chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe, symptomatic, aortic stenosis s/p successful transcatheter aortic valve replacement. Recovery in the hospital and discharged home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt recv vax on 10/8/97; 10-12 hr later pt exp vomiting & dizziness.
erythema/redness; discomfort; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 3 days after receiving Shingrix, the patient experienced erythema (Verbatim: erythema/redness) and discomfort (Verbatim: discomfort). The outcome of the erythema and discomfort were resolved.   It was unknown if the reporter considered the erythema and discomfort to be related to Shingrix.     It was unknown if the company considered the erythema and discomfort to be related to Shingrix.   Additional Information: GSK Receipt Date- 06-NOV-2023 The physician reported that he had erythema and discomfort 3 days after first Shingrix vaccine administration. Redness and discomfort resolved without intervention in both cases. This case was linked with US2023AMR154563 reported by the same reporter for different patient. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023AMR154563:Same Reporter
0ne week after first shot developed cutaneous Covid in left arm.  Very sore uncomfortable itchy red and swollen. Last about 24 to 36 hours.  Did seem better after two does of Claritin24  After second shot in right arm about 12 hours later very severe flu like symptoms intense body  and joint inflammation over the course of 24 to 36 hours. Only pedialyte and Tylenol during this time.  Once improvement began noticed swollen lymph node right arm
I had a hard time breathing. Felt as if I had been running. Lasted about 24 hours slowly getting better as time passed. I fainted at one point. I?m not sure if this matters but I had covid twice last time was a few months ago.  I keep seeing on the news hospitals are over run so I wanted to wait until I couldn?t wait any longer before doing that and about 16 hours later it started to ease. It?s been 2 days I still don?t have a appetite.
ZOSTAVAX subq shot given 8/19/16 in right upper arm. Patient has heat, redness and tenderness around injection site. The site appears swollen. Swelling has increased over past 24 hr. Swollen site appears to be about 4 inches in diameter.
Extremely tired; flushed face; fever of 99.8; upper body aches.
This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. For the lot # M043987 with expiration date on 20-OCT-2018, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours; but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 576 hours (dates between 27-MAR-2017 and 30-MAY-2017). For the lot # N003993 (expiration date was not reported), the storage temperature was from 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours and it was also reported that there were multiple previous temperature excursions with a total cumulative time frame of 216 hours (dates between 15-FEB-2017 and 31-MAR-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002362: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA011484: US-009507513-1706USA011486:
Within 4 hours post-shot:  injection site pain, swelling Approximately 16 hours post-vaccination:  moderate muscle aches, headache, tiredness lasting  almost 36 hours Approximately 24 hours post-vaccination:  low-grade fever 100.8  (treated with tylenol) Approximately 36 hours post-vaccination:  sore throat lasting for more than 24 hours (on-going as of this report) Approximately 48 hours post-vaccination:  fever 101.7  (treated with tylenol)  This report is being made at 67 hours post-vaccination, and at this time I'm still experiencing the sore throat and mild tiredness.
Infant found not breathing, no pulse. Death certificate lists cause of death as SIDS, autopsy revealed no abnormalities.
Patient came into pharmacy on 9/26/18 to report he has been experiencing extremely pain arm movement that limited his motion, and difficulty grasping objects with his hand. He said he had tried to use ice and heat but it wasn't helping. He said he didn't have these effects until 'a few days after' the vaccine but didn't state a specific date to me. He said the pain/issues have increased and decreased but not gone away. He also stated he thought the vaccine was administered 'pretty high' on his arm, and that it 'surprised him'. Patient does not have a primary care doctor here yet but will find one in a few days if NSAIDs don't help.
Seen in the ER for a fever or 101 (R), low fluid intake, diarrhea.
Probably broke out after their flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: This case was reported by a patient's cousin via interactive digital media. The patient probably broke out after having their flu shot. The reporter advised to stay away from it.  Additional supportive information: Follow-up would not possible, as no contact details were available. The case has been linked with the case US2022AMR121170 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR121170:Same reporter US-GSK-US2022AMR121183:Same reporter - Invalid case
-Vertigo (severe). Starting 2 or 3 weeks after 2nd vaccine shot. Most likely vestibular vertigo/neuritis -Lasted up to 3 months.  -Threw up 3 times due to vertigo -Treating with Dramamine. Haven't had a vertigo spell for 4 months
Red irritation running from site down to underneath arm (4 in x 1 in). Sore kidneys, congested head, muscles stiffness.
Patient came in for her second dose of the Covid 19 vaccine. She was given Moderna for the first dose and Pfizer for second dose.
I feel like the skin off my bones are being peeled off  I?ve lost 7 toenails  I don?t sleep I feel like I?m in a fog Today I weighed 107 lbs
overall bad feeling; Fatigued; My left arm was sore at the injection site./Soreness at the right arm injection site was worse than the Moderna shot.; I received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (overall bad feeling), FATIGUE (Fatigued), VACCINATION SITE PAIN (My left arm was sore at the injection site./Soreness at the right arm injection site was worse than the Moderna shot.) and WRONG PRODUCT ADMINISTERED (I received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 12-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced VACCINATION SITE PAIN (My left arm was sore at the injection site./Soreness at the right arm injection site was worse than the Moderna shot.) and WRONG PRODUCT ADMINISTERED (I received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent). On 13-Oct-2022, the patient experienced FEELING ABNORMAL (overall bad feeling) and FATIGUE (Fatigued). On 14-Oct-2022, FEELING ABNORMAL (overall bad feeling) and FATIGUE (Fatigued) had resolved. At the time of the report, VACCINATION SITE PAIN (My left arm was sore at the injection site./Soreness at the right arm injection site was worse than the Moderna shot.) and WRONG PRODUCT ADMINISTERED (I received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent) outcome was unknown.            No concomitant medications were reported.  The patient was mistakenly given the pediatric dose of the regular Moderna Covid-19 vaccine [Monovalent], instead of the Moderna Covid-19 Vaccine, Bivalent. It was reported that the patient also got the senior dose of the flu shot in right arm. Soreness at the right arm injection site was worse than the Moderna shot.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659988 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659988:Crosslinked with MOD22-026790 (wife's case) same reporter.
Headache; Fatigue; Fever; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0107) via an unspecified route of administration in the arm left on 14May2021 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in May2021, the patient experienced headache, fatigue, fever, injection site pain. The clinical outcome of the events headache, fatigue, fever, injection site pain was unknown.  No follow-up attempts are needed. No further information is expected.
¨going trough a small Flu illness with  : tearing, sneezing , mucus¨; Fatigue; Muscle pain; Pain in the arm of the injection ( Left) for almost 2 days; pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (¨going trough a small Flu illness with  : tearing, sneezing , mucus¨), PAIN IN EXTREMITY (Pain in the arm of the injection ( Left) for almost 2 days), MATERNAL EXPOSURE DURING PREGNANCY (pregnant), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     no medical history was reported.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 23-Mar-2021 and the estimated date of delivery was 28-Dec-2021. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection ( Left) for almost 2 days) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (¨going trough a small Flu illness with  : tearing, sneezing , mucus¨), FATIGUE (Fatigue) and MYALGIA (Muscle pain). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  The patient was treated with ACETAMINOPHEN for Pain, at a dose of 1 dosage form and PARACETAMOL for Pain, at a dose of 1 dosage form. On 23-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (¨going trough a small Flu illness with  : tearing, sneezing , mucus¨), PAIN IN EXTREMITY (Pain in the arm of the injection ( Left) for almost 2 days), FATIGUE (Fatigue) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications include pregnancy medications daily   This case was linked to US-MODERNATX, INC.-MOD-2021-161014 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Internal review on 28- JUL-2021, resulted in the updates of pregnancy details; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-161014:Husband's case
mom recv vax 15NOV95 & became pregnant;mom delivered child by cesarean section-nl delivery;pt exp transient tachypnea which resolved in 12hr;@ time of report child growing well & developing nl;
Standard side effect, it seems, just reporting for tracking. EXTREME tiredness/lethargy 36-72 hours after Pfizer Bion Tech vaccine dose 2. No other side effects, did not require any medical treatment, self-resolved with time.
Information has been received from a physician concerning 3 patients who were each in contact with a person who was vaccinated with one does of varicella virus vaccine live. Subsequently, these patients developed a breakthrough case which was considered direct transmission from the vaccinated persons. Additional information has been requested.
Itchy rash at vaccine location that appeared 8 days after vaccine.  Itching lasted 4 days. Used hydrocortisone cream for relief.
Patient received the Janssen Vaccine Covid-19 injection and immediately afterwards asked for a trash can. She immediately passed out and fell forward. She hit her head on the wall and received a cut.  We called the paramedics and she was transported to the emergency room at the local hospital.
Patient said she has aversion to needles and may faint prior to given shots. Exhibited paleness about 15 seconds after second shot. Lost consciousness for about 30 seconds and came back.
Patient is a 68-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. Patient denies having adverse reaction with first dose of Pfizer. Patient given 30-minute observation time with EMTs for history of severe allergy to shrimp. At 1:59 pm, the patient received her second dose of Pfizer (lot number EW0187, expires on 08/2021) on right deltoid. At 2:17 pm, patient reports itchiness on face and arms. Patient has 2 hives on left forearm of approximately 2 cm in diameter. Patient?s face flushed. RN responded by taking patient's vitals while lead RN drew up IM Benadryl. At 2:17 pm: BP 138/70, SPO2 98%, HR 80. At 2:21 pm, RN gave patient 50 mg/1mL of IM Benadryl in left deltoid. At 2:26 pm: BP 132/72, SPO2 97%, HR 77. Patient denies SOB. At 2:31 pm: BP 132/70, SPO2 97%, HR 79. Patient describes itching as ?getting better?. At 2:35 pm: BP 128/70, SPO2 98%, HR 77. Patient states she is ?feeling fine? and denies SOB and itching. Redness in patient?s face resolved. Two hives on patient?s arm remain present. At 2:40 pm: BP 128/70, SPO2 99%, HR 76. Patient provided with education on when to call 911, including shortness of breath. At 2:47 pm, patient states she would like to leave facility. Patient and caregiver state they will follow up with patient?s PCP. Patient?s caregiver pushed patient in wheelchair to parking lot.
Pt received 2nd dose of Pfizer Covid vaccine today approx 9:14AM; pfizer lot number EL9266. Patient has hx of throat swelling from PO Sulfa. Pt alerted nurse at 9:35AM that she was experiencing a generalized prickle sensation. P60 O2RA 97%. At 09:54AM pt experiencing widespread prickle sensation, tightening in throat, difficulty swallowing, disorientation, and light headedness. Epi 0.3mg auto injector(Lot 0FM534) administered left leg 9:54AM per RN; BP 198/72 P75, O2RA 98%. EMS called 9:55AM, arrived at 9:59AM and assumed care of patient. Patient transported to Hospital.
Pt came to pharmacy w/redness on arm and itching (on 1/10/17). Recommended BENADRYL to pt.
c/o red spots on face, neck & back, vomiting included;pt devel knot on lt leg were inj given ;devel bruise & cried uncontrollably;this was not nl for child behavior according to mom;
My lungs felt heavy and when I walked up the stairs and got to the top I was out of breath. I came down and had to sit down and I was out of breath but it took a good 30 minutes before I could catch my breath and the next day the same thing happened and I was just out of breath and my doctor had prescribed me steroids' because I have asthma and I called her and told her and because of my family testing positive she advised me to come in. I tested positive for COVID-19 on 7/22/22. She would not give me the antiviral because I have been having symptoms for 5 days so she prescribed me antibiotics and steroids. She wouldn't give me anything for my asthma.
Pt developed itching at injection site afternoon after receiving injection, by next day (8/23/2017) entire arm was red and hot. Pt saw primary care Dr who administered SOLU-MEDROL.
Note HCT was 52. She called at 15:30 complaining of s/s dizziness, headache, nausea, vomited unknown amount, sweating. When she left Center with no complaints. Outside tempature was in the 90's. No airconditioning in car. Was treated in ER for dehydration later on that evening.
Sweating and chills and coughing running noise, and over fatigue .  Fever of 102.
Patient received COVID vaccine off site on 6/11/2021 - he received Moderna and it was thought that it was his 2nd dose of Moderna and that he received 1st dose of Moderna on 5/11/2021, but his first dose of COVID vaccine was actually J & J (Janssen) vaccine given on 5/5/2021 so he didn't need a 2nd dose. Patient was notified of error by the person who administered vaccine and did not voice any questions or concerns.
1/8/22 44 yr/o female who presents with a 7-day history of illness.  She states 7 days ago she developed initially a sore throat which has since nearly resolved.  This was followed by chills, fever with a T-max of 101 and coughing.  She states since her illness began she is also experience right-sided lower abdominal pain along with diarrhea.  The abdominal pain is intermittent and last for several minutes.  She denies aggravating or relieving factors.  She denies difficulty swallowing, syncope, recent fall or injury, vomiting, headache, chest pain.  She does report some mild dyspnea. PE Constitutional - Non toxic appearing AT, no gross conjunctival injection Neck is supple Heart - no murmur, gallop or rub 1/8/22  Lungs -no wheeze, good air movement, no resp distress Abdomen - Positive bowel sounds, soft, positive right lower quadrant tenderness, no rebound, no guard, non-distended Extremities - No edema, intact pulses Skinno visible rash Neuroalert, appropriate, speech intact Psych normal behavior   1/10/22 Discharge note  44-year-old female with a past medical history of metastatic breast cancer who was admitted to the hospital for COVID-19 infection.  Upon hospitalization, COVID-19 test came back positive.  A CT chest was ordered which did not reveal any evidence of pulmonary embolism or groundglass opacities.  Over the course of her hospital stay, patient's condition improved.  Since she remained stable on room air, patient was medically stable for discharge.  Patient was discharged home and will continue to quarantine until her symptoms have resolved.  She is currently vaccinated against COVID-19 but did not get the booster.
Head starting pulling to the left with no control of neck muscles. Cold and later after the second shot on Feb 11 broke out in hives.
The client experienced mild nausea and anxiety 5 minutes after receiving his first Pfizer covid vaccine. He left observation after 15 minutes at 1345 with no treatment, except bottled water. An hour later at 1445 the client returned to Observation c/o increasing nausea and vomiting. At this time, I administered 50 mg IM benadryl to the client. The client waited in observation for 30 additional minutes and left at 1515. At this time of departure, the client had no signs or symptoms of N/V.
vaginal infection; This is a spontaneous report from a contactable physician received by Pfizer from (GL-052821-13037).  A 49-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; solution for injection, lot number, expiration date was not reported), via intramuscular route, on 16Mar2021, at dose 1, single for covid-19 immunization. Medical history included skin cancer and rosacea. She had no dental work in the past 6-12 months. The patient's concomitant medications were not reported. The patient experienced the vulva area removed (two weeks prior to 23Apr2021) and a vaginal infection post-surgery on 09Apr2021. The patient second dose of vaccination on 13Apr2021 for covid-19 immunization. Therapeutic measures included anti-biotics taken as a result of vaginal infection. The outcome of the events was unknown.  The lot number for [bnt162b2], was not provided and will be requested during follow up.
Whole top of arm red, very hot, itching, lump at injection site; these symptoms lasted about 1 week then resolved.
Fever 102 Cold sore where one was never located previously  Cold chills Sore arm
Pt was given second dose in COVID vaccine series, she proceeded to lab to have routine lab testing done, she was stuck twice, after second stick lab staff noted patient was pale, diaphoretic & states she "felt funny".  They notified nursing staff & provider.  Vitals were obtained, as well as EKG, FSBS. Pt stated she had not eaten today and it was 4pm, encouraged PO fluids. Pts initial BP 74/43, o2 Sat 100%, FSBS 108, BP after a few minutes was 102/92,  EKG obtained & read by provider. patient's color returned and she stated she felt better. Pt was observed in clinic for approx. 45minutes,pt was able to leave clinic ambulatory after event.
Feeling pain at the injection site, hurting worse than the needle, if he moves his arm it hurts; Chronic fatigue; Had a little bit of an adverse reaction after the second vaccine; Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a little bit of an adverse reaction after the second vaccine), VACCINATION SITE PAIN (Feeling pain at the injection site, hurting worse than the needle, if he moves his arm it hurts), the first episode of FATIGUE (Chronic fatigue) and the second episode of FATIGUE (Chronic fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (Had a little bit of an adverse reaction after the second vaccine) and the first episode of FATIGUE (Chronic fatigue). In April 2021, the patient experienced the second episode of FATIGUE (Chronic fatigue). On 24-Jun-2021, the patient experienced VACCINATION SITE PAIN (Feeling pain at the injection site, hurting worse than the needle, if he moves his arm it hurts). At the time of the report, VACCINATION COMPLICATION (Had a little bit of an adverse reaction after the second vaccine) outcome was unknown and VACCINATION SITE PAIN (Feeling pain at the injection site, hurting worse than the needle, if he moves his arm it hurts) and the last episode of FATIGUE (Chronic fatigue) had not resolved.            Concomitant product information was not provided.  Treatment information was not provided.