chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Sore Arm; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headaches). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headaches) outcome was unknown. Not Provided      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 details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-042810.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 : included No New Information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042810:sibling case (reporter)
This case was reported by a consumer and described the occurrence of injection site rash in a 77-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date unknown) for prophylaxis. On 3rd December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX and had a rash below where the patient had received the vaccine it was about 3 inch long and 2 inch high. The rash was also a bit itchy. The rash lasted about 2 weeks it slowly went away. The patient went to her physician several days after the rash started and he suggested that the patient should report it to GlaxoSmithKline. The reporter consented to follow up.
TD given in right arm intramuscularly and Meningitis given in left arm subcutaneously, both vaccines were given on 12/19/2005.  Per doctor patient started with swelling at both sites and warm to touch on 12/20/2005.  Fever of 103 on 12/21/2005.  Doctor suggested warm compress, use Benadryl and follow up on 12/23/2005.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The healthcare worker reported that the patient who received her first 0.5 ml dose of GARDASIL intramuscularly on 02-OCT-2012, received her second 0.5 ml dose of GARDASIL intramuscularly on 16-OCT-2012. At the time of the report, no adverse effect reported. Additional information has been requested.
Approximately 10 patients received the expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Approximately 10 patients received the expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Approximately 10 patients received the expired vaccine). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Approximately 10 patients received the expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reported stated that 1 vial that was frozen was received from another provider.   The vaccine had a written expiration date of 28-Sep-2021. The vaccine expiration date was later confirmed as 14-Sep-2021.   No concomitant medications were reported.  No treatment information was reported.
Pt vomited x1, feelings of faint, blurred vision, difficulty hearing. Decreased B/P. Symptoms resolved after 30 min, B/P increased. Pt sent home.
CHILLS; ON AND OFF FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, and on and off fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and on and off fever. This report was non-serious.
Mom called about 30 minutes after leaving office and said son was broken out, eyes swollen, crying.  Told her to give 1/2 teaspoon Benadryl and to call doctor in 1 hour.
Immediate fatigue, moderate arm soreness, then developed 100.0 fever that persists into Day 2, and unresponsive to 2X extra strength tylenol. Severe headache.
extremely sick; huge fever; chills; nauseated; extremely tired; sleepy; hurt all over/ every bone in her body was hurting; diarrhea; it flet like the flu; felt out of it; headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EN6205, NDC number: unknown, Expiry Date: unknown), via an unknown route of administration in left arm on 15Mar2021 at 14:40 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. Limited information available as consumer hung up the call abruptly, hence product details (NDC, UPC, LOT and expiration date) and further details were unknown. The patient's medical history included asthma and had allergies; both were from unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), montelukast sodium (SINGULAIR MINI), ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP), cetirizine hydrochloride (ZYRTEC ALLERGY) and zinc; all were taken for an unknown indication from an unknown date. On 16Mar2021, twelve hours after the vaccine at about 2:00 am, the patient experienced huge fever, chills, nauseated, extremely tied, diarrhea, felt out of it, headache, it felt like the flu and was sleepy, hurt all over/ every bone in her body was hurting. On an unknown date, she got extremely sick. She received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021. Caller stated her second dose scheduled on 05Apr2021, but she does not know if she should get the second dose because she got extremely sick after first dose. Twelve hours after the vaccine at 02:00 am, she woke up with a huge fever, chills, nauseated, extremely tied and sleepy, hurt all over and had diarhea. She never felt that bad before stating every bone in her body was hurting. Described it as the weirdest thing stating it felt like the flu. She thought she should wake her husband up and go to the ER. Her husband called her HCP because she was so sick. She would not call her symptoms severe or call it an allergic reaction. Her HCP advised to take two Benadryl and sleep it off. The caller basically had every side effect on the list and it lasted almost 2 days, it was so weird. Usually did not have anything go wrong, it was so bizarre and she was leery about getting the second vaccine scheduled on 05Apr2021. The caller felt worse after the vaccine than when she had covid itself. She had COVID on 16 December2020 (around Christmas) and waited 90 days to get the first dose of the vaccine. On 8Jan2021, she had a positive antibody test. Caller stated HCP advised to do antibody titers and when they wane, get the second dose. The outcome of events huge fever', chills', nauseated', diarrhea', felt out of it', headache', it felt like the flu' and sleepy' was recovered on an unknown date in 2021, the outcome of the remaining events was unknown.   Follow up attempts are completed. No further information is expected.
20 hours - 28 hours after vaccination, all of the above and headache and nausea; 20 hours - 28 hours after vaccination, all of the above and headache and nausea; Around 28 hours after vaccination, vomited 5 times; Approximately 10 hours after vaccination, arm pain; Approximately 10 hours after vaccination, arm pain, chills and fatigue; Approximately 10 hours after vaccination, arm pain, chills and fatigue; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; 14 hours - 20 hours after vaccination, arm pain, chills, body aches, thirst, fatigue, difficulty sleeping; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3247) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no other relevant medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received within two weeks of vaccination was not reported. It was not reported whether the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3247) via an unspecified route of administration in the left arm on 05Feb2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021 at 20:00, approximately 10 hours after vaccination, the patient experienced arm pain, chills and fatigue. On 26Feb2021, 14 hours - 20 hours after vaccination, the patient experienced arm pain, chills, body aches, thirst, fatigue, difficulty sleeping. On 27Feb2021, 20 hours - 28 hours after vaccination, all of these and headache and nausea. On 27Feb2021, around 28 hours after vaccination, the patient vomited 5 times. In 30-36 hours symptoms started to subside and 48 hours after vaccine, symptoms were mostly gone except for sore arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue, body aches, thirst, difficulty sleeping, headache and nausea, vomiting was resolved on an unknown date in 2021, while that of arm pain was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PAIN IN EXTREMITY (sore arm), PRURITUS (hives are itchy/itching), FEELING HOT (hives are hot) and SCRATCH (She has been scratching) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (diagnosis date was 24th March of unknown year). On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PRURITUS (hives are itchy/itching) and FEELING HOT (hives are hot). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), SCRATCH (She has been scratching), SCAR (has scars), SLEEP DISORDER (itching has also impacted her sleep) and RASH (rash). At the time of the report, URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PAIN IN EXTREMITY (sore arm), PRURITUS (hives are itchy/itching), FEELING HOT (hives are hot), SCRATCH (She has been scratching), SCAR (has scars), SLEEP DISORDER (itching has also impacted her sleep) and RASH (rash) outcome was unknown. The patient did not have any significant past medical history and no allergies. Concomitant medication of the patient was not reported. The patient had seen other people online confirming similar symptoms as of her. She had an appointment with 2 different dermatologists who were unable to help her because the rash was not present upon their assessment. She was given an anti-itch cream and an oral medication (unknown medication, possibly starts with an H) for her symptoms which had not helped. She also spoke to her primary care physician who referred her to an allergist.
Patient came back in 1 hour after shot was administered claiming her throat was closing up tingling around shoulder and groin. "Just not feeling right" Patient later said she fell as well. 1 EPIPEN was administered which improved patient status. EMS came and patient refused therapy.
15 minutes after face flush. Later about 1:30 am, sore arm returned and face itching and 1 degree of temperature
The night I got the vaccine 3/10 my arm was sore just like any other vaccine I?ve received. Two days later, I woke up and noticed a welt on my arm that was about two inches in diameter. It was itchy and painful. I could not lift my arms up. By noon it had doubled, and the slightest touch was unbearable. The ?Covid arm? was also hot in temperature. That night, it was at its worst at 5 inches in diameter and it was even more swollen. It stayed that way for three more days before it started to go down. A week after my vaccine a bruise developed where the welt was. Two weeks after my vaccination it was still bruised and swollen. It felt like a tide pod when I touched it. My mom encouraged me to go to urgent care. So on 3/26/21, I went to urgent care and was told it was a cyst. My arm is currently still squishy at the welt and bruised. I have an appointment on 4/19 at my dermatologist for further care.
Baby's grandmother came to clinic on 2/19/02 and spoke with head nurse and requested immunization record and told that baby was fine until week after shots; was laughing and playing but when father went to wake baby on Friday morning 2/15/02, baby was blue. States father tried to revive until ambulance came. States they coded baby 8 times at hospital. Transported to hospital in ICU with seizures and high fever. States MD said shots were the cause of the baby's illness. Condition at present unknown. As per follow up letter pt has not been in clinic since 02/11/2002.  Nurse follow up on 05/20/04 states: Apnea.  Nurse follow up on 07/14/04 states: Diminished vision.
Pain near shot location beginning two hours after the shot and lasting for at least 24 hours; Fever between 99.1 and 100.4 starting twelve hours after the shot Muscle aches in legs and back starting twelve hours after the shot
arm pain/ Injection site pain; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included essential thrombocythemia. Concomitant products included ruxolitinib phosphate (Jakafi).   On 15th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The medical history and concomitant medication were not reported. On 15th May 2019, the patient went to his primary care physician (PCP) for his annual visit where he was given 1st Shingrix shot. The patient had no problems with it other than a sore arm. The patient received Jakafi tablets 15mg tablets BID on unknown date for essential Thrombocythemia (ET), which led to off label use.  The batch number and expiration date were not reported. On 06th August 2019, the patient went to get the 2nd dose but was refused because the manufacture recommended against it. There was no other information reported.
mom calls today stating pt has consistently run a 102-103 fever w/little dec w/APAP or Ibuprofen;pt also excessively cranky per mom;
Received both vaccines and directly afterwards, pt was feeling dizzy and light headed. He started shaking as well and we took his BP, and it is was 81/53. This didn't resolve over a half hour, so the pt asked us to call 911. The paramedics responded after 5 minutes and evaluated the pt. His BP came back up, but he was still feeling dizzy and unable to walk, so he decided to take an ambulance to be on the safe side so that medical professionals could run some more tests to make sure he was okay.
SHORTNESS OF BREATH; RACING HEART; BODY ACHES; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced racing heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and body aches, and had not recovered from racing heart, and shortness of breath. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Never been pregnant. Received vaccination on 10/09 @250pm. Defacated on 10/10 around 545am. ?entire toilet bloody ?bloody tissue ?blood was bright red in toilet ?bright red and pinkish on tissue ?no blood noted in stool  ?stool was formed Defacated on 10/10 around 6pm stool was formed ?no blood in toilet or on tissue ?stool had black portions not attributable to anything in diet Defacated on 10/11 around 545am ?stool was formed ?bright red portions noted in Still ?bright red blood and clots on tissue Overall during the 3 days: no abnormal stomach pains noted; defacation was not strained or painful; stool was not hard; there was no anal tear that would have caused the bleeding; nausea and fatigue were noticed on 10/10 and 10/11.
This spontaneous report as received from a other health professional refers to a unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with VAQTA lot numbers M036458 and N005274 oral for prophylaxis. On an unknown date, the vaccine was incorrectly storage. Sender's Comments: US-009507513-1708USA012513: US-009507513-1708USA005527.
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146045, 2015SA146046, 2015SA146047,2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patient's electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves a patient (age and gender not reported), who was vaccinated with a dose of INFLUENZA VACCINE (IIV) (manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient developed a possible allergic reaction to the vaccine. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Documents held by sender: none. Follow-up information received from physician on 19 October 2015. No additional information was provided.
Vaccine Not removed From Freezer at 2 wk mark- at 3 wks and administered consult and manuf  Notified Pt after repeat dose Repeat 11/21/21
9 hours after vaccination - intense chills followed by vomiting. Symptoms lasted 2-3 hours. 12 hours after vaccination - fever of 102, headache, intense exhaustion. These symptoms lasted 12 hours
Reportedly, the pt developed shoulder capsulitis on 11/23/98. The pt was reportedly seen by a neurologist on 11/24/98.