chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's mother, notified Health Services on 8/14/19 at 10:00 am regarding adverse reaction to immunization.  Patient's daughter complains of Left Arm hurting  after shots, but Mother did not notice redness and swelling to left upper arm until 8/14/19. Mother reports symptoms of red, hot, knot on left arm.  Provider explained to mother that child is most likely having a localized adverse reaction .  Mother denies child having fever, shortness of breath, or any other acute/emergency symptoms. Provider recommended to mother to  take her daughter to a doctor for further evaluation if symptoms become worse or that she may follow up with clinic with further concerns as needed.  Mother was able to verbalize understanding to all the above and denies further concerns at this time. Provider informed mother that the injection given into the left arm was the Kinrix, a combo vaccine for Dtap and IPV.
injection site muscle soreness; patient received her first dose of VARIVAX, intramuscularly; This spontaneous report was received from a nurse, regarding a 42-year-old non-pregnant, female patient. The patient's concomitant medications included sterile diluent (manufacturer unknown), rizatriptan benzoate (MAXALT MLT) and (XANAX). It was reported that the patient did not have any pertinent medical history. His drug reactions or allergies included a penicillin allergy.   On 15-NOV-2019, the patient was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 ml once, intramuscularly as routine immunization (prophylaxis) (incorrect route of product administration) (anatomical location was not provided; lot number S020158, expiration date reported as 30-JUN-2021, and upon internal validation stablished as the same).   On that same day, the patient experienced muscle soreness (myalgia). It was reported that no laboratories or diagnostics tests were performed, and that the patient did not seek medical attention. The patient recovered from the event on approximately 19-NOV-2019 (reported as: after three to four days).   There was no causality assessment provided between myalgia occurrence and vaccination with varicella virus vaccine live (Oka/Merck) (VARIVAX).
Injection given 6/9/15, patient noticed rash on arms and legs only the following morning on 6/10/2015. Patient had to work on 6/10, came to pharmacy 6/11/15 complaining of rash and itching. Told pt to contact physician immediately.
Pt received shot at 3:30 pm on 2/17/21  and was sitting in the 15 minute observation area when she expressed that she was having a tightness across her chest and was having difficulty breathing.  After speaking with the patient I learned she had a ventolin  inhaler and asked her to use it.  I told her to stay for another 10 min to be watched and assess if she needed further care.  After 5 min she expressed that she was not improving.  The decision was made to call 911 so that she could evaluated.  Paramedics arrived and evaluated her, and decided to transport  her to Kaiser hospital as they said they "couldn't rule anything out in the field".
Severe redness of face, throat, and chest, "felt like my body was on fire"; hives on bilateral inner arms and entire chest; burning sensation on soles of both feet; facial and lip swelling.    Oral benadryl was taken and symptoms subsided after 45 minutes.
My breathing hasn't been well I'm currently on oxygen, I've been having heart problems, I got Covid after the first dose, got the second dose and booster but symptoms were mild. 4 days after the first dose, I was having trouble breathing and went to the hospital. I was hospitalized with Covid and in the hospital for 8 days. I developed ammonia March 2020; I was given blood thinners for blood clots in my lungs. I was given medication at the hospital for a year and developed bigger health problems. I ask my doctor if I have long term Covid, but I was given no direct answer and told I was fine. I went to lung doctor and told I was fine lungs working at 80 percent heart functioning at 50 percent. Hospitalized twice, first time 7 days and second time 8 days.
Anaphalaxis: hives, flushing/redness, itchiness, tongue swelling/tightness in chest. Self-administered Auvi-q epinephrine, went to the Hospital, received prednisone, pepcid, benedryl. Prednisone taper for 4 days after
This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an Unspecified date the patient was previously treated with covid-19 vaccine ad26. cov2.s from unspecified manufacturer (Dose Number in Series: 1) for prophylactic vaccination and did not report any adverse events.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (Dose Number in Series: 2) 1 total administered on 17-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster dose the patient experienced expired vaccine used. (Dose Number in Series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of expired vaccine used was not reported.  This report was non-serious.
Has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 09-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-253017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Email address added.
Developed TPLL a rare leukemia. Severely increase in WBC especially T cells. Other abnormal counts.
I missed my period for the month of August.   My last period date was July 24th as of date I have not received my period.    Secondly on September 11, 2021.  I start getting Bowl Movements with blood in it.  The stools are soft and the urge to go is more frequent.
Information has been received from SPMSD (manufacturer control# was not reported) on 04-AUG-2016. Information has been received from a nurse referring to her daughter of unknown age via a video. On an unknown date the patient was vaccinated with MMR II (lot#, strength, dosage, frequency and route unspecified). On an unknown date, following the vaccine administration, the patient had difficulty walking and was unable to walk. The outcome of the events was unknown. The causality was not reported. This is one of two reports from the same TV program. Upon internal review, the event of "unable to walk" to be medically significant. Additional information is not expected since no contact information is provided.
Pt received TdaP and Typhoid tabs on 1/23/15. Hives, swelling, redness developed 1/28/15 only around injection site on (L) deltoid. Pt taking CLARITIN 24 hr. antihistamine.
No adverse event; 7 Patients received expired booster doses after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 Patients received expired booster doses after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 Patients received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 Patients received expired booster doses after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 Patients received expired booster doses after manufacturer date of expiry).    Concomitant medications was not provided by the reporter.  Patients received expired booster doses after manufacturer date of expiry. On 29JUL2022 the vail thawed and kept in the refrigerator. The vial doesn't undergo any temperature excursions.  Treatment information was not provided.
Four inch raised red welt across abdomen; Four inch raised red welt across abdomen; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (BNT162B2, Solution for injection; Batch/Lot Number: EV6199), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:00 as SINGLE DOSE for covid-19 immunisation. The patient's Medical history and concomitant medications were not reported. The patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient previously took "BNT162B2" on 10Feb2021 at 67 years for "COVID-19 immunisation" (product=COVID 19, brand=Pfizer, lot number=EM9809, lot unknown=False, administration date=10Feb2021, administration time=03:00 PM, vaccine location=Left arm, dose number=1). On 03Mar2021 15:00 patient experienced four inch raised red welt across abdomen. No treatment was provided for the events. The outcome for the events was recovered on 03Mar20201 16:00.  No follow-up attempts are possible. No further information is expected.
Patient received FLUZONE HD and PNEUMOVAX in arm 10/13/16. Contacted pharmacy 11/28/16 to complain of persistent shoulder pain has seen dr. and been to physical therapy, but pain persists.
Patient is very active.  She has loss of appetite, pain and fatigue; doesn't have strength to perform normal activities. Very out of norm that she cancelled normal activities on Friday and Monday because she did not feel well.   Patient could not walk, hips/sciatic pain flared up, flu-like symptoms, intermittent headache, pain/cartilage inflammation on her ribs. Per reporter, patient contacted pharmacist but not sure what was recommended.  Patient just wants to lay down and sleep. Reporter not sure if patient received same type of Flu vaccine prior.
Dizziness,  Nausea, Fatigue, Light Diarrhea and stomach feels empty and uneasy all the time.  These symptoms have been around for a long time over 3 weeks and do not seem. to go away.
Patient had an emergency room visit and was told that she could not receive the 2nd dose. She had swollen lips the next day along with right sided swelling, especially in her right foot. Blood pressure was high
24hrs post vax pt became very hot to touch, had unusual cry & unconsolable for an entire evening. (mo also noticed "jerky body movements). Following day pt was pale, listless & warm to touch; Tylenol used to reduce fever.
This spontaneous report as received from a physician via a sales representative refers to a currently 15 year old male patient. The patient's current conditions were not reported. Pertinent medical history was none. On an unknown date, the patient was vaccinated with first dose and second dose of GARDASIL injection 120 Y (unknown and dose) intramuscularly at a standard dose. Concomitant therapies included VARIVAX (Merck), MENACTRA and unspecified hepatitis A vaccine. No adverse effects were reported for the first dose. On an unknown date, after receiving the second dose of GARDASIL, the patient experienced swelling and pain in the upper region of his right arm which had begun to extend down his elbow. No treatment was received in response to the events. The outcome of the events was reported as recovered. Causality assessment was not provided. There was no product quality complaint (PQC) involved and no PQC was filed. Additional information is not expected as the reporter denied contact.
This spontaneous report as received from a pharmacist via company representative refers to a 85 years old female patient with no pertinent medical history and with no drug reactions/allergies. On an unknown date the patient was vaccinated with the second dose of ZOSTAVAX dose, route of administration not provided. In April 2013 (reported as "2 months ago") the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention via speaking to the pharmacist. The outcome of adverse event was reported as recovering/resolving. The relatedness for ZOSTAVAX was not reported. Additional information has been requested.
Left health department, in car-driven by sister and their way home. Pt stated didn't feel good, sister noted body stiffened - muscle became tight and syncope followed. 911 called pt started to arouse - No tx given. Parents called and release in their care.
Extreme pain while shot being administered from my shoulder to my finger tips, the same pain as the Flu vaccine. Immediately I felt dizzy after the shot was administered. After leaving the store, walking to the car, I started feeling short of breath and nauseous from being so dizzy. Since I had just had the Flu vaccine in December and the symptoms mimicked that my husband immediately drove me to the local Hospital. Enroute to the hospital I became itchy all over my neck, arms, and torso. I was immediately brought into a treatment area where the nurses started an IV and the doctor, Dr., came in the room and immediately advised to give me Benadryl and steroids via IV. After some time the itchiness/hives had subsided a little bit but I developed a headache. After being monitored by staff in the ER, I was later released with 3 prescriptions for:   Benadryl, steroids, and an epipen.  The arm pain continued for approximately two weeks after receiving the vaccine.  I followed up with my primary after the allergic reaction.
Hallucination on Day 1 and day 3. Lasted about 3-5 minutes followed by 36 hours of lethargy and photosensitivity. Shortness of Breath on Day 4.
Around 7:30 Saturday evening, I began to feel very bad. My body ached, all the normal symptoms one would expect to have after a vaccination of this time. However, I started having Hallucinations, hearing people talking to me, etc. throughout Saturday night the Hallucinations began to get worse. At first, I saw people walking through the house. In the beginning would tell them to get out. But it was such a strange night. My mind felt like it was floating. I sat down mostly and children came and sat all around me. They were trying to tell me something. I didn?t listen to them. I was too scared. They didn?t hurt me. Thiese Hallucinations are still happening. I just went to try to wash a load of clothes. I bent over to swirl the bleach around in my water. Horrible things came up out of that water. I know they were not real. I?m scared. I have never had this happen to me. I need this to stop. How am I going fo work?  I have kids.  I have never had anything like this happen to me until I took that COVID  Booster Vaccination. This is a scary situation and someone needs to fix it.
On May 19th, went for my typical job of about 3 miles.  I barely got 1/2 mile and was completely out of breath and could only go 1-2 blocks thereafter with needing a break to barely get home. Then on Monday May 30th, woke up at 5am with a deep calf pain.  It wasnt a cramp or strain or pull from prior exercises; it felt very different.  Monitored rest of Monday, Tuesday seemed to lesson a little but came back in the evening and kept me up most of the night with constant pain.  Went to urgent care on Wednesday June 1st.  Received an ultrasound that determined I had a blood clot in my right calf.  It was 5cm and by Friday for my 2nd ultrasound, grown to 14cm.  I have been put on Xarelto 15mg, 2x/day for next 3 weeks then going to 20mg, 1x/day
This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On 05-FEB-2016, the patients were administered improperly stored doses, by a time frame of an hours and 30 minutes with a temperature of 57F, of GARDASIL 9 (Lot # L048237, expiration date 08-MAY-2017; Lot # L016429, expiration date 09-AUG-2017; Lot # L018351, expiration date 11-AUG-2017). No adverse effect reported. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Hurt to move the arm; Horrible aches in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm). On 16-Jun-2021, PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-259182 (Patient Link).
Noticed increasing muscular weakness over next 4 days after receiving Influenza vaccine. Diagnosed with mild Guilliane-Barre Syndrome on 10/8.  11/19/09 Neurology consultation report received service date 10/8/09. Assessment: Diagnosis of Muscle Weakness. Diagnosis of Tremors. Patient began having muscle aches and pains 48 hours after flu shot, later weak and tired, problems walking, decrease in quadraceps strength, tremors, problems with grip. Has started improving. DTR's 1+.
Pregnant patient reported she has received both doses of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Jul-2021. On 31-Oct-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine). The delivery occurred  on 11-Jul-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient reported she has received both doses of the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
pt seen clinic 4SEP92 w/leg weakness & numbness & dec ability to walk; adm to hosp; bilat weakness; acute transverse myelitis; hypertension; asthma; osterarthritis of Lumbar spine; obesity; twitch; inability to void;
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with first 0.5ml dose of GARDASIL (route and lot number not provided). The physician reported that the patient experienced chills and fever after vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Pressure on rear upper left side of my head.  Pressure always in the same spot approximately 3" circle.    Pressure has decreased somewhat now after 16 days but it is still there.  For the first week or I would describe the pressure as if something was trying to push a section of my scalp off.
after waiting 15 minutes from receiving injection, patient stated tongue was feeling itchy, we gave her 10mL of benadryl, she waited an additional 15 minutes and felt fine.
Patient was vaccinated at 11:58 AM. During her observation, she appeared to be resting/sitting quietly in her chair.  At approximately 1227, RN was trying to arouse patient.  On my arrival, patient was not responsive.  Shortly after that, patient became responsive to voice.  She was oriented to person, place and time.  Speech was slurred. Grips were weak bilaterally, No pronator drift.   Initial VS at 1230 were T- 37.0, HR- 108, R-16, BP 200/120, spO2 99% on 6L by NRB.  VS  at 1238- P- 113, SpO2 99% on 6L NRB, BP 180/90.   Patient's husband, located in parking lot and brought in. verified that patient was not acting normally.     EMS arrived at 1241.  SBAR report given.   RN CEN
Patient reports that her left arm, where she received the pneumonia vaccine started swelling the day of the vaccination. It is about 5 inch swelling with redness around injection site.  She reports it was severely painful to lift her arm but it has since resolved.
Patient is a merchant marine. History given by a RN.  HPI:  10 days post smallpox vaccination, patient developed erythematous, pruritic papules/pustules on his back and chest.  Lesions do not have the appearance of the smallpox vaccination site.  No lesions on palms or soles.  No oral lesions.  Afebrile and feels fine otherwise.  Treatment:  Benadryl and was initially placed in separate quarters on the ship.  Careful monitoring by RN on the ship.
Left Arm, Pain, swollen deltoid area, redness, firmness of deltoid (relative to contra-lateral), calor of deltoid 99.8 F vs 95.0 F on contra-lateral.  We took patient to Dr. today 1:30PM who said that the reaction would likely dissipate in a few days.
Narrative:  Patient received two doses of COVID 19 vaccine in Jan 2021. The patient tested positive for COVID 19 on 5 Oct 21 and was hospitalized with chest pain and cough. The patient was monitored and discharged on 6 October 2021. Reported per EUA.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient was vaccinated with the first dose of GARDASIL in September 2013 (dose, route, lot # and expired date were not reported). The patient was vaccinated with the second dose of GARDASIL in December 2013 (dose, route, lot # and expired date were not reported). Patient was in the office; however was sent to unspecified primary care physician to complete GARDASIL vaccination series. No adverse effects were reported. Additional information has been requested.
Patient was given the oral rotarix diluent only. The diluent was not mixed with the vaccine. There was no adverse reaction at the time the diluent was given.