chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knocked me down worse; Knocked me down worse; very sick; fatigued; Chilled; Achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 11Nov2021 10:00 (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 number:1 (11:45 am), Lot number:EL32A8,, Anatomical location:Right arm), administration date: 28Jan2021, when the patient was 77 years old, for COVID-19 immunization; Bnt162b2 (Dose number:2 (11:50 am), Dose anatomical location: Arm), administration date: 18Feb2021, when the patient was 77 years old, for covid- 19 immunization. The following information was reported: DIZZINESS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "Knocked me down worse"; ILLNESS (non-serious), outcome "unknown", described as "very sick"; FATIGUE (non-serious), outcome "unknown", described as "fatigued"; CHILLS (non-serious), outcome "unknown", described as "Chilled"; PAIN (non-serious), outcome "unknown", described as "Achy".  Additional information:   Patient and her husband contracted COVID 19 in Nov2020. They had it for 5 weeks. At one point they checked into the Emergency Room at local (Hospital withheld) because they were not well, and wanted to make sure that they didn't have pneumonia. Her husband was coughing a lot, and she was having difficulty breathing - along with the other COVID 19 symptoms such as extreme fatigue.  The hospital ran us through their protocols for COVID 19, and determined that their lungs were clear. they each were given were given 5 steroid tablets, and sent home to recuperate. Fortunately they have good neighbours who checked on them, and brought them groceries.  The day after first COVID shot, they both started with chills and fever, then fatigue. They felt as though they had Covid all over again. The symptoms lasted about 24 hours. After the second shot, she  was knocked down, got up, and laid back down, and was down for the day. S.he just felt tired, and awful for the entire day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
adverse reaction or side effect was experienced: none; pneumonia vaccine on 2014 and 2016; This spontaneous report has been received from a lawyer, from a case in litigation for zoster vaccine live (ZOSTAVAX) (regulatory authority # 1907USA003436), concerning an elderly female patient.  On unspecified dates in 2014 and 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumonia vaccine) (manufacturer unknown) (strengths, doses, routes, anatomical locations, lot numbers and expiration dates were not reported) as prophylaxis (inappropriate schedule of product administration). It was stated that no adverse reaction or side effect was experienced due to the patient's vaccination.; Sender's Comments:  US-009507513-2103USA001236:
Dizziness, fatigue started around 11am, pressure headache including jaw  started 6pm. Slept on and off, dizziness continued until next morning. I don?t know if this was related to shot because I do have back issues but my entire spine had a burning pain. Next morning everything was fine, including back pain.
Client states developed nausea, vomiting and diarrhea 6 27 06 and a rash that itched. States had chills and headache that PM. on 6-29-06 called health dept to report symptoms. States vomiting and diarrhea stopped after 12 hours but rash has developed into quarter sized welts severe itching and reports heaviness in chest. Went to emergency room 6-29-06 to be checked. Client sent home without treatment.
Itchy and red hive-like rash on legs and stomach/chest. From Monday afternoon to Tuesday evening. Gave him Benadryl, and had to give him Claritin.
A report has been received from a Health Professional concerning herself. No information regarding relevant history and concomitant medication was provided. The patient received FLUMIST (intranasal), once/single administration on an unknown date. The patient said that she had a severe headache and sinus symptoms for 1.5 weeks after she received the vaccine with Lot FJ2235. Action taken with FLUMIST was unknown. The outcome of the event of severe headache and sinus symptoms was unknown. The company physician considered sinus symptoms to be serious with seriousness criteria of important medical event and sinus symptoms to be non serious.
pain, swelling lt upper arm;seen 3 days p/vax;rx atarax, erythro;
Breast cancer; This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy) and non-drug therapy (Radiation). On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient received Shingrix vaccine on left upper arm and was diagnosed with breast cancer for which she was under treatment chemotherapy and radiation. Due to this treatment patient was not able to receive second dose of shingrix within 2 to 6 months.  The patient did not state clearly that she was diagnosed after the vaccine, but she explained the events situation in order that it seems like she was diagnosed after the first dose of Shingrix. The patient don't have batch number and expiry date. The reporter gave a consent to follow-up with health care professional.
developed redness and swelling not just at the injection site but in the whole upper arm; developed redness and swelling not just at the injection site but in the whole upper arm; developed redness and swelling not just at the injection site but in the whole upper arm; developed redness and swelling not just at the injection site but in the whole upper arm; Information has been received from a physician via a field representative referring to a 11 or 12 years old male patient. The patient's concomitant, medical history, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route, lot number and expiration date were not reported) for prophylaxis. The reporter stated she did not know if this was a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or if the patient received previous doses. On an unknown date, the patient developed redness and swelling not just at the injection site, but in the whole upper arm following the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was unknown if the treatment was given for the events. It was unknown if lab diagnostics or studies were performed. The patient went to the emergency room to seek medical attention. The outcome of the events was recovered. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
PATIENT WAS DIAGNOSED WITH SHINGLES 1 WEEK AFTER RECEIVING SHINGRIX VACCINE ... PRESENTED WITH LESIONS ON ABDOMEN AND TRUNK AND BACK
Itchy rash at injection site; Itchy rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), alpha-1 antitrypsin deficiency and vasculitis. The patient had history of known allergies to medications, food or other products. The patient received unspecified concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 09Mar2021 at 09:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 17:00, the patient experienced itchy rash at injection site. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the event itchy rash at injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Client received dose #1 of rabies vaccine yesterday morning (9/12/05) Client reports that he noted what he referred to as "blood clots" on his upper outer thigh this AM and does not recall injuring himself.  He is concerned that it may be caused from the vaccination.  He denies pain in area.  He stated that he had a slight headache the day he received the vaccine but had no other side effects.  By photos sent by client, there appears to be contusions possibly due to injury which he does not recall occured to the area.  He was advised to see his private physician and also seek advice on whether he should continue with the series of rabies vaccine.
Mom called to report s/s right arm red, hot, swollen- and denies pain advised mom to use cold compress with children's Tylenol or Motrin with 4 hours on needed with worsening or no improvement - return to ER or MD- mom took child to ER and advised by ER - she infected antibiotics and antinflammatory prescribed - phone case daily as Motrin 7-17-07 - mom states child better.
I went to check to see if my low platelets had dropped.  I went to get blood work, it confirmed that it had.  I got medicine for it.
pt devel vertigo, n/v;no other sx;+ mild end gaze nystagmus rt gaze;
Slight itching presented on day 7. Red rash appeared on Day 8, with slight raising and hardening underneath. Rash is round, 1.5? in diameter, with greater itching.
Spiked fever of 102 next day had vomiting and diarrhea, had to phone call into dr.    2 more urgent calls into the dr on day 4 after vaccination had to also then go into emergancy room 4 days after vaccination for croupy, congestion, cough, rhinorrhea, runny nose and fever continuation.  Only taking 3 bottles and had only 2 wet diapers. not drinking well  temp up to 103 and still vomiting, also pulling at ears.  diagnosed with an upper respiratory infection.  7 days after again in the emergancy room continuation of issues with not getting better and continued vomiting.
Pt vaccinated w/Meruvax II two days later developed a fever of 102degrees. 1 wk later developed arthritis.  Approx 2 wks following the development of arthritis she exp profound fatigue.
April 7, my husband & I got the shot. Same night, we started feeling chills, fever, muscle pain, fatigue, headache all at one time gradually increasing throught the day. Only in the eve, we could contact our physician & advised to take paracetomol( acetominophen)  and we took three doses with 4 hrs interval. The next day eve, we came to normalcy with our regular work, less tiredness, less muscle ache, less headache (not fully gone)and fever stopped. After 3rd day- april 9th till today there are no side effects mild or adverse seen in us. Still due to recent reports/news about J&J, we would like to stay vigilant for next 2months.. Hence, wanted to voulntarily report or update on our experience of the shots
This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient has slurred speech and wants to know if this is a normal side effect. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
p/vax pt devel lightheaded like was going to vomit when in restroom;nausea;sick;
pt recv vax & exp a more severe nausea & vomiting w/dehydration;
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-OCT-2018 or 22-OCT-2018 the patient was vaccinated with improperly stored VARIVAX (lot # N029628 and expiration date 23-NOV-2019, route, strength, dose and frequency were not reported) for prophylaxis. Medical assistant also reported the sterile diluent (lot # M041989 and expiration date 03-JUL-2019) used to reconstitute VARIVAX did not undergo a temperature excursion. No adverse effects were reported. The temperature excursion was 6 Fahrenheit to 14 Fahrenheit (12 Fahrenheit) for 1 hour and 59 minutes. The previous excursion was 6 Fahrenheit to 14 Fahrenheit for 47 hours and 57 minutes and 15 Fahrenheit to 46 Fahrenheit for 39 hours and 57 minutes. The call was because of a data logger. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA012249: US-009507513-1810USA012248.
Information has been received from a physician concerning a 4 year old female who on 17 Oct 2002 was vaccinated with a dose Varivax. Concomitant therapy included DPT. On 26 Apr 2006 the patient developed less than 50 varicella lesions on her face and legs. The patient did not have a fever. Unspecified medical attention was sought. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Broke out in hives all over the body; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration (at the age of 75-years-old) administered in Arm Left on 08Feb2021 14:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included chronic obstructive pulmonary disease, hypertension, ulcerative colitis, blood cholesterol increased, hypersensitivity, rubber sensitivity. Concomitant medications included Detrol, Gabapentin, Tylenol Arthritis, Lialda, Ano. Previously known allergies included tetracycline allergy and latex allergy. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection), dose 1, on 15Jan2021 09:45, Lot number:EL8982 on left arm at a single dose for Covid-19 Immunisation. The patient did not have covid prior to vaccination. The patient was not tested for covid post vaccination. The patient did not receive any other vaccination in four weeks. The patient experienced broke out in hives all over the body on 13Feb2021 12:00. Therapeutic measures were taken as a result of urticaria. Patient was not tested positive for covid prior and post vaccination. Treatment medications included prednisone, vistaril, zyrtec, Pepcid. Event was considered non-serious as reported. Outcome of the event was reported as not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021190875 similar report from same reporter
C/O Severe Right arm pain.  States cannot raise Right arm. Has pain radiating from shoulder to elbow with attempt to raise arm
29 weeks pregnant.   Painful lump in arm that felt warm to touch.  Bump was red.  Small red bumps on entire right arm, including wrists.
Sickness; Rash both legs; Streptococcal infection; Ear infection; Fever; Erythropapular rash/red bumps; Psoriasis; Respiratory infection; This is a solicited report from a marketing program facilitated collect received from a non-contactable consumer (patient) based on information received by Pfizer from (manufacturer control number: 21K-163-4078279-00). A 58-year-old female patient received bnt162b2 (BNT162B2) dose 3 intramuscular on 08Sep2021 (at the age of 58 years old, Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at CF for psoriatic arthritis. Medical history included psoriatic arthropathy. The patient's concomitant medications were not reported. The patient previously received dose 1 (01Jan2021) and 2 (01Feb2021) of BNT162B2 for covid-19 immunisation and experienced rash on legs, strep infection, respiratory infection, ear infection, fever and red bumps that would had psoriasis on both shins in front and cracked tooth. On unknown dates in 2021, the patient experienced rash on both legs, strep infection, respiratory infection, ear infection, fever and Erythropapular rash/red bumps that would had psoriasis on both shins in front. In Sep2021, the patient experienced sick. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of event sickness was recovering and other events was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the events of sick, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for adalimumab was not provided. The reporters causality for the event of rash on legs with adalimumab was no reasonable possibility. The reporters causality for the events of sick, rash on legs, strep infection, respiratory infection, ear infection, fever, red bumps that would had psoriasis on both shins in front unknown onset for BNT162B2 was probable.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events respiratory tract infection and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Menveo with sterile water administered; Menveo with sterile water administered; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva580a, expiry date 31st August 2022) for prophylaxis.   On 5th January 2022, the patient received Menveo (intramuscular) .5 ml. On 5th January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The HCP (health care professional) inadvertently reconstituted Menveo with sterile water instead of the MenCYW-135 liquid conjugate and administered the dose to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up. This case had been linked with case US2021249278, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021249278:Same reporter
Shingles outbreak 15-21 April 2021 and again 26 April 2021.
Unknown if it is related to the vaccine, but began experiencing red, scaly skin on eyelids and pronounced puffiness of eyelids. Slight redness in corner of and underneath eyes with puffiness also.  Have gone through elimination of possible allergens and am scheduled for allergy testing to look for a cause.
About 30 minutes or so after injection, patient had reaction. The patient had really bad tremors, blood pressure was ok but pulse was fluctuating. Nurse was at bedside providing oxygen through mask. He was given aspirin and didn't need EpiPen. 911 was called and patient was transported
BODY ACHE; SORE ARM; FEVER; TIREDNESS; 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, route of admin not reported, batch number: unknown) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced body ache. On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. On 2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, fever, body ache, and tiredness. This report was non-serious.
Wife of patient states that patient has gone blind, and blindness started after 2nd dose of moderna vaccine
It definitely triggered my AutoImmune Disease (Hashimotos).; it can trigger Auto-Immune disease flare-ups; brain fog; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in arm left on 29May2021 15:00 (Lot Number: EW0168) at 45-year-old as single dose covid-19 immunisation. Medical history included Hashimotos from an unknown date. The patient concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient previously took atropine and experienced drug allergy. The patient historical vaccine included bnt162b2 dose 1 via an unspecified route of administration, administered in Arm Left on May2021 (Lot Number: EW0167) at age of 45-year-old as single dose for covid-19 immunisation. It definitely triggered AutoImmune Disease (Hashimotos). Within 24 hours the patient was extremely cold; especially extremities and unable to get warm. Neck swelled, and had brain fog for 24 hours. The patient was familiar with these symptoms from before she had them under control. She never had fever/chills; she took my temperature often. None of this was life-threatening or serious by any means; the patient was only reporting to have a record that it can trigger Auto-Immune disease flare-ups. The patient did not experience any of the other "typical' vaccine symptoms. The Adverse Event started from 30May2021, 12:00 PM. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Recovered on 31May2021 12:00.