chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20-month-old patient was inadvertently administered Quadracel, rather that the intended Pentacel, with no reported adverse event; 20-month-old patient was inadvertently administered Quadracel, with no reported adverse event; 20-month-old patient was inadvertently administered Quadracel intramuscularly in the right thigh, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00752068) and transmitted to Sanofi on 02-Sep-2021.  This case involves a 20 month old female patient who was inadvertently administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] intramuscularly in the right thigh today, rather that the intended DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (wrong product administered, product administered to patient of inappropriate age and product administered at inappropriate site).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 02-Sep-2021, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5772BA and expiry date: 17-Sep-2022, once) via an intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of PENTACEL (VERO) and QUADRACEL) and inappropriate age at vaccine administration and Vaccine administered at inappropriate site (with respect to use of QUADRACEL) (latency on same day).  At the 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 guidelines. 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.
Presented to the clinic on 1/23/02 for a pneumonia vaccine at 10 a.m. on 1/24/03 PT returned to the clinic complained of tenderness and redness in the left arm which started at 9 p.m. on 1/23/03. PT states "it hasn't been unbearable." PHN examined the PT's left arm, noticed redness, warm to touch. Redness on left arm is approximately 60 mm wide. Advised PT to apply warm compresses and follow up with MD. Referred back to private MD.
pt recv vax 22JUL96 & on 10MAR97 pt exp chickenpox w/100 lesions;the lesions were fluid filled & pt was running a questionable fever;
Client was administered vaccine that was expired by two and a half months. Client was re-immunized as advised by medical director to make sure valid dose was administered.
headache, flu-like symptoms, nausea, and vomiting, extreme weakness for 48 hours then 3 days woozy
Narrative: Patient noticed tingling in left arm then to head and then to tongue after moderna bivalent vaccination. Lef arm tingling and head tingling resolved after 10 min but tongue tingling persists. Patient was advised to go to ED but left.
sore arm; Neck and stomach were burning like fever; fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Neck and stomach were burning like fever), PYREXIA (fever 100F) and PAIN IN EXTREMITY (sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN WARM (Neck and stomach were burning like fever), PYREXIA (fever 100F) and PAIN IN EXTREMITY (sore arm). At the time of the report, SKIN WARM (Neck and stomach were burning like fever), PYREXIA (fever 100F) and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: body temperature 100F fever was reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported  Treatment for the events were  acetaminophen included
This spontaneous report as received from a healthcare professional (healthcare worker) refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L001316, expiration date: 10-NOV-2016; lot # reported as L013192, expiration date: 19-JAN-2017, dose, frequency were not reported). default to orally. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came in 4/1/15 to say her arm where injection site was given was still painful off and on since 3/17/15 no swelling or redness just pain indicated patient was to have doctor appointment 4/1/15 to check it out.
1st thing I noticed about 20 minutes after receiving the shot, my left eye started involuntarily twitching. And I just felt tired the rest of the day.   I had trouble sleeping that night because my abdominal area and my body in general felt uncomfortable. I ended up dosing off after a while. But then woke up out of my sleep at 3am or 4am because of stomach pain, and dizziness. I wobbled to the bathroom thinking I might feel better is I pooped. My stomach was very irritated but I could not go so I got up, washed my hands, woke my boyfriend up because I extremely nauseous, dizzy and weak. He got me  Tylenol, but as soon as I was about the take it, I felt as if I were about the faint, my vision went black, but my eye opened, I couldn't walk and stumbled into my dresser. My boyfriend carried me to the bed and he called 911. I had shakiness, a cold sweat, I was out of breath. The paramedic came and didn't leave until I felt better.   Ever since the shot I've had extreme gastrointestinal symptoms I'm dizzy, weak, and nauseous all the time. And my body is constantly on a low vibration. And at night these vibrations intensify, they become extreme tremors and it starts internally in my gut and comes outward, I've been to the hospital 3 times for this same issues. call test come back normal. I  have been constipated since receiving the vaccine, my doctor recommended a laxatives' or prune juice. I haven't had a normal bowel movement since. I had to take leave from work for 3 weeks. I have not gotten better so i just decided to suck it up return to work, as now  I have no money. Occasionally I'll feel random in voluntary twitches in other parts of my body, not just my left eye anymore. I have never had any serious gastrointestinal issues before nor have I ever had issues with bowel movements. The only issues I was trying to handle was my issues swallowing. and i had to put it on pause because the complications from the vaccine have been more debilitating. I've read about many others with gastrointestinal issues after the vaccine and very few accounts of the tremors and shaking.
Severe swelling, stiffness, febrile area - of bicep & shoulder treatment Prednisone 10mg.
the patient had pain with the injection and afterwards.  She has shoulder pain over a week later that is debilitating.  Her arm is throbbing and it's hard for her to lift anything.  She can't her arm over her head.   She is taking Ibuprofen.  Dr. sent her 10/16/20 to see an Orthopedic Surgeon Dr.
partial dose. Liquid portion of Menveo was given; partial dose. Liquid portion of Menveo was given; given on 1st july 2021 and this was the second dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA439A, expiry date 31st August 2022) for prophylaxis.   Previously administered products included Menveo (received 1st dose on an unknown date).   On 1st July 2021, the patient received the 2nd dose of Menveo. On 1st July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered were unknown.  Additional details were provided as follows: The patient received liquid portion of Menveo this was the second dose in the series first dose was given properly, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered. HCP wanted to know if the patient had to be vaccinated again after the second dose was a partial dose. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with an allergy to possibly penicillin (manufacturer unknown). The patient's medical history included unspecified lung surgery in October 2014. On 17-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route of administration, lot# and expiration date were not reported). The patient's concomitant therapy was reported as unspecified topical medications. On 20-AUG-2015, the patient developed pharyngitis and unspecified blisters (four or so on her left hand, two on her right hand, and a few on her stomach) after receiving ZOSTAVAX. No treatment was given for the adverse events and no laboratory tests were performed. The patient went into a pharmacy on 25-AUG-2015 and informed the pharmacist of the events. The outcome of pharyngitis and blister was reported as not recovered. Causality assessment between the adverse events and the therapy with ZOSTAVAX was not provided. This is one of two reports concerning the same patient. Additional information has been requested.
Constant muscular pain 9/10 in L arm (shoulder) with limited range of motion. Pain is worse at night, there is weakness when lifting arm and with abduction. Pain non-relived by OTC analgesics.
This spontaneous report was received nurse via company representative and refers to a patient of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On 15-DEC-2015, the patient was vaccinated with first dose of GARDASIL (dosing details and lot# not reported) for prophylaxis. Then on 01-SEP-2016, the patient received a second dose in the series which was GARDASIL 9 (Interchange of vaccine products and wrong drug administered). No adverse effects reported.
ON 8TH DAY POST VACCINATION-  WITH BANDAID STILL IN PLACE- INJECTION SITE BECAME REDDENED, AND FIRM TO TOUCH. 1/30 CLIENT WENT TO SEEK MEDICAL CARE AT A STAT CARE---  GIVEN DIAGNOSIS OF BEGINNING CELLULITIS, AND TREATED WITH KEFLEX 500MG TID
This spontaneous report as received from a Nurse Practitioner (reported also as "nurse prescriber") refers to a 25-year-old patient of unknown gender. The patient's medical history, concomitant therapy and concurrent conditions were not provided. On 26-MAY-2017, the patient received an expired dose of GARDASIL lot # K006960, expiry date: 19-FEB-2017, intramuscularly (dose not provided). No adverse effects were reported. Additional information has been requested.
About 2 hours after getting the shot I began feeling very tired and low energy. By that evening my joints were really hurting me. It lasted about 48 hours.
Injection site soreness 10 hours post administration; Still sore injection site this morning; Mild headache, muscle achiness and chills also 10 hours post administration of vaccine; Mild headache, muscle achiness and chills also 10 hours post administration of vaccine; Mild headache, muscle achiness and chills also 10 hours post administration of vaccine; This is a spontaneous report from a contactable other HCP. This 47-year-old female other HCP (patient) reported for self that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231) intramuscularly at the right arm at single dose for COVID-19 immunization on 23Dec2020; 09:45 AM. Relevant medical history included Asthma, Ulcerative Colitis and allergies to Penicillin, Fiorinal with Codeine. The patient received Ibuprofen, Mesalamine, Pantoprazole within 2 weeks of vaccination. The patient experienced injection site soreness 10 hours post administration on 23Dec020, mild headache, muscle achiness and chills also 10 hours post administration of vaccine. The patient felt better in the next morning on 24Dec2020, while she still had sore injection site this morning. No treatment was received. The final outcome of events was resolved. All events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
16Nov90 pt vax;  20Nov90 taken to hosp, w/ swelling from knee to hip, unable to walk.  Admitted tx w/ meds.
Information has been received from a consumer concerning his niece a 14 year old female who in September 2007, was vaccinated with a second dose of GARDASIL. Subsequently the patient experienced flat brown spots all the way down the arm she was vaccinated. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Broke out in a severe case of hives. I required emergency room medical attention. Throat began to swell and tighten up. Went to emergency room. Was given an IV of Benadryl,Predisone, Pepcid. This was caused by the Pneumovax 23SYR vaccine that I received on 02/22/2022. The vaccine was given to me by the pharmacist. On the recommendation of my primary doctor due to receiving the pneumococcal vaccine first a year ago.
Patient received COVID-19 vaccine on 11/22/2021 that had been reconstituted on 11/19/2021; so vaccine was out of 6-hour use range.
Note from M.D. - This 13 year old male is accompanied by his father with complaint of hives reaction over torso after receiving two injections yesterday at the Health Department. Patient has marked itching over chest and back. The raised rash was first noted upon waking this morning. No other complaints. Rash likely linked to immunizations received yesterday.
Opened at 5:24 PM on 01Sep2021, In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge.; The vial was put back into the refrigerator. The vial was also stored overnight in the fridge.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Opened at 5:24 PM on 01Sep2021, In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) and PRODUCT STORAGE ERROR (The vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021 at 3:08 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Opened at 5:24 PM on 01Sep2021, In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) and PRODUCT STORAGE ERROR (The vial was put back into the refrigerator. The vial was also stored overnight in the fridge.). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Opened at 5:24 PM on 01Sep2021, In between doses, the vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) and PRODUCT STORAGE ERROR (The vial was put back into the refrigerator. The vial was also stored overnight in the fridge.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.   This case was linked to MOD-2021-311050, MOD-2021-311328, MOD-2021-311050, MOD-2021-311221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Significant follow up received : second dose details added On 15-Sep-2021: Follow up contains no new information.
Patient called the pharmacy the day after the vaccination and reported break through bleeding in her menstrual cycle.  She usually is very regular and shouldn't cycle until the 26th of the month.  Patient will continue to monitor.
Injection site had a slightly raised area, like a pimple.  Approximately 1 inch away, a swollen ridge about 3 inches long in the bicep.  By the 3rd day after the injection, still has slightly raised area at injection site, but now a red, swollen and hot area about the size of a plum on the bicep. Arm sore to move or touch.
I have a temperature: it started around 12 am, the highest is 100.22 at 3 am and then it started go down. At 5 pm it completely gone
Muscle aches; swollen lymph nodes; generalized fatigue; nausea; This is a spontaneous report from a non-contactable nurse. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the right arm on 23Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On 25Jan2021, the patient experienced muscle aches, swollen lymph nodes, generalized fatigue, and nausea. No treatment was received for the adverse events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
I have had test to check my circulation in my leg; Pain; Swelling; Foot swelled up; my toes mainly, red, painful, burning sensation; my toes mainly, red, painful, burning sensation; my toes mainly, red, painful, burning sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 (Lot number: EW0170) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (LOT# for first shot: ER8731, anatomical site: right arm), administration date: 15Apr2021, for Covid-19 immunisation. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I have had test to check my circulation in my leg"; PAIN (non-serious), outcome "unknown", described as "Pain"; SWELLING (non-serious), outcome "unknown", described as "Swelling"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Foot swelled up"; BURNING SENSATION (non-serious), ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "my toes mainly, red, painful, burning sensation". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, swelling.  Additional information: Consumer stated he got his second Pfizer COVID shot on May 6th (not clarified) and his foot swelled up, toes mainly, red, painful, burning sensation. He went to the doctor on May 21st. Consumer reported that he had some lab test. After having the 2nd COVID Vaccine he had X-ray and MRI. He also had test to check circulation in his leg and in his feet different test. He doesn't know the name of them or do not have right off hand. He has a test for gout, a test for infection for diabetes and several others and he would have to go into his health portals to look them. (Further clarification about the laboratory test and the laboratory results were unknown, hence not captured as event). Consumer stated that he was taking treatment in response to adverse event, pain pills and he took Prednisone to bring down the swelling. He had done that 3 times.   No follow-up attempts are possible. No further information is expected.
she came to Clinic on 5/27/21. complained of headache since taking second covid vaccine. she had a negative covid POC test, trial Excedrin 6/3/21 complained of headache . baclofen, heat, stretching  ergonomics 6/8/21 complained of headache . labs ordered and a CT head without contrast
Temp elevated 101 to 102 orally w/large bug bite type hive occuring on pts face; no tingling of mouth or swelling of tongue; pt had recvd MMR p/1PM 17JAN92; mom instructed to take pt to ER;
Breakthrough case admission after third dose Pfizer 2/10/21 Lot# EL9267 Pfizer 3/3/21 Lot# EN6205 Pfizer 11/23/21 Lot# FJ1620
Patient described feeling flushed, Nausea, dizzy, and anxious after receiving shot
Face was swollen; Itching and had hives on different locations on her body; Itching and had hives on different locations on her body; This is a spontaneous case, initially received from other non-health professional via Communications (reference number: SEQ19-07176) on 02-Dec-2019, concerning an 8-year-old female patient.   The patient's relevant medical history includes penicillin allergy and allergy to ibuprofen, both caused a small rash.  The patient didn't have any concomitant medications.  On 23-Nov-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location:  left deltoid, batch number and expiration date: not reported] for influenza prophylaxis.   On 24-Nov-2019, the patient experienced itching and had hives on different locations on her body. The patient was treated with Allegra (fexofenadine hydrochloride) and Benadryl (diphenhydramine hydrochloride), at unspecified dose, route of administration and frequency.  The hives cleared but her face was swollen.  On 26-Nov-2019, the patient was taken to urgent care and was given prednisone and told to continue the Allegra and Benadryl. She was given a prescription for an Epipen (epinephrine).  On 29-Nov-2019, the outcome of swelling face and itching were resolved.  The reporter assessed the case as serious but did not provide causality assessment.  The case was linked with 201907059 (due to same reporter).  Company Comment: The patient experienced swelling face, urticaria and pruritus one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. Reportedly, the patient didn't take concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Sender's Comments: The patient experienced swelling face, urticaria and pruritus one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. Reportedly, the patient didn't take concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as related.