chrisvoncsefalvay/vaers-outcomes huggingface dataset:
possible thrombosis reaction; Unexpected bruising near injection site.; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; minimal pain/stiffness following the shot; minimal pain/stiffness following the shot; This is a spontaneous report from a contactable consumer (patient).   A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 53-year-old via an unspecified route of administration, administered in Arm Left on 20Apr2021 11:15 (Lot Number: EW0153) at 1st dose, single for covid-19 immunisation.  The patient medical history was not reported. The patient received no 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. Concomitant medication included famotidine (PEPCID AC).  The patient previously took flu shot in Oct2020, prilosec [omeprazole magnesium] for seasonal allergy and experienced drug hypersensitivity.  The patient experienced unexpected bruising near injection site. Bruise was the size of the bandaid, approximately 1" x 2". Bruising had persisted for more than a week now. The patient had never experienced bruising like this with other vaccines. He would like to rule out possible thrombosis reaction before second shot. He did not have bruising at any other locations other than the injection site.  Bruise was purple and red splotches and has now progressed to mostly yellow. He believed the discoloration was a reaction to the vaccine and not the result of the needle. The shot itself was painful but patient felt minimal pain/stiffness following the shot. The event start date was on 20Apr2021. No treatment was received. The outcome was unknown.
Injection site pain and itching and swelling - starting within one hour of shot - sore elbow, arm (knots on legs, started 9-9-14). Tired, chills, temp of 102.7 8pm on 9-9-14. Has been on TYLENOL for pain.
Subject received vaccination Wednesday Dec 16th in the afternoon.  He became symptomatic (shortness of breath, low grade fever) the next day.  Went to the Emergency room on Saturday Dec. 26th, 2020 due to shortness of breath, had an 02 Sat of 60%,  and was hospitalized in the ICU at another hospital (due to bed unavailability).
Chills; Aches/aches and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (COMIRNATY), administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 77 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, SINGLE), for Covid-19 immunization, reaction(s): "tiredness"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "tiredness". The following information was reported: CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Aches/aches and pain".  Additional information :Patient is very achy and just would like to take either Advil, Tylenol, or Aspirin for the aches and pain. States her doctor is in PRIVACY and she is presently in PRIVACY . Wants to know is there a protocol on what pills she can take when achy in general, what pain reliever can she take.  Follow-up attempts completed. No further information is expected.
LOW HEART RATE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, and lisinopril for high blood pressure. On 25-APR-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) below 60 bpm. On 24-JUL-2021, Laboratory data included: Heart rate (NR: not provided) 69 bpm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 115/72 mmHg, and Heart rate (NR: not provided) 68-78 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low heart rate. This report was non-serious.
Mild headache and nausea after sitting in observation for about 25 minutes. Refused any intervention by observation staff including VS. Declined evaluation by EMS.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number DK74P, expiry date unknown). The patient's past medical history included shoulder operation, cholesterol (be cholesterol issues and shoulder repair for respective historical sections), thyroidectomy and tonsillectomy (thyroid and tonsil taken out). Concomitant products included Aspirin, Levothyroxine, vitamin d and COQ10. On 17th February 2018, the patient received the 1st dose of SHINGRIX. On 18th February 2018, 1 days after receiving SHINGRIX, the patient experienced fever, back pain and pain in the arm. The patient was treated with TYLENOL and TAMIFLU. On 19th February 2018, the outcome of the fever, back pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, back pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received no other vaccines on the day of vaccination with SHINGRIX. The morning after the patient received SHINGRIX in her left deltoid she experienced pain in her back and arm. The reporter stated that she usually got this when she had a fever. Reporter stated that she had a high fever of 100.8 degree F despite taking TYLENOL. She visited a nurse practitioner at a clinic who prescribed her TAMIFLU. The reporter stated that she felt 100 percent by the morning of previous day before reporting.
over 42 days between vaccines. 1st dose 06/04/2021, 2nd dose 07/29/21
2nd dose of the DTap series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: 2nd dose of the DTap series). The outcome of the inappropriate schedule of vaccine administered 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: 13-MAR-2023 A healthcare professional (HCP) informed that Kinrix was administered to a patient as the 2nd dose of the DTap series instead of being the 5th dose of the series. The HCP told that such thing had also happened to a lot of other patients, but in that moment, she only had available the information of one patient. The reporter consented to follow up. This case is linked with US2023054684, reported by same reporter.  A lot of patient received Kinrix as a 2nd dose of Dtap series, which led to inappropriate schedule of vaccine administered.; Sender's Comments:  US-GSK-US2023054684:Same reporter. Identified patient.
I got the vaccine Tuesday evening and felt fine until Wednesday morning when I got a migraine and a fever. Thursday I felt mostly fine just some tiredness and a little weakness. Friday evening I started to feel light headed and then by Friday night I felt a lump in my throat and my neck felt like it was burning. The burning continued into Saturday. I went to the pharmacist and he told me to take some Tylenol and an antihistamine. That helped a lot with the burning feeling. Sunday I felt very weak all day and felt more of a slight tightness in my throat. Monday the weakness and tightness in the throat continued just not as extreme.
received a 0.25ml dose as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a second dose). At the time of the report, ACCIDENTAL UNDERDOSE (received a 0.25ml dose as a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Facial twitching (left cheek, eyelid, and mild numbness of lower left lip.
I received a rash at the injection site within a couple hours after receiving the first dose of the Moderna COVID-19 vaccine. The rash worsened after my second dose 4 weeks later. It has now been almost 8 weeks since the rash appeared, and it still has not gone away. It looks like small red and yellow bumps covering my upper arm. There is no soreness or itchiness associated with the bumps, but they do seem to improve but then return.
Patient had sudden onset of vertigo that started at 11 AM, associated with nausea and vomiting.
Patients injection site immediately bruised and became inflammed. The site was swollen and very hard. Pharmacist placed an ice pack on site until the swelling went away. Bruise remained.
pt recv vax;v for 5 min p/vax;apap given;45 mins later,broke out w/ hives;ears bright red,started wheezing;called clinic;dph & adrenalin given;also intal for asthma;stayed in MD ofc till 4:30pm;
Received vaccine 3/3/15 (PREVNAR and shingles). Rash occurred 3/10/15 (located waistband side).
Onset 5/7/22 of widespread rash.  Started with spots on thighs and then spread all over body.   No treatment needed.
Eye tearing and sclera injection first, evolving into periorbital edema given 40mg IM Solueorlef and 20mg Benadryl IM sent to ER.
On or about Nov. 2, 2011 my feet started feeling like they were asleep. Then my legs started feeling the same. About 2 weeks later I could not walk very good I was feeling numb from the waist down. Started having no strength from the waist down. Then my fingertips started feeling the same.
"Symptoms started approximately one week after getting the vaccine. Initially had trouble getting up from seated position. Sometimes feels off balance. He felt leg weakness and imbalance. He states it started to get better in last 1-2 weeks. He still feels tired. He says it is 50% better at this time. Patient can get up from seated position reliably at this point. He denies any autoimmune diseases or FH of Guillane Barre syndrome. Recommend MRI brain, C-spine, and T-spine at that time which subsequently revealed scattered T2/FLAIR hyperintensities suspicious for demyelinating disorder" - Neurologist Note on 5/3/21
On Feb. 9, 2000, the pt developed chicken pox. The pt presented to a physician with 35 pox. No treatment was given. Additionally it was noted that 2 other pts experienced similar reactions. Follow-up information from a physician indicated that on 02/17/2000, the pt recovered.
suspected vaccination failure; I did. I broke out from the second one; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. It was reported that the patient broke out with shingles from the second one. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation and exact time to onset for shingles were unknown.
Difficulty moving the affected arm; Redness (and swelling) at the injection site; (Redness and) swelling at the injection site; A large knot distal to the injection site above the elbow; This is a spontaneous case, reported by pharmacist to Agency (Case ID: SEQ19-02900) and initially received on 18-Sep-2019, concerning a female patient of unknown age.  The patient's relevant medical history and concomitant medications were not provided.  On 17-Sep-2019, in the morning, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, batch number: 260395, expiration date: 30-Jun-2020, anatomical location: left deltoid, route of administration: intramuscular (IM)] for protection against seasonal influenza.  On the same day, after vaccination, the patient developed redness and swelling at he injection site, a large knot distal to the injection site above the elbow and difficulty moving the affected arm. The patient did not received any treatment measures.  At the time of reporting, the outcome of the events was ongoing.  The reporter assessed the case as non serious and did not provided causality criteria.  The reporter did not give the permission to be contacted for further information.  Company Comment: The patient experienced injected limb mobility decreased, injection site erythema, injection site swelling and vaccination site induration on the same day, after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal relationship between the suspect product and all the events is assessed as related.; Reporter's Comments: The patient experienced injected limb mobility decreased, injection site erythema, injection site swelling and vaccination site induration on the same day, after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causal relationship between the suspect product and all the events is assessed as related.
Pt received a 7th dose of Anthrax in error on 3/21/08 and a Typhoid dose on 3/21/08 when he had previously received a Typhoid dose on 1/12/08.
On 5-16-2022, I started noticing a cough and tested with a home Covid test and it was negative. On 5-17-2022, I had a slight headache and the cough was worse. I took another home Covid test and it was positive. On 5-18, the cough was a lot worse. I had a telehealth visit on 5-18 and was prescribed Vitamin D, Vitamin C, Zinc, tessalon perle and a z-pack (Azithromycin). I am fine now. I am reporting a breakthrough case of covid.
I had severe sore throat, stuffy nose, running nose, and very tired. I was in bed for about 6 day. I also had brain fog. The fatigue and sore throat was my biggest issue. These lasted for about 7 or 8 days. On Feb 13th, I tested positive for COVID-19. I went to urgent care, they also tested me for Strep, negative results.
already been hospitalized once with RSV; already been hospitalized once with RSV; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID:.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization, medically significant), outcome "unknown" and all described as "already been hospitalized once with RSV".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine ABRYSVO administration.
Headache shortly after and lasting to present, arm soreness later that evening with increased redness at site, body aches and joint pain that first night, the next morning a baseball size swollen red area around injection site, fever within 36 hours up to 101. Pain in all joints, exhaustion,  body and muscle soreness, still present after 48 hours and injection site redness, heat, & swollen with small blister like bumps 2 times larger than day before. Shoulder pain in left arm as well.
Starting feeling bad about 4 hours after vaccination. By the next day (4/11) had difficulty breathing, nausea, severe bladder pain, stabbing pain in stomach, epigastric pain, chest pain, and alternating between severe chills and feeling hot. By 4/12 most of this had subsided and she was experiencing weakness and fatigue, in addition to loss of appetite. This resolved over the next few days.
Injection arm unable to lift,, basically immobile; Numbness in mouth; Severe chills; Fever  2+ days,; Severe headache; Severe body ache; Lymph nodes in injection arm and neck swollen; Lymph nodes in injection arm and neck painful; Face twitch and painful days 3- 5; Face twitch and painful days 3- 5; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 10:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had relevant medical history (unspecified) and allergies to medications, food, or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 11:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021 at 02:45, the patient experienced severe chills, fever for 2 plus days, severe headache, severe body ache all lasting for 4 days. Lymph nodes in injected arm and neck was swollen and painful. The patient had face twitch and painful for 3-5 days. On 17Apr2021 day 7, the patient experienced numbness in mouth. On 20Apr2021 day 10, on the day of reporting the patient was unable to lift injected arm and was basically immobile. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe chills, fever, severe headache, severe body ache, lymph nodes in injected arm and neck swollen and painful, face twitch and painful was recovered with sequelae on an unknown date in Apr2021. The clinical outcome of the event numbness in mouth was unknown; while that of the event injected arm unable to lift and was basically immobile was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Rash on left upper leg. Looks like shingles but has no shingle symptoms (pain, fever, chill ect).; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 29-years-old), as a single dose, for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine 4 weeks, prior to COVID vaccine. The patient did not receive any medications 2 weeks, prior to COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 14Mar2021, the patient experienced rash on left upper leg which looked like shingles but had no shingle symptoms (pain, fever, chill etc). The clinical outcome of the rash  was recovering at the time of reporting.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Pt recvd 2nd dose of vax 28MAY92 & w/in several days following vax -3 to 4 wks later exp polyarthritis w/pain in back, hips & ankles;
administration of Menveo diluent only; administration of Menveo diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30th June 2023) for prophylaxis.   On 4th August 2022, the patient received Menveo. On 4th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 04-AUG-2022 Reporter's comment: The Medical Assistant(MA) reported administration of Menveo diluent only and not the lyophilized portion of Menveo. The reporter consented to follow-up. Additional supportive information: The patient was given only the Menveo diluent and not the lyophilized portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions or allergies who on 09-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. On 18-JUL- 2008 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot no. 0250X). There was no concomitant medication. The patient experienced almost identical symptoms after receiving the first and second dose. The patient developed enlarged lymph nodes with fatigue and lower abdominal pain within 24 hours of the vaccinations. The symptoms disappeared within 36 to 72 hours after the vaccination in both cases. The patient called the physician to seek unspecified medical attention. Additional information has been requested.
At the time even thou all information was shared with the employee's,contractors and dependents, the family brought in the son for a Covid 19 vaccine.  Was then identified when putting in data in system, did contact DOH and finally got an answer so informed family that this was off label use for the vaccine. Not yet cleared for 16 year old.  Our administrative staff was non medical and didn't even question, now trained and alerted.
Presented symptoms of diarrhea the night of vaccination. Then showed signs of sore throat and bumps on back of legs and stomach the next day.