expected.
Information has been received from a licensed practical nurse concerning her 62 year old female friend who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced herpes simplex around the mouth.  Additional information is not expected.
still gets shingles after having the shots/Suspected vaccination failure; still gets shingles after having the shots; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (mother had years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt unlucky that still got shingles after had the shots. However it was not nearly as bad as patient's mom had years ago before they had a vaccine. The patient stated that Get your vaccine or suffer. This case was considered as suspected vaccination failure as details regarding laboratory confirmation and  TTO were unknown at the time of reporting. This case had been linked with case US2021AMR073674, as reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073674:same reporter
This spontaneous report as received from a health professional refers to a 19 years old male patient. Medical history, current conditions and concomitant medication were not reported. On 19-SEP-2014, the patient was vaccinated with a pediatric dose of VAQTA (25/0.5) vial. (Lot number: K000707, expiration date was not reported) in error. The patient was indicated to receive an adult dose. The reporter does not have any record of this patient ever receiving a previous dose of hepatitis A vaccine. No adverse experience had been reported. The outcome of a patient received a pediatric dose of VAQTA in error was unknown. Additional information has been requested.
Episode of Guillain-Barre Syndrome; This literature case was received on 21-Mar-2022 and concerned a male patient of an unspecified age. At the time of this report, the patient was 71-year-old.   The aim of this case report was to weight the risks and benefits of SARS-CoV-2 vaccinations in patient with a previous history of Guillain-Barre syndrome (GBS) post-influenza vaccination and to determine the safety of SARS-CoV-2 administration.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, several years ago as reported, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; route of administration, anatomical location, dose and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an episode of Guillain-Barre syndrome (GBS) and had physiotherapy.   On an unspecified date, the patient recovered from the event of Guillain-Barre syndrome.   The reporter assessed the event as related to influenza virus vaccine polyvalent. The patient had an episode of Guillain-Barre syndrome temporary related to influenza vaccination.  The event of Guillain-Barre syndrome was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.    Company comment: A male patient of unspecified age experienced an episode of Guillain-Barré syndrome (GBS) after receiving influenza virus vaccine polyvalent. Elapsed time between vaccination and the onset of the event is unknown. Due to this lack of information regarding chronology, causality is unassessable. Agency criteria for GBS could not be assessed due to insufficient information.; Reporter's Comments: The patient had an episode of Guillain-Barre syndrome temporary related to influenza vaccination.; Sender's Comments: A male patient of unspecified age experienced an episode of Guillain-Barré syndrome (GBS) after receiving influenza virus vaccine polyvalent. Elapsed time between vaccination and the onset of the event is unknown. Due to this lack of information regarding chronology, causality is unassessable. Agency criteria for GBS could not be assessed due to insufficient information.