chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient admitted for spontaneous abortion 12 weeks into pregnancy. She had received the H1N1 vaccine approximately 1 week earlier. She is Gravida 8, Para 4 - 0- 3- 4. The attending asked that this report be filed at the patients demands. 12/8 and 12/9/2009 MR, ED records for 11/20/2009, operative reports for 11/18 and 11/21/2009. Patient was 12 weeks pregnant, had US done on 11/16/2009 which noted no FHT, patient had a D&C on 11/18/2009. Presented to ED on 11/20/2009 with c/o's fever, malaise, nausea/vomiting and severe abdominal pain, a repeat Pelvic US was done which noted retained products of conception, a repeat D&C was done, and tx'd with IV ABX 12/31/2009 OB-GYN prenatal visits.
throat was itching; Tested positive for virus 10 days after receiving 1st dose.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.On 10Feb2021,The patient tested positive for virus 10 days after receiving 1st dose and her throat was itching.The patient underwent lab tests and procedures which included SARS-CoV-1 test:positive on 10Feb2021. The outcome of events were unknown.  Information on the Lot/Batch number has been requested.
This spontaneous report was received from a nurse refers to a multiple unspecified patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PEDVAXHIB (lot # was not provided). No adverse effect was reported. Temperature 48.79 Fahrenheit, time frame was 13 hours for 30 minutes. Previous temperature excursion was 46.5 Fahrenheit for 10 hours 48 minutes. There was no data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Raised hives in a ring with central clearing, around the injection site on L upper arm. The site is warm, pruritic, not painful but uncomfortable. I noticed the site was itching on 01/19 but noticed the actual rash on 01/20. On 01/20 I used a topical steroid ointment over the rash and took an antihistamine. On 01/21 the rash was still present but improved from 01/20.
Vaccine given 10/26/16. Inflammatory nodule noted on left leg 11/4/16. Generalized rash developed 11/6/16; clinic visit 11/7/16.
Keep getting flutters in my heart. It feels like my body is out of control when it happens.
Pt states that after receiving 1st Anthrax shot on 3/30/2000; a hard knot appeared on left side of nose. Pt states that over a period of the next 2 days, the knot swelled and the entire left eye swelled shut, on the 3rd day. Pt states that it took 3 days for the swelling to go away. Pt states that the same incident happened with the 2nd Anthrax shot.
The day after I received the second dose of the COVID-19  vaccine,  I developed tingling in my right arm that progressed to intense pain in my arm whenever I used it or just at various time. MRI's showed that I have a  Cavernoma in my spine that had not be identified before due to never having any symptoms. The symptoms indicate that the Cavernoma had been activated and had started to bleed, causing the neurological symptoms. The symptoms have continued  and  neurosurgery will be occurring to remove the Cavernoma.
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA002267: US-009507513-1907USA012219: US-009507513-1907USA012223:
Pt was given 2nd dose too early at vaccination clinic.  First dose was given on 1/4/21 and patient came for 2nd dose on 1/20/21.  Vaccine was administered before nurse administering vaccine checked pt's vaccine card
experienced som e dizziness; eyes ache; body aches; vomiting; diarrhea; arm was sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore), HEADACHE (headache), VOMITING (vomiting), DIARRHOEA (diarrhea) and DIZZINESS (experienced som e dizziness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable stomach (Felt bad on stomach after taking Tylenol as treatment drug.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and HEADACHE (headache). On 17-Jan-2021, the patient experienced VOMITING (vomiting) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced DIZZINESS (experienced som e dizziness), EYE PAIN (eyes ache) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (arm was sore), HEADACHE (headache), VOMITING (vomiting), DIARRHOEA (diarrhea), DIZZINESS (experienced som e dizziness), EYE PAIN (eyes ache) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Several patients were administered PROQUAD during this temperature excursion.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 04-DEC-2020, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter (route of administration was not reported), lot number T021302 rHA and expiration date 19-DEC-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -5 degree Celsius (°C) for 20 hours; no previous temperature excursion were reported.  The call was made due to a digital data logger.
Major (L) muscle soreness, throbbing, joint felt warm and swollen. Joint aches, H/A low-grade fever, flu-like symptoms x >72 hours after onset.
Individual presented to clinic requesting second dose of Pfizer vaccine. Individual was accidently administered a Janssen vaccine instead of Pfizer they requested. Individual was observed for 30 minutes and had no reaction.
Patient, who is an adult, was given a pediatric does of Hep A inadvertently. No S/S of any reaction.
Dizziness, body aches, headache, strong fatigue, sweating and chills at night, vibration feeling throughout body, sore arm
Patient vaccinated 5/10. At same time diagnosed with acute otitis media and prescribed amoxicillin twice daily. No missed doses. Starting 5/18 PM was noted to have erythematous patchy rash on trunk and lower extremities. 5/19 started with fever (102F rectal), rash spread to include larger erythematous patches with dusky centers. Patient was advised to stop amoxicillin after taking AM dose on 5/19, transitioned to azithromycin. 5/20 progression of rash to targetoid lesions. presented to ED on 5/21 with diffuse erythematous rash on trunk with some scattered macular areas on neck and extremities. Pt evaluated by pediatric infectious diseases and diagnosed with erythema multiforme, suspect related to amoxicillin. Patient treated with supportive care with full resolution of symptoms and discharge on 5/23/22.
presenting with fever, vomiting.  appetite change, chills, fatigue.  Positive for headaches.  Sepsis, COVID, pneumonia, intra-abdominal infection, metabolic derangement/dehydration, UTI, rule out neutropenic fever.  start albuterol PRN, robitussin PRN   -for now, empiric antibiotics with cefepime, flagyl
Itching  and red surrounding injection site.  Started 1 week after receiving shot.  Continuing since then.
On 05/30/21 I  woke up about 5am with chest pain, shortness of breath, palpitations, heart racing. Drove myself to the ER. Had EKG, labs done, Metoprolol given in ER. Was told I was in Afib.  I stayed in ER until shortly after 4pm. I saw Cardiology doctors and then given discharge instructions for a  follow up appt for Echo and cardiology doctor appt. Before leaving the ER I returned to normal sinus rhythm.
0200 Fri 29MAr fever inc 105, fever subsided 48 hrs post vax;
GARDASIL # 3 and Hepatitis A #2 given IM on left deltoid at 5:30 pm on 08-20-2010. 5 seconds after giving shots, patient had syncope (+) seizure like movement x 10 seconds- Patient with one jerking movement of upper extremity - patient was given the IM immunization seated on mother's lap - she hit the left side of the lap but did not have concussion/patient made to lie down pulse ox - monitoring (+) HR (+) BP - monitored - patient made to lie down and observed in office x one hour.
severe stomach pain; This is a spontaneous report from a contactable consumer (the patient's mother).  A 19-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced severe stomach pain on 06Apr2021 with outcome of not recovered. The reported event was considered an Important Medical Event.  The patient underwent lab tests and procedures which included blood test: on 10Apr2021 and  computerised tomogram: on 10Apr2021  .    Course of the event. The reporter stated that  her 19 year old son had his first vaccine on 01Apr2021, they didn't know anything and on 07Apr2021 he got severe stomach pain in the middle of the night. The reporter said they tried to self medicate, that maybe he was just dehydrated because he had been outside. The reporter says they went to the ER on 10APR2021 with the same pains but they couldn't find anything on the CAT scan. The reporter says they gave him something to relax his stomach, she can't remember what, and that it appeared to work but now he is off work with severe stomach pains. She says they changed what he ate, they are not sure what happened.  No follow-up attempts are needed. No further information is expected.
missed a dose, patient is four years old; patient is four years old, dose of 3 was on 9/25/2021; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included POLIOMYELITIS VACCINE INACTIVATED (IPV (INACTIVATED POLIO VACCINE)).   On 25th September 2021, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 25th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: Nurse reported that a patient missed a dose of Infanrix/ DTaP. The patient was four years old. The patient's last dose of DTaP and IPV  was on 25th September 2021. The physician heard that the patient should receive DTaP and IPV separately in this situation. The reporter did not consent to follow-up. No other information was provided.  Additional Supportive Information: The patient received 3rd dose at inappropriate age which led to inappropriate age at vaccine administration. The patient did not received 4th dose which led to incomplete course of vaccination.
Within one hour after vaccination a small area of erythema developed.  Over the course of the next 12 hours, erythema, warmth and edema progressed involving entire right upper arm from axilla to olecrenon.  Mom described arm as very firm. No associated fever, joint involvement or evidence of systemic illness.  Patient seen in PMD's office 48 hours later with area of erythema 10 x 13, nonindurated, blanching with no tenderness.  Mom reports significant improvement at that time.
DEAD; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnic origin. 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, and batch number and expiry date were not reported) 1 total, 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.  The reporter stated that, "my brother took their vaccine and was dead a few days later". On an unspecified date, the patient died. The cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220250755-COVID-19 VACCINE AD26.COV2.S-Dead. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Abcess at R arm injection site; redness, swelling, warmth, hard; treatment: Clindamycin
Patient had redness and swelling near injection site about five days after vaccine was given. Patient was seen by pediatric orthopedist who diagnosed him with an abscess, where they performed an incision and drainage of the abscess. The orthopedist also consulted the local infectious disease department.
Immediately after (approximately 3 hours), more pain than usual. Next day when I woke up couldn't move shoulder. Diagnosed now as a torn rotator cuff.
RASH, ITCHING, UNKNOWN IF RELATED TO VACCINE OR HOTEL STAY.
Patient used the restroom. After washing her hands and walking without assist, patient stated she felt like her blood pressure was really high - "like when I had a reaction to another medication." Patient was seated, VS taken Temp 98.3, O2 Sat 96%, patient was encouraged to hydrate given a water bottle. EMT arrived immediately on scene and took over. Vital sign monitored. After  few minutes, patient felt better and was discharged with a companion. Patient advised to seek medical consult as needed. VS at departure B/P 120/90, HR 86, O2 Sat 96%.
fast heartbeat, lightheaded, shakes, chills, felt like throat was closing. Gave patient diphenhydramine 50 mg and had her sit with her head down. Patient felt she was well enough to drive home and throat closing felt better.  Time course was over 1 hour.
Upper body rash, pounding and racing heartbeat. No prior heart or health issues. Now I'm having anxiety due to being forced to have second shot as a City employee.
No adverse events. Expired vaccine administered beyond use date/time (19.75 hours) outside of fridge temperature.
flushed face, faint feeling, swelling of lips, tongue and throat, itchy red skin, difficulty breathing and swallowing, dizziness, light-headedness, needed and epinephrine injection, ambulance, taken to emergency room stayed under observation for several hours. Benadryl for several days after, had relapse of same conditions after two days. After a couple of months, condition on leg developed known as Erythema nodosum, a type of panniculitis which is caused by an allergic reaction to medication; this condition continues to worsen
Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine since an unknown date. Concomitant products included NORTRIPTYLINE, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) and VITAMIN D NOS for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Lab tests were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed fever 101, went to ER, fever gone but had large local reaction rt deltoid, given VICODIN for pain, used ice, saw PCP 11/27/10, large local reaction, took anti-inflammatories ice initially then heat and rest reaction subsided, pain resolved.
This case was reported by a nurse and described the occurrence of generalized petechial rash in a 2-month-old pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. Concurrent vaccines/medications, concurrent medical conditions and medical history were not provided. On an unknown date, the pt received the 2nd dose of Pediarix (lot 21882B2). On an unspecified date post-immunization, the pt experienced a generalized petechial rash. The events were unresolved as of 10/03/2003.
Narrative:  71 YO male with PMH IPF s/p bilateral lung transplant in 2015, DM2, HTN, CAD, CKD who presented to ED on 02/22/22 with 3 days of cough,  fatigue, malaise, found to have COVID19 infection with hypoxia. Treated with supplemental oxygen, remdesivir 2/22-3/1 and dexamethasone 2/23-3/2. Given sotrovimab on 2/26/22. Pt improved and discharged to home on 3/2/22.
waves of nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of NAUSEA (waves of nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ASCORBIC ACID (VITAMINS C) for an unknown indication.    On 05-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced NAUSEA (waves of nausea). At the time of the report, NAUSEA (waves of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by reporter..
Approximately 2 inches from my injection site, I developed a blister.; This is a spontaneous report from a contactable nurse, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8725) via an unspecified route of administration in the right arm on 06Apr2021 at 16:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer, rheumatoid arthritis, COVID-19 and penicillin allergy. The patient previously received erythromycin (MANUFACTURER UNKNOWN), cephalosporins (MANUFACTURER UNKNOWN), for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 07Apr2021 at 09:30 the patient experienced blister approximately 2 inches from her injection site. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event  blister approximately 2 inches from her injection site was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Within 5-7 minutes of getting the vaccine, I felt a cold sensation in my brain followed by a tingly sensation in my face, sick on my stomach, dizziness and feeling faint. My husband told me to lean by in my chair, and I did. For a minute or two I felt slightly better, but then it started again; my stomach hurt, I felt dizzy and felt like I was going to faint. My husband got out of the car and went to get the paramedics. When they arrived, they asked me if I could walk to the tent. I knew I had to because I knew I was in trouble. When I got to the tent, I sat down and told the paramedics I was going to faint, and I did. When I regained consciousness, I threw up twice. The paramedics put a heart monitor on me, (from what my husband told me) they took my blood sugar, (I heard the paramedic say the result, and I told him I was not a diabetic). They put an IV in me, and gave me fluids, (from what my husband told me). They sent me by ambulance to ER. In the ED, I told the doctor what happened. She said what happened were not the side effects of the vaccine. After lying supine for sometime, I started to feel the same symptoms again; sick on my stomach, dizziness and feeling like I'm going to faint. I called out for someone. When the doctor came in, I told her I was starting feel the same way as before. She said my labs were great, and they were ready to discharge me; but I could stay if I wasn't ready to go. I told her I trusted her judgement, and was discharged. Throughout the day, I had the same symptoms, but did not faint again.
Fever: onset; 2-20-2020 st 9:30pm Slight headache onset 2-20-2021 at 10:00pm