chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO concomitant and treatment drugs were provided.
Yesterday, my arm developed a swollen, hot, red, itchy patch in a circular form around the injection site. Today, it is still swollen and red. Very strange a week after the injection.
Adverse reaction; A spontaneous report was received from a consumer concerning a unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events adverse reaction.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On an unknown date, the outcome of event adverse reaction was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
R57.9 SHOCK, UNSPECIFIED 6/30/2022 EMPTY SELLA SYNDROME R57.9 SHOCK, UNSPECIFIED 6/30/2022 ADENOCARCINOMA, AMPULLA OF VATER
Fever, Swelling, at injection site/ no drainage, no discharge, warm to touch. (Tdap)
Patient passed out sitting up in a chair a couple minutes after the vaccination was given while I was holding the cotton ball to his arm. Patient was visibly anxious prior to the vaccination and stated to me that he doesn't do well with shots. After a couple of seconds the patient came to,  he was disoriented and visible sweating. Nurses came over from the clinic next door to assist while the paramedics were in route. The patient stated to have not ate all day. Patient asked for water, said he felt fine but was a little dizzy. The paramedics arrived, checked the patient's vitals during this time the patient vomited up the water.
Six months after the 2nd vaccine, I still have pain at the injection site. My mobility is limited and the pain sometimes wakes me up at night.
24 hours after injection patient experienced swelling of her face and weakness in her legs. These symptoms lasted for approximately 24 hours
Patient received pneumococcal polysaccharide vaccine PPSV23 on 6/22/17 and presented with redness, warmth, and itching on 6/23/17. A prescription for prednisone was provided to be filled outside the clinic. Erythema multiform. Urticaria Pruritus. Erythema; Pruritus; Swelling. Prednisone.
Booster; Hair loss; Hair loss was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 (Lot number: FF2589) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, First Covid vaccine: 15Feb2021, Lot Number / Expiry Date: EN5319 , Route, Anatomical Location: left arm, No. of Previous Doses: NA), administration date: 15Feb2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, Second Covid vaccine: 08Mar2021, Lot Number/Expiration Date: EN6203, Anatomical Location: left arm, No. of Previous Doses: one), administration date: 08Mar2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "hair loss". The following information was reported: IMMUNISATION (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Booster"; ALOPECIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Hair loss"; CONDITION AGGRAVATED (non-serious) with onset Oct2021, outcome "not recovered", described as "Hair loss was reported as worsened".  Additional information: No additional vaccines administered on same date of the Pfizer suspect. The patient doesn't have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. No emergency room and physician office visit. No relevant tests. The patient stated that the hair loss started after the second dose, and the booster dose.  No follow-up attempts are possible. No further information is expected.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years and seven months old female patient who experienced clearing her throat, sniffling and stomach bloating and gas, while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AD; expiry date: 30-Jun-2019 via intramuscular route in the left upper thigh. On an unknown date, the patient developed a non-serious clearing her throat, sniffling and stomach bloating and gas following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. No lab data reported. Final diagnosis was stomach bloating and gas, sniffling and clearing her throat. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as Unknown. Additional information was received from consumer on 22-Oct-2018. Product coding was updated in field and narrative. List of documents held by sender- none.
Huge raised knot the size of a silver dollar. Fever in the spot of vaccination. Knot is and was very hard and tender.
Very loud and debilitating ringing in my ears. I?ve always had ringing in my ears for the last 36 years from my time spent board the flight deck of an aircraft carrier, however, shortly after receiving the vaccine the sound is very very loud and debilitating
Fever onset pm after vaccinations. The next day she had fever, developed swelling left leg and would not bear weight or use it much. Afebrile 9/21/06, bearing wt, still swollen, sm bump at site.
No Adverse effect- Patient was given intial pfizer dose instead of the Pfizer Bivalent booster
A rash on the right hip that was bruising, red and warm to touch; Had the normal adverse reaction of injection site pain and swelling; Had the normal adverse reaction of injection site pain and swelling; This non-serious spontaneous safety report, with reference number 02264111/ 02264110 was received by a partner on 07-OCT-2022 and forwarded on 10-OCT-2022 from a physician.   The reporter did not assess the causal relationship between Vaxelis and the reported events of "A rash on the right hip that was bruising, red and warm to touch" and "Had the normal adverse reaction of injection site pain and swelling".  Further information is expected.  Significant follow-up information was received on 28-OCT-2022 from a HCP.  The reporter assessed the causal relationship between Vaxelis and the reported events of "A rash on the right hip that was bruising, red and warm to touch" and "Had the normal adverse reaction of injection site pain and swelling".  No further information is expected.
Duplicate vaccines given and incorrect recording. Mom questioned the number of vaccines given but denied any reactions. 5 shots given - child not behind in vaccines.
No other issues or concerns noted; patient was given the 3rd dose early/ 1st dose was given November 16, 2021, 2nd dose March 16, 2022, and the 3rd dose should have been given in July 2022, but was given on 5/18/2022; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 16-NOV-2021, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On 16-MAR-2022, the patient was vaccinated with the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On 18-MAY-2022, the patient was vaccinated with the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis, which was given early, as it should have been given in July 2022 (inappropriate schedule of product administration). No other issues or concerns were noted (no adverse event).
This is a spontaneous report from a contactable Nurse. This Nurse reported for a 24-year-old female patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/Lot number EL3247, Expiration date: Not reported), dose 2 intramuscular, administered in Arm Left on 16Feb2021 as DOSE 2, SINGLE and BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number EL3247, Expiration date: Not reported), dose 1 intramuscular, administered in Arm Left on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 11Aug2021 patient experienced positive covid19 PCR test on 11Aug2021. The patient underwent lab tests which included covid-19 positive on 11Aug2021. Positive COVID19 PCR test Nasal Swab. Since the vaccination, has the patient had been tested for COVID-19. The outcome of both events was unknown.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Discomfort and itching, followed by her face swelling up, especially her eyes and lips.
approximatley 40-45 mintues after receiving vaccine I was driving to work and my tongue and lips began to swell.  Difficult time talking or taking a drink of water.  Arrived at work and after approxiamtely 20-25 minutes symptoms began to submit.  I did take over the counter bendaryl.  I did not seek further medical treatment since I am a Paramedic and was around other Paramedics that day.
Sore arm; Slight feeling of fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm) and fatigue (Verbatim: Slight feeling of fatigue). The outcome of the pain in arm and fatigue were not reported.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and fatigue to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051907, US2023AMR051910   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient wife via interactive digital media. The patient and his wife received the 2 shingles vaccines. neither of both had any side effects, other than a sore 3 arm and a slight feeling of fatigue the following day. The reporter have heard many horror stories of people who have had shingles.  The follow-up could not be possible as no contact details were available. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments:  US-GSK-US2023AMR051910:Same rporter US-GSK-US2023AMR051907:Same reporter US-GSK-US2023AMR051912:Same reporter -  HUSBAND case
This spontaneous report as received from a healthcare worker, refers to a 70 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 24-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot# J000443, expiration date: 11-APR-2014) 0.65 ml, subcutaneous. There were no concomitant medications. On 28-SEP-2013, the patient experienced shingles on her face. The outcome of  shingles on her face was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the singles on her face was not reported. No lab diagnostics studies were performed. Patient sought medical attention: office visit on 30-SEP-2013. Additional information has been requested.
Painful joints bilateral hands first three fingers. Bilateral wrists painful joints. Burning fire pain problems with bending fingers.
Starting having diarrhea - 10/16 - flu shot 10/8. Stopped 11/3/14. Flu shot 11/11 - started diarrhea 11/17.
Lyophilized powder reconstituted with 0.7 mL normal saline; Lyophilized powder reconstituted with 0.7 mL normal saline; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 58-year-old patient who received Herpes zoster (Shingrix) (batch number E344C, expiry date 1st April 2023) for prophylaxis.   On 26th November 2021, the patient received Shingrix. On 26th November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The director of nurse reported that, patient received Lyophilized powder reconstituted with 0.7 ml normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR262063:same reporter
experiencing sore muscles in neck where she can barely turn her head; Some soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (experiencing sore muscles in neck where she can barely turn her head) and VACCINATION SITE PAIN (Some soreness at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M201A) for COVID-19 vaccination.     The patient's past medical history included Neck pain (She had a history of stiff/painful neck tenderness).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced NECK PAIN (experiencing sore muscles in neck where she can barely turn her head) and VACCINATION SITE PAIN (Some soreness at injection site). At the time of the report, NECK PAIN (experiencing sore muscles in neck where she can barely turn her head) and VACCINATION SITE PAIN (Some soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
48 hours after my first Pfizer vaccine I broke out with a rash all over my arms and legs. I itched for 2 weeks non-stop mostly near nerve endings like the palm of my hands and feet.
The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration; The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001m21a) for COVID-19 vaccination.     Patient had no Acute and Chronic illness at the time of vaccination.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Apr-2022 and administered to patient on 09-May-2022 post 30day usage duration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by reporter. No treatment information was provided by reporter Date the vial was initially stored in the refrigerator: 06Apr2022. The vial didn't undergo any temperature excursions.
spike in blood preasure; This case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced increased blood pressure. On an unknown date, the outcome of the increased blood pressure was unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix and experienced spike in blood pressure. The reporter consented for follow up.
No additional AEs were reported/no vaccine reaction; The healthcare worker is reporting that a patient received improperly stored vaccine/power outage; This spontaneous report has been received from a healthcare worker and refers to a 4-year-old male patient. His current conditions included tie tong and disorder of speech. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 17-AUG-2023, the patient was vaccinated at the private doctor's office/hospital with public funds with 1 dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection in the left arm (lot number x000996 has been verified to be valid, expiration date 08-JUL-2024); which was previously improperly stored at a temperature of 29 Fahrenheit (F) during 4 hours and 30 minutes. The power outage occurred at 5:49 am (product storage error). Additionally, it was reported that the vaccine had no previous temperature excursion and no additional adverse events or vaccine reactions were reported. Digital Data Logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA007442: US-009507513-2308USA007540: US-009507513-2308USA007507:
For 2 weeks after taking the vaccine, the muscle in left arm was tense, hard and hot.   The muscle was also swollen.  On 1/19/21, the area where vaccine was given was very itchy and a rash was visible.
First time was sitting in recliner and world tilted on it's axis. Had a floating sensation thought was having a stroke, lasted a couple of minutes, was sitting entire time. It stopped and started having further episodes like this whether I was walking, standing or sitting. Felt like I lost all senses of balance. When walking I would stumble, had to grab surface to stay upright. Fell 2 different times to the left, but it was a slow fall and was able to catch myself. Went to doctor had an MRI, inconclusive. Diagnosed Vestibular episodes. Going for Ultrasound for Carotid Artery tomorrow. Labs have all come back normal.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient missed her 2nd Dose of the COVID-19 on 03May2021, because she tested positive with COVID 19 after her first shot of the COVID 19 Vaccine on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date. The outcome of the events was unknown.  Information on the  lot/batch number has been requested.