chrisvoncsefalvay/vaers-outcomes huggingface dataset:
your head is bleeding; My wife heard my fall; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 08Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 for COVID-19 immunization and experienced fall, felt dizzy and cut on his head. On Tuesday, 16Feb2021, the patient went to bathroom and the patient next remembered he was on his bed (3 yards away). Patient's wife heard his fall and came into the bedroom and she said that patient's head is bleeding. He had no recollection of episode. EMT arrived and patient was hospitalized on 16Feb2021. 5 staples were put in his head in hospital. On Tuesday and Wednesday (16Feb2021 and 17Feb2021), scan of his head was done, loop recorder inserted in his chest, ultrasound of carotids, echo cardiogram and pharmacologic stress test were also performed. On Wednesday 17Feb2021 17:30, the patient discharged from hospital. On 24Feb2021, chest incision was checked by technician and on 02Mar2021, staples were removed in hospital. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
2x3 inch area of redness and itchiness around injection site. Somewhat tender. Heard its called "covid arm"
Two adverse reactions in a row of aches, pains, severe headache lasting 8 days. Also weakness
SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial unsolicited case received from a health care professional on 31 Jul 2017. This case involves six-patients (age and gender not reported) who were vaccinated with a dose of FLUZONE HD, and a dose of FLUZONE QIV (Batch numbers, expiry date, dose, dose in series, route, and site of administration were not reported for both vaccines) on an unspecified day in late Aug 2016. The medical history and concomitant medications of patients were not reported. On an unspecified day in May 2017, few months after the vaccination, the patients were diagnosed with influenza via nasal swab (which was positive) when presented with flu like symptoms. It was also reported as does not know if A or B strain or vaccine substrain. Patients were required to visit doctor or ER (emergency room). It was also a case of suspected vaccination failure. The patients' other relevant lab tests were not reported. Patients were treated with TAMIFLU. On an unknown date, all the patients were recovered from the events. Upon internal review the company decided to consider the case as serious due to important medical events influenza and vaccination failure. List of documents held by sender: none. Sender's Comments: 6 patients experienced influenza infection after vaccination with FLUZONE HD and FLUZONE QIV. Time to onset is too long and the dosage regimen followed by the patients is also not reported. Even though the event is listed post vaccination with the suspects it could not be confirmed if the strain responsible for infection was the same used in the vaccines. Therefore based upon the diagnosis made by nasal swab this was a case of suspected vaccination failure. More information regarding possibility of the patients getting infected via alternate sources should be requested. Also, information regarding patients dosage regimen and medical history should also be requested to help in assessment of this case. Based upon the reported information the role of the vaccine cannot be assessed.
Information has been received from a HCP concerning a 6 month old white male who on 05-JAN-2001 was vaccinated with a first dose of Comvax. Concomitant therapy included IPOL and Tripedia. On 05-JAN-2001 the pt developed a hard red lump in his thigh where Comvax was administered. Subsequently the pt recovered after 2 months. The reporter also reported that 6 other infants developed injection site pain, redness and swelling while vaccinated with Comvax. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, 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 SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed Shingles after receiving SHINGRIX. The pharmacist said that the patient did not receive vaccine at his facility, and did not have other details at time of initial report.
On the 8th day on 4/16/2021-Patient at noon notice red patches all over both legs, very itchy and few raised area.  Took benadryl by mouth at night.  Patient  states very uncomfortable at night.
Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab; Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shortness of breath. Previously administered products included for Atrial fibrillation: Diltiazem; for an unreported indication: PREDNISON ("burst" (one-week course)). Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL] and DULOXETINE HYDROCHLORIDE (DUAL [DULOXETINE HYDROCHLORIDE]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Stroke, at a dose of 1 dosage form and LISINOPRIL ongoing since an unknown date for Stroke, at a dose of 1 dosage form. At the time of the report, CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) and DYSPNOEA (Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now) outcome was unknown.            Patient stated that he was on one litter of oxygen (unknown flow rate). Patient stated the stroke affected his right "writing" hand. He reported that he had no history of heart problems prior to receiving the Moderna COVID-19 vaccine series   Action taken with mRNA-1273 in response to the events was not applicable.  Based on current available information and the temporal association between product use and the start date of the events which is greater than two (2) months a causal relationship is unlikely.   This case was linked to MOD-2021-238669 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events which is greater than two (2) months a causal relationship is unlikely.
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Adult female patient who was administered with only the diluent of PENTACEL without mixing it with the ACTHIB diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Lower eyelids were swollen; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SWELLING OF EYELID (Lower eyelids were swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for an unknown indication.     Concurrent medical conditions included Glaucoma. Concomitant products included BRIMONIDINE TARTRATE (ALPHAGAN) for Glaucoma.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced SWELLING OF EYELID (Lower eyelids were swollen). At the time of the report, SWELLING OF EYELID (Lower eyelids were swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the information provided, a strong temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded; Reporter's Comments: Based on the information provided, a strong temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded
Child received Hep A, PREVNAR, Hib, MMR, varicella on 6-22-11. Awoke at 6:00 am 6-23-11 with rash on body. "Low grade" fever per mom. Rash appears widespread on legs, arms, abdomen & per mom, child seemed uncomfortable, & scratched at it continuously. No meds given. Seen 6-23-11 by FNP, no problems with breathing reported. No anaphylaxis.
Pt received vaccine at 4 PM, he called the pharmacy at 5:30 PM stating that he thought he might be having a reaction to the vaccine. His head and arms were tingling, he was nauseated and felt clammy. He is a diabetic and has heart disease. He had not eaten since lunch and was unsure of his blood sugar reading or his blood pressure. His wife said she "felt it was one of his heart episodes and not related to the vaccine". He was going to go to the emergency room.
DEATHS; This spontaneous report received from a consumer via a company representative concerned 3 patients of unspecified sex, 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 administration not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported 1 total administered 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.  "It was reported that, on an unknown date, JNJ vaccine caused 3 known deaths". The patients died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event death was fatal This report was serious (Death).; Sender's Comments: V0: 20210936591-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Skin around the shot got inflamed, 2 days post administration. As per pt, almost like sunburn, sore, warmer than the rest of pt's skin.
Headache, chest discomfort located in the sternum and in between scapulas. Pain best described as the pain felt when you breathe cold air in too hard.
passed out; i may have had a TIA; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 11:15 (at the age of 59-year-old) at single dose for COVID-19 immunization. Medical history included high blood pressure. The patient had no known allergies. Concomitant medication included losartan. No other vaccine in four weeks. No COVID prior vaccination. On 19Mar2021 11:15 AM, the patient immediately passed out and was taken by ambulance to hospital. They said that he may have had a TIA (even though the CT scan and MRI were clean). The patient will not get the 2nd vaccine because of his reaction. The adverse events resulted in Emergency room/department or urgent care, Hospitalization. He was hospitalized on 19Mar2021. The patient had nasal swab test on 19Mar2021 with negative result. The patient received treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Head felt heavy/full/tingly starting about 6 pm on day of vaccination, fell asleep around 9:30 pm and woke up about 11 pm with left arm pain, very fatigued. Went back to sleep and woke up around 4 am with fever up to 100.6F, headache, muscle aches, joint pain, and extreme fatigue. My left axilla was swollen with arm pain to mid left chest and back, and my axillary lymph node was painful and swollen to about the size of a large grape. I took 440 mg of Aleve around 8:30 when the fever did not subside. The fever broke and did not return. I slept most of the day and was unable to work. My left axillary lymph node is still palpable as of today, 1/15.
Patient reported to be sore right after the injection. On June 24th, 3 days after the vaccination, patient swelling and redness at the site of injection and described it as big as the size of her palm. She also stated that it progressed to be itchy and hot when touched. Patient took a total 3 doses of 50 mg BENADRYL since June 24th to June 25th and patient had noticed a significant improvement with the swelling, redness, and itchiness. Patient will follow up and discuss this reaction furthermore with her doctor in August to consult about getting the second dose.
During the night of vaccine I wasn't feeling very well. The next day after my vaccine I woke up and knew I had a fever 101.2.  Insurance sent a kit so I got out this monitor and it showed a fever.  Body aches weren't too bad but I was really tired.  I was drinking  water and tea to stay hydrated.  Had fever for 1 day and a half.  Felt tired for full 2 days.  In bed most of the first day. Overall I was just really weak and tired. After the third day I started to feel much better.
abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN (abdominal pain). At the time of the report, ABDOMINAL PAIN (abdominal pain) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Normal soreness in the arm that was expected.  Pinky finger and ring finger on left arm was tingly as if numb and wrist became extremely sore.  Seven days later wrist is still extremely sore.  OTC pain medication does not help, nor does pain creams.
Client verbalized feeling lightheaded and heart racing.  Client was then evaluated by Fire Rescue and was observed additional 15 mins.  After 15 mins. re-evaluation, per Fire Rescue client symptoms resolved.  Client exit the facility at 11:45am.
pt recv vax 31OCT95 & 19MAY96 pt devel full blown chickenpox w/over 100 lesions;pt had a t102 & marked pruritus;
Information has been received from a physician concerning an infant who was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot number not reported). The physician reported that the infant subsequently developed GERD and irritability. Unspecified medical attention was sought. The physician recommended further testing for the GERD (not further specified). At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/10/2006.  Follow-up information has been received from a physician concerning a 15-week-old white male who on 07-JUL-2006, at 1000, was vaccinated PO with the first dose of ROTATEQ (Lot #653661/0138F).   Concomitant vaccinations administered on that same day and time included a dose of DAPTACEL, a dose of COMVAX, a dose of PREVNAR and a dose of IPOL.  Illness at the time of vaccination included nasal congestion.  The physician reported that on the night of 14-AUG-2006, the patient began crying.  On 31-AUG-2006, the patient was seen by the physician and was noted to have thrush and refusal to feed.  On 05-SEP-2005, the patient was crying and had difficulty eating.  On 13-SEP-2006, a diagnosis of GERD was made.  On 29-SEP-2006, a Barium swallow and upper GI series were both normal.  On 06-OCT-2006, a modified Barium swallow revealed that the patient had a disorganized suck-swallow (physician felt that this may have been present since birth as the patient's mother was unable to breast feed).  The physician felt that due to the patient's disorganized suck-swallow, her GERD was not related to ROTATEQ.  The patient improved with famotidine (MSD) and REGLAN.  It was also noted that the patient was only formula fed and had multiple changes in brand and type.  At the time of this report, the patient was recovering, but was noted not to be fully recovered.  Additional information has been requested.
Dermo diagnosed psoriasis  from head to ankles (including private parts!). No prior skin issues. Never had psoriasis before. Topical steroids prescribed for a month. Some relief - but not completely!
Breakthrough case admission after 3 vaccines Moderna 2/27/21 Lot# 030A21A;  Moderna 2/27/21 Lot# 010A21AQ;  Moderna 3/27/21 Lot# 018B21A
I received the first dose of the Pfizer Covid vaccine on Tuesday, December 22 at 0730 in my left deltoid muscle.  I felt fine that day - just some injection site soreness later that day that radiated to my left neck. On Wednesday, I experienced some fatigue, headache and moderate backache and neck ache which were all side effects that I expected. On Thursday, December 24 at approximately 1330, I experienced tingling of the tongue. It began at the tip of the tongue, but spread to the entire tongue over a five minute period. At the same time, my throat became scratchy/itchy.  I realized that this was an allergic reaction and took 2 25mg Benadryl capsules. The symptoms resolved in about 20 to 25 minutes. I never experienced trouble breathing, speaking or swallowing. I also reviewed everything that I ate, drank, etc. in the last 24-48 hours and there was nothing new.   About four hours later, I developed an intensely itchy rash. It began on my trunk, then spread to my bilateral upper extremities, then neck. My face and scalp also itched although they did not have a rash. My face was just red. There were no other symptoms. I took 2 more 25 mg Benadryl at this time. It took about 45 minutes or so for the symptoms to resolve this time. Since that time, I have experienced significant body aches and fatigue ( more than initially), mild headache and nausea.  Due to the holidays, I was unable to report this incident to employee health until this morning, Monday, December 28. I have received no further instructions.      On Friday, December 25, I noticed that I developed multiple apthous ulcers on my gums and hard palate. Since that day, I have experienced extreme fatigue, body aches and a mild persistent headache and nausea.
Fluad was given in the right arm in the upper portion and the pneumovax was given at approximately 2 inches below . Patient presented 4 days later with what appeared to be a skin infection. I recommended that she go to the urgent care immediately (6 doors down).
Redness around shot. Got pneumonia - was in the hospital 5 days. On 12/17/2016 I got a flu shot at pharmacy, they said I should get a pneumonia shot so I went back on 12/23/2016 for the pneumonia shot, my arm got a little red. By Thursday 12/29/2016 at about 4:30 in the afternoon I started feeling achy and cold chilled. On Friday I went to urgent care at about 4:30 and they checked me for the flu. I did not have the flu so they said if I did not feel better to come back. The next day I went back with a fever and a bad cough. They put me on a Z-PAK, a inhaler and cough medicine. I wasn't getting any better and couldn't get my temp below 103 so I went to the emergency room. They took an x-ray of my lungs and said I had pneumonia and since I was not getting better with the Z-PAK they admitted me to the hospital. I was given 3 antibiotics at a time through IV. Had to have another x-ray and a CT scan. I was in the hospital 5 days. I have been seeing a lung specialist and just had a follow up CT scan on 2/17/2017 and need to go back to Dr. on March 3rd. I haven't got my strength back to normal and still have a little cough. So I would say I had a reaction to the shot I got.
rash; round circle which was swollen, around the injection site; arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm soreness), RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 24-Feb-2021, the patient experienced RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site). On 13-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed antibiotics by her HCP but she did not take it.