chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 101; Body aches; Severe headache; Stomach ache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 21Apr2021 at 07:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 30Mar2021 at 15:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 23:00, the patient experienced fever 101, body aches, severe headache, stomach ache, nausea and fatigue for more than 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 22Apr2021, the patient underwent lab test which included body temperature test and the result was found to be 101 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101, body aches, severe headache, stomachache, nausea and fatigue were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
vaccine were exposed to 16.8 F Celsius for 3 and a half hours /no AE; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case received from an other health professional and consumer non health care professional via Medical Information (Reference number- 00771168).  This case was considered as non-valid due to no involvement of patient.  This case involved vaccines POLIOMYELITIS VACCINE (INACTIVATED) [IPOL], DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL], MENINGOCOCCAL VACCINE [MENACTRA], DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL], HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] AND QUADRIVALENT INFLUENZA VACCINE [QUADRIVALENT INFLUENZA VACCINE] (lot number and expiry date not reported) were exposed to 16.8 f celsius for 3 and a half hours /no adverse event (product storage error).  It was potential medication error case due to product storage error temperature too low.  It was not reported whether any patient had received the product and experienced any adverse 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.
WEIRD SENSE OF SMELL; WEIRD SENSE OF TASTE; RUNNY NOSE; COUGH; SORENESS ON THE LEFT ARM; BURNING PAIN ON THE LEFT ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure (152/80), and chronic obstructive pulmonary disease (copd). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-AUG-2021, the subject experienced burning pain on the left arm. On 03-AUG-2021, the subject experienced weird sense of smell. On 03-AUG-2021, the subject experienced weird sense of taste. On 03-AUG-2021, the subject experienced runny nose. On 03-AUG-2021, the subject experienced cough. On 03-AUG-2021, the subject experienced soreness on the left arm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 152/80 (High). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning pain on the left arm on 03-AUG-2021, and had not recovered from soreness on the left arm, weird sense of smell, weird sense of taste, runny nose, and cough. This report was non-serious.
Patient got very lightheaded, passed out, convulsed for about 30 secs while siting in chair and then came to and remembered everything that happened prior to.
respiratory distress issues; severe bloating; gas; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 01Mar2021 at 17:45 (Batch/Lot number was not reported) as single dose (at the age of 72 years-old), and dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 72 years-old) for COVID-19 immunisation.  Medical history included severe petro-chemical allergies: petroleum based products, etc. (i.e. gas - diesel fumes, sharpie pens,magic markers, paint, developers, paving materials).  The patient had no other relevant medical history. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine and no other medications within two weeks prior to the vaccine. On 03Mar2021 at 14:00 the patient experienced respiratory distress issues, severe bloating, gas, and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. The patient reported the severe bloating, gas, diarrhea are now chronic issues, they are constant. The patient did not receive treatment for the respiratory distress issues. The patient received unspecified treatments from the physician for severe bloating, gas, diarrhea but the treatments have been unsuccessful. The events have been now ongoing for 6+ weeks and the patient stated they have ruled out glutten, dairy, etc as exasperators.  The outcome of the events respiratory distress issues, severe bloating, gas, and diarrhea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Blood pressure swings from 155/93 to 91/51. Blood pressure drops after eating.; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: FF2587), via an unspecified route of administration, administered in left arm on 08Oct2021 at 15:00 (at the age of 52-years) as dose 3 (booster), single for covid-19 immunization at a Pharmacy or Drug Store. The patient medical history reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in left arm on 08Feb2021 at 10:00 (at the age of 51-years) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM6203), via an unspecified route of administration, administered in left arm on 01Mar2021 at 10:30 (at the age of 51-years) as dose 2, single for covid-19 immunization. The patient had known allergies to shrimp, Aspirin, ibuprofen, penicillin. The patient had not received any other vaccine within 4 weeks prior to Covid vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included doxycycline (DOXYCYCLINE). On 25Oct2021, the patient had blood pressure swings from 155/93 to 91/51, blood pressure dropped after eating. This resulted in emergency room visit. The patient underwent lab tests and procedures which included blood pressure measurement: 155/93 on an unspecified date in Oct2021 and 91/51 on an unspecified date in Oct2021. The patient was tested for covid 19 after vaccination with a nasal swab test on 26Oct2021, showed sars-cov-2 test negative. It was unknown if the patient had received any treatment for the event. The outcome of the event was not recovered at the time of report.   Follow-up attempts are completed. No further information is expected.
Erythema, swelling, purulent drainage @ injection site.  Pt is elderly discomfort, noticed slight discomfort on day after vaccine, didn't pay much attention to it.  Site seen by family and they called for f/u care on 11/29.  Pt seen on 11/30 and dx with cellulitis and tx'd with doxycycline.
fever; body ache; headache; tired; no appetite; This is a spontaneous report received from a contactable consumer (patient).  An unspecified gender 73-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 09Jun2021 09:00 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19May2021 09:00 for COVID-19 immunization. On 10Jun2021 patient was experienced with fever, body ache, headache, tired and no appetite. Outcome of events was recovered on 12Jun2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient received 2mos vaccinations on 6/21/11 at 8:30 am. Went to the ER on 6/21/11 at 1:00 with complaint of seizure lasting about one minute fever of 101. Patient was admitted for observation.
teraphy non-responder; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B 1 ml and the 2nd dose of Engerix B 1 ml. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced overdose, adult product administered to child, overdose and adult product administered to child. On an unknown date, the outcome of the overdose, adult product administered to child, overdose and adult product administered to child were unknown.  Additional details were provided as follows: The product and patient identifiers were unknown. The patient received a 1 ml dose for doses one and two of the patient's hepatitis B series, which led to overdose and adult product administered to child.   Follow up information received from nurse on 3rd January 2019: The patient presumably had completed a childhood hepatitis B series and upon going to college had titers tested that were negative which led to Therapy non-responder. The reporter given 2 doses of hepatitis B, it was unsure which brand was used. The patient never followed up for the 3rd dose. If it was Engerix-B, technically,being a booster dose, 1ml was acceptable for this age so it would not be an adverse event. The health care professional never had contact with this invidiual- individual vaccine record was available at the health center and nurse had reviewed it and called GSK with questions about how to handle repeat dosing or  booster for non-responders, should the patient go to their office for dose 3. The patient had yet to be seen.  The health care professional did not want to be associated with the adverse event as it was documented. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. The reporter did not consent to follow up.
No other issues or concers noted; Nurse calling to report that a patient was administered expired dose of MMR II on 11/7/2022.  No PQC  AE 0228198 reported MMRII:   LOT:  T034389 EXP: Oct 8, 2022 No other issues or concerns noted. No follow-up.; This spontaneous report was received from  a registered nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-NOV-2022, the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneous injection, unk, lot #T034389, expiration date: 08-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided). No other issues or concerns noted.
Skin urticaria; no skin thickening, induration or subcutaneous nodules.
12 mo. with URI and OM seen with fever and refuses to bear wt. Dx: (L) toxic synovitis at hip.
Patient was suppose to receive second dose of Pfizer series. Patient was inappropriately given 0.5ml Janssen vaccine. Pt was notified and was understanding. Was given recommendation on next steps.
AFTER RECEIVING THIS DOSE SHE FELT ANXIOUS. ON SITE EMS RESPONDED. VITALS LISTED BELOW SHE WAS MONITORED AND FELT BETTER AND WAS RELEASED TO HOME.
Baby began crying and was inconsolable. When baby was put down he would scream, when he was being held he whimpered constantly. Baby was walked, held, offered food, changed, bathed, but nothing comforted him. At about 3:30 his temperature was checked it was 101.8 pediatrician was called I was advised he was having a reaction to the shot. Give Tylenol and a dose of Benadryl. Both were given. After giving Tylenol an hour earlier his temperature was checked it was 102.1 @4:30pm given a luke warm bath. At 6pm temperature was checked again it was 101.5. At 8pm temperature was 103.9 given a dose of Motrin and a luke warm bath. At 8:45 temperature was 104.2. Taken to emergency room at that time. Upon arriving at emergency room was given a Tylenol suppository. Strep test was done as well as ear exam both were negative.  Left hospital at 11:15pm with instructions to give Motrin and Tylenol alternating.
large red area which was hot at injection site; little red at injection site/large red area at the injection site again; injection site sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 30th December 2021, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient received first Shingrix vaccine one week ago of reporting day. The patients arm was a little red at injection site and sore but that went away in a few days. On the reporting day, the patient noticed that he/she had a large red area, which was also hot at the injection site again.  The patient asked was this an allergic reaction.
Patient states she developed a "knot" at the site of injection that was hot and red the day she received the vaccine. The next day she reported she developed aching down her arm into the back of her shoulder and into her armpit. She states all of these symptoms resolved after one week.
w/in approx 2 hrs of getting shot leg from knee to groin became red, hot swollen; also started non-stop high pitched crying which cont for most of noc; t102;
No additional AE; Nurse reporting patient was administered VAQTA after labeled expiration date.; This spontaneous report was received from a Licensed Practical Nurse, referring to a patient of unspecified age and gender as reporter refuse to provide information. The patient's concurrent conditions, concomitant medications, pertinent medical history, past drug reactions or allergies were not provided.  On 20-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 50 units per milliliter (50U/1.0 ML) injection at a dose of 1 milliliter administer once (1 mL/once) (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number T040581 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 28-MAR-2022) for prophylaxis (expired product administered).  No additional adverse event was reported (no adverse event). No product quality complaints (PQC) reported.
muscular dystrophy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR DYSTROPHY (muscular dystrophy) 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 MUSCULAR DYSTROPHY (muscular dystrophy). At the time of the report, MUSCULAR DYSTROPHY (muscular dystrophy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was mentioned. No treatment medication was mentioned.
pT. CALLED DAY AFTER VACCINATION AND STATED THAT SHE HAD SOME SWELLING AND REDNESS AND MINOR PAIN AT INJECTION SITE. told her cold compress and keep an eye on it. came by pharmacy monday morning (3 days after injection) and had been to the dr. which gave her antibiotics to treat cellulitis. Her arm was very red, swollen, and very tender to the touch. Will follow up with dr. if she does not improve.
No adverse event; Pneunococcal vaccine was given in 2015 and 2016; This spontaneous report has been received from a lawyer (reporter), via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (case#: 1807USA003721), concerning a 65-year-old male patient.   The patient smoked cigarettes since 1968 to 1984, 1-2 packs per day. He was diagnosed with chickenpox in 1955 at the age of 6 (units were not reported). He never received chickenpox vaccine. The patient's concurrent conditions included anxiety/, depression (since 2010) , emphysema (mild), gastroesophageal reflux disease (GERD)/ reflux, high cholesterol, and hypertension (high blood pressure). The patient's surgical history included orthopedic surgery and tonsillectomy.   Historical vaccines include: unspecified influenza vaccine on 06-DEC-2007,04-NOV-2011,21-DEC-2012, in 2013 and in 2014; unspecified diphtheria vaccine on 08-AUG-2003 and in 2013 with no adverse events reported.  The patient received the following vaccinations: unspecified influenza vaccine in 2014 with no adverse events reported. .   In 2015 and in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (Inappropriate schedule of product administration). No adverse event reported.  The patient received the following vaccinations: unspecified influenza vaccine in 2015, 2016, and 2018 with no adverse events reported.   This is one of the several reports received from the same patient.
Positive swelling and mild redness around the injection site with warmth. Non tender. BENADRYL 7.5 ml given.
On 2/4/21 around 2:00 a.m. patient had a high fever and head to toe body aches; shortness of breath to the point of panting. Patient took tylenol and then advil every 4 hrs (400 mg) and would find relieve for a couple hours. Patient had severe pain, also severe constipation and cramping. These reactions went well in the early morning of 2/5/21 and abated some; had to call out from work on 2/4/21 and 2/5/21. On 2/6/21, patient still had weakness and fatigue; tried running errands and had to go  home right away and nap. On 2/7/21, patient felt much better and is at work today, 2/8/21.
Information has been received from a physician of unknown age and gender, concerning themselves. On an unknown date, the patient was vaccinated with PNEUMOVAX23. On an unknown date the patient experienced injection site reaction after PNEUMOVAX23 and reported that it gave them a "very sore arm and spread across upper back to other upper arm for 36 hours". The outcome of the events was unknown. The reporter considered sore arms and upper back to be related to PNEUMOVAX23. Relatedness for the injection site reaction was not specified. Additional information has been requested.
Day after had headache, fatigue and chills.  2 days after had rash all over torso front and back which lasted 2 days.  Have had  back pain since that continues all the time.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-JAN-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
I experienced after my second dose knots under my skin, lymph nodes swelled under my arms to the point my doctor put me on antibiotics but my lymph nodes have not gone away. I also experienced a lymph node on my neck, left side and under my ear which also happened when I got my first dose. I had difficulty turning my neck to the sides. I went to talk to my my family nurse practitioner about my swollen lymph nodes. My lymph nodes are very painful to touch under my left arm. When I push my lymph node is so painful to touch and sore. My family nurse practitioner placed me antibiotics. To this day, I still have the lymph nodes which seem to be reoccurring. This second vaccine was really rough on me and stayed in bed for four days, felt also like I had the flu.  I am also a breast cancer survivor and I am concerned about my lymph nodes and I go back to see my family nurse practitioner on 07-15-2021.