chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bump 2cm x 2cm with reddish blue discoloration on thigh - was decreased significantly by office visit time per mom.
From initial information received at manufacturer on 4/11/03, it was reported that a 16 year old male patient received, in the left deltoid, the first dose in series of 4 IMOVAX RABIES vaccinations on 3/7/03, lot number/route not reported. Patient also received, in the left deltoid, the first dose of RABIES IMMUNE GLOBULIN on 3/7/03, lot number/route not reported. Patient then received, within 4 weeks of vaccination date, 2nd, 3rd, and 4th doses of this series. Second dose was given on 3/14/03, third dose given on 3/21/03, and fourth dose was given on 4/4/03, all were given in the left deltoid. ON 3/10/03, the patient experienced dysphagia, severe pain over his chest wall and muscle spasms. He did not have a fever. Patient was hospitalized for 4 days, date and time were not reported. Patient has not recovered from these events. Patient was not taking any medications at time of vaccination and had no pre-existing diagnosis. Patient was bit by a Feral cat sometime in early March 2003. From additional info received on 9/12/03 from a health care professional at the reporting physician's office, the physician's address and phone number were updated. From additional info received on 10/7/03, from the reporting physician's office, it ws reported that the pt had recovered from the events. The physician stated that he "would have someone fax over a copy of the discharge summary regarding this pt." This info was also requested from the medical records dept at the hospital. No further info is available at this time. Follow up on 11/03/2003: "From additional information received on 10/23/2003 from the medical records department it was reported that the patient cannot be identified.  No further information is anticipated, this case is considered closed." Follow up on 11/17/2003: "From additional information received on 09/12/2003 from a health care professional at the reporting physician's office, the physician's address and phone number were updated.  From additional information received on 10/07/2003, from the reporting physician's office, it was reported that the patient had recovered from the events.  The physician stated that he "would have someone fax over a copy of the discharge summary regarding this patient."  This information was also requested fromt he medical records department at the hospital.  No further information is available at this time."
swelling in breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (swelling in breast) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced BREAST SWELLING (swelling in breast). At the time of the report, BREAST SWELLING (swelling in breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. The patient did not mention any treatment medications.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Began menstrual spotting 6 days before expected period. Cycle is usually regular, and this is the first time spotting. Period started 2 days early.   Left side jaw and teeth pain began one week after shot and has not subsided after 3 weeks. Also, left side headaches. Pain is moving around and dentist felt it was related to the nerve and not a dental issue. This is still ongoing.
Kinrix given to a 18-month-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 14-MAR-2023, the patient received Kinrix. On 14-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 18-month-old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-MAR-2023 CMA stated that a patient was inadvertently administered Kinrix.  She stated she thought the patient should have received the individual components and not the combined. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Patient received recent dose 13 days after already getting a flu vaccine. Mother claims she didn't know child had one for this flu season. Other dose given 8/30/2023.
Individual received 2nd dose of Moderna. 10 minutes into observation employee vomited and reported tingling of cheek and part of tongue.
Several irruptions /along a dermatome / these eruptions have not gone away; This case was reported by a other health professional via interactive digital media and described the occurrence of eruption in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced eruption. On an unknown date, the outcome of the eruption was not recovered/not resolved.   It was unknown if the reporter considered the eruption to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's husband. The age at vaccination was not reported. About eight weeks before the date of reporting in 2020, the patient received Shingrix. After receiving Shingrix, the patient had several irruptions that are along a dermatome and these eruptions have not gone away.
Information has been received from a certified medical assistant (C.M.A) referring to a patient of unknown age and gender. No relevant medical history or concomitant conditions were reported. On 28-NOV-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M031944,expiration date 27-DEC-2017; dose and route were not reported). No adverse effects were reported. It was reported that there was no previous temperature excursion and a data logger was involved. The vaccine was exposed to -10.7 Celsius degree for 1 hour and 46 minutes. This is one of two reports received from the same source. Additional information has been requested.
Felt like flu; Freezing; Sweat porously; Fluid in ear; Chills; Fever; Sore body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Sore body). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like flu), FEELING COLD (Freezing), HYPERHIDROSIS (Sweat porously), OTORRHOEA (Fluid in ear), PYREXIA (Fever), MYALGIA (Sore body) and CHILLS (Chills) outcome was unknown and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101 (High) Fever 101 degrees F. On an unknown date, Body temperature: 102 (High) Ran 102 temperature.         Concomitant product use was not provided by the reporter. Treatment information was not provided. She states that no medications resolved the headache. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. As per client, MO error in DOB capture.   This case was linked to MOD-2021-065271, MOD-2021-130965, MOD-2021-131034 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Added new events headache, fluid in ear, felt like flu, freezing, chills and sweat porously.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) on 12-SEP-2012. The patient was not experiencing any known symptoms. It was unspecified whether the patient had sought medical attention or not. The outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 12-OCT-2016, the patient was vaccinated with improperly stored (16.2 C for 8 hours) doses of M-M-R II (lot # L047134, expiry date 24-NOV-2017, dose, dose number, vaccination  site, route unspecified). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
I had serve pain in all my joint. It was worst in December and in February. I could not move. I was crawling. I went to the doctor about it. They put steroids. They did blood work, normal result. They are sending me to do x-rays and a bone density. I feel like I am a 100 years old now.
exposed to room temperatures; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In AUG-2023, the patient received Menveo. In AUG-2023, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: exposed to room temperatures).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2023 The reporter was looking on guidance and how to proceed regarding Menveo liquid formulation extended stability information.  The vaccines arrived on Friday night and they probably were exposed to room temperatures.  Somehow, vaccines were moved to a seller area.  The tag alert showed number 2 and 3 meaning that there was a temperature excursion, however 60 units were purchase and distributed and administered to patients. The reporter consented to follow up. The Menveo vaccines were exposed to room temperatures and administered to patients, which led to incorrect storage of vaccine.
A two hour period of full body chills in a room temperature environment (even with full body clothing).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 06Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2023) Negative, notes: I tested negative on 23Jan2023 and 24Jan2023; (24Jan2023) Negative, notes: I tested negative on 23Jan2023 and 24Jan2023; (29Jan2023) Positive, notes: I tested positive today, 29Jan2023. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Patient tested negative on 23Jan2023 and 24Jan2023. Patient tested positive today, 29Jan2023. Patient noticed that she sounded more nasal as the week went on but didn't think much of it.
I had asked my sons Ped to split up his 8 month vaccination shot (which he really recieved when he was 9months old) because he started acting funny after his 6 month shot by acting funny I mean showing signs of autism or PDD. His ped. did not split his shots up and the CMA gave him bruises and swollen legs for six weeks. He also developed a 102 fever that I had to constantly break and his so call Autism syptoms progressed and got worse and his ped. has done nothing about it.
patient became hypotonic, pale in color, and less responsive within 5 minutes of vaccine administration. Oxygen saturation dropped to 60. Patient resumed normal color and oxygen saturation about 5 minutes following.
This case was reported by a consumer and described the occurrence of meningitis in a female patient who received SHINGRIX (batch number ZG47A, expiry date unknown) for prophylaxis. Co-suspect products included TETANUS TOXOID (TETANUS VACCINE) for prophylaxis. Concurrent medical conditions included tooth infection (treating with antibiotics). On 19th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, the patient received TETANUS VACCINE at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced meningitis (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), rash, increased blood pressure and inability to work. On an unknown date, the outcome of the meningitis, passed out, rash, increased blood pressure and inability to work were unknown. It was unknown if the reporter considered the meningitis, passed out, rash, increased blood pressure and inability to work to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. Allegedly the patient was reach by the staff pharmacist for her 2nd dose for the Shingles vaccination. She informed the staff pharmacist that she had a reaction to the injection. After receiving SHINGRIX, in 2018, the patient experienced elevated blood pressure and a rash and she passed out at work. She had to have medical treatment due to her side effects from the vaccination. She missed 6 weeks off work and she was diagnosed with meningitis, she also confirmed that she had a Tetanus shot. It was unknown if the reporter considered the meningitis, passed out, rash, increased blood pressure and inability to work to be related to Tetanus shot.
Woke up with an extremely sore left arm (injection side) that did not want to move. Very, very tired, and very achy. I had chills on and off.  It lasted about 36 hours altogether. No fever. (Still better than getting COVID)
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. The temperature excursion and its time for administered doses of vaccine was unknown by the reporter. It was unknown if data logger was involved. There was an unspecified number of multiple ongoing excursions since April 2017. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011987: US-009507513-1709USA011988: US-009507513-1709USA011986.
Site: Redness at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Back pain-Medium, Systemic: Headache-Medium
Swollen left arm with blisters/very red.  Augmentin E.S for 10 days (Antibiotic) 750mg of Rocephin (IM).
No energy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jul-2021 and was forwarded to Moderna on 21-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 ASTHENIA (No energy). At the time of the report, ASTHENIA (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab data was not provided. Patient had suffered from temperature for week due to  first dose of COVID-19 vaccine.   This case was linked to MOD-2021-262837 (Patient Link).
Fever of 101.3; Itchiness at the injection site; Swelling at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2022, the patient received the 2nd dose of Shingrix. On 28th February 2022, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site swelling and injection site erythema. On 1st March 2022, the patient experienced fever. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, injection site erythema and fever to be related to Shingrix.  Additional details were reported as follows: The patient reported case for himself. The reporter reported that he received his 2nd dose of the Shingrix vaccine on Monday, 28th February 2022. Since then he had been experiencing redness, swelling and itchiness at the injection site. The reporter was inquiring if the symptoms he was experiencing were normal. The reporter did not consent to follow-up. The reporter declined permission to contact HCP (Health care professional).
itchy knot at the site of injection; itchy knot at the site of injection; Red knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy knot at the site of injection), VACCINATION SITE MASS (itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy knot at the site of injection), VACCINATION SITE MASS (itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). At the time of the report, VACCINATION SITE PRURITUS (itchy knot at the site of injection), VACCINATION SITE MASS (itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication or treatment was reported
Redness and pain. Defined outline of redness around shot location. Pain from wrist to shoulder.  Same as first dose. Redness lasted two weeks.
Patient said they had the normal sore arm for a couple days but it turned into nerve pain where he could not lift his arm very far above his head. No redness or irritation at the site. Will make doctors appt and call us back.
COVID-19; COVID-19; Vaccination site pain/sore arm with all three doses; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4042085-00 (AbbVie).  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1151978) at citrate free and second regimen subcutaneous (Lot number: 1155481) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain/sore arm with all three doses". The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events Vaccination site pain/ sore arm with all three doses and COVID-19 with Humira (Adalimumab) was no reasonable possibility.   Causality for Pfizer Biontech Covid-19 Vaccine: The reporter's causality for the events Vaccination site pain/ sore arm with all three doses was probable and for COVID-19 was not reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available.
This case was reported by the father of a consumer and described the occurrence of change in behavior in a 39-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  There were no concurrent medications.  On 20 March 2011 the subject received 1st dose of BOOSTRIX at 0.5 ml in the left arm.  On 20 March 2011, less than one day after vaccination with BOOSTRIX, the subject experienced change in behavior (acting like a 2 to 3 year old) and disorientation.  The subject was taken to the emergency room and was hospitalised for 4 days.  At the time of reporting, disorientation was worse and change in behavior was unresolved.  Two physicians treating the subject reportedly stated that they could only attribute the subjects reactions to BOOSTRIX.