chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed some type of skin condition on her back and has a fear/concern that it may be shingles; Developed some type of skin condition on her back and has a fear/concern that it may be shingles; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's husband) reported that a 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN9581) via an unspecified route of administration on 04Feb2021 as 1st dose, single for COVID-19 immunisation. Medical history included thyroid condition (she takes a medication for thyroid condition, but she was always done that). Concomitant medication included medication for thyroid condition. On 26Feb2021 the patient developed some type of skin condition on her back and has a fear/concern that it may be shingles. She was due for her second dose on 02Mar2021. On 26Feb developed skin condition that she fears might be shingles. She is not certain, but her concern was that it might be and she worried that it might be a conflict with the second dose which is scheduled for 02Mar2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Generalized Erythematous Papular lesions with crusting in different stages of healing.  Varivax administered 17 days ago on clinic visit on 02/28/2004.  Treatment:  Calamine lotion and Benadryl 12.5mg every 6 hours as needed for itching.
Missed her second appointment; tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her second appointment) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced COVID-19 (tested positive for covid). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her second appointment). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her second appointment) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 09-Mar-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. After 09-Mar-2021, the patient took two more tests on unspecified dates which came back negative. No treatment information was provided.   Reporter did not allow further contact
Pateint had  the vaccine and  then had a sports event and  then went home and had a headache and nausea. Had something to eat and  then went to his girlfriend's house  to drop her off. He was returning from there and thinks he had blacked out for few seconds and woke up after his car hit a concrete steps on side of road. The air bag deflated.. EMS was  on the scene and took him to Er and had him checked. he was admitted for observation for 1 day
Patient had a local reaction to the first immunization, which was redness and swelling. She understood that the booster shot might present a more severe reaction. The patient pre-medicated with Allegra.  The Moderna Covid vaccine was administered and the patient sat under observance for 30 minutes. The patient left the store to her vehicle and came back immediately, complaining  of being hot, and an increased heart rate. The patient then sat and drank water but did not feel good.  I administered 25mg of Benadryl to patient based on her not having a reaction. She was moved into a room and I began to monitor her Blood Pressure and Heart rate. Initial reading was 165/107 and pulse of 104. 2nd reading was 171/111 and pulse of 114. The patient then complained of her tongue starting to tingle as well as her hands. Her BP rose to 181/114 and pulse of 151. I asked if she wanted medical attention and she agreed. I administered 0.3mg epi-pen after consulting her and had my staff call 911.  EMT staff arrived within 15 minutes and monitored the patient until her BP and HR slowly decreased. The patient declined any further treatment and was diagnosed as having a SEVERE Panic Attack. The patient then waited for her husband to arrive and left the store.
This spontaneous report received from a health care student refers to a 16 year old male patient. No pertinent medical history was reported. No drug allergy/reactions was reported. On 15-DEC-2013 the patient was vaccinated with GARDASIL Quadrivalent (dose 1; dose, route and frequency: unknown) for immunization. On 24-NOV-2015, the patient was vaccinated with GARDASIL 9; dose 2; dose, route and frequency: unknown; lot number: L028083; expiry date: 03-SEP-2017) as the second dose (interchange of vaccine products and inappropriate schedule of drug administration). No adverse effects were reported. The outcome of interchange of vaccine products was unknown. The causality of interchange of vaccine products is not reported. Additional information has been requested.
patient received PENTACEL, DAPTACEL and ACT-HIB so the DTAP and Hib portion is doubled with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old female patient where patient received pentacel, diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] and act-hib so the dtap and hib portion is doubled with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (pentacel), HIB VACCINE conj (tet tox) (ACT HIB) and hepatitis A vaccine (hepatitis A) for Immunisation.  On 22-Aug-2023, the patient received 0.5 ml (TOTAL) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot C6013AA and expiration date- 05-Jul-2024) via intramuscular route in Left leg (strength: not provided) for Immunization (extra dose administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
weakness, joint pain, muscular pain, insomnia, numbness, headache, anxiety, skin itch, bone pain, ringing ears, constipation, visual changes, hair loss
presented w/cellulitis 1 day p/vax;tx w/augmentin improved p/1 days on augmentin;
1 hour after vaccine itching, redness, elevated small bumps in arms. 6.5 hours after the vaccine had flushing and tachycardia up to 130. Had to call FIRE  RESCUE .,Took tachycardia meds
Red swollen hot to touch itchy on first shot the red spot wasn't as large as the second shot. It hurts to touch it. It's very red and swollen. It itches as well.
Pt has red rash that is non-circular near site of injection, painful to the touch, not warm to the touch - roughly 2 inches long and wide. Just appeared this morning.
Injection site: pain, redness, hard. Tiredness, Muscle pain, Chills, Joint Pain, Fatigue.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that an unspecified number of patients received unspecified doses of improperly stored GARDASIL, product lot # K005881, expiry date reported as 14-JAN-2017. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events were unknown. This is one of the several reports from the same source. Additional information has been requested.
Initial and follow-up information has been received from a physician's office manager, pharmacist, and a registered nurse concerning a 54 year old white female patient who on 01-NOV-2007 at 08:00 was vaccinated IM in the left buttocks with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 657145/1226U). Concomitant vaccination included influenza virus vaccine (unspecified) (Lot# U2466AA) administered in the left deltoid. On 01-NOV-2007 the patient experienced fever with aching and chills, decreased arm mobility and redness at the injection site. The patient visited the school district nurse. The patient's outcome was not reported. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
SHORTNESS OF BREATH; APPETITE LOST; LOSS OF TASTE; CHEST PAIN; CHILLS; HEADACHE; TIREDNESS; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hepatitis c.  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 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced shortness of breath, appetite lost, loss of taste, chest pain, chills, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, chest pain, shortness of breath, tiredness, appetite lost, and loss of taste. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
I got out the car at store and went in and all of a sudden my head started to pound. It was a loud machine outside the store and its like my head was pounding to the sound of the machine. Every since then I have had bad headache.
Headache, chills, nausea, diarrhea, extreme fatigue, body aches, mild confusion
Initial report was received 17 June 2010 via a lay press publication dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTAP vaccinations (lot number not reported). The information contained in the lay press publication had been retrieved from an immediate publication news released posted by a Agency on 16 June 2010. A copy of this news release was retrieved on 17 June 2010. This case represents one of the six of reported patients. The other patients are captured in case numbers 2010-03433, 2010-03434, 2010-03436, 2010-03437 and 2010-03438. An 11-year-old male patient had received five prior doses of DTAP and "also had his booster shot" (manufacturers, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving his booster vaccination, he was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: News Release.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021469753 (Pfizer). A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 13:45 (Lot number: ER8735) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "Amoxicillin" (unspecified if ongoing), notes: Known allergies: Amoxicillin; "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Had Covid a while ago" (unspecified if ongoing), notes: Caller clarifies that the patient had Covid prior to receiving the vaccine.; "tingling in his face" (not ongoing), notes: patient had Covid, he had tingling in his face which resolved in two days. Concomitant medication(s) included: OMEPRAZOLE; VALACYCLOVIR [VALACICLOVIR]; IBUPROFEN. The following information was reported: PARAESTHESIA (non-serious) with onset 06Apr2021 14:15, outcome "not recovered", described as "Tingling and slight numbness started in face roughly 25 min after injection/Tingling that radiated in his hands, arms, and legs"; FEELING ABNORMAL (non-serious) with onset 06Apr2021 14:15, outcome "not recovered", described as "Its just feel weird"; HYPOAESTHESIA (non-serious) with onset 06Apr2021 14:15, outcome "recovered" (2021), described as "Tingling and slight numbness started in face roughly 25 min after injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, feeling abnormal, hypoaesthesia. Additional information: When the patient had Covid, he had tingling in his face which resolved in two days. Since the vaccination, the patient was not tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first vaccination, he has the same tingling. The patient had tingling and slight numbness (fizzing) and within a few hours, the patient had the tingling radiating down his arms and legs. Started in the face roughly 25 minutes after injection. Spread to upper body later in the day. Still present 3 days later. There was tingling but no numbness. The patient still has this (tingling) a little bit. No physical signs of any rash or redness at injection sight or elsewhere. Did not appear to be Bell's Palsy as patient had complete control over my face. It just feels weird. She had not heard of this side effect of the vaccine and this was new to her. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacy technician concerning a currently 65 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with ZOSTAVAX lot #J007208; expiration date: 20-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with ZOSTAVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
10/9/14 Pt crying after received PENTACEL in (R) thigh. 10/10/14 (R) thigh with mild induration from injection site, extending along distal area of induration. Seems tender. No redness.
Shingles; This is a spontaneous report from a contactable Physician via a sales representative. This is one of 5th case out of 6th Patients. A patient of unspecified age and gender received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. It was reported that on COVID 19 vaccine 6 patients developed shingles following vaccination. Event took place after use of product. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
30 minutes after vaccines given, broke out in an itchy rash on hands, legs, feet.
after administering the vaccine, we noticed it had expired 7 days prior to.  Called the manufacturer GSK and they did not have any studies in support of revaccinating the patient and instead, based on their inhouse analytical potency testing, the vaccine is within normal accepted immunogenecity if administered within 30 days of expiration date.  Patient has not reported any adverse events at this time.
Large  redness on (L) upper arm and swelling. Fever and nausea.
Siezure,     First ever siezure, lasted over 3 minutes, loss of breathing
Beginning same day as vaccination pt had redness and swelling from site of injection to elbow. Middle of the night had chills. The next morning pt had severe headache and body aches with fever around 100 degrees Fahrenheit. Pt took ADVIL, which helped some with the symptoms. Headache lasted about 24 hours, body aches lasted about a week. Pt spoke with primary care physician who told her to take ADVIL and to just monitor. Pt states when pt is very warm the area of the arm gets red.
Patient indicated that her arm was very sore 2 weeks after receiving vaccine. Arm was weak.
Tested positive for Covid/Had 3 positive tests; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for Covid/Had 3 positive tests) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 027C21A, 030L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Sulfonamide allergy and Penicillin allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced COVID-19 (Tested positive for Covid/Had 3 positive tests). At the time of the report, COVID-19 (Tested positive for Covid/Had 3 positive tests) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2022, SARS-CoV-2 test: Positive. In October 2022, SARS-CoV-2 test: Positive and Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient had 3 positive covid-19 test until the 22-Oct-2022. No treatment medication were provided.
Moderna COVID-19 Vaccine EUA Approximately 24 hours after receiving the vaccine, I developed a headache, fever, chills, and extreme muscle soreness in my upper arm.  These were among the expected side effects and lasted 48 hours. As you can see from my list of meds, I am taking medication for anxiety and depression.  The odd symptom I developed was extreme depression.  I felt as bad as I did before I ever started taking my meds.  This lasted for 7 days, and I woke up the 8th day feeling perfectly normal again.
#1 injection administered on 1/13/03 10am, 6pm experienced light-headedness, note has a history of dizziness, went to sleep 10pm. Noticed some blotchy areas on both inner ?, went to sleep. 2am-SOB and heart felt racey, next am 9:52 seen in ER, symptoms subsided, rash and still dizzy. No chest or heart discomfort a tthat time. Blotches were fading. Antivert 25mg po administered at 11:10 1/14/03. D/C at 11:25. Note: I was not informed of any reaction until 2/14/03. I had follow up visit with PCP post speaking with me. All complete information just received today 2/26/03.
Woke up to aches and muscle pain, developed 101 degree fever & chills lasting through the night. Fever broke around 6 AM following morning, woke up drenched in sweat after very turbulent sleep.
This spontaneous report as received from a consumer refers to her daughter, a 15 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On an unknown date in June 2012, the patient was vaccinated with a dose of GARDASIL Vial WET SD 120 Y, lot #, dose, frequency, route unspecified. On 03-SEP-2013 the patient was vaccinated with her 4th dose of GARDASIL Vial WET SD 120 Y, lot#, dose, frequency, route unspecified. Concomitant therapy possibly included an unspecified hepatitis A virus vaccine (manufacturer unknown). On 03-SEP-2013 the patient passed out after receiving the 4th dose of GARDASIL. No treatment was given for the event, and no lab diagnostics studies performed. The outcome of the event was unknown. Additional information is not expected.
Pt noted pain on movement w/ lt shoulder & also limited ROM; sx were noted the day p/vax & continued to present;
Cardiac Arrest noted 26MAR @ approx 7PM; Brought to ER-Resuscitation efforts did not help;
Patient presented with mother both from workplace for COVID vaccine.  Vaccine given but patient was only 17 years of age.   Unable to reach patient to discuss side effects, left message to call.
At day 46 past my first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (At day 46 past my first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (At day 46 past my first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (At day 46 past my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.   Reporter did not allow further contact
Mom called today 9DEC91 saying pt devel hives all over body about 4 1/2 hrs p/recvd immun on 5DEC91; mom said throat was swelling shut; pt was taken to MD & given Epi, Pediapred, & Atarax;
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not reported. On an unknown date, the patient was going to be vaccinated with the first dose of GARDASIL 9 lot # reported as M03548 with expiration date 31-MAY-2020, for prophylaxis (frequency and route were not reported), but its vial was leaking from the rubber stopper so the medical assistant attempted to draw the solution but it was not enough for a 0.5 ml dose. Consequently, the patient missed the first dose of GARDASIL 9. No adverse effects were reported. Lot number M03548 is an invalid lot number for GARDASIL 9.
pt recv vax 6DEC95 & varicella antibody titer was performed on 5MAR96& was positive for seroconversion;MAR97 pt exposed to children w/chickenpox & devel a vesicular pustular rash consisting of <50 lesions;devel fever & body aches;
Muscle tremors and shaking jolt me awake. Feels like backside is electrified lying in bed. Pulse throbbing throughout body. Started the night I received shot. Horrid lethargy and headache. I rested two days off work. Continual jolting and twitching at night.