chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; LPN calling to report that expired lot of VAQTA ADULT (EXP 1/14/2023) was administered on 2/23/2023; This spontaneous report was received from licensed practical nurse and refers to a 20-year-old male.The  patients' concurrent conditions, medical history, concomitant therapies and historical drug were not provided.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter, lot #U021561, expiration date: 14-JAN-2023 (expired product administered), administered intramuscularly for prophylaxis (strength was not provided).  No additional adverse event was reported.
Headache, full body ache, joint pain, ringing ears, abdominal pain (left side), exhaustion, dizziness, difficulty concentrating, rapidly cycling from hot to cold and back,  injection site pain/swelling/heat All symptoms occurred within the first 8 to 10 hours, treatment being rest, OTC pain meds, and hydration.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 11-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (rHA (recombinant human albumin), lot #L003856, expiration date 05-FEB-2017, strength, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 192 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reported of chills, Headaches, sorethroat, pain on left deltoid, swollen with harden lump; no redness, no throbbing. Patient stated to call in sick, missed 1 day of work.
chills, body aches, swollen left clavicular node, red and painful left side. fever 100.4 Narrative:
Information has been received from a case in litigation for WAES #0610USA022225 from a physician via medical records concerning a 55 year old female with no known allergies and history of pernicious anemia, hypothyroidism and back surgery who on an unspecified date was vaccinated with a dose of MMR II (manufacturer unknown). The patient presented to the emergency medicine department with a history of pain in the left elbow and wrist as well as the right elbow and wrist along with some numbness in the hands, as well as burning pain and tenderness. The patient stated that the symptoms started two weeks after receiving the MMR II (manufacturer unknown). The patient had a work-up with a physician and the symptoms improved somewhat with ROFECOXIB (MSD) dose, duration not reported), although was having difficulty "today" (date not specified) and this evening concerning getting comfortable enough to get some sleep. The physician reported that the patient had apparent discomfort in flexing the hands and wrists. The patient was reported to have an apparent inflammatory reaction after receiving the MMR II (manufacturer unknown). The patient was treated with PREDNISONE 40 mg PO in the EMD, tapering dose 20 mg, 10 mg and 5 mg each of the following days and then stop. The patient was given VICODIN tablets one to two tabs PO every 4 to 6 hours when needed for pain. The patient was instructed to follow-up with physician in two days if the symptoms do not improve or to return to the EMD if symptoms worsen. The patient was discharged instable condition. No further information is available.
Mother reports 1 to 2 hours after vaccination child started running a temp or 101.5-101.9 with temporal thermometer with loose, stinky stools. Mother reports alternated giving Tylenol and Motrin for fever. Child would not eat solid food but nursed okay. Mother reported above symptoms to the child's physician and he visited with her over the phone but did not see the child. Mother reports no fever since Tuesday, August 6 and the loose stools were lessening.
My first period since getting shot (about 3 weeks later) was extremely heavy, so heavy to the point that no pad or tampon and need to wear adult diaper to stop bleeding.  Also was more clotty then normal.  I thought maybe it was just a one off but it's continued like that since.  After 27 years of having the same period and then a few weeks after the shot it significantly gets heavier and has stayed that way points to the shot as a possible cause.
Pt with known hx of seizures, rec'd her 2nd dose Pfizer at COVID-19 vaccine clinic @1505.  Pt had "aura" while in observation area w/ husband and observation RN.  Pt took her own home Ativan dose PO.  At approx 1519, pt had focal seizure with mild arm flexion; no head/oral trauma; no falls/injury.  Her husband reported this to be a normal seizure for her and stated her seizures usually last <5min.  At 1521, pt was taken to extended observation area room via personal wheelchair; VS were stable upon arrival to extended observation.  The Dr.was also notified and came to observation room for evaluation @1525.  Per husband, seizure lasted approx 10 mins.  Pt then post-ictal and responsive.  VS obtained & stable; BP129/84, HR99, RR20, O2 Sat97% on RA.  Approx 1543, pt had second seizure while sitting in wheelchair.  MD  & 2RNs at bedside for safety.  911 was called at this time.  IV access established 22g R wrist with IVF NS infusing.  Placed pt on 2L O2 via NC per MD request.  VS remained stable throughout seizure.  Patient post-ictal, verbal, interacting, maintaining own airway.  Paramedics arrived @ 1603; report given to medics and transferred to the Hospital for further valuation by ambulance.
Big toes on both feet became black at base of nail.; Toes became inflamed and hot; This is a spontaneous report from a contactable consumer (patient). An 80-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6200, expiry date was not reported), via an unspecified route of administration, administered in arm left on 27Feb2021 at 15:45 (age at vaccination: 80-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported and had no known allergies. The patient concomitant medications included levothyroxine sodium (LEVOTHYROXIN); phytosterols NOS (CHOLESTOFF ORIGINAL); vitamins; chondroitin sulfate, glucosamine hydrochloride, methylsulfonylmethane (TRIPLEFLEX). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN5318, expiry date was not reported) via an unspecified route of administration, administered on arm left (age at vaccination: 80-years-old) on 06Feb2021 at 15:00, as dose 1 single for covid-19 immunisation. On 04Mar2021 at 19:00, the patient had experienced black discoloration at base of nail of big toes on both feet and toes became inflamed and hot. Patient received no treatment for the events. The patient had not received any other vaccine within 4 weeks. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
There was no adverse effect as a result of this vaccine administration error and no harm to the patient. After the error happened, we consulted with our Chief of Pediatrics/ID specialist and he said it would be best to enter it in VAERS. The parent was notified and a physician discussed the error with mom and answered all of her questions/concerns and assured her there was no harm to the patient's health.
Patient was administered a pediatric dose 0.2 but is over 12 years of age and should have received an adult dose at 0.3.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. The patients were vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (lot number not reported). It was reported that the patients in the past experienced pain at the injection sites as ZOSTAVAX was being injected. The pain was temporary and went away when the injections were completed. The patients sought medical attention by speaking with the pharmacist. At the time of the report, the patients had recovered from the events. Additional information has been requested.
Information has been received from a physician's assistant concerning a 32 year old female patient with an allergy to penicillin who was vaccinated with four 1 ml doses of RECOMBIVAX HB (lot # not reported), respectively. The first and second doses were received on 24-JUL-2007 and 28-AUG-2007, respectively. The dates of the third and fourth dose were not reported. The patient had a negative Hepatitis B titer after receiving the initial three doses regimen (considered a vaccination failure). It was noted that the patient received the fourth dose but still responded with a negative titer. The patient had not experienced any known symptoms. The patient sought medical attention at the practice. Additional information has been requested.
sweating around her neck; felt really hot instantly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating around her neck) and FEELING HOT (felt really hot instantly) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced HYPERHIDROSIS (sweating around her neck) and FEELING HOT (felt really hot instantly). At the time of the report, HYPERHIDROSIS (sweating around her neck) and FEELING HOT (felt really hot instantly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 07/15/2022 around 05:30AM in the morning I had a raspy throat. I went to work I thought It was nothing for me. In the evening around 05:00PM I started feeling chills and slight cough. I felt like something was off so I took the COVID-19 test that day and It was positive. I called my doctor and they called in a prescription for me for PAXLOVID I took it for 5 days.
Pregnancy; Initial Report Received on 02-May-2022  A health care professional (HCP) reported to the HEPLISAV-B pregnancy registry that a female patient (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history was reported.  The last menstrual period (LMP), estimated date of delivery (EDD), pregnancy history, and pregnancy risk factors were not reported.    No relevant concomitant medications were reported.    On an unspecified date (# weeks of gestation or # trimester unknown), the pregnant patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, injection site not reported).   On an unspecified date, the patient delivered the baby (no additional information was provided).   On 02-May-2022, the HCP reported that the patient delivered recently and received a dose of the HEPLISAV-B vaccine. The HCP wanted to see if her patient could enroll in the pregnancy registry. She was informed that the pregnancy registry did not take retrospective cases unless there was a birth effect, which she confirmed that the baby did not have any birth defects. No further information was provided since the HCP did not obtain permission from the patient.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Extreme fatigue and vertigo the day following the vaccine, vertigo persisted for 6 days
Severely itchy hives covering my entire body.  Started with an itchy scalp, and now includes my entire body. dermatographia is also covering my body.  The spots show up in different spots every time, and they itch intensely, lasting about 30 mins if I do not scratch the hives.  When the hives are scratched they last longer and swelling occurs.
Sz-like episode; eyes rolled back, became limp & unresponsive; Admitted to Hosp; Felt episodes temporally assoc w/inject; Started Phenobarb 31OCT89; On apnea monitor because breathing problems noted;
Presented to ED w/ c/o COVID-19 symptoms; cough/SOB; admitted for COVID-19 pna w/hypoxia; tx w/ steroids, abx, O2; weaned to RA; dc'd home.
Sore arm; had the Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE REACTION (had the Moderna arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) 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 PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE REACTION (had the Moderna arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE REACTION (had the Moderna arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No new information On 14-Apr-2021: Event And Email ID updated
Problem with close-up vision; Blurred vision; Metallic taste in her mouth; Heart started racing; Mind felt foggy; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), DYSGEUSIA (Metallic taste in her mouth), PALPITATIONS (Heart started racing), FEELING ABNORMAL (Mind felt foggy) and VISUAL IMPAIRMENT (Problem with close-up vision) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VISION BLURRED (Blurred vision), DYSGEUSIA (Metallic taste in her mouth), PALPITATIONS (Heart started racing) and FEELING ABNORMAL (Mind felt foggy). On 24-Feb-2021, the patient experienced VISUAL IMPAIRMENT (Problem with close-up vision). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 for Feeling abnormal, Taste metallic and Visual impairment, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurred vision), DYSGEUSIA (Metallic taste in her mouth), PALPITATIONS (Heart started racing), FEELING ABNORMAL (Mind felt foggy) and VISUAL IMPAIRMENT (Problem with close-up vision) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.
hives whole body;denied SOB;advised to take DPH or claritin;took claritin;clearing;
very difficult to wake up for 4 to 5hr;apnea alarm went off, no fever;
Client reported itching and redness on right shoulder.  Had used Benadryl gel and rubbing alcohol with warm compresses for itching.
Patient received Pneumovax 0.5cc IM in right arm on 02/17/2005 at 12:20PM. Mom called stating patient visited the emergency room on 02/17/2005 because of arm swelling and redness with weakness.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No pertinent medical history was reported. On 02-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX, .5 ml, subcutaneous. No concomitant medication was reported. On 02-SEP-2014, the patient received improperly stored VARIVAX, exposed to 23F for 3 hours. No adverse effects were reported. The outcome of patient received improperly stored VARIVAX was unknown. No further information was provided. No PQC was involved. This is one of the several reports. Additional information has been requested.
Sore throat; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER. BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jun2021 at 10:00 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 12:00 (at the age of 12-year-old) as a single dose for COVID-19 immunisation and received  a second dose of hpv vaccine (MANUFACTURER UNKNOWN) in the left arm on 03Jun2021 for immunisation within four weeks prior to the vaccination. 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 06Jun2021 at 16:00, 6 hours after vaccination, the patient experienced sore throat and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore throat and fever was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received form a nurse via a company representative refers to a female patient of unknown age. On an unknown date in December 2013 the patient was vaccinated with ZOSTAVAX, dose and route were not provided. The patient was seen in the office on an unspecified date with a swollen and red arm. It was reported that there was no rash, and the nurse had mentioned something about giving TYLENOL as treatment. The outcome of swollen arm is unknown. Additional information has been requested.
pt devel a fever & myalgia;these sx lasted a short time & resolved;this is one of 3 pts who exp above rxn;
Rash/hives on palms and soles, intensive itching peaked 3-4 days after vaccination, high blood pressure (155/90) for 4 days and chest pain (never had before).
About 5pm on day of injection I became very tired.  By 7pm I had all over muscle aches & low grade fever.  About 11pm I started having chills and continued shaking and being extremely cold until about 4:30-5:00am when the fever finally broke.  All the next day I was very tired and achey.  I took Tylenol every 6 hours which seemed to help.  I woke up this morning (2 days after injection) back to normal with no apparent symptoms other than my arm that received the injection being very sore.
Patients arm turned red all the way to elbow and was hot to the touch. Patient did not need to go to doctor because problem resolved over the next couple of days.
He basically got alopecia areata after receiving the vaccine; His son experienced alopecia areata or hair loss after the first dose and second dose; Upon receipt of follow-up information on 10Aug2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  A 7-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 7 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BIOTIN; MULTIVITAMIN [VITAMINS NOS]. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown", described as "He basically got alopecia areata after receiving the vaccine"; ALOPECIA (non-serious), outcome "unknown", described as "His son experienced alopecia areata or hair loss after the first dose and second dose". Therapeutic measures were taken as a result of alopecia areata, alopecia.  Additional information: The patient used topical cream for the AA which is Alopecia areata, it is Fluocinolone acetonide (treatment). He also used a previous cream called Tofacitinib topical cream (treatment) and he also used Clobetasol Propionate topical solution (treatment). Today he also received a shot, injection steroid today and that is called Kenalog and expected to receive that once a month. No other medical condition. No investigations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per hospital report Accidentally injected Shingrix diluent prior to mixing with vaccine vial.
Arm is really sore; Pretty significant pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore) and VACCINATION SITE PAIN (Pretty significant pain in the arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, PANTOPRAZOLE, CICLOSPORIN (RESTASIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and ESCITALOPRAM for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore) and VACCINATION SITE PAIN (Pretty significant pain in the arm of the injection). At the time of the report, PAIN IN EXTREMITY (Arm is really sore) and VACCINATION SITE PAIN (Pretty significant pain in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided   Reporter did not allow further contact
?Moderna COVID-19 Vaccine EUA?  Red, raised rash on arm near injection site.
Extreme Headaches remaining after fever symptoms subsided. Have persisted for since the 2nd dose.
psoriasis eruption all over his body; Swollen hands, especially on the left hand; This spontaneous case was reported by a consumer and describes the occurrence of GUTTATE PSORIASIS (psoriasis eruption all over his body) and PERIPHERAL SWELLING (Swollen hands, especially on the left hand) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced GUTTATE PSORIASIS (psoriasis eruption all over his body) and PERIPHERAL SWELLING (Swollen hands, especially on the left hand). At the time of the report, GUTTATE PSORIASIS (psoriasis eruption all over his body) and PERIPHERAL SWELLING (Swollen hands, especially on the left hand) outcome was unknown.            The reporter stated that he has taken Otezta in the past. No treatment medication were reported. no concomitant product was reported
Pain, felt faint, color drained from face, profuse sweating, difficulty obtaining verbal response, had to keep rousing her to keep her from fainting.