chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CUT ON HIS TOE; TOOK CEPHALEXIN WHILE ON VIVOTIF; This spontaneous case (PVX2019-924) was received from a consumer on 18-Apr-2019. It describes a 73-year-old elderly male consumer who had a "cut on his toe", after the administration of Vivotif for an unknown indication. He also "took cephalexin while on Vivotif" for toe injury.  Case report: The consumer took Vivotif doses on 12-Apr-2019, 14-Apr-2019, 16-Apr-2019, and 18-Apr-2019, respectively. He had a cut on his right foot's big toe either on 15-Apr-2019 or 16-Apr-2019 because of the accident either by a podiatrist at a routine foot care checkup or because of his golf shoes. Later, on 16-Apr-2019 he went to a doctor for the cut. Doctor prescribed cephalexin for the injury. He took cephalexin (500 mg) on 17-Apr-2019. Cephalexin course was a week long and he had a planned trip on 28-Apr-2019.  Action taken with Vivotif with respect to the event "cut on his toe" was dosage maintained while with respect to the event "took cephalexin while on Vivotif" was not applicable.  Action taken with cephalexin with respect to the event "cut on his toe" and "took cephalexin while on Vivotif" was not applicable.  The clinical outcome of the events "cut on his toe" and "took cephalexin while on Vivotif" was unknown.  The reporter considered the event cut on his toe was unrelated to vaccine.  Company's Comment: The causality of the events "cut on his toe" and "took cephalexin while on Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment : The causality of the events  "cut on his toe" and "took cephalexin while on Vivotif" was considered as not applicable.
Swollen left arm. Larger than an egg size bump at injection site redness and swelling. Fever 103. Joint pain. Headache
Information has been received from a physician concerning a female who in approximately July 2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (659182/1757U) and she was late getting her menstrual cycle. The patient's outcome was not reported. Additional information has been requested.
sensation of swelling of the throat; there being no physical signs of swelling only a sensation; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sensation of swelling of the throat; there being no physical signs of swelling only a sensation. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366943
Vaccine was given to a 16 year old instead of an 18 year old.  No adverse events occurred. Patient is fine.
Rash formed all over the left side of torso and hips. First red spots I noticed about 3-4 days after first vaccine shot. Rash Lasted a total of 8 weeks. Red spots, slightly itchy, no fever.  After a week of having rash I made an appointment with PCP. They said I had pityriasis rosea. I was given triamcinolone acetonide cream and acyclovir 800mg. I took medication 5 times a day for 7 days.
Redness, swelling, pain at injection site with associated fevers. SX for 4-5 days post vaccine.
1 sz w/fever, focal-2nd sz w/o fever, gen w/in 24hr of being vaccinated w/DPT/HIB
Achy, headache, no appetite, chills lasted for 14 hours. Headache continued for another 12 hours
The day after the injection, there was arm discomfort, fatigue, and body aches?none of which were terrible and were easily treated with Tylenol.  Roughly 12 days after the booster, I began to have heart flutters. They occurred more often in the morning and evening, but were felt during the day. They were fairly regularly occurring during said time intervals leading up to my visit with Dr. I had been to a local Hospital affiliated Urgent Care clinic the day before I saw Dr. They have continued through 10/3, but are far less frequent. Heart palpitations were most prominent on the days of 9/22?9/25. There have been no palpitations today, 10/4. I have had no arm pain, chest pain, swelling of the extremities, or abnormal fatigue. I was given a halter monitor, fitted by a Hospital's cardiology department on Friday, 9/30. I have been wearing the monitor since then and will continue to wear it for 4 weeks.
Pt. had chicken pox, meningitis and tetanus booster injections on 8-2-11.
Vesicles or blisters, surrounded by indurated erythema 5 cm, dusky cutis marmorata of > 10 cm. Because of the spreading erythema and tenderness treated with TMP-SMX for cellulitis.
Headache, Tylenol, symptoms controlled,  symptoms resolved after 24 hours Fever, Tylenol, symptoms controlled, symptoms resolved after 24 hours Chills, rest, symptoms resolved after 24 hours Fatigue, rest, symptoms resolved after 48 hours Nausea, rest, symptoms resolved after 24 hours Early menstruation: Came 24 hours after second shot, 2 weeks early, always have been on time in the past and has never come early before.
Left Shoulder redness,  pain, swelling. and itching that started 2 hours after injection. Swelling to left bicep extending to upper chest. Redness to bicep with warmth. Patient took Benadryl that night. Prescribed Keflex
It started as a postnasal drip and my throat was very sore and I had difficulty swallowing. It started that night and the following morning, I was positive. I went to a clinic and got a prescription for the other antiviral medication not Paxlovid.  By that time, I started getting a headache, achiness and fatigue. It just got worse. After three days of taking the antiviral, it started to get better. As of last night, I thought it was all over, and I think this morning I have the rebound. I have congestion and sore throat. Not as bad as last time but definitely a change.
3/10 received the first dose of Modorna vaccine, the redness, swelling and itching around the injection area started on 3/17, the area doubled in size on 3/18. I started to take Benadryl and use Hydrocortisone cream. As of today 3/22,  the condition is not improved at all.  its size looks larger.
Sleep was disrupted the night after the shot.  Arose at 7 a.m., Headache.    Bathed, morning chores then onto an 8:45 pre-trial meeting and feeling off, lethargic all morning, I kept hydrating.  Interacting with others via internet was too taxing and the crash began.  Meeting ended about 9:10 I went back to bed and that is when I began to vomit.  From then until about 5 p.m. I had non-stop nausea, vomiting, coughing, sweats and chills.  Today I am still feeling the dehydration and lethargy still.  Did some work but not near a full day, which after yesterday I REALLY NEED TO DO.  Much to catch up, glad i only had one curt appearance.  I was given Moderna.  Friend of mine who I was in contact with during this time told me of this service and encouraged me to report.
one of the side effect of this COVID Vaccine is blood clot all over your body and a rash; one of the side effect of this COVID Vaccine is blood clot all over your body and a rash; This is a spontaneous report received from a contactable consumer. This consumer reported for a female patient (best friend) that. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. It was reported that She was calling because her best friend, who was like her sister, she was in hospital right now, she got the 1st dose of Pfizer COVID-19 Vaccine and then now she got the 2nd one on Wednesday, this Wednesday i.e 15Sep2021 that passed we are concerned because she was actually hospitalized and we want to know if one of the side effect of this COVID Vaccine was blood clot all over your body and a rash." She further stated it's an emergency right like she was in hospital, we don't have answer from anyone, she can't wait till Monday, it's Saturday. Not even the doctor in the ER knows what's going on with her. They have done bacterial test and everything with her. Reporter was requested to contact Physician. Events requires emergency room visit. The patient underwent lab tests and procedures which included bacterial test: unknown results on Sep2021. Outcome of event was unknown.   This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
No adverse effect; patient was inadvertently administered one expired dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 29-APR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 dose, intramuscularly, lot # R002487, expiry date 21-APR-2019 for prophylaxis. No adverse effects were reported.
PT LOST CONSCIOUSNESS 5 MINUTES AFTER VACCINE, SLOW HEART RATE, CLAMMY SKIN, NAUSEA, UNCONTROLLED BLADDER RELEASE. PT REGAINED CONSCIOUSNESS AFTER 30 SECONDS AND AMBULANCE WAS CALLED. BP NORMAL AND PT RECOVERED AFTER ABOUT 20MINUTES AND WAS ABLE TO WALK ON HER OWN.
fast heartbeat after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat after vaccination) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (fast heartbeat after vaccination). At the time of the report, HEART RATE INCREASED (fast heartbeat after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants , treatments are provided
Medical assistant calling to report an expired MMRII dose that was administered to a patient. Date of administration: 6Jun2022, date of expiration: 21Apr2022. Vaccine has not undergone any temperature excursions. No PQC. No additional information.; This spontaneous report was received from a medical assistant and referred to a patient of unspecified age and gender. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) 0.5 ml, lot number T013725, expiration date: 21-APR-2022, administered as prophylaxis (strength, vaccination schedule, and route of administration were not provided) (expired product administered). Vaccine had not undergone any temperature excursions. At the time of reporting, the outcome of expired product administered was unknown.
2 hours after receiving flu shot got pain in left arm (deep pain). Could not use arm. Used ice and ALEVE over the weekend. Rec'd X-ray Monday 9/23/09. Needs MRI.
Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of GARDASIL on 12-JAN-2007. The patient had normal pap smear test on 12-JAN-2007 and negative HPV test. She then received the first dose of GARDASIL. On 15-MAR-2007, she received the second dose of GARDASIL. On 19-JUL-2007 the patient had the third dose of GARDASIL. Patient had a negative HPV test and normal pap smear on 07-MAR-2008. On 13-MAR-2009, she had a typical pap smear and then she had a high risk HPV. The patient sought medical attention to physician. At the time of the report the AE did not improve. Additional information has been requested.
hospitalized for covid 19 pna, respiratory failure, asthma exacerbation on the background of COVID-19
Received Janssen COVID-19 vaccine on 4/12. Reports onset of mouth sores 2-3 days later. She called her doctor on 5/17 and was having no relief. She was given valtrex, but no improvement after 4 days, then was given augmentin. She was admitted to hospital on 5/26 due to difficulty swallowing.  She was noted to have multiple ulcerations mouth throat, palate.  PCR was sent for HSV and is negative.  PCR for SARS-CoV2 was negative.  She had no skin lesions. A serology for coxsackie is pending.  She had no exposure to children.
Patient was given Flu and ZOSTAVAX vaccine on afternoon of 12/13/16. Pt waited for about 5 minutes or so at Pharmacy after given vaccine and then left because she did not experience any reactions at the time.  Patient came back to Pharmacy on the afternoon of 12/15/16 complaining of a red painful rash at the site of the ZOSTAVAX injection of the right arm. Patient also told RPh that she also have a headache which may or may not be related to the event. RPh on duty called patient's primary doctor for advice. Doctor advise patient  to go seek medical attention. Patient immediately went to an urgent care facility. Patient came back to Pharmacy about 30 minutes later with a prescription for an antibiotic. Patient said she was diagnosed with cellulitis. Patient said the RPh who administered the vaccine didn't inject her in the area that was swab by alcohol but instead it she injected to the side of the area that was swabbed by alcohol. Incident currently ended here. RPh to call patient at a later date to check up on her.
Anaphylactic, nausea, flushing, angio-edema, and SOB.
extreme pain and burning at the site of breast biopsy; extreme pain and burning at the site of breast biopsy; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (extreme pain and burning at the site of breast biopsy) and BURNING SENSATION (extreme pain and burning at the site of breast biopsy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12220A) for COVID-19 vaccination.     The patient's past medical history included Breast biopsy on 18-Nov-2020.   On 11-Feb-2021, the patient received second 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) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced BREAST PAIN (extreme pain and burning at the site of breast biopsy) and BURNING SENSATION (extreme pain and burning at the site of breast biopsy). At the time of the report, BREAST PAIN (extreme pain and burning at the site of breast biopsy) and BURNING SENSATION (extreme pain and burning at the site of breast biopsy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Biopsy breast: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
RESIDENT 1ST DOSE OF MODERNA VACCINE ADMINISTERED ON 01/04/2021 AT 8:30PM, RESIDENT FOUND UNRESPONSIVE ON 01/05/2021.
Patient states given flu shot too high in arm, has been to 3 doctors with no diagnosis. Orthopedic doctor states she has "SIRVA". Patient can't move arm higher than 3 inch above wrist, has trouble putting on clothes but is able to move it. Says in pain every day.
Chills, Malaise, Headache, Fever (101.7), myalgias
Within 10 minutes of patient being observed, they noted they felt like they were going to pass out (lightheadedness, cold sweats). I asked patient if he would like to go back to the immunization room and lay down, he said yes. Walked him back with some assistance. Within 5 feet of the door, patient had trouble standing and said he couldn't see anything. I got the immunization room door open and patient lost consciousness. I helped him to the floor and elevated his legs. Within 30 seconds patient re-gained consciousness and was able to tell me if he was ok or not. He was able to converse, knew his name, etc. I told him I was going to go get an ice pack. I left the room for 60 seconds, got ice pack out of freezer, and alerted other pharmacist of the situation. Returned and patient was still lying down, conscious. Put ice pack near his carotid artery on neck. After 5 minutes, patient was able to get into seated position, unassisted. I stayed with him in immunization room for 30 minutes. He did not express any other symptoms other than being jittery and cold. He was able to walk around the room unassisted after 30 minutes. I asked if he had far to drive to go home or if there was anyone that would be able to pick him up. He said he felt ok to drive. I offered that he could stay under observation as long as he would like. He declined and was able to leave pharmacy on his own.
A review of the medical records and interview noted that pt received AVA # 1 in Nov 2000 and # 2 and # 3 during deployment in Jan 2001. He reported that it was shortly after AVA # 3 the he began to notice small patches of pruritic blisters that started on his hands, then on other areas of his body to include arms, feet and thighs. He denied any prior hx of skin issues. The lesion would appear intermittently, last a couple of wks and then resolve. He reported that they do not always reoccur in the same places and has no known precipitated factors. He has multiple visits to include an allergy consult in Aug 2001 and was assessed as having a contact dermatitis. Due to problems controlling his symptoms with various creams and a round of steroids he underwent a civilian dermatology evaluation in Jun 2004. He had skin testing for trees, grasses, molds, and animals. Testing noted strong positives to the majority of trees, grasses and weeds, with neg results to molds and animals. He was assessed as having a chronic urticarial/vesicular dermatitis of undetermined etiology, and an autoimmune process was ruled out. He continued to have reoccurrences of rash without relief from antihistamines and topical steroids. In Jan 07 he was evaluated by a military dermatologist and underwent a skin biopsy which revealed spongiotic dermatitis with focal overlying parakeratosis. He was assessed and treated for atopic eczematous dermatitis. Despite treatment with creams and moisturizers, he continues to have problems with his skin.
Approximately 8 days post dose 1 Moderna Covid 19 Vaccination patient developed the symptoms of what has now been termed as "Covid Arm".  A rash developed post vaccination what is on the arm of the injection, swelling has occurred which has now moved down the arm. The arm is warm to the touch and also causes pain.
Body aches, fever transient vision loss (rule out TIA) left hemifacial paralysis (Bell's Palsy)
Patient states that she felt "woozy" and itchy left hand.  30 min after vaccine.
This spontaneous report was received from a company representative regarding her 15 year old son who was a patient. The patient was vaccinated with GARDASIL, (lot number was not reported) intramuscularly. There was no concomitant medication. The reporter stated that she could not remember when her son who was patient received his 1st or 2nd dose. She reported that the patient was late receiving the 3rd dose. She does not remember the date when his 3rd dose should have been administered. No treatment information was reported. There was no lab diagnostics studies. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
The patient did receive the correct amount of vaccine of 0.3ml of the vaccine once reconstituted. It is likely that the pt received a more concentrated dose of the vaccine.  This was discovered after trying to draw up the correct number of vaccines from the vial and the vial was short. It appears that too much diluent was left in the diluent bottle and thus it was deduced that the amount of diluent used was 0.8ml instead of 1.8ml. Based on deduction, the vaccine was most likely in a stronger concentration than it was supposed to be. The vaccine was likely not reconstituted/diluted properly.  There was no adverse reaction noted at the 15 minutes the pt stayed for supervision after the dose was administered. The issue was reported to her PCP. The pt was notified later in the day at approximately 3:20pm and still not having any adverse reaction.  I also did a f/u call to her the morning after the vaccine was given.  She was fatigued and slept alot and was having some nausea. These are some of the expected side effects of getting the vaccine. She stated she was doing fine however.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:20 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 56.34  Concomitant products were not provided.  On 03-Apr-2021 vials were moved to clinic. On 30-Mar-2021 the vaccines were moved to fridge. On 03-Apr-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34. The vaccine beyond use date was reported as 29-Apr-2021.  Vial was stored in cooler 1, on 03-Apr-2021, temperature excursion at 8 AM: 38  9 AM: 34, 10 AM: 38 and 11 AM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).