chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a blood clot in his left arm; possible sepsis; malnourishment; dehydration.; became so weak he slumped down; health has steadily declined; This is a spontaneous report from a contactable consumer (patient's son). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on an unspecified date (batch/lot number was not reported) as 2nd dose, single for covid-19 immunisation.  Medical history included Parkinson's disease, essential thrombocythaemia, and chronic kidney disease which were all under control; and allergies to latex and iodine. The patient's concomitant medications were not reported. On 01Mar2021, shortly after second dose, the patient became so weak, he slumped down and had to be lifted by reporter's uncle, after this incident, his health has steadily declined and now he was hospitalized again on an unspecified date with a blood clot in his left arm, possible sepsis, malnourishment and dehydration. He has Parkinson disease, essential thrombocythemia, chronic kidney disease; however, all were under control until he was vaccinated with the second shot. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for covid-19. The patient underwent lab tests and procedures which included covid test: negative on an unspecified date. Outcome of events was not recovered.  Information about lot/batch number has been requested.
Eyes Swollen, cughing, sneezing. Seen by MD and given Zertec in the office. Was to take Zertec 1 tsp daily for 5 day. Given samples and Rx
Information has been received from a physician concerning a 11 year old male patient with sickle cell disease who "approximately 2 weeks ago", on approximately 11-MAY-2011 was vaccinated with the first dose of GARDASIL. On approximately 11-MAY-2011, the patient was admitted to a medical center that evening with sickle cell crisis. It was reported that the patient was later transferred to a hospital on an unspecified date. At the time of the report, the patient's present status was unknown. Sickle cell disease was considered to be immediately life-threatening by the physician. Additional information has been requested.
Initial report received on 23 September 2013 from a pharmacist. A female patient of unknown age, whose medical history included diabetes mellitus and concomitant medications was not reported, received a dose of FLUZONE via intramuscular route for prophylactic vaccination from 19-Sep-2013. After vaccination, on 20-Sep-2013 the patient experienced a purplish area size of a dime at insertion site, hardness and some redness also present. Pharmacist reported that patient stated it was painful and itching. The events were ongoing at the time of this report. List of documents held by sender: none. Follow up information was received from health care professional on 23 September 2013. The cases were received on 21 March 2014 at GPV. It was reported that patient believed that the vaccine was given subcutaneously.
After patient was vaccinated, reports feeling unbalance, paramedic gives her alcohol and takes her vitals BP 130/90, sat 99, pulse 85. She waited 30 minutes for any adverse reaction to vaccine. After 30 minutes when patient was leaving she was feeling unbalance and reports not having breakfast that morning. She had water and her family brought her some breakfast. Paramedic called the ambulance.
ADMINISTRATION OF POTENTIALLY EXPIRED VACCINE; VIAL WAS OPENED  AT 9.35AM AND THE VACCINE WAS ADMINISTERED AT 6.50PM (AFTER 6 HOURS OF OPENING); This spontaneous report received from a health care professional concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 27-MAY-2021 18:50 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administration of potentially expired vaccine. On 27-MAY-2021, the subject experienced vial was opened at 9.35am and the vaccine was administered at 6.50pm (after 6 hours of opening). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of potentially expired vaccine and vial was opened at 9.35am and the vaccine was administered at 6.50pm (after 6 hours of opening) was not reported. This report was non-serious.
Patient reported feeling hot and tired upon awaking at 10:00 10/16 states symptoms resolved ~1700 10/16/09.
Initial unsolicited report received from a physician on 17 February 2015. A 2-month old male patient, medical history and concomitant medications were not reported, had received the intramuscular dose of DTP manufacturer unknown, (batch number, expiry date and site of administration were not reported) on an unspecified date. It was reported the patient had never received another pertussis containing vaccine. On an unknown date, after vaccination the patient had 4 hour crying spell and was diagnosed with a possible neurologic reaction to pertussis vaccine. The patient required ER/doctor visit. Laboratory investigation and corrective treatments were not reported. On an unspecified date patient was recovered from the events. It was also reported that the patient was 25 and has had no issues with Dt or other vaccines. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were reported as unknown. At the time of this report, outcome of the event was resolved on an unspecified date. Documents held by sender: none.
Vasovagel episode following vaccine injection lasted for under 1 minute. Patient reported chest discomfort following syncope that releaved in 2 minutes. EKG was performed and resulted at normal. Patient's skin was palor and clammy which releived within 10 minutes. Patient and mother reported symptoms were fully resolved at her follow-up PCP visit.
he had an aneurysm; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (he had an aneurysm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (for aneurysm) on 25-Mar-2021.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ANEURYSM (he had an aneurysm). The patient was treated with Surgery for Aneurysm. At the time of the report, ANEURYSM (he had an aneurysm) outcome was unknown.            The patient started taking a blood thinner after the surgery. Concomitant medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-151149 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-151149:
Patient developed increased obsessive symptoms , trouble wearing clothes, sleeping issues, potty issues. Resolving now. Began right after recieving vaccine. No treatment.
The wrong bivalent vaccine and dose were given. The patient was contacted by their PCP, instructed to come back in and received the correct bivalent vaccine per guidelines.
soreness in arm; Raw pink spot; Arm started to get darker; Started to peel like it was a chemical burn; Burn like blister; Arm got a huge rash all around upper arm and bicep/Moderna arm rash; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn) and BLISTER (Burn like blister) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 007C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn), BLISTER (Burn like blister), RASH (Arm got a huge rash all around upper arm and bicep/Moderna arm rash) and FATIGUE (kind of tired). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn), BLISTER (Burn like blister), RASH (Arm got a huge rash all around upper arm and bicep/Moderna arm rash) and FATIGUE (kind of tired) outcome was unknown.            Patient reports there was still a raw pink spot but other parts looks like it could have been getting better but she's not sure if it was or if it will peel again.   This case was linked to MOD-2021-402840, MOD-2021-402890, MOD-2021-402890 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received, contains non significant information,Pictures has been added
Extreme diziness, left arm numb and tingly, bad brain fog, dizziness has not stopped since 4 days after vaccine, every day. Cannot complete simple tasks at work as fast, hard to concentrate, pressure in ears, balance feels off. Hard to manage day to day routine with my kids, dizzy all the time, This is affecting my work, my lifestyle and every day concentration
Felt like he had the flu; Arm was sore below injection sit; Arm was swollen bellow injection site; Red spot below the injection site that was swollen and hard; Red spot below the injection site that was swollen and hard; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th August 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 9th August 2019, the patient experienced pain in arm and swelling arm. In August 2019, the patient experienced localized erythema and induration. On 9th August 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm, swelling arm, localized erythema and induration were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, swelling arm, localized erythema and induration to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient felt like he had the flu the next day after receiving the vaccination and resolved after two days. The third day after receiving the vaccination, the patient's arm was sore and swollen approximately 4 inches below the injection site.  The patient also experienced red spot again 4 inches below the injection site that was swollen, and hard. The patient gave permission for her physician to be contacted. This case has been linked with case US2019160424, reported by the same reporter.
tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown.  No follow-up attempts are possible. No further information is expected.
on the 18th i was in the Dr office and went to take my blood pressure i got up to get my weight and went to walk to the scale IN front of me and instead i was walking backwards instead of forward.  i stopped myself but i couldn't make myself  forward only going backward. my brain wasn't telling me to walk back but my feet were moving backward. Finally stopped and was able to make myself move forward. i was fully aware of what was happening but just couldn't stop it.
tested positive to COVID-19/wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (reporting for son). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's son (the patient) received the first dose of the Pfizer-BioNtech COVID-19 vaccine on an unknown date. Two (2) days later he wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat. About 8 days after the shot, he tested positive to COVID-19. He was asked to quarantine for 10 days and will have a second COVID-19 test then. His breathing was ok. He will probably have to wait 3 months for his second shot. The doctor told him it might be a false read.  The event was reported as non-serious. The outcome of the event "tested positive to COVID-19/wasn't feeling right, had a cold, stuffed nosed, throat was bad, and 3 days after he has soreness in his throat" was uknown.   Information on the lot/batch number has been requested.
Immunization given 7/15/03. Patient in office to see doctor 7/18/03; injection site red and swollen, hot to touch. On follow-up letter from doctor dated 09/10/2003: "I am reviewing the info she (his nurse) sent you and realize that it was much too brief and this reaction requires further explanation. She reported that the injection site was red, swollen and hot to touch. It was severe enough to require 3 office visits. The injection was given on 7/15/03 along with IPV and MMR. On 7/18/03 mom came back to the office and indicated that the child limped on his leg for about a day but since that has had no problem walking and is essentially asymptomatic with exception of about a 6x6 in round indurated red tender area on the left anterior thigh. The shot puncture could still be seen in the upper part of the indurated area. The injection was given in an appropriate area. The hips and knees flex completely so there was no sign of compartment syndrome. This area was angry enough for me to be concerned about cellulitis and the child was placed on Duricef 500 mg BID plus heat. Recheck on 7/20/03 again, asymptomatic with normal gait with exception of manipulation of the left thigh area. The left thigh was still swollen, the area was slightly larger but the erythema had faded significantly and was no longer hot. Antiobiotics were continued as well as heat. Recheck again on 7/25/03, now 10 days post DTAP. The child is totally asymptomatic and running around without any difficulty. The left anterior thigh still had about an 8-inch faint pink area which was not tender, not indurated or hot. It is felt that this was all local DTAP reaction, probably was not infected even though he did get a course of antibiotics. There was never any adenopathy."
Patient had a local reaction that included redness and swelling at the injection site where Hib vaccine was administered.
Body aches; Pain at the site of injection; Fever; Really bad fatigue; Just want to sleep; This is a spontaneous report from a contactable consumer or other non hcp.     A 66-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was Reported that, Caller stated for herself and husband we had a few side effects after receiving the second dose of the Pfizer COVID-19 vaccine 10 days ago. Nothing severe. The first dose was no problem both had body aches, pain at the site of injection, fever and really bad fatigue. The fatigue is getting better but it's still there. We felt so tired we just want to sleep. Caller's husband is 73 years old. She was 66 years old. Caller wants to know if we have any data on how long the fatigue should last. Caller heard generally within 2-3 days side effects starts to lessen. The outcome of the events was unknown on an unspecified date and the case was assessed as non serious.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
I the Medical Assitant administered an ADULT pfizer to a 9 yr old child.  she recived a full dose of 0.3 FL3198 to the RD  no reaction
This spontaneous report as received from a physician via a nurse refers to a 13 month old male patient. There was no relevant medical history and no concomitant medication was taken. On 25-MAR-2013 the patient was vaccinated with M-M-R II lot # H011885 dose 1, 0.5 ml, subcutaneous. On 02-APR-2013, the patient experienced fever. On 04-APR-2013, the patient experienced erythema maculopapular rash. The outcome of erythema maculopapular rash and fever was unknown. The action taken regarding M-M-R II  was unknown. The reporter causality was unknown. Additional information is not expected.
Dizziness when he stands up; Shortness of breath; Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th January 2022, the patient received the 1st dose of Shingrix (intramuscular). In January 2022, less than a week after receiving Shingrix, the patient experienced injection site pain. On 26th January 2022, the patient experienced dizziness and shortness of breath. On an unknown date, the outcome of the injection site pain and shortness of breath were recovered/resolved and the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, dizziness and shortness of breath to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself.  The patient had soreness at the injection site that lasted about a day. During the afternoon of 26th January 2022 he started having dizziness when he stands up and shortness of breath. The reporter had nothing else to report. Consent to follow up was requested.
Hives on the back of both arms, approximately 3 hours after vaccination.  Resolved with benadryl.
Mother took patient to ED at 6:00PM same day for possible seizure activity. ED diagnosed with Rigors.
Went back to school after his appointment 10/16/18 and at bedtime complained to mom that his arm hurt, she did not look at it until 10/17/18 around noon. He had a fever of 100.6, shortly after he vomited once.
12.27  Pt to ED reports he's had exertional shortness of breath over the last 2 weeks. Starting yesterday he developed severe difficulty breathing 12/28 Dx COVID-19 Pneumonia treating w/ decadron  12/30 episodes of panic attacks this morning. pt is being followed by Pulmonary Medicine and now he is on oxygen 4L by nasal cannula.  He is still on Decadron 6 mg once a day and he continued to be on remdesivir plus baricitinib 1/3 Pt left with home O2 that was delivered to bedside and medications from pharmacy. Pt left in stable condition
Information has been received from a lawyer regarding a case in litigation concerning an approximately 73 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2015, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). On or about 03-MAR-2017, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.