chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIGHT EYE BLOODSHOT DUE TO A BLOOD VESSEL BURSTING IN THE EYE; BORDERLINE MIGRAINES; DIARRHEA; EXTREME ILLNESS FOR TWO WHOLE WEEKS; COULD NOT EVEN GET OUT OF BED FOR THE FIRST WEEK; This spontaneous report received from a consumer (daughter) concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery, and concurrent conditions included a little overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient had some alarming symptoms. She was extremely ill for two whole weeks. She was nauseous, vomiting, (subsumed under borderline migraine) had diarrhea and could not even get out of bed for the first week. After those extreme symptoms subsided she had one eye( her right eye) was completely bloodshot due to a blood vessel bursting in her eye. She called her primary care doctor and they told her that they were uncertain if that was even a symptom or not. She also had very painful headaches (subsumed under borderline migraine), borderline migraines and her primary care doctor told her that if it persisted or got any worse to go to the emergency room or possibly go in to the doctor's office. Reporter stated that blood clots were not something that really ran in their family bloodline. Patient hadn't had any real health problems other than having a hip replacement surgery and being a little overweight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from, diarrhea, extreme illness for two whole weeks, could not even get out of bed for the first week, and the outcome of right eye bloodshot due to a blood vessel bursting in the eye and borderline migraines, was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210532621-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Eye blood shot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported.   Information about lot/batch number has been requested.
Sore thoat, nausea, vomiting, cough, and runny nose
Approximately 15 minutes after vaccination patient experienced metallic taste in mouth, felt flushed, heart was racing, sweating, and felt clammy. He was taken to a room to lie down and he reports blood pressure was elevated at 152/110. He was given Benadryl and after approximately 45 minutes his blood pressure went back to normal and patient was feeling well enough to go home. Over the course of 24 hours after the vaccine he felt very achey and at one point had a fever of 103 degrees Fahrenheit, which lasted about 4-6 hours. Patient said he took Tylenol to help with these adverse effects but it did not help very much.  Around the injection site he had a bump the size of a ping pong ball and it was red and warm, but the bump completely went away by the fourth day after receiving the vaccine.
Took 3 of 4 doses. On day 3 a macular non-urticarial rash developed.
2 of her friends who took the vaccine got pancreatic cancer within 3 months after taking the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC CARCINOMA (medically significant), outcome "unknown", described as "2 of her friends who took the vaccine got pancreatic cancer within 3 months after taking the vaccine".  Clinical Course: Caller also mentions that she has not taken the Pfizer Covid 19 vaccine because she was fearful and because 2 of her friends who took the vaccine got pancreatic cancer within 3 months after taking the vaccine. Caller also mentions that her brother who got a dose of the vaccine experienced rashes. She asks if the Pfizer Covid 19 vaccine causes HIV and cancer (specifically pancreatic cancer).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201032212 same reporter/drug/AE, different patient;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced rash, injection site swelling, injection site erythema, injection site warmth, fever and shortness of breath. On 17th October 2018, the patient experienced injection site pain, driving ability disturbed, fatigue, muscle weakness and fuzzy. On 18th October 2018, the patient experienced unsteadiness. On 20th October 2018, the patient experienced pruritus. The patient was treated with Steroid Cream. On an unknown date, the outcome of the injection site pain, driving ability disturbed, fatigue, muscle weakness, rash, injection site swelling, injection site erythema, injection site warmth, pruritus, fever, shortness of breath, fuzzy and unsteadiness were unknown. It was unknown if the reporter considered the injection site pain, driving ability disturbed, fatigue, muscle weakness, rash, injection site swelling, injection site erythema, injection site warmth, pruritus, fever, shortness of breath, fuzzy and unsteadiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine at 13:30 PM. The patient experienced pain as the vaccine was administered. Around 4 PM, 2 hours and 30 minutes after receiving SHINGRIX, her head felt fuzzy and she was afraid to drive. Less than a day after receiving SHINGRIX, the patient experienced extreme fatigue and tiredness and muscle weakness. By 7 PM, she fell into a deep sleep and stayed in bed for about 3 hours. At 10:15 PM, she went to the restroom and went back to sleep. On Thursday, 1 day after receiving SHINGRIX, she was still fatigued with muscle weakness and felt wobbly. On Friday, 2 days after receiving SHINGRIX, the patient was still hurting and the injection site was red, hot and swollen. On Saturday, 3 days after receiving SHINGRIX, she had itching that spread around her upper arm. The patient had a rash that looked like chickenpox down her arm and legs down to her shins as well as on her face. Her dermatologist gave her a steroid cream. The heat had gone down a little. The patient had an appointment with her internist the day after reporting.
booster; experienced confusion; disorientation while driving.; Fugue state; slept for 4 hours; Extra dose administered; Off-label; This is a spontaneous report from a non-contactable consumer (Patient). A 61-years-old male patient received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: FC3182), via an unspecified route of administration on 17Aug2021 at 12:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had previously received first and second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not Known about allergies. On 18Aug2021, 12 hours post booster shot (third shot) experienced confusion and disorientation while driving. Fugue state.  Did not know my location, could not read the time of day correctly.  Pulled vehicle over and slept for 4 hours. Awakened oriented. I have no significant medical condition, do not drink or use drugs, had adequate sleep the night before, muscular build. Therapeutic measures were taken as a result of events. The outcome of the events was recovered confusion, disorientation, Fugue state, slept for 4 hours on an unknown date 2021 and unknown for other events.   No follow-up attempts are possible; No further information is expected.
no adverse event; patient was inadvertently given PREVNAR 20 at her local pharmacy when she requested the product VAXNEUVANCE; patient was inadvertently given PREVNAR 20 at her local pharmacy when she requested the product VAXNEUVANCE; This spontaneous report was received from a female consumer of unknown age reporting on herself. On 11-JAN-2023, the patient was inadvertently given pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) (dose, route and lot # not reported) when she requested pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). The patient stated she was high risk and she had already been vaccinated with pneumococcal vaccine conj 13v (crm197)) (PREVNAR 13) in the past, but she wanted pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) to be protected against the additional strains. She stated there was a confusion at the pharmacy she went to and they did not think they had pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and did not know what pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was so they gave her the pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) instead (Product confusion, Wrong product administered).
Tired, achy, headache, fever, chills, nausea, muscle aches, dizziness, couldn't lift arm past 90 degrees.  All symptoms showed up about 4 hours after shot (12 pm) and did not subside until about 1 pm Tuesday May 4th.
Narrative: 50 year old FEMALE presents today with chief complaint of feeling weak, with some dizziness immediately after receiving her first COVID 19 immunization today. Apparently, patient has multiple allergies to vaccinations such as rubella and smallpox. States she is having no difficulty in breathing, talking and swallowing. States she was cleared by her allergist for this vaccination.Benadryl 25 mg IMO 650 mg acetaminophen ordered for nausea and headache. Patient was monitored and observed for 2 hours on the observation area. The nausea, dizziness and headache improved significantly Discharged with instructions to call EMS if any shortness of breath, difficulty swallowing, swelling of the lips or throat occur. Follow-up with PCP
I received SHINGRIX injection 1 of 2 Friday night, had soreness in that arm which wasn't unexpected. On Monday (3 days after the injection) I developed redness and swelling in a large patch near the injection area on my left arm. The redness was present from Monday until Thursday evening and is finally almost back to normal - almost an entire week after receiving the vaccination.
Flare of rash typical of my autoimmune progesterone dermatitis diagnosis. I was diagnosed with APD several years ago and have since treated it effectively with hormonal birth control. This controls my flares/rashes. However tonight, 3 days post-vaccine, the rash is back.
pt recvd vax & later mom heard thump & pt was found in floor unconscious 1-2 mins, no sz; afebrile 28MAR94;
A few days after immunization 7/5/05, 4-5" round, red area L deltoid at site of injection (DPAT and HEP A)
Administration Error:  17 year old patient received a 1st dose Moderna (indicated at this time for 18 years and older).  No adverse effects were noted in the immediate observation phase.  Patient has not yet received dose #2, but we will recommended a second dose with Moderna per current recommendations.
After both Pfizer Covid vaccines and the most recent Moderna booster (October 28), I broke out in severe hives.  I after the first 2 vaccines in March & April, was treated with two rounds of steroids  and given ointments. The hives started subsiding 5 months  (September) after the 2nd shot .  Then hives came back 6 weeks after the Moderna booster, using ointments  but body had received too much steroids so was not prescribed it this time.
Pt felt nauseated and dizzy after receiving vaccine, one emesis , nausea and dizziness resolved, no further issues noted.
fainted when I sat down; stood up and started to feel dizzy; I felt throat pain like strep throat pain; started feeling very intensive cramps in my lower abdomen like very intense period cramps for about 10 minutes.; felt very weak with no energy to get out of bed; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3302) via an unspecified route of administration, administered on the right arm on 11Mar2021 16:00 at a single dose for COVID-19 immunisation. Medical history included low thyroid. There were no concomitant medications. After receiving the shot of the vaccine on 11Mar2021 16:00, the patient stood up and started to feel dizzy. She was able to find a nearby chair and fainted when she sat down. When she woke up seconds later of fainting, she felt throat pain like strep throat pain and then she started feeling very intensive cramps in her lower abdomen like very intense period cramps for about 10 minutes. The patient stated that nobody in the (Pharmacy name) was prepared to react to these symptoms and the rescue took too long to come in, when they came in she was feeling better and did not see the need of going to the hospital. But it was an immediate reaction that affected 3 different parts of her body that was very painful. During the day and the day after she felt very weak with no energy to get out of bed. "I am wondering if I can still receive the second dose after this reaction to the first dose?" No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a pharmacy drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
On 6/4/99, the pt woke up with 12 pustules. On 6/5/99, the pt developed a runny nose and continued to break out for a total of 25 pustules all confined to the lower trunk and diaper area and 3 on the legs. The pt was diagnosed with chicken pox. It had resolved on 6/6/99.
tested positive for covid-19 Fever, congestion and chest; tested positive for covid-19 Fever, congestion and chest; This is a spontaneous report from a contactable consumer (patient) reported that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: ER8729) as dose 1, single and dose 2 via an unspecified route of administration on 14May2021 (Batch/Lot Number: EW0171) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient is tested positive for covid-19 Fever, congestion and chest on 08Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Aug2021. The seriousness criteria was medically significant for the event covid-19. The event outcome was Unknown.  No follow-up attempts are possible. No further information is expected.
Pt arrived to observation area without difficulty. 1-2 mins later, Pt c/o generalized itching and hives noted lt arm and neck. EMS obtained vital signs HR 82, SPO2 96, RR 16, BP 112/76. Per EMS bilat lungs clear. Pt then begins audible wheezing.  Pt given epi 1mg IM to Rt deltoid. Pt also gave herself 2 puffs of her prescribed albuterol. Within 1min pt denies itching and audible wheezing stops. Pt states she feels much better, but complained of HA.Pt monitored for 30 mins and advised to go to ER for further monitoring. Pt denied wanting to be transported per EMS. Pt states husband will transport her to ER. Pt ambulatory to wheelchair, vitals per EMS HR 90, SPO2 97, RR 18.Pt advised of benefits of going to ER and risks of not. Pt verbalizes understanding and continued to state that husband will transport her, denying wanting EMS transport.
The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain; First dose on 14-MAY-2021/ patient didn't receive the 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain) and PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain). At the time of the report, PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain) had not resolved and PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Patient  saw a hematologist, the pain in her arm and leg was so great she thought it was thrombosis, but it was not. She is still has a lot of pain. On 29-Sep-2021 she has an appointment with a new GP since hers did not help her and said she should return in 6 months, she is also trying to see a neurologist.  she did not receive the 2nd dose.  Treatment information was not provided.
Injection reaction  with spreading redness, hard swelling, tenderness within 24 hours.  Headache day 2. Fatigue day 2. Asthma attack that was unexpected night of vaccine n.
Patients arm on 03/18/2013 was swollen, red and bruised.  Bruising look as if was residing.
Local swelling at site of DTaP, with hives and itch. No constitution symptoms. Responded to cool compress, po Benadryl. Discharged on Benadryl prescription. Will return.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 42 years and 6 months.  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.   It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.  No concomitant medications were reported.  The patient not had any adverse reactions and no reports of any reactions after the administration of vaccine. The patient got Moderna vaccine with Ndc code 80777027399.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown.  No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Case number PHEH2015US016860, is an initial spontaneous report from a physician received on 25 Aug 2015. This report refers to a patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with first dose of BEXSERO (batch number: not reported) on 27 Jul 2015. On 03 Aug 2015, the patient experienced ulcerative colitis and bloody stools. Final outcome, seriousness and causality were not reported. Seriousness of the event colitis ulcerative was upgraded based on Novartis Important Medical Events list.
I couldn?t lift my arm above shoulder height or laterally without extreme pain for the first few days. The pain lessened  for a day or two and then came back, but not as severe. It is uncomfortable to lift it even after applying heat and taking Extra strength Tylenol and Ibuprofen. It is keeping me awake at night and limiting movement in the upper right shoulder/bicep  area.
Mother reports temp of 103 degrees vomiting, diarrhea starting 12/29/08.  Seen at hospital on 1/1/09
Vaginal swelling, itching, rawness. Currently on 3-month course of antibiotic Clindamycin.   Note that this has not been determined to be an adverse event related to the Covid-19 vaccine but am reporting it on the chance there is a correlation.