chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling faint; Weak; Rapid pulse; Heart skipping; Numbness in fingers/ in toes; Tingling in fingers and toes; Ringing in ears; Heat in ears; Intermittently seeing stars; Extremely dry mouth; Hoarseness in voice; Dry cough; This is a spontaneous report from a contactable consumer. This 52-years-old non-pregnant female consumer (patient) reported herself received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6206), via an unspecified route of administration, administered in right arm on 04Mar2021 08:45 (at the age of 52-years-old) as single dose for covid-19 immunization was administered in Pharmacy or Drug Store facility. Medical history included mitral valve prolapse, paroxysmal Afib and migraine disease. Patient known allergies were none. Concomitant medications included metoprolol succinate 25 mg and Zyrtec-D (cetirizine hydrochloride, pseudoephedrine hydrochloride). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021, patient had no symptoms until 9:15, approximately 30 mins after the vaccination, she began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, intermittently seeing stars, extremely dry mouth, hoarseness in voice and dry cough when speaking. She went to her sister's dental office where, approximately 1 hour later, her sister given her 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula. When not resolved after approximately 1.5 hours, proceeded to the hospital Emergency Room. The patient underwent lab tests and procedures which included BP 131/82, pulse 81, blood sugar 126 ml/dl and EKG normal. In ER doctor gave her Famotidine and a steroid and kept under observation for a couple of hours. Patient also took Zyrtec as treatment medication. All events were resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as recovering as most symptoms had subsided and was released at approximately 14:30 or 15:00 on 04Mar2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer and a school nurse concerning 41 child pts who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the pts developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 pts were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 7 year old pt who on 17SEP1996 was vaccinated with a dose of varicella virus vaccine live. On 10MAR2003, the pt developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other pts that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional info is not expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-MAR-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Information has been received from a physician concerning a 16 year old female patient with no known allergies and no medical history who in 1995 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not reported) and on 07-JAN-2011 was vaccinated with a second dose of VARIVAX (Merck) (Lot # not reported). Suspect therapy included on 07-JAN-2011 she was also vaccinated with a third dose of GARDASIL (Lot # not reported) on the same day. Concomitant therapy included minocycline. The physician reported that on 07-JAN-2011 the patient experienced angioneurotic edema after receiving a second dose of VARIVAX (Merck). The patient's arm at the injection site of VARIVAX (Merck) on later the same day felt warm, swollen, and painful. The next day on 08-JAN-2011 her arm was swollen down to her elbow and felt heavy. She was instructed by another physician to take BENADRYL. On 09-JAN-2011 the patient was examined by the other physician and the patient's hands, arms, and face were swollen, she had hives and felt as if she had a lump in her throat. On unspecified date she was taken to the emergency room but was not admitted. On unspecified date she was treated with BENADRYL and a tapering dose of prednisone. The physician stated that the patient on unspecified date had discontinued using BENADRYL because it causes drowsiness. It was also reported that the patient was currently taking ZYRTEC, complete blood cell count (dates and no results reported), other blood tests (not results reported) and serum immunoglobulin E test (IGE) (high). At the time of the report the patient's outcome was recovering. Additional information has been requested.
Swollen, hard, red, warm  bump  2.5 inches long and 1 inch wide on arm?not at injection site, but starting 1 inch  lower on the arm and extending down
No reaction at site - given deltoid. + Axillary lymph node - swollen/painful
Information has been received from a registered nurse concerning a 11 year old patient who on 22-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 666863/0467Z), 0.5 mL (route of administration not reported). Concomitant therapy included BOOSTRIX. It was reported that on 23-JUL-2010 the patient experienced localized reaction, discomfort, swelling, redness at the injection site after receiving VARIVAX (Merck) (unknown whether this was the first or second dose). At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-APR-2018, the patient was inadvertently administered an expired dose of RECOMBIVAX HB, intramuscular injection, lot # L048236 and expiration date on 31-MAR-2018, for prophylaxis (dose and anatomical location were not reported). No temperature excursion was involved and no adverse effects were reported.
LOWER LIMB EMBOLISM-BLOOD CLOT, TIGHTNESS, HEAT AND PAIN WHEN WALKING, TREATING PHYSICIAN COULD NOT CONTRIBUTE TO ANY OTHER HEALTH CONDITIONS OR REASONS
Pregnant at time of vaccination; This spontaneous retrospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Internal review on 24-Jun-21 resulted in updates to pregnancy details.
Reporting this as a hospitalized breakthrough COVID case. Patient received Pfizer COVID vaccine on 1/22/21 and 2/12/21 at an outside facility. Patient was admitted in our facility Medical Center from 7/22/21-7/28/21 for COVID  PNA (with hypoxia and AKI). He was given dexamethasone (not candidate for remdesivir). His hypoxia improved and requiring 3L NC with ambulation. He was discharged home with O2 on 7/28/21 and will restart chronic prednisone once he finishes 10 days of dexamethasone. Patient is immunosuppressed s/p kidney transplant.
This spontaneous report as received from a medical assistant refers to a 5 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 02-FEB-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (strength and dose were not reported). The lot number and expiration date were unspecified (K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 31Aug2021 at 14:00 as dose 3 (booster), single (Lot number: EW0167) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive, notes: I tested positive for Covid-19 on 29May2022; (08Jun2022) Positive, notes: I tested positive for Covid-19 again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive for Covid-19 on 29May2022 and was immediately prescribed Paxlovid by his doctor (Patient is healthy and do not take any medications). Patient completed the treatment 03Jun (morning), and was recuperating well. On 08Jun2022, patient felt fatigued and a scratchy throat. Patient tested positive for Covid-19 again. Currently, 10Jun, patient have a runny nose, slight cough and feel tired.  Investigational report: Conclusion: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EW0167 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0167, fill lot EP8698, and the formulated drug product lot EP8595. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant concerning an approximately 74 year old female patient (currently 75 year old) with allergy to penicillin, hypothyroidism, asthma, hypertension and tachycardia, who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant therapy included aspirin, calcium, (unspecified) (+) vitamin D (unspecified), omega-3 marine triglycerides, FLOVENT, levothyroxine Na, lisinopril-HCTZ (manufacturer unknown), vitamins (unspecified) and PREMARIN. The reporter stated that on an unknown date the patient developed a red, swollen left arm (the same arm where she received the PNEUMOVAX 23) and the entire arm was red swollen. This resolved 1 week later. The patient sought unspecified medical attention - spoke to physician's office. At the time of the report the patient's status was recovered. Follow up information has been received from the physician concerning the approximately 72 year old female retired patient with allergy to penicillin and no illness at time of vaccination, who in 1998 was vaccinated with the first dose of PNEUMOVAX 23 (route and lot number not reported). The physician stated that in 2008 the patient received a booster of the PNEUMOVAX 23 (route and lot number not reported). The physician reported that 24 hours after injection, it was noted swelling and red-mottled arm, 6 inches lower than injection site, and it "threw everyone off". The physician stated that the patient was advised after the fact that this could had resulted in muscle loss. At the time of the report, the patient's muscle loss outcome was unknown. The events were considered to be immediately life-threatening by the reporting physician. Additional information has been requested.
Within 5 minutes of COVID - 19 Vaccination employee reports her tongue felt numb.  45 minutes later in her office her tongue began to swell.  Took 800mg Ibuprofen, 25mg Benadryl.  By 5pm symptoms appeared resolved.  Saturday developed 3 - 4 sores on her mouth/ gums with pain 3 out of 10.  No meds taken.  Edema resolved.  Sores remain in her  mouth as of 1/15/2021.
He reports that he received his COVID booster (Moderna) at clinic two weeks ago today in his L arm.    He tells me that he is experiencing nerve pain, numbness, and tingling in his left shoulder, arm, hand & deltoid area that began 2 hours after his booster. He reports he did not experience any pain/soreness at the time of vaccine administration. He then developed severe muscle cramping and pain in his left shoulder, arm & deltoid that keeps him awake at night.  He reports taking muscle relaxants (methylcarbamol), tylenol, and ibuprofen with minimal symptom improvement in order to help him sleep and to function during the day. He's been to PT, chiropractor, massage therapist, and acupuncture without significant symptom improvement.  He reports the pain level is the same, but slightly less frequent than two weeks ago.
Initial misuse report received from a healthcare professional on 03 June 2013. A dose of TENIVAC that had expired in April (year not specified) was given to a patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
04/10/2021 The day of second vaccination I began to feel abdominal pain a few minutes after the vaccination. Throughout the night it was getting worse and worse until the next day where I went to a clinic to see what was going on. I was excruciating pain due to my abdomen getting worse, the clinic sent me to the ER where they gave me morphine to help manage the pain, they went ahead and then did a sonogram, they found that my large intestine was inflamed and was 3 time the normal size. They were able to give me antibiotics and then sent me home with antibiotics and morphine to help with the symptoms. It took about a week until my symptoms subsided. I then had two UTIs back to back in December and January. I then had the flu a few weeks ago and have been doing well since then.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 03-SEP-2014, the patient was vaccinated with doses of ZOSTAVAX (LOT# unknown, expiry date unknown) that were exposed to a supported temperature excursion. Concomitant medication was not reported. There was no product quality complaint. No adverse experience has been observed. Outcome of the event was unknown. This case linked to other cases 1409USA002420 and 1409USA002126(Same reporter link). Additional information is not expected.
headache, chills, body aches, fever developed at about 8:30 pm. Fever reached 100.9 during the night, diminished the following day but lasted until mid-afternoon. All symptoms except headache mostly gone by evening of 4/17. Headache persisted for another 12 hours. Soreness at the site of the shot was minimal.
Found swollen lymph nodes in left armpit  30 minutes after vaccine #2. Sought medical attention a week later, followed by two rounds of imaging to confirm/ diagnose/ treat. Nodes cause mild to moderate pain and discomfort, on a scale of 4-5 out of 10.
Shot @ 250pm; couldn't even Tell she'd poked me! Mentioned Dr reiterating advice re tylenol and ibuprofen; that I take Both, ibuprofen due @ 3pm. 2 nurses said should be okay since I'm used to it. Advice is re profilactic use against side effects. ~ Left @ 305p (15min watch for allergic reaction) Left grocery @ 345pm, headed north to pick up dinner Almost immediately, it felt like I'd been hit in the left eye with a baseball bat (cheekbone & eye socket); REALLY Intense 'migraine', left side only. Took back road to dinner, finally subsided to an odd ache. Called clinic as soon as I parked.  Checked w nurse - it IS a side effect. "Don't take any ibuprofen." I'd taken mine @ 305pm with my Gaba. Don't take any more. Tylenol is okay. Recording this, it is now 5:55pm, and ache has migrated to center forehead; also experiencing facial numbness, left side & lips. ARGH! 607pm, now into the right side of forehead, somewhat into the temple.  Oh! At the left lower back of the skull, near lymph node. Man! This thing just keeps bouncing around! 620pm back at the left cheekbone & eye socket  Oh! I Did take my temp shortly after getting home, 97.6° - my norm ?~? Slept well, thru the night. Left arm pain when I rolled, so Nope. Called clinic to ask about advil,  Can resume taking as usual. Per nurse. Fri evening, sat w chin in hand; pain in left jawbone along the bottom. That passed/eased at least. Then, have 'pain to touch' at base of skull. (Was rubbing neck) ~ as of Wed 3.31, haven't experienced any more 'vac migraines' for a while. Did have some (approx 5) intermittently for abt two weeks after. ~ also experienced extreme fatigue/exhaustion 1st 60 - 72 hours before back to my norm.
user received their flu shot, they noticed the stock expired 30JUN21 with no adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received via health professional.  This case involves patient of unspecified demographics who received their Influenza Vaccine (Flu Vaccine), they noticed the stock expired 30jun21 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired suspect Flu Vaccine produced by unknown manufacturer expiry date 30-Jun-2021 at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination, they noticed the stock expired 30jun21 with no adverse event (expired product administered) at same day latency.  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.
Information has been received from a healthcare worker concerning unspecified number of patients of unknown age. In July 2014, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided), that had been exposed to 1 degree centigrade for 84 hours (temperature excursion was reported as "supported"). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
pt recv vax & devel migraine, vertigo, felt like body was racing, tremors in hands & head, saw MD 28JUN97;BP has become inc;bili 2.8;still sick;not sleeping well, very tired & dizzy;
MIGRAINE TYPE HEADACHE; PAIN IN NOSE; FEELING OF PIMPLE INSIDE NOSE; PAIN IN EYES; PRESSURE IN LEFT EYE; BLINKING LIGHT AURA IN LEFT EYE; NASAL PRESSURE; FEELING OF BUMPS INSIDE NOSE; PAIN IN FOREHEAD/A LOT OF HEADACHES; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social drinker, and non smoker, and other pre-existing medical conditions included the patient have no known drug allergies, 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol. On 05-APR-2021, the subject experienced migraine type headache. On 05-APR-2021, the subject experienced pain in nose. On 05-APR-2021, the subject experienced feeling of pimple inside nose. On 05-APR-2021, the subject experienced pain in eyes. On 05-APR-2021, the subject experienced pressure in left eye. On 05-APR-2021, the subject experienced blinking light aura in left eye. On 05-APR-2021, the subject experienced nasal pressure. On 05-APR-2021, the subject experienced feeling of bumps inside nose. On 05-APR-2021, the subject experienced pain in forehead/a lot of headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in nose, feeling of pimple inside nose, and feeling of bumps inside nose on 07-APR-2021, had not recovered from pain in forehead/a lot of headaches, migraine type headache, pain in eyes, pressure in left eye, and blinking light aura in left eye, and the outcome of nasal pressure was not reported. This report was non-serious.
Patient complained of itching shortly after being vaccinated. B/P was taken 139/99 HR 79 O2 97 4 Benadryls were given with water Resolved
Evening of vaccine had temperature on/off.  Woke up 45 hours after vaccine with headache, body ache, nausea and chills.  Scheduled appt with PCP 48 hours after vaccine.