chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently administered FLUZONE QIV instead of the intended FLUZONE HIGH DOSE QIV with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 80 years old female patient who was inadvertently administered Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] instead of the intended Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received an unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: 7A5C3) (Expiry date: 30-Jun-2024) (Frequency: once) (Strength: Standard) via intramuscular route in the left arm for immunization.  On 11-Sep-2023, the patient was inadvertently administered Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] instead of the intended Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event (wrong product administered) (latency: same day).   It was reported, Caller reporting a patient was inadvertently administered FLUZONE QIV instead of the intended FLUZONE HIGH DOSE QIV. Caller with question on whether patient needs additional dose. This situation is reported as a medication error due to administering FLUZONE QIV instead of the intended FLUZONE HIGH DOSE QIV. No further information provided by reporter.    Action taken: not applicable.  Outcome: Unknown   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.
she tested COVID-19 positive; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that received her first vaccine shot on 01Feb2021 and she tested COVID-19 positive on 03Feb2021. Her second dose schedule is on 22Feb2021. The patient asked if she should still take the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Tiredness; Fever; Chills; aches; Headache; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old non-pregnant female patient received second dose BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL3247) via unspecified route of administration and administered in left arm on 22Feb2021 at 11:30AM for COVID-19 Immunization (at the age of 46 years). Medical history and Concomitant medications were not reported. The patient previously took first dose BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL3247) via unspecified route of administration and administered in left arm on 08Feb2021 at 11:00AM for COVID-19 Immunization. It was reported patient did not received no other vaccine in four weeks and also no other medications in two weeks. No Known allergies. On 23Feb2021 at 03:00 PM the patient had experienced tiredness, fever, chills, aches, headache. It was reported that no covid prior to vaccination and also not tested covid post vaccination. The patient did not received any treatment for the events. The clinical outcome of the events were recovered.      No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with 1 dose of improperly stored VARIVAX from either Lot # reported as L050560, expiry date: 14-DEC-2017, Lot # L044525, expiry date: 9-NOV-2017, Lot # reported as M002063, expiry date: 12-JAN-2018, Lot # L050956, expiry date: 17-DEC-2017 or Lot # L044524, expiry date: 09-NOV-2017 (dose, frequency and route of administration were not reported). Nurse was unable to confirm which lot the dose was administered from. No adverse effects reported. Additional information has been requested.
Headache, muscle aches, injection site pain, weakness in legs, dizziness. During the night of second day post-injection, I woke in a sweat and from then on my symptoms subsided and were completely gone by the next day. I never felt feverish before the sweats began.
I tested positive for Covid on 8/30/2021; I tested positive for Covid on 8/30/2021; This is a spontaneous report from a contactable Consumer (patient, self-reported). A 38-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via intramuscular, in Arm Left, on 10Mar2021, as unknown, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included chronic sinusitis. Concomitant medications included montelukast sodi-um (SINGULAIR), magnesium, and ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN). Past drug included Reglan and was allergic to Reglan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. On 30Aug2021, the patient was tested positive for Covid on 30Aug2021. The patient underwent lab tests and procedure included Covid-19 test with positive result on 30Aug2021. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's past medications included ciprofloxacin, codeine, morphine, ROCEPHIN and propoxyphene. The patient was allergic to ciprofloxacin, clindamycin, codeine, morphine, ROCEPHIN and propoxyphene. Information on patient's concomitant medications were not reported. On 27-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose were frequency were not reported) (lot # N025563, expiration date: 08-APR-2019) intramuscularly for vaccination. On 27-FEB-2018, the patient developed redness, swelling and pain at the injection site (hospitalization) that lasted for weeks. The patient sought medical attention and the patient went and treated at the emergency room of an unknown hospital on the same day where he received an unknown treatment. Treatment was given for the adverse events. The outcome of injection site swelling, injection site pain and injection site erythema was reported as not recovered/not resolved. The relationship between events and PNEUMOVAX 23 was not provided. There was no product quality complaint (PQC) reported. The reporter considered the events as serious due to hospitalization. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA001659.
This case was reported by a pharmacist via sales rep and described the occurrence of Guillain Barre syndrome in a 60-year-old male patient who received SHINGRIX. On 23rd March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 59 or 60 years old. The pharmacist reported that he overheard information about the patient presenting the Guillain Barre Syndrome after vaccination. The patient was taken to the emergency room and then transferred to another hospital. The patient was in intensive care unit. The pharmacist overheard that the patient might be released on 29th March 2018 and moved to a rehabilitation center. This was all the information that the representative was provided with.
Arm was red, swollen and hot just after the shot and continued for 2 days.  It seemed fine until day 7 when I woke with the arm red, inflamed and sore.  Muscle on arm is visibly swollen.
Localized cutaneous reaction of increasing size, 10 x 20 cm, erythematous macule.
Nausea, diarrhea, tiredness, aches, tachycardia
High fever (102 - 103 degrees), excessive crying, no appetite, unable to sleep. Cycle Tylenol and Motrin to maintain fever, baths, extra bottles.
Starting on Monday, I started getting hives and a rash. It would travel, start with both forearms and then a few hours later move to hands, scalp, and or chest. Kind of itching and burning. It lasted until yesterday. I didn't have a new laundry detergent or soaps, no new foods. I took Zyrtec finally and that appears to have resolved it. Flu shot was received about 6 weeks before this one.
5 hrs after receiving the flu shot in the right arm, pt developed pain and swelling in her right shoulder .  She had pain in shoulder and neck and back.  Hard to move, pt couldn't sleep.
hives/rash all over body that lasted 3 days.  Called PCP and prescribed medications to help with allergic response.
10 minutes after vaccines administered, pt developed a petechiae rash to neck and around eyes. Pt denies itching. No respiratory difficulty. Dr examined pt. Benadryl one teaspoon administered. Pt waited x 45 minutes in office. No further change in pt. 4-23-08 called to check on pt. rash persists. Denies itching.
Pt. states that after receiving the 2nd dose of Moderna 04/24/2021, started experiencing symptoms 06/2021 of Flu-like symptoms. Continuing 3 months with chronic cough, Covid Negative, Chest X-Rays preformed mid 07/2021 = Clear. Treated with Anti-Viral and Prednisone.
This spontaneous report as received from a nurse refers to a 10 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ oral. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patients were administered improperly stored ROTATEQ over the last three months (in 2014). No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
a red welt appeared an inch below the injections site; arm soreness; warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in January 2020, refer case US2020107091).   On 20th June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and skin warm. On 22nd June 2020, the patient experienced erythema urticarial. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the skin warm and erythema urticarial were unknown.   It was unknown if the reporter considered the pain in arm, skin warm and erythema urticarial to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had arm soreness.   The area was also warm to the touch and was soreness runs about 4 inches in diameter.  At the date of reporting the patient had red welt appeared an inch below the injections site.   The welt was 2 in diameter and 1 high. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107091:same reporter
Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (Diabetes at baseline).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Diabetes Medications.  The patient did not received any treatment.
This spontaneous report as received from a 26 year old female patient reporting on herself. The patient's mother was also a reporter. The patient did not have important pertinent medical history or drug reactions nor allergies. On 05-AUG-2016 in the late afternoon, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly. Concomitant therapies included LEXAPRO. On 05-AUG-2016, within maybe a minute, after receiving the vaccine, she proceeded to leave the clinic. As the patient was leaving, her ears began ringing and she started to feel dizzy. She sat in a chair in the waiting room and the dizziness progressed. A nurse practitioner handed her a cup of water and said stated that she looked very pale so advised her to sit for a bit. Also the nurse practitioner took the patient's blood pressure and it read 90/60 unit not provided. She indicated this was low for blood pressure and gave her a lollipop to give her a sugar boost. Lab diagnostic studies were not performed. The patient also stated that after 20 minutes that day, she felt much better and left the clinic on her own. The outcome of the events was reported as recovered/resolved on 05-AUG-2016. Causality assessment was not reported. Additional information is not expected, because contact details were not provided.
FEVER(100.5), CHILLS, HEADACHE, NAUSEA, RAPID HEART BEAT, SWELLING @ INJECTION SITE, SHORTNESS OF BREATH; DRY MOUTH DRY EBEY FLUSHED, FATIGUED, FREQUENT BOWEL MOVEMENT 7 URINATION. COUGH
(L) arm tender, red, swollen. No Fever Pediatric Doctor called - administer TYLENOL for pain & cold compresses.
Pt reported itchiness in her arm, forehead, and eyes.  Pt was administered w/ 25mg Benadryl LOT 0810127
swelling on right side of face and jaw; swelling on right side of tongue; swelling on right side of throat; It is affecting eating mechanically; Soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on right side of face and jaw), SWOLLEN TONGUE (swelling on right side of tongue), PHARYNGEAL SWELLING (swelling on right side of throat), MASTICATION DISORDER (It is affecting eating mechanically) and PAIN (Soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (swelling on right side of face and jaw), SWOLLEN TONGUE (swelling on right side of tongue), PHARYNGEAL SWELLING (swelling on right side of throat), MASTICATION DISORDER (It is affecting eating mechanically) and PAIN (Soreness). At the time of the report, SWELLING FACE (swelling on right side of face and jaw), SWOLLEN TONGUE (swelling on right side of tongue), PHARYNGEAL SWELLING (swelling on right side of throat), MASTICATION DISORDER (It is affecting eating mechanically) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
where the needle actually hits, it was a little sore/tenderness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis" (ongoing), notes: she had MS for seven years now and takes infusions for MS. Concomitant medication(s) included: RITUXAN taken for multiple sclerosis. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "where the needle actually hits, it was a little sore/tenderness at the injection site".  Additional information: The patient received the first dose of the BNT162B2 in Feb2021. She received dose in the left arm and had complaints of tenderness at the injection site, where the needle actually hits, it was a little sore. Vaccination facility type was pharmacy. No prior vaccinations (within 4 weeks).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is 30 YO male, he was here to receive his booster of pfizer covid vaccine at 5:30 pm. after the vaccine, pt was unconscious not responding to external stimuli for a brief moment during 15-min observation. patient was hot to touch, pale-looking. patient was brought from chair down to laying on the floor-patient regain conscious by responding to who, where, what. Patient reported that he was lightheaded and was needle phobia. BP 140/80 mmHg on Right Arm, Pulse 76, PO2 95% using manual BP cuff techniques and pulse oximeter at 5:40 PM. EMS was called and arrived at 5:45 PM. Patient refused to go to the hospital and left the pharmacy around 6:15 PM. Patient reported that he is feeling okay when asked before leaving.
Large hive on inside of upper arm opposite side of where the injection was but same arm as vaccine evening of vaccine. Extreme fatigue following day with mild headache
she had it also after the shots/ Suspected vaccination failure; she had it also after the shots; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient had shingles after the Shingles vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked with US2021AMR103693 and US2021AMR103686, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103693:same reporter US-GLAXOSMITHKLINE-US2021AMR103686:same reporter
patient were given IPOL instead of Prevnar 13 with no reported adverse event; Initial information received on 22-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old and unknown gender patient and is reported patient were given IPV (VERO) [IPOL] instead of pneumococcal vaccine CONJ 13V (CRM197) [prevnar 13] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site  On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) instead of PREVNAR 13 (wrong product administered) latency on the same day.Information on the batch number was requested.  Reportedly The patient is 15 months old and they were given IPOL instead of Prevnar 13. The patient previously received 3 doses of IPOL at 2, 5, and 7 months.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient were given ipol instead of prevnar 13/incorrectly administered ipol to a patient, with no reported adverse event.  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.