chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received two-doses of ADACEL in 28-days without realizing already received injection with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Global Medical Information (Reference number- 00759955) and transmitted to Sanofi on 08-Sep-2021.  This case involves a 50-year-old female patient who received two-doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (suspension for injection) 0.5 mL (total, once) [lot U67028A, expiry date 20-Jun-2022] via intramuscular route at an unknown administration site on 08-Sep-2021 for prophylactic vaccination in 28-days without realizing already received injection (extra dose administered).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to extra dose administered (latency was on same day).  At the time of report, no adverse event 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.
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
She was 76 years old;This was her 3rd pneumococcal 13-valent conjugate vaccine in 4 years; feels okay but tired; This is a spontaneous report from a contactable physician. A 76-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration, in 2016 (first dose; lot number M51193), in 2017 (second dose; lot number S58702) and on 18Sep2020 (third dose; lot number 300051971022) at a single dose for immunisation. Medical history included ongoing hypertension, ongoing hyperglycaemia, and ongoing hyperlipids; all were diagnosed before receiving the vaccines. There were no concomitant medications. The patient went to the hospital for the flu shot. They also offered her pneumococcal 13-valent conjugate vaccine. She was 76 years old and she didn't go there asking for it, but was offered it. The patient asked if she was due. They gave it to her. The doctor received a report and they looked at her chart. This was her 3rd pneumococcal 13-valent conjugate vaccine in 4 years. She had one in 2016, one in 2017, and one in 2020. The doctor doesn't know if there is a problem with her getting three. She has contacted the patient. The patient said she feels okay but tired. She generally feels tired though so the doctor wouldn't consider that a new feeling. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sire right arm at injection site and flu type symptoms  the day after vaccine.  Second day after vaccine sore neck/shoulder muscles which grew increasingly worse.  Rash developed on 11/16/2021.  Went to urgent care on 11/17/2021 and diagnosed with shingles.
Local allergic rxn @ inject site about 8cm diameter of pruritic erythematous edematous rashes laslted aobut 10 days;
This report describes a male subject (age unspec'd) who did not respond to immunization with Hep B vaccine. This report was received from a nurse. Medical history, concurrent conditions, and concurrent medications were not specified. The nurse reported that the subject received the Hep B vaccine immunizations series (dates unspec'd) and "was a non-or low-responder".
very tired; headache; Arm was very sore; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in arm left in the morning on 04Jun2021 as a single dose for COVID-19 immunisation. Medical history included stage 3 chronic kidney disease from May2021 and was ongoing; High blood pressure diagnosed at the end of Feb2021 or beginning of Mar2021 and was ongoing; High cholesterol diagnosed at the end of Feb2021 or beginning of Mar2021 and was ongoing; Acid reflux from unspecified date in 2021 was ongoing and acid reflux diagnosed at the end of Feb2021 or beginning of Mar2021; pneumonia from on an unknown date in Jan2021. He reported that he was in the hospital the first week of Jan2021, on 07Jan2021 or 08Jan2021 the time, he didn't know that it shut down his immune system and his kidneys took a bigger hit than they already had, and he had pneumonia. He reported that he was in the hospital for a good 8 or 9 days and shortly after he was discharged and after that he started the medications for blood pressure, cholesterol, and acid reflux. He reported that the biggest thing was that he had to wait until his doctor cleared him to get the Covid-19 vaccine as he has some other medical issues and once his doctor said to get the Covid-19 vaccine, he got it. Concomitant medications included amlodipine besilate (Film-coated tablet) taken 10 mg once daily for blood pressure from 2021 and ongoing; atorvastatin taken 20mg once daily for Cholesterol abnormal from 2021 and was ongoing; pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40) taken 40mg once daily for acid reflux from an unspecified start date and was ongoing. The patient's arm was very sore on 04Jun2021. The patient was very tired on 05Jun2021 and had headache on 05Jun2021. The outcome of the events was recovered on an unknown date in Jun2021.   Follow up activities has been raised.
Pt reports that after receiving vaccines, her left arm felt like dead weight. Additionally, she developed a sore throat with shooting pain on left side of jaw and left ear pain. Also developed headache. Arm symptoms resolved in 24 hours. Other symptoms did not
Information has been received from a physician concerning a female patient who was vaccinated with a second dose of Gardasil. The physician reported that post vaccination patient fainted and wet herself. She was monitored and recovered. She did not have this adverse event after her first dose of Gardasil. No other information was available. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a physician concerning a female patient who on 13-AUG-2007, at 01:00 PM was vaccinated with a second dose of GARDASIL lot #657872/0515U. The physician reported that post vaccination patient fainted and wet herself. She was monitored and recovered. She did not have this adverse event after her first dose of GARDASIL. No other information was available. In the follow up it was reported that "fainting resulted from shock of injection not from vaccine". Additional information is not expected.
One week after vaccination, reported right arm and right scapular weakness, numbness, tingling and pain.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with Sjogren's syndrome, hypothyroidism, hypercholesterolaemia and reaction to food additive. The patient had reaction, nausea, after monosodium glutamate (MSG) intake. On 14-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K018172, expiration date 02-DEC-2015), 0.65 ml, subcutaneous in the left post-lateral triceps subcutaneously. Concomitant therapies included levothyroxine sodium (manufacturer unknown) and simvastatin (manufacturer unknown). On 17-APR-2015 (in the morning), the patient awakened with pain and swelling at her injection site (also reported that event occurred over 48 hours after receiving ZOSTAVAX). Her arm remained painful and swollen at the injection site for 4 or 5 days. The patient did not develop a rash. Lab diagnostics studies were not performed. The outcome of injection site pain and injection site swelling was reported as recovered/resolved on an unknown day in April 2015. The relatedness between pain and swelling at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
Hot flashes; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HOT FLUSH (Hot flashes) and CHILLS (Chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, HOT FLUSH (Hot flashes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Fainting, vomit, up & down heart rate and blood pressure, numbness in limbs, constipation, headache, chest pain, back spinal pain, passing out. Have had cardiologist testing but no neurologist test. Still having the problems nothing resolved! Symptoms all day everyday!
Pt recvd HIB vax on 26JUN92 & on 18JUL92 pt devel meningitis; pt exp was considered life-threateing; pt recvd previous HIB vax on 5MAY92;
Itching, slightly raised red rash on upper left arm around injection site. Rash has increased slightly in size over the past 24 hours.  Muscle under rash is tight and rash area is slightly warm.
24 hours after injection, pt. had vertigo with nausea, diaphoresis, decreased BP, and unsteady gait.
Tinnitus; Raised bump of the upper back; Trouble sleeping; Sore arm; Fatigue; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus), CONTUSION (Raised bump of the upper back), INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache). On 07-Jan-2021, the patient experienced TINNITUS (Tinnitus) and CONTUSION (Raised bump of the upper back). On 08-Jan-2021, INSOMNIA (Trouble sleeping), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. On 11-Jan-2021, CONTUSION (Raised bump of the upper back) had resolved. At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Lab tests were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had a fever for about 24 hours, a headache for about 2 hours until I took Advil, and a sore arm for about 48 hours.
Nearly one week after the shot in my left arm, my right arm began to be taken over by a blister like rash. It started on my forearm and spread upwards, within days, my entire arm was bright red and covered in a blistery rash. It looked like I had a large, red sleeve tattoo that had taken over from wrist to shoulder. My right  arm was swollen and filled with fluid, and in some places, felt bruised. It was throbbing and tingling--the tingling was similar to when your foot falls asleep My chest became heavy and a small, presistent cough started. The rash began spreading across my chest and back, up my neck, across my abdomen and eventually appeared on my legs and left arm--but nothing like the right arm, which looked almost mutant. The weirdest part is it is not the arm the vaccine was administered into.
Pink rash on genital area and nausea from early to mid January, 2022, saw primary care physician 1/31/2021. Rash was consistent with previous rash from 8/2020, which was also instance of a positive COVID-19 test. Diagnosed as dermatitis and prescribed a topical cream to treat the rash which resolved after a few weeks of use. Omeprazole was offered, but refused. Nausea issues persisted with loose and frequent stools and lower abdominal pain. Saw a new provider 3/2/2022 for second opinion. Omeprazole was ordered along with blood and fecal labs. Based on results, Cipro and Flagyl were ordered for a week due to possible GI infection and inflammation. Probiotic was also started during course of antibiotics. Symptoms improved somewhat after course of antibiotics. Referred to gastroenterologist for consult. On 3/28/2022 additional labs ordered, abdominal ultrasound, and scheduled for upper and lower endoscopy. Endoscopy completed 4/11/2022, noted gastritis, esophogitis, and ulcerated terminal ilium.  Concern for possible Crohn's disease was noted and Mesalamine and famotodine were ordered. Episode of syncope occurred 4/22/2022, medication was stopped and lab work ordered. Mesalamine was stopped and switched to Sulfasalazine. GI issues are still being monitored.
Lethargy/fever @ 6 days of age-hospitalized for septic work up-no obvious source of fever found;
Grunting, generalized body stiffness, hand/feet blue lasting 1 minute.
Patient becomes positive and symptomatic; Patient becomes positive and symptomatic; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Patient becomes positive and symptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive, notes: COVID 19 Treatment; Negative, notes: Negative after completion of paxlovid; positive, notes: positive and symptomatic. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was administered on 7/23/23, 2 days beyond BUD (7/21/23)
Still unable to raise arm above head; throbbing pain upon movement; diffficulty getting out of bed and putting on bra. NOTE: Pt. says that 2nd dose was in Right arm and not Left arm, however documentation states that both were given in Left arm.
fever/shaking/chills for 24 hours, starting 6-9hours after administration
Pt received a flu shot at the flu clinic on Oct 4 2006. He received his flu vaccine from the biojector. Called in Dec complaining that his arm was still sore to his wrist.
Three months later I contracted COVID - 19. I took an at home test and it was positive, afterwards I reach out for a telehealth visit to get a prescription of Paxlovid, but I had to go into office but couldn't make it.
This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper. As the secured lock was popped off the vial the rubber stopper was dented in and off a little. It was reported that, when the nurses removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication leaked. On 04-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from a leaking vial. There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-gauge needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. At the time of this report, no adverse event was reported. This case is linked to case 201805389 due to same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034101. Based on the QA Investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. The reporter assessed the case as non-serious. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative and the case comment were amended accordingly.
Pt. was given PENTACIL at 9:00 am on 6/1/09.  He went to daycare and when mom picked him up in afternoon noticed area around shot on anterior thigh was red & slightly swollen.  Instructed to give TYLENOL & cool wet compress
a patient received a 0.5 ml second dose of Pentacel vaccine which had a temperature excursion below zero, no adverse event; Initial information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA255196, 2019SA255155 and 2019SA254282 (same reporter).  This case involves a four months old male patient who received a 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine which had a temperature excursion below zero lot UJ135AA, expiry date: 26-Feb-2021 via intramuscular route in the left thigh on 12-JUL-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included a dose of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to incorrect product storage.  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 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.
Pain at injection site at right deltoid, burning pain that radiated down his right arm, subtle mottling of skin at the back of his hand. No itch or welts. Ice pack was applied at inj. site. Note: he had been calm and tolerated the tetanus booster fine at the right upper arm on the same evening.