chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE WAS GIVEN AFTER THE 2 HOURS LIMIT; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced vaccine was given after the 2 hours limit. On 25-AUG-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine was given after the 2 hours limit and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210854907.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 79-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805457 was crossed linked to original cases 201804863 due to same reporter.
This case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that she had the patient whom presented with a severe rash 2 to 3 days after receiving a dose of SHINGRIX. The two patient experienced rash and one patient's rash looked similar to shingles (refer case US2018GSK157610). The patient received the vaccine at local pharmacy and neither could be attributed to anything else. The reporter did not agree to contact for follow up. This case has been linked with case US2018GSK157610, reported by the same reporter.
Vaccination on patient under 18 y/o; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ONDANSETRON HYDROCHLORIDE (ONDANSETRON ODT) from 23-Dec-2020 to an unknown date for Nausea and Vomiting, PRENATAL MULTIVITAMIN + DHA from 23-Dec-2020 to an unknown date for Pregnancy.    On 11-Feb-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Nov-2020 and the estimated date of delivery was 21-Aug-2021. On 11-Feb-2021 at 2:15 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 11-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) had resolved. On 11-Feb-2021 at 2:15 PM, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy test: positive (Positive) Positive.     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.   No information regarding treatment was provided.  It was reported that the patient is doing well and did not experience an adverse reaction to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Pregnancy Report received that included significant information.
3/24/2021 - Soreness at injection site, nearly resolved at 3/29/2021 3/25/2021 - Fever of 99.5, took acetaminophen, resolved after 4 fours 3/27/2021 - Red spot about 2-1/2 inches in diameter near injection site appeared 3 days after vaccination, sore and slightly raised, lighter in color at 3/29/2021 and not sore or raised.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Influenza vaccine for prophylaxis. The patient's past medical history included pneumonia (hospitalized for pneumonia for 12 days). Concurrent medical conditions included chronic obstructive pulmonary disease and emphysema. On an unknown date, the patient received the 1st dose of Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had denied permission to contact their physician. This case has been linked with case US2018139480 reported by the same reporter for the same patient.
Developed lips swelling, throat tightened, diaphoresis = angioedema.
weird headache; chills; This is a spontaneous report from consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 22Mar2021 at 16:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. The medical history included simple partial seizures (mild form of epilepsy). Concomitant medication included lexapro (MANUFACTURER UNKNOWN) started on an unknown date for simple partial seizures. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 01Mar2021 at 15:00 (at the age of 61-year-old), as single dose for COVID-19 immunisation. The patient previously experienced drug allergy with codeine. Prior to 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. It was reported that after getting the 2nd shot on Monday (22Mar2021), the patient felt a weird headache which was started on Tuesday on 23Mar2021 afternoon. The patient came home from work to rest. The patient experienced chills for a few hours and the headache worsened. The chills ceased but the headache lingered. Wednesday on 24Mar2021 and today (Thursday 25Mar2021) the patient still had the headache and today (at the time of reporting) was the worse day so far. It was a weird headache, the patient felt it on the top right side of head and the pain goes down the back right side. The patient rarely gets headaches and was very concerned that this has gone on for several days and was persisting at this moment. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken. The clinical outcome of chills was recovered and the outcome of headache was not resolved at the time of report.  No follow-up attempts are possible; No further information is expected.
Swelling and pain to (L) arm. Redness. DX: Cellulitis. RX: KEFLEX (250 mg).
No additional adverse events reported; Caller reporting the administration of expired ROTATEQ; This spontaneous report as received from a other referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 18-MAY-2021, the patient was vaccinated with ran expired dose (expired product administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter (mL) for prophylaxis (strength, route of administration, and anatomical location were not reported; lot # 1661000 had been verified to be a valid number; expiration date 13-MAY-2021). No additional adverse events reported.
VASOVAGAL SYNCOPE WITHIN FIVE MINTUES OF ADMINISTRATION. MOTHER OF CHILD RETURNED TO THE OFFICE AFTER PATIENT PASSED OUT IN THE HALLWAY. MOTHER OF CHILD CALLED 911 WHEN CHILD FAINTED. PATIENT WAS BROUGHT BACK INTO OUR OFFICE, PLACED FLAT ON TABLE. VITALS CHECKED. PATIENT ALSO WAS EVALUATED BY EMT AS MOC HAD CALLED 911. CHILD RELEASED WITH PARENT WHEN FEELING BETTER, DECLINED TRANSPORT TO THE HOSPITAL.
Sore left arm and red streaks down left arm for first 8 days after shot.  Full body rash began on day 9 after shot (Sept 9th) and is continuing as of today. .  Headache began on day 17  after shot (Sept 16th) and is continuing as of today.
12 x 14 cm erythema, swelling. Tender centrally, itchy. Advised to give BENADRYL.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  COAGULOPATHY, UNSPECIFIED TYPE HYPOXIA
This spontaneous report was received from a physician via a company representative and refers to a 78 year old patient. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 16-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot number an expiration date were not reported). On 17-FEB-2017 (reported as the day after receiving ZOSTAVAX, also reported as 17-FEB-2016), the patient experienced difficulty in breathing. He sought medical attention by contacting the physician and was treated for the event with an unspecified medication. The patient had an unspecified blood test and computed tomography scan performed, all tests had normal results. The outcome of the event was unknown at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
all three sites were he have the injection are swelling; sore/ painful/ all three sites were he have the injection are sore and painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (all three sites were he have the injection are swelling) and VACCINATION SITE PAIN (sore/ painful/ all three sites were he have the injection are sore and painful) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced VACCINATION SITE SWELLING (all three sites were he have the injection are swelling) and VACCINATION SITE PAIN (sore/ painful/ all three sites were he have the injection are sore and painful). At the time of the report, VACCINATION SITE SWELLING (all three sites were he have the injection are swelling) and VACCINATION SITE PAIN (sore/ painful/ all three sites were he have the injection are sore and painful) had not resolved.            No concomitant products were reported.   Patient received the booster dose.  No treatment information was reported.
101.8 fever that night, 100.4 next morning. Eczema flare (including new places on her body) starting the next morning,  and continuing to worsen.
Soreness in muscles; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in muscles) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness in muscles). At the time of the report, MYALGIA (Soreness in muscles) had resolved.            Patient was  not on any concomitant medication. Patient had  not taken any treatment.  The  soreness in the muscle went away In a day or two.   This case was linked to MOD-2021-424520, MOD-2021-424465 (Patient Link).
Patient went into full convulsive seizure for about 15 minutes three days after vaccination given.  Ambulance was called where medication was given to get her out of seizure. She did not come out of it on her own. Ambulance took to ER where she was hospitalized overnight. This was the second seizure reaction to a vaccine. Patient has a history of seizures, and they are triggered by fighting illness in her body.
stroke, pleocytosis, homonymous hemianopsia & h/a are reported in pt who recvd flu vax in OCT93; approx 2 wks p/vax pt exp lt temporal h/a & impaired rt vision; pt hospitalized NOV93; dc bilateral homonymous hemianopsia;
Pruritic rash, fever/chills, joint pain wrists, finger and knees. Swollen face, fingers and feet/ankles. Cold, purple toes & fingers. He was diagnosed with serum sickness.
pt recvd vax; inject site start to hurt; pt had accute pain & pins & needles feeling from shoulder to fingers & was tx w/ steroids;
At first, I had only faint little bumps similar to that of measles. They were located under my arms. On the 22nd, the bumps had started to itch horribly. I used anti-itch cream. The bumps spread to my lower back. Eventually, the rash went away. However, a new rash came back. This time, it itched even worse than before and spread over my chest, the top of my abdomen, most of my lower back, and on my neck.  For the measles like rash, I went to the clinic. They administered a steroid shot and prescribed me some medication. Which helped the rash go away. For the newer, different rash, I ended up going back to the clinic. They were unsure of what was happening and prescribed me the Triamcinolone Acetonide Cream. The cream helps a lot with the itching. It has been over a month now, and I still have the rash. It'll go away for a day and come back. I have not gone in for the second dose of the MMR vaccine.
NUMBNESS, TINGLING, LIMITED RANGE OF MOTION. TREATMENT: MEDROL AS PRESCRIBED, TYLENOL AS NEEDED.
11DEC97 pt reporting muscles still sore @ site of inj;denies other sx;did not seek medical attention;pt reported muscles still sore but improved;referred to MD;advised to notify hlth care provider of poss rxn to Td;
Soreness on ribs; Strained or something/Not pain but like I've been hit on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Soreness on ribs) and MUSCLE STRAIN (Strained or something/Not pain but like I've been hit on the left side) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058M21A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM and POTASSIUM CHLORIDE for an unknown indication.   On 25-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Soreness on ribs) and MUSCLE STRAIN (Strained or something/Not pain but like I've been hit on the left side). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Soreness on ribs) and MUSCLE STRAIN (Strained or something/Not pain but like I've been hit on the left side) had not resolved.            Concomitant medication also included heart blood thinner. Patient did not receive other vaccine within 1 month prior to Moderna vaccine. Treatment details was not reported by the reporter.
PREVNAR 13 redness of upper arm; C/o of redness on left upper arm from Pneumococcal PCV 13 (PREVNAR 13), he denies pain or itching at the site, denies fever and his wife is retired nurse and reports that she has been monitoring his the redness and applying cold compresses to the site.
This spontaneous report was received from a physician, via company representative, refers to a 14 year old male patient. The patient's medical history and concurrent conditions were not reported. The physician stated that the patient received the first dose of GARDASIL (dosage, lot# and expiration date were not reported) on 14-AUG-2013, then received the second dose of GARDASIL (dosage, lot# and expiration date were no reported), on 11-AUG-2014 and finally on 18-NOV-2015, was vaccinated with GARDASIL 9 (dosage, lot# and expiration date were no reported), as third dose. No product quality complain was involved. The physician reported that on 18-NOV-2015, (reported as at the time of the third dose) the patient was experiencing "possible genital warts", but he was not 100% sure if it was HIV. The outcome of genital warts and interchange of vaccine products was unknown. Additional information has been requested.
PATIENT CALLED TODAY AND SPOKE WITH PHARMACIST AND TOLD THAT SHE HAVE RIGHT SIDE OF HEAD IS NUMB. PAIN IN CHEEKBONE. EYES ARE SWALLON.  PHARMACIST TOLD HER TO SEE HER PRIMAMARY DOCTOR AND CHECK OUT THESE SYMPTOMS.
GENERAL MUSCLE ATROPHY TYPE FEELING; KIDNEY PAIN; BEEN DOWN; MASSIVE HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced general muscle atrophy type feeling, kidney pain, been down, and massive headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the been down, kidney pain, massive headaches and general muscle atrophy type feeling was not reported. This report was non-serious.
Information has been received from a consumer concerning her 8 year old grandson, with no pertinent medical history, concurrent conditions or drug reactions/allergies, who on 04-DEC-2007 was sitting in the waiting room of his grandparents' physician's office while they were vaccinated with ZOSTAVAX.  The consumer reported that on approximately 11-DEC-2007, the boy felt very tired, complained about abdominal pain, had a lack of appetite, and developed a rash on his left side by the ribs that was painful but not itchy.  The patient was seen by his pediatrician who diagnosed shingles.  The patient's shingles persisted.  Additional information was received from the administering physician who noted that the grandmother was a 67 year old white retired female who was vaccinated on 04-DEC-2007 with ZOSTAVAX subcutaneously.  According to the grandmother, her grandson had chickenpox at a young age.  No further information available.  Follow up information was received from the physician who reported that the patient was diagnosed with shingles on 18 DEC 2007, and that the patient had had natural chickenpox at four months of age.  It was further noted that there was no information available regarding "zoster vaccine live exposure".  No further information is expected.
Severe sinus congestion, leading to sinus infection, bronchitis and asthma. The effects have been steady since taking the 2nd dose. Several doses of antibiotics, sinus cultures, blood work, etc. have continued from May to current date (12-10-21).  Patient started IV antibiotics today 12/10/21. After 14 days, the hope is to have the sinuses clear. If not, will seek auto immune treatment.
Facial swelling plus worsening of chronic urticaria (which typically does not involve facial lesions or facial swelling)
I awoke in the middle of the night with my hands, feet, nose, thighs just above my knees and buttocks were freezing.  I could not feel anything with my hands, especially when I tried to check my pulse.  The temperature in the house was 76 degrees.  I could tell I had been clenching my teeth as my jaws and teeth ached (I put in a bite guard).  I was very out of sorts and confused, got a blanket and a cup of water.  Woke up several more times for a cup of water.  After about 2 hours, I got the feeling back in my hands.  After about 4 hours, my feet were at normal temperature again.  I awoke with a headache (5 out of 10) and it took me a while to awaken enough to be able to tell my husband what happened.  The skin on my upper buttocks feels like I may be getting shingles, very sensitive to touch.  It is now 31 hours after the vaccine and I still have a dull headache. This was my second dose, 3 months after the first one.
Headache; Fatigue; localized muscle soreness at injection site; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, fatigue, localized muscle soreness at injection site on an unspecified date, which are general post-vaccine symptoms. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On Tuesday, 10/2/2007 I received an influenza vaccine. In the evening of the same day I began to experience wheezing, chest pain/pressure, shortness of breath, coughing and fatigue. I called my doctor who recommended Benadryl of which I took. I went back to see him today, 10/5/2007 and he said that I was wheezing and prescribed Albuterol inhaler and rest for the next several days.
Baby had been breastfed following vaccines and then left our office at 10:10 am with mom. Went on an errand to bank with mom. When she arrived home at approximately 11:30am per mom, maternal grandmother took her out of car seat and noted unusual breathing pattern with "short gasping breaths." Mom noticed "funny breathing" and baby was fussy and less interactive. Upon arrival at office at approximately 1:30pm, baby had occasional grunting with 100% oxygen saturation on room air. Less interactive than when she was seen in our office earlier that morning. Her heart rate was 199. She felt quite warm to touch, rectal temperature was 100. Her diaper was wet with pink discoloration consistent with urate crystals. Urinalysis revealed no blood in urine and crystals noted with next wet diaper. Baby given acetaminophen in office and fell asleep briefly, after 30 minutes she was awake, interactive and smiling, back to her baseline.