chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 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. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore arm. This report was non-serious. This case, from the same reporter is linked to 20211232396.
General lethargy and sore shoulder started at day 1 and persisted through day 6. However, starting day 3, bilateral subjective tinnitus began with a high-pitch ringing in ears perceived around 12 kHz. This condition was most irritating in quiet rooms and when sleeping. Some days seemed that it was disappearing but then would come back. Eventually after about 6-7 weeks, this tinnitus was no longer noticeable.
Patient experienced adverse reaction to Hep A vaccine lot number 7439F EXP: 02/20/20, 1100 vitals BP:171/95 P:129, 1102 vitals BP:179/80 P:115 Note: Patient started feeling better, 1104 vitals SPO2: 100% Note: EPI PEN given 1104. EMS called 1104 C/O CP, 1106 vitals BP:166/73 P:110 RESP:20 SPO2:99% Note: Patient's chest feels better, 1110 vitals BP:172/104 P:96 SPO2:100%, 1112 NOTE: EMS arrived, 1113 NOTE: Patient transferred to emergency room.
She got her vaccine, first started to feel the lethargy.  Later in the night her arm started to burn, has had some problems with paresthesia's.  Then that went away and then her heart started to race, felt strange in her own body, her head felt light headed and she felt nausea.  She called the UC and they told her to come in.  They did 2 EKG's and asked to do another one.  The 2nd one they asked if she had had a heart attack or a cardiac arrest and they wanted her to go to the ER.  Her parents came to get her, they did blood work, EKG's and a chest x-ray and they want her to get a FU with a cardiologist.  This lasted for about 4-5 hours and then went away.    She went to medical Center.    She did not have any reactions like this with the other vaccines, the last one just no energy.
Covid 19 positive. Mild case- only needed to speak with MD on the phone. No live office visit required.
Systemic: Abdominal Pain-Medium, Systemic: swollen lymph nodes under left arm pit-Medium, Additional Details: patient also reported what she describes as menstrual cramping - though she is post menopausal.  asked if ab pain upon exam was attributed to enlarged spleen - md didn't because pt followed up with gynecologist who stated that they have seen causes of menstrual like pain in their post menopausal women.  still dealing with slight pain - fu with me again - patient chose to get second dose
pt experienced pain at injection site , fatigue, general pain all over the body.  pt made repeated trips to er on 5/4/2021, 5/10/2021 and 5/14/2021 pt saw pcp on 5/14 . pt tried naproxen, cyclobenzaprine and methylprednisolone dose pack symptoms have not resolved pt lost job as a result of missed work.. and is awaiting test for nerve conduction.
Husband states that 3 days after administration of travel vaccines pt. experienced tingling in feet and legs, leading to progressive paralysis up the body. Diagnosed as Guillain-Barre' syndrome. Pt. being treated at hospital.
ON 2/27/2020 1 DAY AFTER THE IMZ THE PT REPORTED EXTREME MALAISE ALLDAY, PAIN, SWELLING, AND HOT TO TOUCH AT THE INJECTION SITE. PATIENT WAS ADVISED TO TAKE IBUPROFEN AND USE A COLD COMPRESSION ON ARM
Stomach didn't feel really well; vomiting and diarrhea until 9PM that night off and on; vomiting and diarrhea until 9PM that night off and on; a little nauseated; developed a strange type of headache on one side of head; strange headache went into ear; strange headache went into jaw; felt very weak every day,Was "whipped" since then/ Felt very weak every day; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (strange headache went into ear), PAIN IN JAW (strange headache went into jaw), ABDOMINAL DISCOMFORT (Stomach didn't feel really well), ASTHENIA (felt very weak every day,Was "whipped" since then/ Felt very weak every day) and DIARRHOEA (vomiting and diarrhea until 9PM that night off and on) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE) and METOPROLOL for Blood pressure management, FENOFIBRATE, MIRABEGRON (MYRBETRIQ) and GABAPENTIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (felt very weak every day,Was "whipped" since then/ Felt very weak every day). On 23-Nov-2021, the patient experienced EAR PAIN (strange headache went into ear), PAIN IN JAW (strange headache went into jaw) and HEADACHE (developed a strange type of headache on one side of head). On 24-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach didn't feel really well), DIARRHOEA (vomiting and diarrhea until 9PM that night off and on), VOMITING (vomiting and diarrhea until 9PM that night off and on) and NAUSEA (a little nauseated). On 24-Nov-2021, DIARRHOEA (vomiting and diarrhea until 9PM that night off and on) and VOMITING (vomiting and diarrhea until 9PM that night off and on) had resolved. On 26-Nov-2021, NAUSEA (a little nauseated) had resolved. At the time of the report, EAR PAIN (strange headache went into ear), PAIN IN JAW (strange headache went into jaw), ABDOMINAL DISCOMFORT (Stomach didn't feel really well), ASTHENIA (felt very weak every day,Was "whipped" since then/ Felt very weak every day) and HEADACHE (developed a strange type of headache on one side of head) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included supplements for an unknown indication.  Patient did not use any treatment for her symptoms and consumed fluids until Friday morning (26Nov2021). Patient reported that on the day of the report, she felt almost human again.
Admitted on 8/1/21. Received J&J vaccine on 1/23/21. Patient presents with SOB that started that morning. Diagnosed with acute respiratory failure with hypoxia and hypercapnea and COVID pneumonia. Treated with COVID protocol, steroids, antibiotics and remdesivir. Patient improved and was transferred to a rehab facility on 8/9/21.
pt recv vax;started w/ n&v;rash around scrotum;small sz;large sz w/ stopping of breathing;T of 103;lethargy;
Patient received vaccine on 10-6-08 at about 11:30am. Later in the evening hives developed all over her body. She called the pharmacy on Wednesday, at that time the hives were still present, but were not as severe as on Tuesday. She came into the pharmacy on Thursday morning (10-9-08) to show us her hives and ask about management and how long the reaction could last.
Expired vaccine administered; This case was reported by a nurse via patient support programs and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7VA99, expiry date unknown) for prophylaxis.   On 13th December 2022, the patient received Havrix. On 13th December 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-Dec-2022 and 16-Dec-2022 Reporter's comment: The patient was not experiencing any symptoms, but the reporter wanted to see if the patient should come in to the office to be seen/treated. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Flank pain began 1 week after shingles vaccine and shingles rash began in area of pain 9 days after vaccine.
Pale, limp w/fever 102.8F 2 hrs post inject; Whined through the night; Fine next morning; Similar episode w/2nd shot but not to the same extent; Was in for recurrent ear infect;
after receiving the Shingrix injection, they did not feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable. The reporter stated that she had heard other people say that after receiving the Shingrix injection, they did not feel well.  No additional information was provided. The reporter did not consent to follow up.
Swelling and redness on left upper arm measuring 14/5 cm by 9 cm.
Pt. states that after receiving the 3rd dose of Pfizer 01/26/2022, started experiencing symptoms that evening of vomiting (2hrs), rash developing throughout the body, and "bitter" taste. Transported to Emergency department for treatment, treated with 2 Epi-Pens (symptoms subsided). Discharged with Zofran and 1 Epi-Pen for self-treatment. No noted Primary visit/communications.
Chills, arm pain, slight headache but only lasted a few hours - less than 24 hours
Noticed softball sized swelling at injection site. Itchy, hot, painful at 10/26. Only local reaction. Pt taking BENADRYL, using ice on site.
about 1PM 3NOV94 pt devel swelling & redness about the eyes w/some itching; also exp generalized myalgia, arthralgia & malaise; tx was rest-no medications; sx resolved w/in 1-2 days;
seizures; This is a spontaneous report from a contactable consumer (Patient's husband).   A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 70-year-old via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Lot Number: EN6203) as single dose, second dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Lot Number: EN8727) as single dose both for covid-19 immunisation.  Medical history included High blood pressure, atrial fibrillation. No family medical history. No prior vaccination within 4 weeks. Ongoing Concomitant medications included rivaroxaban (XARELTO); losartan taken for hypertension; hydrochlorothiazide taken for blood pressure abnormal, fluid imbalance; diltiazem hydrochloride (CARTIA XT) taken for atrial fibrillation; loratadine.  After the first shot, about a week and a half later, she started having seizures in Mar2021. Since the second shot, it had gotten worse. The event resulted in Emergency Room visit. She was taken in twice. The first time, she was in the hospital for 4 days. This occurred last month, in Mar2021. After the second dose, she had been hospitalized, the end of March, almost April. They took her twice. The first time, they did a bunch of tests and were questioning seizure or a stroke. At the end, they thought it was a seizure. She then came home and had it worse. They put her on medication. The patient underwent lab tests and procedures which included tests: all were negative, computerised tomogram: unknown results, electroencephalogram: unknown results, magnetic resonance imaging: unknown results all in Mar2021.  The events outcome was not recovered.
Pt recevied J and J vaccine on 4/12/21 and Moderna 11/9/21 and came to clinic for the bivalent Pfizer vaccine on 10/18/22. Due to mix up of the Pfizer monovalent and bivalent vaccine- she may have gotten either the monovalent or bivalent Pfizer vaccine. She has some pain and swelling of the upper arm
Exactly 48 hours after receiving the first of 2 injections of the new shingles vaccine, patient suffered a mini-stroke that left his right side very weak. MRI showed it was near the left lobe of the thalamus. By 9/29/18, injection site and upper arm swelled to twice it normal size lasting 4 days with a significant bruise and a lot of pain.
I have had migraines every single day since my first, which worsened with the second.; This is a spontaneous report received from a Pfizer Sponsored Program Pfizer.com - General Company Information. A contactable consumer reported that a patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose and second dose via an unspecified route of administration on an unspecified date (BNT162B2, solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient have had migraines every single day since first, which worsened with the second on an unspecified date in 2021. The outcome of event was unknown.   Information about batch/lot number has been requested.
Case previously recorded as MA2009-5674. Initial case report received via healthcare professional on 20 Nov 2009. An 8-year-old female child was vaccinated with S-OIV FLUVIRIN (batch no. 1008145P) on 16 Nov 2009. The recommended age is 4+. No adverse events reported. Company reference no.: NA09-008579.
The patient reported he got the second of 2 SHINGRIX vaccines on 2/9/19 at Pharmacy. I do not have the specifics for lot number. He presented to me for F/U of URI symptoms on 2/25/19 and I noted a blister above his left lip and near left nares. On further review he had a cluster of 3 blisters to the left eye on the lateral aspect. I brought that to his attention, he referred to them as "cold sores" and noted them first on 2/20/19. There was mild pain, no vision changes. He was outside of the 72 hr window for antivirals. He had some mild discomfort at the site but was not terribly bothered by the lesions. I was concerned given this occurred within 10-11 days of the date he had the second SHINGIX vaccine. I am not clear if the 2 are related, but I am concerned about the timing.
Swelling and knot at injection site, sporadic soreness in joints on arm and back(spine)adjacent to injection site, Headache,Diarrhea
3/18/21, Day after Vaccine,  drowzy in the morning, around 12:00 p.m. I had a brief period of incoherent speach and a few moments of having trouble putting sentences together. Around 2:00 a moment of temporary blindness in my left eye.  03/19/21 -03/20/21, extreme fatigue, stayed in bed.   03/21/21, fatigue, light-headed, slightly dizzy 03/22/21, right side leg and arm became numb as if asleep. Went to Hospital Emergency. I had a stroke, had a Carotid Endarterectomy at medical center, was in the Hospital for 5 days, two weeks after surgery became seriously enemic and d_Dimers are still elevated THE CONTINUATION PAGE IS INOPT. AND WOULD HAVE LIKED TO EXPLAIN IN FURTHER DETAIL.
12/6/11 - Pt called & said arm where injection very sore & had 2 shots in arm - 1 in injection size & 1 below - very warm & sore. - Pt came into pharmacy tonight & had gone to any ARNP - said she had infection at injection site. Started on antibiotics.
Patient got the injection and quickly developed a fever and felt weak.  Family was contacted and he was sent to Hospital.
The pt describes feeling hyper then having trouble breathing in the evening. She called the ER, they advised her to take Benadryl. She did and it relieved the symptoms.
Has chronic condition of AFIB that was controlled for 3 years prior to vaccine  within 1 month of getting vaccine started having signs of AFIB coinciding with his exercises and it has become more pronounced since then, has seen a doctor 2 times since this started, was told to continue to monitor be sure to hydrate well, and  if get worse call doctor.
Patient fainted after the 15 minute wait time when walking to the car in the parking lot then again when in the car. After eating a snack, patient felt better.
Patient presented to health department to receive J&J covid vaccine. She told the clerk that this would be her first dose. The nurse verified with the patient that this was a first dose vaccine while reviewing all paperwork. J&J vaccine administered. The nurse was submitting the information into web roster and noted what she thought to be an error on the patient's social security number. The nurse went to verify the correct social  and noticed that a pfizer vaccine was documented for this same patient on this same day. The nurse then questioned the patient asking if the patient received a pfizer dose at the location documented and the patient stated "no." The nurse responded " ok, that's fine. I will just notify the location and let them know that they documented in error." the patient responded "I lied. I went this morning and got it at walmart" the patient then elaborated that she would not have time to receive the second dose before leaving for her cruise, so she came here to receive the J&J. Nurse manager notified as well as the district medical director. Patient observed for 15 min- no signs and symptoms or adverse events noted.
pt recvd 3 doses of Engerix-B & have not responded; titers were checked 6 wks p/vax series completed; 1 booster dose was given; titers will be re-checked in 6 wks; 2 pts have recvd 6 doses & still not responded;
Tiredness; left ear ache; This is a spontaneous report from a contactable consumer (patient's daughter).   An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 20Apr2021 14:00 at the age of 84-years-old (Batch/Lot Number: Not Provided) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient had the vaccine yesterday on 20Apr2021 and was having side effects. She wanted to go over the side effects and what to do. It was for the Pfizer Coronavirus vaccine. Stated that this was her first dose. Stated that she was sleeping, having tiredness and ear ache in Apr2021. Stated that she got the vaccine at 2pm. Stated that she looked at list of symptoms and has never had ear aches. Wanted to know if ear aches was part of it and what to do about it. Stated that the ear ache was for her left ear. Stated that she received the vaccine on the right. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
two short waves of numbness through his body; This is a spontaneous report received from a non-contactable consumer patient of unspecified age and gender received first dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced two short waves of numbness through his body on 15Apr2021. The outcome of the events was unknown. The patient was suggested to followup with MD if symptoms return.  No follow-up attempts are needed. No further information is expected.
Patient developed severe urticaria 10 minutes after her vaccines.  She was immediately given 20 mg of Benadryl po.  No respiratory distress at any time.  She continued to have urticaria and was given 15 mg sc of epinepherine.  The symptoms subsided and the patient was being transported to the ED.  She then at about 20 minutes post dose developed symptoms again.  911 was called and she was brought to the ED via ambulance.  No wheezing or respiratory distress.
Nerve pain in left leg. Moves around. Sometimes it is in the ankle area, sometimes below knee, sometimes lateral side of calf, sometimes groin, sometimes lateral side of thigh. It is never in the joints. Sometimes stabbing pain, sometimes sharp ache, sometimes dull ache, sometimes searing pain or burning, sometimes icy cold. Sometimes it is mild 2 or 3/10; sometimes medium 5 or 6/10 at times it has been at least 9/10. It can feel good one minute and then be very painful without any movement or other change in position within 10 minutes. Sometimes responds well to NSAIDs, sometimes it does not. Almost always feels better in the AM before getting out of bed. Can be very painful within minutes of getting out of bed.
On Right arm, inside, halfway between elbow and wrist, patient noticed six tiny, raised fluid filled bumps. Redness in the area, swelling and itchy.
Increase in myoclonic like activity. Child has having episodes before the vaccines but had a noticeable increase. Differential diagnosis per Hospital include Sandifer Syndrome, reflux, myoclonic jerk, infantile spasm. Patient is responsive during episodes and no postictal phase per the hospitalist. Referred to neurology for further evaluation and advised to go to the ER if anything changes.
Nausea; Headache; Fever of 100.4 degree F; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 100.4 degree F) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL and CLOPIDOGREL for an unknown indication.    On 17-Feb-1971, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 100.4 degree F). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 100.4 degree F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 100.4 degrees f abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was taken by the patient.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.